ORGANON & CO Stock Price, News & Analysis

Organon (NYSE: OGN) reported Q2 2025 financial results with revenue of $1.594 billion, down 1% year-over-year. The company posted diluted EPS of $0.56 and non-GAAP Adjusted EPS of $1.00, including a $46 million gain from debt extinguishment.

Key segment performance showed Women's Health revenue up 3%, Biosimilars revenue increased 5%, while Established Brands declined 3%. The company achieved an Adjusted EBITDA of $522 million with a 32.7% margin. During the quarter, Organon repaid $345 million of long-term debt and is on track to achieve a net debt to Adjusted EBITDA ratio below 4.0x by year-end.

The company raised its full-year 2025 revenue guidance to $6.275-$6.375 billion while maintaining its Adjusted EBITDA margin guidance at 31.0-32.0%.

Organon (NYSE: OGN), a global healthcare company focused on women's health, has scheduled its second quarter 2025 financial results announcement for August 5, 2025. The company will release results before market open, followed by a webcast and conference call at 8:30 a.m. EDT.

Investors can access the live webcast through Organon's investor relations website, with a replay available approximately two hours after the event. Institutional investors and analysts can participate via phone using the toll-free numbers (888) 596-4144 for U.S. and Canada, or (646) 968-2525 with Conference ID: 1036555#.

Organon (NYSE: OGN) announced that VTAMA® (tapinarof) cream, 1% received a strong recommendation from the American Academy of Dermatology (AAD) in their 2025 guidelines for treating adult atopic dermatitis (AD).

The recommendation is based on the ADORING clinical trials, highlighting VTAMA as an effective steroid-free treatment option with no label restrictions on use. The Phase 3 ADORING 3 study demonstrated a potential treatment-free interval averaging 80 days after treatment success.

VTAMA cream was FDA-approved in December 2024 for AD treatment in adults and children aged 2 and older. The treatment addresses a significant market, as 26 million Americans are affected by AD, including 16.5 million adults, with 6.6 million having moderate to severe cases.

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.

The FDA has granted interchangeability designation to HADLIMA™ (adalimumab-bwwd) injection by Samsung Bioepis and Organon (NYSE: OGN), making it interchangeable with all presentations of Humira. The designation covers both high- and low-concentration formulations (40 mg/0.4 mL & 40 mg/0.8 mL) in autoinjector, prefilled syringe, and single-dose vial formats. This allows pharmacists to substitute HADLIMA for Humira without consulting prescribers, subject to state laws. The interchangeability designation was supported by clinical data demonstrating comparable pharmacokinetics, efficacy, safety, and immunogenicity between HADLIMA and Humira. Notably, patients paid over four times less out-of-pocket per month for HADLIMA compared to Humira, potentially improving access to treatment.

Organon (NYSE: OGN) reported Q1 2025 results with revenue of $1.513 billion, down 7% as-reported and 4% at constant currency. Key highlights include:

- 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.