This text should be viewed in conjunction with Organon's Q2 2022 earnings call
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Except for historical information herein, this presentation includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about management's expectations about Organon's future financial performance and prospects. Forward-looking statements may be identified by words such as "expects," "intends," "anticipates," "plans," "believes," "seeks," "estimates," "will" or words of similar meaning. These statements are based upon the current beliefs and expectations of the
company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, an inability to execute on our business development strategy or realize the benefits of our planned acquisitions; general economic factors, including interest rate and currency exchange rate fluctuations; general industry conditions and competition; the impact of the ongoing COVID-19 pandemic and emergence of variant strains; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; challenges inherent in new
product development, including obtaining regulatory approval; the company's ability to accurately predict its future financial results and performance; the
company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; difficulties developing and sustaining relationships with commercial counterparties; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's filings with the Securities and Exchange Commission (SEC), including the company's Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent SEC filings, available at the SEC's Internet site (www.sec.gov).
Disclaimer statement, cont.
This presentation contains "non-GAAP financial measures," which are financial measures that either exclude or include amounts that are not excluded or included in the most directly comparable measures calculated and presented in accordance with U.S. generally accepted accounting principles ("GAAP"). Specifically, the company makes use of the non-GAAP financial measures Adjusted EBITDA, Adjusted Net Income, and Adjusted diluted EPS, which are not recognized terms under GAAP and are presented only as a supplement to the company's GAAP financial statements. The company believes that these non-GAAP financial measures help to enhance an understanding of the
company's financial performance. However, the presentation of these measures has limitations as an analytical tool and should not be
considered in isolation, or as a substitute for the company's results as reported under GAAP. Because not all companies use identical calculations, the presentations of these non-GAAP measures may not be comparable to other similarly titled measures of other companies. You should refer to the appendix of this presentation for relevant definitions and reconciliations of non-GAAP financial measures contained herein to the most directly comparable GAAP measures. In addition, the company's full-year 2022 guidance measures (other than revenues) are provided on a non-GAAP basis because the company is unable to reasonably predict certain items contained in the GAAP measures. Such items include, but are not limited to, acquisition related expenses, restructuring and related expenses, stock-based compensation and other items not reflective of the company's ongoing operations. The company uses non-GAAP financial measures in its operational and financial decision making, and believes that it is useful to exclude certain items in order to focus on what it regards to be a more meaningful representation of the underlying operating performance of the business.
Second quarter 2022 highlights
All franchises show growth Ex-FX
Improved trajectory for Established Brands
Expanded biosimilars portfolio with additional R&D collaborator; Shanghai Henlius Biotech Inc.
Revenues of $1,585 million
$512 million Adjusted EBITDA, inclusive of$97M in acquired
IPR&D and milestones
$1.25 Adjusted EPS from continuing operations,inclusive of negative $0.30 impact from acquired IPR&D and milestones
Balancing commercial and pipeline business development
Commercialized/soon to be
March 2022 - Licensing agreement forXaciato™
February 2022 - Acquisition of commercial rights toMarvelon™ andMercilon™ in certain Asian markets
June 2021 - Acq. of Alydia Health and its
Building a pipeline
July 2022 - Licensing agreement for a novelinvestigationalnon-hormonal,on-demandcontraceptive candidate with Cirqle Biomedical
June 2022 - Licensing agreement to commercializeInvestigational Perjeta® (Pertuzumab) and Prolia®/Xgeva®
(Denosumab) biosimilar candidates
July 2021 - Licensing ofinvestigational agent, ebopiprant
December 2021 - Acquisition ofForendo Pharma
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