ANI Pharmaceuticals(US:ANIP)2024-02-29 17:00Financial 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]