AMPH Amphastar Pharmaceuticals Inc.

18.69
-0.57  -3%
Previous Close 19.26
Open 19.22
52 Week Low 12.325
52 Week High 22.69
Market Cap $887,850,115
Shares 47,504,019
Float 30,277,909
Enterprise Value $855,310,115
Volume 155,290
Av. Daily Volume 218,183
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Drug Pipeline

Drug Stage Notes
Naloxone Intranasal
Opioid overdose
CRL
CRL
CRL announced February 21, 2017.
Primatene Mist (epinephrine inhalation aerosol)
Asthma
CRL
CRL
CRL issued December 27, 2016.

Latest News

  1. RANCHO CUCAMONGA, Calif., Dec. 29, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved its Abbreviated New Drug Application ("ANDA") for Glucagon for Injection Emergency Kit, 1 mg. Glucagon is indicated for the treatment of severe hypoglycemia and is also used as a diagnostic aid. Amphastar's newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly's Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin.

    Amphastar's CEO and President, Dr. Jack Zhang, commented: "This approval is yet another milestone for the Company and marks the first-ever FDA…

    RANCHO CUCAMONGA, Calif., Dec. 29, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved its Abbreviated New Drug Application ("ANDA") for Glucagon for Injection Emergency Kit, 1 mg. Glucagon is indicated for the treatment of severe hypoglycemia and is also used as a diagnostic aid. Amphastar's newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly's Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin.

    Amphastar's CEO and President, Dr. Jack Zhang, commented: "This approval is yet another milestone for the Company and marks the first-ever FDA approval of a generic version of rDNA Glucagon. Using a dedicated process and sophisticated characterization technology, we demonstrated to the Agency that our highly purified synthetic peptide product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), which is an rDNA product. This further highlights Amphastar's considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities."

    According to IQVIA, the U.S. sales for Eli Lilly's Glucagon Emergency Kit for Low Blood Sugar, 1 mg, were approximately $144 million, and the overall U.S. sales of brand products containing glucagon for injection, 1 mg, were approximately $306 million for the 12 months ended September 30, 2020.

    Amphastar plans to launch this Glucagon for Injection Emergency Kit, which it previously referred to as AMP-001, within two months.

    Pipeline Information

    The Company currently has four ANDAs filed with the FDA, which are targeting products with a market size of approximately $1.4 billion, three biosimilar products in development targeting products with a market size of approximately $13.0 billion, and nine generic products in development targeting products with a market size of approximately $12.0 billion. This market information is based on IQVIA data for the 12 months ended September 30, 2020. The Company is developing multiple proprietary pipeline products for injectable and intranasal dosage forms, including a new drug application for intranasal naloxone and intranasal epinephrine.

    Amphastar's Chinese subsidiary, ANP, currently has 14 Drug Master Files, or DMF, on file with the FDA and is developing several additional DMFs.

    Company Information

    Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin API products.  Most of the Company's finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers.  More information and resources are available at www.amphastar.com.

    Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar®, Primatene MIST®, Amphadase®, and Cortrosyn®, are the property of Amphastar.

    Forward-Looking Statements

    All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the Company's expectations regarding future financial performance, backlog, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to its pipeline of product candidates, its share buyback program and other future events. These statements are not historical facts but rather are based on Amphastar's historical performance and its current expectations, estimates, and projections regarding Amphastar's business, operations, and other similar or related factors. Words such as "may," "might," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expect," "intend," "plan," "project," "believe," "estimate," and other similar or related expressions are used to identify these forward-looking statements. However, not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control.  Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission. You can locate these reports through the Company's website at http://ir.amphastar.com and on the SEC's website at www.sec.gov.  Amphastar undertakes no obligation to revise or update information in this press release to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause Amphastar's expectations to change.

    Noted products are trademarks or registered trademarks of their respective owners.

    Contact Information: 

    Amphastar Pharmaceuticals, Inc.

    Bill Peters

    Chief Financial Officer

    (909) 980-9484

    Source: Amphastar Pharmaceuticals, Inc.



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  2. RANCHO CUCAMONGA, Calif., Nov. 06, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company") today reported results for the three months ended September 30, 2020.

    Third Quarter Highlights

    • Net revenues of $83.4 million for the third quarter
    • GAAP net income of $3.9 million, or $0.08 per share, for the third quarter
    • Adjusted non-GAAP net income of $7.6 million, or $0.15 per share, for the third quarter

    Dr. Jack Zhang, Amphastar's President and Chief Executive Officer, commented: "We once again demonstrated growth due to the continued strength of Primatene Mist® and the re-launch of our epinephrine vial product. Additionally, we are very excited about the significant progress on our intranasal epinephrine…

    RANCHO CUCAMONGA, Calif., Nov. 06, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company") today reported results for the three months ended September 30, 2020.

    Third Quarter Highlights

    • Net revenues of $83.4 million for the third quarter
    • GAAP net income of $3.9 million, or $0.08 per share, for the third quarter
    • Adjusted non-GAAP net income of $7.6 million, or $0.15 per share, for the third quarter

    Dr. Jack Zhang, Amphastar's President and Chief Executive Officer, commented: "We once again demonstrated growth due to the continued strength of Primatene Mist® and the re-launch of our epinephrine vial product. Additionally, we are very excited about the significant progress on our intranasal epinephrine product as this product once again illustrates our scientific and technical strengths."

                  
      Three Months Ended  Nine Months Ended  
      September 30,  September 30,  
      2020 2019 2020 2019 
        
      (in thousands, except per share data) 
    Net revenues $83,431 $80,137 $253,925 $238,974 
    GAAP net income attributable to Amphastar $3,919 $1,310 $7,676 $49,965 
    Adjusted non-GAAP net income attributable to Amphastar* $7,629 $5,169 $23,622 $14,171 
    GAAP diluted EPS attributable to Amphastar stockholders $0.08 $0.03 $0.16 $1.00 
    Adjusted non-GAAP diluted EPS attributable to Amphastar stockholders* $0.15 $0.10 $0.48 $0.28 

    _________________

     * Adjusted non-GAAP net income attributable to Amphastar and Adjusted non-GAAP diluted EPS attributable to Amphastar stockholders are non-GAAP financial measures.  Please see the discussion in the section entitled "Non-GAAP Financial Measures" and the reconciliation of GAAP to non-GAAP financial measures in Table III of this press release.

    Third Quarter Results

                 
      Three Months Ended       
      September 30,  Change 
      2020 2019 Dollars    % 
          
      (in thousands)   
    Net revenues:            
    Primatene Mist® $12,988 $3,654 $9,334  255 %  
    Enoxaparin  11,647  9,573  2,074  22 %  
    Lidocaine  10,657  11,670  (1,013) (9)%  
    Phytonadione  10,470  10,916  (446) (4)%  
    Naloxone  8,739  10,613  (1,874) (18)%  
    Epinephrine  5,370  3,756  1,614  43 %  
    Other finished pharmaceutical products  21,464  25,547  (4,083) (16)%  
    Total finished pharmaceutical products net revenues $81,335 $75,729 $5,606  7 %  
    API  2,096  4,408  (2,312) (52)%  
    Total net revenues $83,431 $80,137 $3,294  4 %  
                   

    Changes in net revenues were primarily driven by:

    • Increased sales of Primatene Mist® primarily resulting from

      • The continued success of our nationwide television, radio, and digital marketing campaign

      • Growth in online sales through Amazon

      • Launching Primatene Mist® at Kroger, the largest grocery store chain in the United States
    • Increased sales of enoxaparin primarily due to higher unit volumes
    • Increased epinephrine sales due to the launch of our recently approved epinephrine injection, USP 30mg/30mL multi-dose vial product during the second quarter of 2020
    • Decreased naloxone sales due to lower average selling price because of increased competition
    • Decreased lidocaine and other finished pharmaceutical product sales due to lower demand, largely due to competitors returning to their normal distribution levels
                 
      Three Months Ended       
      September 30,  Change 
      2020 2019 Dollars    % 
          
      (in thousands)   
    Net revenues $83,431 $80,137 $3,294 4% 
    Cost of revenues  46,923  44,885  2,038 5% 
    Gross profit $36,508 $35,252 $1,256 4% 
    as % of net revenues  44%  44%      

    Changes in cost of revenues and the resulting gross margin were primarily driven by:

    • Increased sales of Primatene Mist® and the launch of epinephrine injection multi-dose vial, both of which have higher margins
    • Decreased sales of naloxone and other finished pharmaceutical products with higher margins
                 
      Three Months Ended       
      September 30,  Change 
      2020 2019 Dollars    % 
          
      (in thousands)   
    Selling, distribution, and marketing $3,673 $3,221 $452  14 % 
    General and administrative  11,674  11,021  653  6 % 
    Research and development  17,644  18,606  (962) (5)% 
    • Marketing and distribution expenses increased primarily related to Primatene Mist®, including the cost of a national television, radio and digital marketing campaign, which began in July 2019
    • General and administrative expenses increased primarily due to increased legal expenses
    • Research and development expenses decreased due to lower expenses in China, partially offset by increased domestic expenses related to our generic inhalation product pipeline, our insulin biosimilar programs and our intranasal epinephrine program

    Cash flow provided by operating activities for the nine months ended September 30, 2020, was $40.4 million.

    Impact of COVID-19

    As a result of the COVID-19 pandemic, during the first quarter and second quarter, sales of Primatene Mist® and certain hospital products increased, while sales of certain products frequently used in elective produces, such as Cortrosyn® and lidocaine jelly, decreased. During the third quarter of 2020, sales of these products returned to levels closer to those experienced prior to the COVID-19 pandemic. The Company has not experienced any significant negative impacts on its cash flows or operations as a result of the COVID-19 pandemic. All of the Company's production facilities continued to operate during the quarter as they had prior to the COVID-19 pandemic with very little change, other than for enhanced safety measures intended to prevent the spread of the virus. It is not possible at this time to estimate the complete impact that the COVID-19 pandemic could have on our business, including our customers and suppliers, as the impact will depend on future developments of the pandemic, which are highly uncertain and cannot be predicted.

    Pipeline Information

    The Company currently has five ANDAs on file with the FDA targeting products with a market size of approximately $1.5 billion, three biosimilar products in development targeting products with a market size of approximately $13 billion, and nine generic products in development targeting products with a market size of approximately $12 billion. This market information is based on IQVIA data for the 12 months ended September 30, 2020. The Company is currently developing multiple proprietary products for injectable and intranasal dosage forms.

    Amphastar's Chinese subsidiary, ANP, currently has 14 Drug Master Files, or DMFs, on file with the FDA and is developing several additional DMFs.

    Company Information

    Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin API products. Most of the Company's finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. More information and resources are available at www.amphastar.com.

    Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar®, Primatene Mist®, Amphadase® and Cortrosyn®, are the property of Amphastar.

    Non-GAAP Financial Measures

    To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. generally accepted accounting principles ("GAAP"), the Company is disclosing non-GAAP financial measures when providing financial results. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results, including (i) Adjusted non-GAAP net income (loss) attributed to Amphastar and (ii) Adjusted non-GAAP diluted EPS attributed to Amphastar's stockholders, which exclude amortization expense, share-based compensation, impairment charges, executive severance expense, and legal settlements, in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance because the Company's management uses these measures internally for forecasting, budgeting, and measuring its operating performance. Whenever the Company uses such non-GAAP measures, it will provide a reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measures. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measures set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP.

    Conference Call Information

    The Company will hold a conference call to discuss its financial results today, November 6, 2020, at 9:00 a.m. Pacific Time.

    To access the conference call, dial toll-free (877) 881-2595 or (315) 625-3083 for international callers, five minutes before the conference. The passcode for the conference call is 7086853.

    The call can also be accessed on the Investors page on the Company's website at www.amphastar.com

    Forward-Looking Statements

    All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to the Company's expectations regarding future financial performance, backlog, sales and marketing of its products, market size and growth, product development, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to its pipeline of product candidates, its share buyback program and other future events, such as the impact of the COVID-19 pandemic and related responses of business and governments to the pandemic on our operations and personnel, and on commercial activity and demand across our business operations and results of operations. These statements are not historical facts but rather are based on Amphastar's historical performance and its current expectations, estimates, and projections regarding Amphastar's business, operations, and other similar or related factors. Words such as "may," "might," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expect," "intend," "plan," "project," "believe," "estimate," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control.  Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission, including in the Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 16, 2020. In particular, the extent of COVID-19's impact on our business will depend on several factors, including the severity, duration and extent of the pandemic, as well as actions taken by governments, businesses, and consumers in response to the pandemic, all of which continue to evolve and remain uncertain at this time. You can locate these reports through the Company's website at http://ir.amphastar.com and on the SEC's website at www.sec.gov.  The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause Amphastar's expectations to change.

    Contact Information: 

    Amphastar Pharmaceuticals, Inc.

    Bill Peters

    Chief Financial Officer

    (909) 980-9484



    Table I

    Amphastar Pharmaceuticals, Inc.

    Condensed Consolidated Statement of Operations

    (Unaudited; in thousands, except per share data)

                  
      Three Months Ended  Nine Months Ended  
      September 30,  September 30,  
      2020 2019  2020  2019  
                  
    Net revenues $83,431 $80,137  $253,925  $238,974  
    Cost of revenues  46,923  44,885   147,417   140,432  
    Gross profit  36,508  35,252   106,508   98,542  
                  
    Operating expenses:             
    Selling, distribution, and marketing  3,673  3,221   10,993   9,354  
    General and administrative  11,674  11,021   38,344   39,774  
    Research and development  17,644  18,606   49,096   49,209  
    Total operating expenses  32,991  32,848   98,433   98,337  
                  
    Income from operations  3,517  2,404   8,075   205  
                  
    Non-operating income (expenses), net  3,561  (822)  3,304   58,837  
                  
    Income before income taxes  7,078  1,582   11,379   59,042  
    Income tax provision  2,285  598   4,490   13,292  
                  
    Net income $4,793 $984  $6,889  $45,750  
                  
    Net income (loss) attributable to non-controlling interests $874 $(326) $(787) $(4,215) 
                  
    Net income attributable to Amphastar $3,919 $1,310  $7,676  $49,965  
                  
    Net income per share attributable to Amphastar stockholders:             
    Basic $0.08 $0.03  $0.16  $1.06  
    Diluted $0.08 $0.03  $0.16  $1.00  
                  
    Weighted-average shares used to compute net income per share attributable to Amphastar stockholders:             
    Basic  47,496  47,239   46,886   47,030  
    Diluted  49,848  50,075   48,922   50,128  



    Table II

    Amphastar Pharmaceuticals, Inc.

    Condensed Consolidated Balance Sheets

    (Unaudited; in thousands, except share data)

           
         September 30,     December 31, 
      2020  2019 
      (unaudited)   
    ASSETS      
    Current assets:      
    Cash and cash equivalents $87,910  $73,685 
    Restricted cash  1,865   1,865 
    Short-term investments  10,873   11,675 
    Restricted short-term investments  2,200   2,290 
    Accounts receivable, net  52,382   45,376 
    Inventories  108,870   110,501 
    Income tax refunds and deposits  1,455   311 
    Prepaid expenses and other assets  10,986   9,538 
    Total current assets  276,541   255,241 
           
    Property, plant, and equipment, net  245,881   233,856 
    Finance lease right-of-use assets  693   887 
    Operating lease right-of-use assets  20,256   18,805 
    Goodwill and intangible assets, net  40,377   41,153 
    Other assets  7,735   11,156 
    Deferred tax assets  22,235   25,873 
    Total assets $613,718  $586,971 
           
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Current liabilities:      
    Accounts payable and accrued liabilities $79,292  $77,051 
    Income taxes payable  1,619   2,042 
    Current portion of long-term debt  12,167   7,741 
    Current portion of operating lease liabilities  3,639   3,175 
    Total current liabilities  96,717   90,009 
           
    Long-term reserve for income tax liabilities  3,425   3,425 
    Long-term debt, net of current portion  32,903   39,394 
    Long-term operating lease liabilities, net of current portion  17,534   16,315 
    Deferred tax liabilities  823   867 
    Other long-term liabilities  11,354   9,433 
    Total liabilities  162,756   159,443 
    Commitments and contingencies      
    Stockholders' equity:      
    Preferred stock: par value $0.0001; 20,000,000 shares authorized; no shares issued and outstanding      
    Common stock: par value $0.0001; 300,000,000 shares authorized; 54,623,837 and 47,534,215 shares issued and outstanding as of September 30, 2020 and 52,495,483 and 46,576,968 shares issued and outstanding as of December 31, 2019, respectively  5   5 
    Additional paid-in capital  404,084   367,305 
    Retained earnings  124,046   116,370 
    Accumulated other comprehensive loss  (4,478)  (4,687)
    Treasury stock  (118,425)  (97,627)
    Total Amphastar Pharmaceuticals, Inc. stockholders' equity  405,232   381,366 
    Non-controlling interests  45,730   46,162 
    Total equity  450,962   427,528 
    Total liabilities and stockholders' equity $613,718  $586,971 
             



    Table III

    Amphastar Pharmaceuticals, Inc.

    Reconciliation of Non-GAAP Measures

    (Unaudited; in thousands, except per share data)

                 
      Three Months Ended  Nine Months Ended
      September 30,  September 30, 
      2020  2019  2020  2019 
                 
    GAAP net income $4,793  $984  $6,889  $45,750 
    Adjusted for:            
    Intangible amortization  262   251   771   777 
    Share-based compensation  4,370   4,294   13,846   13,000 
    Impairment of long-lived assets  130   11   160   194 
    Expense related to executive separation agreement        4,869    
    Gain on litigation settlement           (59,900)
    Income tax (benefit) provision on pre-tax adjustments  (943)  (598)  (3,392)  10,422 
    Non-GAAP net income $8,612  $4,942  $23,143  $10,243 
                 
    Non-GAAP net income (loss) attributable to non-controlling interests $983  $(227) $(479) $(3,928)
                 
    Non-GAAP net income attributable to Amphastar $7,629  $5,169  $23,622  $14,171 
                 
    Non-GAAP net income per share attributable to Amphastar stockholders:            
    Basic $0.16  $0.11  $0.50  $0.30 
    Diluted $0.15  $0.10  $0.48  $0.28 
                 
    Weighted-average shares used to compute non-GAAP net income per share attributable to Amphastar stockholders:            
    Basic  47,496   47,239   46,886   47,030 
    Diluted  49,848   50,075   48,922   50,128 



                          
      Three Months Ended September 30, 2020
                     
        Selling, General  Research Non-operating Income Non-controlling
      Cost of  distribution and and income  tax provision interest
      revenue and marketing administrative development (expense), net (benefit) adjustment
    GAAP $46,923  $3,673  $11,674  $17,644  $3,561 $2,285 $874 
    Intangible amortization  (229)     (33)         12 
    Share-based compensation  (947)  (120)  (2,899)  (404)      117 
    Impairment of long-lived assets  (19)     (111)         8 
    Income tax provision (benefit) on pre-tax adjustments                943  (28)
    Non-GAAP $45,728  $3,553  $8,631  $17,240  $3,561 $3,228 $983 
                               

    Reconciliation of Non-GAAP Measures (continued)

                          
      Three Months Ended September 30, 2019
                     
        Selling, General  Research Non-operating Income Non-controlling
      Cost of  distribution and and income  tax provision interest
      revenue and marketing administrative development (expense), net (benefit) adjustment
    GAAP $44,885  $3,221  $11,021  $18,606  $(822) $598 $(326)
    Intangible amortization  (216)     (35)          12 
    Share-based compensation  (701)  (96)  (3,138)  (359)       107 
    Impairment of long-lived assets  (4)     (11)  4        6 
    Income tax provision (benefit) on pre-tax adjustments                 598  (26)
    Non-GAAP $43,964  $3,125  $7,837  $18,251  $(822) $1,196 $(227)
                                



                          
      Nine Months Ended September 30, 2020
                     
        Selling, General  Research Non-operating Income Non-controlling
      Cost of  distribution and and income  tax provision interest
      revenue and marketing administrative development (expense), net (benefit) adjustment
    GAAP $147,417  $10,993  $38,344  $49,096  $3,304 $4,490 $(787)
    Intangible amortization  (670)     (101)         34 
    Share-based compensation  (3,276)  (350)  (8,851)  (1,369)      330 
    Impairment of long-lived assets  (32)     (128)         15 
    Expense related to executive separation agreement        (4,869)          
    Income tax provision (benefit) on pre-tax adjustments                3,392  (71)
    Non-GAAP $143,439  $10,643  $24,395  $47,727  $3,304 $7,882 $(479)
                               



                          
      Nine Months Ended September 30, 2019
                     
        Selling, General  Research Non-operating Income Non-controlling
      Cost of  distribution and and income  tax provision interest
      revenue and marketing administrative development (expense), net (benefit) adjustment
    GAAP $140,432  $9,354  $39,774  $49,209  $58,837  $13,292  $(4,215)
    Intangible amortization  (669)     (108)           34 
    Share-based compensation  (2,939)  (285)  (8,577)  (1,199)        257 
    Impairment of long-lived assets  (69)     (23)  (102)        55 
    Gain on litigation settlement              (59,900)      
    Income tax benefit on pre-tax adjustments                 (10,422)  (59)
    Non-GAAP $136,755  $9,069  $31,066  $47,908  $(1,063) $2,870  $(3,928)
                                 
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  3. RANCHO CUCAMONGA, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the Company will release results for its third quarter of 2020 ended September 30, 2020, before the market opens on Friday, November 6th, 2020, and will hold a conference call to discuss its financial results at 9:00 a.m. Pacific Time.

    To access the conference call, dial toll free (877) 881-2595, five minutes before the conference. The passcode for the conference call is 7086853.

    The call can also be accessed on the Investors page on the Company's website www.amphastar.com.

    Amphastar is a specialty pharmaceutical company that primarily develops, manufactures, markets, and sells generic and proprietary injectable and inhalation…

    RANCHO CUCAMONGA, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the Company will release results for its third quarter of 2020 ended September 30, 2020, before the market opens on Friday, November 6th, 2020, and will hold a conference call to discuss its financial results at 9:00 a.m. Pacific Time.

    To access the conference call, dial toll free (877) 881-2595, five minutes before the conference. The passcode for the conference call is 7086853.

    The call can also be accessed on the Investors page on the Company's website www.amphastar.com.

    Amphastar is a specialty pharmaceutical company that primarily develops, manufactures, markets, and sells generic and proprietary injectable and inhalation products, including products with high technical barriers to market entry. Most of the Company's products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers.

    Forward Looking Statements

    All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to the Company's expectations regarding future financial performance, backlog, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to its pipeline of product candidates, its share buyback program and other future events, such as the impact of the COVID-19 pandemic and related responses of business and governments to the pandemic on our operations and personnel, and on commercial activity and demand across our business operations and results of operations. These statements are not historical facts but rather are based on Amphastar's historical performance and its current expectations, estimates, and projections regarding Amphastar's business, operations, and other similar or related factors. Words such as "may," "might," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expect," "intend," "plan," "project," "believe," "estimate," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control.  Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission, including in the Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 16, 2020. In particular, the extent of COVID-19's impact on our business will depend on several factors, including the severity, duration and extent of the pandemic, as well as actions taken by governments, businesses, and consumers in response to the pandemic, all of which continue to evolve and remain uncertain at this time. You can locate these reports through the Company's website at http://ir.amphastar.com and on the SEC's website at www.sec.gov.  The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause Amphastar's expectations to change.

    Contact:

    William J. Peters

    Chief Financial Officer

    (909) 980-9484

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  4. RANCHO CUCAMONGA, Calif., Oct. 06, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") approved the Company's Abbreviated New Drug Application ("ANDA") for Atropine Sulfate injection 0.1mg/mL in the 10 mL Luer-Jet® Prefilled Syringe System. For the past 40 years, the Company has sold and marketed the product under the "grandfather" exception (now termed "unapproved") to the FDA's "Prescription Drug Wrap-Up" program. Net revenues for the Company's Atropine Sulfate injection for the year ended December 31, 2019 were $12.2 million.

    Amphastar's CEO and President, Dr. Jack Zhang, commented: "The FDA's approval of our Atropine Sulfate product, a product often on the Agency's…

    RANCHO CUCAMONGA, Calif., Oct. 06, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") approved the Company's Abbreviated New Drug Application ("ANDA") for Atropine Sulfate injection 0.1mg/mL in the 10 mL Luer-Jet® Prefilled Syringe System. For the past 40 years, the Company has sold and marketed the product under the "grandfather" exception (now termed "unapproved") to the FDA's "Prescription Drug Wrap-Up" program. Net revenues for the Company's Atropine Sulfate injection for the year ended December 31, 2019 were $12.2 million.



    Amphastar's CEO and President, Dr. Jack Zhang, commented: "The FDA's approval of our Atropine Sulfate product, a product often on the Agency's Drug Shortage list, offers an opportunity to ensure quality products are produced at the highest standard and highlights Amphastar's manufacturing capacity to fulfill such market needs."



    Pipeline Information



    The Company currently has four ANDAs filed with the FDA, which are targeting products with a market size of approximately $1.5 billion, three biosimilar products in development targeting products with a market size of approximately $13.0 billion, and nine generic products in development targeting products with a market size of approximately $12.0 billion. This market information is based on IQVIA data for the 12 months ended June 30, 2020. The Company is developing multiple proprietary pipeline products for injectable and intranasal dosage forms, including a new drug application for intranasal naloxone.



    Amphastar's Chinese subsidiary, ANP, currently has 14 Drug Master Files, or DMF, on file with the FDA and is developing several additional DMFs.



    Company Information



    Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin API products.  Most of the Company's finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers.  More information and resources are available at www.amphastar.com.



    Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar®, Primatene Mist®, Amphadase®, and Cortrosyn®, are the property of Amphastar.



    Forward-Looking Statements



    All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the Company's expectations regarding future financial performance, backlog, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to its pipeline of product candidates, its share buyback program and other future events. These statements are not historical facts but rather are based on Amphastar's historical performance and its current expectations, estimates, and projections regarding Amphastar's business, operations, and other similar or related factors. Words such as "may," "might," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expect," "intend," "plan," "project," "believe," "estimate," and other similar or related expressions are used to identify these forward-looking statements. However, not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control.  Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission. You can locate these reports through the Company's website at http://ir.amphastar.com and on the SEC's website at www.sec.gov.  Amphastar undertakes no obligation to revise or update information in this press release to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause Amphastar's expectations to change.



    Noted products are trademarks or registered trademarks of their respective owners.



    Contact Information: 

    Amphastar Pharmaceuticals, Inc.

    Bill Peters

    Chief Financial Officer

    (909) 980-9484

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  5. RANCHO CUCAMONGA, Calif., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced today that Bill Peters, CFO, Dan Dischner, Vice President of Corporate Communications and Human Resources, and Tony Marrs, Sr. Vice President Regulatory Affairs and Clinical Operations will participate in an Analyst-Moderated fireside chat at the Wells Fargo 2020 Virtual Healthcare Conference on Thursday, September 10, 2020 at 3:20 p.m. Eastern Time.

    This presentation will be made available with a live webcast and may be accessed by visiting Amphastar's Pharmaceuticals website at http://ir.amphastar.com . This webcast will be available for 90 days following the presentation.

    About Amphastar:

    Amphastar is a specialty pharmaceutical…

    RANCHO CUCAMONGA, Calif., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced today that Bill Peters, CFO, Dan Dischner, Vice President of Corporate Communications and Human Resources, and Tony Marrs, Sr. Vice President Regulatory Affairs and Clinical Operations will participate in an Analyst-Moderated fireside chat at the Wells Fargo 2020 Virtual Healthcare Conference on Thursday, September 10, 2020 at 3:20 p.m. Eastern Time.

    This presentation will be made available with a live webcast and may be accessed by visiting Amphastar's Pharmaceuticals website at http://ir.amphastar.com . This webcast will be available for 90 days following the presentation.

    About Amphastar:

    Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin active pharmaceutical ingredient products. Most of the Company's finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. More information is available at the Company's website at www.amphastar.com.

    The Amphastar Pharmaceuticals' logo and other trademarks or service marks of Amphastar Pharmaceuticals, Inc., including, but not limited to Primatene®, Amphadase® and Cortrosyn®, are the property of Amphastar Pharmaceuticals, Inc.

    Forward-Looking Statement:

    All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to the Company's expectations regarding future financial performance, backlog, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to its pipeline of product candidates, its share buyback program and other future events, such as the impact of the COVID-19 pandemic and related responses of business and governments to the pandemic on our operations and personnel, and on commercial activity and demand across our business operations and results of operations. These statements are not historical facts but rather are based on Amphastar's historical performance and its current expectations, estimates, and projections regarding Amphastar's business, operations and other similar or related factors. Words such as "may," "might," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expect," "intend," "plan," "project," "believe," "estimate," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control.  Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission, including in the Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 16, 2020. In particular, the extent of COVID-19's impact on our business will depend on several factors, including the severity, duration and extent of the pandemic, as well as actions taken by governments, businesses, and consumers in response to the pandemic, all of which continue to evolve and remain uncertain at this time. You can locate these reports through the Company's website at http://ir.amphastar.com and on the SEC's website at www.sec.gov.  The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause Amphastar's expectations to change.

    Contact:

    Bill Peters

    Chief Financial Officer

    (909) 476-3416

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