ANIP ANI Pharmaceuticals Inc.

30.43
+0.33  (+1%)
Previous Close 30.1
Open 30.26
52 Week Low 23.55
52 Week High 39.9999
Market Cap $388,028,510
Shares 12,751,512
Float 8,302,600
Enterprise Value $554,383,616
Volume 9,380
Av. Daily Volume 59,265
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Drug Stage Catalyst Date
Cortrophin Gel
Acute exacerbations of multiple sclerosis, rheumatoid arthritis, systemic lupus erythematous and ulcerative colitis
PDUFA
PDUFA
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Latest News

  1. ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced that Nikhil Lalwani, Chief Executive Officer, and Stephen Carey, Chief Financial Officer, will present at the Cantor Virtual Global Healthcare Conference 2021 as follows:

    Date:  Thursday, September 30, 2021
    Time: 8:00 a.m. ET 
    Webcast Link:  https://wsw.com/webcast/cantor12/anip/2073680

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.anipharmaceuticals.com, under the Investors section.

    About ANI

    ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription…

    ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced that Nikhil Lalwani, Chief Executive Officer, and Stephen Carey, Chief Financial Officer, will present at the Cantor Virtual Global Healthcare Conference 2021 as follows:

    Date:  Thursday, September 30, 2021

    Time: 8:00 a.m. ET 

    Webcast Link:  https://wsw.com/webcast/cantor12/anip/2073680

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.anipharmaceuticals.com, under the Investors section.

    About ANI



    ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products. Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin Gel® franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. For more information, please visit our website www.anipharmaceuticals.com.

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  2. -- Current annual market for reference listed drug ("RLD") Bystolic® totals more than $1 billion --

    -- Simultaneous launch from two manufacturing sites --

    ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced the launch of Nebivolol Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg.

    ANI's Nebivolol Tablets is the generic version of the reference listed drug ("RLD") Bystolic®. The current annual U.S. market for Bystolic 2.5 mg, 5 mg, 10 mg, and 20 mg strengths is approximately $1.05 billion, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

    "The launch of Nebivolol Tablets highlights our research and development capabilities. On day one, we simultaneously launched across two manufacturing sites…

    -- Current annual market for reference listed drug ("RLD") Bystolic® totals more than $1 billion --

    -- Simultaneous launch from two manufacturing sites --

    ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced the launch of Nebivolol Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg.

    ANI's Nebivolol Tablets is the generic version of the reference listed drug ("RLD") Bystolic®. The current annual U.S. market for Bystolic 2.5 mg, 5 mg, 10 mg, and 20 mg strengths is approximately $1.05 billion, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

    "The launch of Nebivolol Tablets highlights our research and development capabilities. On day one, we simultaneously launched across two manufacturing sites, including our site in Baudette, Minnesota, thus showcasing our ability to secure the supply chain for patients and customers," stated Nikhil Lalwani, President and CEO of ANI Pharmaceuticals, Inc.

    About Nebivolol Tablets

    Nebivolol Tablets are indicated for the treatment of hypertension, to lower blood pressure and may be used alone or in combination with other antihypertensive agents. For more information, including the complete list of indications and usages, please see the Full Prescribing Information.

    About ANI

    ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products. Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin Gel® franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. For more information, please visit our website www.anipharmaceuticals.com.

    Forward-Looking Statements

    To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the development, manufacturing and commercialization of the product and any additional product launches from the Company's generic pipeline, other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "plans," "potential," "future," "believes," "intends," "continue," other words of similar meaning, derivations of such words and the use of future dates.

    Uncertainties and risks may cause the Company's actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to, the risk that the Company may face with respect to successful launch of new products; competition from other products; acquisitions; contract manufacturing arrangements; delays or failure in obtaining product approval from the U.S. Food and Drug Administration; general business and economic conditions; market trends; products development; regulatory and other approvals and marketing.

    More detailed information on these and additional factors that could affect the Company's actual results are described in the Company's filings with the Securities and Exchange Commission ("SEC"), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company's current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

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  3. -- Prescription Drug User Fee Act ("PDUFA") target action date is October 29, 2021 --

    ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced that the Company's supplemental New Drug Application ("sNDA") for Purified Cortrophin® Gel ("Cortrophin Gel") has been accepted by the U.S. Food and Drug Administration ("FDA") for review.

    "FDA's acceptance of our sNDA for Cortrophin Gel marks a significant milestone for ANI. With a PDUFA target action date of October 29, 2021, we are one step closer to bringing a much-needed product to patients and healthcare providers. We look forward to further productive engagement with the FDA, and in parallel, we are focused on preparations for the launch of Cortrophin Gel," stated Nikhil…

    -- Prescription Drug User Fee Act ("PDUFA") target action date is October 29, 2021 --

    ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced that the Company's supplemental New Drug Application ("sNDA") for Purified Cortrophin® Gel ("Cortrophin Gel") has been accepted by the U.S. Food and Drug Administration ("FDA") for review.

    "FDA's acceptance of our sNDA for Cortrophin Gel marks a significant milestone for ANI. With a PDUFA target action date of October 29, 2021, we are one step closer to bringing a much-needed product to patients and healthcare providers. We look forward to further productive engagement with the FDA, and in parallel, we are focused on preparations for the launch of Cortrophin Gel," stated Nikhil Lalwani, Chief Executive Officer of ANI Pharmaceuticals.

    Chris Mutz, Chief Commercial Officer and Head of Rare Disease of ANI Pharmaceuticals, stated, "The availability of a second corticotropin – or ACTH-based – treatment is meaningful for patients struggling with the devastating consequences of chronic auto-immune disorders, including multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome."

    About Purified Cortrophin Gel

    Purified Cortrophin Gel (Repository Corticotropin Injection USP) is a purified adrenocorticotropic hormone (ACTH) previously approved in the U.S. for multiple indications including multiple sclerosis (MS), rheumatoid arthritis (RA), and nephrotic syndrome (NS).

    About ANI

    ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products. Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. For more information, please visit our website www.anipharmaceuticals.com.

    Forward-Looking Statements

    To the extent any statements made in this release relate to information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "anticipates," "will," "expects," "plans," "potential," "future," "believes," "intends," "continue," other words of similar meaning, derivations of such words, and the use of future dates. These forward-looking statements include statements regarding the timing of approval of our sNDA for Cortrophin Gel, the clinical development of Cortrophin Gel, and the potential benefit of Cortrophin Gel to patients and size of the market opportunity to the Company if approved by the FDA. Risks and uncertainties that may cause the Company's actual results to be materially different than those expressed in or implied by such forward-looking statements include, but are not limited to, uncertainties inherent in the development of pharmaceutical products, ANI's reliance on third parties over which it may not always have full control, costs and regulatory requirements relating to contract manufacturing arrangements, delays or failure in obtaining product approvals from the FDA, increased competition and strategies employed by competitors, uncertainties regarding the COVID-19 pandemic, market trends for our products, regulatory environment and changes, regulatory and other approvals related to product development and manufacturing, and other risks and uncertainties that are described in ANI's Annual Report on Form 10-K, quarterly reports on Form 10-Q, and other periodic reports filed with the U.S. Securities and Exchanges Commission.

    Any forward-looking statements in this news release speak only as of the date of this news release and are based on the Company's current beliefs, assumptions, and expectations. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

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  4. -- Second quarter 2021 net revenues of $48.6 million; net loss of $14.1 million and diluted loss per share of ($1.17) --

    -- Second quarter adjusted non-GAAP EBITDA of $13.1 million and adjusted non-GAAP diluted earnings per share of $0.67 --

    -- Refiled supplemental new drug application ("sNDA") for Cortrophin Gel with U.S Food and Drug Administration ("FDA") on June 29, 2021; goal date is October 29, 2021 --

    -- Pending acquisition of Novitium Pharma LLC on track to close in second half 2021--

    -- Expanded branded products portfolio through acquisition of Sandoz Inc. NDAs --

    ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced business highlights and financial results for the three and six months ended June 30…

    -- Second quarter 2021 net revenues of $48.6 million; net loss of $14.1 million and diluted loss per share of ($1.17) --

    -- Second quarter adjusted non-GAAP EBITDA of $13.1 million and adjusted non-GAAP diluted earnings per share of $0.67 --

    -- Refiled supplemental new drug application ("sNDA") for Cortrophin Gel with U.S Food and Drug Administration ("FDA") on June 29, 2021; goal date is October 29, 2021 --

    -- Pending acquisition of Novitium Pharma LLC on track to close in second half 2021--

    -- Expanded branded products portfolio through acquisition of Sandoz Inc. NDAs --

    ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced business highlights and financial results for the three and six months ended June 30, 2021.

    Second Quarter and Recent Business Highlights:

    • The Company refiled its supplemental new drug application ("sNDA") for Cortrophin® Gel with the U.S. Food and Drug Administration ("FDA" or the "Agency") on June 29, 2021; goal date is October 29, 2021;
    • Acquisition of Novitium Pharma LLC ("Novitium"), a privately held, New Jersey-based high-growth pharmaceutical company, is on track to close in the second half of 2021, pending Federal Trade Commission ("FTC") clearance and customary closing conditions; and
    • Acquired new drug applications ("NDAs") from Sandoz Inc. for a portfolio of dermatology products.

    Second Quarter 2021 Financial Highlights:

    • Net revenues were $48.6 million compared to $48.5 million in Q2 2020.
    • GAAP net loss was $14.1 million, and diluted GAAP loss per share was ($1.17).
    • Adjusted non-GAAP EBITDA was $13.1 million.
    • Adjusted non-GAAP diluted earnings per share was $0.67.
    • Cash and cash equivalents were $24.3 million, net accounts receivable was $92.6 million, and face value of debt was $205.7 million as of June 30, 2021.

    "In the second quarter, we made meaningful progress executing on the four pillars of our growth strategy. Most notably, on June 29, we refiled our sNDA with the FDA for Cortrophin Gel. Since that time, we have engaged in productive communication with the Agency. In support of this important asset, we are continuing to strengthen our leadership team to drive our commercial strategy forward. This refiling is a significant milestone for the organization, and I am proud of what we have accomplished to date. If approved, Cortrophin has the potential to improve access for patients in need and transform ANI," said Nikhil Lalwani, President and CEO of ANI.

    "We appreciate our stockholders' overwhelming support for the Novitium acquisition at our Annual Meeting of Stockholders. The transaction is on track to close later this year, and planning for maximizing the value of the combined assets for all stakeholders is well under way. We have also integrated the four dermatology products acquired from Sandoz, thus expanding our branded portfolio. It is an important and exciting time for ANI, and we look forward to providing updates as we move forward on our growth journey," concluded Lalwani.

    Second Quarter 2021 Financial Results

    Net Revenues

    (in thousands)

     

    Three Months Ended

    June 30,

     

     

    2021

     

    2020

    Generic pharmaceutical products

     

    $

    34,199

     

    $

    33,400

    Branded pharmaceutical products

     

     

    11,038

     

     

    10,633

    Contract manufacturing

     

     

    2,322

     

     

    2,900

    Royalty and other income

     

     

    1,066

     

     

    1,537

    Total net revenues

     

    $

    48,625

     

    $

    48,470

    Net revenues for generic pharmaceutical products were $34.2 million during the three months ended June 30, 2021, an increase of 2.4% compared to $33.4 million for the same period in 2020. From a product perspective, the net increase was due to increased sales of Fenofibrate, Potassium Citrate Extended Release, Vancomycin Oral Solution, and the second quarter 2021 launch of Nicardipine. These increases were somewhat tempered by declines in sales of Methazolamide, Miglustat, Penicillamine, and Mixed Amphetamine Salts.

    Net revenues for branded pharmaceutical products were $11.0 million during the three months ended June 30, 2021, an increase of 3.8% compared to $10.6 million for the same period in 2020. The increase primarily reflects the launch of the products acquired in the Sandoz, Inc. acquisition in the second quarter of 2021 and increased sales of InnoPran XL. These increases were tempered by decreased revenues of Atacand and Arimidex.

    Contract manufacturing revenues were $2.3 million during the three months ended June 30, 2021, a decrease of 19.9% compared to $2.9 million for the same period in 2020, due to a decreased volume of orders from contract manufacturing customers in the period.

    Royalty and other revenues were $1.1 million during the three months ended June 30, 2021, a decrease of $0.4 million from $1.5 million for the same period in 2020, primarily due to decreases in product development revenues earned by ANI Canada and a the non-recurrence of royalty revenue related to Yescarta®. These decreases were tempered by licensing revenues earned during the three months ended June 30, 2021.

    Operating expenses increased by 7.4% to $64.2 million for the three months ended June 30, 2021, from $59.8 million in the prior year period.

    Cost of sales, excluding depreciation and amortization, increased by $1.6 million to $22.3 million in the second quarter of 2021 from prior year period, primarily as a result of increased volumes in the current year period. The increase was tempered by a $1.2 million decrease related to a decrease in sales of products subject to profit sharing arrangements.

    Research and development expenses decreased to $2.8 million in the second quarter of 2021 from $3.0 million in the second quarter of 2020, primarily due to the non-recurrence of $0.4 million of 2020 severance related expense associated with the restructuring of our internal Cortrophin development team.

    Selling, general and administrative expenses decreased by $2.4 million in the second quarter of 2021 to $18.8 million compared to $21.2 million in the comparable quarter in 2020. The decrease primarily reflects the non-recurrence of $6.5 million of termination benefit expenses related to the 2020 departure of the Company's former President and CEO. The Company also incurred recruitment and related legal charges associated with the CEO search in the second quarter 2020. These decreases were offset by $1.7 million of transaction expenses related to the pending Novitium acquisition and $2.5 million in sales and marketing expenses related to Cortrophin pre-launch activities incurred during the three months ended June 30, 2021.

    On August 3, 2021, the Company entered into a Settlement Agreement with Arbor Pharmaceuticals, LLC to resolve all claims related to a civil proceeding which was pending trial later this month. Under the terms of the agreement, ANI will pay Arbor $8.4 million and Arbor will dismiss all claims against ANI. Neither party admitted wrongdoing in reaching this settlement. The Company recorded an $8.4 million charge to the second quarter Statement of Operations and will pay the settlement from cash on the balance sheet.

    Depreciation and amortization increased by 1.1% in the second quarter of 2021 to $11.3 million from $11.2 million in the comparable quarter in 2020, primarily due to the amortization of the NDAs acquired in April 2021 from Sandoz Inc., partially offset by assets that became fully amortized in 2020.

    Net loss for the second quarter of 2021 was $14.1 million as compared to net loss of $12.3 million in the prior year period. Diluted loss per share for the three months ended June 30, 2021 was ($1.17), compared to diluted loss per share of ($1.03) in the prior year period.

    Adjusted non-GAAP diluted earnings per share was $0.67 in the second quarter of 2021 compared to $0.69 in the second quarter of 2020.

    For reconciliations of adjusted non-GAAP EBITDA and adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure, please see Table 3 and Table 4, respectively.

    Liquidity

    As of June 30, 2021, the Company had $24.2 million in unrestricted cash and cash equivalents plus $92.6 million in net accounts receivable. The Company had $205.7 million (face value) in outstanding debt as of June 30, 2021.

    Conference Call

    As previously announced, ANI Pharmaceuticals management will host its second quarter 2021 conference call as follows:

    Date   Friday, August 6, 2021
    Time   8:30 a.m. ET
    Toll free (U.S.)   (866) 342-8591
       
    Webcast (live and replay)   www.anipharmaceuticals.com, under the "Investors" section

    A replay of the conference call will be available within two hours of the call's completion and will remain accessible for one week by dialing 800-695-0974 and entering access code 5412658.

    Non-GAAP Financial Measures

    Adjusted non-GAAP EBITDA

    ANI's management considers adjusted non-GAAP EBITDA to be an important financial indicator of ANI's operating performance, providing investors and analysts with a useful measure of operating results unaffected by non-cash stock-based compensation and differences in capital structures, tax structures, capital investment cycles, ages of related assets, and compensation structures among otherwise comparable companies. Management uses adjusted non-GAAP EBITDA when analyzing Company performance.

    Adjusted non-GAAP EBITDA is defined as net income, excluding tax expense or benefit, interest expense, (net), other expense, (net), depreciation, amortization, the excess of fair value over cost of acquired inventory, non-cash stock-based compensation expense, expense from acquired in-process research and development, Novitium transaction expenses, Cortrophin pre-launch charges, asset impairments, legal settlement expense, and certain other items that vary in frequency and impact on ANI's results of operations. Adjusted non-GAAP EBITDA should be considered in addition to, but not in lieu of, net income or loss reported under GAAP. A reconciliation of adjusted non-GAAP EBITDA to the most directly comparable GAAP financial measure is provided below.

    Adjusted non-GAAP Net Income

    ANI's management considers adjusted non-GAAP net income to be an important financial indicator of ANI's operating performance, providing investors and analysts with a useful measure of operating results unaffected by the excess of fair value over cost of acquired inventory sold, non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, Cortrophin pre-launch charges, acquired in-process research and development ("IPR&D") expense, Novitium transaction expenses, asset impairments, legal settlement expense, and certain other items that vary in frequency and impact on ANI's results of operations. Management uses adjusted non-GAAP net income when analyzing Company performance.

    Adjusted non-GAAP net income is defined as net income, plus the excess of fair value over cost of acquired inventory sold, non-cash stock-based compensation expense, Novitium transaction expenses, non-cash interest expense, depreciation and amortization expense, expense from acquired in-process research and development, Cortrophin pre-launch charges, asset impairments, legal settlement expense, and certain other items that vary in frequency and impact on ANI's results of operations, less the tax impact of these adjustments calculated using an estimated statutory tax rate. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI's results. Adjusted non-GAAP net income should be considered in addition to, but not in lieu of, net income reported under GAAP. A reconciliation of adjusted non-GAAP net income to the most directly comparable GAAP financial measure is provided below.

    Adjusted non-GAAP Diluted Earnings per Share

    ANI's management considers adjusted non-GAAP diluted earnings per share to be an important financial indicator of ANI's operating performance, providing investors and analysts with a useful measure of operating results unaffected by the excess of fair value over cost of acquired inventory sold, non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, Cortrophin pre-launch charges, acquired IPR&D expense, Novitium transaction expenses, asset impairments, legal settlement expense, and certain other items that vary in frequency and impact on ANI's results of operations. Management uses adjusted non-GAAP diluted earnings per share when analyzing Company performance.

    Adjusted non-GAAP diluted earnings per share is defined as adjusted non-GAAP net income, as defined above, divided by the diluted weighted average shares outstanding during the period. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI's results. Adjusted non-GAAP diluted earnings per share should be considered in addition to, but not in lieu of, diluted earnings or loss per share reported under GAAP. A reconciliation of adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure is provided below.

    About ANI

    ANI Pharmaceuticals, Inc. is an integrated specialty pharmaceutical company focused on delivering value to our customers by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals. We focus on niche and high barrier to entry opportunities including controlled substances, oncology products (anti-cancers), hormones and steroids, and complex formulations. For more information, please visit our website www.anipharmaceuticals.com.

    Forward-Looking Statements

    To the extent any statements made in this release relate to information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the Company's corporate strategy, the pending acquisition of Novitium and anticipated benefits and results of such acquisition, future operations, products, financial position, operating results and prospects, including plans for growth, the Company's pipeline or potential markets therefor, plans for existing ANDAs, timing of approval of our sNDA for Cortrophin Gel and commercialization plans, and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "plans," "potential," "future," "believes," "intends," "continue," other words of similar meaning, derivations of such words and the use of future dates.

    Uncertainties and risks may cause the Company's actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to, the risk that the Company may not be able to obtain the requisite FTC approval or satisfy other closing conditions to complete the Novitium acquisition or such approvals will be further delayed, risks the Company may face with respect to importing raw materials; the use of single source suppliers and the time it may take to validate and qualify another supplier, if necessary; increased competition and strategies employed by competitors; the ability to realize benefits anticipated from acquisitions; costs and regulatory requirements relating to contract manufacturing arrangements; delays or failure in obtaining product approvals from the U.S. Food and Drug Administration; general business and economic conditions, including the ongoing impact of the COVID-19 pandemic; market trends for our products; regulatory environment and changes; and regulatory and other approvals relating to product development and manufacturing.

    More detailed information on these and additional factors that could affect the Company's actual results are described in the Company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company's current beliefs, assumptions, and expectations. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

    Financial Tables Follow

    ANI Pharmaceuticals, Inc. and Subsidiaries
    Table 1: US GAAP Statement of Operations
    (unaudited, in thousands, except per share amounts)
     
     

    Three Months Ended June 30,

     

    Six Months Ended June 30,

    2021

     

    2020

     

    2021

     

    2020

    Net Revenues

    $

    48,625

     

    $

    48,470

     

    $

    103,146

     

    $

    98,244

     

     
    Operating Expenses:

     

    Cost of sales (excl. depreciation and amortization)

     

    22,314

     

     

    20,695

     

     

    42,299

     

     

    42,499

     

    Research and development

     

    2,805

     

     

    3,035

     

     

    5,773

     

     

    9,379

     

    Selling, general, and administrative

     

    18,820

     

     

    21,213

     

     

    36,407

     

     

    34,896

     

    Depreciation and amortization

     

    11,324

     

     

    11,198

     

     

    22,222

     

     

    22,381

     

    Legal settlement expense

     

    8,400

     

     

    -

     

     

    8,400

     

     

    -

     

    Cortrophin pre-launch charges

     

    515

     

     

    3,636

     

     

    553

     

     

    8,238

     

     
    Total Operating Expenses

     

    64,178

     

     

    59,777

     

     

    115,654

     

     

    117,393

     

     
    Operating Loss

     

    (15,553

    )

     

    (11,307

    )

     

    (12,508

    )

     

    (19,149

    )

     
    Other Expense, Net
    Interest expense, net

     

    (2,531

    )

     

    (2,356

    )

     

    (4,985

    )

     

    (4,388

    )

    Other expense, net

     

    (67

    )

     

    (116

    )

     

    (582

    )

     

    (106

    )

     
    Loss Before Benefit for Income Taxes

     

    (18,151

    )

     

    (13,779

    )

     

    (18,075

    )

     

    (23,643

    )

     
    Benefit for income taxes

     

    4,045

     

     

    1,443

     

     

    4,055

     

     

    4,296

     

     
    Net Loss

    $

    (14,106

    )

    $

    (12,336

    )

    $

    (14,020

    )

    $

    (19,347

    )

     
    Loss Per Share
    Basic Loss Per Share

    $

    (1.17

    )

    $

    (1.03

    )

    $

    (1.16

    )

    $

    (1.62

    )

    Diluted Loss Per Share

    $

    (1.17

    )

    $

    (1.03

    )

    $

    (1.16

    )

    $

    (1.62

    )

     
    Basic Weighted-Average Shares Outstanding

     

    12,085

     

     

    11,967

     

     

    12,045

     

     

    11,935

     

    Diluted Weighted-Average Shares Outstanding

     

    12,085

     

     

    11,967

     

     

    12,045

     

     

    11,935

     

    ANI Pharmaceuticals, Inc. and Subsidiaries
    Table 2: US GAAP Balance Sheets
    (unaudited, in thousands)
         
         
      June 30,

    2021
      December 31,

    2020
    Current Assets    
    Cash and cash equivalents  

    $

    24,261

     

     

    $

    7,864

     

    Accounts receivable, net  

     

    92,648

     

     

     

    95,793

     

    Inventories, net  

     

    67,634

     

     

     

    60,803

     

    Prepaid income taxes  

     

    2,375

     

     

     

    -

     

    Prepaid expenses and other current assets  

     

    4,881

     

     

     

    5,861

     

    Total Current Assets  

     

    191,799

     

     

     

    170,321

     

         
    Property and equipment  

     

    60,336

     

     

     

    58,797

     

    Accumulated depreciation  

     

    (20,002

    )

     

     

    (17,528

    )

    Property and equipment, net  

     

    40,334

     

     

     

    41,269

     

    Restricted cash  

     

    5,001

     

     

     

    5,003

     

    Deferred tax assets, net of deferred tax liabilities and valuation allowance  

     

    58,526

     

     

     

    51,704

     

    Intangible assets, net  

     

    180,199

     

     

     

    188,511

     

    Goodwill  

     

    3,580

     

     

     

    3,580

     

    Other non-current assets  

     

    720

     

     

     

    802

     

    Total Assets  

    $

    480,159

     

     

    $

    461,190

     

         
    Current Liabilities    
    Current debt, net of deferred financing costs  

    $

    15,182

     

     

    $

    13,243

     

    Accounts payable  

     

    12,977

     

     

     

    11,261

     

    Accrued expenses and other  

     

    11,582

     

     

     

    2,456

     

    Accrued royalties  

     

    4,688

     

     

     

    6,407

     

    Accrued compensation and related expenses  

     

    4,319

     

     

     

    6,231

     

    Current income taxes payable, net  

     

    -

     

     

     

    3,906

     

    Accrued government rebates  

     

    8,740

     

     

     

    7,826

     

    Returned goods reserve  

     

    31,904

     

     

     

    27,155

     

    Deferred revenue  

     

    62

     

     

     

    80

     

    Total Current Liabilities  

     

    89,454

     

     

     

    78,565

     

         
    Non-current debt, net of deferred financing costs and current component  

     

    189,525

     

     

     

    172,443

     

    Derivatives and other non-current liabilities  

     

    9,263

     

     

     

    14,482

     

    Total Liabilities  

     

    288,242

     

     

     

    265,490

     

         
    Stockholders' Equity    
    Common stock  

     

    1

     

     

     

    1

     

    Treasury stock  

     

    (3,062

    )

     

     

    (2,246

    )

    Additional paid-in capital  

     

    219,403

     

     

     

    214,354

     

    Accumulated deficit  

     

    (18,992

    )

     

     

    (4,972

    )

    Accumulated other comprehensive loss, net of tax  

     

    (5,433

    )

     

     

    (11,437

    )

    Total Stockholders' Equity  

     

    191,917

     

     

     

    195,700

     

         
    Total Liabilities and Stockholders' Equity  

    $

    480,159

     

     

    $

    461,190

     

    ANI Pharmaceuticals, Inc. and Subsidiaries
    Table 3: Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation
    (unaudited, in thousands)
       
       
       
     

    Three Months Ended June 30,

     

    2021

     

    2020

    Net Loss  

     $

    (14,106

    )

     

     $

    (12,336

    )

       
    Add/(Subtract):    
    Interest expense, net  

     

          2,531

     

     

     

          2,356

     

    Other expense, net  

     

               67

     

     

     

             116

     

    Benefit for income taxes  

     

         (4,045

    )

     

     

        (1,443

    )

    Depreciation and amortization  

     

        11,324

     

     

     

        11,198

     

    Legal settlement expense  

     

          8,400

     

     

     

                 -

     

    Cortrophin pre-launch charges and sales & marketing expenses  

     

          2,902

     

     

     

          3,636

     

    Stock-based compensation(1)  

     

          2,844

     

     

     

          2,271

     

    CEO transition items(2)  

     

                 -

     

     

     

          7,145

     

    Cortrophin team restructuring  

     

                 -

     

     

     

             401

     

    Asset impairments(3)  

     

                 -

     

     

     

              40

     

    Excess of fair value over cost of acquired inventory  

     

          1,492

     

     

     

          1,420

     

    Charges related to market exits  

     

                 -

     

     

     

             567

     

    Novitium transaction expenses  

     

          1,690

     

     

     

                 -

     

    Adjusted non-GAAP EBITDA  

     $

      13,099

     

     

     $

    15,371

     

       
      Reconciliation of certain adjusted non-GAAP accounts:
      Cost of sales (excl.

    depreciation and

    amortization)
      Selling, general, and

    administrative

    expenses
      Research and

    development

    expenses
     
      Three Months Ended

    June 30,
      Three Months Ended

    June 30,
      Three Months Ended

    June 30,
     

    2021

     

    2020

     

    2021

     

    2020

     

    2021

     

    2020

    As reported:

     

     $

       22,314

     

     

     $

       20,695

     

     

     $

       18,820

     

     

     $

       21,213

     

     

     $

        2,805

     

     

     $

        3,035

     

                 
    Cortrophin pre-launch charges and sales & marketing expenses      

     

          (2,387

    )

         
    Stock-based compensation(1)  

     

                (6

    )

     

     

              (39

    )

     

     

          (2,683

    )

     

     

          (2,074

    )

     

     

             (155

    )

     

     

             (158

    )

    CEO transition items(2)        

     

          (7,145

    )

       
    Cortrophin team restructuring        

     

              (47

    )

       

     

             (354

    )

    Asset impairments(3)    

     

              (40

    )

           
    Excess of fair value over cost of acquired inventory  

     

          (1,492

    )

     

     

          (1,420

    )

           
    Charges related to market exits    

     

             (267

    )

           

     

             (300

    )

    Novitium transaction expenses      

     

          (1,690

    )

         

    As adjusted:

     

     $

       20,816

     

     

     $

       18,929

     

     

     $

       12,060

     

     

     $

       11,947

     

     

     $

        2,650

     

     

     $

        2,223

     

               
     

    Six Months Ended June 30,

     

    2021

     

    2020

         
    Net Loss  

     $

    (14,020

    )

     

     $

    (19,347

    )

         
    Add/(Subtract):    
    Interest expense, net  

     

          4,985

     

     

     

          4,388

     

    Other expense, net  

     

             582

     

     

     

             106

     

    Benefit for income taxes  

     

         (4,055

    )

     

     

        (4,296

    )

    Depreciation and amortization  

     

        22,222

     

     

     

        22,381

     

    Legal settlement expense  

     

          8,400

     

     

     

                 -

     

    Cortrophin pre-launch charges and sales & marketing expenses  

     

          3,044

     

     

     

          8,238

     

    Stock-based compensation(1)  

     

          4,713

     

     

     

          4,695

     

    CEO transition items(2)  

     

                 -

     

     

     

          7,145

     

    Cortrophin team restructuring  

     

                 -

     

     

     

             401

     

    Acquired IPR&D expense  

     

                 -

     

     

     

          3,784

     

    Asset impairments(3)  

     

                 -

     

     

     

             792

     

    Excess of fair value over cost of acquired inventory  

     

          1,492

     

     

     

          4,071

     

    Charges related to market exits  

     

                 -

     

     

     

             567

     

    Novitium transaction expenses  

     

          4,633

     

     

     

                 -

     

    Adjusted non-GAAP EBITDA  

     $

      31,996

     

     

     $

    32,925

     

         
     

    Reconciliation of certain adjusted non-GAAP accounts:

     

    Cost of sales (excl.

    depreciation and

    amortization)

     

    Selling, general, and

    administrative

    expenses

     

    Research and

    development

    expenses

     

     

     

     

     

     

     

    Six Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2021

     

    2020

     

    2021

     

    2020

     

    2021

     

    2020

    As reported:

     

    $

    42,299

     

     

    $

    42,499

     

     

    $

    36,407

     

     

    $

    34,896

     

     

    $

    5,773

     

     

    $

    9,379

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cortrophin pre-launch charges and sales & marketing expenses  

     

     

     

     

     

    (2,490

    )

     

     

     

     

     

     

    Stock-based compensation(1)  

     

    (10

    )

     

     

    (69

    )

     

     

    (4,429

    )

     

     

    (4,273

    )

     

     

    (274

    )

     

     

    (353

    )

    CEO transition items(2)  

     

     

     

     

     

     

     

    (7,145

    )

     

     

     

     

    Cortrophin team restructuring  

     

     

     

     

     

     

     

    (47

    )

     

     

     

     

    (354

    )

    Acquired IPR&D expense  

     

     

     

     

     

     

     

     

     

     

     

    (3,784

    )

    Asset impairments(3)  

     

     

     

    (740

    )

     

     

     

     

    (52

    )

     

     

     

     

    Excess of fair value over cost of acquired inventory  

     

    (1,492

    )

     

     

    (4,071

    )

     

     

     

     

     

     

     

     

    Charges related to market exits  

     

     

     

    (267

    )

     

     

     

     

     

     

     

     

    (300

    )

    Novitium transaction expenses  

     

     

     

     

     

    (4,633

    )

     

     

     

     

     

     

    As adjusted: 

     

    $

    40,797

     

     

    $

    37,352

     

     

    $

    24,855

     

     

    $

    23,379

     

     

    $

    5,499

     

     

    $

    4,588

     

               

    (1) For the three and six months ended June 30, 2020, Stock-based compensation excludes $3.4 million of stock-based compensation expense associated with the departure of a former President and CEO. This amount is included in this table as part of CEO transition items.

    (2) For the three and six months ended June 30, 2020, CEO transition items is comprised of $3.4 million of stock compensation expense and $3.1 million of expense for salary continuation, bonus and other fringe benefits associated with the departure of a former President and CEO, as well as certain legal and recruiting costs related to the search for a permanent replacement.
    (3) For the three months ended June 30, 2020, Asset impairments is comprised of a finished goods inventory reserve for Bretylium. For the six months ended June 30, 2020, it is comprised of finished goods inventory reserves for Bretylium and an accounts receivable reserve due to customer bankruptcy, tempered by a modest recovery of previously reserved inventory related to market exits.
    ANI Pharmaceuticals, Inc. and Subsidiaries
    Table 4: Adjusted non-GAAP Net Income and Adjusted non-GAAP Diluted Earnings per Share Reconciliation
    (unaudited, in thousands, except per share amounts)
     

    Three Months Ended June 30,

    Six Months Ended June 30,

    2021

     

    2020

     

    2021

     

    2020

    Net Loss

    $

    (14,106

    )

    $

    (12,336

    )

    $

    (14,020

    )

    $

    (19,347

    )

     
    Add/(Subtract):
    Non-cash interest expense

     

    539

     

     

    500

     

     

    1,085

     

     

    657

     

    Depreciation and amortization expense

     

    11,324

     

     

    11,198

     

     

    22,222

     

     

    22,381

     

    Cortrophin pre-launch charges and sales & marketing expenses

     

    2,902

     

     

    3,636

     

     

    3,044

     

     

    8,238

     

    Legal settlement expense

     

    8,400

     

     

    -

     

     

    8,400

     

     

    -

     

    Acquired IPR&D expense

     

    -

     

     

    -

     

     

    -

     

     

    3,784

     

    Stock-based compensation(1)

     

    2,844

     

     

    2,271

     

     

    4,713

     

     

    4,695

     

    CEO transition items(2)

     

    -

     

     

    7,145

     

     

    -

     

     

    7,145

     

    Cortrophin team restructuring

     

    -

     

     

    401

     

     

    -

     

     

    401

     

    Asset impairments(3)

     

    -

     

     

    40

     

     

    -

     

     

    792

     

    Excess of fair value over cost of acquired inventory

     

    1,492

     

     

    1,420

     

     

    1,492

     

     

    4,071

     

    Charges related to market exits

     

    -

     

     

    567

     

     

    -

     

     

    567

     

    Novitium transaction expenses

     

    1,690

     

     

    -

     

     

    4,633

     

     

    -

     

    Less:
    Estimated tax impact of adjustments (calc. at 24%)

     

    (7,006

    )

     

    (6,523

    )

     

    (10,941

    )

     

    (12,655

    )

     
    Adjusted non-GAAP Net Income

    $

    8,080

     

    $

    8,319

     

    $

    20,627

     

    $

    20,729

     

     
    Diluted Weighted-Average
    Shares Outstanding

     

    12,085

     

     

    11,967

     

     

    12,045

     

     

    11,935

     

    Adjusted Diluted Weighted-Average
    Shares Outstanding

     

    12,100

     

     

    11,982

     

     

    12,059

     

     

    11,964

     

     
    Adjusted non-GAAP
    Diluted Earnings per Share

    $

    0.67

     

    $

    0.69

     

    $

    1.71

     

    $

    1.73

     

    (1) For the three and six months ended June 30, 2020, Stock-based compensation excludes $3.4 million of stock-based compensation expense associated with the departure of a former President and CEO. This amount is included in this table as part of CEO transition items.
    (2) For the three and six months ended June 30, 2020, CEO transition items is comprised of $3.4 million of stock compensation expense and $3.1 million of expense for salary continuation, bonus and other fringe benefits associated with the departure of a former President and CEO, as well as certain legal and recruiting costs related to the search for a permanent replacement.
    (3) For the three months ended June 30, 2020, Asset impairments is comprised of a finished goods inventory reserve for Bretylium. For the six months ended June 30, 2020, it is comprised of finished goods inventory reserves for Bretylium and an accounts receivable reserve due to customer bankruptcy, tempered by a modest recovery of previously reserved inventory related to market exits.

     

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  5. ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced that the Company will release its second quarter 2021 financial results on Friday, August 6, 2021.

    Nikhil Lalwani, President and Chief Executive Officer, and Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, will host a conference call to discuss the results as follows:

    Date

    Friday, August 6, 2021

    Time

    8:30 a.m. ET

    Toll free (U.S.)

    866-342-8591

    Webcast (live and replay)

    www.anipharmaceuticals.com, under the "Investors" section

    A replay of the conference call will be available within two hours of the call's completion and will remain accessible for one-week by dialing 800-695-0974 and entering access…

    ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced that the Company will release its second quarter 2021 financial results on Friday, August 6, 2021.

    Nikhil Lalwani, President and Chief Executive Officer, and Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, will host a conference call to discuss the results as follows:

    Date

    Friday, August 6, 2021

    Time

    8:30 a.m. ET

    Toll free (U.S.)

    866-342-8591

    Webcast (live and replay)

    www.anipharmaceuticals.com, under the "Investors" section

    A replay of the conference call will be available within two hours of the call's completion and will remain accessible for one-week by dialing 800-695-0974 and entering access code 5412658.

    About ANI

    ANI Pharmaceuticals, Inc. is an integrated specialty pharmaceutical company focused on delivering value to our customers by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals. We focus on niche and high barrier to entry opportunities including controlled substances, oncology products (anti-cancers), hormones and steroids, and complex formulations. For more information, please visit our website www.anipharmaceuticals.com.

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