Amneal Pharmaceuticals
Chirag Patel
Co-founder,Co-CEO and President
Jefferies Healthcare Conference June 5, 2024
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 regarding management's intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as "plans," "expects," "will," "anticipates," "estimates," and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our dependence on third-party agreements for a portion of our product offerings; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third- party agreements for a portion of our product offerings; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including recent events affecting the financial services industry; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A common stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company's filings with the Securities and Exchange Commission, including under Item 1A, "Risk Factors" in the Company's most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.
Non-GAAP Financial Measures
This presentation includes certain non-GAAP financial measures, including EBITDA, adjusted EBITDA, adjusted net income, and adjusted diluted EPS, which are intended as supplemental measures of the Company's performance that are not required by or presented in accordance with GAAP. Adjusted diluted EPS reflects diluted earnings per share based on adjusted net income, which is net loss adjusted to (A) exclude (i) non-cash interest, (ii) GAAP provision for income taxes, (iii) amortization, (iv) stock-based compensation, (v) acquisition, site closure expenses, and idle facility expenses, (vi) restructuring and other charges, (vii) charges related to certain legal matters, including interest, net, (viii) asset impairment charges, (ix) change in fair value of contingent consideration, (x) increase in tax receivable agreement liability, (xi) system implementation expense, (xii) other and (xiii) net income attributable to non-controlling interests not associated with Class B common stock, and (B) include non-GAAP provision for income taxes. Non-GAAP adjusted diluted EPS for the three months ended March 31, 2024 was calculated assuming the weighted average diluted shares outstanding of Class A common stock. Non-GAAP adjusted diluted EPS for the three months ended March 31, 2023 was calculated assuming (i) the weighted average diluted shares outstanding of Class A common stock and (ii) as if all shares of Class B common stock were converted to shares of Class A common stock as of January 1, 2023. Management uses these non-GAAP measures internally to evaluate and manage the Company's operations and to better understand its business because they facilitate a comparative assessment of the Company's operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the
Company's operations and underlying operational performance. The compensation committee of the Company's board of directors also uses certain of these measures to evaluate management's performance and set its compensation. The Company believes
that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company's financial condition and operating results facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company's financial performance, results of operations and trends while viewing the information through the eyes of management. These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company's financial statements; do not reflect changes in, or cash requirements for, working capital needs; and do not reflect interest expense, or the requirements necessary to service interest or principal payments on debt. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company's GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to any measure determined in accordance with GAAP.
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Presentation agenda
1 | Macro healthcare trends |
and drug shortages | |
2 | Our strategy and |
key differentiators | |
3 | Amneal overview |
4 | Growth acceleration |
Chirag Patel,
Co-Founder,Co-CEO
and President
3
1) Macro healthcare trends | 2) Our strategy & differentiators | 3) Amneal overview | 4) Growth acceleration |
Macro trends are accelerating growth in essential medicines
Macro trend
Global aging population using more daily medicines than ever
Increasing demand for affordable medicines and dependable supply
Amneal value proposition
Growing portfolio of 280+ medicines across Retail, Injectables, Biosimilars and Specialty
Industry-leading pharmaceutical R&D and manufacturing capabilities
69%
U.S. patients
on 1 Rx(1)
22%
U.S. patients
on 5+ Rx's(1)
1M+
U.S. Parkinson's
patients(2)
~92%
prescriptions are
generics(3)
~$94B
U.S. branded lose of
exclusivity 2024-2028(3)
323
active drug shortages on current ASHP list(4)
Amneal is poised to benefit from favorable sector tailwinds as a global diversified pharmaceuticals company
(1) | Based on survey of U.S. adults aged 40-79 per CDC National Center for Health Statistics Data Brief No. 347, August 2019: https://www.cdc.gov/nchs/products/databriefs/db347.htm | 4 |
(2) | Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10. Marras et al. NPJ Parkinsons Dis. 2018;4:21. |
- Per IQVIA report: The Use of Medicines in the U.S. 2024, published May 7, 2024
-
Per American Society of Health-Systems Pharmacists (ASHP) Drug Shortages Statistics - ASHP
Note: Retail, Injectables and Biosimilars are part of the Generics segment.
1) Macro healthcare trends | 2) Our strategy & differentiators | 3) Amneal overview | 4) Growth acceleration |
U.S. drug shortages are at a record high
U.S. Active Drug Shortages by Quarter (per ASHP)
• Shortages are at the highest level since tracking began in 2001. About half are injectables. Products in short supply include chemotherapy and ADHD medications.
• We believe industry wide supply chain disruptions are due to unsustainability of marketplace dynamics. 56% of molecules in shortage are less than $1.
Source: Per American Society of Health-Systems Pharmacists (ASHP) Drug Shortages Statistics - ASHP | 5 |
Note: Each point represents the number of active shortages at the end of each quarter. |
1) Macro healthcare trends | 2) Our strategy & differentiators | 3) Amneal overview | 4) Growth acceleration |
Amneal Pharmaceuticals - We make healthy possible®
- Global, diversified pharmaceutical company that provides access to high-quality, affordable, and essential medicines
- Growing portfolio of 280+ commercial Amneal medicines across Retail, Injectables, Biosimilars and Specialty, and our AvKARE distribution business
- Highly productive R&D engine focused on complex and high-value products where there is less innovation and less competitors
- Global manufacturing and robust commercial capabilities at scale
- Delivering sustainable growth and maintaining disciplined capital allocation to support long-term growth and continued deleveraging
280+ | 86 | 67 | ~175M | $2.55-2.65B$580-620M$260-300M | |
Products in | FDA Pending | Generics Pipeline | Annual U.S. scripts | Net Revenue(3) | Adjusted EBITDA(3)(4) Operating Cash Flow(3)(5) |
Portfolio | ANDAs(1) | Programs(1) | filled by Amneal(2) |
<4x
Net Leverage
in 2025(6)
Note: Injectables and Biosimilars are part of the Generics reportable segment.
(1) | As of Q1'24 earnings. | |
(2) Per IQVIA for full year 2023. | 6 | |
(3) | Full year 2024 guidance as of Q1'24 earnings. |
- Adjusted EBITDA is a non-GAAP measure. Please see language under the heading "Non-GAAP Financial Measures" in today's presentation for a discussion of Non-GAAP measures.
- Operating Cash Flow (OCF) guidance for 2024 does not contemplate one-time and non-recurring items such as legal settlements and other discrete items.
- Net leverage reflects net debt (gross debt less total cash) compared to LTM Adjusted EBITDA.
1) Macro healthcare trends | 2) Our strategy & differentiators | 3) Amneal overview | 4) Growth acceleration |
Our growth strategy as a diversified pharmaceutical company
Business area | Net Revenue |
LTM Q1 2024 | |
Retail | |
Generics | |
Injectables | |
$1.519B | |
Biosimilars | |
International |
Strategy for growth | Growth projection(1) | |
Grow #4 U.S. Generics portfolio of ~240 products with new | Low-single digit growth | |
launches and shift to complex dosage forms | ||
Expand portfolio of 40+ institutional products through new launches | $300M+ revenue by 2025 | |
and leverage new capacity to be Top 5 in U.S. and a global player | High-single | |
Drive initial portfolio and add more biosimilars to the pipeline to be | $200M+ peak U.S. sales by | digit growth |
Top 5 in U.S. and a global player | 2025 from 1st 3 biosimilars(2) |
Market expansion in India, Europe, China and rest of the world - | Add $50-100M revenue by 2027 |
either direct or through licensing | |
Specialty | $404M | Grow branded portfolio with focus on Neurology and Endocrinology | $500M+ revenue by 2027 reflecting |
high-single digit growth | |||
AvKARE | $572M | Grow across government, institutional and distribution channels | $650M+ by 2025 reflecting |
double-digit growth | |||
(1) | Growth projection reflects the potential outcomes of delivering our long-term strategy and is based on the current macro environment and expected product pipeline launches, among other assumptions. | 7 |
(2) | Represents the total peak U.S. sales for our first three oncology biosimilars (filgrastim, pegfilgrastim and bevacizumab). |
1) Macro healthcare trends | 2) Our strategy & differentiators | 3) Amneal overview | 4) Growth acceleration |
Differentiated R&D and manufacturing capabilities
Best-in-class R&D and manufacturing capabilities delivering complex & high-value dosage forms
INJECTABLES | TRANSDERMALS | ORAL SOLIDS, |
& STERILE | Matrix | LIQUIDS & TOPICALS |
Peptides | IR/ER tablets | |
Hydrogel | ||
Microspheres | Form Fill Seal | Hard and Softgel Capsules |
Liposomes | Hormonals | Oral liquids |
General and Oncology | Creams | |
Injectables |
OPHTHALMICS & | INHALATION | DEVICES | DRUG DELIVERY |
OTICS | Metered Dose | Rings | TECHNOLOGY |
Solutions | GRANDE: Advanced | ||
Dry Powder | Autoinjectors | ||
Suspension | Nasal Spray Pumps | Gastric Retention | |
Emulsion | Blow Fill Seal | System | |
Inhalation |
Global network of FDA-approved, cGMP manufacturing sites
• | Co-located manufacturing | • | Internally operated facilities help |
and R&D centers maximize efficiency | maintain control of the supply chain | ||
• | In-house API capabilities | • | Trusted manufacturer with track record |
of delivering best-in-class quality |
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1) Macro healthcare trends | 2) Our strategy & differentiators | 3) Amneal overview | 4) Growth acceleration |
Deep pipeline as our wheel of innovation keeps turning
Robust Generics R&D engine
~67 pipeline
programs with
~$27B TAM
~86 pending ANDA's with ~$50B TAM
270+
commercial
Retail &
Injectable
products
Expanding U.S. biosimilars portfolio
ALYMSYS®
bevacizumab-maly (Avastin®)
FYLNETRA®
pegfilgrastim-pbbk (Neulasta®)
RELEUKO® filgrastim-ayow(Neupogen®)
- Added 2 biosimilars to enhance our pipeline with denosumab biosimilar candidates for Prolia® and XGEVA®
- Added 2 peg-filgrastim programs (On-Bodyinjector & Prefilled autoinjector) to pipeline
Specialty branded pipeline(1)
Potential | Program | Therapeutic | |
Launch | Area | ||
Launched | ONGENTYS® | Parkinson's | |
Q1 | 2024 | Disease | |
Q3 | 2024(2) | IPX203 | Parkinson's |
Disease | |||
Q1 | 2025 | DHE | Migraine and |
Autoinjector | Cluster Headache | ||
2026-2027 | K-114 | Hypothyroidism | |
Note: Total Addressable market (TAM) are approximate IQVIA (brand + active generics) MAT February 2024 sales ($ in millions). All trademarks are property of their respective owners. | 9 | |
(1) | Pipeline includes investigational products not approved by FDA. Any such expected launch is subject to certain assumptions and factors, many of which are outside our control, such as regulatory approval, and may be subject to change. | |
(2) | Pending successful CRL resolution and FDA approval. |
1) Macro healthcare trends | 2) Our strategy & differentiators | 3) Amneal overview | 4) Growth acceleration |
Continued commitment to quality and compliance
Leading quality and compliance track record. Since Amneal's founding, our facilities (US and India) have been inspected by the FDA 101 times, yielding no official action indicated (OAI) classifications or warning letters
15 | 100+ | ||||||||||||||||||||||||||||
13 | 12 | 12 | FDA Inspections | ||||||||||||||||||||||||||
(since 2005) | |||||||||||||||||||||||||||||
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2 | 1 | 1 | 1 | ||||||||||||||||||||||||||
Brookhaven, Branchburg, Hauppauge, | Matoda, | Paterson, | Piscataway, | Rajoda, | Vizag & | East | Hyderabad, Bridgewater, | Palli, | Pipan, | Cashel, | |||||||||||||||||||
NY | NJ | NY | India | NJ | NJ | India | Dahej, India Hanover, NJ | India | NJ | India | India | Ireland |
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Amneal Pharmaceuticals Inc. published this content on 05 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 05 June 2024 12:45:07 UTC.