• Third quarter 2024 revenue of $1.582 billion, up 4% as-reported and up 5% at constant currency
• Third quarter 2024 diluted earnings per share of $1.38 and non-GAAP Adjusted diluted earnings per share of $0.87; both reported and non-GAAP Adjusted diluted earnings per share include $51 million of expense, or $0.16 per share, for acquired in-process research and development (IPR&D) and milestones
• Third quarter 2024 net income of $359 million and Adjusted EBITDA (non-GAAP) of $459 million
• Guidance range for full year 2024 revenue narrowed to $6.375 billion to $6.425 billion, mid-point of the range raised by $50 million; Guidance range for Adjusted EBITDA margin (non-GAAP) revised to 30.0% to 31.0%, inclusive of the $51 million of IPR&D expense incurred in the third quarter

JERSEY CITY, N.J. / Oct 31, 2024 / Business Wire / Organon (NYSE: OGN) today announced its results for the third quarter ended September 30, 2024.

"In 2024 our commercial execution has been very strong. Our largest product, Nexplanon, is well positioned to deliver $1 billion of revenue next year and we've added other notable growth drivers with Emgality and most recently, VTAMA," said Kevin Ali, Organon's Chief Executive Officer. "Further, we have been extremely disciplined on operating costs and driving Adjusted EBITDA growth in support of achieving $1 billion of free cash flow before one-time costs for full year 2024."

Third Quarter 2024 Revenue

For the third quarter of 2024, total revenue was $1.582 billion, up 4% as-reported and up 5% excluding the impact of foreign currency (ex-FX).

Women's Health revenue increased 5% as-reported and 6% ex-FX in the third quarter of 2024 compared with the third quarter of 2023 primarily driven by 11% ex-FX growth in Nexplanon® (etonogestrel implant). Nexplanon's strong performance was primarily due to increased demand, favorable price and discount rates in the United States and increased demand in international markets, partially offset by the timing of tenders in Latin America. The company's fertility portfolio grew 14% ex-FX as a result of increased demand in the United States, and to a lesser extent, launches in various international markets, partially offset by unfavorable discount rates in the United States.

Performance in the Women's Health franchise was partially offset by sales of NuvaRing® (etonogestrel / ethinyl estradiol vaginal ring), a vaginal contraceptive product, which declined 45% ex-FX during the period due to ongoing generic competition and the negative impact of increased government discount rates in the United States.

Biosimilars revenue grew 16% as-reported basis and 17% ex-FX in the third quarter of 2024, compared with the third quarter of 2023, primarily due to the uptake of Hadlima® (adalimumab-bwwd) since its July 2023 launch in the U.S. Sales of Renflexis® (infliximab-abda) increased 4% ex-FX in the third quarter primarily due to continued demand growth in the U.S. and Canada partially offset by unfavorable discount rates in the U.S. Sales of Ontruzant® (trastuzumab-dttb) declined 49% ex-FX in the period due to the timing of tenders in Brazil and lower demand in the U.S. and Europe.

Established Brands revenue grew 2% as-reported 3% ex-FX in the third quarter of 2024. Contribution from the recent licensing of Emgality® (galcanezumab-gnlm)⁽¹⁾, growth in China and recovery in injectable steroids were the strongest drivers of third quarter's 9% volume growth which more than offset unfavorable pricing in Japan. The company expects revenue growth in the Established Brands franchise to be approximately flat for full year 2024 on an ex-FX basis.

(1) Emgality is a trademark registered in the United States in the name of Eli Lilly and Company (used under license).

Third Quarter 2024 Profitability

Gross margin was 58.3% as-reported and 61.7% on a non-GAAP adjusted basis in the third quarter of 2024 compared with 59.7% as-reported and 62.6% on a non-GAAP adjusted basis in the third quarter of 2023. The lower Adjusted gross margin was primarily related to unfavorable product mix and price.

Net income for the third quarter of 2024 was $359 million, or $1.38 per diluted share, compared with $58 million, or $0.23 per diluted share, in the third quarter of 2023. Non-GAAP Adjusted net income was $226 million, or $0.87 per diluted share, compared with $223 million, or $0.87 per diluted share, in 2023. GAAP net income benefited from the release of a valuation allowance in the amount of $210 million against a tax asset of one of the company's Swiss entities.

Non-GAAP Adjusted EBITDA margin was 29.0% in the third quarter of 2024 compared with 29.4% in the third quarter of 2023 primarily due to $51 million of IPR&D expense in the third quarter of 2024 compared with no such expense in the prior year period. Selling, general and administrative and research and development expenses were down 5% year over year as a result of the company's cost containment efforts including lower clinical spend and a reduction in headcount related to restructuring initiatives and lower cost associated with the implementation of the company's ERP system.

Capital Allocation

Today, Organon’s Board of Directors declared a quarterly dividend of $0.28 for each issued and outstanding share of the company's common stock. The dividend is payable on December 12, 2024, to stockholders of record at the close of business on November 12, 2024.

As of September 30, 2024, cash and cash equivalents were $763 million, and debt was $8.7 billion.

Full Year Guidance

Organon does not provide GAAP financial measures on a forward-looking basis because the company cannot predict with reasonable certainty and without unreasonable effort, the ultimate outcome of legal proceedings, unusual gains and losses, the occurrence of matters creating GAAP tax impacts, and acquisition-related expenses. These items are uncertain, depend on various factors, and could be material to Organon’s results computed in accordance with GAAP.

Full year 2024 financial guidance is presented below on a non-GAAP basis, except revenue.

*Updated R&D expense guidance includes $51 million of IPR&D and milestone expense incurred in the quarter ended September 30, 2024. R&D guidance does not take into consideration a forward-looking view of IPR&D and milestone expense.

Webcast Information

Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its third quarter 2024 financial results. To listen to the event and view the presentation slides via webcast, join from the Organon Investor Relations website at https://www.organon.com/investor-relations/events-and-presentations/. A replay of the webcast will be available approximately two hours after the conclusion of the live event on the company’s website. Institutional investors and analysts interested in participating in the call must register in advance by clicking on this link: https://registrations.events/direct/Q4I58511172

Following registration, participants will receive a confirmation email containing details on how to join the conference call, including dial-in information and a unique passcode and registrant ID. Pre-registration will allow participants to bypass an operator and be placed directly into the call.

About Organon

Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers more than 60 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical partners and innovators looking to commercialize their products by leveraging its scale and agile presence in fast growing international markets.

Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook.

Cautionary Note Regarding Non-GAAP Financial Measures

This press release contains “non-GAAP financial measures,” which are financial measures that either exclude or include amounts that are correspondingly 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 EBITDA margin, Adjusted gross margin, Adjusted gross profit, 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. This press release also provides certain measures that exclude the impact of foreign exchange. We calculate foreign exchange by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. 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. Please refer to Table 4 and Table 5 of this press release for additional information, including 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 2024 guidance measures (other than revenue) 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, the ultimate outcome of legal proceedings, unusual gains and losses, the occurrence of matters creating GAAP tax impacts and other items not reflective of the company's ongoing operations.

The company’s management uses the non-GAAP financial measures described above to evaluate the company’s performance and to guide operational and financial decision making. Further, the company’s management believes that these non-GAAP financial measures, which exclude certain items, help to enhance its ability to meaningfully communicate its underlying business performance, financial condition and results of operations.

Cautionary Note Regarding Forward-Looking Statements

Except for historical information, this press release 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, including full-year 2024 guidance estimates and predictions regarding other financial information and metrics, and franchise and product performance and strategy expectations for future periods. Forward-looking statements may be identified by words such as “will,” “pursuing,” “expects,” “intends,” “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, pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; an inability to fully execute on our product development and commercialization plans in the United States, Europe, and elsewhere internationally; an inability to adapt to the industry-wide trend toward highly discounted channels; difficulties implementing or executing on Organon’s acquisition strategy, difficulties integrating such acquisitions (including its recent acquisition of Dermavant Sciences Ltd.) or any other failure to recognize the benefits of such acquisitions; changes in tax laws or other tax guidance which could adversely affect our cash tax liability, effective tax rates, and results of operations and lead to greater audit scrutiny; expanded brand and class competition in the markets in which the company operates; global tensions, which may result in disruptions in the broader global economic environment; governmental initiatives that adversely impact our marketing activities, particularly in China; volatility in our stock price; political and social pressures, or regulatory developments, that adversely impact demand for, availability of, or patient access to contraception or fertility products; recent Supreme Court decisions and other developments impacting regulatory agencies and their rule making, including related financial market reactions, tax planning and international trade practices; difficulties with performance of third parties we rely on for our business growth; the failure of any supplier to provide substances, materials, or services as agreed; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as our products lose patent protection; any failure by us to obtain an additional period of market exclusivity in the United States for Nexplanon subsequent to the expiration of certain current patents in 2027; the impact of the 2024 United States presidential election and any resulting public policy changes affecting women and their health care decisions, including changes in financial outcomes resulting from candidate positions on healthcare topics and the possible impact on related laws, regulations and policies following the election; the impact of higher selling and promotional costs; and the impact of cyberattacks or other events that may affect Organon’s information technology systems or those of third parties.

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 most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov).