Ani Pharmaceuticals, Inc. · NASDAQ:ANIP
Ani Pharmaceuticals — H.C. Wainwright Annual Global Investment Conference 2022
15 slides from Ani Pharmaceuticals's conference presentation, September 2022
Slide 1: H.C. Wainwright Annual Global Investment Conference
H.C. Wainwright Annual Global Investment Conference September 2022 © 2022 ANI Pharmaceuticals, Inc. 1
Slide 2: Disclaimer
Disclaimer 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 statements, including the expected benefits
Slide 3: ANI Pharmaceuticals US-focused diversified biopharmaceuticals
Strong trajectory for launch of lead Rare Disease asset Purified Cortrophin® Gel1 • Transformational opportunity in ~$600MM ACTH market • Since Q1 2022 launch, 500 new patient cases initiated by 250+ unique prescribers • Raised Cortrophin Gel 2022 net revenue guidance to $40MM - 45MM at Q2 earnings
Slide 4: Strong and Growing U.S.-Focused Biopharmaceuticals Company
Strong and Growing U.S.-Focused Biopharmaceuticals Company Revenues (2021) ANI in Numbers Others CDMO 86 16 6% Largest Product’s 7% 5% Generic Products Branded Products Percentage of Total Revenue in 2021 22% Branded $216MM / $40MM - $45MM $295MM - $315MM Cortrophin Gel 2022E Revenues 2021 / 2022E R
Slide 5: Cortrophin Gel is a transformational opportunity
Cortrophin Gel is a transformational Cortrophin Gel is approved for all current ACTH indications, opportunity for ANI; potential significant with the exception of infantile spasms growth driver with commercial longevity • Other ~$600M ACTH market in 2021 • Uveitis ~10% ~80% (1) of ACTH market • Sarc
Slide 6: Experienced Rare Disease Leadership Team to Deliver a Successful Launch
Experienced Rare Disease Leadership Team to Deliver a Successful Launch Team Member Position Prior Experience • 25+ years industry experience CCO Chris Mutz • Commercial leadership at Alexion & Merck Head of Rare Disease • 7 rare disease launches • Hematologist / Oncologist Mary Pao • Global and NA
Slide 7: Cortrophin Gel Launch First 6 Months
Raised 2022 Cortrophin Gel revenue guidance to $40MM to $45MM from $35MM to $40MM Over 250 unique prescribers have initiated 500+ new patient cases • Approximately one third of unique prescribers have enrolled more than one patient • Since Q1 earnings report, new patient cases and unique prescribers
Slide 8: Strong Business Development Engine Fueled Growth of Established Brands & Generics
Strong Business Development Engine Fueled Growth of Established Brands & Generics Business Units Over The Years Generics Class Seller Products Brands 2022 Oakrum Pharma 4 limited competition ANDAs Class Seller Products Harris Fluconazole Veregen 2020 Ricon Clobetasol cream Oxistat 2021 Sandoz Amerig
Slide 9: Novitium acquisition: Added best-in-class R&D engine
Actual Expected Novitium acquisition: Added Annual ANDA Filings by Novitium best-in-class R&D engine with Generics and 505(b)(2) capabilities 14 14 12 9 7 Post-acquisition, ANI ranked #6 number 6 in number of ANDA approvals in past 12 months 2017 2018 2019 2020 2021 Retained position as leader in #1
Slide 10: Significant Progress Made on Key Integration Priorities with Novitium
Significant Progress Made on Key Integration Priorities with Novitium • Successfully launched several products with Ensured business continuity & minimized disruption on day 1 approximately $600mm in annualized sales during 2022, per Accelerated capture of high-value synergies IQVIA • Filed 8 new AN
Slide 11: Consolidation of Manufacturing Network to Capture Operational Synergies of $7-$8 million
Consolidation of Manufacturing Network to Capture Operational Synergies of $7-$8 million Ø Proactive step to drive cost competitiveness and sustainability of generics business Ø Manufacturing network well positioned to ensure new product launches and supply continuity for patients and customers Ø Op
Slide 12: Significant North American Manufacturing Footprint
Significant North American Manufacturing Footprint with ample capacity and strong GMP track record Baudette, MN Baudette, MN East Windsor, NJ 130k sf Containment Facility - 47k sf 100k sf • 100K ft2 of manufacturing, packaging, lab, • Manufacturing, packaging, warehouse • Manufacturing, packaging, w
Slide 13: Poised for Return to Strong Financial Growth
Poised for Return to Strong Financial Growth Revenues Non-GAAP Gross Profit – 11% $295- eC A GR evenu $315 2E R – 202 2018 $216 7% $207 $208 A GR – $202 ross Profit C 2 022E G 2018 – $174 $147 $134 $125 $127 2018 2019 2020 2021 2022E 2018 2019 2020 2021 2022E © 2022 ANI Pharmaceuticals, Inc. 13
Slide 14: Appendix
APPENDIX © 2022 ANI Pharmaceuticals, Inc. 14
Slide 15: EBITDA Reconciliation
EBITDA Reconciliation Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation (unaudited, in thousands) Year Ended Six Months December 31, Ended June 30, 2021 2022 Net Loss $ (42,603) $ (35,053) Add/(Subtract): Interest expense, net 11,922 13,282 Other expense, net(1) 6,243 75 Be
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