Amneal Pharmaceuticals, Inc. · NASDAQ:AMRX
Amneal Pharmaceuticals — Q1 2021 Earnings Presentation
35 slides from Amneal Pharmaceuticals's earnings presentation, May 7, 2021
Slide 1: Q1 2021 Earnings Call: Strategic Priorities and Financial Results
Q1 2021 Earnings Call Strategic Priorities and Financial Results May 7, 2021
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 U.S. Private Securities Litigation Reform Act of 1995). Such forward- looking statements include statements regarding managem
Slide 3: Non-GAAP Financial Measures
Non-GAAP Financial Measures This release includes certain non-GAAP financial measures, including adjusted EBITDA, adjusted net income, adjusted net income per diluted share, adjusted gross profit, adjusted gross margin, adjusted operating income adjusted cost of goods sold, adjusted selling general
Slide 4: Agenda
Agenda 1 Strategic Execution & Amneal 2.0 Chirag and Chintu Patel, Co-CEOs Q1 2021 Financial Results 2 Full Year 2021 Guidance Tasos Konidaris, EVP & CFO 3 Closing Remarks Chirag Patel, Co-CEO 4 Q&A 4
Slide 5: Amneal 2.0: Positioned For The Next Phase of Growth
Amneal 2.0: Positioned For Chirag and Chintu Patel The Next Phase Co-CEOs of Growth 5
Slide 6: Executing on Our Strategic Priorities
Executing on Our Strategic Priorities Solid Q1 Financial Performance Grow our Base Business Net Revenue: $493 Million Revitalize Generics with new product launches and market share growth Adjusted EBITDA: $126 Million Grow Specialty by focusing on Rytary and Unithroid Adjusted Diluted EPS: $0.20 Man
Slide 7: 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 8: Complementing portfolio & adding new growth drivers
Complementing portfolio & adding new growth drivers Proven Track Record Across Complex Dosage Forms Inserts / Implants / Vaginal Transdermal Patches Oral Liquids/ Topicals Nasal Sprays Injectables OSDs Ring • EluRyng (Etonogestrel + • Estradiol Transdermal • Sucralfate Suspension • Mometasone Nasal
Slide 9: Full pipeline update: Generics
Full pipeline update: Generics Pending or Tentatively Approved ANDA Pipeline Products in Development 102 pending ANDAs with an aggregate addressable market of ~$47 billion We are actively developing 96 Oral Solids: 53 Injectables: 21 Ophthalmics / Otics: 7 additional generic product $2,663 candidate
Slide 10: Expand product mix & end markets: Key focus areas
Expand product mix & end markets: Key focus areas Complex Generics Biosimilars Injectables Current Pipeline • 40+ expected sterile launches (vials, bags, PFS*) from 2021-2025 • Current Status: Filed – awaiting FDA • Focus: 505(b)2 injectables, 503B compounding opportunities acceptance • Expected Lau
Slide 11: Drive organic and inorganic growth
Drive organic and inorganic growth • Leverage commercial expertise in Neurology and Endocrinology to drive growth of Rytary and Unithroid • Advance our two R&D Neurology programs of IPX-203 and K-127 and maximize Kashiv’s proprietary drug delivery technologies to ensure long term sustainable organic
Slide 12: Driving growth in our Specialty Business
Driving growth in our Specialty Business Expanding pipeline with Kashiv Drive commercialization of existing products Advance existing pipeline Specialty Net Revenue ($ millions) $41 SPECIALTY PHARMA $38 IPX-203 K-114 $13 $16 K-127 K-128 Rytary Unithroid Q1 2020 Q1 2021 12
Slide 13: IPX203 Phase IIb Results
IPX203 Phase IIb Results IPX203 decreased “off” time and increased good “on” time compared with IR CD/LD IPX203 decreased “off” time by 2.3 hours IPX203 increased good “on” time by 1.9 hours compared with IR CD/LD compared with IR CD/LD IR CD/LD Baseline: 5.2 hr IPX203 Day 15: 5.5 hours Baseline: 5.
Slide 14: IPX-203 Phase III
IPX-203 Phase III General: • N = 400 • 20-week, randomized, double blind • Top line data expected 2H 2021 Primary Endpoint: Change from baseline in “Good on” time in hours per day at end of double-blind treatment period (Visit 7 or early termination): • "Good on" time is defined as the sum of “On” t
Slide 15: 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 Expected Benefits of IPX-203 Developed with innovative technology containing immediate and sustained-re
Slide 16: 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 Expected Benefits of K-127 Developed through Kashiv Specialty’s proprietary GRANDE / Oros drug delivery technologies Delivers fast-acting neuromuscu
Slide 17: Kashiv Specialty accelerates Amneal's transition to specialty pharma
Kashiv Specialty accelerates Amneal’s transition to specialty pharma IPX-203 K-127 K-128 K-114 • Carbidopa-levodopa • Pyridostigmine QD; oral extended • THP hydrochloride capsules, oral Product • LT3 sustained release tablets release extended release Indication Myasthenia Gravis Sialorrhea & Movemen
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: Financial Review
Financial Tasos Review Konidaris EVP & CFO
Slide 20: Q1 2021 Results
Q1 2021 Results Adjusted Results(1) Favorable product mix and operational efficiencies drive margin Variance expansion $ in millions Q1 2021 Q1 2020 Q4 2020 YOY Sequential Revenue 493.1 498.5 510.0 (5.4) (16.9) • Revenue reflects mild flu and cold season, higher purchases last year at the onset of t
Slide 21: Generics Segment Adjusted Results
Generics Segment Adjusted Results(1) $ millions Net Revenue Gross Margin Operating Income 352.6 44.6% 102.5 342.1 42.1% 312.5 37.8% 86.0 78.8 Q1 21 Q1 20 Q4 20 Q1 21 Q1 20 Q4 20 Q1 21 Q1 20 Q4 20 ▪ Year-over-year: ~$23 million relates to mild flu and ▪ Year-over-year: Favorable product mix, operatin
Slide 22: Specialty Segment Adjusted Results
Specialty Segment Adjusted Results(1) $ millions Net Revenue Gross Margin Operating Income 95.9 78.4% 51.5 74.6% 74.3% 88.0 85.5 39.3 38.2 Q1 21 Q1 20 Q4 20 Q1 21 Q1 20 Q4 20 Q1 21 Q1 20 Q4 20 ▪ Year-over-year: Growth in Rytary and Unithroid as ▪ Year-over-year and Sequential: Favorable product mix
Slide 23: AvKARE Segment Adjusted Results
AvKARE Segment Adjusted Results(1) $ millions Net Revenue Gross Margin Operating Income 84.7 82.4 19.6% 19.1% 9.1 17.2% 6.8 58.0 6.1 Q1 21 Q1 20 Q4 20 Q1 21 Q1 20 Q4 20 Q1 21 Q1 20 Q4 20 ▪ Year-over-year increase: Q1 21 reflect three months ▪ Year-over-year and sequential: Reflects mix of ▪ Year-ove
Slide 24: Quarterly Trending Summary
Quarterly Trending Summary Adjusted Results (1) Q1 2021 Q4 2020 Q3 2020 Q2 2020 Q1 2020 (in $ millions except for Adjusted Diluted EPS) Net Revenues 493.1 510.0 519.3 464.7 498.5 Generics 312.5 342.1 341.9 306.6 352.6 Specialty 95.9 85.5 87.9 94.3 88.0 AvKARE 84.7 82.4 89.5 63.8 58.0 Adjusted EBITDA
Slide 25: Balance Sheet and Liquidity
Balance Sheet and Liquidity $ millions Liquidity as of March 31, 2021 March 31, 2021 December 31, 2020 Current portion and long-term debt(1) 2,758 2,779 ▪ Cash and cash equivalents $456 Cash and cash equivalents(2) 456 347 ▪ ABL Available(6) $435 Net Debt(3) 2,302 2,432 Gross Debt to LTM Adjusted EB
Slide 26: Maintaining 2021 Financial Outlook
Maintaining 2021 Financial Outlook(1) (in $ millions except for Adjusted Diluted EPS) 2020 2021 Guidance Net Revenues $1,993 $2,100 - $2,200 Adjusted EBITDA $456 $500 - $540 Adjusted Diluted EPS(2) $0.63 $0.70 – $0.85 Weighted Average Diluted Shares ~301 million ~303 million Outstanding(3) Operating
Slide 27: Key Takeaways
Key Takeaways Strong operational and financial Starting 2021 with solid Amneal 2.0 driving our next performance in Q1 momentum phase of growth • Broad, relevant product portfolio • Solid revenue performance • Building on our recent success, reflects the diversity and we continue to evolve our • Impr
Slide 28: Appendix: Non-GAAP Reconciliations
Appendix: Non-GAAP Reconciliations
Slide 29: Reconciliation of Net Income (Loss) to Adjusted Net Income and Adjusted Diluted EPS
Reconciliation of Net Income (Loss) to Adjusted Net Income and Calculation of Adjusted Diluted EPS ($) in millions Three months ended March 31, 2021 December 31, 2020 September 30, 2020 June 30, 2020 March 31, 2020 Net income (loss) $ 14.5 $ (7.0) $ (22.0) $ (23.9) $ 121.5 Adjusted to add (deduct):
Slide 30: Reconciliation of Net Income (Loss) to EBITDA and Adjusted EBITDA
Reconciliation of Net Income (Loss) to EBITDA and Adjusted EBITDA ($) in millions Three months ended March 31, 2021 December 31, 2020 September 30, 2020 June 30, 2020 March 31, 2020 Net income (loss) $ 14.5 $ (7.0) $ (22.0) $ (23.9) $ 121.5 Adjusted to add (deduct): Interest expense, net 33.9 34.5 3
Slide 31: Reconciliation of Generics Operating Income to Adjusted Operating Income
Reconciliation of Generics Operating Income to Generics Adjusted Operating Income ($) in millions Three Months Ended March 31, 2021 Three Months Ended March 31, 2020 Three Months Ended December 31, 2020 As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAA
Slide 32: Reconciliation of Specialty Operating Income to Adjusted Operating Income
Reconciliation of Specialty Operating Income to Specialty Adjusted Operating Income ($) in millions Three Months Ended March 31, 2021 Three Months Ended March 31, 2020 Three Months Ended December 31, 2020 As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP As Reported Adjustments Non-G
Slide 33: Reconciliation of AvKARE Operating Income to Adjusted Operating Income
Reconciliation of AvKARE Operating Income to AvKARE Adjusted Operating Income ($) in millions Three Months Ended March 31, 2021 Three Months Ended March 31, 2020 Three Months Ended December 31, 2020 As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP Ne
Slide 34: Reconciliation of SG&A to Adjusted SG&A
Reconciliation of Selling, General & Administrative to Adjusted Selling, General, & Administrative ($) in millions Three months ended March 31, 2021 March 31, 2020 December 31, 2020 Selling, general and administrative $ 90.7 $ 77.9 $ 84.7 Adjusted to deduct: Amortization 6.2 6.5 8.7 Stock-based comp
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