Ani Pharmaceuticals, Inc. · NASDAQ:ANIP
Ani Pharmaceuticals — Q3 2023 Earnings Presentation
18 slides from Ani Pharmaceuticals's earnings presentation, Feb 8, 2024
Slide 1: February 2024
February 2024 © 2024 ANI Pharmaceuticals, Inc. 1
Slide 2: Disclaimer
Disclaimer © 2024 ANI Pharmaceuticals, Inc. 2 This presentation by ANI Pharmaceuticals, Inc (“ANI” or the “Company”) contains forward-looking statements, including information about management's view of the Company’s future expectations, plans and prospects, as well as other forward-looking statemen
Slide 3: Rare Disease, Generics and Established Brands drive robust profitable growth
ANI Pharmaceuticals: Rare Disease, Generics and Established Brands businesses drive robust profitable growth Key Growth Drivers Rare Disease business with lead asset Purified Cortrophin Gel (PCG) and expansion through M&A Established Brands Generics with enhanced R&D capabilities & supply reliabilit
Slide 4: Q3 2023: Achieved record financial results
© 2024 ANI Pharmaceuticals, Inc. 4 Q3 2023: Achieved record financial results Q3 Revenues $132M 57% YoY Q3 Diluted non-GAAP EPS(1) $1.27 119% YoY Q3 Cortrophin Revenues $30M 136% YoY Q3 Adj. Non-GAAP EBITDA(1) $36M 98% YoY Year-to-Date Cash Flow from Operations(2) $74M Q3 Generic, Established Brands
Slide 5: Raised full year 2023 guidance for third quarter in a row
© 2024 ANI Pharmaceuticals, Inc. 5 Raised full year 2023 guidance for third quarter in a row (1) Adjusted Non-GAAP Gross Margin, Adjusted non-GAAP EBITDA, and Adjusted Non-GAAP Diluted EPS are non-GAAP financial measures. Metric ($ millions except per share amounts) Revised Full Year 2023 Guidance P
Slide 6: Revenue growth driven by momentum across Rare Disease, Generics and Established Brands
© 2024 ANI Pharmaceuticals, Inc. 6 Revenue growth driven by momentum across Rare Disease, Generics and Established Brands 216 42 $- 2021 2022 $100-$107 2023E Generics, Est. Brands, Royalties, and Other Rare Disease 140-157% Note: Figures presented may not total due to rounding. (1) Guidance shared a
Slide 7: Profitability driven by gross profit pull through and leveraging of Rare Disease infrastructure
© 2024 ANI Pharmaceuticals, Inc. 7 Profitability driven by gross profit pull through and leveraging of Rare Disease infrastructure (1) Guidance shared at 3rd quarter earnings call (2) CAGR is calculated based on midpoint Adjusted Non-GAAP Gross-Margin ($ million) Adjusted Non-GAAP EBITDA(1) ($ milli
Slide 8: Rare Disease: ANI's primary growth engine accelerating with lead asset
$17.6 $16.3 $24.3 $29.7 Rare Disease: ANI’s primary growth engine accelerating with lead asset Purified Cortrophin Gel (PCG) as foundation Continued strong momentum with record number of new patient starts and new cases initiated in Q3’23 • Grew all targeted specialties of neurology, nephrology and
Slide 9: ACTH Class has shown year-over-year quarterly unit growth for six consecutive quarters
ACTH Class has shown year-over-year quarterly unit growth for six consecutive quarters since Cortrophin launch Source: IQVIA ACTH Units – Year-over-Year Change From Q2 2022 to Q3 2023, the ACTH category has demonstrated six consecutive quarters of growth year-over-year 22% 20% 18% 16% 14% 12% 10% 8%
Slide 10: Focused efforts ongoing to increase scope and scale of Rare Disease business through M&A
Focused efforts ongoing to increase scope and scale of Rare Disease business through M&A Assets’ patent protection profile Assets’ peak year revenue forecast Priority 1: Rare disease opportunities in priority therapeutic areas for ANI, specifically Nephrology, Neurology, Rheumatology and Pulmonology
Slide 11: Superior R&D capabilities and operational excellence driving growth in Generics
Superior R&D capabilities and operational excellence driving growth in Generics Superior pipeline and new product launch execution • Increased R&D investment with focus on niche opportunities • Filed six new ANDAs in 2023 and three 505(b)2 NDA applications • Retained top 12 ranking in number of ANDA
Slide 12: U.S.-based manufacturing footprint; strong GMP track record
U.S.-based manufacturing footprint; strong GMP track record, including successful FDA audits at all three sites • Manufacturing, packaging, warehouse • Schedule CII vault & CIII cage space • Lab space - R&D/analytical testing • Solutions, suspensions, topicals, tablets, capsules, and powder for susp
Slide 13: Executive Leadership Team with proven track records and broad industry expertise
Executive Leadership Team with proven track records and broad industry expertise Meredith Cook SVP, Legal & General Counsel ‒ 20+ years of legal and leadershipexperience in specialtyand genericspharmaceuticals ‒ Served as Vice Presidentand AssociateGC for AmnealPharmaceuticals ‒ Previouslywith Morga
Slide 14: Investment summary
Robust and nimble Generics segment delivering growth • Demonstrated R&D excellence in filings and launch execution • Providing reliability of supply with US-based manufacturing and strong GMP track record Experienced purpose-driven team • Dedicated employees with deep experience and expertise in Rar
Slide 15: ANI recently celebrated a decade since listing on the NASDAQ
ANI recently celebrated a decade since listing on the NASDAQ © 2024 ANI Pharmaceuticals, Inc. 15
Slide 16: February 2024
February 2024 © 2024 ANI Pharmaceuticals, Inc. 16
Slide 17: Adjusted non-GAAP EBITDA calculation – 3Q 2023 and 2022
Adjusted non-GAAP EBITDA calculation – 3Q 2023 and 2022 (1) Impact of Canada operations includes CDMO revenues, cost of sales relating to CDMO revenues, all selling, general, and administrative expenses, and all research and development expenses recorded in Canada in the period presented, exclusive
Slide 18: Adjusted non-GAAP EBITDA calculation – full year 2022 and 2021
Adjusted non-GAAP EBITDA calculation – full year 2022 and 2021 © 2024 ANI Pharmaceuticals, Inc. 18 (1) Adjustment to other expense, net excludes $750K of income related to the sale of an ANDA during the three months ended December 31, 2021, and excludes $750K and $1.9 million of income related to th