ORGANON & CO Stock Price, News & Analysis

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.

Organon (NYSE: OGN), a global healthcare company focused on women's health, has announced it will release its fourth quarter and full year 2024 financial results on February 13, 2025, before market open. The company will host a conference call and webcast at 8:30 a.m. EST on the same day.

The company has indicated that it does not expect to record any milestone expense in the fourth quarter of 2024. Organon notes that the results are preliminary and subject to quarterly financial statement closing procedures.

Interested parties 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 must pre-register to participate in the conference call.

Organon (NYSE: OGN) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. CEO Kevin Ali and CFO Matthew Walsh will engage in a fireside chat scheduled for Monday, January 13th, 2025, at 3:45 p.m. PT. The event will be accessible to investors, analysts, media representatives, and the general public through a live audio webcast, which can be accessed via the provided conference link.

Organon (NYSE: OGN) announced FDA approval of VTAMA® (tapinarof) cream, 1% for treating atopic dermatitis in adults and children aged 2 and older. The approval came ahead of the March 2025 target date. In pivotal studies ADORING 1 and 2, up to 46% of patients achieved treatment success at Week 8 versus 18% on vehicle.

The drug demonstrated powerful skin clearance with patients remaining treatment-free for ~80 consecutive days in the 48-week long-term extension study. VTAMA showed rapid itch relief within 24 hours and maintained a favorable safety profile. Common side effects included upper respiratory tract infection (12%) and folliculitis (9%).

The FDA has extended its review period for VTAMA® (tapinarof) cream, 1% for atopic dermatitis treatment in adults and children aged 2 and older by three months. The new target date is March 12, 2025, moved from December 12, 2024. The extension follows FDA's request for final datasets from the long-term extension study. The FDA has not raised safety, efficacy, or approvability concerns. Organon projects $125 million in VTAMA revenue for 2025, with an approximate 75 basis point headwind to Adjusted EBITDA margin.

Organon (OGN) reported strong Q3 2024 results with revenue of $1.582 billion, up 4% as-reported and 5% at constant currency. The company achieved net income of $359 million and diluted EPS of $1.38. Women's Health revenue grew 5%, Biosimilars increased 16%, and Established Brands rose 2%. The company narrowed its full-year 2024 revenue guidance to $6.375-$6.425 billion and revised Adjusted EBITDA margin to 30.0-31.0%. Nexplanon showed strong performance with 11% growth, positioning it to deliver $1 billion in revenue next year. The Board declared a quarterly dividend of $0.28 per share.

Shanghai Henlius Biotech and Organon (NYSE: OGN) announced the US FDA's acceptance of their Biologics License Application (BLA) for HLX14, a biosimilar candidate of PROLIA/XGEVA (denosumab). The application is supported by comprehensive head-to-head studies, including analytical comparisons and two clinical trials. Under a 2022 license agreement, Organon holds exclusive commercialization rights for HLX14 in the US, EU, and Canada, excluding China. The clinical program included a phase 1 study in healthy males and a phase 3 trial in postmenopausal women with high-risk osteoporosis.

Organon (NYSE: OGN) has completed its acquisition of Dermavant Sciences from Roivant, expanding its dermatology portfolio with VTAMA® (tapinarof) cream. VTAMA is a novel nonbiologic, non-steroidal topical therapy FDA-approved for plaque psoriasis in adults, with no safety label warnings or use restrictions. The FDA is reviewing VTAMA for atopic dermatitis treatment in adults and children, with a decision expected in Q4 2024. The acquisition strengthens Organon's dermatology capabilities, particularly in treating chronic inflammatory skin conditions that affect millions globally, with psoriasis and atopic dermatitis having significant impact on quality of life.

Organon (NYSE: OGN), a global healthcare company focusing on women's health, will release its third quarter 2024 financial results on October 31, 2024, before a webcast and conference call at 8:30 a.m. EDT. The company anticipates recording $51 million in milestone expenses for Q3 2024, impacting both GAAP and non-GAAP earnings per share by approximately $0.16. Of this, $50 million relates to a denosumab biosimilar candidate progressing under an agreement with Shanghai Henlius Biotech, Inc.

Organon notes that IPR&D and milestones are not included in their financial guidance due to uncertainty in timing. The Q3 2024 results are preliminary and subject to finalization. Interested parties can access the live call via webcast on Organon's website, with a replay available approximately two hours after the event.