Amneal Pharmaceuticals, Inc. · NASDAQ:AMRX
Amneal Pharmaceuticals — Q4 2021 Earnings Presentation
36 slides from Amneal Pharmaceuticals's earnings presentation, Mar 2, 2022
Slide 1: Q4 & Full Year 2021 Earnings Call
Q4 & Full Year 2021 Earnings Call March 2, 2022 g
Slide 2: Cautionary Statement on Forward Looking Statements
Cautionary Statement on Forward Looking Statements 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
Slide 3: Q4 2021 Earnings Call Agenda and Participants
Q4 2021 Earnings Call Agenda Today’s participants Q4 2021 and FY 2021 1 Business Update Chirag and Chintu Patel, Co-CEOs Q4 and FY 2021 Financial 2 Results and 2022 Guidance Tasos Konidaris, EVP & CFO Chirag Patel, Co-CEO Chintu Patel, Co-CEO Tasos Konidaris, EVP & CFO Closing Remarks 3 Chirag Patel
Slide 4: Q4 2021 and FY 2021 Business Update
Q4 2021 and FY 2021 Business Update Chirag and Chintu Patel Co-CEOs 4
Slide 5: 2021 year-end summary: Executing on our strategic priorities
2021 year-end summary: Executing on our strategic priorities Strong financial performance with Growth in all 3 business segments and growth across our diversified businesses expanding our market leadership positions • Net Revenue: $2,094 million +5% driven by growth across the • Generics growth +2%
Slide 6: Our strategy for growth as a global essential medicines company
Our strategy for growth as a global essential medicines company $ millions 2021 Strategy for growth Market size (1) Grow our top 5 U.S. Generics portfolio of 225+ products with 20-30 new Today $19.9B Retail $1,239 product launches annually – focused on complex areas 2025 $21.5B Expand portfolio of ~
Slide 7: Amneal's commitment to innovation
Amneal’s commitment to innovation Reflects the timing of when a new product in each category was initially launched or is expected to launch by Amneal 2024-2025 K-114 2022 (Hypothyroidism, Biosimilars T4 sub-indication) filgrastim, 2023-2024 pegfilgrastim, K-127 2002 2008 2015 2017 2020 & bevacizuma
Slide 8: Mix shift to complex Generics is driving more durable growth
GENERICS Mix shift to complex Generics is driving more durable growth Purposeful mix shift to more complex product portfolio drives durable top-line growth at higher levels of profitability Generics net revenues mix ($’s) Pipeline mix Generics net revenues Generics adjusted gross margins (# of produ
Slide 9: Our wheel of innovation in Generics keeps turning
GENERICS Our wheel of innovation in Generics keeps turning Actively developing additional candidates in our pipeline across increasingly complex dosage forms (particularly drug-device combinations and injectables) with 87% non-oral solids ~128 pipeline products with Oral Solids: 49 Injections: 29 Op
Slide 10: Increasingly complex portfolio with rich pipeline
GENERICS Increasingly complex portfolio with rich pipeline Velocity of • 44 new products in 2020-2021 generated $176 million in new product revenue in 2021 (1) early to market • Amneal was 1st or 2nd to be approved for ~46% of new products launched from 2019 to 2021 new product launches • Highest nu
Slide 11: Baclofen franchise acquisition advances strategy in 3 key areas
INJECTABLES | BIOSIMILARS | SPECIALTY Baclofen franchise acquisition advances strategy in 3 key areas Adding assets and building capabilities in three key growth areas Transaction overview • Lioresal® is an intrathecal baclofen product Institutional • Acquisition of Saol Therapeutic’s Baclofen Franc
Slide 12: Additional growth vectors through portfolio expansion
INJECTABLES | BIOSIMILARS | INTERNATIONAL Additional growth vectors through portfolio expansion Expanding Injectables with new Entering Biosimilars market near-term Entering select international markets products and global capabilities and build the business for the long-term with impactful products
Slide 13: Expanding branded portfolio expected to drive growth
SPECIALTY Expanding branded portfolio expected to drive growth Organic growth of existing products + New branded launches in the pipeline (1) + Business development $378M 2022 2023 2024 2025 2026 TM • Pursue strategic, accretive (1) LYVISPAH (2) DHE transactions focused on • Strong branded Rytary Au
Slide 14: Select Specialty programs and key milestones
SPECIALTY Select Specialty programs and key milestones Therapeutic PK/PD Phase 1 Approval Product Pre-Clinical Phase 3 Submission Q4’21 Update Area and Phase 2 and Launch LYVISPAHTM Spasticity • Expect commercial launch in June 2022 Migraine and ✓ NDA currently under review with FDA DHE Cluster Auto
Slide 15: Branded pipeline expected to expand portfolio and create value
SPECIALTY Branded pipeline expected to expand portfolio and create value LYVISPAHTM DHE Autoinjector IPX-203 K-127 K-114 K-128 Product Baclofen oral granules Dihydroergotamine Carbidopa-levodopa Pyridostigmine QD, LT3 sustained release THP hydrochloride (FDA approved Nov. 2021) mesylate oral extende
Slide 16: Proprietary drug delivery technologies that can improve release
SPECIALTY Proprietary drug delivery technologies that can improve release 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 i
Slide 17: Focused on affordable, essential medicines for patients in need
Focused on affordable, essential medicines for patients in need Purpose-driven company with the core tenets of good ESG practices instilled throughout the organization (our strategy, operations and people) Amneal is focused on providing affordability and accessibility for patients. ~$10B In 2020, Am
Slide 18: Q4 and FY 2021 Financial Results and 2022 Guidance
Q4 and FY 2021 Financial Results and 2022 Guidance Tasos Konidaris EVP & CFO 18
Slide 19: Q4 2021 Results
Q4 2021 Results Results (1) $ millions except for EPS Q4 2021 Q4 2020 Change Key Drivers / Commentary • Growth across all 3 segments with Generics and AvKARE driven by new Net Revenue $537 $510 +5.3% products, and Specialty driven by Rytary and Unithroid Adjusted Gross Margin 43.3% 40.6% +270 bps •
Slide 20: Full Year 2021 Results
Full Year 2021 Results Results (1) $ millions except for EPS 2021 2020 Change Key Drivers / Commentary • Growth across all 3 segments: Generics (driven by $176M in new product Net Revenue $2,094 $1,993 +5.1% revenue), Specialty (driven by promoted brands) and AvKARE Distribution (driven by new produ
Slide 21: Generics Segment – Q4 2021 & Full Year 2021 Results
Generics Segment – Q4 2021 & Full Year 2021 Results Results (1) Fourth Quarter Full Year Q4 Key Drivers / Commentary $ millions 2021 2020 2021 2020 • New products launched in 2020 and 2021 that contributed $35M $346 $342 $1,366 $1,343 Net Revenue in incremental Q4 revenue, partially offset by price
Slide 22: Specialty Segment – Q4 2021 & Full Year 2021 Results
Specialty Segment – Q4 2021 & Full Year 2021 Results Results (1) Fourth Quarter Full Year Q4 Key Drivers / Commentary $ millions 2021 2020 2021 2020 $101 $85 $378 $356 Net Revenue • Continued growth in promoted brands, Rytary and Unithroid +18.2% +6.4% Adjusted 78.3% 74.3% 77.9% 74.2% • Favorable pr
Slide 23: AvKARE Segment – Q4 2021 & Full Year 2021 Results
AvKARE Segment – Q4 2021 & Full Year 2021 Results Results (1) Fourth Quarter Full Year Q4 Key Drivers / Commentary $ millions 2021 2020 2021 2020 $90 $82 $349 $294 Net Revenue • New product introductions in the federal healthcare market +8.7% +18.8% Adjusted 20.0% 17.2% 19.0% 17.5% • Favorable produ
Slide 24: Quarterly trending summary
Quarterly trending summary Results (1) $ millions except for Adjusted Diluted EPS Q4 2021 Q3 2021 Q2 2021 Q1 2021 Q4 2020 Q3 2020 Q2 2020 Q1 2020 Net Revenue $537 $529 $535 $493 $510 $519 $465 $499 Generics $346 $347 $360 $313 $342 $342 $307 $353 Specialty $101 $93 $89 $96 $85 $88 $94 $88 AvKARE $90
Slide 25: Balance sheet and liquidity update
Balance sheet and liquidity update December 31, Strengthening balance sheet $ millions 2021 2020 7.0x (1) Current portion and long-term debt $2,711 $2,779 5.3x 4.6x (2) Cash and cash equivalents $257 $347 (3) Net Debt $2,454 $2,432 (4) (5) Dec-19 Dec-20 Dec-21 Gross Debt to LTM Adjusted EBITDA 5.0x
Slide 26: Strong performance driven by innovation and execution
Strong performance driven by innovation and execution Net revenue growth Adjusted gross margin expansion Adjusted EBITDA growth $ millions % of net revenue $ millions +13% CAGR +23% CAGR 46% $2,094 $538 $1,993 $456 44% $356 $1,626 42% 2019 2020 2021 2019 2020 2021 2019 2020 2021 26
Slide 27: 2022 financial outlook
2022 financial outlook (1) $ millions except for Adjusted Diluted EPS 2022 Guidance 2021 Actual Net Revenue $2,150 - $2,250 $2,094 Adjusted EBITDA $540 - $560 $538 (2) Adjusted Diluted EPS $0.80 - $0.85 $0.85 Weighted Average Diluted (3) ~307 million 304 million Shares Outstanding (4) Operating Cash
Slide 28: We make healthy possible
2 Yamneal We make healthy possible®
Slide 29: Appendix: Non-GAAP Reconciliations
Appendix: Non-GAAP Reconciliations
Slide 30: Reconciliation of net (loss) income to EBITDA and adjusted EBITDA
Reconciliation of net (loss) income to EBITDA and adjusted EBITDA ($) in millions Three months ended Twelve months ended Dec. 31, Sept. 30, June 30, March Dec. 31, Sept. 30, June 30, March Dec. 31, Dec. 31, Dec. 31, 2021 2021 2021 31, 2021 2020 2020 2020 31, 2020 2021 2020 2019 Net (loss) income $ (
Slide 31: 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 ($) in millions Three months ended Twelve months ended Dec. 31, Sept. June March Dec. 31, Sept. June March Dec. 31, Dec. 31, Dec. 31, 2021 30, 2021 30, 2021 31, 2021 2020 30, 2020 30, 2020 31, 2020 202
Slide 32: Reconciliation of cost of goods sold and gross margin to adjusted
Reconciliation of consolidated cost of goods sold to adjusted cost of goods sold and gross margin to adjusted gross margin ($) in millions Three months ended Twelve months ended Dec. 31, 2021 Sept. 30, 2021 June 30, 2021 March 31, 2021 Dec. 31, 2020 Sept. 30, 2020 June 30, 2020 March 31, 2020 Dec. 3
Slide 33: Reconciliation of Generics operating income to segment adjusted operating income
Reconciliation of Generics operating income to segment adjusted operating income ($) in millions Three Months Ended December 31, 2021 Three Months Ended December 31, 2020 As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP Net revenue $ 346.3 — $ 346.3 $ 342.1 — $ 342.1 Cost of goods s
Slide 34: Reconciliation of Specialty operating income to segment adjusted operating income
Reconciliation of Specialty operating income to segment adjusted operating income ($) in millions Three Months Ended December 31, 2021 Three Months Ended December 31, 2020 As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP Net revenue $ 101.0 — $ 101.0 $ 85.5 — $ 85.5 Cost of goods so
Slide 35: Reconciliation of AvKARE operating income to segment adjusted operating income
Reconciliation of AvKARE operating income (loss) to segment adjusted operating income ($) in millions Three Months Ended December 31, 2021 Three Months Ended December 31, 2020 As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP Net revenue $ 89.6 — $ 89.6 $ 82.4 — $ 82.4 Cost of goods
Slide 36: Additional Reconciliations
Additional Reconciliations Reconciliation of selling, general & administrative to adjusted selling, general, & administrative Reconciliation of research and development to adjusted research and development ($) in millions Three months ended Twelve months ended ($) in millions Three months ended Twel
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