Amneal Pharmaceuticals, Inc. · NASDAQ:AMRX
Amneal Pharmaceuticals — Q3 2021 Earnings Presentation
44 slides from Amneal Pharmaceuticals's earnings presentation, Nov 3, 2021
Slide 1: Q3 2021 Earnings Call
Q3 2021 Earnings Call November 3, 2021 g
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 manageme
Slide 3: Earnings call agenda
Earnings call agenda Q3 2021 Business Update 1 Chirag and Chintu Patel, Co-CEOs Q3 2021 Financial Update 2 Tasos Konidaris, EVP & CFO Closing Remarks 3 Chirag Patel, Co-CEO 4 Q&A 3
Slide 4: Q3 2021 Business Update
Q3 2021 Business Update Chirag and Chintu Patel Co-CEOs 4
Slide 5: Executing on our strategic priorities
Executing on our strategic priorities Solid Q3 financial results reflects Grow our Generics and Specialty businesses continued performance and momentum and build our market leadership positions • Net Revenue: $529 Million +2% driven by Generics • Durable Generics growth driven by new product innovat
Slide 6: Our Amneal 2.0 growth strategy
Our Amneal 2.0 growth strategy Grow our leading portfolio with increasingly complex products across dosage forms (including Injectables, Ophthalmics and Biosimilars) that leverages core competencies in manufacturing and innovation Drive organic growth, advance our pipeline, and pursue M&A focused on
Slide 7: Focused on affordable, essential medicines for patients in need
Focused on affordable, essential medicines for patients in need • Amneal is a purpose-driven company with the core tenets of good ESG practices instilled throughout the organization Key ESG highlights about Amneal since its founding in 2002. • First, we have an unwavering commitment to the highest F
Slide 8: Grow our leading portfolio with increasingly complex products across dosage forms
Grow our leading portfolio with increasingly complex products across dosage forms (including Injectables, Ophthalmics and Biosimilars) that leverages core competencies in manufacturing and innovation • Leverage our broad commercial presence to grow our market position • Increase speed of innovation
Slide 9: Overview of our Generics business – nothing generic about it
Overview of our Generics business – nothing generic about it Diverse, durable, and leading Generics business is increasingly complex and more difficult to replicate % of Generics Net Revenue YTD 2021 Market leadership • Top 5 U.S. generic player by number of prescriptions (1) Launched position • Ove
Slide 10: Amneal’s innovation history in Generics in new dosage forms
Amneal’s innovation history in Generics in new dosage forms Reflects the timing of when a new product in each dosage form category was initially launched by Amneal or is expected to launch 2008 2015 2016 2022-2023 Oral liquids Injectables 2002 Inserts / Implants 2019 Biosimilars Amneal founded Trans
Slide 11: Acquisition is a pivotal step in accelerating our injectables strategy
Acquisition is a pivotal step in accelerating our injectables strategy by expanding our core capabilities and global capacity • Acquiring a 293,000 square foot injectables manufacturing facility in India to expand infrastructure and capacity for the Strategic U.S. market, and build foundation for in
Slide 12: Complementing portfolio and adding new growth drivers
Complementing portfolio and adding new growth drivers Proven track record of innovation across complex dosage forms Inserts / Implants / Transdermal Oral Liquids / Nasal Oral Solid Injectables / Ophthalmics Vaginal Ring Patches Topicals Sprays Doses • EluRyng (Etonogestrel + • Estradiol Transdermal
Slide 13: Generics pipeline update
Generics pipeline update Pending or Tentatively Approved ANDA Pipeline Products in Development 102 pending ANDAs with a total addressable market (TAM) of ~$46B Oral Solids: 50 Injectables: 21 Ophthalmics / Otics: 6 • Actively developing 122 additional generic candidates across all major $2,552 $24,6
Slide 14: Our wheel of innovation in Generics keeps turning
Our wheel of innovation in Generics keeps turning Every year we drive innovation… …to generate durable growth ~125 pipeline • Constantly refreshing our pipeline, • Generics net revenue grew 3% in products as we file new ANDA’s 2020 and 2% in 2021 YTD in the midst of the COVID-19 pandemic • Expect to
Slide 15: Additional vectors for growth in generics
Additional vectors for growth in generics through expanding our product portfolio and end markets Injectables Biosimilars International Expansion • ~$125M annual revenue today, with 3 plants Current Pipeline Fosun Partnership: China • Expect 40+ sterile launches from 2021-2025 • BLA Filed, expected
Slide 16: Drive organic growth, advance our pipeline, and pursue M&A
Drive organic growth, advance our pipeline, and pursue M&A focused on Neurology, Endocrinology and other therapeutic areas • Leverage commercial expertise in Neurology and Endocrinology to drive growth of Rytary and Unithroid • Advance our key R&D programs, including IPX-203 and K-127, and maximize
Slide 17: Driving growth and building our Specialty business portfolio
Driving growth and building our Specialty business portfolio $277M Specialty net revenue in YTD’21 Advancing our pipeline with these upcoming expected launches 2022 2023 2024 2025 2026 DHE Autoinjector (Migraine and Cluster Headache) Other Specialty Rytary IPX-203 $108 $122 (Parkinson’s) K-127 (Myas
Slide 18: Select Specialty programs and key milestones
Select Specialty programs and key milestones Therapeutic PK/PD Phase 1 Approval Product Pre-Clinical Phase 3 Submission Q3’21 Update Area and Phase 2 and Launch Migraine and ✓ NDA currently under review with FDA DHE Cluster Autoinjector Headache • Expect commercial launch in mid-2022, upon approval
Slide 19: Executing on our Specialty pipeline will generate a lot of value
Executing on our Specialty pipeline will generate a lot of value DHE Autoinjector IPX-203 K-127 K-114 K-128 Dihydroergotamine mesylate Pyridostigmine QD; oral THP hydrochloride capsules, oral Product Carbidopa-levodopa LT3 sustained release tablets (DHE) extended release extended release Indication
Slide 20: Advancing the Development of IPX-203 for Parkinson’s Disease
Advancing the Development of IPX-203 for Parkinson’s Disease IPX-203 is a carbidopa-levodopa (CD/LD) treatment for patients with Parkinson’s disease and an investigational product not approved by FDA We are excited about the commercial opportunity that IPX-203 represents Developed with an innovative
Slide 21: Proprietary drug delivery technology platforms from Kashiv
Proprietary drug delivery technology platforms from Kashiv GRANDE: Advanced Gastric Retention System KRONOTEC: Modified Release Technology Enables sustained 12–24 hour delivery for drugs with site-specific Modifies drug kinetics to mimic physiological patterns and targets absorption in upper GI trac
Slide 22: Q3 2021 Financial Update
Q3 2021 Financial Update Tasos Konidaris EVP & CFO 22
Slide 23: Solid Q3 2021 driven by continued operational execution
Solid Q3 2021 driven by continued operational execution • Third quarter results reflect the ongoing momentum we’ve seen this year and the durability of our business • Solid net revenue and sustained higher gross margins driven by new products and operational execution generated adjusted EBITDA of $1
Slide 24: Q3 2021 Adjusted Results
Q3 2021 Adjusted Results (1) $ millions except for Adjusted Diluted EPS Q3 2021 Q3 2020 Change Key Drivers / Commentary • Generics new product growth offset price deflation Net Revenue $528.6 $519.3 +1.8% • Good growth in Specialty driven by promoted brands, Rytary and Unithroid Adjusted Gross Margi
Slide 25: Generics Segment – Q3 2021
Generics Segment – Q3 2021 Adjusted Results (1) $ millions Q3 2021 Q3 2020 Change Key Drivers / Commentary • Reflects strong performance from new products launched in Net Revenue $347.1 $341.9 +1.5% 2020 and 2021 that contributed $45M in incremental Q3 revenue • Results include a tough prior year co
Slide 26: Specialty Segment – Q3 2021
Specialty Segment – Q3 2021 Adjusted Results (1) $ millions Q3 2021 Q3 2020 Change Key Drivers / Commentary • Reflects continued growth in promoted brands, Rytary and Net Revenue $92.7 $87.9 5.6% Unithroid, partially offset by declines in non-promoted brands Gross Margin 78.7% 74.3% +440 bps • Refle
Slide 27: AvKARE Distribution Segment – Q3 2021
AvKARE Distribution Segment – Q3 2021 Adjusted Results (1,2) $ millions Q3 2021 Q3 2020 Change Key Drivers / Commentary Net Revenue $88.7 $89.5 (0.9%) • Impacted by a tough prior year compare Gross Margin 17.2% 14.5% +270 bps • Due to favorable product mix Operating $6.9 $6.3 +10.1% • Driven primari
Slide 28: Quarterly trending summary
Quarterly trending summary Adjusted Results (1) $ millions except for Adjusted Diluted EPS Q3 2021 Q2 2021 Q1 2021 Q4 2020 Q3 2020 Q2 2020 Q1 2020 Net Revenue $529 $535 $493 $510 $519 $465 $499 Generics $347 $360 $313 $342 $342 $307 $353 Specialty $93 $89 $96 $85 $88 $94 $88 AvKARE $89 $86 $85 $82 $
Slide 29: Balance sheet and liquidity update
Balance sheet and liquidity update September 30, December 31, $ millions Key Drivers / Commentary 2021 2020 Current portion and $2,718 $2,779 • Prepayment of $25M of gross debt in Q3’21 long-term debt (1) Cash and cash • Lower leverage driven by strong EBITDA $311 $347 equivalents performance over t
Slide 30: 2021 financial outlook
Updated guidance 2021 financial outlook (1) $ millions except for 2021 Updated 2021 Prior 2020 Actual Adjusted Diluted EPS Guidance Guidance Net Revenue ~$2,100 $2,100 - $2,200 $1,993 Adjusted EBITDA $530 - $550 $500 - $540 $456 Adjusted Diluted EPS $0.78 – $0.88 $0.70 – $0.85 $0.63 (2) Weighted Ave
Slide 31: Continued momentum in 2021 as we execute Amneal 2.0 strategy
Continued momentum in 2021 as we execute Amneal 2.0 strategy • Strong revenue and sustained higher profitability reflects the durability of our diversified product portfolio driven by new products, strong commercial execution and operating performance • Meaningful new products and operating efficien
Slide 32: Appendix: Non-GAAP Reconciliations
Appendix: Non-GAAP Reconciliations
Slide 33: Reconciliation of net (loss) income to adjusted net income and adjusted diluted EPS
Reconciliation of net (loss) income to adjusted net income and calculation of adjusted diluted EPS ($) in millions Three months ended Twelve months ended September 30, 2021 June 30, 2021 March 31, 2021 December 31, 2020 September 30, 2020 June 30, 2020 March 31, 2020 December 31, 2020 Net (loss) inc
Slide 34: Reconciliation of net (loss) income to EBITDA and adjusted EBITDA
Reconciliation of net (loss) income to EBITDA and adjusted EBITDA ($) in millions Three months ended Twelve months ended September 30, 2021 June 30, 2021 March 31, 2021 December 31, 2020 September 30, 2020 June 30, 2020 March 31, 2020 December 31, 2020 Net (loss) income $ (6.1) $ 32.2 $ 14.5 $ (7.0)
Slide 35: Reconciliation of Generics operating income to adjusted operating income
Reconciliation of Generics operating income to Generics adjusted operating income ($) in millions Three Months Ended September 30, 2021 Three Months Ended September 30, 2020 As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP Net revenue $ 347.1 $ — $ 347.1 $ 341.9 $ — $ 341.9 Cost of
Slide 36: Reconciliation of Specialty operating income to adjusted operating income
Reconciliation of Specialty operating income to Specialty adjusted operating income ($) in millions Three Months Ended September 30, 2021 Three Months Ended September 30, 2020 As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP Net revenue $ 92.7 $ — $ 92.7 $ 87.9 $ — $ 87.9 Cost of go
Slide 37: Reconciliation of AvKARE operating income to adjusted operating income
Reconciliation of AvKARE operating income (loss) to AvKARE adjusted operating income ($) in millions Three Months Ended September 30, 2021 Three Months Ended September 30, 2020 As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP Net revenue $ 88.7 $ — $ 88.7 $ 89.5 $ — $ 89.5 Cost of g
Slide 38: Reconciliation of consolidated cost of goods sold to adjusted cost of goods sold
Reconciliation of consolidated cost of goods sold to adjusted cost of goods sold and gross margin to adjusted gross margin ($) in millions Three months ended September 30, 2021 June 30, 2021 March 31, 2021 December 31, 2020 September 30, 2020 June 30, 2020 March 31, 2020 Net Revenue $ 528.6 $ 535.1
Slide 39: Reconciliation of Generics cost of goods sold to adjusted cost of goods sold
Reconciliation of Generics cost of goods sold to adjusted cost of goods sold and gross margin to adjusted gross margin ($) in millions Nine months ended Twelve months ended September 30, 2021 September 30, 2020 December 31, 2020 December 31, 2019 Net Revenue $ 1,020.0 $ 1,001.0 $ 1,343.2 $ 1,308.8 C
Slide 40: Reconciliation of Specialty cost of goods sold to adjusted cost of goods sold
Reconciliation of Specialty cost of goods sold to adjusted cost of goods sold and gross margin to adjusted gross margin ($) in millions Nine months ended Twelve months ended September 30, 2021 September 30, 2020 December 31, 2020 December 31, 2019 Net Revenue $ 277.3 $ 270.1 $ 355.6 $ 317.5 Cost of
Slide 41: Reconciliation of SG&A to adjusted SG&A
Reconciliation of selling, general & administrative to adjusted selling, general, & administrative ($) in millions Three months ended September 30, 2021 September 30, 2020 Selling, general and administrative $ 91.4 $ 83.1 Adjusted to deduct (add): Amortization 6.2 8.7 Stock-based compensation expens
Slide 42: Reconciliation of research and development to adjusted R&D
Reconciliation of research and development to adjusted research and development ($) in millions Three months ended September 30, 2021 September 30, 2020 Research and development $ 50.5 $ 46.6 Adjusted to deduct (add): Stock-based compensation expense 1.3 0.9 Research and development milestones 2.5 6
Slide 43: Balance sheet and liquidity summary
Balance sheet and liquidity summary $ millions Sept 2021 Dec 2020 Dec 2019 Current portion and (1) $2,718 $2,779 $2,631 long-term debt Cash and cash (2) $311 $347 $153 equivalents (3) Net Debt $2,408 $2,432 $2,478 Gross Debt to LTM (4) (5) 5.2x 6.0x 7.4x Adjusted EBITDA Net Debt to LTM (3) (5) 4.6x
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