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 ...

Financial Data and Key Metrics - Q2 2021 revenues totaled $48.6 million, compared to $48.5 million in Q2 2020, showing minimal growth [8] - Adjusted non-GAAP EBITDA for Q2 2021 was $13.1 million, down $2.3 million or 15% from Q2 2020 [20] - Gross margin for Q2 2021 was 57.2%, compared to 60.9% in Q2 2020, primarily due to increased volumes at lower average selling prices [18] - Net debt as of June 30, 2021, increased to $181.5 million, up from $159.5 million as of March 31, 2021, driven by borrowings for the Sandoz acquisition [21] Business Line Performance - Generic products sales were $34.2 million in Q2 2021, up 2.4% from $33.4 million in Q2 2020, driven by increased sales of fenofibrate, Potassium Citrate ER, vancomycin oral solution, and the launch of Nicardipine [16] - Branded products sales were $11 million in Q2 2021, up 3.8% from $10.6 million in Q2 2020, primarily due to the launch of four products acquired from Sandoz and increased sales of InnoPran XL [17] - Contract manufacturing revenues decreased to $2.3 million in Q2 2021 from $2.9 million in Q2 2020, due to lower order volumes [17] - Royalty and other revenues decreased to $1.1 million in Q2 2021 from $1.5 million in Q2 2020, reflecting declines in product development revenues and non-recurrence of Yescarta royalties [17] Market Performance - The U.S. generic prescription market showed initial signs of recovery in Q2 2021, with total prescriptions up compared to prior year and prior quarter, though still below pre-COVID levels [15] Company Strategy and Industry Competition - The company refiled its sNDA for Cortrophin Gel on June 29, 2021, with a goal date of October 29, 2021, marking a significant milestone in its growth strategy [7][9] - The acquisition of Novitium is on track to close in the second half of 2021, pending FTC clearance, and is expected to enhance R&D capabilities and focus on niche opportunities [11][12] - The company acquired the NDAs for Oxistat, Veregen, and Pandel cream, and the ANDA for ApexiCon cream from Sandoz, integrating these dermatology products into its portfolio [13] - The company is monitoring competitive dynamics in the Cortrophin market, particularly the decline in sales of Acthar, and believes its holistic commercial strategy addresses these challenges [27] Management Commentary on Operating Environment and Future Outlook - The company remains cautious about the impact of COVID-19 on script activity and reiterates its full-year guidance, albeit with a continued orientation towards the low end of the range [21] - The company is focused on executing its four-pillar growth strategy, including building a successful Cortrophin business, strengthening its generics business, maximizing the value of its established brands, and enhancing R&D capabilities [7][11][13] Other Important Information - The company entered into a settlement agreement with Arbor Pharmaceuticals, resolving long-standing commercial litigation, resulting in an $8.4 million charge in Q2 2021 [20] - Novitium has gained approval to launch nine new products and filed four new ANDAs, performing in line with or ahead of investment expectations [12][31] Q&A Session Summary Question: FDA interactions and competitive dynamics for Cortrophin - The company has engaged in productive communication with the FDA regarding the sNDA for Cortrophin Gel and is pleased with the progress [26] - The company cannot comment on specific labeling discussions, including the infantile spasms indication, due to competitive reasons [27] - The company is monitoring the decline in sales of Acthar and believes its commercial strategy addresses the competitive challenges [27] Question: Novitium acquisition and FTC review - The Novitium acquisition remains on track to close in the second half of 2021, with active planning for integration and combining complementary strengths [30] - Novitium has maintained a strong track record with the FDA, including a successful GMP inspection, which is a positive indicator for the acquisition [31]

Table of Contents Titleofeachclass:Trading CommonStock 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 September 30, 2020 ☐ 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 char ...