Organon & Co. (NYSE:OGN) outlined a 2026 outlook broadly in line with 2025 results, highlighting efforts to stabilize revenue, hold profitability steady, and continue deleveraging, while also fielding investor questions around product-specific headwinds and its biosimilars strategy.
2025 results and key business drivers
Interim CEO Joe Morrissey said Organon delivered $6.2 billion in 2025 revenue and $1.9 billion of adjusted EBITDA. Revenue declined 3% on both a reported and ex-FX basis, though management said the company’s biosimilar franchise performed better than expected, led by HADLIMA and contributions from new launches.
- Vtama, which delivered $128 million of global revenue in 2025
- Emgality and the fertility business, which both grew strongly in 2025 (as described by management)
- Biosimilars, driven primarily by HADLIMA and additional contributions from a denosumab biosimilar launch and TOFIDENCE, which Organon acquired in the second quarter of 2025
These gains partially offset headwinds, including the continued impact of the loss of exclusivity (LOE) for Atozet and challenges that emerged during the year. Morrissey highlighted policy-related changes in the U.S. affecting Nexplanon access and a revision to medical guidelines in certain international markets that deprioritized montelukast, impacting SINGULAIR.
Nexplanon update: five-year label and ongoing headwinds
Management emphasized a notable regulatory milestone: the FDA approved Organon’s supplemental NDA to extend Nexplanon’s duration from three to five years, supported by a study that included women across varying body mass indices, including overweight or obesity.
The approval also includes a new risk evaluation and mitigation strategy (REMS) program. Morrissey said this will enhance Organon’s existing clinical training and controlled distribution program that has been in place since 2006.
CFO Matt Walsh said Women’s Health revenue fell 16% ex-FX in the fourth quarter and 2% for the full year. Nexplanon sales decreased 20% ex-FX in Q4 and 4% for 2025. Walsh attributed 2025 Nexplanon performance to a combination of one-time and ongoing factors, including an approximately $17 million fourth-quarter impact tied to the cessation of certain U.S. wholesaler sales practices identified in the Audit Committee’s internal investigation disclosed in late October, which he said was contained to 2025.
Looking to 2026, Walsh described several factors expected to persist, including continued policy-driven access restrictions affecting Planned Parenthood and Federally Qualified Health Centers, changing purchase behavior among some smaller independent clinics, and a volume headwind from fewer reinsertions as the product transitions to a five-year label. He also cited expected strong ex-U.S. growth, particularly in Latin America, as an offset.
On the company’s 2026 sales guidance, management said Nexplanon is expected to be roughly flat year over year. In Q&A, Morrissey added that around 10%–15% (he referenced roughly 13%) of insertions annually are reinsertions, and that moving to a five-year duration creates an inflection point in volume. Walsh said 2026 will likely be the most pronounced year for that reinsertion headwind, with the risk persisting in 2027 at a “fairly significantly lower level.”
Organon’s Head of R&D Juan Camilo Arjona Ferreira said the company is “pretty confident” it can recertify prescribers under the REMS program, noting previously certified physicians will have a small requirement that takes around 15–20 minutes. He said the team believes it can maintain volume based on the retraining plan.
Biosimilars performance and pipeline developments
In biosimilars, Walsh said HADLIMA grew 61% ex-FX globally for the full year, driven by its clinical profile, pricing strategy, and expansion into Canada and Puerto Rico. The segment also benefited from a denosumab biosimilar that was FDA-approved in August and launched in the U.S. in late September, as well as TOFIDENCE.
For 2026, management expects biosimilars to deliver flat to modest growth, with HADLIMA and new assets expected to offset declines in Ontruzant and Renflexis due to their maturity.
Walsh also said Organon entered into a settlement with Genentech granting a license to begin launching a pertuzumab biosimilar in the U.K. in 2027 and the U.S. in 2028.
On potential regulatory changes, management was asked about FDA draft guidance that could limit comparative efficacy study requirements for biosimilars. Morrissey said Organon views this as incremental and reaffirmed its approach of selecting partners and sequencing launches.
Discussing the denosumab launch opportunity, management characterized the category as highly competitive on both volume and price. Walsh said peak revenue over both reference products is modeled at around $100 million total over roughly a five-year timeframe.
Margins, cash flow, and balance sheet priorities
Organon reported an adjusted gross margin of 56.7% in Q4 2025, down from 60.6% a year earlier, driven by pricing pressure and unfavorable product mix. Full-year 2025 adjusted gross margin was 60.1% versus 61.6% in 2024. Adjusted EBITDA margin was 25.4% in Q4 and 30.7% for the full year, with full-year margin described as consistent with 2024 as lower R&D expense offset gross margin pressure.
On GAAP results, the company posted a Q4 2025 net loss of $205 million (or $0.79 per diluted share), compared with net income of $109 million in Q4 2024. Walsh said the quarter included a non-cash goodwill impairment of $301 million tied to the decline in the company’s stock price and underperformance in the U.S. Non-GAAP adjusted net income was $165 million in Q4 and $954 million for the full year.
Free cash flow for 2025 was $960 million before one-time costs, consistent with the prior year. Walsh said 2025 one-time costs tied to restructuring and manufacturing separation activities totaled about $270 million, with manufacturing separation costs expected to be about $100 million in 2026. Management expects 2026 free cash flow to resemble 2024 and 2025 due to higher CapEx and increased net working capital consumption, largely from inventory in established brands and biosimilars.
Organon ended 2025 with net leverage of approximately 4.3x. Walsh said the company retired about $530 million of debt during the year, including open-market repurchases and cancellation of notes due 2031, and expects to reach net leverage below 4x by the end of 2026. Morrissey also highlighted the decision to lower the dividend payout ratio to fund debt reduction and noted the divestiture of the JADA System generated approximately $390 million in net proceeds to support deleveraging in 2026.
2026 outlook: flat revenue and EBITDA, with key moving parts
Management guided to approximately $6.2 billion in 2026 revenue and about $1.9 billion in adjusted EBITDA, describing results as “very much in line” with 2025. Walsh said the JADA System delivered $74 million of revenue in 2025 and that the January 2026 divestiture represents a roughly 120-basis-point headwind to consolidated revenue in 2026, which management expects to be offset by a modest FX tailwind.
In its 2026 revenue bridge, management cited expectations for:
- LOE impact of about $40 million, including smaller LOEs such as Clarinex in Japan and potential for a generic of Dulera in the U.S.
- VBP impact of about $30 million, tied to Fosamax inclusion in round eleven
- Price headwind of about $75 million (about 1.2%), helped by lapping one-time Q4 2025 gross-to-net adjustments and anticipated stability in U.S. gross-to-net
- Volume growth of about $150 million (about 2.4%), driven by Vtama, Emgality, biosimilars, and Nexplanon ex-U.S.
Walsh said adjusted gross margin in 2026 is expected to decline about 75–100 basis points, with the primary driver being higher cost of goods sold tied to the release of accumulated foreign exchange translation on inventory that is later matched to revenue upon sale.
For 2026, management expects interest expense of about $500 million, depreciation of about $140 million, and a fully diluted share count of approximately 265 million. The company’s non-GAAP tax rate is expected to be 27.5%–29.5%, which Walsh said reflects factors including the full-year impact of OECD Pillar Two and higher nondeductible interest expense.
On quarterly phasing, Walsh said revenue growth is expected to build through the year while operating expenses are more evenly spread, making Q1 likely the lowest-margin quarter and potentially similar to Q4 2025.
In Q&A, Board Chair Carrie Cox said the company would not answer questions about “other matters” referenced in its press release that were brought to the audit committee’s attention the prior day. She also addressed a question about the CEO search, saying the board has a special committee and a “very robust process underway,” but had no public update to share.
About Organon & Co. (NYSE:OGN)
Organon & Co is a global healthcare company that was established as an independent, publicly traded entity following its spin-off from Merck & Co in June 2021. Headquartered in Jersey City, New Jersey, Organon focuses on delivering therapeutic solutions across women’s health, biosimilars, and established brands. The company’s creation reflected a strategic effort to concentrate on specialty pharmaceuticals and legacy products with proven patient impact.
In women’s health, Organon provides a broad portfolio of products addressing reproductive and gynecological conditions, including fertility treatments, contraception, and hormone replacement therapies.
