ANI Pharmaceuticals, Inc., a specialty pharmaceutical company, develops, manufactures, and markets branded and generic prescription pharmaceuticals in the United States and Canada. It focuses on producing controlled substances, oncology products, hormones and steroids, and other formulations. The company manufactures oral solid dose products; semi-solids, liquids, and topicals; and potent products, as well as performs contract manufacturing for other pharmaceutical companies. It markets its products through retail pharmacy chains, wholesalers, distributors and mail order pharmacies, and group purchasing organizations. The company was founded in 2001 and is headquartered in Baudette, Minnesota.
IPO Year:
Exchange: NASDAQ
Website: anipharmaceuticals.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 7/10/2025 | $84.00 | Buy | H.C. Wainwright |
| 3/14/2025 | $80.00 | Buy | Jefferies |
| 3/12/2025 | $85.00 | Overweight | Analyst |
| 12/11/2024 | $80.00 | Outperform | Leerink Partners |
| 10/11/2024 | $68.00 | Overweight | Piper Sandler |
| 3/15/2024 | $80.00 | Overweight | CapitalOne |
| 8/22/2023 | $60.00 → $73.00 | Buy | H.C. Wainwright |
| 3/1/2023 | $55.00 | Buy | Guggenheim |
| 9/7/2022 | $50.00 | Buy | H.C. Wainwright |
| 11/2/2021 | $60.00 → $65.00 | Outperform | Raymond James |
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4 - ANI PHARMACEUTICALS INC (0001023024) (Issuer)
4 - ANI PHARMACEUTICALS INC (0001023024) (Issuer)
4 - ANI PHARMACEUTICALS INC (0001023024) (Issuer)
4 - ANI PHARMACEUTICALS INC (0001023024) (Issuer)
4 - ANI PHARMACEUTICALS INC (0001023024) (Issuer)
4 - ANI PHARMACEUTICALS INC (0001023024) (Issuer)
4 - ANI PHARMACEUTICALS INC (0001023024) (Issuer)
4 - ANI PHARMACEUTICALS INC (0001023024) (Issuer)
4 - ANI PHARMACEUTICALS INC (0001023024) (Issuer)
4 - ANI PHARMACEUTICALS INC (0001023024) (Issuer)
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Generated record quarterly net revenues of $211.4 million, representing year-over-year growth of 53.1% on a reported basis and 37.0% on an organic basisTotal Rare Disease quarterly net revenues of $104.0 million, which includes: Purified Cortrophin® Gel net revenues of $81.6 million, an increase of 66.0% year-over-year, andILUVIEN® and YUTIQ® net revenues of $22.3 million Generics quarterly net revenues of $90.3 million, an increase of 22.1% year-over-year Delivered record quarterly adjusted non-GAAP EBITDA of $54.1 million, an increase of 62.8% year-over-yearDiluted GAAP income per share of $0.36 and record adjusted non-GAAP diluted earnings per share of $1.80Increased 2025 guidance
PRINCETON, N.J., Aug. 01, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced that the Company will release its second quarter 2025 financial results on Friday, August 8, 2025, prior to the market open. Nikhil Lalwani, President and Chief Executive Officer, Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, Chris Mutz, Head of Rare Disease, and Mary Pao, M.D., Ph.D., Chief Medical Officer, will host a conference call to discuss the results as follows: DateFriday, August 8, 2025 Time8:30 a.m. ET Toll free (U.S.)800-343-4136 Conference ID5034065 Webcast (live and replay)www.anipharmaceuticals.com, under
IRVINE, Calif., July 29, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ:CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced that a jury in the Superior Court of the State of Delaware (the "Court") unanimously found in favor of CG Oncology on all claims in a March 2024 lawsuit brought by ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) ("ANI"). The jury unanimously rejected all of ANI Pharmaceuticals' claims for unjust enrichment damages after Judge Sheldon K. Rennie, on July 16, 2025, had ruled in favor of CG Oncology that, as a matter of law, ANI Pharm
Trial evaluated number of supplemental injections needed for the treatment of DME for patients on ILUVIEN versus the aflibercept arm Study Enrolled Treatment-Naïve, or Almost Naïve, Patients with DME Results presented by Michael A. Singer, M.D. in a paper-on-demand presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting Conference call scheduled for today at 8:30 am ET PRINCETON, N.J., July 23, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced results from the NEW DAY clinical trial of ILUVIEN® (fluocinolone acetonide intravitreal implant), 0.19 mg (ILUVIEN) for use in patients with diabetic macula
PRINCETON, N.J., July 02, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced that Nikhil Lalwani, President and Chief Executive Officer, will host 1x1 meetings at the Leerink Partners Therapeutics Forum: I&I and Metabolism on Tuesday, July 8, 2025, in Boston, MA. About ANI Pharmaceuticals, Inc. ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) is a diversified biopharmaceutical company committed to its mission of "Serving Patients, Improving Lives" by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets n
PRINCETON, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced new preclinical data on the use of Purified Cortrophin Gel (repository corticotropin injection USP) (Cortrophin Gel) in a mouse model of murine collagen-induced inflammatory arthritis. "In a preclinical model of murine collagen-induced arthritis, repository corticotrophin injection attenuated joint swelling in mice, and decreased inflammatory cytokine response without causing additional bone turnover, as compared to controls," said Mary Pao, MD, PhD, Chief Medical Officer of Rare Disease at ANI. "These data further expand our understanding of Cortrophin Gel's mec
PRINCETON, N.J., May 27, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that Nikhil Lalwani, Chief Executive Officer, will present at the 2025 Jefferies Global Healthcare Conference in New York City as follows: Date:Wednesday, June 4, 2025 Time:2:35pm ET Webcast:Click Here To schedule a 1x1 meeting with the Company, please contact your Jefferies representative at [email protected]. The live and archived webcast will be accessible from the Company's website at www.anipharmaceuticals.com, under the Investors section under Events and Presentations. The replay of the webcast will be accessible for 60 days. About ANI
Purified Cortrophin Gel is the only ACTH therapy approved by the FDA for the treatment of acute gout flares Trial to be conducted by Dr. Hyon Choi at Massachusetts General Hospital and will compare the safety and efficacy of two dose levels of Purified Cortrophin Gel for the treatment of acute gout flares PRINCETON, N.J., May 22, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced the initiation of a Phase 4 clinical trial at Massachusetts General Hospital to compare the safety and efficacy of two dose levels (40 USP units and 80 USP units) of Purified Cortrophin Gel (repository corticotropin injection USP) (Cortrophin Gel) for the treat
PRINCETON, N.J., May 12, 2025 (GLOBE NEWSWIRE) -- 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 H.C. Wainwright 3rd Annual BioConnect Investor Conference at NASDAQ as follows: Date:Tuesday, May 20, 2025 Time:1:30pm ET Webcast:Click Here To schedule a 1x1 meeting with management, please contact [email protected]. The live and archived webcast will be accessible from the Company's website at www.anipharmaceuticals.com, under the Investors section under Events and Presentations. The replay of the webcast will be accessible for 90 days. About
Generated record quarterly net revenues of $197.1 million, representing year-over-year growth of 43.4%Total Rare Disease quarterly net revenues of $69.0 million, which includes: Purified Cortrophin® Gel net revenues of $52.9 million, an increase of 43.1% year-over-year, andILUVIEN® and YUTIQ® net revenues of $16.1 million Record Generics net revenues of $98.7 million, an increase of 40.5% year-over-yearDelivered record quarterly adjusted non-GAAP EBITDA of $50.7 million, an increase of 34.9% year-over-yearDiluted GAAP income per share of $0.69 and record adjusted non-GAAP diluted earnings per share of $1.70Increased 2025 guidance with expected net revenues of $768.0 million to $793.0 million
Live FDA approvals issued by the Food and Drug Administration and FDA breaking news
Submission status for ANI PHARMS INC's drug HYDROCODONE BITARTRATE AND IBUPROFEN (SUPPL-6) with active ingredient HYDROCODONE BITARTRATE; IBUPROFEN has changed to 'Approval' on 03/04/2021. Application Category: ANDA, Application Number: 077454, Application Classification: Labeling
Submission status for ANI PHARMS INC's drug OXYCODONE AND ASPIRIN (SUPPL-30) with active ingredient ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE has changed to 'Approval' on 03/04/2021. Application Category: ANDA, Application Number: 040255, Application Classification: Labeling
Submission status for ANI PHARMS INC's drug EZETIMIBE AND SIMVASTATIN (SUPPL-10) with active ingredient EZETIMIBE; SIMVASTATIN has changed to 'Approval' on 02/23/2021. Application Category: ANDA, Application Number: 201890, Application Classification: Labeling
Submission status for ANI PHARMS INC's drug TEMOZOLOMIDE (SUPPL-9) with active ingredient TEMOZOLOMIDE has changed to 'Approval' on 01/04/2021. Application Category: ANDA, Application Number: 203490, Application Classification: Labeling
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H.C. Wainwright initiated coverage of ANI Pharma with a rating of Buy and set a new price target of $84.00
Jefferies initiated coverage of ANI Pharma with a rating of Buy and set a new price target of $80.00
Analyst initiated coverage of ANI Pharma with a rating of Overweight and set a new price target of $85.00
Leerink Partners initiated coverage of ANI Pharma with a rating of Outperform and set a new price target of $80.00
Piper Sandler initiated coverage of ANI Pharma with a rating of Overweight and set a new price target of $68.00
CapitalOne initiated coverage of ANI Pharma with a rating of Overweight and set a new price target of $80.00
H.C. Wainwright reiterated coverage of ANI Pharma with a rating of Buy and set a new price target of $73.00 from $60.00 previously
Guggenheim initiated coverage of ANI Pharma with a rating of Buy and set a new price target of $55.00
H.C. Wainwright initiated coverage of ANI Pharma with a rating of Buy and set a new price target of $50.00
Raymond James reiterated coverage of ANI Pharmaceuticals with a rating of Outperform and set a new price target of $65.00 from $60.00 previously
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Generated record quarterly net revenues of $211.4 million, representing year-over-year growth of 53.1% on a reported basis and 37.0% on an organic basisTotal Rare Disease quarterly net revenues of $104.0 million, which includes: Purified Cortrophin® Gel net revenues of $81.6 million, an increase of 66.0% year-over-year, andILUVIEN® and YUTIQ® net revenues of $22.3 million Generics quarterly net revenues of $90.3 million, an increase of 22.1% year-over-year Delivered record quarterly adjusted non-GAAP EBITDA of $54.1 million, an increase of 62.8% year-over-yearDiluted GAAP income per share of $0.36 and record adjusted non-GAAP diluted earnings per share of $1.80Increased 2025 guidance
PRINCETON, N.J., Aug. 01, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced that the Company will release its second quarter 2025 financial results on Friday, August 8, 2025, prior to the market open. Nikhil Lalwani, President and Chief Executive Officer, Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, Chris Mutz, Head of Rare Disease, and Mary Pao, M.D., Ph.D., Chief Medical Officer, will host a conference call to discuss the results as follows: DateFriday, August 8, 2025 Time8:30 a.m. ET Toll free (U.S.)800-343-4136 Conference ID5034065 Webcast (live and replay)www.anipharmaceuticals.com, under
Trial evaluated number of supplemental injections needed for the treatment of DME for patients on ILUVIEN versus the aflibercept arm Study Enrolled Treatment-Naïve, or Almost Naïve, Patients with DME Results presented by Michael A. Singer, M.D. in a paper-on-demand presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting Conference call scheduled for today at 8:30 am ET PRINCETON, N.J., July 23, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced results from the NEW DAY clinical trial of ILUVIEN® (fluocinolone acetonide intravitreal implant), 0.19 mg (ILUVIEN) for use in patients with diabetic macula
Generated record quarterly net revenues of $197.1 million, representing year-over-year growth of 43.4%Total Rare Disease quarterly net revenues of $69.0 million, which includes: Purified Cortrophin® Gel net revenues of $52.9 million, an increase of 43.1% year-over-year, andILUVIEN® and YUTIQ® net revenues of $16.1 million Record Generics net revenues of $98.7 million, an increase of 40.5% year-over-yearDelivered record quarterly adjusted non-GAAP EBITDA of $50.7 million, an increase of 34.9% year-over-yearDiluted GAAP income per share of $0.69 and record adjusted non-GAAP diluted earnings per share of $1.70Increased 2025 guidance with expected net revenues of $768.0 million to $793.0 million
PRINCETON, N.J., April 09, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced that the Company will release its first quarter 2025 financial results on Friday, May 9, 2025, prior to the market open. Nikhil Lalwani, President and Chief Executive Officer, Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, and Chris Mutz, Head of Rare Disease, will host a conference call to discuss the results as follows: DateFriday, May 9, 2025 Time8:00 a.m. ET Toll free (U.S.)800-225-9448 Conference ID4921902 Webcast (live and replay) www.anipharmaceuticals.com, under the "Investors" section A re
Generated record quarterly net revenues of $190.6 million, representing year-over-year growth of 44.8%Total Rare Disease quarterly net revenue of $87.0 million, which includes: Record quarterly net revenue for Purified Cortrophin® Gel of $59.4 million, an increase of 42.3% year-over-year, andILUVIEN® and YUTIQ® net revenues of $27.6 million in the first full quarter of ownership following the acquisition of Alimera Sciences Delivered record quarterly adjusted non-GAAP EBITDA of $50.0 million, an increase of 65.7% year-over-yearDiluted GAAP loss per share of $(0.55) and adjusted non-GAAP diluted earnings per share of $1.63Increased 2025 guidance with expected net revenu
PRINCETON, N.J., Feb. 18, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced that the Company will release its fourth quarter and full year 2024 financial results on Friday, February 28, 2025, prior to the market open. Nikhil Lalwani, President and Chief Executive Officer, Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, and Chris Mutz, Head of Rare Disease, will host a conference call to discuss the results as follows: Date Friday, February 28, 2025 Time8:00 a.m. ET Toll free (U.S.) 800-579-2543 Conference ID4860276 Webcast (live and replay) www.anipharmaceuticals.com, under the "Investors" section
For full year 2024, the Company expects total net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS to be at or above the guidance ranges provided on November 8, 2024Rare Disease Segment performed in line with expectations, with Purified Cortrophin Gel net revenues of $197.8 million to $198.4 million for the full year 2024 and ILUVIEN and YUTIQ net revenues of $30.4 million to $31.0 million for the post-acquisition period from September 16, 2024 to December 31, 2024, based on preliminary, unaudited resultsEstablished preliminary financial outlook for 2025, including total net revenues of $739 million to $759 million and adjusted non-GAAP EBITDA of $182 million to $192 mil
Generated record quarterly net revenues of $148.3 million, representing year-over-year growth of 12.5%, and record Purified Cortrophin® Gel net revenues of $52.6 million, an increase of 76.8% year-over-yearNet loss of $(24.2) million and adjusted non-GAAP EBITDA of $35.1 millionDiluted GAAP loss per share of $(1.27) and adjusted non-GAAP diluted earnings per share of $1.34Completed the acquisition of Alimera Sciences, Inc. on September 16, 2024, adding two commercial assets ILUVIEN® and YUTIQ® with significant growth potential to its Rare Disease portfolioImplemented new capital structure that is expected to reduce interest expense by approximately $39.0 million on an annualized basis (1)Inc
PRINCETON, N.J., Oct. 30, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced that the Company will release its third quarter 2024 financial results on Friday, November 8, 2024, prior to the market open. Nikhil Lalwani, President and Chief Executive Officer, Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, and Chris Mutz, Head of Rare Disease, will host a conference call to discuss the results as follows: DateFriday, November 8, 2024 Time8:00 a.m. ET Toll free (U.S.)800-445-7795 Conference ID4757982 Webcast (live and replay)www.anipharmaceuticals.com, under the "Investors" section A replay of the c
Live Leadership Updates
Long time industry leader, Chairman of the Board Patrick Walsh replaces CEO Bill Humphries DURHAM, N.C., Jan. 13, 2025 /PRNewswire/ -- Alcami Corporation ("Alcami"), a leading contract development and manufacturing organization (CDMO), today announced the resignation of Bill Humphries. Alcami's Board Chair and former Chief Executive Officer Patrick Walsh will serve as Interim CEO, ensuring the continuation of smooth operations and a strong client-centric approach from a proven industry veteran. "On behalf of the Board, I'd like to express gratitude to Bill for his leadership
-- Mr. Leonard is an accomplished leader with 35 years of pharmaceuticals and healthcare experience -- Mr. Leonard has significant expertise in pharmacy benefits management, health insurance, and specialty and retail pharmacy -- BAUDETTE, Minn., Aug. 23, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced the addition of Matthew J. Leonard, R.Ph. to its Board of Directors. Mr. Leonard brings more than 35 years of experience as an accomplished leader and innovator within the pharmaceutical industry. This appointment is effective immediately. "We are delighted to add Matthew (Matt) Leonard to our Board of Directors. With his deep leadershi
ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) ("ANI" or the "Company") today announced that Krista L. Davis will join the Company as Chief Human Resources Officer, effective September 12. Ms. Davis brings to the Company over 20 years of executive leadership experience in human resources, talent management, and organizational development. "Ms. Davis is an important addition to our leadership team and will bring strategic and innovative thought leadership to our priority people and organizational issues. Krista has a long track record of driving organizational effectiveness and delivering results across industries and cultures, most recently with Novartis, where she led global human resources for
ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) (ANI or the Company) today announced that Meredith W. Cook will join the Company as SVP, General Counsel and Corporate Secretary, effective July 18. Ms. Cook brings over 20 years of legal and leadership experience in specialty and generics pharmaceuticals, including in corporate governance, mergers and acquisitions (M&A), strategic transactions, and intellectual property (IP). "We are delighted to welcome Ms. Cook to our leadership team. Meredith is an accomplished attorney with demonstrated leadership and expertise in the pharmaceutical industry and will no doubt play an important role in the Company's continued growth. Her guidance and perspectives
-- Dr. Tannenbaum's successful track record in driving commercial excellence to contribute as Company executes Purified Cortrophin GelTM launch -- ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) (ANI or the Company) today announced the addition of Renee P. Tannenbaum, Pharm.D., MBA, to its Board of Directors. Dr. Tannenbaum has over 35 years of management experience in the pharmaceutical industry. This appointment is effective immediately and increases ANI's Board of Directors to nine members. "We are honored to bring Dr. Tannenbaum's vast biopharmaceutical commercial experience and expertise to our Board of Directors. With her many accomplishments and proven track record of developing and implem
-- ANI Pharmaceuticals appoints Mary Pao, M.D., Ph.D., as Chief Medical Officer, Rare Disease, and Elizabeth Powell, J.D., as Chief Compliance Officer and Head of Legal, Rare Disease -- -- Dr. Pao and Ms. Powell, collectively, bring four decades of pharmaceutical industry experience to their roles in support of the commercialization of Purified Cortrophin™ Gel (repository corticotropin injection USP) -- -- Rare Disease Business Unit leadership hires build on recent Cortrophin Gel milestones -- ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) (ANI or the Company) today announced two additions to its Rare Disease Business Unit leadership team. Mary Pao, M.D., Ph.D., has been appointed Chief Medical
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