Amneal Pharmaceuticals, Inc. · NASDAQ:AMRX
Amneal Pharmaceuticals — Q4 2022 Earnings Presentation
27 slides from Amneal Pharmaceuticals's earnings presentation, Mar 2, 2023
Slide 1: Q4 2022 Earnings Call
Q4 2022 Earnings Call March 2, 2023 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
Q4 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, Jason Daly,
Slide 4: Key takeaways for Q4 2022 and Full Year 2022
Key takeaways for Q4 2022 and Full Year 2022 • Strong Q4 net revenue of $610M reflects growth across all 3 segments driving Q4 adjusted EBITDA of $154M Strong Q4’22 • Consistent level of adjusted EBITDA in FY22 of $514M and solid FY22 reflects topline growth of +6% and solid gross margins • Made tar
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
Slide 6: Amneal's business has increasingly diversified since 2019
Amneal’s business has increasingly diversified since 2019 Expanding our global product portfolio Driving durable financial performance Oral solid Generics • Reducing from majority of total $ millions (1) FY 2019 FY 2022 revenues to less than 20% by 2027 Net Revenue $1,626 $2,212 Complex Generics • I
Slide 7: Amneal key growth catalysts
Amneal key growth catalysts ✓ Recent approvals/launches include Colesevelam HCl, Brexpiprazole, Fesoterodine fumarate, and Lurasidone • 2023/2024 planned launches include in Ophthalmics/Otics: gCiproDex®, Fluorometholone acetate, gRestasis®, and gPred- Retail Forte®; in Inhalation/Nasal: 2 ANDAs pen
Slide 8: Focused on affordability and access to essential medicines
Focused on affordability and access to essential medicines In November, we launched our second biosimilar, RELEUKO®, in Innovation the U.S. as we believe biosimilars represent the next wave of affordable medicines Amneal is a In January, we signed a license agreement with Orion purpose-driven Global
Slide 9: Diversified portfolio with less concentration in oral solid Generics
GENERICS | SPECIALTY | AVKARE Diversified portfolio with less concentration in oral solid Generics Purposeful mix shift to more complex Generics portfolio Diversified and expanding revenue base Generics net revenues mix ($’s) Pipeline mix Revenue contribution across our portfolio (# of products) 202
Slide 10: 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 11: 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 ~84 pipeline products with Oral Solids: 39 Injections: 33 Ophthal/Otic: 10 ~$38B TAM $19,461 $1,996 $3,329 Pending $1,633 $12,450 ANDA’s $870 $200 ~103 AND
Slide 12: 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® FYLNETRA® biosimilars • Expanding portfolio through in-licensi
Slide 13: Transforming our Specialty business with expanding portfolio
SPECIALTY Transforming our Specialty business with expanding portfolio Drive growth in Execute on Specialty pipeline with Expect $500M+ key brands $500M to $1B in potential peak U.S. sales sales by 2027 (1) Estimated $500M+ Program Therapeutic Area Launch New Q3’23 IPX203 Parkinson’s Launches $374M
Slide 14: Branded pipeline expected to expand portfolio and create value
SPECIALTY Branded pipeline expected to expand portfolio and create value IPX203 K-127 DHE Autoinjector K-128 K-114 K-130 Program Dihydroergotamine Carbidopa-levodopa Pyridostigmine ER Trihexyphenidyl ER Liothyronine ER Pyridostigmine ER mesylate Hypothyroidism Symptomatic neurogenic Indication Migra
Slide 15: IPX203 is a novel, long-lasting formulation of extended-release CD/LD
IPX203 is a novel, long-lasting formulation of extended-release CD/LD that, if approved, would deliver more “Good On” time with fewer doses Parkinson’s disease (PD) overview Potential benefits of IPX203 Potential $300-500M peak sales Expect broad adoption ~1 million Innovative formulation due to nov
Slide 16: Entering select international markets with impactful products
INTERNATIONAL EXPANSION Entering select international markets with impactful products (1) MARKET SIZE Q4 2022 Updates Expect to be commercial in $194B 2027 • Signed long-term agreement China in 2023 with 7 products filed and more with Orion to distribute $166B planned over time with our Generic prod
Slide 17: Q4 2022 and 2021 results
Q4 2022 and 2021 results Results (1) Q4 2022 Q4 2021 Change Key Drivers / Commentary $ millions except for EPS Net Revenue $610 $537 +13.6% • Driven by growth across Generics, AvKARE, and Specialty segments Adjusted Gross Margin 43.4% 43.3% +10 bps • In-line with prior year reflecting gross margin s
Slide 18: Full Year 2022 and 2021 results
Full Year 2022 and 2021 results Results (1) FY 2022 FY 2021 Change Key Drivers / Commentary $ millions except for EPS • Driven by Generics, AvKARE distribution channel, and Specialty promoted Net Revenue $2,212 $2,094 +5.7% products, partially offset by loss of exclusivity of Zomig® nasal spray • Un
Slide 19: Q4 and Full Year 2022 and 2021 performance by segment
Q4 and Full Year 2022 and 2021 performance by segment Results (1) Fourth Quarter Full Year Q4 Key Drivers / Commentary $ millions 2022 2021 2022 2021 $399 $346 $1,432 $1,366 • Driven by new product launches Net Revenue and oseltamivir (strong flu season) +15.3% +4.8% Generics Adjusted 41.6% 39.1% 42
Slide 20: Full Year 2023 guidance
Full Year 2023 guidance $ millions except for 2023 Guidance 2022 Actual (1) Adjusted Diluted EPS Net Revenue $2,250 - $2,350 $2,212 Adjusted EBITDA $500 - $530 $514 (2) Adjusted Diluted EPS $0.40 - $0.50 $0.68 Weighted Average Diluted (3) ~307 million 305 million Shares Outstanding (4) Operating Cas
Slide 21: Balance sheet and liquidity update
Balance sheet and liquidity update $ millions December 31, 2022 December 31, 2021 (1) Current portion and long-term debt $2,682 $2,711 (2) Cash and cash equivalents $35 $257 (3) Net Debt $2,647 $2,454 (4) LTM Adjusted EBITDA $514 $512 Gross Debt to LTM Adjusted EBITDA 5.2x 5.3x Net Debt to LTM Adjus
Slide 22: Appendix: Non-GAAP Reconciliations
Appendix: Non-GAAP Reconciliations
Slide 23: Reconciliation of net (loss) income to EBITDA
Reconciliation of net (loss) income to EBITDA ($) in millions Three Months Ended December 31, Year Ended December 31, 2022 2021 2022 2021 2019 Net (loss) income $ (5.9) $ (20.5) $ (254.8) $ 20.1 $ (603.6) Adjusted to add: Interest expense, net 47.0 34.0 158.4 136.3 168.2 (Benefit from) provision for
Slide 24: Reconciliation of net (loss) income to adjusted results
Reconciliation of net (loss) income to adjusted results ($) in millions Three Months Ended December 31, Year Ended December 31, 2022 2021 2022 2021 Net (loss) income $ (5.9) $ (20.5) $ (254.8) $ 20.1 Adjusted to add (deduct): Non-cash interest 1.9 2.1 7.7 8.3 GAAP (benefit from) provision for income
Slide 25: Reconciliation of cost of goods sold
Reconciliation of cost of goods sold ($) in millions Three Months Ended December 31, Year Ended December 31, 2022 2021 2022 2021 Net Revenue $ 609.8 $ 536.9 $ 2,212.3 $ 2,093.7 Cost of goods sold 389.0 348.5 1,416.5 1,302.0 Cost of goods sold impairment charges 5.3 22.0 11.1 22.7 Gross profit $ 215.
Slide 26: 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. 26
Slide 27: Additional Reconciliations
Additional Reconciliations Reconciliation of selling, general & administrative to adjusted selling, general & administrative expense: ($) in millions Three Months Ended December 31, Year Ended December 31, 2022 2021 2022 2021 Selling, general and administrative expense $ 102.2 $ 97.2 $ 399.7 $ 365.5
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