Amneal Pharmaceuticals, Inc. · NASDAQ:AMRX
Amneal Pharmaceuticals — Q3 2022 Earnings Presentation
24 slides from Amneal Pharmaceuticals's earnings presentation, Nov 4, 2022
Slide 1: Q3 2022 Earnings Call
Q3 2022 Earnings Call November 4, 2022 g
Slide 2: Cautionary Statement on Forward Looking Statements
Cautionary Statement on Forward Looking Statements Certain statements contained herein, 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 reg
Slide 3: Agenda and Today's Participants
Q3 2022 Earnings Call Agenda Today’s participants 1 Business Update Chirag and Chintu Patel, Co-CEOs 2 Financial Results Tasos Konidaris, EVP & CFO Chirag Patel, Chintu Patel, Tasos Konidaris, Co-CEO Co-CEO EVP & CFO 3 Closing Remarks Chirag Patel, Co-CEO 4 Q&A Andy Boyer, Harsher Singh, Gustavo Pes
Slide 4: Key takeaways for Q3 2022
Key takeaways for Q3 2022 • Q3 net revenue of $546M reflects durable Q3’22 performance performance across all 3 segments: Generics, reflects diversity of Specialty and AvKARE, and adjusted EBITDA of our portfolio $126M(1) reflects topline growth, solid gross margins and key investments to support ne
Slide 5: Our strategy for growth as a global essential medicines company
Our strategy for growth as a global essential medicines company Amneal develops, manufactures, commercializes and distributes a growing and diverse portfolio of essential medicines, including complex generics, injectables, biosimilars and specialty branded pharmaceuticals. Through this diversified a
Slide 6: Upcoming key catalysts and growth drivers
Upcoming key catalysts and growth drivers ✓ On-track for 2022 launches: Recent approvals of Carvedilol ER (OSD) and Ipratropium bromide – 2 formulations (Nasal) • Select 2022/2023 planned launches include in Ophthalmics/Otics: gCiproDex®, Fluorometholone acetate, gRestasis®, and Retail gPred-Forte®
Slide 7: Focused on affordable, essential medicines for patients in need
Focused on affordable, essential medicines for patients in need Innovation In October, our first biosimilar, ALYMSYS®, launched in the U.S. as we and Access believe biosimilars represent the next wave of affordable medicines Amneal is a Access and In August, we submitted our New Drug Application to
Slide 8: Diversified portfolio with less concentration in oral solid Generics
GENERICS | SPECIALTY | AVKARE Diversified portfolio with less concentration in oral solid Generics Purposeful mix shift to more complex Generics portfolio Diversified and growing revenue base Generics net revenues mix ($’s) Pipeline mix Revenue contribution by business (# of products) 2021 revenues
Slide 9: Scaling our injectables business to drive substantial growth
INJECTABLES Scaling our injectables business to drive substantial growth Expanding portfolio and infrastructure with key capabilities at 4 sites to drive injectables revenue growth • Targeting 30-40 launches from now to 2025 in ✓ Across presentation formats: Vials, Prefilled $ millions complex areas
Slide 10: Our wheel of innovation in Generics keeps turning
GENERICS Our wheel of innovation in Generics keeps turning Developing pipeline across increasingly complex dosage forms with 88% non-oral solids ~106 pipeline products with Oral Solids: 44 Injections: 31 Ophthal/Otic: 7 ~$45B TAM $19,461 $3,645 $2,944 Pending $12,450 ANDA’s $1,053 $48 $183 ~102 ANDA
Slide 11: Entering U.S. biosimilar market with key oncology products
BIOSIMILARS Entering U.S. biosimilar market with key oncology products ~$4B TOTAL (1) Estimated U.S. market size for our first three U.S. approved ~$2B BIOSIMILARS oncology biosimilars Approved Our biosimilars strategy: Alymsys® Releuko® FylnetraTM biosimilars • Expanding portfolio through in-licens
Slide 12: Expanding branded portfolio expected to drive growth
SPECIALTY Expanding branded portfolio expected to drive growth YTD growth of existing products + New branded launches in the pipeline (1) + Business development $272M 2023 2024 2025 2026 IPX203 (Parkinson’s) • Pursue strategic, accretive • Rytary® revenue +7% transactions focused on DHE with TRx +6%
Slide 13: Branded pipeline expected to expand portfolio and create value
SPECIALTY Branded pipeline expected to expand portfolio and create value Product IPX203 DHE Autoinjector K-127 K-114 K-128 Carbidopa-levodopa Dihydroergotamine mesylate Pyridostigmine QD, oral ER LT3 sustained release tablets THP hydrochloride capsules ER Indication Migraine and Cluster Headache Hyp
Slide 14: Entering select international markets with impactful products
INTERNATIONAL Entering select international markets with impactful products (1) MARKET SIZE Expect to be commercial in $197B 2025 China in 2023 with 5 products filed currently and more planned over time $168B with our partner Fosun TODAY Building a presence in India $36B 2025 Focusing on the hospita
Slide 15: Q3 2022 Results
Q3 2022 Results Results (1) Q3 2022 Q3 2021 Change Key Drivers / Commentary $ millions except for EPS • Driven by AvKARE distribution channel, Generics, and Specialty promoted Net Revenue $546 $529 +3.2% products, partially offset by loss of exclusivity of Zomig® nasal spray • Unfavorable product mi
Slide 16: Q3 2022 Performance by Segment
Q3 2022 Performance by Segment Results (1) Third Quarter Key Drivers / Commentary $ millions 2022 2021 $350 $347 • Driven by our injectables portfolio, Adrenaclick® epinephrine auto-injector, and Net Revenue new product launches, which offset declines in our legacy products +0.9% Generics Adjusted 4
Slide 17: Maintaining full year 2022 guidance
Maintaining full year 2022 guidance $ millions except for 2022 Guidance 2021 Actual (1) Adjusted Diluted EPS Net Revenue $2,150 - $2,250 $2,094 (2) Adjusted EBITDA $500 - $520 $512 (2) (3) Adjusted Diluted EPS $0.65 - $0.70 $0.78 Weighted Average Diluted (4) ~305 million 304 million Shares Outstandi
Slide 18: Balance sheet and liquidity update
Balance sheet and liquidity update $ millions September 30, 2022 December 31, 2021 (1) Current portion and long-term debt $2,697 $2,711 (2) Cash and cash equivalents $96 $257 (3) Net Debt $2,601 $2,454 (4) LTM Adjusted EBITDA $482 $512 Gross Debt to LTM Adjusted EBITDA 5.6x 5.3x Net Debt to LTM Adju
Slide 19: Appendix: Non-GAAP Reconciliations
Appendix: Non-GAAP Reconciliations
Slide 20: Reconciliation of net (loss) income to EBITDA
Reconciliation of net (loss) income to EBITDA ($) in millions Three Months Ended Nine Months Ended Twelve Months Ended September 30, September 30, December 31, 2022 2021 2022 2021 2021 Net (loss) income $ (2.4) $ (6.1) $ (248.9) $ 40.6 $ 20.1 Adjusted to add: Interest expense, net 42.4 34.4 111.3 10
Slide 21: Reconciliation of net (loss) income to adjusted results
Reconciliation of net (loss) income to adjusted results ($) in millions Three Months Ended Nine Months Ended Twelve Months Ended September 30, September 30, December 31, 2022 2021 2022 2021 2021 Net (loss) income $ (2.4) $ (6.1) $ (248.9) $ 40.6 $ 20.1 Adjusted to add (deduct): Non-cash interest 1.9
Slide 22: Reconciliation of cost of goods sold
Reconciliation of cost of goods sold ($) in millions Three months ended Nine months ended September 30, 2022 September 30, 2021 September 30, 2022 September 30, 2021 Net Revenue $ 545.6 $ 528.6 $ 1,602.5 $ 1,556.8 Cost of goods sold 350.6 329.4 1,027.4 953.5 Cost of goods sold impairment charges 0.7
Slide 23: Reconciliation of segment gross profit to adjusted results
Reconciliation of segment gross profit to adjusted results Note: Due to rounding, numbers presented may not add up precisely to the totals provided and percentages may not precisely reflect the absolute figures. 23
Slide 24: Additional Reconciliations
Additional Reconciliations Reconciliation of selling, general & administrative to adjusted selling, general & administrative expense: ($) in millions Three Months Ended Nine Months Ended September 30, 2022 September 30, 2021 September 30, 2022 September 30, 2021 Selling, general and administrative e
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