1. EWING, N.J., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that Robert F. Apple, President and Chief Executive Officer, will participate and host investor meetings at the H.C. Wainwright 23rd Annual Global Investment Conference being held on September 13-15, 2021.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development…

    EWING, N.J., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that Robert F. Apple, President and Chief Executive Officer, will participate and host investor meetings at the H.C. Wainwright 23rd Annual Global Investment Conference being held on September 13-15, 2021.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; future prescriptions and sales of OTREXUP®; successful commercialization of NOCDURNA® in the U.S. and market acceptance and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the FDA letter seeking withdrawal, the outcome of the FDA hearing and whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; Teva's ability to successfully commercialize generic teriparatide in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 trial of the drug device combination product for selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; the timing and results of the clinical development program for ATRS-1902 adrenal crisis rescue auto-injector, future NDA submission and FDA approval of the same, and if approved, future market acceptance and revenue for the same; FDA approval of Teva's ANDAs for both generic Forteo® and Byetta® and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including the Company's urology assets in development as well as Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com



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  2. Increased Revenue 39% Year-Over-Year to $45.0 Million

    Doubled Net Income to $4.4 Million, or $0.03 Per Basic and Diluted Earnings Per Share

    EWING, N.J., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today reported financial and operating results for the second quarter ended June 30, 2021 with record revenue of $45.0 million and net income of $4.4 million, or $0.03 per basic and diluted earnings per share.

    Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, "We believe our strong second quarter performance highlights the growth opportunities that prevail across our diversified business. XYOSTED and Teva's generic EpiPen continue…

    Increased Revenue 39% Year-Over-Year to $45.0 Million

    Doubled Net Income to $4.4 Million, or $0.03 Per Basic and Diluted Earnings Per Share

    EWING, N.J., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today reported financial and operating results for the second quarter ended June 30, 2021 with record revenue of $45.0 million and net income of $4.4 million, or $0.03 per basic and diluted earnings per share.

    Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, "We believe our strong second quarter performance highlights the growth opportunities that prevail across our diversified business. XYOSTED and Teva's generic EpiPen continue to be the primary drivers of our 39% year-over-year revenue increase and we continue to expect our full year revenue guidance to be in the range of $175-200 million. As we look ahead, we expect the advancement of our proprietary pipeline as well as our partner's programs to support our future growth. With the unveiling of ATRS-1902 as hydrocortisone with a new autoinjector platform for adrenal crisis rescue, we are eager to initiate the PK study following the FDA's recent acceptance of our IND submission. With our Quickshot autoinjector, we are also excited for our partner Idorsia's initiation of their global Phase 3 study for selatogrel as a heart attack rescue pen as well as the potential NDA filing of Pfizer's undisclosed rescue pen in the second half of 2021. Overall, we believe the diversification of our business remains foundational to our ongoing success."

    Second Quarter 2021 and Recent Highlights

    • XYOSTED® total prescriptions in the second quarter 2021 increased 50% year-over-year and 15% sequentially from first quarter 2021, according to IQVIA.



    • Teva's generic EpiPen prescriptions increased 153% year-over-year, contributing to a 47% increase in EpiPen product and royalty revenue



    • Submitted the IND and received FDA acceptance for ATRS-1902 for adrenal crisis rescue



    • Partner Idorsia Ltd initiating global Phase 3 study with selatogrel for acute myocardial infarction



    • Completed $15.0 million principal pre-payment of Hercules term loan and reduced associated interest expense by $1.2 million annually

    Second Quarter 2021 Financial Results

    Total revenue generated from product sales, license and development activities and royalties was $45.0 million for the three months ended June 30, 2021, a 39% increase compared to $32.4 million in the same period in 2020. For the six months ended June 30, 2021, total revenue was $87.1 million, a 33% increase from $65.5 million for the comparable period in 2020.

    Product sales were $27.9 million for the three months ended June 30, 2021, a 13% increase compared to $24.7 million for the same period in 2020. For the six months ended June 30, 2021, product sales were $57.0 million, a 10% increase from $51.8 million in the comparable period in 2020.   

    Sales of our proprietary products XYOSTED®, OTREXUP® and NOCDURNA® generated revenue of $19.0 million and $37.7 million for the three and six months ended June 30, 2021, respectively, as compared to $14.8 million and $27.4 million for the three and six months ended June 30, 2020, respectively. The 28% and 37% increase in proprietary product sales for the three and six months ended June 30, 2021, respectively, compared to the same periods in 2020 were principally attributable to continued growth in prescriptions and sales of XYOSTED®.

    Partnered product sales were $9.0 million and $19.4 million for the three and six months ended June 30, 2021, respectively, as compared to $9.8 million and $24.4 million for the three and six months ended June 30, 2020, respectively. The net decrease in sales of partnered products for the second quarter and six months ended June 30, 2021 as compared to the same periods in 2020 is primarily attributable to a decrease in sales of sumatriptan to Teva and Makena® autoinjectors to AMAG.

    Licensing and development revenue was $7.2 million and $12.2 million for the three and six month ended June 30, 2021, respectively, as compared to $2.7 million and $4.4 million for the comparable periods in 2020, respectively. The increase in licensing and development revenue for the three and six months ended June 30, 2021 was primarily a result of incremental development and maintenance activities with Teva and our other ongoing partnered development projects.

    Royalty revenue was $9.9 million for the three months ended June 30, 2021 compared to $5.0 million for the same period in 2020. For the six months ended June 30, 2021, royalty revenue was $17.9 million, as compared to $9.3 million for the same period in 2020. The net increase in royalty revenue in the three and six months ended June 30, 2021 was attributable to an increase in royalties from Teva on their net sales of generic EpiPen®.

    Research and development expenses were $4.0 million and $6.7 million for the three and six months ended June 30, 2021, respectively, as compared to $2.4 million and $5.4 million for the comparable periods in 2020, respectively. The increase in research and development costs incurred in 2021 as compared to 2020 was attributable to our ongoing internal development programs.

    Selling, general and administrative expenses were $17.7 million and $35.3 million for the three and six months ended June 30, 2021, respectively, as compared to $14.4 million and $30.9 million for the comparable periods in 2020, respectively. The net increase in selling, general and administrative expenses for the three and six months ended June 30, 2021 was primarily due to an increase in sales and marketing expenses that had declined during the pandemic and incremental costs associated with NOCDURNA®. General and administrative expenses increased due to increases in compensation and professional services.

    Net income was $4.4 million, or $0.03 per basic and diluted earnings per share for the second quarter 2021, compared to $2.2 million, or $0.01 per basic and diluted earnings per share in the same period in 2020. Net income was $8.2 million, or $0.05 per basic and diluted earnings per share for the six months ended June 30, 2021 compared to a net loss of $0.2 million, or $0.00 loss per basic and diluted earnings per share in the comparable period of 2020.

    As of June 30, 2021, cash and cash equivalents were $45.1 million compared to $53.1 million as of December 31, 2020. In June 2021, Antares made a $15.0 million principal prepayment and reduced our loan balance with Hercules Capital to $25.0 million. The Company generated cash from operations of $8.4 million for the six months ended June 30, 2021.

    Full-Year 2021 Financial Guidance

    The Company today reaffirmed full-year 2021 revenue guidance in the range of $175-200 million, which represents a 17% to 34% year-over-year growth rate and assumes no significant disruptions to supply or operations due to the ongoing COVID-19 pandemic.

    Webcast and Conference Call Information

    The Antares management team will provide a Company update and review the second quarter and year-to-date financial results via conference call and webcast today, August 5, 2021, at 8:30am ET (Eastern Time). The webcast of the conference call will include a slide presentation, which can be accessed in the investor relations section of the Company's website (www.antarespharma.com) under "Webcasts & Presentations". Alternatively, callers may participate in the audio portion of the conference call by dialing (800) 367-2403 for domestic callers and (334) 777-6978 for international callers. Callers should reference the Antares Pharma conference call or conference ID number 3020992.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; future prescriptions and sales of OTREXUP®; successful commercialization of NOCDURNA® in the U.S. and market acceptance and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; Teva's ability to successfully commercialize generic teriparatide in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 trial of the drug device combination product for selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; the timing and results of the clinical development program for ATRS-1902 adrenal crisis rescue auto-injector, future NDA submission and FDA approval of the same, and if approved, future market acceptance and revenue for the same; FDA approval of Teva's ANDAs for both generic Forteo® and Byetta® and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including the Company's urology assets in development as well as Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com

    TABLES FOLLOW

    ANTARES PHARMA, INC.

    Table 1 - CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)

    (unaudited)

      Three Months Ended     Six Months Ended    
      June 30,  Increase June 30,  Increase
      2021  2020  (Decrease) 2021  2020  (Decrease)
    Revenue:                      
    Product sales $27,904  $24,665  13% $57,039  $51,762  10%
    Development and licensing revenue  7,167   2,687  167%  12,151   4,442  174%
    Royalties  9,907   5,032  97%  17,871   9,259  93%
    Total revenue  44,978   32,384  39%  87,061   65,463  33%
    Operating expenses:                      
    Cost of product sales  11,630   10,927  6%  24,128   24,941  (3)%
    Cost of development revenue  4,810   1,550  210%  8,757   2,583  239%
    Research and development  4,047   2,417  67%  6,687   5,398  24%
    Selling, general and administrative  17,704   14,448  23%  35,311   30,870  14%
    Total operating expenses  38,191   29,342  30%  74,883   63,792  17%
    Operating income  6,787   3,042  123%  12,178   1,671  629%
    Other expense  (1,224)  (867) 41%  (2,232)  (1,852) 21%
    Net income (loss) before income taxes  5,563   2,175  156%  9,946   (181) **
    Income tax expense  (1,143)    **  (1,733)    **
    Net income (loss) $4,420  $2,175  103% $8,213  $(181) **
    Net income (loss) per common share, basic $0.03  $0.01     $0.05  $(0.00)   
    Net income (loss) per common share, diluted $0.03  $0.01     $0.05  $(0.00)   
    Weighted average common shares outstanding,                      
    Basic  169,043   165,703      168,436   165,566    
    Diluted  174,813   169,228      174,851   165,566    
                           

    ANTARES PHARMA, INC.

    Table 2 – CONSOLIDATED REVENUE DETAILS

    (in thousands)

    (unaudited)

      Three Months Ended    Six Months Ended   
      June 30,  Increase June 30,  Increase
      2021  2020  (Decrease) 2021  2020  (Decrease)
    Proprietary product sales:                     
    XYOSTED® $14,739  $10,902  35%  $29,128  $19,905  46% 
    OTREXUP®  3,426   3,944  (13)%   6,994   7,507  (7)% 
    NOCDURNA®  788     100%   1,563      100% 
    Total proprietary product sales  18,953   14,846  28%   37,685   27,412  37% 
    Partnered product sales  8,951   9,819  (9)%   19,354   24,350  (21)% 
    Total product sales  27,904   24,665  13%   57,039   51,762  10% 
    Development and licensing revenue  7,167   2,687  167%   12,151   4,442  174% 
    Royalties  9,907   5,032  97%   17,871   9,259  93% 
    Total revenue $44,978  $32,384  39%  $87,061  $65,463  33% 
                          

    ANTARES PHARMA, INC.

    Table 3 – CONSOLIDATED CONDENSED BALANCE SHEETS

    (in thousands)

    (unaudited)

      June 30,  December 31, 
      2021  2020 
    Assets        
    Cash and cash equivalents $45,126  $53,137 
    Accounts receivable  54,224   42,221 
    Inventories  18,644   18,216 
    Contract assets  5,725   8,140 
    Prepaids and other current assets  4,244   4,877 
    Property and equipment, net  25,590   24,020 
    Deferred tax assets  45,249   46,982 
    Other assets  13,817   14,938 
    Total Assets $212,619  $212,531 
             
    Liabilities and Stockholders' Equity        
    Accounts payable and accrued expenses $46,487  $43,032 
    Long-term debt  26,151   40,899 
    Other liabilities  7,953   9,485 
    Stockholders' equity  132,028   119,115 
    Total Liabilities and Stockholders' Equity $212,619  $212,531 
             



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  3. EWING, N.J., July 28, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced it will release its second quarter 2021 financial and operating results on Thursday, August 5, 2021, before the market opens.

    Antares will host a conference call on Thursday, August 5, 2021 at 8:30am ET to discuss the results. The dial-in numbers are (800) 367-2403 for domestic callers and (334) 777-6978 for international callers. The conference ID number is 3020992. A live webcast and replay of the conference call will be available online from the investor relations section of the Antares Pharma corporate website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty…

    EWING, N.J., July 28, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced it will release its second quarter 2021 financial and operating results on Thursday, August 5, 2021, before the market opens.

    Antares will host a conference call on Thursday, August 5, 2021 at 8:30am ET to discuss the results. The dial-in numbers are (800) 367-2403 for domestic callers and (334) 777-6978 for international callers. The conference ID number is 3020992. A live webcast and replay of the conference call will be available online from the investor relations section of the Antares Pharma corporate website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; future prescriptions and sales of OTREXUP®; successful commercialization of NOCDURNA® in the U.S. and market acceptance and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; Teva's ability to successfully commercialize generic teriparatide in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 trial of the drug device combination product for selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; the timing and results of the clinical development program for ATRS-1902 adrenal crisis rescue auto-injector, future NDA submission and FDA approval of the same, and if approved, future market acceptance and revenue for the same; FDA approval of Teva's ANDAs for both generic Forteo® and Byetta® and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including the Company's endocrinology and urology assets in development as well as Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com 



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  4. EWING, N.J., July 22, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug Application (IND) for ATRS-1902 for adrenal crisis rescue. The active IND enables Antares to initiate a Phase 1 clinical study for ATRS-1902 for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver hydrocortisone.

    "The FDA acceptance of this IND is an important milestone in the development of a novel formulation and delivery of hydrocortisone in a crisis situation. We believe acute adrenal insufficiency…

    EWING, N.J., July 22, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug Application (IND) for ATRS-1902 for adrenal crisis rescue. The active IND enables Antares to initiate a Phase 1 clinical study for ATRS-1902 for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver hydrocortisone.

    "The FDA acceptance of this IND is an important milestone in the development of a novel formulation and delivery of hydrocortisone in a crisis situation. We believe acute adrenal insufficiency is a medical emergency which would benefit from a simplified and readily-available way to administer an essential treatment during a possibly life-threatening situation," commented Dr. Peter Richardson, MRCP (UK), EVP, Research and Development and Chief Medical Officer of Antares Pharma.

    Adrenal crisis is a potentially fatal condition associated mainly with an acute deficiency of cortisol, which is a hormone produced and released by the adrenal gland, and commonly occurs in patients with long-term adrenal insufficiency. Current standard of care for the management of acute adrenal crises includes Solu-Cortef®, which is an anti-inflammatory glucocorticoid. With hydrocortisone sodium succinate as the active ingredient, Solu-Cortef® is provided as a sterile powder that needs to be reconstituted for intravenous or intramuscular injection and can represent a potentially time-consuming and cumbersome injection process, particularly challenging in a crisis situation.

    Robert F. Apple, President and Chief Executive Officer of Antares Pharma, added, "We are pleased to be able to advance the development of our proprietary pipeline with the FDA acceptance of this IND. With a novel expansion to our device technology platform, we hope to enhance the clinical benefit and offer key advantages to this important patient population at a critical time. We also look forward to the opportunity to leverage the success that our commercial team continues to garner with XYOSTED to ATRS-1902, as both products have an endocrinology call point. We are excited to continue to invest in our proprietary pipeline to support our potential future growth."

    The IND application for ATRS-1902 includes a protocol for an initial clinical study to compare the pharmacokinetic (PK) profile of the Company's novel formulation of hydrocortisone versus Solu-Cortef®, which is expected to initiate in 2H 2021. Assuming this study is completed successfully, a second study will then be conducted utilizing Antares' proprietary auto-injector technology which has been developed to provide reliability and ease-of-use in emergency situations by the patient or caregiver. We believe these two studies will be the basis of our anticipated 505(b)(2) NDA filing with the FDA expected towards the end of 2022.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the timing and results of the clinical development program for ATRS-1901 adrenal crisis rescue auto-injector, future NDA submission and FDA approval of the same, and if approved, future market acceptance and revenue for the same, the Company's ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; future prescriptions and sales of OTREXUP®; successful commercialization of NOCDURNA® in the U.S. and market acceptance and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; Teva's ability to successfully commercialize generic teriparatide in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 trial of the drug device combination product for selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's ANDAs for both generic Forteo® and Byetta® and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including the Company's urology assets in development as well as Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com



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  5. EWING, N.J., July 07, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to present at the Ladenburg Thalmann Annual Healthcare Conference.

    Details of the presentation are as follows:

    Event: Ladenburg Thalmann Annual Healthcare Conference
    Format:Fireside Chat and 1x1 Meetings
    Presentation Date:Wednesday, July 14, 2021
    Presentation Time:2:30pm ET

    A live webcast of the presentation will be available under the "For Investors" section of the Antares Pharma website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development…

    EWING, N.J., July 07, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to present at the Ladenburg Thalmann Annual Healthcare Conference.

    Details of the presentation are as follows:

    Event: Ladenburg Thalmann Annual Healthcare Conference
    Format:Fireside Chat and 1x1 Meetings
    Presentation Date:Wednesday, July 14, 2021
    Presentation Time:2:30pm ET

    A live webcast of the presentation will be available under the "For Investors" section of the Antares Pharma website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; future prescriptions and sales of OTREXUP®; successful commercialization of NOCDURNA® in the U.S. and market acceptance and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; Teva's ability to successfully commercialize generic teriparatide in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 trial of the drug device combination product for selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's ANDAs for both generic Forteo® and Byetta® and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including the Company's endocrinology and urology assets in development as well as Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com



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  6. EWING, N.J., June 28, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that its partner Idorsia Ltd ("Idorsia") initiated its Phase 3 registration study to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia's P2Y12 receptor antagonist, in suspected acute myocardial infarction ("AMI") utilizing Antares' Quickshot® auto-injector.

    Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, "We are excited to play an important role in Idorsia's development of selatogrel with our autoinjector technology. The strong collaboration between our teams has allowed Idorsia to achieve this important milestone of…

    EWING, N.J., June 28, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that its partner Idorsia Ltd ("Idorsia") initiated its Phase 3 registration study to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia's P2Y12 receptor antagonist, in suspected acute myocardial infarction ("AMI") utilizing Antares' Quickshot® auto-injector.

    Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, "We are excited to play an important role in Idorsia's development of selatogrel with our autoinjector technology. The strong collaboration between our teams has allowed Idorsia to achieve this important milestone of initiating the Phase 3 study of this novel combination product in approximately eighteen months from the signing of our development agreement. The opportunity to self-inject selatogrel at the onset of symptoms from a suspected heart attack represents a compelling proposition for patients and we believe Idorsia's commitment to that innovation could prove revolutionary. We look forward to continuing to support Idorsia's clinical advancement of selatogrel."

    Idorsia is initiating an international, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the clinical efficacy and safety of 16 mg selatogrel when self-administered (on top of standard-of-care) upon occurrence of symptoms suggestive of an acute myocardial infarction. The primary efficacy endpoint is the occurrence of death from any cause, or non-fatal AMI after any study treatment self-administration. The study will enroll approximately 14,000 patients who are at high risk of recurrent AMI, at approximately 250 sites in approximately 30 countries.

    A Special Protocol Assessment has been agreed with the U.S. Food and Drug Administration ("FDA") for Idorsia's selatogrel. This indicates the FDA is in agreement with the adequacy and acceptability of specific critical elements of overall protocol design (e.g., entry criteria, dose selection, endpoints and planned analyses) for a study intended to support a future marketing application.

    In December 2020, the FDA designated Idorsia's investigation of selatogrel for the treatment of a suspected AMI in adult patients with a history of AMI as a "fast-track" development program. This designation is intended to promote communication and collaboration between the FDA and pharmaceutical companies for drugs that treat serious conditions and fill an unmet medical need.

    Idorsia selected Antares' Quickshot® autoinjector for the development of selatogrel due to the robustness, reliability, ease-of-use and emergency-ready capabilities of our technology. Idorsia has confirmed the usability of the Quickshot® autoinjector in the clinical development program through human factor validation studies.

    Antares entered into a global development agreement with Idorsia in November 2019. Under the terms of the agreement, Antares will provide clinical supply to Idorsia during clinical development in addition to fully packaged product upon FDA or foreign regulatory approval. Idorsia is responsible for the clinical development and regulatory approvals of the combination product. Idorsia will be responsible for global commercialization of the product, pending regulatory approvals, and Antares will be entitled to receive royalties on net sales of the commercial product.

    About Acute Myocardial Infarction (AMI)

    An AMI, or heart attack, is a life-threatening condition that occurs when blood flow to the heart muscle (myocardium) is suddenly decreased or completely cut off. It is usually caused by a blood clot or blockage in one or more of the coronary vessels supplying blood to the heart muscle. An AMI requires immediate treatment and medical attention, as any delay in intervention can result in irreversible damage to the heart muscle. According to the U.S. Centers for Disease Control and Prevention, each year more than 800,000 persons living in the US will suffer a heart attack.[1]

    1. Benjamin EJ, et al. Heart Disease and Stroke Statistics—2019 Update: A Report From the American Heart Association. Circulation 2019;139(10):e56-e528.

    About Idorsia

    Idorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

    Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet – the ideal constellation to translate R&D efforts into business success.

    Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 900 highly qualified specialists dedicated to realizing our ambitious targets.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: successful development including the timing and results of the Phase 3 trial of the drug device combination product for selatogrel with Idorsia Ltd and FDA and global regulatory approvals and future revenue from the same; the Company's ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com



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  7.  

    Ad hoc announcement pursuant to Art. 53 LR

    • Idorsia to host an investor webcast to discuss the Phase 3 study today at 14:30hrs CEST

    Allschwil, Switzerland – June 28, 2021
    Idorsia Ltd (SIX: IDIA) today announced the initiation of the Phase 3 registration study "SOS-AMI" to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia's P2Y12 receptor antagonist, in suspected acute myocardial infarction (AMI).

    An AMI, or heart attack, is a life-threatening condition that occurs when blood flow to the heart muscle (myocardium) is suddenly decreased or completely cut off by a blood clot in one or more of the coronary vessels. An AMI requires immediate treatment, as any delay in intervention can result in irreversible damage…

     

    Ad hoc announcement pursuant to Art. 53 LR

    • Idorsia to host an investor webcast to discuss the Phase 3 study today at 14:30hrs CEST

    Allschwil, Switzerland – June 28, 2021

    Idorsia Ltd (SIX: IDIA) today announced the initiation of the Phase 3 registration study "SOS-AMI" to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia's P2Y12 receptor antagonist, in suspected acute myocardial infarction (AMI).

    An AMI, or heart attack, is a life-threatening condition that occurs when blood flow to the heart muscle (myocardium) is suddenly decreased or completely cut off by a blood clot in one or more of the coronary vessels. An AMI requires immediate treatment, as any delay in intervention can result in irreversible damage to the heart muscle and adverse clinical outcomes. According to the US Centers for Disease Control and Prevention, each year more than 800,000 persons living in the US will suffer a heart attack.[1]

    Although the management of AMI has improved in recent decades, morbidity and mortality associated with AMI remain high. The majority of deaths occur outside the hospital.[2,3] Early action is crucial for survival and to preserve heart muscle.

    Besides aspirin, there are no treatment options currently available for the critical time from onset of AMI symptoms to first medical contact. The development of selatogrel in an autoinjector aims to fulfill this medical gap: upon symptoms suggestive of a heart attack, patients would self-inject selatogrel as early as possible and immediately call for emergency medical help.

    Martine Clozel, MD and Chief Scientific Officer at Idorsia, commented:

    "From the moment that symptoms start, the clock is ticking. Thrombus formation is progressing, and ischemia is rapidly causing irreversible damage to the heart. In the initial stages of thrombus formation, platelet aggregation dominates – a process in which the platelet P2Y12 receptor plays a key role. If left untreated, the thrombus will become fibrin rich, at which point platelets have a more limited role in thrombus formation. This suggests that a fast-acting P2Y12 receptor antagonist could cut short the thrombus formation in the initial stages of thrombus formation. Our drug discovery team has created a compound with unique properties which might fill this important therapeutic gap."

    Dr Deepak L. Bhatt, MD, MPH, Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital, Professor of Medicine at Harvard Medical School, and Chair of the Steering Committee for SOS-AMI, commented:

    "P2Y12 receptor antagonists have been used in the treatment of millions of patients globally, and their safety and efficacy profiles are well established. Despite the success of chronic treatment with this class and other effective interventions, patients are still suffering recurrent heart attacks. The idea for patients to self-inject early in the onset of symptoms is truly innovative. The subcutaneous route of administration could overcome the onset delay observed with oral compounds from the same class."

    To be effective, any antithrombotic treatment for use at the onset of AMI symptoms should be rapidly absorbed and potent, acting quickly to inhibit thrombus formation at an early stage. Inhibition should be reversed after a few hours to avoid interfering with later patient management decisions. It must also have an appropriate safety profile for use prior to formal diagnosis of AMI. Selatogrel has the potential to satisfy these necessary conditions.

    Selatogrel administered subcutaneously is a potent, highly selective, fast-acting, reversible P2Y12 receptor antagonist. Two published Phase 2 studies, one in patients with chronic coronary syndromes and one in patients with AMI showed fast and reversible inhibition of platelet aggregation. Subcutaneous administration of selatogrel 16 mg has demonstrated a rapid onset of action, within 15 minutes, with the magnitude of the effect extending over approximately eight hours. Selatogrel was safe and well tolerated in both studies.[6,7]

    About the Antares Pharma integrated drug delivery device

    In late 2019, Idorsia entered into a global development agreement with Antares Pharma, a US-based leader in autoinjector and rescue pen technologies, to design and customize an autoinjector for selatogrel. The Antares autoinjector was selected for its robustness, reliability, ease-of-use and emergency-ready capabilities – key characteristics necessary due to the nature of AMI. Idorsia has confirmed the usability of the Antares autoinjector through human factor validation studies.

    About Selatogrel Outcome Study in suspected Acute Myocardial Infarction "SOS-AMI"

    Idorsia is initiating an international, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the clinical efficacy and safety of 16 mg selatogrel when self-administered (on top of standard-of-care) upon occurrence of symptoms suggestive of an acute myocardial infarction. The primary efficacy endpoint is the occurrence of death from any cause, or non-fatal AMI after any study treatment self-administration. The study will enroll approximately 14,000 patients who are at high risk of recurrent AMI, at around 250 sites in about 30 countries.

    A Special Protocol Assessment has been agreed with the FDA. This indicates the FDA is in agreement with the adequacy and acceptability of specific critical elements of overall protocol design (e.g., entry criteria, dose selection, endpoints and planned analyses) for a study intended to support a future marketing application.

    In December 2020, the FDA designated the investigation of selatogrel for the treatment of a suspected AMI in adult patients with a history of AMI as a "fast-track" development program. This designation is intended to promote communication and collaboration between the FDA and pharmaceutical companies for drugs that treat serious conditions and fill an unmet medical need.

    Guy Braunstein, MD and Head of Global Clinical Development at Idorsia, added:

    "Selatogrel has a pharmacokinetic and pharmacodynamic profile that results in a fast onset, and short duration of action - making it suitable for administration at the onset of symptoms. It is potent and highly selective for the P2Y12 receptor and was well-tolerated in the Phase 2 studies. Further to these properties, selatogrel is suitable for subcutaneous administration, giving rise to the real innovation in SOS-AMI: self-administration as early as possible after onset of symptoms of a suspected AMI. We are now ready to put selatogrel in the hands of patients and I am looking forward to seeing SOS-AMI progress in the course of the next 2-3 years."

    SOS-AMI has been designed as a patient-centric study in collaboration with patients. Patients participating in SOS-AMI will be trained by qualified professionals appointed at each study site, on how to recognize AMI symptoms, on how and where to self-inject treatment, and to call for emergency medical help immediately. Trainers will use standardized material mirrored across all countries, which has been developed with the support of education experts, feed-back from post-MI patients, and in alignment with current guidelines. The patient is empowered through focused education to take action. In addition, regular interaction is performed by telephone with the designated site trainer, minimizing the burden on the patient, particularly during times of a global pandemic.

    Dr Mary Mooney, Assistant professor at the School of Nursing and Midwifery, Trinity College Dublin, and Member of the Steering Committee for SOS-AMI, commented:

    "I am passionate about patient education and involving patients in their own care. SOS-AMI pushes the boundaries of heart attack care provision. It puts the patient at the center of the study and empowers them to manage their heart attack symptoms. This means that our success will be heavily dependent on patients' responses, but I believe patients are ready for this challenge. For our part, we are educating patients on how to recognize the symptoms of AMI, how to use the study autoinjector, and to call emergency services after using the study autoinjector. We should strive for a world where slowing or stopping of a heart attack is as simple as a self-injection. We know the potential is there, we just need to see if it can be realized."

    Jean-Paul Clozel, MD and Chief Executive Officer, concluded:

    "Self-administration is currently used to treat a number of emergent medical conditions – why not AMI? Anyone can have a good idea, but drug innovation happens when a great team with a great compound, takes a great idea and runs with it. With our integrated drug delivery device, the potential to self-administer selatogrel in the critical time period immediately following onset of suspected AMI symptoms could be revolutionary for patients."

    Notes to the editor

    Investor webcast

    An investor conference call and webcast will be held to discuss the Phase 3 program. The call will start with presentations by senior management, followed by a Q&A session (live access to the speakers).

    Date:        Monday June 28, 2021

    Time:        14:30 CEST | 13:30 BST | 08:30 EDT

    Webcast participants should visit Idorsia's website www.idorsia.com 10-15 minutes before the webcast is due to start.

    Conference call participants should start calling the number below 10-15 minutes before the conference is due to start.

    Dial-in:        CH: +41 44 580 6522 | UK: +44 20 3009 2470 | US: +1 877 423 0830

    PIN:            27481532#

    About acute myocardial infarction (AMI)

    An AMI, or heart attack, is a life-threatening condition that occurs when blood flow to the heart muscle (myocardium) is suddenly decreased or completely cut off. It is usually caused by a blood clot or blockage in one or more of the coronary vessels supplying blood to the heart muscle. An AMI requires immediate treatment and medical attention, as any delay in intervention can result in irreversible damage to the heart muscle. According to the US Centers for Disease Control and Prevention, each year more than 800,000 persons living in the US will suffer a heart attack.[1]

    The need for an early intervention has been highlighted by the guidelines of the European Society of Cardiology, which identified the prehospital phase as the most critical for high-risk patients and reiterated that efforts must be made to reduce the delay in initiation of treatment in order to reduce death.[4,5]

    Data supporting selatogrel in suspected AMI

    Idorsia has completed a multicenter, double blind, randomized, placebo-controlled study assessing the pharmacodynamics, pharmacokinetics, tolerability and safety of a single subcutaneous injection of selatogrel in adults with chronic coronary syndrome. In this study, 346 patients receiving conventional background oral antiplatelet therapy (e.g. acetylsalicylic acid, P2Y12 receptor antagonists) were randomized to receive either selatogrel 8 mg, 16 mg or placebo. The primary objective of the study was to characterize inhibition of platelet aggregation relative to placebo after a single subcutaneous injection of selatogrel either in the thigh or in the abdomen at 2 different doses in patients with chronic coronary syndromes.[6]

    Idorsia has also completed a multi-center, open-label, randomized, exploratory study to assess the onset of platelet aggregation inhibition after a single subcutaneous injection of selatogrel in adults with acute myocardial infarction. In this study, 48 patients with confirmed diagnosis of AMI and time from onset of symptoms of more than 30 min and less than 6 hours were randomized to receive either selatogrel 8 mg or 16 mg in addition to conventional antithrombotic treatment (e.g., acetylsalicylic acid, oral P2Y12 receptor antagonists, anticoagulants). The primary objective of the study was to assess the inhibition of platelet aggregation 30 minutes after a single subcutaneous injection of selatogrel in patients with AMI.[7]

    About P2Y12 receptor antagonism

    Platelet adhesion, activation and aggregation play a pivotal role in atherothrombosis. An essential element in the platelet activation process is the interaction of adenosine diphosphate (ADP) with the platelet P2Y12 receptor. This platelet activation and aggregation can be inhibited by antagonizing the platelet P2Y12 receptor. This prevents the binding of ADP

    to the receptor, which reduces platelet aggregation and the reaction of platelets to stimuli of thrombus aggregation.

    About Dr Deepak L. Bhatt

    Deepak L. Bhatt MD, MPH, FACC, FAHA, FSCAI, FESC, is Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and Professor of Medicine at Harvard Medical School.

    After graduating as valedictorian from Boston Latin School, Dr Bhatt obtained his undergraduate science degree as a National Merit Scholar at MIT while also serving as a research associate at Harvard Medical School. He received his medical doctorate from Cornell University and a Master of Public Health with a concentration in clinical effectiveness from Harvard University. His internship and residency in internal medicine were at the Hospital of the University of Pennsylvania, and his cardiovascular training was at Cleveland Clinic. He also completed fellowships in interventional cardiology and cerebral and peripheral vascular intervention and served as Chief Interventional Fellow at Cleveland Clinic, where he spent several years as an interventional cardiologist and an Associate Professor of Medicine. He served for many years as Director of the Interventional Cardiology Fellowship, Associate Director of the Cardiovascular Medicine Fellowship, and Associate Director of the Cardiovascular Coordinating Center. He was then recruited to be the Chief of Cardiology at VA Boston Healthcare System and served in that role for several years. He was a Senior Investigator in the TIMI Study Group for over a decade. He was selected by Brigham and Women's Hospital as the 2014 Eugene Braunwald Scholar. He has been listed in Best Doctors in America from 2005 to 2020. He received the Eugene Braunwald Teaching Award for Excellence in the Teaching of Clinical Cardiology from Brigham and Women's Hospital in 2017, ACC's Distinguished Mentor Award in 2018, and AHA's Distinguished Scientist Award in 2019.

    Dr Bhatt has authored or co-authored over 1650 publications and has been listed by the Web of Science Group as a Highly Cited Researcher from 2014 to 2020. He is the Editor of Cardiovascular Intervention: A Companion to Braunwald's Heart Disease and of Opie's Cardiovascular Drugs: A Companion to Braunwald's Heart Disease. He is Senior Associate Editor for News and Clinical Trials for ACC.org. He is the Editor of the peer-reviewed Journal of Invasive Cardiology and Editor-in-Chief of the Harvard Heart Letter for patients. Dr Bhatt receives funding paid to Brigham and Women's Hospital from Idorsia for his role as the Chair of the Steering Committee for SOS-AMI.

    About Dr Mary Mooney

    Dr Mary Mooney (PhD, MSc, RGN, RM, RNT, MA, Higher. Diploma Cardiovascular Studies) is an assistant professor in the School of Nursing and Midwifery, Trinity College Dublin. Her research areas focus predominantly on cardiac-related aspects of patient care and nurse education. Her research experience encompasses qualitative and quantitative research methods, including randomized controlled trials. Mary's PhD was a randomized controlled trial that comprised delivering an educational intervention to patients with Acute Coronary Syndrome. This Health Research Board (HRB) funded study was the first RCT in the world to target and successfully reduce patient pre-hospital delay time and its groundbreaking effect has been renowned for its effectiveness in reducing patient delay in the presence of heart attack symptoms. Dr Mooney has many publications, is widely cited, and her work has contributed to the development of further international research with which she is currently actively engaged.

    In terms of research funding, Mary has been Principal Investigator or a co-applicant across a range of projects, from a variety of funding sources. She has wide national and international collaborates with whom she is actively engaged in research. Mary maintains a clinical remit in cardiology, in addition to her academic role, and is an external examiner for post-graduate programs in other universities. As an elected committee member for the Irish Nurses Cardiovascular association (INCA), she contributes to the delivery of cardiovascular education of nurses in Ireland. She is actively engaged in research, most of which is concerned with cardiovascular or critical care. She has worked as a researcher and clinical advisor to an Irish Enterprise, funded by Enterprise Ireland She has been an invited speaker and presenter across a range of national and international events. Dr Mooney serves as a consultant to Idorsia.

    About Antares Pharma Inc. (NASDAQ:ATRS)

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies.

    Key literature

    1. Benjamin EJ, et al. Heart Disease and Stroke Statistics—2019 Update: A Report From the American Heart Association. Circulation 2019;139(10):e56-e528.
    2. Adnet F, et al. Incidence of acute myocardial infarction resulting in sudden death outside the hospital. Emerg Med J. 2011;28(10):884–6.
    3. Norris RM. Fatality outside hospital from acute coronary events in three British health districts, 1994-5. United Kingdom Heart Attack Study Collaborative Group. BMJ 1998;316(7137):1065–70.
    4. Ibanez B, et al. 2017 ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J 2018;39(2):119–77
    5. Neumann FJ, et al. 2018 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J 2019;40(2):87–165
    6. Storey R. F, et al. Pharmacodynamics, pharmacokinetics, and safety of single-dose subcutaneous administration of selatogrel, a novel P2Y12 receptor antagonist, in patients with chronic coronary syndromes. Eur Heart J 2019;0, 1-9, doi:10.1093/eurheartj/ehz807
    7. Sinnaeve P, et al. Subcutaneous Selatogrel Inhibits Platelet Aggregation in Patients With Acute Myocardial Infarction. J Am Coll Cardiol. 2020 May 26;75(20):2588-2597. doi: 10.1016/j.jacc.2020.03.059. PMID: 32439008.
    8. Juif P, et al. Clinical Pharmacology of the Reversible and Potent P2Y12 Receptor Antagonist ACT-246475 After Single Subcutaneous Administration in Healthy Male Subjects. The Journal of Clinical Pharmacology 2019, 59(1): 123-130. doi:10.1002/jcph.1296

    About Idorsia

    Idorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

    Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet – the ideal constellation to translate R&D efforts into business success.

    Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 900 highly qualified specialists dedicated to realizing our ambitious targets.

    For further information, please contact

    Andrew C. Weiss

    Senior Vice President, Head of Investor Relations & Corporate Communications

    Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil

    +41 58 844 10 10

    investor.relations@idorsia.com

    media.relations@idorsia.com

    www.idorsia.com

    The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

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  8. EWING, N.J., June 22, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical study of ATRS-1902 for adrenal crisis rescue. The IND application for ATRS-1902, and its corresponding development program, supports a proposed indication for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver hydrocortisone.

    "Adrenal crisis is a potentially fatal condition associated mainly with an acute deficiency of cortisol…

    EWING, N.J., June 22, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical study of ATRS-1902 for adrenal crisis rescue. The IND application for ATRS-1902, and its corresponding development program, supports a proposed indication for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver hydrocortisone.

    "Adrenal crisis is a potentially fatal condition associated mainly with an acute deficiency of cortisol, which is a hormone produced and released by the adrenal gland, and commonly occurs in patients with long-term adrenal insufficiency. It is estimated that primary adrenal insufficiency, or Addison's disease, affects approximately 100 to 140 of every million people(1). Secondary adrenal insufficiency is more common, affecting approximately 150 to 280 people per million(2)(3)," commented Dr. Peter Richardson, EVP, Research and Development and Chief Medical Officer of Antares Pharma.

    Current standard of care for the management of acute adrenal crises includes Solu-Cortef®, which is an anti-inflammatory glucocorticoid. With hydrocortisone sodium succinate as the active ingredient, Solu-Cortef® is provided as a sterile powder that needs to be reconstituted for intravenous or intramuscular injection and can represent a time-consuming and cumbersome injection process, particularly challenging in a crisis situation.

    Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, "This IND submission represents a key milestone for Antares as we continue to advance our proprietary pipeline. With a novel expansion to our device technology platforms, we believe ATRS-1902 could potentially offer a better solution for patients in need of rescue therapy compared to current standard of care. Positive results from an initial user study and payer survey further highlight the key advantages and opportunity for this rescue therapy. We look forward to providing more detail on the timeline and market opportunity following FDA acceptance of the IND."

    Following written feedback from the FDA at a Pre-IND meeting, the IND application for ATRS-1902 includes a proposed protocol for an initial clinical study to compare the pharmacokinetic profile of our novel formulation of hydrocortisone versus Solu-Cortef®. The FDA will review our IND application and determine the acceptability of the submission before Antares can commence the proposed phase 1 trial for ATRS-1902. After this study is completed, a second study will then be conducted utilizing our proprietary auto-injector technology which has been developed for high reliability and ease-of-use in emergency situations by the patient or caregiver. We believe these two studies will be the basis of our anticipated 505(b)(2) NDA filing with the FDA towards the end of 2022.

    (1) Bornstein SR, Allolio B, Arlt W, et al. Diagnosis and treatment of primary adrenal insufficiency: an Endocrine Society clinical practice guideline. The Journal of Clinical Endocrinology and Metabolism. 2016;101(2):364–369.

    (2) Charmandari E, Nicolaides NC, Chrousos GP. Adrenal insufficiency. Lancet. 2014;383(9935):2152–2167.

    (3) Chabre O, Goichot B, Zenaty D, Bertherat J. Group 1. Epidemiology of primary and secondary adrenal insufficiency: prevalence and incidence, acute adrenal insufficiency, long-term morbidity and mortality. Annals of Endocrinology (Paris). 2017;78(6):490–494.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: whether the FDA will accept the IND as submitted and the Company's ability to commence the phase 1 clinical study for ATRS-1902 and the timing and results of the phase 1 study and the overall development program for this project, future FDA approval of ATRS-1902 and potential revenue from the same, the Company's ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; future prescriptions and sales of OTREXUP®; successful commercialization of NOCDURNA® in the U.S. and market acceptance and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; Teva's ability to successfully commercialize generic teriparatide in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's ANDAs for both generic Forteo® and Byetta® and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including the Company's endocrinology and urology assets in development as well as Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com



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  9. EWING, N.J., June 15, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to present at the Raymond James Human Health Innovations Conference.

    Details of the presentation are as follows:
      
    Event:Raymond James Human Health Innovations Conference
    Format:Fireside Chat and 1x1 Meetings
    Presentation Date:Tuesday, June 22, 2021
    Presentation Time:10:40am ET

    A live webcast of the presentation will be available under the "For Investors" section of the Antares Pharma website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the…

    EWING, N.J., June 15, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to present at the Raymond James Human Health Innovations Conference.

    Details of the presentation are as follows:
      
    Event:Raymond James Human Health Innovations Conference
    Format:Fireside Chat and 1x1 Meetings
    Presentation Date:Tuesday, June 22, 2021
    Presentation Time:10:40am ET

    A live webcast of the presentation will be available under the "For Investors" section of the Antares Pharma website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; future prescriptions and sales of OTREXUP®; successful commercialization of NOCDURNA® in the U.S. and market acceptance and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; Teva's ability to successfully commercialize generic teriparatide in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's ANDAs for both generic Forteo® and Byetta® and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including the Company's endocrinology and urology assets in development as well as Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com



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  10. EWING, N.J., May 26, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to present at the Jefferies Virtual Healthcare Conference.

    Details of the presentation are as follows:
      
    Event:Jefferies Virtual Healthcare Conference
    Format:Fireside Chat and 1x1 Meetings
    Presentation Date:Wednesday, June 2, 2021
    Presentation Time:10:00am ET

    A live webcast of the presentation will be available under the "For Investors" section of the Antares Pharma website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development…

    EWING, N.J., May 26, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to present at the Jefferies Virtual Healthcare Conference.

    Details of the presentation are as follows:

      
    Event:Jefferies Virtual Healthcare Conference
    Format:Fireside Chat and 1x1 Meetings
    Presentation Date:Wednesday, June 2, 2021
    Presentation Time:10:00am ET

    A live webcast of the presentation will be available under the "For Investors" section of the Antares Pharma website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; future prescriptions and sales of OTREXUP®; successful commercialization of NOCDURNA® in the U.S. and market acceptance and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; Teva's ability to successfully commercialize generic teriparatide in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's ANDAs for both generic Forteo® and Byetta® and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including the Company's endocrinology and urology assets in development as well as Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com



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  11. EWING, N.J., May 06, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced the appointment of Joseph V. Renda as Senior Vice President of Commercial. Mr. Renda succeeds Patrick Shea who resigned to pursue other interests.

    Mr. Renda has had a successful career in leading commercial sales, marketing, and operations at large and mid-sized pharmaceutical companies. Prior to joining Antares, Mr. Renda was Vice President, U.S. Sales Autoimmune and Rare Disease at Mallinckrodt Pharmaceuticals where he led a 200-person organization responsible for over $1B in annual sales and managed 5 unique therapeutic areas and institutional account teams. From 2012 to 2018, he held various…

    EWING, N.J., May 06, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced the appointment of Joseph V. Renda as Senior Vice President of Commercial. Mr. Renda succeeds Patrick Shea who resigned to pursue other interests.

    Mr. Renda has had a successful career in leading commercial sales, marketing, and operations at large and mid-sized pharmaceutical companies. Prior to joining Antares, Mr. Renda was Vice President, U.S. Sales Autoimmune and Rare Disease at Mallinckrodt Pharmaceuticals where he led a 200-person organization responsible for over $1B in annual sales and managed 5 unique therapeutic areas and institutional account teams. From 2012 to 2018, he held various positions of increasing responsibility at Novo Nordisk including Marketing Brand Director, Women's Health Care and leading the commercial operations and effectiveness function responsible for a 150-person sales force. He was ultimately promoted to Vice President, U.S. Sales Biopharmaceutical Division leading a national sales team with over $600M in annual sales. Prior to that, he was Regional Business Director at Pfizer managing one of the largest U.S. sales regions with 175 sales and account representatives after serving in varying director and operational roles. He also previously served as Manager, U.S. Urology Marketing and Alliances at the Pharmacia Corporation and began his career in sales at The Upjohn Company. Mr. Renda earned his Bachelor of Science degree from Pennsylvania State University.

    Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, "We are excited to welcome Joe to Antares. We believe his extensive commercial background aligns with our strategic initiatives to enhance the strong growth trajectory of our proprietary portfolio with our flagship product XYOSTED and our recently launched NOCDURNA. Joe's proven success in sales, marketing and sales operations across therapeutic areas will be instrumental in leading our sales organization and commercial activities. We expect a seamless transition and remain enthusiastic about the growth opportunities across our business."

    Mr. Renda, added, "I am honoured with the opportunity to lead the U.S. commercial team at Antares and build upon their success to date. I believe their proprietary assets are well positioned in attractive markets and will continue to capture market share. I look forward to leveraging my extensive sales, marketing, and operations experience and contributing to the next phase of their growth with an expanded portfolio."

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the success of Mr. Renda as SVP, Commercial and future sales; the Company's ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; future prescriptions and sales of OTREXUP® ; successful commercialization of NOCDURNA® in the U.S. and market acceptance and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; Teva's ability to successfully commercialize generic teriparatide in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's pending ANDAs for both generic Forteo® and Exenatide and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including the Company's endocrinology and urology assets in development as well as Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com 



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  12. Increased Revenue 27% Year-Over-Year to $42.1 Million

    Increased Net Income to $3.8 Million, or $0.02 Per Basic and Diluted Earnings Per Share

    EWING, N.J., May 06, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today reported financial and operating results for the quarter ended March 31, 2021 with record first quarter revenue of $42.1 million and net income of $3.8 million, or $0.02 per basic and diluted earnings per share.

    Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, "Our strong first quarter results with a 27% year-over-year revenue increase continue to highlight the growth opportunities and initiatives we have across our diversified…

    Increased Revenue 27% Year-Over-Year to $42.1 Million

    Increased Net Income to $3.8 Million, or $0.02 Per Basic and Diluted Earnings Per Share

    EWING, N.J., May 06, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today reported financial and operating results for the quarter ended March 31, 2021 with record first quarter revenue of $42.1 million and net income of $3.8 million, or $0.02 per basic and diluted earnings per share.

    Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, "Our strong first quarter results with a 27% year-over-year revenue increase continue to highlight the growth opportunities and initiatives we have across our diversified business. With XYOSTED total prescription growth of 50% year-over-year, we expect to continue to build positive momentum throughout the year as patient visits to physician offices increase and our sales representatives garner more in-office physician details, and as vaccines are administered and the pandemic slows. Furthermore, our commercial organization implemented an enhanced targeting strategy that reinforces the expansion opportunities for XYOSTED and the relaunch of NOCDURNA. We are also very pleased with the 48% year-over-year increase in prescriptions from our partner Teva's generic EpiPen and look forward to the potential approval of their generic teriparatide in the U.S. Overall, as we concurrently advance our robust development pipeline with an expanded leadership team, we believe we have a diverse product portfolio that will support our full year 2021 revenue guidance as well as future growth."

    First Quarter 2021 and Recent Highlights

    • XYOSTED® revenue in the first quarter 2021 increased 60% year-over-year to $14.4 million with total prescriptions increasing 50% year-over-year, according to IQVIA



    • Teva's generic EpiPen prescriptions in the first quarter 2021 increased 48% year-over-year, contributing to a 40% increase in EpiPen product and royalty revenue



    • Appointed Dr. Peter Richardson as Executive Vice President, Research and Development and Chief Medical Officer to continue to advance our proprietary pipeline



    • Appointed Joseph Renda as Senior Vice President of Commercial, who will be responsible for sales, marketing and data analytics



    First Quarter 2021 Financial Results

    Total revenue generated from product sales, license and development activities and royalties was $42.1 million for the three months ended March 31, 2021, a 27% increase compared to $33.1 million in the same period in 2020.

    Sales of our proprietary products XYOSTED®, OTREXUP® and NOCDURNA® generated revenue of $18.7 million for the three months ended March 31, 2021, as compared to $12.6 million for the three months ended March 31, 2020. The 49% increase in proprietary product sales was principally attributable to continued growth in prescriptions and sales of XYOSTED®.

    Partnered product sales were $10.4 million for the three months ended March 31, 2021, as compared to $14.5 million for the three months ended March 31, 2020. The net decrease in sales of partnered products is attributable to a decrease in sales of sumatriptan to Teva and Makena® auto injectors to AMAG, offset by an increase in sales to Teva of generic EpiPen auto-injectors.

    Development and licensing revenue was $5.0 million for the three months ended March 31, 2021, as compared to $1.8 million for the comparable period in 2020. The increase in development revenue was primarily from incremental development and maintenance of Teva's partnered products and the Idorsia selatogrel rescue pen development program.

    Royalty revenue was $8.0 million for the three months ended March 31, 2021, as compared to $4.2 million for the same period in 2020. The increase in royalty revenue was primarily attributable to an increase in royalties from Teva on their net sales of generic EpiPen.

    Research and development expenses were $2.6 million for the three months ended March 31, 2021, as compared to $3.0 million for the comparable period in 2020. The decrease in research and development costs was due to the timing of clinical studies for our internal pipeline products.

    Selling, general and administrative expenses were $17.6 million for the three months ended March 31, 2021, as compared to $16.4 million for the comparable periods in 2020. The increase in selling, general and administrative expenses was primarily due to an increase in sales and marketing costs for our proprietary products and increases in compensation and professional services.

    Net income was $3.8 million, or $0.02 per basic and diluted share for the first quarter 2021, as compared to a net loss of $2.4 million, or $0.01 per basic and diluted loss per share in the same period in 2020.  

    As of March 31, 2021, cash and cash equivalents were $55.7 million compared to $53.1 million as of December 31, 2020. The Company generated cash from operation of $2.0 million for the three months ended March 31, 2021.

    Full-Year 2021 Financial Guidance

    The Company today reaffirmed full-year 2021 revenue guidance in the range of $175-200 million, which represents a 17% to 34% year-over-year growth rate and assumes no significant disruptions to supply or operations due to the ongoing COVID-19 pandemic and a range of revenue scenarios for the potential approval and launch of generic Forteo® by our partner Teva in the U.S.

    Webcast and Conference Call Information

    The Antares management team will provide a Company update and review the first quarter 2021 financial results via conference call and webcast today, May 6, 2021, at 8:30am ET (Eastern Time). The webcast of the conference call will include a slide presentation, which can be accessed in the investor relations section of the Company's website (www.antarespharma.com) under "Webcasts & Presentations". Alternatively, callers may participate in the audio portion of the conference call by dialing (800) 367-2403 for domestic callers and (334) 777-6978 for international callers. Callers should reference the Antares Pharma conference call or conference ID number 1237332.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; future prescriptions and sales of OTREXUP®; successful commercialization of NOCDURNA® in the U.S. and market acceptance and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; Teva's ability to successfully commercialize generic teriparatide in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's pending ANDAs for both generic Forteo® and Byetta® and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including the Company's endocrinology and urology assets in development as well as Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com

    TABLES FOLLOW

    ANTARES PHARMA, INC.

    Table 1 - CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS

    (amounts in thousands except per share amounts)

    (unaudited)

      Three Months Ended     
      March 31,  Increase 
      2021  2020  (Decrease) 
    Revenue:            
    Product sales $29,135  $27,097  8% 
    Development and licensing revenue  4,984   1,755  184% 
    Royalties  7,964   4,227  88% 
    Total revenue  42,083   33,079  27% 
    Operating expenses:            
    Cost of product sales  12,498   14,014  (11)% 
    Cost of development revenue  3,947   1,033  282% 
    Research and development  2,640   2,981  (11)% 
    Selling, general and administrative  17,607   16,422  7% 
    Total operating expenses  36,692   34,450  7% 
    Operating income (loss)  5,391   (1,371) ** 
    Other expense  (1,008)  (985) 2% 
    Net income (loss) before income taxes  4,383   (2,356) ** 
    Income tax expense  (590)    ** 
    Net income (loss) $3,793  $(2,356) ** 
    Net income (loss) per common share, basic $0.02  $(0.01)    
    Net income (loss) per common share, diluted $0.02  $(0.01)    
    Basic weighted average common shares outstanding  167,822   165,429     
    Diluted weighted average common shares outstanding  174,908   165,429     

    ANTARES PHARMA, INC.

    Table 2 – CONSOLIDATED REVENUE DETAILS

    (amounts in thousands)

    (unaudited)

      Three Months Ended  
      March 31,  
      2021  2020  
    Proprietary product sales:         
    XYOSTED® $14,389  $9,003  
    OTREXUP®  3,567   3,563  
    NOCDURNA®  776     
    Total proprietary product sales  18,732   12,566  
    Partnered product sales  10,403   14,531  
    Total product sales  29,135   27,097  
    Development and licensing revenue  4,984   1,755  
    Royalties  7,964   4,227  
    Total revenue $42,083  $33,079  

    ANTARES PHARMA, INC.

    Table 3 – CONSOLIDATED CONDENSED BALANCE SHEETS

    (amounts in thousands)

    (unaudited)

      March 31,  December 31, 
      2021  2020 
    Assets        
    Cash and cash equivalents $55,652  $53,137 
    Accounts receivable  42,940   42,221 
    Inventories  19,614   18,216 
    Contract assets  10,960   8,140 
    Prepaids and other current assets  4,352   4,877 
    Property and equipment, net  24,276   24,020 
    Deferred tax assets  46,392   46,982 
    Other assets  14,271   14,938 
    Total Assets $218,457  $212,531 
             
    Liabilities and Stockholders' Equity        
    Accounts payable and accrued expenses $44,314  $43,032 
    Long-term debt  41,025   40,899 
    Other liabilities  6,893   9,485 
    Stockholders' equity  126,225   119,115 
    Total Liabilities and Stockholders' Equity $218,457  $212,531 
             

     



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  13. EWING, N.J., May 03, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that data highlighting the therapeutic potential of subcutaneous testosterone enanthate in younger hypogonadal populations was presented in a poster presentation at the Pediatric Endocrine Society (PES) 2021 Virtual Annual Meeting on April 30 – May 3, 2021.

    The poster presentation entitled, "Allometric Scaling of Testosterone Enanthate Pharmacokinetics from Adult Males to Adolescent Hypogonadal Males (30-60 kg) After IM and SC Administration Using Population PK Modeling", was presented by Maria Vogiatzi, MD*, Professor of Pediatrics and Director, Adrenal and Puberty Center, Division of Endocrinology…

    EWING, N.J., May 03, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that data highlighting the therapeutic potential of subcutaneous testosterone enanthate in younger hypogonadal populations was presented in a poster presentation at the Pediatric Endocrine Society (PES) 2021 Virtual Annual Meeting on April 30 – May 3, 2021.

    The poster presentation entitled, "Allometric Scaling of Testosterone Enanthate Pharmacokinetics from Adult Males to Adolescent Hypogonadal Males (30-60 kg) After IM and SC Administration Using Population PK Modeling", was presented by Maria Vogiatzi, MD*, Professor of Pediatrics and Director, Adrenal and Puberty Center, Division of Endocrinology and Diabetes, Children's Hospital of Philadelphia, Philadelphia, PA. Pharmacokinetic modelling of datasets from the Company's Phase 2 trial for XYOSTED® for the treatment of hypogonadism in adult males was performed to permit the extrapolation of testosterone exposure to patients with body weights typical of preadolescent males. The PK modelling showed that subcutaneous testosterone enanthate dosed at a reduced frequency predicted testosterone exposure similar to normal adolescents and could represent a viable treatment option for permanently hypogonadal adolescent males, who require lifelong hormonal support.

    Dr. Vogiatzi commented, "We were pleased to be able to share this novel data extrapolation with our colleagues and peers. Although XYOSTED has been FDA-approved for the treatment of testosterone deficiency only in adult males, our analysis of the PK data suggests that it could also potentially be confirmed for use in adolescent hypogonadal males with additional clinical studies. There are currently no approved autoinjectors to deliver subcutaneous testosterone in this medically underserved population. We appreciate the recognition of the Pediatric Endocrine Society that allowed us to present these important findings."

    The poster presentation can be accessed at PES Annual Meeting | Pediatric Endocrine Society (pedsendo.org).

    XYOSTED® (testosterone enanthate) injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Safety and efficacy of XYOSTED® in males less than 18 years old have not been established. Please see Prescribing Information including important safety information and boxed warning at www.xyosted.com.

    * Dr. Maria Vogiatzi is a consultant of Antares Pharma, Inc.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the successful outcome of any future clinical trials to treat hypogonadal adolescent males and FDA approval of an indication for this patient population; the Company's ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; future prescriptions and sales of OTREXUP®; successful commercialization of NOCDURNA® in the U.S. and market acceptance and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same;; Teva's ability to successfully commercialize generic teriparatide in in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's pending ANDAs for both generic Forteo® and Exenatide and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including the Company's endocrinology and urology assets in development as well as Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com



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  14. EWING, N.J., April 28, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to participate and host investor meetings at the 7th Annual Truist Securities 2021 Life Sciences Summit being held virtually on May 4-5, 2021.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates…

    EWING, N.J., April 28, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to participate and host investor meetings at the 7th Annual Truist Securities 2021 Life Sciences Summit being held virtually on May 4-5, 2021.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; future prescriptions and sales of OTREXUP®; successful commercialization of NOCDURNA® in the U.S. and market acceptance and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; Teva's ability to successfully commercialize generic teriparatide in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's pending ANDAs for both generic Forteo® and Exenatide and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including the Company's endocrinology and urology assets in development as well as Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com



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  15. EWING, N.J., April 27, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced it will release its first quarter 2021 financial and operating results on Thursday, May 6, 2021, before the market opens.

    Antares will host a conference call on Thursday, May 6, 2021 at 8:30am ET to discuss the results. The dial-in numbers are (800) 367-2403 for domestic callers and (334) 777-6978 for international callers. The conference ID number is 1237332. A live webcast and replay of the conference call will be available online from the investor relations section of the Antares Pharma corporate website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty…

    EWING, N.J., April 27, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced it will release its first quarter 2021 financial and operating results on Thursday, May 6, 2021, before the market opens.

    Antares will host a conference call on Thursday, May 6, 2021 at 8:30am ET to discuss the results. The dial-in numbers are (800) 367-2403 for domestic callers and (334) 777-6978 for international callers. The conference ID number is 1237332. A live webcast and replay of the conference call will be available online from the investor relations section of the Antares Pharma corporate website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; future prescriptions and sales of OTREXUP® ; successful commercialization of NOCDURNA® in the U.S. and market acceptance and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; Teva's ability to successfully commercialize generic teriparatide in in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's pending ANDAs for both generic Forteo® and Exenatide and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including the Company's endocrinology and urology assets in development as well as Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as "may", "will'', ''should", "would", "expect", "intend", "plan", "anticipate", "believe", "estimate", "predict", "potential", "seem", "seek", "future", "continue", or "appear" or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com



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  16. EWING, N.J., April 26, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced the appointment of Peter Richardson, MRCP, as Executive Vice President, Research and Development and Chief Medical Officer. In this role, Dr. Richardson will oversee the Company's proprietary research and development programs, including ideation, formulation, clinical operations, pharmacovigilance and medical affairs.

    Dr. Richardson has over 25 years of research and development experience in the pharmaceutical and medical device industry. He has created centers of excellence that have enabled and supported product development pipelines encompassing small molecules, biologics, novel formulations…

    EWING, N.J., April 26, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced the appointment of Peter Richardson, MRCP, as Executive Vice President, Research and Development and Chief Medical Officer. In this role, Dr. Richardson will oversee the Company's proprietary research and development programs, including ideation, formulation, clinical operations, pharmacovigilance and medical affairs.

    Dr. Richardson has over 25 years of research and development experience in the pharmaceutical and medical device industry. He has created centers of excellence that have enabled and supported product development pipelines encompassing small molecules, biologics, novel formulations, combination products, and medical devices. During his career, Dr. Richardson has managed clinical development programs leading to the submission, review, and approvals of NDAs, sNDAs, BLAs and Marketing Authorization Applications in the U.S., Europe and Japan for over 20 marketed products.

    Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, "Peter brings a wealth of experience and expertise in multiple therapeutic areas including endocrinology and product development to the organization. As we remain focused on advancing our proprietary pipeline with ATRS-1901, a urology-oncology auto-injector product, and ATRS-1902, an endocrinology rescue pen, we believe his career in the pharmaceutical industry and proven track record, will support our continued success and further enhance the opportunities around our portfolio and technology. We are pleased to welcome Peter to the leadership team as we prepare for our next stage of growth."

    From 2016 until the acquisition of the company in 2020, Dr. Richardson was Chief Medical Officer for Adare Pharmaceuticals and Vice President of Research and Development and President, Adare Pharmaceuticals US. From 2012 to 2016, he served as Head of Clinical and Regulatory Affairs and Chief Medical Officer at Alcon, the eye care division of Novartis, having previously led development organizations for Novartis Pharmaceuticals from 1996 to 2005, where he was responsible for successful product approvals in multiple therapeutic areas. He also previously served as Chief Scientific Officer and Corporate Vice President of MannKind Corporation from 2005 to 2012.

    Dr. Richardson earned his Bachelor of Medical Sciences from the University of Nottingham and his Bachelor of Medicine and Bachelor of Surgery from the University of Nottingham Medical School. He is a member of the Royal College of Physicians, United Kingdom.

    Dr. Richardson, added, "I am delighted to join Antares at this juncture of their growth and development. I am impressed by the success they have already garnered in their proprietary and partnered business and I look forward to working with an exceptional organization that remains dedicated to product development."

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the success of Dr. Peter Richardson in his new role at Antares and the success of future research and development programs, the Company's ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; successful commercialization of NOCDURNA® in the United States and market acceptance and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the recent FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; future prescriptions and sales of OTREXUP®; Teva's ability to successfully commercialize generic teriparatide in 11 countries in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's pending ANDA for generic Forteo® and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including the Company's endocrinology and urology assets in development as well as Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com



    Primary Logo

    View Full Article Hide Full Article
  17. Full-Year 2020 Revenue Increases 21% Year-Over-Year to $149.6 Million

    Full-Year 2020 Net Income Before Income Taxes of $9.9 Million, or $0.06 per Share

    Full-Year 2020 Net Income of $56.2 Million, including a Net Tax Benefit of $46.3 million

    EWING, N.J., March 02, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today reported financial and operating results for the fourth quarter ended December 31, 2020 with record revenue of $44.1 million and net income of $51.4 million, or basic and diluted earnings per share of $0.31 and $0.30, respectively, which included a net tax benefit of $46.3 million. The Company also reported record full-year 2020 revenue of $149.6 million and net…

    Full-Year 2020 Revenue Increases 21% Year-Over-Year to $149.6 Million

    Full-Year 2020 Net Income Before Income Taxes of $9.9 Million, or $0.06 per Share

    Full-Year 2020 Net Income of $56.2 Million, including a Net Tax Benefit of $46.3 million

    EWING, N.J., March 02, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today reported financial and operating results for the fourth quarter ended December 31, 2020 with record revenue of $44.1 million and net income of $51.4 million, or basic and diluted earnings per share of $0.31 and $0.30, respectively, which included a net tax benefit of $46.3 million. The Company also reported record full-year 2020 revenue of $149.6 million and net income of $56.2 million, or basic and diluted earnings per share of $0.34 and $0.33, respectively. The full year net income included the above referenced net tax benefit of $46.3 million or $0.28 and $0.27 per basic and diluted share, respectively, resulting from a deferred tax asset valuation allowance reversal. (See Table 3 for details of the components of net income and computation of per share amounts.)

    Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, "We are very proud of our accomplishments this past year that contributed to record annual revenue of $150 million. Despite ongoing challenges due to the global COVID-19 pandemic, the diversification of our business with our proprietary and partner revenue continues to bolster our overall growth, profitability, and cash flow. Driven by strong demand for XYOSTED, our proprietary revenue grew to $63 million in 2020. The reach of our commercial sales organization to urologists and endocrinologists has continued to drive the success of XYOSTED as well as support the expansion of our proprietary portfolio with NOCDURNA. We look forward to further expanding our internal pipeline as we advance our endocrinology and urology assets from successful Pre-IND meetings with the FDA last year to IND submissions this year. Our partner business also had another strong year with total revenue of $87 million driven in large part to the significant increases in market share of Teva's generic EpiPen."

    "As we look ahead, our full-year 2021 revenue guidance of $175-200 million, which represents 17% to 34% year-over-year growth, anticipates continued growth in XYOSTED as well as our partner products. We also remain excited about the potential FDA approval of Teva's generic Forteo, ongoing progress for Pfizer's undisclosed asset, and the initiation of Idorsia's Phase III trial for their selatogrel rescue pen program that has received fast-track designation by the FDA. Overall, the diversification of our business has proven to be a strong foundation from which we will continue to expand."

    Fourth Quarter 2020 and Recent Highlights

    • XYOSTED® total prescriptions in the fourth quarter 2020 increased 13% sequentially and 76% year-over-year, according to IQVIA.



    • Entered an exclusive license agreement with Ferring Pharmaceuticals for NOCDURNA® in the U.S. that expands our proprietary portfolio and leverages our commercial organization.



    • Recorded an income tax benefit of $46.3 million for the fourth quarter and full-year 2020 resulting primarily from the net valuation allowance release of $53.4 million on deferred tax assets.



    • Announced full-year 2021 revenue guidance of $175-200 million, which represents a 17% to 34% year-over-year growth rate and assumes a range of revenue scenarios for the potential approval and launch of generic Forteo® by our partner Teva in the U.S.

    Fourth Quarter and Full-Year 2020 Financial Results

    Total revenue generated from product sales, license and development activities and royalties was $44.1 million for the three months ended December 31, 2020, a 17% increase compared to $37.8 million in the same period in 2019. For the full year ended December 31, 2020, total revenue was $149.6 million, a 21% increase from $123.9 million for the comparable period in 2019.

    Product sales were $33.1 million for the three months ended December 31, 2020, a 16% increase compared to $28.5 million for the same period in 2019. For the twelve-month period ended December 31, 2020, product sales were $113.8 million, a 24% increase from $92.1 million in the comparable period in 2019.   

    Sales of our proprietary products XYOSTED®, OTREXUP® and NOCDURNA® generated revenue of $19.7 million and $62.9 million for the three months and full-year ended December 31, 2020, respectively, as compared to $14.0 million and $39.2 million for the three months and full-year ended December 31, 2019, respectively. The 41% and 60% increase in proprietary product sales for the three-month and full-year ended December 31, 2020 respectively, compared to the three months and full-year ended December 31, 2019 were principally attributable to continued growth in prescriptions and sales of XYOSTED®.

    Partnered product sales were $13.4 million and $14.5 million for the three months ended December 31, 2020 and 2019, respectively, and $51.0 million and $52.9 million for the full year ended December 31, 2020 and 2019, respectively. The net decrease in sales of partnered products for the fourth quarter and full-year ended December 31, 2020 as compared to the same periods in 2019 is attributable to decreased sales of needle-free devices to Ferring, a decrease in sales of Makena® auto injectors to AMAG and a reduction in pre-launch quantities of generic teriparatide devices sold to Teva in previous periods. These decreases were offset by an increase in sales to Teva of their generic EpiPen auto-injectors.

    Licensing and development revenue was $5.7 million and $14.5 million for the three and twelve-month periods ended December 31, 2020, respectively, as compared to $3.2 million and $7.5 million for the comparable periods in 2019, respectively. The increase in licensing and development revenue for the fourth quarter and full year ended December 31, 2020 was primarily from the Pfizer rescue pen and the Idorsia selatogrel pen development programs.

    Royalty revenue was $5.3 million for the three months ended December 31, 2020 compared to $6.2 million for the same period in 2019. For the twelve-month period ended December 31, 2020, royalty revenue was $21.3 million, as compared to $24.2 million for the same period in 2019. The net decrease in royalty revenue was primarily attributable to a decline in royalties recognized from AMAG on their net sales of the Makena® subcutaneous auto injectors offset by an increase in royalties from Teva on their net sales of generic EpiPen.

    Research and development expenses were $2.3 million and $10.1 million for the three and twelve-month periods ended December 31, 2020, respectively, as compared to $2.9 million and $10.6 million for the comparable periods in 2019, respectively. The decrease in research and development costs incurred in 2020 as compared to 2019 was due to the timing of clinical studies for our internal pipeline products.

    Selling, general and administrative expenses were $16.7 million and $62.8 million for the three and twelve-month periods ended December 31, 2020, respectively, as compared to $15.4 million and $61.8 million for the comparable periods in 2019, respectively. The net increase in selling, general and administrative expenses for the three and twelve-month period ended December 31, 2020 was primarily due to increases in payroll and equity-based compensation costs and additional overhead costs of our new facility, offset by reductions in sales and marketing costs incurred as a result of the various stay at home orders and travel restrictions related to the COVID-19 pandemic.

    Antares recorded an income tax benefit of $46.3 million for the fourth quarter and full-year 2020 resulting primarily from the net valuation allowance release of $53.4 million on our deferred tax assets. As of December 31, 2020, management concluded that as a result of generating pre-tax earnings, utilization of net operating loss carryovers and future projected pre-tax earnings, it is more likely than not that nearly all of our deferred taxes are realizable and may be utilized to offset future tax liabilities.

    Including the tax benefit, net income was $51.4 million, or $0.31 and $0.30 per basic and diluted share, respectively, for the fourth quarter of 2020, compared to $4.7 million, or $0.03 per basic and diluted share in the same period in 2019. Net income was $56.2 million, or $0.34 and $0.33 per basic and diluted share, respectively, for the full year ended December 31, 2020 compared to a net loss of $2.0 million, or $0.01 loss per basic and diluted share in the comparable period of 2019.

    As of December 31, 2020, cash and cash equivalents were $53.1 million compared to $45.7 million as of December 31, 2019. Cash generated from operations was $21.3 million for the full-year ended December 31, 2020, compared to cash used in operations of $10.6 million for the full-year ended December 31, 2019.

    Full-Year 2021 Financial Guidance

    The Company today reaffirmed full-year 2021 revenue guidance in the range of $175-200 million, which represents a 17% to 34% year-over-year growth rate and assumes no significant disruptions to supply or operations due to the ongoing COVID-19 pandemic and a range of revenue scenarios for the potential approval and launch of generic Forteo® by our partner Teva in the U.S.

    Webcast and Conference Call Information

    The Antares management team will provide a Company update and review the fourth quarter and full-year 2020 financial results via conference call and webcast today, March 2, 2021, at 8:30am ET (Eastern Time). The webcast of the conference call will include a slide presentation, which can be accessed in the investor relations section of the Company's website (www.antarespharma.com) under "Webcasts & Presentations". Alternatively, callers may participate in the audio portion of the conference call by dialing (888) 254-3590 for domestic callers and (323) 994-2093 for international callers. Callers should reference the Antares Pharma conference call or conference ID number 1389407.

    About Antares Pharma

    Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; successful commercialization of NOCDURNA® in the United States and market acceptance and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the recent FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; future prescriptions and sales of OTREXUP®; Teva's ability to successfully commercialize generic teriparatide in 11 countries in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's pending ANDA for generic Forteo® and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including the Company's endocrinology and urology assets in development as well as Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com

    TABLES FOLLOW

    ANTARES PHARMA, INC.

    Table 1 - CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS

    (amounts in thousands except per share amounts)

    (unaudited)

      For the Quarter Ended      For the Year Ended     
      December 31,  Increase  December 31,  Increase 
      2020  2019  (Decrease)  2020  2019  (Decrease) 
    Revenue:                        
    Product sales $33,125  $28,496  16%  $113,834  $92,103  24% 
    Development and licensing revenue  5,703   3,164  80%   14,466   7,529  92% 
    Royalties  5,305   6,179  (14)%   21,299   24,232  (12)% 
    Total revenue  44,133   37,839  17%   149,599   123,864  21% 
    Operating expenses:                        
    Cost of product sales  15,404   12,476  23%   53,960   46,267  17% 
    Cost of development revenue  3,655   1,550  136%   9,140   4,208  117% 
    Research and development  2,318   2,880  (20)%   10,121   10,624  (5)% 
    Selling, general and administrative  16,658   15,366  8%   62,759   61,773  2% 
    Total operating expenses  38,035   32,272  18%   135,980   122,872  11% 
    Operating income  6,098   5,567  10%   13,619   992  1273% 
    Other expense  (992)  (872) 14%   (3,698)  (3,019) 22% 
    Net income (loss) before income taxes  5,106   4,695  9%   9,921   (2,027) ** 
    Income tax benefit  46,280     **   46,280     ** 
    Net income (loss) $51,386  $4,695  994%  $56,201  $(2,027) ** 
    Net income (loss) per common share, basic $0.31  $0.03      $0.34  $(0.01)    
    Net income (loss) per common share, diluted $0.30  $0.03      $0.33  $(0.01)    
    Basic weighted average common shares outstanding  166,744   163,952       166,066   162,574     
    Diluted weighted average common shares outstanding  171,412   171,238       170,155   162,574     
                             

    ANTARES PHARMA, INC.

    Table 2 – CONSOLIDATED DETAILS OF REVENUE

    (amounts in thousands)

    (unaudited)

      Quarter Ended December 31,  Year Ended December 31, 
      2020  2019  2020  2019 
    Proprietary product sales:                
    XYOSTED® $14,399  $8,423  $46,549  $20,769 
    OTREXUP®  4,442   5,579   15,468   18,446 
    NOCDURNA®  861      861    
    Total proprietary product sales  19,702   14,002   62,878   39,215 
    Partnered product sales  13,423   14,494   50,956   52,888 
    Total product sales  33,125   28,496   113,834   92,103 
    Development revenue  5,703   3,164   14,466   7,529 
    Royalties  5,305   6,179   21,299   24,232 
    Total revenue $44,133  $37,839  $149,599  $123,864 
                     

    ANTARES PHARMA, INC.

    Table 3 – COMPONENTS OF NET INCOME (LOSS) AND COMPUTATION OF PER SHARE AMOUNTS

    (amounts in thousands)

    (unaudited)

      Quarter Ended December 31,  Year Ended December 31, 
      2020  2019  2020  2019 
    Net income (loss) before income taxes $5,106  $4,695  $9,921  $(2,027)
    Pre-tax earnings (loss) per share, basic and diluted $0.03  $0.03  $0.06  $(0.01)
                     
    Income tax benefit $46,280  $  $46,280  $ 
    Tax benefit per common share, basic $0.28  $  $0.28  $ 
    Tax benefit per common share, diluted $0.27  $  $0.27  $ 
                     
    Net income (loss) $51,386  $4,695  $56,201  $(2,027)
    Net income (loss) per common share, basic $0.31  $0.03  $0.34  $(0.01)
    Net income (loss) per common share, diluted $0.30  $0.03  $0.33  $(0.01)
                     
    Basic weighted average common shares outstanding  166,744   163,952   166,066   162,574 
    Diluted weighted average common shares outstanding  171,412   171,238   170,155   162,574 

    ANTARES PHARMA, INC.

    Table 4 – CONSOLIDATED CONDENSED BALANCE SHEETS

    (amounts in thousands)

    (unaudited)

      December 31,  December 31, 
      2020  2019 
    Assets        
    Cash, cash equivalents and investments $53,137  $45,721 
    Accounts receivable  42,221   35,074 
    Inventories  18,216   16,000 
    Property and equipment  24,020   15,961 
    Deferred tax assets  46,982    
    Goodwill and intangibles  8,788   1,573 
    Other assets  19,167   18,422 
    Total Assets $212,531  $132,751 
             
    Liabilities and Stockholders' Equity        
    Accounts payable and accrued expenses $41,829  $29,428 
    Long-term debt  40,899   40,395 
    Other liabilities  10,688   8,428 
    Stockholders' equity  119,115   54,500 
    Total Liabilities and Stockholders' Equity $212,531  $132,751 


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  18. EWING, N.J., Feb. 24, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to present and host investor meetings at the Raymond James 42nd Annual Virtual Institutional Investors Conference and the Cowen 41st Annual Virtual Healthcare Conference.

    Details of the presentations are as follows:

    Event:Raymond James 42nd Annual Virtual Institutional Investors Conference
    Format:Fireside Chat and 1x1 Meetings
    Fireside Chat Date:Wednesday, March 3, 2021
    Fireside Chat Time:3:50pm ET
      
    Event:Cowen 41st Annual Virtual Healthcare Conference
    Format:Fireside Chat and 1x1 Meetings
    Fireside Chat Date:Thursday, March

    EWING, N.J., Feb. 24, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to present and host investor meetings at the Raymond James 42nd Annual Virtual Institutional Investors Conference and the Cowen 41st Annual Virtual Healthcare Conference.

    Details of the presentations are as follows:

    Event:Raymond James 42nd Annual Virtual Institutional Investors Conference
    Format:Fireside Chat and 1x1 Meetings
    Fireside Chat Date:Wednesday, March 3, 2021
    Fireside Chat Time:3:50pm ET
      
    Event:Cowen 41st Annual Virtual Healthcare Conference
    Format:Fireside Chat and 1x1 Meetings
    Fireside Chat Date:Thursday, March 4, 2021
    Fireside Chat Time:9:10am ET

    A live webcast of the fireside chats will be available under the "For Investors" section of the Antares Pharma website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the 2020 and 2021 full-year revenue guidance; the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; successful commercialization of NOCDURNA® in the United States and market acceptance and future revenue from the same: commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the recent FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; future prescriptions and sales of OTREXUP®; Teva's ability to successfully commercialize generic teriparatide in 11 countries in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's pending ANDA for generic Forteo® and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com



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  19. EWING, N.J., Feb. 23, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced it will release its fourth quarter and full-year 2020 financial and operating results on Tuesday, March 2, 2021, before the market opens.

    Antares will host a conference call on Tuesday, March 2, 2021 at 8:30am ET to discuss the results. The dial-in numbers are (888) 254-3590 for domestic callers and (323) 994-2093 for international callers. The conference ID number is 1389407. A live webcast and replay of the conference call will be available online from the investor relations section of the Antares Pharma corporate website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc…

    EWING, N.J., Feb. 23, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced it will release its fourth quarter and full-year 2020 financial and operating results on Tuesday, March 2, 2021, before the market opens.

    Antares will host a conference call on Tuesday, March 2, 2021 at 8:30am ET to discuss the results. The dial-in numbers are (888) 254-3590 for domestic callers and (323) 994-2093 for international callers. The conference ID number is 1389407. A live webcast and replay of the conference call will be available online from the investor relations section of the Antares Pharma corporate website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the 2020 and 2021 full-year revenue guidance; the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; successful commercialization of NOCDURNA® in the United States and market acceptance and future revenue from the same: commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the recent FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; future prescriptions and sales of OTREXUP®; Teva's ability to successfully commercialize generic teriparatide in 11 countries in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's pending ANDA for generic Forteo® and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com



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  20. EWING, N.J., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to participate and host investor meetings at the SVB Leerink 10th Annual Virtual Global Healthcare Conference being held on February 22-26, 2021.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various…

    EWING, N.J., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to participate and host investor meetings at the SVB Leerink 10th Annual Virtual Global Healthcare Conference being held on February 22-26, 2021.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the 2020 and 2021 full-year revenue guidance; the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; successful commercialization of NOCDURNA® in the United States and market acceptance and future revenue from the same: commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the recent FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; future prescriptions and sales of OTREXUP®; Teva's ability to successfully commercialize generic teriparatide in 11 countries in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's pending ANDA for generic Forteo® and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com



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  21. EWING, N.J., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced guidance for full-year 2021 and expects revenue to be in a range of $175 to $200 million, which assumes no significant disruptions to supply or operations due to the ongoing COVID-19 pandemic. The Company also updated its guidance for full-year 2020 and expects revenue to be in a range of $145 to $150 million from $135 to $155 million.

    Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, "We are pleased with the significant commercial advancements we made last year, primarily driven by strong demand for XYOSTED and Teva's generic EpiPen, despite the challenging…

    EWING, N.J., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced guidance for full-year 2021 and expects revenue to be in a range of $175 to $200 million, which assumes no significant disruptions to supply or operations due to the ongoing COVID-19 pandemic. The Company also updated its guidance for full-year 2020 and expects revenue to be in a range of $145 to $150 million from $135 to $155 million.

    Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, "We are pleased with the significant commercial advancements we made last year, primarily driven by strong demand for XYOSTED and Teva's generic EpiPen, despite the challenging environment due to the global pandemic. Based on these achievements, we have narrowed our full-year 2020 revenue guidance. As we look ahead, we expect growing demand for XYOSTED and the generic EpiPen, in addition to a successful relaunch of NOCDURNA. Our expectations for 19-36% year-over-year revenue growth in 2021, based on the mid-point of the 2020 guidance, also assumes a range of revenue scenarios for the potential approval and launch of Forteo by our partner Teva in the U.S."

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the 2020 and 2021 full-year revenue guidance; the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; successful commercialization of NOCDURNA® in the United States and market acceptance and future revenue from the same: commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG Pharmaceuticals' Makena® subcutaneous auto injector following the recent FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether Makena® will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; future prescriptions and sales of OTREXUP®; Teva's ability to successfully commercialize generic teriparatide in 11 countries in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's pending ANDA for generic Forteo® and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com



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  22. EWING, N.J., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced that Robert F. Apple, President and Chief Executive Officer has participated in a fireside chat presentation and will host investor meetings at the Piper Sandler 32nd Annual Virtual Healthcare Conference being held on December 1-3, 2020.

    The pre-recorded webcast of the fireside chat will be available under the "For Investors" section of the Antares Pharma website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using…

    EWING, N.J., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced that Robert F. Apple, President and Chief Executive Officer has participated in a fireside chat presentation and will host investor meetings at the Piper Sandler 32nd Annual Virtual Healthcare Conference being held on December 1-3, 2020.

    The pre-recorded webcast of the fireside chat will be available under the "For Investors" section of the Antares Pharma website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), Covis Pharma (Covis), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the 2020 full-year revenue guidance; the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; successful commercialization of NOCDURNA® in the United States and market acceptance and future revenue from the same: commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; whether the FDA will withdraw marketing approval for Covis' Makena® subcutaneous auto injector following the recent FDA letter seeking withdrawal, whether Covis will be granted an appeal hearing and if granted, whether Covis will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; future prescriptions and sales of OTREXUP®; Teva's ability to successfully commercialize generic teriparatide in 11 countries in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's pending ANDA for generic Forteo and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com 



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  23. EWING, N.J., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced that Robert F. Apple, President and Chief Executive Officer is scheduled to present at the Jefferies Virtual London Healthcare Conference.

    Details of the presentation are as follows:

    Event:Jefferies Virtual London Healthcare Conference
    Format:Fireside Chat and 1x1 Meetings
    Fireside Chat Date:Tuesday, November 17, 2020
    Fireside Chat Time:1:45pm ET

    A live webcast of the fireside chat will be available under the "For Investors" section of the Antares Pharma website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the…

    EWING, N.J., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced that Robert F. Apple, President and Chief Executive Officer is scheduled to present at the Jefferies Virtual London Healthcare Conference.

    Details of the presentation are as follows:

    Event:Jefferies Virtual London Healthcare Conference
    Format:Fireside Chat and 1x1 Meetings
    Fireside Chat Date:Tuesday, November 17, 2020
    Fireside Chat Time:1:45pm ET

    A live webcast of the fireside chat will be available under the "For Investors" section of the Antares Pharma website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc. (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the reinstated 2020 full-year revenue guidance; the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; successful commercialization of NOCDURNA® in the United States and market acceptance and future revenue from the same: commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG's Makena® subcutaneous auto injector following the recent FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether AMAG will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; future prescriptions and sales of OTREXUP®; Teva's ability to successfully commercialize generic teriparatide in 11 countries in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's pending ANDA for generic Forteo and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com

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  24. Third Quarter 2020 Revenue Increases 17% Year-Over-Year to $40.0 Million

    Third Quarter 2020 Net Income of $5.0 Million, or EPS of $0.03

    EWING, N.J., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today reported financial and operating results for the third quarter ended September 30, 2020 with record revenue of $40.0 million and net income of $5.0 million, or earnings per share of $0.03. The Company also reported record nine-month year-to-date revenue of $105.5 million, a 23% increase versus the first nine months of 2019.

    "We are excited to report another quarter of strong financial results that illustrate the significant growth across our diversified…

    Third Quarter 2020 Revenue Increases 17% Year-Over-Year to $40.0 Million

    Third Quarter 2020 Net Income of $5.0 Million, or EPS of $0.03

    EWING, N.J., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today reported financial and operating results for the third quarter ended September 30, 2020 with record revenue of $40.0 million and net income of $5.0 million, or earnings per share of $0.03. The Company also reported record nine-month year-to-date revenue of $105.5 million, a 23% increase versus the first nine months of 2019.

    "We are excited to report another quarter of strong financial results that illustrate the significant growth across our diversified business of both proprietary and partner revenue. Our total revenue increased almost 17% year-over-year to $40.0 million, primarily driven by strong demand for XYOSTED and Teva's generic Epipen. XYOSTED continues to represent our biggest growth driver, with 129% quarterly growth and 237% year-to-date growth in total prescriptions compared to the same periods in 2019. We believe the ongoing challenges for patients and physicians due to the pandemic will further support the increased demand for an easy-to-use, painless at-home testosterone replacement therapy. While we also remain committed to the development of our internal pipeline focused on urology and endocrinology, we are excited about the recent U.S. licensing of NOCDURNA which immediately expands our proprietary portfolio offering and leverages our existing salesforce given the significant overlap in urology call points," said Robert F. Apple, President and Chief Executive Officer of Antares Pharma.

    "Furthermore, we have a development pipeline with our partners that we believe are underappreciated opportunities. As generic teriparatide is launched in 11 European countries, Canada and Israel by Teva, we remain eager for the potential U.S approval. We also look forward to Idorsia initiating their Phase 3 trial for the selatogrel pen and being able to provide a timeline for the Pfizer program as we look ahead. Overall, we believe our diversified business will continue to advance and support our future aggressive growth," Mr. Apple concluded.

    Third Quarter 2020 and Recent Highlights

    • Reported third quarter 2020 total revenue of $40.0 million, an increase of 17% compared to $34.3 million in the same period last year.   Proprietary product revenue increased 38% to $15.8 million compared to $11.5 million in the third quarter of 2019. Total partnered product, development and royalty revenue was $24.2 million for the third quarter 2020 compared to $22.8 million in the third quarter 2019, representing an increase of 6%.



    • Reported third quarter 2020 net income of $5.0 million, or earnings per share of $0.03 compared to net income of $1.0 million, or earnings per share of $0.01 in the comparable period last year.         
    • XYOSTED® total prescriptions in the third quarter 2020 increased 15% sequentially and 129% year-over-year, according to IQVIA.



    • Entered into an exclusive license agreement with Ferring Pharmaceuticals for the marketed urology product NOCDURNA® (desmopressin acetate), which is indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to urinate, in the United States.

    Third Quarter 2020 Financial Results

    Total revenue generated from product sales, license and development activities and royalties was $40.0 million for the three months ended September 30, 2020, a 17% increase compared to $34.3 million in the same period in 2019. For the nine months ended September 30, 2020, total revenue was $105.5 million, a 23% increase from $86.0 million for the comparable period in 2019.

    Product sales were $28.9 million for the three months ended September 30, 2020, a 17% increase compared to $24.7 million for the same period in 2019. For the nine-month period ended September 30, 2020, product sales were $80.7 million, a 27% increase from $63.6 million in the comparable period in 2019.   

    Sales of our proprietary products XYOSTED® and OTREXUP® generated revenue of $15.8 million and $43.2 million for the three and nine months ended September 30, 2020, respectively, as compared to $11.5 million and $25.2 million for the three and nine months ended September 30, 2019, respectively. The 38% and 71% increase in proprietary product sales for the three and nine months ended September 30, 2020 respectively, compared to the three and nine months ended September 30, 2019 were principally attributable to continued growth in prescriptions and sales of XYOSTED®.

    Partnered product sales were $13.2 million for both the three months ended September 30, 2020 and 2019, and $37.5 million and $38.4 million for the nine months ended September 30, 2020 and 2019, respectively. The net decrease in sales of partnered products for the nine months ended September 30, 2020 as compared to the same period in 2019 is attributable to decreased sales of needle-free devices to Ferring, a decrease in sales of Makena® auto injectors to AMAG and a reduction in pre-launch quantities of generic teriparatide devices sold to Teva in previous periods.   These decreases were offset by an increase in sales to Teva of their generic EpiPen auto-injectors.

    Licensing and development revenue was $4.3 million and $8.8 million for the three and nine-month periods ended September 30, 2020, respectively, as compared to $1.2 million and $4.4 million for the comparable periods in 2019, respectively. The increase in licensing and development revenue for the nine months ended September 30, 2020 was primarily from the Pfizer rescue pen and the Idorsia selatogrel pen development programs.

    Royalty revenue was $6.7 million for the three months ended September 30, 2020 compared to $8.4 million for the same period in 2019. For the nine-month period ended September 30, 2020, royalty revenue was $16.0 million, as compared to $18.1 million for the same period in 2019. The net decrease in royalty revenue was primarily attributable to a decline in royalties recognized from AMAG on their net sales of the Makena® subcutaneous auto injectors offset by an increase in royalties from Teva on their net sales of Epinephrine Injection USP.

    Gross profit was $23.5 million and $21.2 million for the three months ended September 30, 2020 and 2019, respectively, and $61.4 million and $49.6 million for the nine months ended September 30, 2020 and 2019, respectively. The increase in gross profit was primarily attributable to the increase in proprietary product sales.

    Total operating expenses were $17.6 million for the third quarter of 2020 compared to $19.2 million in the comparable period of 2019. Total operating expenses for the nine months ended September 30, 2020 were $53.9 million as compared to $54.2 million for the comparable period in 2019. The decrease in operating expenses for the three and nine-month periods of 2020 as compared to the same periods in 2019 was primarily attributable to a reduction in sales and marketing costs incurred as a result of the various stay-at-home orders and travel restrictions related to COVID-19.

    Net income was $5.0 million, or $0.03 per share for the third quarter of 2020, compared to $1.0 million, or $0.01 per share in the same period in 2019. Net income was $4.8 million, or $0.03 per share for the nine months ended September 30, 2020 compared to a net loss of $6.7 million, or $0.04 loss per share in the comparable period of 2019.

    As of September 30, 2020, cash, cash equivalents and short-term investments were $52.2 million compared to $45.7 million as of December 31, 2019. Cash generated from operations was $14.2 million for the nine months ended September 30, 2020, compared to cash used in operations of $9.5 million for the nine months ended September 30, 2019.

    Full-Year 2020 Financial Guidance

    The Company today reaffirmed full-year 2020 revenue guidance in the range of $135 to $155 million, which represents a 9% to 25% year-over-year growth rate.

    Webcast and Conference Call Information

    The Antares management team will provide a Company update and review third quarter 2020 financial results via conference call and webcast today, November 5, 2020, at 8:30am ET (Eastern Time). The webcast of the conference call will include a slide presentation, which can be accessed in the investor relations section of the Company's website (www.antarespharma.com) under "Webcasts & Presentations". Alternatively, callers may participate in the audio portion of the conference call by dialing (888) 204-4368 for domestic callers and (323) 994-2093 for international callers. Callers should reference the Antares Pharma conference call or conference ID number 6925216.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc. (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the reinstated 2020 full-year revenue guidance; the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; successful commercialization of NOCDURNA® in the United States and market acceptance and future revenue from the same: commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; whether the FDA will withdraw marketing approval for AMAG's Makena® subcutaneous auto injector following the recent FDA letter seeking withdrawal, whether AMAG will be granted an appeal hearing and if granted, whether AMAG will be successful and future prescriptions, market acceptance and revenue from the same; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; future prescriptions and sales of OTREXUP®; Teva's ability to successfully commercialize generic teriparatide in 11 countries in Europe, Canada and Israel and future revenue from the same, successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's pending ANDA for generic Forteo and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including Pfizer's undisclosed development product; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com

    TABLES TO FOLLOW



    ANTARES PHARMA, INC.

    Table 1 - CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS

    (amounts in thousands, except per share amounts)

    (unaudited)

      Three Months Ended      Nine Months Ended     
      September 30,  Increase  September 30,  Increase 
      2020  2019  (Decrease)  2020  2019  (Decrease) 
    Revenue:                        
    Product sales $28,947  $24,687  17%  $80,709  $63,607  27% 
    Licensing and development revenue  4,321   1,211  257%   8,763   4,365  101% 
    Royalties  6,735   8,408  (20)%   15,994   18,053  (11)% 
    Total revenue  40,003   34,306  17%   105,466   86,025  23% 
    Cost of Revenue  16,517   13,062  26%   44,041   36,449  21% 
    Gross profit  23,486   21,244  11%   61,425   49,576  24% 
    Research and development  2,405   2,863  (16)%   7,803   7,744  1% 
    Selling, general and administrative  15,231   16,385  (7)%   46,101   46,407  (1)% 
    Total operating expenses  17,636   19,248  (8)%   53,904   54,151  0% 
    Operating income (loss)  5,850   1,996  193%   7,521   (4,575) ** 
    Other expense  (854)  (953) (10)%   (2,706)  (2,147) 26% 
    Net income (loss) $4,996  $1,043  379%  $4,815  $(6,722) ** 
    Net income (loss) per common share, basic and diluted $0.03  $0.01      $0.03  $(0.04)    
    Weighted average common shares outstanding:                        
    Basic  166,375   163,119       165,838   162,109     
    Diluted  169,655   168,503       169,759   162,109     
                             

    ANTARES PHARMA, INC.

    Table 2 – CONSOLIDATED DETAIL OF REVENUE FROM PRODUCT SALES

    (amounts in thousands)

    (unaudited)

      Three Months Ended  Nine Months Ended 
      September 30,  September 30, 
      2020  2019  2020  2019 
    Product sales:                
    XYOSTED® $12,245  $7,020  $32,150  $12,346 
    OTREXUP®  3,520   4,438   11,027   12,867 
    Partnered product sales  13,182   13,229   37,532   38,394 
    Total product sales $28,947  $24,687  $80,709  $63,607 



    ANTARES PHARMA, INC.


    Table 3 – CONSOLIDATED CONDENSED BALANCE SHEETS

    (amounts in thousands)

    (unaudited)

      September 30,  December 31, 
      2020  2019 
    Assets        
    Cash, cash equivalents and investments $52,169  $45,721 
    Accounts receivable  42,507   35,074 
    Inventories  19,809   16,000 
    Contract assets  8,784   8,235 
    Property and equipment, net  22,547   15,961 
    Other assets  9,758   11,760 
    Total Assets $155,574  $132,751 
             
    Liabilities and Stockholders' Equity        
    Accounts payable and accrued expenses $40,862  $30,677 
    Deferred revenue  3,277   1,738 
    Long-term debt and other liabilities  46,194   45,836 
    Stockholders' equity  65,241   54,500 
    Total Liabilities and Stockholders' Equity $155,574  $132,751 
             

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  25. EWING, N.J., Oct. 22, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced it will release its third quarter 2020 financial and operating results on Thursday, November 5, 2020, before the market opens.

    Antares will host a conference call on Thursday, November 5, 2020 at 8:30am ET to discuss the results. The dial-in numbers are (888) 204-4368 for domestic callers and (323) 994-2093 for international callers. The conference ID number is 6925216. A live webcast and replay of the conference call will be available online from the investor relations section of the Antares Pharma corporate website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is…

    EWING, N.J., Oct. 22, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced it will release its third quarter 2020 financial and operating results on Thursday, November 5, 2020, before the market opens.

    Antares will host a conference call on Thursday, November 5, 2020 at 8:30am ET to discuss the results. The dial-in numbers are (888) 204-4368 for domestic callers and (323) 994-2093 for international callers. The conference ID number is 6925216. A live webcast and replay of the conference call will be available online from the investor relations section of the Antares Pharma corporate website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc. (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to achieve the reinstated 2020 full-year revenue guidance; the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; successful commercialization of NOCDURNA® in the United States and market acceptance and future revenue from the same: adequate reimbursement coverage and commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; our expectations regarding whether the FDA will be successful in pursuing withdrawal of approval for AMAG's Makena® subcutaneous auto injector following the recent FDA advisory committee meeting and future prescriptions, market acceptance and revenue from the same ; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP®; successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; FDA approval of Teva's pending ANDA for generic Forteo and future revenue from the same; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com

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  26. EWING, N.J., Oct. 01, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced that it entered into an exclusive license agreement with Ferring Pharmaceuticals ("Ferring"), a research-driven, specialty biopharmaceutical group, for the marketed product NOCDURNA® (desmopressin acetate), which is indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to urinate, in the United States (U.S).

    "This license agreement for NOCDURNA immediately expands our urology portfolio, which already includes XYOSTED, the best-selling branded testosterone replacement product in the United States. With a launch expected later in…

    EWING, N.J., Oct. 01, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced that it entered into an exclusive license agreement with Ferring Pharmaceuticals ("Ferring"), a research-driven, specialty biopharmaceutical group, for the marketed product NOCDURNA® (desmopressin acetate), which is indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to urinate, in the United States (U.S).

    "This license agreement for NOCDURNA immediately expands our urology portfolio, which already includes XYOSTED, the best-selling branded testosterone replacement product in the United States. With a launch expected later in the fourth quarter, we look forward to leveraging the urology office call points of our 90-person national sales force and believe the significant overlap enhances execution efficiency and may provide for similar success in NOCDURNA as XYOSTED. Furthermore, we believe NOCDURNA supports our commercial strategy to enhance our growth through the expansion of our proprietary product portfolio," said Robert F. Apple, President and Chief Executive Officer of Antares Pharma. "We remain committed to improving patient care and believe nocturnal polyuria is a clinically underappreciated disease, which leaves a large untreated patient population and significant unmet medical need."

    Ferring commercially launched NOCDURNA® in late 2018 upon approval by the U.S. Food and Drug Administration (FDA) in June 2018 as the first and only rapidly dissolving sublingual tablet that treats adult patients with nocturia, who awaken at least two times per night to urinate, due to nocturnal polyuria (NP). More than 70 million people in the U.S. are affected by nocturia. NP is present in up to 88% of nocturia patients. Patients may already be taking medication for overactive bladder (OAB) or benign prostatic hyperplasia (BPH); however, these medications may not reduce night-time urination because they do not treat NP. In patients diagnosed with NP, the kidneys produce too much urine at night, which can lead to frequent night-time bathroom visits and can be very disruptive to sleep.

    Under the terms of the agreement, Ferring received an upfront payment of $5.0 million upon execution and will be paid an additional $2.5 million at one year from execution and is eligible for tiered royalties and additional commercial milestone payments potentially totalling up to $17.5 million based on net sales of NOCDURNA® in the United States.

    NOCDURNA® is patent-protected with Orange Book-listed patents in the United States with varying expirations through 2030.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc. (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.

    About Ferring Pharmaceuticals

    Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and orthopaedics. For more information, call 1-888-FERRING (1-888-337-7464); visit www.FerringUSA.com.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company's ability to successfully commercialize Nocdurna in the United States and market acceptance and future revenue from the same; the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on reinstated 2020 full-year revenue guidance, demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; market acceptance, adequate reimbursement coverage and commercial success of XYOSTED® and future revenue from the same; successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; our expectations regarding whether the FDA will pursue withdrawal of approval for AMAG Pharmaceuticals Inc.'s Makena® subcutaneous auto injector following the recent FDA advisory committee meeting and future prescriptions, market acceptance and revenue from Makena® subcutaneous auto injector; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP®; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3016

    tbui@antarespharma.com

     

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  27. EWING, N.J., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to present at the H.C. Wainwright 22nd Annual Global Virtual Investment Conference.

    Details of the presentation are as follows:

    Event:H.C. Wainwright 22nd Annual Global Virtual Investment Conference
    Format:Fireside Chat and 1x1 Meetings
    Fireside Chat Date:Monday, September 14, 2020
    Fireside Chat Time:1:30pm ET

    A live webcast of the fireside chat will be available under the "For Investors" section of the Antares Pharma website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology…

    EWING, N.J., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to present at the H.C. Wainwright 22nd Annual Global Virtual Investment Conference.

    Details of the presentation are as follows:

    Event:H.C. Wainwright 22nd Annual Global Virtual Investment Conference
    Format:Fireside Chat and 1x1 Meetings
    Fireside Chat Date:Monday, September 14, 2020
    Fireside Chat Time:1:30pm ET

    A live webcast of the fireside chat will be available under the "For Investors" section of the Antares Pharma website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc. (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described.  Factors that may cause such differences include, but are not limited to: the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on reinstated 2020 full-year revenue guidance, demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; market acceptance, adequate reimbursement coverage and commercial success of XYOSTED® and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; our expectations regarding whether the FDA will pursue withdrawal of approval for AMAG Pharmaceuticals Inc.'s Makena® subcutaneous auto injector following the recent FDA advisory committee meeting and future prescriptions, market acceptance and revenue from Makena® subcutaneous auto injector; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP®;  the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development including Idorsia Pharmaceuticals, Pfizer and Teva;  actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital;  the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission.  The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3020

    tbui@antarespharma.com

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  28. EWING, N.J., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced the appointment of Tram Bui as Vice President of Corporate Communications and Investor Relations.  Ms. Bui will succeed Jack Howarth, Vice President of Corporate Affairs, upon his retirement on August 31, 2020. Tram will report to Fred Powell, Antares Pharma's Chief Financial Officer.

    "I am excited to welcome Tram to Antares to lead our corporate communications and investor relations strategy. We look forward to leveraging her extensive industry experience and strong relationships with the investment community as the Company continues on its growth trajectory," said Fred M. Powell, Executive…

    EWING, N.J., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced the appointment of Tram Bui as Vice President of Corporate Communications and Investor Relations.  Ms. Bui will succeed Jack Howarth, Vice President of Corporate Affairs, upon his retirement on August 31, 2020. Tram will report to Fred Powell, Antares Pharma's Chief Financial Officer.

    "I am excited to welcome Tram to Antares to lead our corporate communications and investor relations strategy. We look forward to leveraging her extensive industry experience and strong relationships with the investment community as the Company continues on its growth trajectory," said Fred M. Powell, Executive Vice President and Chief Financial Officer of the Company. "I would also like to thank Jack for his dedication and many contributions to the company since 2012. He has been instrumental to the development of the Company's communications strategy and we wish him the best of luck in his retirement."  

    Ms. Bui joins Antares Pharma with over 15 years of equity research, communications and investor relations experience. Most recently, she served as Senior Vice President, Investor Relations at The Ruth Group, a boutique investor relations and communications firm specializing in life science and medical technology industries.  Prior to The Ruth Group, Ms. Bui served as a Director at KCSA Strategic Communications, a public and investor relations agency, focused on developing successful investor communications platforms and capital raises for a broad base of public healthcare companies.  Previously, she was a buy-side healthcare analyst for a small cap fund at Lazard Asset Management and served as an institutional equity sales associate at CJS Securities. Ms. Bui received her Bachelor of Science in Marketing from the University of New Orleans.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology.  The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc. (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia).  Antares Pharma's FDA approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described.  Factors that may cause such differences include, but are not limited to: Teva's successful commercialization of teriparatide injection in Europe and future revenue from the same; the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on reinstated 2020 full-year revenue guidance, demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; market acceptance, adequate reimbursement coverage and commercial success of XYOSTED® and future revenue from the same; successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; the ability of Lunatus to obtain regulatory approvals for XYOSTED in Saudi Arabia and UAE and successfully commercialize the product and future revenue from the same; our expectations regarding whether the FDA will pursue withdrawal of approval for AMAG Pharmaceuticals Inc.'s Makena® subcutaneous auto injector following the recent FDA advisory committee meeting and future prescriptions, market acceptance and revenue from Makena® subcutaneous auto injector; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP®;  the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital;  the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission.  The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Tram Bui

    Vice President, Corporate Communications and Investor Relations

    609-359-3020

    tbui@antarespharma.com

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    • Second Quarter 2020 Revenue of $32.4 Million, a 14% Increase Compared to Second Quarter 2019

    • Second Quarter 2020 Net Income of $2.2 Million as Compared to Net Loss of $2.2 Million for Second Quarter 2019
       
    • Reinstates Full-Year 2020 Revenue Guidance Range of $135 to $155 Million

    EWING, N.J., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today reported operating and financial results for the second quarter ended June 30, 2020 with record second quarter revenue of $32.4 million and net income of $2.2 million, or earnings per share of $0.01.  The Company also reported record six-month year-to-date revenue of $65.5 million, a 27% increase versus the first six months of 2019…

    • Second Quarter 2020 Revenue of $32.4 Million, a 14% Increase Compared to Second Quarter 2019



    • Second Quarter 2020 Net Income of $2.2 Million as Compared to Net Loss of $2.2 Million for Second Quarter 2019

       
    • Reinstates Full-Year 2020 Revenue Guidance Range of $135 to $155 Million

    EWING, N.J., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today reported operating and financial results for the second quarter ended June 30, 2020 with record second quarter revenue of $32.4 million and net income of $2.2 million, or earnings per share of $0.01.  The Company also reported record six-month year-to-date revenue of $65.5 million, a 27% increase versus the first six months of 2019.

    "I am very proud of the Antares team for delivering strong quarterly results while navigating the challenges presented by the COVID-19 pandemic. We remain committed to protecting the health and safety of our employees, patients, and health care providers while effectively operating our business to meet the needs of our partners and patients during this unprecedented time. The Company's second quarter revenue of $32.4 million, which represents 14% year-over-year growth, was primarily driven by our proprietary product XYOSTED. The second quarter had the highest number of XYOSTED prescriptions to date, and we believe this is the result of the tremendous execution by our commercial team and highlights the demand for an easy to use, painless at-home testosterone injection option given limited physician and patient access at this time. Revenue from proprietary products, XYOSTED and OTREXUP, our highest margin products, grew 65% in the quarter versus the same period last year and now represent 60% of our total product revenue," said Robert F. Apple, President and Chief Executive Officer of the Company.

    "We also continued to advance our product pipeline with the recently launched Teriparatide Injection ("teriparatide") by Teva, the generic version of Eli Lilly's brand Forsteo, in Canada and certain countries in Europe. According to Teva, the initial launch of teriparatide, which utilizes our multi-dose pen technology, will expand into other European countries later this year.  Additionally, we look forward to a potential U.S. approval of a generic Forteo later this year. Finally, while the pandemic continues to pose some uncertainty for the second half of the year, we are encouraged by the growth of our business and the opportunities ahead, and therefore we have reinstated our revenue guidance for the full year," Mr. Apple concluded.

    Second Quarter 2020 and Recent Highlights

    • Reported second quarter total 2020 revenue of $32.4 million, an increase of 14% compared to the same period last year.  Proprietary product revenue increased 65% to $14.8 million as compared to $9.0 million in the second quarter of 2019.  Reported second quarter 2020 earnings per share of $0.01 as compared to a $0.01 loss per share reported in the comparable period last year.

       
    • According to Symphony Health Solutions, XYOSTED® total prescriptions increased 11% sequentially versus the first quarter of 2020.  Since the product launched, more than one hundred thirty-two thousand prescriptions of XYOSTED® have been written by almost six thousand different physicians.

       
    • Announced the first commercial product using Antares Pharma's multi-dose pen platform was launched by the Company's development partner Teva Pharmaceutical Industries, Ltd.  Teriparatide Injection, the generic version of Eli Lilly's brand product Forsteo® was launched in Austria, Croatia, Denmark, Hungary, Ireland, The Netherlands, Portugal, Sweden, Switzerland, The United Kingdom as well as Canada and Israel.  Teva has indicated they expect to launch in other European countries later this year.

       
    • Announced an exclusive distribution agreement with Lunatus Global Medical Supplies to register, promote and distribute XYOSTED® in Saudi Arabia and the United Arab Emirates.

       
    • Cash, cash equivalents and short-term investments increased to $51.6 million at June 30, 2020, compared to $45.7 million at December 31, 2019.

    Second Quarter 2020 Financial Results

    Total revenue generated from product sales, development activities and royalties was $32.4 million for the three months ended June 30, 2020, a 14% increase compared to $28.4 million in the same period in 2019.  For the six months ended June 30, 2020, total revenue was $65.5 million, a 27% increase from $51.7 million for the comparable period in 2019.

    Product sales were $24.7 million for the three months ended June 30, 2020, a 20% increase compared to $20.6 million for the same period in 2019.  For the six-month period ended June 30, 2020, product sales were $51.8 million, a 33% increase from $38.9 million in the comparable period in 2019.   

    Sales of our proprietary products XYOSTED® and OTREXUP® generated revenue of $14.8 million and $27.4 million for the three and six months ended June 30, 2020, respectively, as compared to $9.0 million and $13.8 million for the three and six months ended June 30, 2019, respectively. The 65% and 99% increase in proprietary product sales for the three and six months ended June 30, 2020 respectively, compared to the three and six months ended June 30, 2019 were principally attributable to sales of XYOSTED®

    Partnered device sales were $9.8 million and $11.6 million for the three months ended June 30, 2020 and 2019, respectively, and $24.4 million and $25.2 million for the six months ended June 30, 2020 and 2019, respectively. The decrease in sales of partnered products for the three and six months ended June 30, 2020 as compared to the same period in 2019 is primarily attributable to a decrease in sales of needle-free devices to Ferring, and a decrease in sales of Sumatriptan Injection USP and  teriparatide devices to Teva.  Antares previously announced the divestiture of the needle-free device to Ferring and shipment of pre-launch quantities of teriparatide devices to Teva during the first two quarters of 2019.

    Licensing and development revenue was $2.7 million and $4.4 million for the three and six-month periods ended June 30, 2020, respectively, compared to $2.2 million and $3.2 million for the comparable periods in 2019, respectively.  Licensing and development revenue for the three and six- month periods was primarily from the Pfizer rescue pen and the Idorsia selatogrel pen development programs.

    Royalty revenue was $5.0 million for the three months ended June 30, 2020 compared to $5.6 million for the same period in 2019.  For the six-month period ended June 30, 2020, royalty revenue was $9.3 million, compared to $9.6 million for the same period in 2019.  The decrease in royalty revenue for the three and six-month periods were primarily attributable to a decline in royalties recognized from AMAG on their net sales of the Makena® subcutaneous auto injector.

    Operating expenses were $16.9 million for the second quarter of 2020 compared to $17.6 million in the comparable period of 2019.  Total operating expenses for the six months ended June 30, 2020 were $36.3 million as compared to $34.9 million for the comparable period in 2019.  The increase in operating expenses for the six-month period of 2020 as compared to the same period in 2019 was primarily attributable to increased head count as well as increased non-cash incentive compensation expense.

    Net income was $2.2 million, or $0.01 per share for the second quarter of 2020, compared to a net loss of $2.2 million, or $0.01 per share in the same period in 2019.  Net loss was $0.2 million, or $0.00 per share for the six months ended June 30, 2020 compared to a net loss of $7.8 million, or $0.05 per share in the comparable period of 2019. 

    At June 30, 2020, cash, cash equivalents and short-term investments were $51.6 million compared to $45.7 million at December 31, 2019.

    2020 Financial Guidance

    The Company today reinstated 2020 full-year revenue guidance in a range of $135 to $155 million, which represents a 9% to 25% year-over-year growth rate.  Given the unprecedented and unpredictable environment created by the COVID-19 pandemic, we reserve the right to revisit revenue guidance at some future point in time.

    Webcast and Conference Call Information

    Antares executives will provide a Company update and review second quarter 2020 financial results via webcast and conference call today, August 6, 2020, at 8:30 a.m. ET (Eastern Time).  The webcast of the conference call, which will include a slide presentation, can be accessed through the link located on the "For Investors" section of the Company's website (www.antarespharma.com) under "Webcasts & Presentations".  Alternatively, callers may participate in the audio portion of the conference call by dialing toll free 1-800-353-6461, or 1-334-323-0501.  Callers should reference the Antares Pharma conference call or conference identification code 5888699.  Callers can access the slide presentation on the "For Investors" section of the Company's website under "Webcasts & Presentations". 

    A telephone replay of the conference call will be available from 11:30 a.m. ET on Thursday, August 6, 2020 through 11:30 a.m. ET on Saturday, September 5, 2020.  To access the replay, callers should dial 1-888-203-1112 or 1-719-457-0820 and enter passcode 5888699. 

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology.  The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc. (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia).  Antares Pharma's FDA approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described.  Factors that may cause such differences include, but are not limited to: Teva's successful commercialization of teriparatide injection in Europe and future revenue from the same; the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on reinstated 2020 full-year revenue guidance, demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; market acceptance, adequate reimbursement coverage and commercial success of XYOSTED® and future revenue from the same; successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; the ability of Lunatus to obtain regulatory approvals for XYOSTED® in Saudi Arabia and UAE and successfully commercialize the product and future revenue from the same; our expectations regarding whether the FDA will pursue withdrawal of approval for AMAG Pharmaceuticals Inc.'s Makena® subcutaneous auto injector following the recent FDA advisory committee meeting and future prescriptions, market acceptance and revenue from Makena® subcutaneous auto injector; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP®;  the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development;  actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital;  the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission.  The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Jack Howarth

    Vice President, Corporate Affairs

    609-359-3016

    jhowarth@antarespharma.com



    ANTARES PHARMA, INC.

    Table 1 - CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS

    (amounts in thousands except per share amounts)

    (unaudited)

      Three Months Ended      Six Months Ended     
      June 30,  Increase  June 30,  Increase 
      2020  2019  (Decrease)  2020  2019  (Decrease) 
    Revenue:                        
    Product sales $24,665  $20,620  20%  $51,762  $38,920  33% 
    Licensing and development revenue  2,687   2,239  20%   4,442   3,154  41% 
    Royalties  5,032   5,574  -10%   9,259   9,645  -4% 
    Total revenue  32,384   28,433  14%   65,463   51,719  27% 
    Cost of Revenue  12,477   12,441  0%   27,524   23,387  18% 
    Gross profit  19,907   15,992  24%   37,939   28,332  34% 
    Research and development  2,417   2,494  -3%   5,398   4,881  11% 
    Selling, general and administrative  14,448   15,087  -4%   30,870   30,022  3% 
    Total operating expenses  16,865   17,581  -4%   36,268   34,903  4% 
    Operating income (loss)  3,042   (1,589) **   1,671   (6,571) ** 
    Other expense  (867)  (637) 36%   (1,852)  (1,194) 55% 
    Net income (loss) $2,175  $(2,226) **  $(181) $(7,765) -98% 
    Net income (loss) per common share, basic and diluted $0.01  $(0.01)     $(0.00) $(0.05)    
    Weighted average common shares outstanding:                        
    Basic  165,703   162,734       165,566   161,596     
    Diluted  169,228   162,734       165,566   161,596     
                             





    ANTARES PHARMA, INC.

    Table 2 – CONSOLIDATED DETAIL OF REVENUE FROM PRODUCT SALES

    (amounts in thousands)

    (unaudited)

      Three Months Ended  Six Months Ended 
      June 30,  June 30, 
      2020  2019  2020  2019 
    Product sales:                
    XYOSTED® $10,902  $4,623  $19,905  $5,326 
    OTREXUP®  3,944   4,361   7,507   8,429 
    Partnered product sales  9,819   11,636   24,350   25,165 
    Total product sales $24,665  $20,620  $51,762  $38,920 
                     





    ANTARES PHARMA, INC.

    Table 3 – CONSOLIDATED CONDENSED BALANCE SHEETS

    (amounts in thousands)

    (unaudited)

      June 30,  December 31, 
      2020  2019 
    Assets        
    Cash, cash equivalents and investments $51,550  $45,721 
    Accounts receivable  34,293   35,074 
    Inventories  19,605   16,000 
    Contract assets  7,013   8,235 
    Equipment, molds, furniture and fixtures, net  19,452   15,961 
    Right of use assets  4,860   5,463 
    Other assets  6,351   6,297 
    Total Assets $143,124  $132,751 
             
    Liabilities and Stockholders' Equity        
    Accounts payable and accrued expenses $37,633  $30,677 
    Deferred revenue  2,341   1,738 
    Long-term debt and other liabilities  45,821   45,836 
    Stockholders' equity  57,329   54,500 
    Total Liabilities and Stockholders' Equity $143,124  $132,751 
             

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  29. EWING, N.J., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS), a pharmaceutical technology company, today announced they have entered into an exclusive distribution agreement with Lunatus Global Medical Supplies ("Lunatus") to distribute and promote the sale of  XYOSTED® in Saudi Arabia and the United Arab Emirates ("UAE"). 

    Under the agreement, Antares will be responsible for the supply of fully packaged product to Lunatus and Lunatus will be responsible for submitting and obtaining regulatory approval for XYOSTED® in Saudi Arabia and the UAE as well as marketing, promotion and distribution of XYOSTED® in these two countries.

    "We believe today's announcement represents the first step in creating increased brand awareness…

    EWING, N.J., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS), a pharmaceutical technology company, today announced they have entered into an exclusive distribution agreement with Lunatus Global Medical Supplies ("Lunatus") to distribute and promote the sale of  XYOSTED® in Saudi Arabia and the United Arab Emirates ("UAE"). 

    Under the agreement, Antares will be responsible for the supply of fully packaged product to Lunatus and Lunatus will be responsible for submitting and obtaining regulatory approval for XYOSTED® in Saudi Arabia and the UAE as well as marketing, promotion and distribution of XYOSTED® in these two countries.

    "We believe today's announcement represents the first step in creating increased brand awareness for XYOSTED in the rest of the world, and look forward to working with our partner Lunatus in that endeavour.  XYOSTED is currently the fastest growing branded testosterone replacement therapy in the U.S.," said Robert F. Apple, President and Chief Executive Officer of the Company."  He continued, "Current treatment options in these two countries include a painful hospital administered testosterone injection given every three months or a topical gel.  Alternatively, XYOSTED would be an attractive new treatment option for physicians and patients given its unique product profile featuring a virtually painless, once-weekly, at-home subcutaneous self-injection.  Lunatus, a Dubai based company, has a proven track record of introducing, building and maintaining profitable brands in the Arabian Gulf and Middle East regions.  We believe this agreement will help lay the groundwork for expanding our global footprint for XYOSTED and represents the first of potentially multiple international distribution agreements."

    "We are excited to bring XYOSTED to Saudi Arabia and the UAE.  XYOSTED is a U.S. FDA approved treatment option for adult men diagnosed with testosterone deficiency," said Dr. Lina Kouatly, President and Chief Executive Officer of Lunatus.  "Assuming regulatory approval in these two countries, we believe our partnership can achieve significant share and expand the market using this novel treatment approach."  

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology.  The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc. (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia).  Antares Pharma's proprietary products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described.  Factors that may cause such differences include, but are not limited to: Lunatus' ability to obtain regulatory approval and successfully commercialize XYOSTED in Saudi Arabia and the United Arab Emirates and the amount of revenue from the same, the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; market acceptance, adequate reimbursement coverage and commercial success of XYOSTED® and future revenue from the same; successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; our expectations regarding whether the FDA will pursue withdrawal of approval for AMAG Pharmaceuticals Inc.'s Makena® subcutaneous auto injector following the recent FDA advisory committee meeting and future prescriptions, market acceptance and revenue from Makena® subcutaneous auto injector; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP®;  the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development;  actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital;  the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission.  The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contacts:

    Jack Howarth

    Vice President, Corporate Affairs

    609-359-3016

    jhowarth@antarespharma.com

    Primary Logo

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  30. EWING, N.J., July 30, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS), a pharmaceutical technology company, today announced it will release its second quarter 2020 financial results and recent operating progress before the market opens on Thursday, August 6, 2020.  Management will host a webcast and conference call at 8:30 a.m. ET (Eastern Time) on August 6, 2020 to discuss the results.

    Interested parties may participate in the conference call by dialing 1-800-353-6461 or 1-334-323-0501 and entering access code 5888699.  We encourage interested parties to dial into the conference call at least 10 minutes prior to the scheduled start time.  A replay of the conference call will be available from 11:30 a.m. ET on Thursday, August…

    EWING, N.J., July 30, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS), a pharmaceutical technology company, today announced it will release its second quarter 2020 financial results and recent operating progress before the market opens on Thursday, August 6, 2020.  Management will host a webcast and conference call at 8:30 a.m. ET (Eastern Time) on August 6, 2020 to discuss the results.

    Interested parties may participate in the conference call by dialing 1-800-353-6461 or 1-334-323-0501 and entering access code 5888699.  We encourage interested parties to dial into the conference call at least 10 minutes prior to the scheduled start time.  A replay of the conference call will be available from 11:30 a.m. ET on Thursday, August 6, 2020 through 11:30 a.m. ET on Saturday, September 5, 2020 by dialing 1-888-203-1112 or 1-719-457-0820 and entering the access code 5888699.  An archive of the slide presentation will also be available under the "For Investors" section of the Antares Website at www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology.  The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc. (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia).  Antares Pharma's proprietary products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described.  Factors that may cause such differences include, but are not limited to: the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; market acceptance, adequate reimbursement coverage and commercial success of XYOSTED® and future revenue from the same; successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; our expectations regarding whether the FDA will pursue withdrawal of approval for AMAG Pharmaceuticals Inc.'s Makena® subcutaneous auto injector following the recent FDA advisory committee meeting and future prescriptions, market acceptance and revenue from Makena® subcutaneous auto injector; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP®;  the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development;  actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital;  the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission.  The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contacts:

    Jack Howarth

    Vice President, Corporate Affairs

    609-359-3016

    jhowarth@antarespharma.com

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  31. EWING, N.J., July 21, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("Antares") ("the Company"), a pharmaceutical technology company, announced the first commercialization of the Company's multi-dose pen platform launched in Europe. Antares development partner Teva, launched Teriparatide Injection ("teriparatide"), the generic version of Eli Lilly's brand product Forsteo®  featuring the Antares multi-dose pen platform in Austria, Croatia, Hungary, The Netherlands, Portugal, Sweden, Switzerland and The United Kingdom and is expected to launch in other European countries later this year.

    Teriparatide injection is a drug-device combination product indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid…

    EWING, N.J., July 21, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("Antares") ("the Company"), a pharmaceutical technology company, announced the first commercialization of the Company's multi-dose pen platform launched in Europe. Antares development partner Teva, launched Teriparatide Injection ("teriparatide"), the generic version of Eli Lilly's brand product Forsteo®  featuring the Antares multi-dose pen platform in Austria, Croatia, Hungary, The Netherlands, Portugal, Sweden, Switzerland and The United Kingdom and is expected to launch in other European countries later this year.

    Teriparatide injection is a drug-device combination product indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men, and in postmenopausal women and in men at increased risk of fracture.   

    "The European launch of this product represents the achievement of another milestone in our development collaboration with Teva.  This is the third successful approval and launch of a drug device combination product which follows the previous launches of the generic epinephrine auto injector and the generic sumatriptan auto injector," said Robert F. Apple, President and Chief Executive Officer of Antares Pharma. 

    Antares previously entered into an exclusive Development, License and Supply Agreement with Teva Pharmaceutical Industries, Ltd. ("Teva"), a global leader in generic and specialty medicines, for a teriparatide injection product to be marketed globally, once approved by the respective regulatory authorities.  Antares is responsible for the manufacturing and supply of the multi-dose pen utilized in Teva's generic teriparatide product.  The scope of the teriparatide license and supply agreement with Teva is worldwide.

    About Teriparatide Injection

    Teriparatide injection is used for the treatment of osteoporosis as the active substance, teriparatide, reduces the risk of bone fracture by stimulating bone formation.  Osteoporosis is a disease that is especially common in women after menopause, but it can also occur in both men and women as a side effect of glucocorticoid treatment. 

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology.  The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc. (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia).  Antares Pharma's FDA approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described.  Factors that may cause such differences include, but are not limited to: Teva's successful commercialization of teriparatide injection in Europe and future revenue from the same; the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; market acceptance, adequate reimbursement coverage and commercial success of XYOSTED® and future revenue from the same; successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; our expectations regarding whether the FDA will pursue withdrawal of approval for AMAG Pharmaceuticals Inc.'s Makena® subcutaneous auto injector following the recent FDA advisory committee meeting and future prescriptions, market acceptance and revenue from Makena® subcutaneous auto injector; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP®;  the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development;  actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital;  the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission.  The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Jack Howarth

    Vice President, Corporate Affairs

    609-359-3016 - jhowarth@antarespharma.com

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  32. EWING, N.J., July 20, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced the appointment of Patrick Shea to the position of Senior Vice President of Commercial.  Mr. Shea will be responsible for leading all commercial activities including sales, sales operations, marketing, trade and market access for the Company and will report to Robert F. Apple, Antares Pharma's President and Chief Executive Officer.   In his role, Mr. Shea's primary responsibilities will be to accelerate the positive growth trajectory of the Company's flagship product XYOSTED® as well as strategic assessment of future potential product opportunities for the commercial organization.  He will…

    EWING, N.J., July 20, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a pharmaceutical technology company, today announced the appointment of Patrick Shea to the position of Senior Vice President of Commercial.  Mr. Shea will be responsible for leading all commercial activities including sales, sales operations, marketing, trade and market access for the Company and will report to Robert F. Apple, Antares Pharma's President and Chief Executive Officer.   In his role, Mr. Shea's primary responsibilities will be to accelerate the positive growth trajectory of the Company's flagship product XYOSTED® as well as strategic assessment of future potential product opportunities for the commercial organization.  He will be replacing Edward Kessig, Senior Vice President of Commercial, who has recently announced his retirement.

    Mr. Shea has over three decades of sales, marketing, market access and commercial operations experience. Most recently Mr. Shea served as Chief Commercial Officer of Egalet Corporation, a specialty pharmaceutical company focused on developing, manufacturing, and commercializing innovative treatments for pain where he led a commercial organization of approximately 100 employees.  Prior to Egalet, he served as Chief Commercial Officer at Clarus Therapeutics, Inc., a men's health specialty pharmaceutical company.  Preceding Clarus he served as vice president of sales and marketing for the U.S. commercial operations of CSL Behring, where he oversaw strategic efforts for sales, marketing and managed care for a specialty biotherapeutics business.  Before that he served as senior vice president of sales and marketing for the U.S. pharmaceutical operations at Astellas Pharmaceuticals leading a commercial team of approximately 1,000, supporting a diverse specialty and critical care portfolio which included significant work in urology. Additional commercial leadership roles were also held at Ligand Pharmaceuticals (pain management and oncology) and Boehringer Ingelheim (urology).

    Robert F. Apple, President and Chief Executive Officer of Antares Pharma, stated, "We are very pleased to have someone with Pat's extensive sales and marketing background join the Antares senior leadership team.  With a proven track record of leading successful commercial organizations of varying sizes and diverse portfolios in the pharmaceutical industry, we believe Pat will be an extremely valuable asset to Antares as we enter the next phase of growth for XYOSTED."   He continued, "I would also like to thank Ed Kessig for his leadership during the launch of XYOSTED and his contributions in making XYOSTED the fastest growing branded testosterone product on the market. Additionally, we believe the commercial team's decision to strategically shift to virtual detailing earlier this year due to the COVID-19 crisis resulted in double digit percentage prescription growth in the second quarter of 2020 despite the challenging physician and patient access conditions that exist today." 

    Mr. Shea commented, "This is a terrific opportunity to join Antares at this time and be a part of the excitement that physicians and patients have shown toward XYOSTED, a novel at-home, self-administered painless injection to treat testosterone deficiency.  I'm looking forward to leading the commercial team as we enter the next phase of growth for the Company and this unique product."

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology.  The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc. (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia).  Antares Pharma's FDA approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described.  Factors that may cause such differences include, but are not limited to: the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; market acceptance, adequate reimbursement coverage and commercial success of XYOSTED® and future revenue from the same; successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; our expectations regarding whether the FDA will pursue withdrawal of approval for AMAG Pharmaceuticals Inc.'s Makena® subcutaneous auto injector following the recent FDA advisory committee meeting and future prescriptions, market acceptance and revenue from Makena® subcutaneous auto injector; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP®;  the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development;  actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital;  the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission.  The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Jack Howarth

    Vice President, Corporate Affairs

    609-359-3016

    jhowarth@antarespharma.com

    Primary Logo

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  33. EWING, N.J., June 11, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), today announced that Robert F. Apple, President and Chief Executive Officer, will present at the Raymond James Human Health Innovation Conference on Thursday, June 18, 2020 at 9:40 a.m. Eastern Time.

    A live webcast of the presentation will be available under the "For Investors" section of the Antares website, www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial…

    EWING, N.J., June 11, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), today announced that Robert F. Apple, President and Chief Executive Officer, will present at the Raymond James Human Health Innovation Conference on Thursday, June 18, 2020 at 9:40 a.m. Eastern Time.

    A live webcast of the presentation will be available under the "For Investors" section of the Antares website, www.antarespharma.com.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc. (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; market acceptance, adequate reimbursement coverage and commercial success of XYOSTED® and future revenue from the same; successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; our expectations regarding whether the FDA will pursue withdrawal of approval for AMAG Pharmaceuticals Inc.'s Makena® subcutaneous auto injector following the recent FDA advisory committee meeting and future prescriptions, market acceptance and revenue from Makena® subcutaneous auto injector; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP®; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission.  The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Jack Howarth

    Vice President, Corporate Affairs

    609-359-3016

    jhowarth@antarespharma.com

    Primary Logo

    View Full Article Hide Full Article
    • First Quarter 2020 Revenue $33.1 Million, a 42% Increase Compared to First Quarter 2019
    • Generated $5.6 Million in Cash from Operations during the First Quarter 2020

    EWING, N.J., May 05, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), today reported operating and financial results for the first quarter ended March 31, 2020 with record first quarter revenue of $33.1 million and a net loss per share of $0.01.

    "Our first quarter revenue performance underscores the strength of our commercial and operations organizations at a time when COVID-19 impacted the global economy and our business during the last month of the quarter. XYOSTED recorded another quarter of double-digit prescription growth over the prior quarter…

    • First Quarter 2020 Revenue $33.1 Million, a 42% Increase Compared to First Quarter 2019
    • Generated $5.6 Million in Cash from Operations during the First Quarter 2020

    EWING, N.J., May 05, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), today reported operating and financial results for the first quarter ended March 31, 2020 with record first quarter revenue of $33.1 million and a net loss per share of $0.01.

    "Our first quarter revenue performance underscores the strength of our commercial and operations organizations at a time when COVID-19 impacted the global economy and our business during the last month of the quarter. XYOSTED recorded another quarter of double-digit prescription growth over the prior quarter driven once again by a significant increase in both patients and prescribers. We continue to believe XYOSTED represents the most effective option for treating low testosterone in hypogonadal men, especially in an at-home treatment setting. On the partnered product front where we provide devices, Teva achieved a thirteen percent increase in generic epipen prescriptions in the first quarter of 2020 versus the fourth quarter of 2019 and importantly achieved a seven percent increase in market share over the same period," said Robert F. Apple, President and Chief Executive Officer of the Company. "With respect to the COVID-19 pandemic, we continue to monitor this global health crisis as it relates to our ongoing operations, and we have taken various steps to potentially reduce the impact of the pandemic on our business. Antares is focused on helping to ensure patients continue to have access to our medicines while protecting the health and well-being of both our employees and our customers. At this time, while we have seen a softening in new patient starts for our products, it is difficult to predict the full financial impact on our business given the current economic slowdown and uncertainty surrounding the duration of the pandemic. However, we believe the Company is in a strong financial position, allowing us to navigate through these unprecedented times while continuing to execute on our key strategic objectives supporting long-term growth."

    First Quarter 2020 and Recent Highlights

    • Reported first quarter total 2020 revenue of $33.1 million, an increase of 42% compared to the same period last year. Proprietary product revenue increased 163% to $12.6 million as compared to the $4.8 million reported in the first quarter of 2019. Partnered product revenue increased 7.4% to $14.5 million compared to $13.5 million in the first quarter of 2019.
       
    • XYOSTED® total prescriptions increased 18% sequentially versus the fourth quarter of 2019. To date, more than one hundred thousand prescriptions of XYOSTED® have been written by approximately fifty three hundred different physicians.
       
    • Reported first quarter 2020 loss per share of $0.01 as compared to a $0.03 loss per share reported in the comparable period last year.
       
    • Generated $5.6 million in cash from operating activities during the first quarter of 2020. Our total cash, cash equivalents and short-term investments increased to $50.3 million at March 31, 2020, compared to $45.7 million at December 31, 2019.

    First Quarter 2020 Financial Results

    Total revenue generated from product sales, development activities and royalties was $33.1 million for the three months ended March 31, 2020, compared to $23.3 million for the comparable period in 2019, a 42% increase.

    Product sales were $27.1 million for the three months ended March 31, 2020, compared to $18.3 million for the comparable period in 2019, a 48% increase.

    Sales of our proprietary products XYOSTED® and OTREXUP® generated revenue of $12.6 million for the three months ended March 31, 2020 as compared to $4.8 million for the three months ended March 31, 2019, a 163% increase. The increase in proprietary product sales for the three months ended March 31, 2020 as compared to the three months ended March 31, 2019 was attributable to XYOSTED®.

    We sell devices, components and fully assembled and packaged product to our partners Teva and AMAG. Partnered product sales were $14.5 million for the three months ended March 31, 2020 as compared to $13.5 million for the comparable period last year. The increase in sales of partnered products for the three months ended March 31, 2020 as compared to the same period in 2019 is primarily attributable to sales of auto injector devices to Teva for use with their Epinephrine Injection USP.

    Licensing and development revenue includes license fees received from partners for the right to use our intellectual property and amounts earned in joint development arrangements with partners under which we perform development activities or develop new products on their behalf. Licensing and development revenue was $1.8 million for the three month period ended March 31, 2020 compared to $0.9 million for the comparable period in 2019. The increase in licensing and development revenue for the first quarter of 2020 was due to work performed on the Pfizer rescue pen and the Idorsia selatogrel pen development programs.

    Royalties are recognized based on in-market sales of products sold by our partners. Royalty revenue was $4.2 million for the three months ended March 31, 2020 compared to $4.1 million for the same period in 2019. The net increase in royalty revenue for the three month period was a result of an overall increase of $1.9 million in royalties received from Teva on their net sales of Epinephrine Injection USP, offset by a decrease of $1.5 million in royalties received from AMAG on their net sales of the Makena® subcutaneous auto injector.

    Operating expenses were $19.4 million for the first quarter of 2020 compared to $17.3 million in the comparable period of 2019. The increase in operating expenses in the first quarter of 2020 was primarily due to incremental sales and marketing expenses related to the commercialization of XYOSTED®.

    Net loss was $2.4 million for the first quarter of 2020, compared to $5.5 million in the comparable period in 2019. Net loss per share was $0.01 for the quarter ended March 31, 2020 and $0.03 for the quarter ended March 31, 2019.

    At March 31, 2020, cash, cash equivalents and short term investments were $50.3 million compared to $45.7 million at December 31, 2019.

    2020 Financial Guidance

    Due to uncertainties caused by the ongoing COVID-19 pandemic, including the impact and duration of shelter-in-place restrictions and a lack of access for certain patients to their physicians' offices, Antares is suspending the previously announced 2020 net revenue guidance.

    Conference Call, Call Replay and Webcast

    Antares executives will provide a Company update and review first quarter 2020 financial results via webcast and conference call today, May 5, 2020, at 8:30 a.m. ET (Eastern Time). The webcast of the conference call, which will include a slide presentation, can be accessed through the link located on the "For Investors" section of the Company's website (www.antarespharma.com) under "Webcasts & Presentations". Alternatively, callers may participate in the audio portion of the conference call by dialing toll free 1-800-367-2403, or 1-334-777-6978. Callers should reference the Antares Pharma conference call or conference identification code 6655382. Callers can access the slide presentation on the "For Investors" section of the Company's website under "Webcasts & Presentations". A telephone replay of the conference call will be available from 11:30 a.m. ET on Tuesday, May 5, 2020 through 11:30 a.m. ET on Thursday, June 4, 2020. To access the replay, callers should dial 1-888-203-1112 or 1-719-457-0820 and enter passcode 6655382.

    About Antares Pharma

    Antares Pharma, Inc. is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc. (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's FDA approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.

    SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; market acceptance, adequate reimbursement coverage and commercial success of XYOSTED® and future revenue from the same; successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; market acceptance of Teva's generic epinephrine auto-injector product and future revenue from the same; our expectations regarding whether the FDA will pursue withdrawal of approval for AMAG Pharmaceuticals Inc.'s Makena® subcutaneous auto injector following the recent FDA advisory committee meeting and future prescriptions, market acceptance and revenue from Makena® subcutaneous auto injector; Teva's ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP®; the timing and results of the Company's or its partners' research projects or clinical trials of product candidates in development; actions by the FDA or other regulatory agencies with respect to the Company's products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company's ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

    Contact:

    Jack Howarth
    Vice President, Corporate Affairs
    609-359-3016
    jhowarth@antarespharma.com

    TABLES FOLLOW


    ANTARES PHARMA, INC.
    Table 1 - CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
    (amounts in thousands except per share amounts)
    (unaudited)

        Three Months Ended          
        March 31,     Increase  
        2020     2019     (Decrease)  
    Revenue:                        
    Product sales   $ 27,097     $ 18,300     48 %  
    Licensing and development revenue     1,755       915     92 %  
    Royalties     4,227       4,071     4 %  
    Total revenue     33,079       23,286     42 %  
    Cost of Revenue     15,047       10,946     37 %  
    Gross profit     18,032       12,340     46 %  
    Research and development     2,981       2,387     25 %  
    Selling, general and administrative     16,422       14,935     10 %  
    Total operating expenses     19,403       17,322     12 %  
    Operating loss     (1,371 )     (4,982 )   (72 )%  
    Other income (expense), net     (985 )     (557 )   77 %  
    Net loss   $ (2,356 )   $ (5,539 )   (57 )%  
    Basic and diluted net loss per common share   $ (0.01 )   $ (0.03 )        
    Basic and diluted weighted average common shares outstanding     165,429       160,446          


    ANTARES PHARMA, INC.
    Table 2 – CONSOLIDATED DETAIL OF REVENUE FROM PRODUCT SALES
    (amounts in thousands)
    (unaudited)

        Three Months Ended
    March 31,
     
        2020     2019  
    Product sales:                
    XYOSTED®   $ 9,003     $ 703  
    OTREXUP®     3,563       4,068  
    Partnered product sales     14,531       13,529  
    Total product sales   $ 27,097     $ 18,300  


    ANTARES PHARMA, INC.
    Table 3 – CONSOLIDATED CONDENSED BALANCE SHEETS
    (amounts in thousands)
    (unaudited)

        March 31,     December 31,  
        2020     2019  
    Assets                
    Cash, cash equivalents and investments   $ 50,317     $ 45,721  
    Accounts receivable     31,412       35,074  
    Inventories     17,309       16,000  
    Contract assets     9,929       8,235  
    Equipment, molds, furniture and fixtures, net     16,223       15,961  
    Goodwill, intangibles and right-of use assets     6,736       7,036  
    Other assets     4,878       4,724  
    Total Assets   $ 136,804     $ 132,751  
                     
    Liabilities and Stockholders' Equity                
    Accounts payable and accrued expenses   $ 35,213     $ 30,677  
    Deferred revenue