Organon & Co. (OGN) Q4 2025 Earnings Call Transcript
Revenue Organon delivered $6.2 billion in revenue in 2025, down 3% year-over-year on both a reported and ex-exchange basis. The decline was attributed to the loss of exclusivity (LOE) of Atozet, policy-related changes in the U.S. for Nexplanon, and revised medical guidelines deprioritizing montelukast in certain international markets.
Adjusted EBITDA Adjusted EBITDA was $1.9 billion in 2025, consistent with the prior year. Despite a 150 basis point gross margin degradation, the company achieved over $200 million in cost savings, which offset investments in growth drivers like Vtama.
Women's Health Revenue Women's health revenue was down 16% ex-FX in Q4 2025 and down 2% for the full year. Nexplanon sales decreased 20% ex-FX in Q4 and 4% for the full year due to U.S. policy-related access restrictions, changes in purchasing practices by smaller clinics, and a transition to a 5-year label. However, strong ex-U.S. growth, particularly in Latin America, partially offset these declines.
Fertility Business Revenue The fertility business declined 6% ex-FX in Q4 2025 but grew 8% for the full year. Growth was driven by U.S. performance in the first half of 2025 and geographic expansion, which offset declines in China due to socioeconomic trends.
Biosimilars Revenue Biosimilars revenue grew, driven by Hadlima, which increased 61% ex-FX globally in 2025. Growth was attributed to its strong clinical profile, effective pricing strategy, and expansion into Canada and Puerto Rico. New launches like denosumab biosimilars and Tofidence also contributed.
Established Brands Revenue Established brands revenue declined 5% ex-FX in Q4 2025 and for the full year. The decline was primarily due to the LOE of Atozet, which was a 400 basis point headwind. However, contributions from Vtama and Emgality helped offset some of the pressure.
Gross Margin Non-GAAP adjusted gross margin was 60.1% for full year 2025, down from 61.6% in 2024. The decline was driven by pricing pressure and unfavorable product mix.
Adjusted EBITDA Margin Adjusted EBITDA margin was 30.7% for full year 2025, consistent with 2024. The decline in gross margin was offset by lower R&D expenses.
Net Income Net loss for Q4 2025 was $205 million, compared to net income of $109 million in Q4 2024. The loss included a non-cash goodwill impairment of $301 million related to stock price decline and underperformance in the U.S.
Free Cash Flow Free cash flow for full year 2025 was $960 million, consistent with the prior year. Onetime costs related to restructuring and manufacturing separation activities were $270 million.
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- Ukraine's Fertility Rate Plummets: Since Russia's full-scale invasion in February 2022, Ukraine's fertility rate has dropped from 1.22 in 2021 to 1.00 by 2025, with some experts warning it could fall to 0.8-0.9, indicating significant impacts on family expansion and potential future labor shortages.
- Russia's Declining Birth Rate: Russia's fertility rate has also decreased from 1.51 in 2021 to 1.37 in 2025, and despite the Kremlin's initiatives to encourage larger families, the lack of effective results reflects a broader societal insecurity affecting women's decisions to have children.
- Long-term Demographic Consequences of War: The four-year conflict has deterred women in both Ukraine and Russia from having children, leading to greater economic and social pressures in the future, particularly as an aging population increases and the labor market faces significant challenges.
- Resistance to Putin's Birth Policies: Despite various incentives introduced by the Russian government, including cash rewards and tax breaks, the low birth rates persist due to women's feelings of insecurity, raising questions about the effectiveness of these policies in addressing demographic concerns.
- Strategic Acquisition: Organon has entered into an agreement to exclusively license MIUDELLA®, a hormone-free copper IUD from Sebela Pharmaceuticals, which is expected to enhance Organon's product portfolio in women's health and strengthen its market position.
- Financial Commitment: Under the agreement, Organon will pay $27.5 million at closing, with potential sales-based milestone payments of up to $505 million, demonstrating the company's confidence in MIUDELLA®'s future market potential.
- FDA Approval Requirements: As the first hormone-free copper IUD approved in the U.S. in 40 years, MIUDELLA® is subject to FDA review of its alternate supply chain, which will impact its market launch timeline and ensure product safety and efficacy.
- Innovation in Women's Health: MIUDELLA® offers a long-acting, reversible, hormone-free contraceptive option that meets diverse reproductive health needs, likely attracting women seeking new contraceptive methods and further driving Organon's growth in this niche market.
- Market Size Growth: The atopic dermatitis treatment market is expected to continue growing positively by 2034, with the United States holding the largest market share, reflecting strong demand for new therapies that drive overall market expansion.
- Introduction of New Therapies: The launch of new therapies such as Rocatinlimab and Amlitelimab is anticipated to transform the market landscape by providing more effective treatment options to meet the increasing patient demand.
- Rising Patient Numbers: In 2024, approximately 53 million diagnosed cases of atopic dermatitis are expected in the 7MM, with the increase in patient numbers directly fueling the demand for advanced treatment options and promoting market growth.
- Changing Competitive Landscape: As new drugs undergo clinical trials and enter the market, competition will intensify, particularly with companies like Eli Lilly leveraging their product portfolios to capture significant market share in the EU4 and Japan, showcasing strong market potential.
- Financial Performance Overview: In 2025, Organon reported $6.2 billion in revenue and $1.9 billion in adjusted EBITDA, despite a 3% year-over-year revenue decline, indicating pressure in a competitive market landscape.
- Product Line Challenges: Sales of Nexplanon decreased by 20% in Q4 and 4% for the full year, reflecting the impact of U.S. policy changes and competitive pressures on women's health products, leading to an overall business downturn.
- Strategic Adjustments: The company opted to lower its dividend payout ratio, reallocating funds for debt reduction, and generated approximately $390 million in net proceeds from the divestiture of the Jada system to enhance financial flexibility.
- Future Outlook: Management anticipates that revenue and adjusted EBITDA for 2026 will align with 2025 figures at $6.2 billion and $1.9 billion, respectively, despite ongoing market challenges and margin pressures.
- Organon Shares Fall: Organon shares experienced a 13% decline following the announcement of a profit miss in the fourth quarter.
- Impact of Earnings Report: The disappointing earnings report has raised concerns among investors regarding the company's financial performance and future outlook.
- Market Reaction: The significant drop in share price reflects investor sentiment and market reaction to the missed profit expectations.
- Future Projections: Analysts are now closely monitoring Organon's strategies and projections to assess potential recovery and growth opportunities.
- Disappointing Financials: Organon's Q4 adjusted EPS of $0.63 and revenue of $1.5B represent approximately 30% and 5% year-over-year declines, respectively, missing consensus estimates of $0.73 and $1.53B, indicating significant financial pressure on the company.
- Women's Health Segment Decline: The Women's Health unit generated $398M in revenue, reflecting a 15% drop year-over-year, marking the second consecutive quarter of decline, primarily due to policy-related demand headwinds in the U.S. and a $17M sales hit from Nexplanon contraceptive implant.
- Biosimilars Growth: Despite overall poor performance, Organon's biosimilar segment expanded by approximately 11% year-over-year, contributing $181M to the topline, showcasing growth potential in this area amidst broader challenges.
- Cautious Future Outlook: The company projects $6.2B in revenue for 2026, slightly below last year's $6.22B but above analysts' expectations of $6.11B, with adjusted EBITDA expected to reach nearly $1.9B, indicating some growth expectations despite ongoing challenges.









