ANI Pharmaceuticals (ANIP) closed the most recent trading day at $55.41, moving -0.32% from the previous trading session. The stock's performance was behind the S&P 500's daily gain of 1.23%. On the other hand, the Dow registered a gain of 1.06%, and the technology-centric Nasdaq increased by 1.7%.Coming into today, shares of the drugmaker had gained 4.63% in the past month. In that same time, the Medical sector gained 3.16%, while the S&P 500 gained 0.94%.The investment community will be closely monitoring ...

BAUDETTE, Minn., Jan. 16, 2024 (GLOBE NEWSWIRE) --  ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Indomethacin Oral Suspension (OS), USP. ANI's Indomethacin OS is the generic version of the Reference Listed Drug (RLD) Indocin® Oral Suspension. The current annual U.S. market for Indomethacin OS is approximately $4.1 million, according to the latest estimates fro ...

ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) Q3 2023 Earnings Conference Call November 8, 2023 8:30 AM ET Company Participants Judy DiClemente - Insight Communications IR Nikhil Lalwani - President and CEO Stephen Carey - CFO Conference Call Participants Les Sulewski - Truist Securities Vamil Divan - Guggenheim Securities Oren Livnat - H.C. Wainwright Operator Good day, everyone, and welcome to the ANI Pharmaceuticals, Inc. Third Quarter 2023 Earnings Results Call. At this time, all participants are in a listen- ...

Table of Contents Large accelerated filer o Accelerated filer x Non-accelerated filer o Smaller reporting company o Emerging growth company o UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q x QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 o TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number 001-31812 ...

Financial Data and Key Metrics Changes - The company reported net quarterly revenues of $116.5 million, an increase of nearly 58% year-over-year and approximately 9% growth over the first quarter of 2023, marking a record quarter [6][14] - Adjusted non-GAAP EBITDA reached $34.1 million, representing a nearly 246% year-over-year increase and a sequential increase from $33 million in the first quarter of 2023 [6][18] - Adjusted non-GAAP diluted EPS was $1.28, reflecting almost a tenfold growth over the second quarter of 2022 [6][18] - The company generated cash of $42 million from operations during the first half of the year [6] Business Segment Performance - Revenues from the Rare Disease segment, specifically from Cortrophin Gel, totaled $24.3 million, an increase of 138% year-over-year and up 49% compared to the first quarter [7][14] - The Generics, Established Brands, and Others segments grew by 45% year-over-year to $92.2 million [9][15] - The company raised its full-year revenue guidance for Cortrophin Gel to $90 million to $100 million, up from $80 million to $90 million, indicating year-over-year growth of 116% to 140% [8][21] Market Data and Key Metrics Changes - The ACTH category has shown robust growth with 12 consecutive months of year-over-year growth from June 2022 to May 2023 [8] - The company has seen strong traction in pulmonology, with early momentum from the expanded sales team [30] Company Strategy and Industry Competition - The company aims to scale its Rare Disease business and is actively pursuing M&A and in-licensing opportunities to enhance its portfolio [9][26] - The focus remains on leveraging U.S. manufacturing capabilities and maintaining a strong GMP track record to capture market opportunities arising from supply disruptions [10][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sustainability of growth across all business segments and highlighted the importance of innovation in commercialization efforts [27] - The company raised its full-year 2023 guidance for net revenues to a range of $425 million to $445 million, reflecting approximately 34% to 41% growth compared to 2022 [20] Other Important Information - The company ended the quarter with $161.7 million in unrestricted cash, bolstered by cash flow from operations and a recent equity raise [19] - Operating expenses increased by 20% to $104.1 million, primarily due to increased sales volumes and R&D activities [16][17] Q&A Session Summary Question: Sustainability of Established Brands segment performance - Management indicated that robust results in Generics and Established Brands showcase the company's ability to leverage U.S. manufacturing and respond to market demand [26][27] Question: Details on Rare Disease asset acquisition - The corporate development team is actively evaluating opportunities that provide synergy with the existing Rare Disease infrastructure [25][26] Question: Areas driving ACTH growth and early uptake in pulmonology - Growth in Purified Cortrophin Gel was driven by new cases initiated and an increase in unique prescribers across targeted specialties [29][30] Question: R&D pipeline focus within Generics - The company continues to invest in R&D with a focus on niche opportunities and smaller asset-level deals to drive growth in the Generics business [32]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark one) x QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 o TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number 001-31812 ANI PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 58-2301143 (State or other j ...

ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) Q1 2023 Earnings Conference Call May 8, 2023 8:30 AM ET Company Participants Judy DiClemente - Insight Communications Investor Relations Nikhil Lalwani - President and Chief Executive Officer Stephen Carey - Chief Financial Officer Conference Call Participants Elliot Wilbur - Raymond James Vamil Divan - Guggenheim Securities Brandon Folkes - Cantor Fitzgerald Greg Fraser - Truist Securities Oren Livnat - H.C. Wainwright Operator Good day, everyone, and welcome to toda ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number 001-31812 ANI PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 58-2301143 (State or other ...

ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) Q4 2022 Earnings Conference Call March 9, 2023 8:30 AM ET Company Participants Judy DiClemente - IR Nikhil Lalwani - President, CEO & Director Stephen Carey - CFO, SVP, Finance & Corporate Secretary Conference Call Participants Elliot Wilbur - Raymond James & Associates Vamil Divan - Guggenheim Securities Gregory Fraser - Truist Securities Brandon Folkes - Cantor Fitzgerald Oren Livnat - H.C. Wainwright & Co. Operator Good morning, everyone, and my name is Ashley, an ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark one) ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______. Commission file number 001-31812 ANI PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 58-2301143 (State ...