Expands women’s health pipeline with novel candidates targeting endometriosis and polycystic ovarian syndrome (PCOS)

Organon (NYSE: OGN), a global women’s healthcare company, today announced the completion of its acquisition of Forendo Pharma, a clinical-stage drug development company focused on novel treatments in women’s health. Forendo’s lead candidate, FOR-6219, is an investigational, potentially first-in-class oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor entering Phase 2 clinical development for endometriosis. Forendo’s pipeline also includes a preclinical program targeting polycystic ovarian syndrome (PCOS).

FOR-6219 has potential to act locally in the target tissues without impacting systemic hormone levels. This potential selective activity allows for its evaluation as a long-term treatment option for endometriosis – a current therapeutic gap.

“Despite the high prevalence of endometriosis, current treatment options are not adequately addressing the painful and challenging symptoms of women living with this disorder,” said Dr. Sandra Milligan, Head of Research & Development at Organon. “Through our acquisition of Forendo, we hope to bring innovation to this therapeutic area and enable future treatment options – in line with our continued focus on building a robust pipeline that addresses a broad spectrum of conditions impacting women.”

Consideration for the transaction includes a $75 million upfront payment, assumption of approximately $9 million of Forendo debt, payments upon the achievement of certain development and regulatory milestones of up to $270 million and commercial milestones payments of up to $600 million, which together could amount to total consideration of $954 million. Moelis & Company acted as exclusive financial advisor to Forendo.

About Organon

Organon is a global healthcare company formed through a spin-off from Merck, (NYSE: MRK) known as MSD outside of the United States and Canada, to focus on improving the health of women throughout their lives. Here for her health, Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the reproductive health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in future growth opportunities in women’s health. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.

Organon has a global footprint that serves people in over 140 markets, world-class commercial capabilities and approximately 9,000 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn and Instagram.

Forward-Looking Statement of Organon

Except for historical information herein, this news 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 acquisition of Forendo and the potential of FOR-6219 to become a long-term treatment option for endometriosis. Forward-looking statements may be identified by words such as “hope,” or “hopes,” “expects,” “potential,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning. These statements include statements about the acquisition of Forendo and the potential for innovation and future treatment options. Such statements are based upon the current beliefs and expectations of Organon’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 acquisition of Forendo or any other planned acquisitions; general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; 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; Organon’s ability to accurately predict its future financial results and performance; Organon’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 Organon’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Organon 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 Organon’s filings with the Securities and Exchange Commission (SEC), including its registration statement on Form 10, available at the SEC’s Internet site (www.sec.gov).

About Forendo

Forendo is pioneering the translation of intracrinology science into first-in-class therapeutic solutions. Intracrinology enables physicians to address diseases on an unprecedented tissue-specific level. Forendo’s lead clinical compound in endometriosis is being evaluated for its potential effect on endometriotic lesions, a significant unmet need. The company’s second program is targeting polycystic ovarian syndrome (PCOS) which currently has no approved therapies. In addition to women’s health programs, Forendo has a strategic collaboration with Novartis leveraging its unique HSD17B platform in chronic liver diseases. Forendo is based in Finland and backed by Novo Seeds, Karolinska Development, Innovestor, Novartis Venture Fund, M Ventures, Vesalius Biocapital III Partners and Sunstone Life Science Ventures. For more information, please visit: www.forendo.com.

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