Amneal Pharmaceuticals, Inc. · NASDAQ:AMRX
Amneal Pharmaceuticals — Q2 2024 Earnings Presentation
36 slides from Amneal Pharmaceuticals's earnings presentation, Aug 9, 2024
Slide 1: Q2 2024 Earnings Call
Q2 2024 Earnings Call August 9, 2024
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
Q2 2024 Earnings Call Agenda Strategy & Business Update 1 Chirag and Chintu Patel, Co-founders and Co-CEOs Chirag Patel, Chintu Patel, Tasos Konidaris, Co-CEO and President Co-CEO EVP & CFO Financial Results 2 Tasos Konidaris, EVP & CFO 3 Q&A Andy Boyer, Joe Renda, Jason Daly, SVP EVP - Generics SVP
Slide 4: Q2 2024 key highlights
Q2 2024 key highlights Record Q2 • Record quarterly financial performance with net revenue of $702M up 17%, Revenue and and adjusted EBITDA of $162M, up 11% Adjusted EBITDA • Broad-based growth across all three business segments Raised • Increased 2024 guidance to $2.7B to $2.8B revenues and $610M t
Slide 5: Executing on Amneal's four pillars of value creation
Executing on Amneal’s four pillars of value creation LTM(3) Q2 Key Pillar Metric 2019 2023 Growth projection(4) 2024 Increased OSD(1) Gx % of #1 53% 25% 25% <20% of revenue by 2027 diversification total revenue Strong financial Revenues $1.6B $2.4B $2.6B High single-digit growth #2 performance Adjus
Slide 6: Global diversified pharmaceutical company with a clear strategy for sustainable growth
Global diversified pharmaceutical company with a clear strategy for sustainable growth Net Revenue Business area Strategy for growth Growth projection(1) LTM Q2 2024 Grow #4 U.S. Generics portfolio of ~240 products with new Retail Low-single digit growth launches and shift to complex dosage forms Ex
Slide 7: Parkinson's Disease is a progressive neurological disorder
Parkinson’s Disease is a progressive neurological disorder Parkinson’s Disease (PD) overview Therapeutic window narrows over time Carbidopa/levodopa (CD/LD) therapy replaces dopamine to Degenerative and incurable manage symptoms of PD and has been the gold standard neurological disease due to pr
Slide 8: Current PD treatment landscape in the U.S.
Current PD treatment landscape in the U.S. Current strategies for treating motor fluctuations in PD patients (1) Increase: Dose/frequency of Switch: To a longer-acting CD/LD + Add-on (options): COMT inhibitor; Dopamine agonist; immediate-release CD/LD MAO-B inhibitor; Rescue medication 2004 2015 201
Slide 9: Introducing CREXONT – a new treatment for Parkinson's
Introducing CREXONT® – a new treatment for Parkinson’s Novel, long-lasting CD/LD formulation Contains IR granules with carbidopa and levodopa for rapid onset of action, and ER pellets with levodopa for long-lasting efficacy(1) (1) IR = Immediate-release; ER = Extended-release (2) Hauser RA, Espay
Slide 10: CREXONT provides more "Good On" time for PD patients
CREXONT® provides more “Good On” time for PD patients 2500 +0.5 hours more “Good On” time per day while taking CREXONT 3 times per day as compared to IR 2000 CREXONT Mean levodopa plasma concentration (ng/mL) CD/LD 5 times per day, per Phase 3 study (P=0.0194)(1) (Mean 587 mg LD) 1500 +1.6 hours
Slide 11: CREXONT commercial strategy to reach more patients
CREXONT® commercial strategy to reach more patients Current U.S. PD Market Clear opportunity to drive broader adoption of CREXONT of patients on CD/LD(1) for the full CD/LD patient population RYTARY 6% • September launch is planned leveraging strong commercial and medical foundation and relationship
Slide 12: Keys to successful CREXONT commercialization
Keys to successful CREXONT® commercialization Novel formulation 10 years of experience Deep clinician and Strong commercial, Best-in-class HCP & that advances with PD providers, advocacy engagement managed care and MSL patient solutions to standard of care payers and patients informs our work organi
Slide 13: Recent and upcoming growth catalysts across portfolio
Recent and upcoming growth catalysts across portfolio Retail Injectables Biosimilars Specialty International Achieved ✓ Launched: Naloxone nasal spray, ✓ Launched: Ropivacaine (IV bag), ✓ Driving uptake of: ✓ Launched: ✓ Launched: India: in 2024 Fluorometholone acetate, Carvedilol ER, Atropine Sulfa
Slide 14: Key near-term growth drivers
Key near-term growth drivers Retail & Injectables Naloxone HCl CREXONT® ALYMSYS® DHE Autoinjector New Launches Nasal Spray (formerly IPX203) Product type Generics portfolio Complex generics Biosimilar Specialty Specialty Migraine and Cluster Therapeutic area All areas Anti-overdose Oncology Parkinso
Slide 15: Our portfolio continues to diversify – making growth sustainable
Our portfolio continues to diversify – making growth sustainable Purposeful mix shift towards a more complex portfolio Diversified revenues driving sustainable growth Generics net revenues mix ($’s) Pipeline mix Total company net revenues mix ($’s) (# of products) 6% Oral Solid AvKARE Specialty Gene
Slide 16: Deep pipeline as our wheel of innovation keeps turning
Deep pipeline as our wheel of innovation keeps turning Developing pipeline across increasingly complex dosage forms with 94% non-oral solids ~65 pipeline programs with Oral Solids: 30 Injectables: 27 Ophthalmics: 11 ~$28B TAM $28,385 $2,617 $1,578 Pending $12,385 $811 $889 $253 $180 $264 $6 ANDA’s $
Slide 17: Expanding injectables portfolio to drive substantial growth
Expanding injectables portfolio to drive substantial growth • Notable supply chain disruptions across various players and (2) Launched 1st 505(b)(2) RTU injectables Significant U.S. chronic drug shortages, including oncology injectables injectables • New vector for Injectables growth with compelling
Slide 18: Rapidly growing biosimilars with key oncology medicines
Rapidly growing biosimilars with key oncology medicines (2) Strong commercial uptake Expected biosimilar pipeline launches Rapidly growing market • ~$192B branded products ALYMSYS® (1) BLA filing Biosimilar (Biologic) Therapeutic areas losing exclusivity 2024-2028(3), bevacizumab- including key biol
Slide 19: Delivering continued double-digit growth in AvKARE
Delivering continued double-digit growth in AvKARE 18%+ revenue CAGR expected from 2020 to 2025 AvKARE strategic focus areas ($ millions) $675+ • Operates as a contract administrator (wholesaler and re-packager selling to hospitals and U.S. $532 Government agencies) with 3 sales channels: – Governme
Slide 20: Expanding our Specialty business with new branded products
Expanding our Specialty business with new branded products Expected specialty Expect $500M+ Specialty highlights Key brands continue to grow pipeline launches(1) sales by 2027 Therapeutic focus on ($ millions) Neurology and $390 $104 ($ millions) $500+ Endocrinology Potential Therapeutic New launc
Slide 21: Building the foundation for international expansion
Building the foundation for international expansion Geography Direct / Partner Strategy and status India Direct • Focusing on hospital critical care, Expanding local diagnostics, ophthalmics, oncology and presence specialty markets • Utilizing local commercial team Europe Partner • Registering selec
Slide 22: Purpose-driven company with ESG tenets instilled throughout
Purpose-driven company with ESG tenets instilled throughout In June, Amneal released its fourth ESG report for 2023. Notably, Environment we reduced greenhouse gas emissions by 131 metric tons of carbon dioxide at our Kentucky sites in 2023. In July, we announced the expansion of our biosimilar Inno
Slide 23: Strong financial performance across all business segments
Strong financial performance across all business segments (2) Net Revenue Growth Adjusted EBITDA Growth ($ millions) +13% - $2,700 – ($ millions) 17% $2,800 $610 – +9% - $2,394 $630 +8% 13% +23% +6% $2,212 +4% +5% $2,094 $390 +9% $558 $1,993 organic $374 $512 $514 $378 $356 $1,626 $532 $406 $294 $34
Slide 24: Q2 2024 financial performance
Q2 2024 financial performance Results(1) Q2 2024 Q2 2023 Change Key Drivers / Commentary $ millions except for EPS Net Revenue $702 $599 +17.1% • Broad-based growth across all business segments Adjusted Gross Margin 41.0% 43.3% (230 bps) • In-line with expectations; Business mix due to AvKARE high g
Slide 25: First half 2024 financial performance
First half 2024 financial performance Results(1) 1H 2024 1H 2023 Change Key Drivers / Commentary $ millions except for EPS Net Revenue $1,361 $1,157 +17.7% • Broad-based double-digit growth across all business segments Adjusted Gross Margin 41.4% 41.4% - • In-line with prior year Adjusted R&D Expens
Slide 26: Performance by segment
Performance by segment Results(1) Second Quarter First Half Q2 Key Drivers / Commentary $ millions 2024 2023 2024 2023 $427 $374 $819 $718 Net Revenue • Strong performance of biosimilars and new launches +14.4% +14.1% Generics Adjusted 41.6% 43.3% 41.7% 40.5% • Unfavorable mix and higher plant spend
Slide 27: Raising full year 2024 guidance
Raising full year 2024 guidance Updated 2024 Prior 2024 (1) (1) 2023 Actual Guidance Guidance Net Revenue $2.70 – $2.80B $2.55 – $2.65B $2.4B Adjusted EBITDA $610 – $630M $580 – $620M $558M (2) Adjusted Diluted EPS $0.57 – $0.63 $0.53 – $0.63 $0.64 Operating Cash Flow, (3) $280 – $320M $260 – $300M
Slide 28: Strong cash generation and continued deleveraging
Strong cash generation and continued deleveraging $ millions 2024E 2023 2022 $ millions Jun 30, 2024 Dec. 31, 2023 Net Revenue $2,700 - $2,800 $2,394 $2,212 Gross debt (3) $2,726 $2,767 Adjusted EBITDA $610 - $630 $558 $514 (4) % of Net Revenue ~22.5% 23.3% 23.2% Total cash $44 $92 (5) (2) Net debt
Slide 29: Appendix: Non-GAAP Reconciliations
Appendix: Non-GAAP Reconciliations
Slide 30: Reconciliation of net income (loss) to EBITDA and Adjusted EBITDA
Reconciliation of net income (loss) to EBITDA and 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. 30
Slide 31: Reconciliation of net (loss) income to EBITDA and Adjusted EBITDA
Reconciliation of net (loss) income to EBITDA and 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. 31
Slide 32: Reconciliation of net income (loss) to adjusted results
Reconciliation of net income (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. 32
Slide 33: 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. 33
Slide 34: 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. 34
Slide 35: 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. 35
Slide 36: 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 1, 2024 for a complete reconcil
Amneal Pharmaceuticals — Q2 2024 Earnings Presentation on 6ix