Amneal Pharmaceuticals, Inc. · NASDAQ:AMRX
Amneal Pharmaceuticals — Q1 2023 Earnings Presentation
30 slides from Amneal Pharmaceuticals's earnings presentation, May 5, 2023
Slide 1: Q1 2023 Earnings Call
Q1 2023 Earnings Call May 5, 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
Q1 2023 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, Joe Renda,
Slide 4: Q1 2023 key highlights: Building blocks of a successful 2023 firmly in place
Q1 2023 key highlights: Building blocks of a successful 2023 firmly in place • Q1 net revenue of $558M, +12% vs. prior year, reflects growth across segments Great start • Q1 adjusted EBITDA of $116M, +16% vs. prior year, driven by strong revenues to 2023 combined with operating expense leverage • Ju
Slide 5: Global pharmaceutical company with clear strategy for growth
Global pharmaceutical company with clear strategy for growth 2022 Net Revenue Business area Strategy for growth Growth projection (1) ($ millions) Retail Grow our $1.25B top 5 U.S. Generics portfolio of ~230 products with Low-single digit Generics impactful new launches and increasingly focused on c
Slide 6: Key growth catalysts across Amneal
Key growth catalysts across Amneal ✓ Recent approvals include Brexpiprazole, Lurasidone, and Tasimelteon • 2023/2024 planned launches include in Ophthalmics/Otics: gCiproDex®, Fluorometholone acetate, gRestasis®, and gPred- Retail Forte®; in Inhalation/Nasal: 4 ANDAs pending including gNarcan®, and
Slide 7: Continued track record of driving growth and profitability
Continued track record of driving growth and profitability Net revenue growth Adjusted EBITDA growth $ millions $ millions $2,212 $512 $514 $2,094 $1,993 $433 $339 $1,626 2019 2020 2021 2022 2019 2020 2021 2022 +11% CAGR from 2019 to 2022 +15% CAGR from 2019 to 2022 Note: See "Non-GAAP Financial Mea
Slide 8: Durable growth profile driven by well diversified portfolio
Durable growth profile driven by well diversified portfolio ($ millions) Generics – New Product launches Pre-2019 2019 - 2023 Biosimilars AvKARE Specialty $2,500 “Mid-single digit” growth $2,250 to $2,350 +5.7% $2,212 +5.1% $2,094 “Mid-single $1,993 digit” growth $2,000 $374 $378 $356 “Double-digit”
Slide 9: Balance sheet update: Key priority remains reducing gross debt
Balance sheet update: Key priority remains reducing gross debt and expect to be below <4x net leverage by the end of 2025 Last Twelve Months Ended March 31, 2023 December 31, 2022 Capital allocation priorities $ millions (1) • Key priority remains reducing gross debt and Gross debt $2,748 $2,740 exp
Slide 10: Diversified portfolio with less concentration in oral solid Generics
Diversified portfolio with less concentration in oral solid Generics Purposeful mix shift to more complex Generics portfolio Diversified and expanding revenue base Generics net revenues mix ($’s) Pipeline mix Revenue contribution across our portfolio (# of products) 2022 revenues by $ and as a % of
Slide 11: 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 ✓ Across presentation formats: Vials, Prefilled $ millions • Targeting 30-40 launches from now to 2025 in complex ar
Slide 12: Amneal's wheel of innovation keeps turning
GENERICS Amneal’s wheel of innovation keeps turning Developing pipeline across increasingly complex dosage forms with 89% non-oral solids ~81 pipeline products with Oral Solids: 37 $23,217 $1,870 Injectables: 32 Ophthal/Otic: 10 ~$38B TAM $1,373 $3,212 Pending $5,165 $1,064 ANDA’s $3,184 $201 ~99 AN
Slide 13: Entering U.S. biosimilar market with key oncology products
BIOSIMILARS Entering U.S. biosimilar market with key oncology products Estimated U.S. market size (1) for our first three U.S. approved ~$2B oncology biosimilars Approved Our biosimilars strategy: ALYMSYS® RELEUKO® FYLNETRA® biosimilars • Expanding portfolio through in-licensing where we can be earl
Slide 14: Transforming our Specialty business with expanding portfolio
SPECIALTY Transforming our Specialty business with expanding portfolio Strong growth Expected specialty Expect $500M+ Specialty highlights of key brands pipeline launches (1) sales by 2027 Therapeutic focus on Neurology ($ millions) ($ millions) $500+ $92 Potential Program Therapeutic Area and End
Slide 15: 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 16: IPX203 is a novel, long-lasting formulation of extended-release CD/LD
SPECIALTY 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
Slide 17: Expect broader adoption of new IPX203 therapy for Parkinson's Disease
SPECIALTY Expect broader adoption of new IPX203 therapy for Parkinson’s Disease U.S. Patient Share of CD/LD Expanding CD/LD market share for IPX203 Source: IQVIA, 12 month average, December 2022 With IPX203, we see a clear opportunity to drive broader adoption 100% to the full CD/LD patient populati
Slide 18: Entering key global markets with impactful pharmaceuticals
INTERNATIONAL EXPANSION Entering key global markets with impactful pharmaceuticals Incremental revenues and profit by leveraging existing portfolio of U.S. FDA products, infrastructure and partnerships Geography Direct / Partner Strategy and status Direct: building • Utilizing commercial team to lau
Slide 19: Focused on affordability and access to essential medicines
Focused on affordability and access to essential medicines Launched first employee resource group (ERG) in India – AmnealWomen to create a safe and empowering platform Empowering where colleagues can raise challenges and focus on Our People solutions to enhance gender diversity and empower women acr
Slide 20: Strong Q1 2023 results
Strong Q1 2023 results Results (1) Q1 2023 Q1 2022 Change Key Drivers / Commentary $ millions except for EPS Net Revenue $558 $498 +12.0% • Driven by strong growth across Generics, AvKARE, and Specialty segments • Discontinuation of a few small legacy products, timing of fixed overhead Adjusted Gros
Slide 21: Q1 2023 performance by segment
Q1 2023 performance by segment Results (1) First Quarter Key Drivers / Commentary $ millions 2023 2022 $344 $318 • Driven by new product launches and higher volumes, partially Net Revenue offset by price erosion +8.2% Generics Adjusted 37.4% 42.1% • Low point of the year reflects timing from the dis
Slide 22: Affirming full year 2023 guidance
Affirming 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) Ope
Slide 23: Appendix: Non-GAAP Reconciliations
Appendix: Non-GAAP Reconciliations
Slide 24: Reconciliation of net (loss) income to EBITDA
Reconciliation of net (loss) income to EBITDA Note: Due to rounding, numbers presented may not add up precisely to the totals provided and percentages may not precisely reflect the absolute figures. 24
Slide 25: Reconciliation of net (loss) to adjusted results
Reconciliation of net (loss) 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. 25
Slide 26: Reconciliation of cost of goods sold
Reconciliation of cost of goods sold 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: 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. 27
Slide 28: Additional Reconciliations
Additional Reconciliations Note: Due to rounding, numbers presented may not add up precisely to the totals provided and percentages may not precisely reflect the absolute figures. 28
Slide 29: Reconciliation of net (loss) income to adjusted EBITDA
Reconciliation of net (loss) income to adjusted EBITDA Note: Due to rounding, numbers presented may not add up precisely to the totals provided and percentages may not precisely reflect the absolute figures. 29
Slide 30: Calculation of Last Twelve Months Gross and Net Leverage
Calculation of Last Twelve Months Gross and Net Leverage Note: Due to rounding, numbers presented may not add up precisely to the totals provided and percentages may not precisely reflect the absolute figures. (1) Refer to the Company's 8-K filed with the SEC on March 3, 2023 for a complete reconcil
Amneal Pharmaceuticals — Q1 2023 Earnings Presentation on 6ix