Amneal Pharmaceuticals, Inc. · NASDAQ:AMRX
Amneal Pharmaceuticals — 39th Annual J.P. Morgan Healthcare Conference (January 2021)
24 slides from Amneal Pharmaceuticals's conference presentation, Jan 13, 2021
Slide 1: 39th Annual J.P. Morgan Healthcare Conference
39th Annual J.P. Morgan Healthcare Conference January 13, 2021 g
Slide 2: Safe Harbor Statement
Safe Harbor Statement Certain statements contained in this presentation, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s
Slide 3: Non-GAAP Financial Measures
Non-GAAP Financial Measures This presentation includes certain non-GAAP financial measures, including adjusted EBITDA and adjusted operating cash flow, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with U.S. General Accep
Slide 4: Track record of growth
Track record of growth * $1,975 Annual revenue performance ($ millions) $1,663 $1,626 $1,018 $1,034 $866 $785 $531 $323 $352 $261 $163 $77 $19 2002 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2002: August 2005: June 2008: May 2011: October 2017: May 2018: August 2019: Janua
Slide 5: Growth strategy at-a-glance
Growth strategy at-a-glance Expand Product Mix and End Markets • Leverage our broad commercial presence to grow market share • Increase speed of innovation of complex generics, including Injectables, Inhalants, Ophthalmics and Biosimilars • Margin expansion through new product launches and operation
Slide 6: Expand Product Mix and End Markets
Expand Product Mix and End Markets • Leverage our broad commercial presence to grow market share • Increase speed of innovation of complex generics, including Injectables, Inhalants, Ophthalmics and Biosimilars • Margin expansion through new product launches and operational efficiencies • Leverage p
Slide 7: Transition toward complex generics: Current portfolio & pipeline
Transition toward complex generics: Current portfolio & pipeline ANDAs Submitted (Pending + TA): 104 Projects Development Pipeline: 85 projects 1% 1% 2% 3% 5% 4% 6% 1% 13% 8% 8% 12% 43% 9% 11% 7% 8% 16% 13% 29% Inhalation Nasal Spray Transdermal Inhalation Nasal Spray Transdermal Oral liquid Oral li
Slide 8: Expand product mix & end markets: Key focus areas
Expand product mix & end markets: Key focus areas Complex Generics Biosimilars Injectables Current Pipeline • 40+ expected sterile launches (vials, bags, PFS*) from 2021-2025 • Current Status: Mid-2021 filing • Focus: 505(b)2 injectables, 503B compounding opportunities • Expected Launch: 2023 • Curr
Slide 9: Expand product mix & end markets: Key focus areas
Expand product mix & end markets: Key focus areas Ex-US Geographic Expansion Channel Expansion Fosun Partnership: China Evaluating Multiple Opportunities • Leveraging Amneal’s ANDA library and regulatory expertise + • Acquisition of AvKARE catalyzed a focused effort on growing our Fosun’s commercial
Slide 10: Drive organic growth and depth of R&D Pipeline
Drive organic growth and depth of R&D Pipeline • Leverage commercial expertise in Neurology and Endocrinology to drive growth of Rytary and Unithroid • Advance our two R&D Neurology programs of IPX-203 and K-127 • The acquisition of Kashiv Specialty adds new branded pipeline programs, additional com
Slide 11: Driving growth in our Specialty Business
Driving growth in our Specialty Business Expanding pipeline with Kashiv Drive commercialization of existing products Advance existing pipeline Specialty 3Q YTD Net Revenue ($ millions) $114 SPECIALTY PHARMA IPX-203 K-114 $40 K-127 K-128 Rytary Unithroid 11
Slide 12: Advancing new product development candidates – IPX-203
Advancing new product development candidates – IPX-203 For treatment of Parkinson’s Disease – a neurodegenerative disorder that affects dopamine-producing neurons in the brain that affect movement Benefits of IPX-203 Developed with innovative technology containing immediate and sustained-release gra
Slide 13: Advancing new product development candidates – K-127
Advancing new product development candidates – K-127 For treatment of Myasthenia Gravis – a rare autoimmune disease that causes extreme muscle weakness Benefits of K-127 Developed through Kashiv Specialty’s proprietary GRANDE / Oros drug delivery technologies Delivers fast-acting neuromuscular impro
Slide 14: Kashiv Specialty accelerates Amneal's transition to specialty pharma
Kashiv Specialty accelerates Amneal’s transition to specialty pharma Strategic Rationale Company Overview • Kashiv Specialty’s team has developed many of Amneal’s most History of successful Gx R&D lucrative products (e.g. Yuvafem and EluRyng) generating ~$600 million in gross profit since 2016 SPECI
Slide 15: Key transaction terms and timeline
Key transaction terms and timeline • On January 11, 2021, Amneal agreed to acquire Kashiv Specialty Pharmaceuticals Timing • Expected closing 2Q, 2021 (Subject to regulatory approval and other customary closing conditions) • Upfront payment of $70 million at closing, and $30 million in January 2022
Slide 16: Specialty: Doubles our branded product pipeline
Specialty: Doubles our branded product pipeline Pre-Transaction Post-Transaction Phase of Phase of Estimated Estimated Program Molecule Indication Development Program Molecule Indication Development Launch Launch 505(b)2 505(b)2 Carbidopa- Parkinson’s Carbidopa- Parkinson’s IPX-203 Phase 3 2023 IPX-
Slide 17: Specialty: Programs complement Amneal's existing branded portfolio
Specialty: Programs complement Amneal’s existing branded portfolio K-127 K-128 K-114 • THP hydrochloride capsules, oral Product • Pyridostigmine QD; oral extended release • LT3 sustained release tablets extended release Indication Myasthenia Gravis Sialorrhea & Movement Disorders Hypothyroidism (T4
Slide 18: Specialty: Proprietary drug delivery technology platforms
Specialty: Proprietary drug delivery technology platforms GRANDE: Advanced Gastric Retention System KRONOTEC: Modified Release Technology Enables sustained 12-24 hour delivery for drugs with site- specific absorption in upper GI tract Easy to swallow: Initial tablet size is small enough for swallowi
Slide 19: Generics: Successful complex Gx collaboration with Amneal
Generics: Successful complex Gx collaboration with Amneal Amneal has had a commercial relationship with Kashiv Specialty for the last 9 years under which several licensed products have generated significant revenue for Amneal • 18 approved generic products; 15+ currently in development or awaiting l
Slide 20: Financial merits of Kashiv Specialty acquisition
Financial merits of Kashiv Specialty acquisition Enhances Amneal’s profitability by acquiring full economics of partnered generics products Expect to add sustainable top-line Specialty growth in the medium-term Improves leverage profile over time Financially accretive due to reduction in royalties a
Slide 21: Financial highlights
Financial highlights ($ in millions) Adjusted Results(1) Balance Sheet and Liquidity Liquidity at September 30, 2020 Net Revenue $1,626 $1,975 ▪ Cash and cash equivalents $284 ▪ ABL Available(7) $498 ➢ Total Liquidity $782 FY 19 FY 20* ➢ Includes substantially all of the $110 million tax refund rece
Slide 22: Appendix: Non-GAAP Reconciliation
Appendix: Non-GAAP Reconciliation 22
Slide 23: Reconciliation of Net Loss to EBITDA and Adjusted EBITDA
Reconciliation of Net Loss to EBITDA and Adjusted EBITDA Full Year 2019 ($ in millions) Net loss $ (603.6) Adjusted to add: Interest expense, net 168.2 Income tax expense 383.3 Depreciation and amortization 207.2 EBITDA (Non-GAAP) $ 155.1 Adjust to add (deduct): Gain from reduction of tax receivable
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