Strengthens and expands U.S. biosimilars immunology portfolio with multi-indication arthritis treatment JERSEY CITY, N.J. / Apr 01, 2025 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a deep expertise in biosimilars, today announced that it has acquired from Biogen Inc. (Nasdaq: BIIB) regulatory and commercial rights in the U.S. for TOFIDENCE ™ , a biosimilar to ACTEMRA ® , for intravenous infusion.... Read More

SHANGHAI, China & JERSEY CITY, N.J. / Mar 28, 2025 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11, an investigational biosimilar of Perjeta ® (pertuzumab). Pertuzumab has been approved in various countries and regions in combination with trastuzumab and... Read More

Low disease activity was observed after a mean duration of 80 consecutive days off-treatment following success with VTAMA cream, with a mean weekly Peak Pruritus Numerical Rating Scale (PP-NRS) score of 2.9 at the end of the treatment-free interval Data presented as late breaker at 2025 American Academy of Dermatology (AAD) Annual Meeting JERSEY CITY, N.J. / Mar 08, 2025 / Business Wire / Organon (NYSE: OGN), a global... Read More

Full year 2024 revenue of $6.4 billion, up 2% as-reported and 3% at constant currency Full year 2024 diluted earnings per share of $3.33 and non-GAAP Adjusted diluted earnings per share of $4.11 Full year 2024 Adjusted EBITDA of $1.96 billion inclusive of $81 million of IPR&D, representing a 30.6% Adjusted EBITDA margin Full year 2025 financial guidance ranges provided Full year revenue range of $6.125 billion - $6.325... Read More

JERSEY CITY, N.J. / Jan 23, 2025 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, will release its fourth quarter and full year 2024 financial results on February 13, 2025, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EST. IPR&D and Milestones Organon does not currently expect to record any milestone expense in the fourth quarter of 2024.... Read More

JERSEY CITY, N.J. / Dec 19, 2024 / Business Wire / Organon (NYSE: OGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the 43 rd Annual J.P. Morgan Healthcare Conference on Monday, January 13th, 2025, at 3:45 p.m. PT. Investors, analysts, members of the media and the general public are invited to listen to a live audio... Read More

EFFICACY: In the pivotal studies, ADORING 1 and ADORING 2, up to 46% of patients on VTAMA cream achieved vIGA-AD™ treatment success at Week 8 versus 18% of patients on vehicle. POWERFUL SKIN CLEARANCE: The majority of patients entered with or achieved complete disease clearance (vIGA-AD=0) at least once in the 48-week open-label ADORING long-term extension (LTE) study and remained treatment-free (remittive effect) for an... Read More

JERSEY CITY, N.J. / Nov 05, 2024 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced that the U.S. Food and Drug Administration (FDA) extended by three months the target action date of its review of the supplemental New Drug Application (sNDA) for VTAMA ® (tapinarof) cream, 1% as a treatment for atopic dermatitis (AD) in... Read More

Third quarter 2024 revenue of $1.582 billion, up 4% as-reported and up 5% at constant currency Third quarter 2024 diluted earnings per share of $1.38 and non-GAAP Adjusted diluted earnings per share of $0.87; both reported and non-GAAP Adjusted diluted earnings per share include $51 million of expense, or $0.16 per share, for acquired in-process research and development (IPR&D) and milestones Third quarter 2024 net income of... Read More

SHANGHAI, China & JERSEY CITY, N.J. / Oct 30, 2024 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX14, an investigational biosimilar of PROLIA/XGEVA (denosumab). Denosumab has been approved in various countries and regions under different trade names for a range of different... Read More

The acquisition expands Organon’s dermatology capabilities with a nonbiologic, non-steroidal topical treatment in the U.S. JERSEY CITY, N.J. / Oct 28, 2024 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced the successful completion of its acquisition of Dermavant Sciences Ltd. from Roivant (NASDAQ: ROIV). Dermavant is a... Read More

Company estimates $51 million of milestone expense in the third quarter JERSEY CITY, N.J. / Oct 09, 2024 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, will release its third quarter 2024 financial results on October 31, 2024, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT. IPR&D and Milestones Organon currently expects that it will record... Read More

Organon Canada's operations are led by a diverse and highly capable team of equally represented men and women, offering a combination of relevant skills and experience, with a mission to deliver impactful medicines and solutions for a healthier every day for everyone, with a focus on women's health. KIRKLAND, QC , Oct. 8, 2024 /CNW/ - Organon Canada, a subsidiary of Organon (NYSE: OGN), a global healthcare company with a... Read More

SHANGHAI, China & JERSEY CITY, N.J. / Sep 30, 2024 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Perjeta ® (pertuzumab) biosimilar HLX11 met the primary endpoint. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates,... Read More

This World Contraception Day, organizations partner to raise awareness of the need to reduce barriers to contraception and invite others to support universal access KIRKLAND, QC and EDMONTON, AB , Sept. 26, 2024 /CNW/ - In recognition of World Contraception Day (WCD) on September 26 , Organon Canada, a subsidiary of Organon (NYSE: OGN), a global healthcare company with a focus on women's health, and the Alberta Women's... Read More

The agreement builds on Organon’s global product portfolio for conditions that impact women disproportionately. Women are three times more likely to experience migraine than men. i JERSEY CITY, N.J. / Aug 20, 2024 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced it has expanded its agreement with Eli Lilly and Company (Lilly) to become the sole distributor and... Read More

Second quarter 2024 revenue of $1.607 billion, flat year-over-year on an as-reported basis and up 2% at constant currency Second quarter 2024 diluted earnings per share of $0.75 and non-GAAP Adjusted diluted earnings per share of $1.12; both reported and non-GAAP Adjusted diluted earnings per share include $15 million of expense, or $0.05 per share, for acquired in-process research and development (IPR&D) and milestones... Read More

Company estimates $15 million of milestone expense in the second quarter JERSEY CITY, N.J. / Jul 09, 2024 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, will release its second quarter 2024 financial results on August 6, 2024, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT. IPR&D and Milestones Organon currently expects that it will record... Read More

SHANGHAI, China & JERSEY CITY, N.J. / May 24, 2024 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14, an investigational Prolia ® and Xgeva ® (denosumab) biosimilar. Denosumab has been approved in various countries and regions under different trade names for a range... Read More

JERSEY CITY, N.J. / May 07, 2024 / Business Wire / Organon (NYSE: OGN) (“Organon”), a global healthcare company with a focus on women’s health, announced today that it, together with Organon Foreign Debt Co-Issuer B.V., a direct wholly-owned subsidiary of Organon, as co-issuer (the “Co-Issuer” and, together with Organon, the “Companies”), have priced an offering of $500 million of 6.750% senior secured notes due 2034 (the... Read More

JERSEY CITY, N.J. / May 07, 2024 / Business Wire / Organon (NYSE: OGN) (“Organon”), a global healthcare company with a focus on women’s health, announced today that it, together with Organon Foreign Debt Co-Issuer B.V., a direct wholly-owned subsidiary of Organon, as co-issuer (the “Co-Issuer” and, together with Organon, the “Companies”), plan to offer, subject to market conditions, $500 million of senior secured notes due... Read More

First quarter 2024 revenue of $1,622 million, up 5% on an as-reported basis and 7% at constant currency First quarter 2024 diluted earnings per share of $0.78 and non-GAAP Adjusted diluted earnings per share of $1.22; both reported and non-GAAP Adjusted diluted earnings per share include $15 million expense, or $(0.05) per share, for acquired in-process research and development (IPR&D) and milestones First quarter 2024 net... Read More

Company estimates $15 million of milestone payments in the first quarter JERSEY CITY, N.J. / Apr 08, 2024 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, will release its first quarter 2024 financial results on May 2, 2024, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT. IPR&D and Milestones Organon currently expects that it will record... Read More

SHANGHAI, China & JERSEY CITY, N.J. / Apr 08, 2024 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia ® and Xgeva ® (denosumab) biosimilar HLX14 met the primary endpoints. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar... Read More

Organon Canada launches 'HER Professional Journey' to support female employees to navigate their career paths, and announces a new commitment to funding menopause-related education KIRKLAND, QC , March 8, 2024 /CNW/ - On International Women's Day, Organon Canada, a subsidiary of Organon (NYSE: OGN), a global healthcare company with a focus on women's health, launches HER Professional Journey and is encouraging businesses in... Read More

JERSEY CITY, N.J. / Feb 20, 2024 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a dedicated commitment to biosimilars, announced that the US Department of Veterans Affairs (VA) has exclusively selected HADLIMA in replacement of HUMIRA (adalimumab) for the VA National Formulary. HADLIMA is an FDA-approved biosimilar to HUMIRA for the treatment of specific autoimmune or autoinflammatory conditions such... Read More

Full year 2023 revenue of $6.3 billion, up 1% as-reported and 3% at constant currency Full year 2023 diluted earnings per share of $3.99 and non-GAAP Adjusted diluted earnings per share of $4.14 Full year 2023 Adjusted EBITDA of $1.9 billion, representing a 31.0% Adjusted EBITDA margin Full year 2024 financial guidance ranges provided; full year revenue range of $6.2 billion to $6.5 billion and Adjusted EBITDA margin in the... Read More

JERSEY CITY, N.J. / Feb 01, 2024 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, will release its fourth quarter and full year 2023 financial results on February 15, 2024, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EST. Interested parties may access the live call via webcast on the Organon website at... Read More

Despite being the most common vaginal condition, 1 BV symptoms are often mistaken for a yeast infection 2 JERSEY CITY, N.J. / Jan 10, 2024 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced that XACIATO™ (clindamycin phosphate) vaginal gel 2% is available by prescription to treat bacterial vaginosis (BV). BV results from an overgrowth of certain bacteria, which upsets... Read More

Regular dividend to remain primary capital allocation priority For full year 2023, the company expects revenue and Adjusted EBITDA margin to be within the ranges provided on November 2, 2023 For full year 2023 the company expects free cash flow before one-time spin-related costs to be above previously provided range For full year 2024, the company expects revenue to grow in the low-single-digit range on a constant currency... Read More

JERSEY CITY, N.J. / Dec 21, 2023 / Business Wire / Organon (NYSE: OGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the 42 nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9th, 2024, at 1:30 p.m. PT. Investors, analysts, members of the media and the general public are invited to listen to a live audio... Read More

Organon becomes the sole distributor and promoter of Emgality ® (galcanezumab) and RAYVOW ™ (lasmiditan) in Europe, building on strong commercial expertise in central nervous system disorders Expands Organon’s European product portfolio in a condition that primarily affects women i JERSEY CITY, N.J. / Dec 18, 2023 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced an... Read More

JERSEY CITY, N.J. / Nov 21, 2023 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Piper Sandler 35 th Annual Healthcare Conference on Wednesday, November 29, 2023 at 11:00 a.m. EST. Investors, analysts, members of the... Read More

sBLA based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: multi-switching group alternating between Humira and high-concentration HADLIMA vs. Humira-continued group Filing acceptance reinforces Samsung Bioepis and Organon’s commitment to provide better access to biologic medicines for patients in the United States INCHEON, South Korea and JERSEY CITY, N.J., Nov. 07, 2023 (GLOBE... Read More

Third quarter 2023 revenue of $1,519 million Third quarter 2023 diluted earnings per share of $0.23 and non-GAAP Adjusted diluted earnings per share of $0.87 Adjusted EBITDA of $447 million Board of Directors declares quarterly dividend of $0.28 per share Full year 2023 financial guidance ranges updated: Revenue range narrowed and lowered to $6.15 billion to $6.25 billion Adjusted EBITDA margin range narrowed and lowered to... Read More

JERSEY CITY, N.J. & SAN FRANCISCO / Nov 01, 2023 / Business Wire / Organon (NYSE:OGN) and Sempre Health today announced a strategic partnership designed to motivate eligible patients to refill their prescriptions on time and improve adherence through an innovative pricing program that offers personalized support. The new program offered by Sempre Health and Organon will enable eligible patients who refill their prescriptions... Read More

HADLIMA ® 40 mg/0.4 mL offers a higher concentration compared to HADLIMA ® 40 mg/0.8 mL The availability of both low and high concentration citrate-free options will help enhance patient care for Canadians through more treatment options, while reinforcing Organon's commitment towards biosimilars KIRKLAND, QC , Oct. 26, 2023 /CNW/ - Organon Canada, a subsidiary of Organon (NYSE: OGN), a global healthcare company with a focus... Read More

JERSEY CITY, N.J. / Oct 19, 2023 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, will release its third quarter 2023 financial results on November 2, 2023, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EST. Interested parties may access the live call via webcast on the Organon website or by clicking here . A replay of the webcast will be... Read More

Her Promise Access Initiative helped prevent 57 million unplanned pregnancies putting the company approximately halfway to its goal of preventing 120 million unplanned pregnancies by 2030 JERSEY CITY, N.J. / Sep 27, 2023 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, has been named to Fortune’s 2023 Change the World list for its leadership in helping women and girls around... Read More

With nearly half of all pregnancies unintended in Canada , all sectors must work together to help tackle this public health issue KIRKLAND , QC , Sept. 26, 2023 /CNW/ - Organon Canada, a subsidiary of Organon (NYSE: OGN), a global healthcare company with a focus on women's health, is declaring its support for universal access... Read More

JADA Rapidly and Effectively Controlled Bleeding Due to PPH, 1 Reinforcing Pivotal Study Results 1 PPH is a Significant Cause of Maternal Morbidities in the U.S. 2,3,4,5 New Exploratory Post-Hoc Analysis Examined the Relationship Between Reported Severe Maternal Morbidity (SMM) Outcomes and Cumulative Blood Loss Prior to JADA Insertion 1 JERSEY CITY, N.J. / Sep 14, 2023 / Business Wire / Organon (NYSE: OGN), a global... Read More

JERSEY CITY, N.J. / Sep 05, 2023 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, today announced the appointment of Juan Camilo Arjona Ferreira, M.D., as Chief Medical Officer (CMO) and Charlotte Owens, M.D., as Head of Medical Affairs and Outcomes Research, strengthening the company’s global clinical and medical capabilities, advancing external relationships and fueling... Read More

Second quarter 2023 revenue of $1,608 million Second quarter 2023 diluted earnings per share of $0.95 and non-GAAP Adjusted diluted earnings per share of $1.31 Adjusted EBITDA of $530 million Board of Directors declares quarterly dividend of $0.28 per share Full year 2023 financial guidance ranges updated: Revenue range narrowed to $6.25 billion to $6.45 billion, primarily reflecting current foreign currency exchange rates... Read More

INCHEON, South Korea and JERSEY CITY, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced topline results from the interchangeability study for SB5, a biosimilar to Humira ® (adalimumab). The Phase 4, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study ( NCT05510063 ) for SB5 was conducted across 33 sites in four... Read More

JERSEY CITY, N.J. / Jul 17, 2023 / Business Wire / Organon (NYSE: OGN), a global women’s healthcare company will release its second quarter 2023 financial results on August 8, 2023, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT. Interested parties may access the live call via webcast on the Organon website at https://www.organon.com/investor-relations/events-and-presentations/ . A replay of... Read More

Autoinjector recognized by the Arthritis Foundation with Ease of Use Certification Individualized patient support program “HADLIMA For You” available including co-pay support Designed to improve access and affordability for patients and the US health care system JERSEY CITY, N.J. & INCHEON, Korea / Jul 01, 2023 / Business Wire... Read More

Second annual report highlights company’s advancements with a focus on innovation and access to ensure a healthier, more sustainable future for women worldwide. JERSEY CITY, N.J. / Jun 27, 2023 / Business Wire / Organon (NYSE: OGN), a global healthcare company focused on women’s health, today released its 2022-2023 Environmental, Social, and Governance (ESG) Report . The report highlights the company’s progress on its... Read More

Agreement is part of a transformative model convening governments, global development banks and other multilateral agencies to use results-based financing to improve the lives of women JERSEY CITY, N.J. / Jun 07, 2023 / Business Wire / Today, Organon (NYSE:OGN), a global healthcare company focused on women’s health, and CAF, Development Bank of Latin America, signed a memorandum of understanding (MOU) to contribute to the... Read More

The project aims to facilitate access for Le Chaînon residents to medical consultations KIRKLAND, QC , May 18, 2023 /CNW/ - As part of Le Chaînon 's 90 th anniversary, Organon Canada , a subsidiary of Organon (NYSE: OGN), a global women's health company, is announcing a contribution of $90,000 to help fund the mission of Le... Read More

First quarter 2023 revenue of $1,538 million First quarter 2023 diluted earnings per share of $0.69 and non-GAAP Adjusted diluted earnings per share of $1.08 Both reported and non-GAAP Adjusted diluted earnings per share include a negative impact of $0.03 per share for acquired in-process research and development (IPR&D) Adjusted EBITDA of $518 million, inclusive of $8 million of acquired IPR&D Board of Directors declares... Read More

JERSEY CITY, N.J. / Apr 20, 2023 / Business Wire / Organon (NYSE: OGN), a global women’s healthcare company will release its first quarter 2023 financial results on May 4, 2023, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT. Interested parties may access the live call via webcast on the Organon website at https://www.organon.com/investor-relations/events-and-presentations/ . A replay of the... Read More

JERSEY CITY, N.J. / Mar 07, 2023 / Business Wire / Organon (NYSE: OGN), a global healthcare company focused on improving women’s health, today announced the launch of a new global initiative, “Her Plan is Her Power,” to accelerate progress toward addressing the public health crisis of unplanned pregnancy. Annually, nearly 50% of pregnancies (approximately 121 million) around the world are estimated to be unplanned, leading... Read More

The WiG evaluation, which comprises over 75 quantitative and qualitative criteria, showcases Organon Canada's consideration for the multiple impacts of diversity and intersectionality on career advancement opportunities for women KIRKLAND, QC , March 3, 2023 /CNW/ - Organon Canada, a subsidiary of Organon (NYSE: OGN), a global women's health company, is excited to share that in line with National Employee Appreciation Day on... Read More

170 employees across Canada will receive paid time off and join 10,000 Organon employees worldwide in dedicating International Women's Day toward investing in women's health KIRKLAND, QC , Feb. 27, 2023 /CNW/ - For far too long, women's health issues have been underfunded, under researched and underserved. Leading up to International Women's Day on March 8 , Organon Canada, a subsidiary of Organon (NYSE: OGN), a global... Read More

JERSEY CITY, N.J. / Feb 16, 2023 / Business Wire / Organon (NYSE: OGN) today announced its results for the fourth quarter and full year ended December 31, 2022. "We enter 2023 with momentum, building off the significant achievements in our short history as an independent company," said Kevin Ali, Organon's CEO. "Since these products have been in our hands, we have set three quarterly sales records for Nexplanon, delivered... Read More

JERSEY CITY, N.J. / Feb 06, 2023 / Business Wire / Organon (NYSE: OGN), a global women’s healthcare company will release its fourth quarter and full year 2022 financial results on February 16, 2023, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EST. Interested parties may access the live call via webcast on the Organon website at... Read More

Agreement reinforces Organon’s continued focus on pursuing new solutions in high-need areas of women’s health Organon (NYSE: OGN), a global women’s healthcare company, today announced a strategic investment in Claria Medical, Inc. a privately-held company developing an investigational medical device being studied for use during minimally invasive laparoscopic hysterectomy. The agreement also grants Organon the option to... Read More