ORGANON & CO Stock Price, News & Analysis

Organon (NYSE: OGN) and Shanghai Henlius Biotech (2696.HK) have received European Commission (EC) approval for two biosimilars: BILDYOS® (denosumab 60 mg/mL) and BILPREVDA® (denosumab 120 mg/1.7 mL), which reference PROLIA and XGEVA respectively.

BILDYOS is approved for treating osteoporosis in postmenopausal women and men at increased fracture risk, bone loss in prostate cancer patients, and glucocorticoid-induced bone loss. BILPREVDA is indicated for preventing skeletal events in advanced bone malignancies and treating giant cell tumors of bone.

The approvals follow successful U.S. FDA authorizations and are based on comprehensive data demonstrating biosimilarity to the reference products. This expansion stems from a 2022 agreement granting Organon exclusive global commercialization rights, except for China.

Organon (NYSE: OGN) and Shanghai Henlius Biotech announced FDA approval of two biosimilars: BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), which are biosimilar versions of PROLIA and XGEVA, respectively.

BILDYOS is indicated for treating various conditions including postmenopausal osteoporosis, increasing bone mass in men with osteoporosis, treating glucocorticoid-induced osteoporosis, and increasing bone mass in patients receiving specific cancer therapies. BILPREVDA is approved for preventing skeletal-related events in patients with multiple myeloma, bone metastases, giant cell tumor of bone, and hypercalcemia of malignancy.

The approvals were based on comprehensive data demonstrating that both biosimilars are highly similar to their reference products with no clinically meaningful differences in safety, purity, and potency.

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.