11/10/2025

speaker
Operator
Conference Operator

Hello and welcome to the Organon third quarter 2025 earnings call and webcast. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, please press star one on your telephone keypad. I would now like to turn the conference over to Jennifer Halczak, Vice President, Investor Relations. You may begin.

speaker
Jennifer Halczak
Vice President, Investor Relations

Thank you, Operator, and good morning, everyone. Today, we will be referencing a presentation that is visible during this call for those of you on our webcast. This presentation will also be available following this call on the Events and Presentations section of our Organon Investor Relations website. Please reference slides 2 and 3 for some brief reminders. I would like to caution listeners that certain information discussed by management during this call will include forward-looking statements. Forward-looking statements can be identified because they do not relate strictly to historical or current facts and use words such as potential, should, will, continue, expects, believes, future, estimates, believes, and other words of similar meaning. Actual results could differ materially from those stated or implied by forward-looking statements due to risks and uncertainties associated with the company's business, which are discussed in the company's filings with the SEC. This includes our most recent Form K and Form 10Q and those amended forms that we filed earlier this morning, as well as our October 27, 2025, Form 8K. These statements are based on information as of today, November 10, 2025, and except as required by law, Organon undertakes no obligation to update or revise any of these forward-looking statements. In addition, we will discuss certain non-GAAP financial measures on this call, which should be considered a supplement to and not a substitute for financial measures prepared in accordance with GAAP. Descriptions of these measures and reconciliations to the comparable GAAP measures are included in today's earnings press release and conference call presentation, both of which are available on our investor relations website and have been furnished to the SEC on a current report on Form 8K. I note that while our full year 2025 guidance measures, other than revenue, are provided on a non-GAAP basis, Organon does not provide GAAP financial measures on a forward-looking basis because we cannot predict with reasonable certainty and without unreasonable effort the ultimate outcome of those 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 our results computed in accordance with GAAP. On the call today, Carrie, Joe, and Matt will address certain information about our internal investigation. Additional information about the investigation is available in our SEC filings. Beyond their statements today and the information in our filings, we will not be taking questions on the investigation. Today, the team will discuss our business, third quarter results, and guidance, and they will take questions on those matters after their prepared remarks. And now I'll turn the call over to Carrie.

speaker
Carrie
Executive Chair

Thank you, Jen. Hello, everyone, and thank you all for joining us today. I've had the privilege of serving as board chair of Organon since 2021. I've been in the pharma industry now over four decades, and about half of those years were spent in global leadership roles, which required navigating businesses through periods of transformation and growth. A good part of that experience was leading Shearing Plow Global Pharmaceuticals until the merger with Merck. So I have a deep understanding of many of our products and markets here at Organon. Since Organon's inception, our mission has been to deliver impactful medicines and solutions for a healthier every day. There is a shared passion at Organon to advance the complete health of women at all stages of her life, and that's what drew me to Organon from the beginning. While we focus on women's health, we also have a diverse portfolio of biosimilars and established brands that are important in markets around the world. I'm here today because I have assumed a new role at Organon as executive chair, following the board's investigation into the company's improper sales practices with two distributors with respect to U.S. sales of Nexplanon. I will be supporting Joe Morrissey, who I will speak about in a minute, as our interim CEO. The board has formed a search committee and will be conducting a search for our permanent CEO. In this role, my focus will be on working closely with our leadership team to ensure that we align our resources to our highest priorities and drive operational performance across the portfolio. I will be deeply engaged in monitoring progress, addressing challenges quickly, and ensuring that every part of the business is working towards our shared goals. The independent internal investigation relating to the company's next one on sale to wholesalers in the U.S. is complete. And our remediation efforts are underway, including enhanced control, certain personnel actions, additional training, and expanded written procedures. The company wholesaler sales practices identified through this investigation have ceased. And we have new leadership at the company and in our U.S. commercial sales area to ensure this does not happen again. The board and I are confident that Joe is the right person to assume the role of interim CEO of Organon and to oversee the remediation measures. He brings integrity, a strong focus on operational excellence, and a deep commitment to executing our strategy. Joe came to Organon from Merck where he spent more than 30 years. At Organon, he was already a member of the executive leadership team and has served as head of global manufacturing and supply chain since Organon's inception, leading the company's efforts to deliver medicines and solutions around the world. We appreciate Joe agreeing to step in at this critical juncture. Importantly, I want to stress that our drive for operational excellence and meeting our goals to move our company forward into the future remains unchanged. With that said, I'll hand it over to Joe so that he can talk a bit about his and Organon's strategic priorities.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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Investor presentation