AMNEAL PHARMACEUTICALS, INC.

(AMRX)
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Delayed Nyse  -  04:00 2022-08-09 pm EDT
3.090 USD   -1.28%
08/08AMNEAL PHARMACEUTICALS, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q)
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08/08Goldman Sachs Trims Amneal Pharmaceuticals Price Target to $4 From $4.50, Maintains Buy Rating
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08/08Amneal Reports Second Quarter 2022 Financial Results
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Amneal Pharmaceuticals : Second Quarter 2022 Earnings Presentation

08/05/2022 | 06:37am EDT

Q2 2022

Earnings Call

August 5, 2022

g

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 or forecasts for the future, including among other things: discussions of future operations and strategies for product launches and product expansion; expected or estimated operating results and financial performance, including pro forma results; impact of acquisitions and dispositions, and estimated returns or assumptions underlying acquisitions and dispositions; the Company's growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, including biosimilars; regulatory approvals and our ability to obtain, maintain and enforce proprietary rights for our products; market position and expenditures. Words such as "plans," "expects," "will," "anticipates," "estimates" and similar words 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. 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, in general, specifically 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 ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; 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 and any associated supply chain disruptions; existing and future legal proceedings, the outcomes of which are uncertain and may divert management resources and require us to incur substantial defense or settlement payments and costs; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the impact of severe weather; the impact of the ongoing COVID-19 pandemic, and the emergence of variant strains; 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 product liability and other claims against us by consumers and other 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 ("FDA") 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; the impact of global economic conditions, including any economic effects stemming from adverse geopolitical events, an economic downturn and inflation rates; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; 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 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

As previously disclosed, beginning in the first quarter of 2022, we no longer exclude research and development milestone expenses related to license and collaboration agreements from our non-GAAP financial measures and our line item components, including adjusted research and development, adjusted EBITDA, adjusted operating income, adjusted net income, net debt, and adjusted earnings per share. Prior period adjusted results have been revised to reflect this change.

This presentation includes certain non-GAAP financial measures, which are identified as non-GAAP measures and are intended as supplemental measures of the Company's performance that are not required by or presented in accordance with U.S. General Accepted Accounting Principles ("GAAP"). 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 operation 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 presentation 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 the corollary metrics in accordance with GAAP. Readers should review the reconciliations and should not rely on any single financial measure to evaluate the Company's business. A reconciliation of each historical non-GAAP measure to the most directly comparable GAAP measure is included in the appendix of this presentation. Amneal's full year 2022 and beyond estimates are based on management's expectations, including with respect to prescription trends, pricing levels, inventory levels, the costs incurred and benefits realized of restructuring activities and the anticipated timing of future product launches and events. The Company cannot provide a reconciliation between non- GAAP projections and the most directly comparable GAAP measures without unreasonable efforts because it is unable to predict with reasonable certainty the ultimate outcome of certain significant items required for the reconciliation. The items include, but are not limited to, acquisition-related expenses, restructuring expenses and benefits, asset impairments and other gains and losses. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results.

2

Q2 2022 Earnings Call

Agenda

Today's participants

1

Business Update

Chirag and Chintu Patel, Co-CEOs

2

Financial Results

Chirag Patel,

Chintu Patel,

Tasos Konidaris,

Tasos Konidaris, EVP & CFO

Co-CEO

Co-CEO

EVP & CFO

3

Closing Remarks

Chirag Patel, Co-CEO

4

Q&A

Andy Boyer,

Harsher Singh,

Jason Daly, SVP

EVP - Generics

SVP - Biosciences

& Chief Legal Officer

3

Key takeaways for Q2 2022

Solid Q2'22

performance

  • Q2 net revenue of $559M and adjusted EBITDA of $135M(1) reflects acceleration from Q1, as expected
  • Q2 performance driven by revenue growth across all
    3 segments: Generics, Specialty and AvKARE

Revised full year

2022 outlook

  • Continue to expect mid-single digit revenue growth and acceleration in the second half of 2022
  • Lowering 2022 adjusted EBITDA guidance for two isolated factors that impact our outlook

Expect key catalysts to drive accelerated growth

  • Expect to launch 1st biosimilars, 5-10 injectables, 15- 20 retail generics and 1 specialty product in 2022
  • Expanding our portfolio and key capabilities in higher growth areas to drive long-term growth

(1) Beginning in the first quarter of 2022, the Company no longer excludes R&D milestone expenses from non-GAAP financial measures.

4

Our strategy for growth as a global essential medicines company

Amneal develops, manufactures, commercializes and distributes a growing and diverse portfolio of essential medicines, including complex generics, injectables, biosimilars and specialty branded pharmaceuticals. Through this diversified and innovative portfolio, we are providing patients increased access to high-quality, affordable medicines and addressing unmet needs.

Affordable Medicines

Unmet

Patient Needs

Global Access

Business area

Strategy for growth

Growth projection(1)

Retail

Grow our top 5 U.S. Generics portfolio of 225+ products with 20-30 new

Low-single digit growth

product launches each year and increasingly focused on complex areas

Injectables

Expand portfolio of ~25 institutional products with 30-40 launches by

$300M+ by 2025

2025 and leverage new capacity to be Top 5 in U.S. and global player

representing 24%+ CAGR

Biosimilars

Enter market with oncology portfolio, pursue new opportunities, leverage

$200M+ peak U.S. sales

key capabilities (e.g., commercial) and be vertically integrated over time

from 1st 3 biosimilars(2)

AvKARE

Grow across federal healthcare, institutional, and distribution channels

Mid-single digit growth

Specialty

Expand Neurology and Endocrinology presence with new technologies

$500M to $1B in peak

U.S. sales from pipeline(3)

International

Enter select new markets by licensing high value, impactful products in

Too early to size -

Europe, China, India and around rest of the world

all incremental

(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.

5

(2)

Represents the total peak U.S. sales for our first three oncology biosimilars (filgrastim, pegfilgrastim and bevacizumab).

(3) Represents the total peak U.S. sales for the Specialty pipeline as calculated by total market prescriptions for disease/therapy multiplied by branded WAC/RX price of market leading brand for the most recent year as per IQVIA.

This is an excerpt of the original content. To continue reading it, access the original document here.

Disclaimer

Amneal Pharmaceuticals Inc. published this content on 05 August 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 05 August 2022 10:35:07 UTC.


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Financials (USD)
Sales 2022 2 204 M - -
Net income 2022 -200 M - -
Net Debt 2022 2 534 M - -
P/E ratio 2022 -
Yield 2022 -
Capitalization 466 M 466 M -
EV / Sales 2022 1,36x
EV / Sales 2023 1,20x
Nbr of Employees 7 000
Free-Float 39,0%
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Number of Analysts 7
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Managers and Directors
Chintu Patel Co-Chief Executive Officer & Director
Chirag K. Patel President & Co-Chief Executive Officer & Director
Anastasios G. Konidaris Executive VP, Chief Financial & Accounting Officer
Paul M. Meister Chairman
Andrew S. Boyer Executive Vice President-Commercial Operations
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