Organon & Co. reports developments as a global healthcare company with portfolios in Women's Health and General Medicines, including biosimilars. Company news commonly covers operating results, product and regulatory updates, and clinical data for medicines such as VTAMA cream for atopic dermatitis and plaque psoriasis, biosimilar approvals including POHERDY, and established women's health brands and devices such as Nexplanon, Follistim, and Jada.
Updates also address capital-structure disclosures, governance matters, shareholder voting topics, and material agreements, alongside the company's commercial activity across more than 140 markets.
Organon (NYSE: OGN) announced that its Phase 2 ELENA proof-of-concept study for OG-6219, an investigational treatment for endometriosis-related pain, failed to meet its primary efficacy endpoint. The study evaluated the oral 17β-hydroxysteroid dehydrogenase type 1 inhibitor in pre-menopausal women aged 18-49 with surgically diagnosed endometriosis.
The randomized, double-blind, placebo-controlled trial assessed three dose levels of OG-6219 against placebo, measuring changes in mean endometriosis-related overall pelvic pain scores. Following these disappointing results, Organon has decided to discontinue the OG-6219 clinical development program. The drug candidate was originally acquired through Organon's acquisition of Forendo Pharma in 2021.
- Women's Health revenue grew 10% (12% ex-FX), driven by Nexplanon's 14% growth - Biosimilars declined 17% (15% ex-FX) due to normalized Ontruzant volumes and competitive pressure - Established Brands fell 11% (8% ex-FX) - Q1 diluted EPS of $0.33 and adjusted EPS of $1.02 - Adjusted EBITDA of $484 million with 32.0% margin
The company affirmed its 2025 guidance, expecting over $900 million in free cash flow before one-time costs. Notably, Organon reset its dividend to $0.08 annually (from $1.12) to strengthen its capital structure and accelerate deleveraging, aiming for a net leverage ratio below 4.0x by year-end.
Organon (NYSE: OGN), a global healthcare company focused on women's health, has announced the appointment of Ramona A. Sequeira to its Board of Directors, effective July 1, 2025. Sequeira, currently President of the Global Portfolio Division at Takeda Pharmaceutical Company, will serve on the Board's Talent Committee.
The appointment expands Organon's Board to 12 directors. Sequeira brings over 30 years of pharmaceutical industry experience, including 20 years at Eli Lilly and 10 years at Takeda. At Takeda, she leads business units across Europe, Canada, China, and Growth and Emerging Markets, while overseeing the Vaccines Business Unit and Global Medical and Commercial Strategy functions.
Sequeira's notable achievements include being the first woman to Chair the Pharmaceutical Research and Manufacturers of America Board of Directors. She currently serves on the Board of Directors of Edwards Life Sciences.
Organon (NYSE: OGN), a global healthcare company focused on women's health, has scheduled its first quarter 2025 financial results release for May 1, 2025. The company will host a webcast and conference call at 8:30 a.m. EDT on the same day.
The company anticipates recording approximately $6 million in milestone expenses for Q1 2025. However, Organon notes that IPR&D (in-process research and development) and milestone expenses are not included in their financial guidance from February 13, 2025, due to uncertainty in timing and forecasting such achievements.
The Q1 2025 results remain subject to quarterly financial statement closing procedures, and actual results may differ from preliminary estimates.
Organon (NYSE: OGN) has acquired U.S. regulatory and commercial rights for TOFIDENCE™, a biosimilar to ACTEMRA®, from Biogen Inc. (Nasdaq: BIIB). TOFIDENCE, launched in May 2024, is the first approved tocilizumab biosimilar in the U.S. market for intravenous infusion.
The treatment is indicated for multiple conditions including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. The acquisition includes three vial sizes: 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL.
The deal structure includes an upfront payment to Biogen, with Organon assuming tiered royalty payments based on net sales and annual net sales milestone payments owed to Bio-Thera Solutions , who will maintain manufacturing rights for the U.S. market.
Henlius Biotech (2696.HK) and Organon (NYSE: OGN) announced that the European Medicines Agency (EMA) has validated their marketing authorization application for HLX11, a biosimilar candidate of Perjeta® (pertuzumab).
The application is supported by a multicenter, randomized, double-blind phase 3 clinical study that compared HLX11 with Perjeta® in HER2-positive breast cancer patients. The study met its primary endpoint of total pathological complete response (tpCR) rate, with secondary endpoints showing comparable results between groups.
Through a 2022 license and supply agreement, Organon holds exclusive commercialization rights for HLX11 in the United States, European Union, and Canada, excluding China.
May Health has appointed Colby Holtshouse as President and CEO to lead the company's development of its novel Ovarian Rebalancing™ technology. The technology is a one-time transvaginal ablation procedure designed to restore ovulation in women with Polycystic Ovary Syndrome (PCOS), affecting 10% of women.
The company is currently conducting the REBALANCE study, an IDE clinical trial to support FDA marketing authorization. The procedure uses radio frequency energy to ablate excess androgen-producing ovarian tissue, aiming to establish regular ovulatory menstrual cycles. This in-office treatment is designed for same-day recovery with minimal discomfort.
Holtshouse brings executive experience from Organon, Alydia Health, and Pelvalon. May Health has completed clinical feasibility studies in Europe and the U.S. and is actively enrolling patients for its IDE clinical study in the United States.
Organon (NYSE: OGN) announced positive results from the Phase 3 ADORING 3 study of VTAMA® (tapinarof) cream for atopic dermatitis treatment. The analysis showed that after achieving treatment success, patients maintained low disease activity during an average 80-day treatment-free period.
The 48-week open-label study involved 728 patients, with 378 achieving completely clear skin. Key findings revealed that 84% of patients maintained mild disease (vIGA-AD score of 2) at the end of the treatment-free interval, with a mean weekly PP-NRS score of 2.9 for itch and an EASI score of 3.4.
The most common treatment-emergent adverse events included folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory tract infection (6.9%). The study reported low discontinuation rates due to adverse events (2.6%). VTAMA cream received FDA approval in December 2024 for atopic dermatitis treatment in adults and children aged 2 years and older.
Organon (OGN) reported full year 2024 revenue of $6.4 billion, up 2% as-reported and 3% at constant currency. The company achieved diluted earnings per share of $3.33 and non-GAAP Adjusted diluted earnings per share of $4.11. Adjusted EBITDA reached $1.96 billion with a 30.6% margin.
For Q4 2024, revenue was $1.592 billion, flat year-over-year. Women's Health remained stable, while Biosimilars declined 18% due to tender timing and pricing pressure. Established Brands grew 2%, benefiting from Emgality and Vtama contributions.
Looking ahead to 2025, Organon projects revenue between $6.125-$6.325 billion, factoring in an approximate $200 million negative impact from foreign exchange. The company expects an Adjusted EBITDA margin range of 31.0-32.0%. A quarterly dividend of $0.28 per share was declared, payable March 13, 2025.