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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- Revenue Decline: Organon reported approximately $6.216 billion in revenue for 2025, a 3% year-over-year decline, reflecting challenges in its women's health and biosimilars segments, particularly a 9% drop in the U.S. market due to policy-related access restrictions.
- Leadership Change: CEO Kevin Ali resigned following an internal investigation, with Joseph Morrissey appointed as interim CEO; while the financial impact of this change is described as small, it has affected investor sentiment and led to stock price volatility.
- Cash Flow and Debt Management: In 2025, Organon generated about $700 million in net cash flow, and despite facing total debt of $8.64 billion, management is focused on debt reduction, aiming to significantly lower net debt levels before the 2028 refinancing deadline.
- Portfolio Risk: Although the biosimilars segment grew by 4% in 2025, the decline in sales of mature products like Nexplanon by 4% and market access restrictions indicate that Organon's product portfolio faces ongoing market pressures, limiting future growth potential.
- New Position: Sio Capital Management disclosed a new position in Organon (OGN) on February 17, 2026, acquiring 3,421,765 shares valued at $24.53 million, indicating confidence in the company's potential.
- Asset Allocation: This investment represents approximately 4% of Sio Capital's 13F reportable assets under management as of December 31, 2025, highlighting the fund's strategic focus in the healthcare sector.
- Company Performance: Organon's shares are priced at $6.03, down about 61% over the past year, significantly underperforming the S&P 500's 16% gain, reflecting the challenges and pressures the company faces in the market.
- Financial Health: With revenue at $6.22 billion and net income plummeting 78% to $187 million, management anticipates flat performance in 2026, demonstrating the company's focus on stabilizing operations amidst financial pressures.
- New Position Established: Sio Capital Management initiated a new position in Organon (NYSE: OGN) in Q4 2026, acquiring 3,421,765 shares, which increased the position value by $24.53 million, indicating a cautious optimism about the company's future potential.
- Position Proportion: This acquisition accounts for 4% of Sio Capital's assets under management, although it does not rank among the top five holdings, reflecting a continued focus on the healthcare sector.
- Performance Pressure: Organon's stock has significantly declined over the past year, down 16% since last quarter, with 2025 revenues slipping 3% to approximately $6.2 billion and net income plummeting 78% to $187 million, highlighting the profitability challenges faced by the company.
- Future Outlook: Despite management's guidance for essentially flat performance in 2026, emphasizing stability over growth, the company still generates about $1.9 billion in adjusted EBITDA, indicating a degree of cash flow resilience amid a heavy debt burden exceeding $8.5 billion.
- Stock Price Decline: Organon (OGN) shares fell 1.38% to $6.44 in afternoon trading on Tuesday, marking a sixth consecutive day of decline, indicating market concerns about its future performance.
- Poor Earnings Report: Last month, Organon reported quarterly earnings that fell short of analysts' expectations, with flat revenue and underperformance in its Women's Health and Established Brands units, although Biosimilars showed growth, reflecting overall pressure on the company's performance.
- Rating and Market Reaction: According to Seeking Alpha's QuantRating system, OGN is rated a Strong Sell with a score of 1.36, indicating strong concerns about future growth, as it received an A- for profitability and valuation but an F for growth and revisions.
- Need for Strategic Transformation: Analysts noted that Organon faces high strategic uncertainty, with management prioritizing debt reduction and margin preservation, expecting no revenue improvement through 2026, making the appointment of a new CEO critical for any turnaround efforts.
- 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.











