Financial Data and Key Metrics Changes - Total revenue for 2023 was $486.8 million, an increase of 54% over 2022 [7] - Adjusted non-GAAP EBITDA reached a record $133.8 million, up 140% year-over-year [7] - Adjusted non-GAAP earnings per share were $4.71, an increase of 246% from 2022 [7] - Fourth quarter revenues were $131.7 million, a 40% increase over Q4 2022 [16] - Net income available to common shareholders for Q4 2023 was $0.7 million, compared to a net loss of $4.7 million in the prior year [18] Business Line Data and Key Metrics Changes - Cortrophin Gel generated $41.7 million in Q4, a year-over-year increase of 137% [8] - For the full year, Cortrophin sales were $112.1 million, representing year-over-year growth of 169% [8] - The generics business generated $71.8 million in revenue during Q4, an increase of 24% over the last year [13] - Established brands and other revenues were $18.1 million in Q4, a decrease of 3% from the prior year [17] Market Data and Key Metrics Changes - Total ACTH unit volume was up 15% in 2023 compared to 2022 [8] - The overall ACTH category has experienced seven consecutive quarters of year-over-year growth [9] - The generics business maintained a strong compliance track record with successful FDA audits [14] Company Strategy and Development Direction - The company plans to expand its rare disease business through M&A and in-licensing, focusing on assets that overlap with current therapeutic areas [12] - Investment in R&D is prioritized to fuel generics growth through new product launches [33] - The company is adding a second geographical region to its pulmonology sales force and expanding into ophthalmology [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory of Cortrophin Gel, expecting revenues to grow 52% to 61% in 2024 [10] - The overall category outlook for ACTH treatments remains robust, with significant growth opportunities [27] - The company does not anticipate additional benefits from supply tailwinds in 2024 [37] Other Important Information - The company ended Q4 with $221.1 million in cash and generated cash flow from operations of $44.7 million [20] - Total company non-GAAP gross margin is expected to be between 62% and 63% in 2024 [23] Q&A Session Summary Question: What market growth is assumed for Cortrophin in 2024? - Management indicated that the overall category outlook remains robust, with significant growth opportunities in ACTH treatments [27] Question: What is the status of additional rare disease assets? - The company is engaged with multiple companies for potential acquisitions, focusing on both current and new therapeutic areas [29] Question: What are the drivers behind the stronger Cortrophin sales? - Increased volumes, effectiveness of the sales force, and record new patient starts are key drivers [32] Question: How will expenses be allocated between SG&A and R&D? - The company plans to invest in both areas, with a focus on supporting generics growth and expanding the Cortrophin Gel franchise [34] Question: What is the progress in pulmonology and the new 1-ml vial for gout? - There has been positive traction in pulmonology, and optimism surrounds the new 1-ml vial for gout, although it is early in the launch [36]

Employee and Workforce - As of January 2024, the company has 642 employees, an increase from 600 employees in January 2023, with 569 located in the U.S. and 72 in India[61] - Approximately 41% of the company's workforce identified as female, and 45% identified as a person of color or indigenous person as of the end of 2023[63] - The company has a health and safety program focused on continuous improvement and employee engagement, with training provided to new employees[67] Financial Performance - Net revenues for 2023 reached $486.8 million, a significant increase of 54% compared to $316.4 million in 2022[349] - Operating income for 2023 was $47.0 million, a turnaround from an operating loss of $35.3 million in 2022[349] - Net income for 2023 was $18.8 million, compared to a net loss of $47.9 million in 2022, marking a substantial improvement[351] - Basic income per share for 2023 was $0.86, compared to a loss of $3.05 per share in 2022[349] - The company reported a total comprehensive income of $15.5 million for 2023, compared to a comprehensive loss of $32.7 million in 2022[351] Assets and Liabilities - As of December 31, 2023, total assets increased to $904.4 million from $760.1 million in 2022, representing an increase of approximately 19%[345] - Total current assets reached $519.8 million, up from $344.3 million in 2022, reflecting a growth of approximately 51%[345] - The company's total liabilities increased to $446.8 million in 2023 from $421.5 million in 2022, a rise of about 6%[345] - Total stockholders' equity increased to $432.7 million in 2023, up from $313.7 million in 2022, representing a growth of around 38%[345] Cash Flow and Investments - Cash and cash equivalents rose significantly to $221.1 million in 2023, compared to $48.2 million in 2022, marking an increase of over 358%[345] - Operating cash flow for 2023 was $118,959 million, compared to a cash outflow of $31,203 million in 2022[358] - The company reported a net cash outflow of $18,511 million from investing activities in 2023, compared to an outflow of $15,738 million in 2022[358] Debt and Interest Rates - The company has a total net leverage ratio requirement not to exceed 4.75:1.00 under its Credit Agreement, with a stricter limit of 4.50:1.00 applicable until September 30, 2023[321] - The company amended its Credit Agreement in July 2023 to transition from LIBOR to SOFR, with specific credit spread adjustments for different interest periods[322] - The company is exposed to interest rate risk, with a 1% change in interest rates potentially impacting interest expense by approximately $1.6 million for the Term Facility[323] - The interest rate under the Term Facility was 11.46% at December 31, 2023[457] - Total interest expense related to the Term Facility for the year ended December 31, 2023, was $32.5 million, compared to $28.4 million in 2022[463] Research and Development - Research and development expenses increased to $34.3 million in 2023, up 54% from $22.3 million in 2022[349] - The company plans to continue expanding its product offerings and investing in research and development to drive future growth[349] Acquisitions and Strategic Initiatives - The company has made strategic acquisitions, including the acquisition of Novitium, which contributed to revenue growth[354] - The acquisition of Novitium was completed for a total consideration of approximately $206.5 million, including cash, restricted shares, and contingent consideration[440] - Novitium generated revenues of $149.9 million in 2023, up from $90.3 million in 2022, indicating significant growth post-acquisition[444] Environmental and Social Governance - The company is committed to environmental stewardship and has formed an ESG Steering Committee to oversee sustainability initiatives[68] - The company has formed the ANI Rare Disease Patient Assistance Program to provide free medicines to uninsured patients in the U.S.[65] Operational Changes - The company has ceased operations at the Oakville, Ontario manufacturing facility as of March 31, 2023, to streamline operations[363] - The company plans to sell the Oakville facility for approximately $14.2 million USD, with the sale expected to close in March 2024[363] Inventory and Revenue Recognition - The company’s inventory as of December 31, 2023, totaled $111.2 million, an increase from $105.4 million in 2022[470] - Revenue is recognized primarily from sales of generic, rare disease, and established brand pharmaceutical products, with control of products typically transferring to customers upon sale[370] - The company continually adjusts its Average Selling Prices (ASPs) based on chargeback activity and other market factors to reflect actual selling prices[423][432] Financial Controls and Reporting - The company maintained effective internal control over financial reporting as of December 31, 2023, according to the audit opinion[338] - The allowance for credit losses was immaterial as of December 31, 2023, and 2022, indicating a stable credit risk profile[379]

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 ...