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Related articleQuarter not tagged2026-10-19Organon to Report Third Quarter 2026 Results in Its Regularly Scheduled Form 10-Q Filing
Business Wire
Organon to Report Third Quarter 2026 Results in Its Regularly Scheduled Form 10-Q Filing
JERSEY CITY, N.J., October 19, 2026--(BUSINESS WIRE)--Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, plans to release its third quarter 2026 financial results via its regularly scheduled Form 10-Q filing with the Securities and Exchange Commission ("SEC"). The company also plans to disclose certain non-GAAP financial measures and their reconciliation to their comparable GAAP measures for the third quarter 2026, which will be disclosed in a Form 8-K filing to be filed on the same day as the Form 10-Q. During the pendency of the previously announced acquisition by Sun Pharmaceutical Industries Limited on April 26, 2026, Organon has suspended its quarterly earnings calls. IPR&D and Milestones Organon does not currently expect to record any milestone expense in the third quarter of 2026. Organon's third quarter results have not been finalized and are subject to the company's quarterly financial statement closing procedures. There can be no assurance that actual results will not differ from the preliminary estimates described herein. About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women's Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook. Cautionary Note Regarding Forward-Looking Statements The information above reflects management's current intentions and expectations for the future with respect to Organon's expectations regarding the filing of its Form 10-Q for the quarter ended September 30, 2026 and related Form 8-K with certain non-GAAP financial measures and comparable GAAP measures and its milestone expenses, which constitute "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are subject to a number of risks, assumpt…Read full documentShow less
JERSEY CITY, N.J., October 19, 2026--(BUSINESS WIRE)--Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, plans to release its third quarter 2026 financial results via its regularly scheduled Form 10-Q filing with the Securities and Exchange Commission ("SEC"). The company also plans to disclose certain non-GAAP financial measures and their reconciliation to their comparable GAAP measures for the third quarter 2026, which will be disclosed in a Form 8-K filing to be filed on the same day as the Form 10-Q. During the pendency of the previously announced acquisition by Sun Pharmaceutical Industries Limited on April 26, 2026, Organon has suspended its quarterly earnings calls. IPR&D and Milestones Organon does not currently expect to record any milestone expense in the third quarter of 2026. Organon's third quarter results have not been finalized and are subject to the company's quarterly financial statement closing procedures. There can be no assurance that actual results will not differ from the preliminary estimates described herein. About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women's Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook. Cautionary Note Regarding Forward-Looking Statements The information above reflects management's current intentions and expectations for the future with respect to Organon's expectations regarding the filing of its Form 10-Q for the quarter ended September 30, 2026 and related Form 8-K with certain non-GAAP financial measures and comparable GAAP measures and its milestone expenses, which constitute "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are subject to a number of risks, assumptions, uncertainties and other factors, such as the completion of Organon's quarter-end closing process, including review by management and the audit committee of the Organon's board of directors, which could result in material changes to the preliminary estimates described herein. Risks and uncertainties include, but are not limited to uncertainties as to the timing of the proposed transaction with Sun Pharma; the risk that the proposed transaction may not be completed on the anticipated terms in a timely manner or at all; the failure to satisfy any of the conditions to the consummation of the proposed transaction; the possibility that competing offers or acquisition proposals for Organon will be made; the possibility that any or all of the various conditions to the consummation of the proposed transaction may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable governmental entities (or any conditions, limitations or restrictions placed on such approvals); the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive agreement, including in circumstances which would require Organon to pay a termination fee; the effect of the announcement or pendency of the proposed transaction on Organon's ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, or its operating results and business generally; risks related to diverting management's attention from Organon's ongoing business operations; the risk that stockholder litigation in connection with the proposed transaction may result in significant costs of defense, indemnification and liability; certain restrictions during the pendency of the proposed transaction that may impact Organon's ability to pursue certain business opportunities or strategic transactions; the risk that any announcements relating to the proposed transaction could have adverse effects on the market price of Organon's common stock, including if the proposed transaction is not consummated; risks that the benefits of the proposed transaction are not realized when and as expected; and legislative, regulatory and economic developments. Although Organon believes that the expectations reflected in its forward-looking statements are reasonable, it cannot assure that those expectations will prove to be correct. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by Organon on its website or otherwise. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon's filings with the SEC, including Organon's most recent Annual Report on Form 10-K and subsequent SEC filings (as amended, where applicable), available at the SEC's Internet site (www.sec.gov). View source version on businesswire.com: https://www.businesswire.com/news/home/20261019387279/en/ Contacts Organon Media Contacts: Karissa Peer (614) 314-8094 Organon Investor Contacts: Jennifer Halchak (201) 275-2711 Renee McKnight (551) 204-6129
Related articleQuarter not tagged2026-10-16Organon Announces Positive Interim Phase 3 Study Results for MIUDELLA®, a Hormone-Free, Intrauterine Device (IUD), Through 6 Years of Use to Be Presented at the 2026 Society of Family Planning Annual Meeting
Business Wire
Organon Announces Positive Interim Phase 3 Study Results for MIUDELLA®, a Hormone-Free, Intrauterine Device (IUD), Through 6 Years of Use to Be Presented at the 2026 Society of Family Planning Annual Meeting
- No new safety signals identified during additional three years of extended use - Organon holds exclusive global licensing rights to MIUDELLA JERSEY CITY, N.J., October 16, 2026--(BUSINESS WIRE)--Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced that Sebela Women's Health will present interim results from an ongoing Phase 3 study evaluating MIUDELLA®, a hormone-free, copper intrauterine device (IUD), through 6 years of use at the 2026 Society of Family Planning (SFP) Annual Meeting, taking place October 17 to 19, 2026, in San Francisco, California. In June 2026, Organon exclusively licensed global rights to MIUDELLA from Sebela Women's Health. The prospective, single-arm Phase 3 study is being conducted by Sebela Women's Health at 42 sites in the United States to evaluate the efficacy and safety of MIUDELLA through 6 years of use. The 6-year outcomes were evaluated in 465 of 1397 and 592 of 1601 enrolled participants in the evaluable-for-pregnancy and safety populations, respectively. The cumulative 6-year Pearl Index was 0.93 (95% CI, 0.62 to 1.34), and the cumulative Kaplan-Meier pregnancy rate was 3.9% (95% CI, 2.7% to 5.8%) at 6 years. Treatment-emergent adverse events reported through 6 years included heavy menstrual bleeding, dysmenorrhea and pelvic discomfort. Bleeding- and pain-related adverse events leading to study discontinuation were observed in 139 participants (8.7%) in year 1 and 11 participants (1.9%) in year 6.1 Follow-up in the study is ongoing. Presentation Details: Title: Efficacy and Safety of a Novel Hormone-Free Intrauterine Device Over 6 Years: Interim Phase 3 Study Results Meeting: 2026 Society of Family Planning Annual Meeting Date: October 17, 2026 Presentation Time and Location: 6 p.m. PT; Exhibit Hall The U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for MIUDELLA for an extended duration of use for up to 6 years, with Prescription Drug User Fee Act (PDUFA) action expected in the second quarter of calendar year 2027. "These interim Phase 3 results add to the clinical evidence for MIUDELLA and represent an important milestone in the ongoing study," said Juan Camilo Arjona Ferreira, MD, Head of Research & Development and Chief Medical Officer at Organon. "The findings support…Read full documentShow less
- No new safety signals identified during additional three years of extended use - Organon holds exclusive global licensing rights to MIUDELLA JERSEY CITY, N.J., October 16, 2026--(BUSINESS WIRE)--Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced that Sebela Women's Health will present interim results from an ongoing Phase 3 study evaluating MIUDELLA®, a hormone-free, copper intrauterine device (IUD), through 6 years of use at the 2026 Society of Family Planning (SFP) Annual Meeting, taking place October 17 to 19, 2026, in San Francisco, California. In June 2026, Organon exclusively licensed global rights to MIUDELLA from Sebela Women's Health. The prospective, single-arm Phase 3 study is being conducted by Sebela Women's Health at 42 sites in the United States to evaluate the efficacy and safety of MIUDELLA through 6 years of use. The 6-year outcomes were evaluated in 465 of 1397 and 592 of 1601 enrolled participants in the evaluable-for-pregnancy and safety populations, respectively. The cumulative 6-year Pearl Index was 0.93 (95% CI, 0.62 to 1.34), and the cumulative Kaplan-Meier pregnancy rate was 3.9% (95% CI, 2.7% to 5.8%) at 6 years. Treatment-emergent adverse events reported through 6 years included heavy menstrual bleeding, dysmenorrhea and pelvic discomfort. Bleeding- and pain-related adverse events leading to study discontinuation were observed in 139 participants (8.7%) in year 1 and 11 participants (1.9%) in year 6.1 Follow-up in the study is ongoing. Presentation Details: Title: Efficacy and Safety of a Novel Hormone-Free Intrauterine Device Over 6 Years: Interim Phase 3 Study Results Meeting: 2026 Society of Family Planning Annual Meeting Date: October 17, 2026 Presentation Time and Location: 6 p.m. PT; Exhibit Hall The U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for MIUDELLA for an extended duration of use for up to 6 years, with Prescription Drug User Fee Act (PDUFA) action expected in the second quarter of calendar year 2027. "These interim Phase 3 results add to the clinical evidence for MIUDELLA and represent an important milestone in the ongoing study," said Juan Camilo Arjona Ferreira, MD, Head of Research & Development and Chief Medical Officer at Organon. "The findings support the FDA review of the supplemental application as we work toward our ambition of expanding hormone-free contraceptive options." "Reaching 6 years of follow-up reflects the continued commitment of the participants, investigators, and study teams involved in this ongoing Phase 3 program," said Kelly Culwell, MD, Chief Medical Officer and Head of Research and Development at Sebela Women's Health. "These findings provide valuable long-term data and contribute to the understanding of participant experience over time. We are grateful to everyone who has made this research possible." The MIUDELLA label includes a Risk Evaluation and Mitigation Strategy (REMS), which is open for enrollment at www.miudellarems.com. Healthcare providers must complete REMS enrollment prior to ordering and inserting MIUDELLA. Healthcare settings where MIUDELLA is dispensed or inserted must also be enrolled in the program by an Authorized Representative. The purpose of the MIUDELLA REMS is to mitigate the risk of complications due to the improper insertion of MIUDELLA by untrained healthcare providers. Please see Important Safety Information below, including Boxed Warning. About the Ongoing Phase 3 Study of MIUDELLA The ongoing Phase 3 study is a prospective, single-arm trial evaluating the efficacy and safety of MIUDELLA in females aged 17 to 45 years across 42 United States sites. The current interim analysis includes outcomes through 6 years of use, with follow-up continuing. About MIUDELLA MIUDELLA is a hormone-free, low-dose copper intrauterine device (IUD) indicated for the prevention of pregnancy in females of reproductive potential for up to 3 years.2 Sebela Women's Health developed MIUDELLA with three clinical trials in the United States in 1,904 women aged 17 to 45 years.2 The Phase 3 prospective, multicenter, single-arm, open-label study was conducted in 42 centers in the United States with a primary endpoint of contraceptive efficacy through 3 years of use as assessed by the Pearl Index (defined as the number of pregnancies per 100 women over one year).2 In the efficacy cohort of women aged 17 to 35 years from the Phase 3 study (n=1397), the first-year Pearl Index was 0.94 (95% CI, 0.43-1.78) and the cumulative 3-year Pearl Index was 1.05 (95% CI, 0.66-1.60)2 – in other words, 99% effective, with an overall placement success rate of ~99%.3 The most common adverse reactions (≥5%) observed in clinical trials were heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post-procedural hemorrhage, and dyspareunia.3 In the first year, 8.5% of participants across all three studies discontinued treatment due to bleeding or pain adverse reactions, which decreased to 3.2% by year 3.3 Expulsion rates related to discontinuation ranged from 1.9% in year 1 to 0.9% in year 3.3 Indication - MIUDELLA® is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 3 years. Selected Safety Information WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION - Improper insertion of intrauterine systems, including MIUDELLA, increases the risk of complications. - Proper training prior to first use of MIUDELLA can minimize the risk of improper insertion. - MIUDELLA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MIUDELLA REMS program to ensure all healthcare providers are trained on the proper insertion of MIUDELLA prior to first use. Further information is available at miudellarems.com and 1-855-337-0772. CONTRAINDICATIONS - Use of MIUDELLA is contraindicated when 1 or more of the following conditions exist: - Pregnancy or suspicion of pregnancy; congenital or acquired abnormalities of the uterus, including leiomyomas, resulting in distortion of the uterine cavity; acute pelvic inflammatory disease (PID); postpartum endometritis or postabortal endometritis in the past 3 months; known or suspected uterine or cervical malignancy; for use as postcoital contraception (emergency contraception); uterine bleeding of unknown etiology; untreated acute cervicitis or vaginitis or other lower genital tract infection; conditions associated with increased susceptibility to pelvic infections; Wilson's disease; a previously placed IUS that has not been removed; hypersensitivity to any component of MIUDELLA including to polypropylene, copper, nitinol, an alloy of nickel and titanium, or any of the trace elements present in the copper component of MIUDELLA. Persons with allergic reactions to these components may suffer an allergic reaction to this intrauterine system. Prior to placement, patients should be counseled on the materials contained in the IUS, as well as potential for allergy/hypersensitivity to these materials. WARNINGS AND PRECAUTIONS - Risk of Complications Due to Improper Insertion: Improper insertion of IUSs, including MIUDELLA, increases the risk of perforation, infection, undiagnosed abnormal bleeding, pregnancy loss (if pregnancy occurs with IUS in situ), and expulsion. Proper training prior to first use of MIUDELLA can minimize the risk of improper insertion. MIUDELLA is available only through a restricted program under a REMS. - MIUDELLA REMS: MIUDELLA is only available through a restricted program under a REMS called MIUDELLA REMS Program to ensure healthcare providers are trained prior to first use. Notable requirements include the following: - Healthcare providers must be certified with the program by enrolling and completing training on the proper insertion of MIUDELLA prior to first use. - Pharmacies and healthcare settings that dispense MIUDELLA must be certified by enrolling in the REMS and must only dispense MIUDELLA to certified healthcare providers. - Further information is available at www.miudellarems.com and 1-855-337-0772. - Ectopic Pregnancy: Promptly evaluate females who become pregnant for ectopic pregnancy while using MIUDELLA. Ectopic pregnancy may require surgery and may result in loss of fertility. - Intrauterine Pregnancy: Increased risk of spontaneous abortion, septic abortion, premature delivery, sepsis, septic shock, and death if pregnancy occurs. Remove MIUDELLA if pregnancy occurs with MIUDELLA in place and the thread ends are visible or can be retrieved from the cervical canal. - Sepsis: Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of IUSs; strict aseptic technique is essential during insertion. - Pelvic Infection: Promptly examine users with complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores after insertion of MIUDELLA. IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. Remove MIUDELLA in cases of recurrent PID or endometritis, or if an acute pelvic infection is severe or does not respond to treatment. Subclinical PID: PID may be asymptomatic but still result in tubal damage and its sequelae. - Perforation: Partial or total perforation of the uterine wall or cervix may occur during insertions, although the perforation may not be detected until sometime later. Perforation may also occur at any time during IUS use. Perforation that results in embedment or translocation may reduce contraceptive efficacy and result in pregnancy. Risk is increased if inserted in postpartum and lactating females and may be increased if inserted in females with fixed, retroverted uteri or noninvoluted uteri. If perforation is suspected or if known perforation occurs during placement, the IUS should be removed as soon as possible. Surgery may be required. Delayed detection or removal of MIUDELLA in cases of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal penetration, intestinal obstruction, abscesses and/or damage to adjacent organs. - Expulsion: Partial or complete expulsion of MIUDELLA has been reported, resulting in the loss of contraceptive protection. MIUDELLA should be placed no earlier than 4 weeks post-pregnancy to mitigate the risk of expulsion that may be increased when the uterus is not completely involuted at the time of insertion. Remove a partially expelled MIUDELLA and do not attempt to push a partially expelled MIUDELLA into the uterus. - Wilson's Disease: MIUDELLA may exacerbate Wilson's disease, a rare genetic disease affecting copper excretion; therefore, the use of MIUDELLA is contraindicated in females with Wilson's disease. - Bleeding Pattern Alterations: Menstrual bleeding may be altered and result in heavier and longer bleeding with spotting. Females complaining of heavy vaginal bleeding should be evaluated and treated, and may need to discontinue MIUDELLA. - Magnetic Resonance Imaging (MRI) Safety Information: Patients using MIUDELLA can be safely scanned with MRI only under certain conditions. - Medical Diathermy: Medical equipment that contains high levels of Radiofrequency (RF) energy such as diathermy may cause health effects (by heating tissue) in females with a metal-containing IUS including MIUDELLA. Avoid using high medical RF transmitter devices in females with MIUDELLA. ADVERSE REACTIONS - Most common adverse reactions (≥5%) observed in clinical trials were heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post-procedural hemorrhage, and dyspareunia. Before prescribing MIUDELLA, please read the full Prescribing Information, including Boxed Warning. About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women's Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately, or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at http://www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook. About Sebela Pharmaceuticals At Sebela Pharmaceuticals, we are building a leading gastroenterology company in the United States and developing innovative products in women's health. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has been innovating, developing, manufacturing, and commercializing gastroenterology products for over 40 years. Braintree has filed an NDA with FDA for tegoprazan, its lead program in GERD. In 2025 Sebela Women's Health obtained FDA approval for Miudella (copper-containing intrauterine system), the first non-hormonal intrauterine device (IUD) for contraception approved in over 40 years. Sebela Pharmaceuticals has operations in Braintree, MA; and Dublin, Ireland. For more information, visit www.sebelapharma.com. Cautionary Note Regarding Organon's Forward-Looking Statements Except for historical information, this press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about the potential benefits of Organon's exclusive license of global rights to MIUDELLA® and expectations regarding the timing of commercialization thereof. Forward-looking statements may be identified by words such as "anticipated," "may," "will," and "expected," among others. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, weakening of economic conditions that could adversely affect the level of demand for MIUDELLA®; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to or affecting Medicare, Medicaid and healthcare reform, pharmaceutical pricing and reimbursement, access to the company's products, international reference pricing, including most-favored-nation drug pricing, and other pricing related initiatives and policy efforts; the impact of tariffs and other trade restrictions or domestic sourcing requirements; expanded brand and class competition in the markets in which the company operates; the failure of any supplier to provide substances, materials, or services as agreed, or otherwise meet their obligations to the company; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties, including Sebela Pharmaceuticals; the impact of higher selling and promotional costs; efficacy, safety or other quality concerns with respect to the company's marketed products, whether or not scientifically justified, leading to product recalls, withdrawals, labeling changes or declining sales; future actions of third parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of healthcare products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing healthcare insurance coverage; the failure by the company or its third party collaborators and/or their suppliers to fulfill their or their regulatory or quality obligations; and volatility of commodity prices, fuel, and shipping rates that impact the costs and/or ability to supply the company's products. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's filings with the SEC, including the company's most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC's Internet site (www.sec.gov). References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites. Sebela Forward-Looking Statement This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sebela Pharmaceuticals, Sebela Women's Health and Braintree Laboratories under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "may," "will," "forecast," "estimated," "expected," and "intend," among others. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the development, launch, introduction and commercial potential of Miudella; growth and opportunity, including peak sales and the potential demand for Miudella, as well as its potential impact on applicable markets; market size; substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development and commercialization of new products. There are no guarantees that Miudella will prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and neither Sebela Pharmaceuticals, Sebela Women's Health, nor Braintree Laboratories agree to undertake any obligation to update publicly such statements to reflect subsequent events or circumstances, except as required by law. 1 Data on file. Organon group of companies. 2 Creinin MD, Gawron LM, Roe AH, et al. Three-year efficacy, safety, and tolerability outcomes from a phase 3 study of a low-dose copper intrauterine device. Contraception. 2025;143:110771. doi:10.1016/j.contraception.2024.110771 3 MIUDELLA. Package insert. Organon; 2026. US-MIU-110110 10/26 View source version on businesswire.com: https://www.businesswire.com/news/home/20261016500412/en/ Contacts Media Contacts: Janine Colavita (732) 861-3806 Karissa Peer (614) 314-8094 Investor Contacts: Jennifer Halchak (201) 275-2711 Renee McKnight (551) 204-6129
Related articleQuarter not tagged2026-09-10The Surprising Pockmarks On Cooper's Earnings That Caused Its Stock To Dive
Investor's Business Daily
The Surprising Pockmarks On Cooper's Earnings That Caused Its Stock To Dive
Investors hammered Cooper Companies on Thursday after the medtech's fiscal third-quarter sales lagged Wall Street's expectations.
Related articleQuarter not tagged2026-07-31Organon Announces Quarterly Dividend
Business Wire
Organon Announces Quarterly Dividend
JERSEY CITY, N.J., July 31, 2026--(BUSINESS WIRE)--Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today that the company’s Board of Directors declared a quarterly dividend of $0.02 for each issued and outstanding share of the company's common stock. The dividend is payable on September 10, 2026, to stockholders of record at the close of business on August 14, 2026. About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook. View source version on businesswire.com: https://www.businesswire.com/news/home/20260731734106/en/ Contacts Organon Media Contacts:Karissa Peer(614) 314-8094Organon Investor Contacts:Jennifer Halchak(201) 275-2711Renee McKnight(551) 204-6129
Related articleQuarter not tagged2026-07-31Organon: Q2 Earnings Snapshot
Associated Press
Organon: Q2 Earnings Snapshot
JERSEY CITY, N.J. (AP) — JERSEY CITY, N.J. (AP) — Organon & Co. (OGN) on Friday reported second-quarter earnings of $108 million. On a per-share basis, the Jersey City, New Jersey-based company said it had net income of 40 cents. Earnings, adjusted for non-recurring costs and stock option expense, came to 85 cents per share. The results missed Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research was for earnings of 87 cents per share. The pharmaceutical company posted revenue of $1.56 billion in the period, beating Street forecasts. Three analysts surveyed by Zacks expected $1.54 billion. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on OGN at https://www.zacks.com/ap/OGN
Related articleQuarter not tagged2026-07-31Compared to Estimates, Organon (OGN) Q2 Earnings: A Look at Key Metrics
Zacks
Compared to Estimates, Organon (OGN) Q2 Earnings: A Look at Key Metrics
For the quarter ended June 2026, Organon (OGN) reported revenue of $1.56 billion, down 2.3% over the same period last year. EPS came in at $0.85, compared to $1.00 in the year-ago quarter. The reported revenue compares to the Zacks Consensus Estimate of $1.54 billion, representing a surprise of +1.09%. The company delivered an EPS surprise of -2.3%, with the consensus EPS estimate being $0.87. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health. Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance. Here is how Organon performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenue- Established Brands- Int'l- Respiratory- Clarinex: $30 million versus the three-analyst average estimate of $30 million. The reported number represents a year-over-year change of -9.1%. Revenue- Established Brands- Int'l- Non-Opioid Pain, Bone and Dermatology- Arcoxia: $69 million versus $60.64 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a +9.5% change. Revenue- Women's Health- Int'l- NuvaRing: $18 million compared to the $19.35 million average estimate based on three analysts. The reported number represents a change of -14.3% year over year. Revenue- Women's Health- U.S.- NuvaRing: $9 million compared to the $3.69 million average estimate based on three analysts. The reported number represents a change of +28.6% year over year. Revenue- Women's Health- Nexplanon/Implanon NXT: $230 million versus the three-analyst average estimate of $227.44 million. The reported number represents a year-over-year change of -4.2%. Revenue- Established Brands Total: $930 million versus $903.41 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a -0.6% change. Revenue- Women's Health- NuvaRing: $27 million versus the three-analyst average estimate of $23.04 million. The reported number represents a year-over-year change of -3.6%. Revenue- Women's Health- Follistim AQ: $5…Read full documentShow less
For the quarter ended June 2026, Organon (OGN) reported revenue of $1.56 billion, down 2.3% over the same period last year. EPS came in at $0.85, compared to $1.00 in the year-ago quarter. The reported revenue compares to the Zacks Consensus Estimate of $1.54 billion, representing a surprise of +1.09%. The company delivered an EPS surprise of -2.3%, with the consensus EPS estimate being $0.87. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health. Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance. Here is how Organon performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenue- Established Brands- Int'l- Respiratory- Clarinex: $30 million versus the three-analyst average estimate of $30 million. The reported number represents a year-over-year change of -9.1%. Revenue- Established Brands- Int'l- Non-Opioid Pain, Bone and Dermatology- Arcoxia: $69 million versus $60.64 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a +9.5% change. Revenue- Women's Health- Int'l- NuvaRing: $18 million compared to the $19.35 million average estimate based on three analysts. The reported number represents a change of -14.3% year over year. Revenue- Women's Health- U.S.- NuvaRing: $9 million compared to the $3.69 million average estimate based on three analysts. The reported number represents a change of +28.6% year over year. Revenue- Women's Health- Nexplanon/Implanon NXT: $230 million versus the three-analyst average estimate of $227.44 million. The reported number represents a year-over-year change of -4.2%. Revenue- Established Brands Total: $930 million versus $903.41 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a -0.6% change. Revenue- Women's Health- NuvaRing: $27 million versus the three-analyst average estimate of $23.04 million. The reported number represents a year-over-year change of -3.6%. Revenue- Women's Health- Follistim AQ: $59 million versus the three-analyst average estimate of $72.4 million. The reported number represents a year-over-year change of -20.3%. Revenue- Biosimilars Total: $195 million versus $188.49 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a +12.7% change. Revenue- Women?s Health Total: $419 million compared to the $426.31 million average estimate based on three analysts. The reported number represents a change of -9.3% year over year. Revenue- Other Total: $14 million versus the three-analyst average estimate of $23.97 million. The reported number represents a year-over-year change of -39.1%. Revenue- Biosimilars- Renflexis: $65 million compared to the $55.52 million average estimate based on three analysts. The reported number represents a change of +3.2% year over year. View all Key Company Metrics for Organon here>>> Shares of Organon have remained unchanged over the past month versus the Zacks S&P 500 composite's -0.5% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Organon & Co. (OGN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Related articleQuarter not tagged2026-07-31Organon (OGN) Lags Q2 Earnings Estimates
Zacks
Organon (OGN) Lags Q2 Earnings Estimates
Organon (OGN) came out with quarterly earnings of $0.85 per share, missing the Zacks Consensus Estimate of $0.87 per share. This compares to earnings of $1 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -2.30%. A quarter ago, it was expected that this pharmaceutical company would post earnings of $0.83 per share when it actually produced earnings of $0.71, delivering a surprise of -14.46%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Organon, which belongs to the Zacks Medical Services industry, posted revenues of $1.56 billion for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 1.09%. This compares to year-ago revenues of $1.59 billion. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Organon shares have added about 89% since the beginning of the year versus the S&P 500's gain of 8.7%. While Organon has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Organon was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will b…Read full documentShow less
Organon (OGN) came out with quarterly earnings of $0.85 per share, missing the Zacks Consensus Estimate of $0.87 per share. This compares to earnings of $1 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -2.30%. A quarter ago, it was expected that this pharmaceutical company would post earnings of $0.83 per share when it actually produced earnings of $0.71, delivering a surprise of -14.46%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Organon, which belongs to the Zacks Medical Services industry, posted revenues of $1.56 billion for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 1.09%. This compares to year-ago revenues of $1.59 billion. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Organon shares have added about 89% since the beginning of the year versus the S&P 500's gain of 8.7%. While Organon has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Organon was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.91 on $1.57 billion in revenues for the coming quarter and $3.37 on $6.11 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical Services is currently in the top 31% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Progyny (PGNY), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 6. This provider of fertility and family building benefits is expected to post quarterly earnings of $0.51 per share in its upcoming report, which represents a year-over-year change of +6.3%. The consensus EPS estimate for the quarter has been revised 7.1% higher over the last 30 days to the current level. Progyny's revenues are expected to be $349.19 million, up 4.9% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Organon & Co. (OGN) : Free Stock Analysis Report Progyny, Inc. (PGNY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Related articleQuarter not tagged2026-07-16Organon to Report Second Quarter 2026 Results in Its Regularly Scheduled Form 10-Q Filing
Business Wire
Organon to Report Second Quarter 2026 Results in Its Regularly Scheduled Form 10-Q Filing
JERSEY CITY, N.J., July 16, 2026--(BUSINESS WIRE)--Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, plans to release its second quarter 2026 financial results via its regularly scheduled Form 10-Q filing with the Securities and Exchange Commission ("SEC"). The company also plans to disclose certain non-GAAP financial measures and their reconciliation to their comparable GAAP measures for the second quarter 2026, which will be disclosed in a Form 8-K filing to be filed on the same day as the Form 10-Q. During the pendency of the previously announced acquisition by Sun Pharmaceutical Industries Limited on April 26, 2026, Organon has suspended its quarterly earnings calls. IPR&D and Milestones Organon currently expects to record approximately $1 million of milestone expense in the second quarter of 2026. Organon’s second quarter results have not been finalized and are subject to the company’s quarterly financial statement closing procedures. There can be no assurance that actual results will not differ from the preliminary estimates described herein. About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook. Cautionary Note Regarding Forward-Looking Statements The information above reflects management’s current intentions and expectations for the future with respect to Organon’s expectations regarding the filing of its Form 10-Q for the quarter ended June 30, 2026 and related Form 8-K with certain non-GAAP financial measures and comparable GAAP measures and its milestone expenses, which constitute "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are subject to a number of ri…Read full documentShow less
JERSEY CITY, N.J., July 16, 2026--(BUSINESS WIRE)--Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, plans to release its second quarter 2026 financial results via its regularly scheduled Form 10-Q filing with the Securities and Exchange Commission ("SEC"). The company also plans to disclose certain non-GAAP financial measures and their reconciliation to their comparable GAAP measures for the second quarter 2026, which will be disclosed in a Form 8-K filing to be filed on the same day as the Form 10-Q. During the pendency of the previously announced acquisition by Sun Pharmaceutical Industries Limited on April 26, 2026, Organon has suspended its quarterly earnings calls. IPR&D and Milestones Organon currently expects to record approximately $1 million of milestone expense in the second quarter of 2026. Organon’s second quarter results have not been finalized and are subject to the company’s quarterly financial statement closing procedures. There can be no assurance that actual results will not differ from the preliminary estimates described herein. About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook. Cautionary Note Regarding Forward-Looking Statements The information above reflects management’s current intentions and expectations for the future with respect to Organon’s expectations regarding the filing of its Form 10-Q for the quarter ended June 30, 2026 and related Form 8-K with certain non-GAAP financial measures and comparable GAAP measures and its milestone expenses, which constitute "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are subject to a number of risks, assumptions, uncertainties and other factors, such as the completion of Organon’s quarter-end closing process, including review by management and the audit committee of the Organon’s board of directors, which could result in material changes to the preliminary estimates described herein. Risks and uncertainties include, but are not limited to uncertainties as to the timing of the proposed transaction with Sun Pharma; the risk that the proposed transaction may not be completed on the anticipated terms in a timely manner or at all; the failure to satisfy any of the conditions to the consummation of the proposed transaction, including receiving, on a timely basis or otherwise, the minimum vote required by Organon’s stockholders to approve the proposed transaction; the possibility that competing offers or acquisition proposals for Organon will be made; the possibility that any or all of the various conditions to the consummation of the proposed transaction may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable governmental entities (or any conditions, limitations or restrictions placed on such approvals); the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive agreement, including in circumstances which would require Organon to pay a termination fee; the effect of the announcement or pendency of the proposed transaction on Organon’s ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, or its operating results and business generally; risks related to diverting management’s attention from Organon’s ongoing business operations; the risk that stockholder litigation in connection with the proposed transaction may result in significant costs of defense, indemnification and liability; certain restrictions during the pendency of the proposed transaction that may impact Organon’s ability to pursue certain business opportunities or strategic transactions; the risk that any announcements relating to the proposed transaction could have adverse effects on the market price of Organon’s common stock, including if the proposed transaction is not consummated; risks that the benefits of the proposed transaction are not realized when and as expected; and legislative, regulatory and economic developments. Although Organon believes that the expectations reflected in its forward-looking statements are reasonable, it cannot assure that those expectations will prove to be correct. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by Organon on its website or otherwise. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings (as amended, where applicable), available at the SEC’s Internet site (www.sec.gov). Additional Information and Where to Find It This press release may be deemed to be solicitation material in respect of the proposed transaction between Organon, Sun Pharmaceutical Holdings USA, Inc. and Sun Pharma America, Inc. In connection with the proposed transaction, Organon filed relevant materials with the SEC, including Organon’s definitive proxy statement on Schedule 14A with the SEC on June 17, 2026, which is available at https://www.sec.gov/Archives/edgar/data/1821825/000119312526266707/d141679ddefa14a.htm (the "Merger Proxy Statement"). Organon mailed the Merger Proxy Statement and a proxy card to its stockholders in connection with the proposed transaction. INVESTORS AND STOCKHOLDERS OF ORGANON ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING THE MERGER PROXY STATEMENT, BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT ORGANON, SUN PHARMACEUTICAL HOLDINGS USA, INC., SUN PHARMA AMERICA, INC. AND THE PROPOSED TRANSACTION AND RELATED MATTERS. Investors and stockholders of Organon are able to obtain these documents free of charge from the SEC’s website at www.sec.gov, or through the investor relations section of Organon’s website, https://www.organon.com. Participants in the Solicitation Organon and its directors, executive officers and other members of management and employees, under SEC rules, may be deemed to be "participants" in the solicitation of proxies from stockholders of Organon in favor of the proposed transaction. Information about Organon’s directors and executive officers is set forth in the Merger Proxy Statement, which is available at https://www.sec.gov/Archives/edgar/data/1821825/000119312526266707/d141679ddefa14a.htm. To the extent holdings of Organon’s securities by its directors or executive officers have changed since the amounts set forth in the Merger Proxy Statement, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC, which are available at https://www.sec.gov/edgar/browse/?CIK=1821825. Additional information concerning the interests of Organon’s participants in the solicitation, which may, in some cases, be different than those of Organon’s stockholders generally, are set forth in the Merger Proxy Statement. View source version on businesswire.com: https://www.businesswire.com/news/home/20260716726929/en/ Contacts Organon Media Contacts:Karissa Peer614-314-8094 Organon Investor Contacts:Jennifer Halchak(201) 275-2711 Renee McKnight(551) 204-6129
Related articleQuarter not tagged2026-04-30Organon: Q1 Earnings Snapshot
Associated Press
Organon: Q1 Earnings Snapshot
JERSEY CITY, N.J. (AP) — JERSEY CITY, N.J. (AP) — Organon & Co. (OGN) on Thursday reported first-quarter profit of $146 million. The Jersey City, New Jersey-based company said it had net income of 55 cents per share. Earnings, adjusted for one-time gains and costs, were 71 cents per share. The results did not meet Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for earnings of 83 cents per share. The pharmaceutical company posted revenue of $1.46 billion in the period, also falling short of Street forecasts. Three analysts surveyed by Zacks expected $1.47 billion. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on OGN at https://www.zacks.com/ap/OGN
Related articleQuarter not tagged2026-04-30Organon Reports Results for the First Quarter Ended March 31, 2026
Business Wire
Organon Reports Results for the First Quarter Ended March 31, 2026
First quarter 2026 revenue of $1.460 billion, down 4% as-reported and down 9% excluding the impact of foreign currency. First quarter 2026 diluted earnings per share of $0.55 and non-GAAP Adjusted diluted earnings per share of $0.71. First quarter 2026 net income of $146 million and Adjusted EBITDA (non-GAAP) of $415 million, representing an Adjusted EBITDA margin of 28.4%. On April 26, 2026, the company announced its pending merger into Sun Pharmaceutical Industries Limited (together with its subsidiaries and/or associated companies, "Sun Pharma") in an all-cash transaction (the "merger"). The merger is expected to close in early 2027, subject to customary closing conditions, including receipt of required regulatory approvals and approval by Organon stockholders. In light of the pending merger, Organon will not be providing financial guidance or hosting quarterly earnings calls. JERSEY CITY, N.J., April 30, 2026--(BUSINESS WIRE)--Organon (NYSE: OGN) today announced its results for the first quarter ended March 31, 2026. First Quarter 2026 Revenue For the first quarter of 2026, total revenue was $1.460 billion, down 4% on an as-reported basis and down 9% excluding the impact of foreign currency (ex-FX), compared with the first quarter of 2025. Women’s Health revenue declined 16% as-reported and declined 19% ex-FX in the first quarter of 2026, compared with the first quarter of 2025. Sales of Nexplanon® (etonogestrel implant) decreased 21% ex-FX in the first quarter compared with the first quarter of 2025. In the U.S., sales of Nexplanon declined 28% primarily due to both decreased physician demand following the five-year label approval which as expected, has delayed reinsertions; and continued uncertainty around federal funding. Outside of the U.S., Nexplanon sales declined 4% ex-FX, due to the timing of shipments in selective emerging markets, partially offset by increased demand and access in Brazil. Sales of oral contraceptives MarvelonTM (desogestrel and ethinyl estradiol pill) and MercilonTM (desogestrel and ethinyl estradiol pill) declined 36% ex-FX in the first quarter of 2026 primarily due to decreased demand and market contraction in China and the timing of shipments in Asia Pacific. Global Fertility revenue was down 9% ex-FX as a result of competition-driven price reductions in the U.S. partially offset by modest market growth in China. In January…Read full documentShow less
First quarter 2026 revenue of $1.460 billion, down 4% as-reported and down 9% excluding the impact of foreign currency. First quarter 2026 diluted earnings per share of $0.55 and non-GAAP Adjusted diluted earnings per share of $0.71. First quarter 2026 net income of $146 million and Adjusted EBITDA (non-GAAP) of $415 million, representing an Adjusted EBITDA margin of 28.4%. On April 26, 2026, the company announced its pending merger into Sun Pharmaceutical Industries Limited (together with its subsidiaries and/or associated companies, "Sun Pharma") in an all-cash transaction (the "merger"). The merger is expected to close in early 2027, subject to customary closing conditions, including receipt of required regulatory approvals and approval by Organon stockholders. In light of the pending merger, Organon will not be providing financial guidance or hosting quarterly earnings calls. JERSEY CITY, N.J., April 30, 2026--(BUSINESS WIRE)--Organon (NYSE: OGN) today announced its results for the first quarter ended March 31, 2026. First Quarter 2026 Revenue For the first quarter of 2026, total revenue was $1.460 billion, down 4% on an as-reported basis and down 9% excluding the impact of foreign currency (ex-FX), compared with the first quarter of 2025. Women’s Health revenue declined 16% as-reported and declined 19% ex-FX in the first quarter of 2026, compared with the first quarter of 2025. Sales of Nexplanon® (etonogestrel implant) decreased 21% ex-FX in the first quarter compared with the first quarter of 2025. In the U.S., sales of Nexplanon declined 28% primarily due to both decreased physician demand following the five-year label approval which as expected, has delayed reinsertions; and continued uncertainty around federal funding. Outside of the U.S., Nexplanon sales declined 4% ex-FX, due to the timing of shipments in selective emerging markets, partially offset by increased demand and access in Brazil. Sales of oral contraceptives MarvelonTM (desogestrel and ethinyl estradiol pill) and MercilonTM (desogestrel and ethinyl estradiol pill) declined 36% ex-FX in the first quarter of 2026 primarily due to decreased demand and market contraction in China and the timing of shipments in Asia Pacific. Global Fertility revenue was down 9% ex-FX as a result of competition-driven price reductions in the U.S. partially offset by modest market growth in China. In January of 2026 the company completed the sale of the Jada® system to Laborie. Biosimilars revenue increased 23% as-reported and 21% ex-FX in the first quarter of 2026, compared with the first quarter of 2025, primarily due to the strong performance of Hadlima® (adalimumab-bwwd) associated with stronger demand in the U.S., and increased demand in Puerto Rico. Biosimilars also benefitted from contribution from new assets, Bildyos® (denosumab-nxxp) and Bilprevda® (denosumab-nxxp) which were approved by the U.S. Food and Drug Administration ("FDA") in the third quarter of 2025, and Tofidence® (tocilizumab-bavi), which the company acquired in the second quarter of 2025. Established Brands revenue declined 1% as-reported and declined 7% ex-FX in the first quarter of 2026. Revenue contribution from Emgality®(1) (galcanezumab-gnlm) partially offset a decline in the respiratory portfolio, which was driven by pricing pressure, as well as volume declines related to the adoption of revised medical guidelines that deprioritize the use of montelukast, including Singulair® (montelukast sodium), in various international markets, most recently, in China. Global sales of Dulera® (mometasone furoate and formoterol fumarate dihydrate) also declined in the first quarter of 2026 primarily due to pricing pressure and decreased demand in the U.S. VTAMA® (tapinarof) grew modestly in the first quarter of 2026 compared with the first quarter of 2025. (1) Organon acquired certain European licensing and distribution rights to Emgality from Eli Lilly and Company ("Eli Lilly") beginning in early 2024. Emgality is a registered trademark of Eli Lilly in the European Union and other countries (used under license). First Quarter 2026 Profitability Reported gross margin in the first quarter of 2026 was 53.6% compared with 55.6% in the prior year period. Non-GAAP Adjusted gross margin was 59.0% in the first quarter of 2026, compared to 61.7% in the first quarter of 2025. Unfavorable pricing and product mix as well as foreign exchange rates were notable drivers in the decline of both reported gross margin and non-GAAP Adjusted gross margin. Net income for the first quarter of 2026 was $146 million, or $0.55 per diluted share, compared with net income of $87 million, or $0.33 per diluted share, in the first quarter of 2025. For the first quarter of 2026, non-GAAP Adjusted net income was $188 million, or $0.71 per diluted share, compared with $265 million, or $1.02 per diluted share, for the first quarter of 2025. Non-GAAP Adjusted EBITDA margin was 28.4% in the first quarter of 2026 compared with 32.0% in the first quarter of 2025. The year-over-year decline was primarily driven by a decrease in Adjusted Gross Margin. Capital Allocation Today, Organon’s Board of Directors declared a quarterly dividend of $0.02 for each issued and outstanding share of the company's common stock. The dividend is payable on June 11, 2026, to stockholders of record at the close of business on May 11, 2026. As of March 31, 2026, cash and cash equivalents were $1.12 billion, and debt was $8.57 billion. Webcast Information As is customary during the pendency of an acquisition, Organon has suspended its quarterly earnings calls and will not host a conference call in conjunction with today’s first quarter earnings release. About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at http://www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook. Cautionary Note Regarding Non-GAAP Financial Measures This press release contains "non-GAAP financial measures," which are financial measures that either exclude or include amounts that are correspondingly not excluded or included in the most directly comparable measures calculated and presented in accordance with U.S. generally accepted accounting principles ("GAAP"). Specifically, the company makes use of the non-GAAP financial measures Adjusted EBITDA, Adjusted EBITDA margin, Adjusted gross margin, Adjusted gross profit, Adjusted net income, Adjusted EPS, and Adjusted diluted EPS, which are not recognized terms under GAAP and are presented only as a supplement to the company’s GAAP financial statements. This press release also provides certain measures that exclude the impact of foreign exchange. We calculate foreign exchange by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. The company believes that these non-GAAP financial measures help to enhance an understanding of the company’s financial performance. However, the presentation of these measures has limitations as an analytical tool and should not be considered in isolation, or as a substitute for the company’s results as reported under GAAP. Because not all companies use identical calculations, the presentations of these non-GAAP measures may not be comparable to other similarly titled measures of other companies. Please refer to Table 4 and Table 5 of this press release for additional information, including relevant definitions and reconciliations of non-GAAP financial measures contained herein to the most directly comparable GAAP measures. The company’s management uses the non-GAAP financial measures described above to evaluate the company’s performance and to guide operational and financial decision making. Further, the company’s management believes that these non-GAAP financial measures, which exclude certain items, help to enhance its ability to meaningfully communicate its underlying business performance, financial condition and results of operations. Cautionary Note Regarding Forward-Looking Statements Except for historical information, this press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to the merger, including the anticipated timing of completion thereof. Forward-looking statements may be identified by words such as "proposed," "will," "continue," "expects," "believes," "estimates," "opportunity," "pursue," "anticipate," "be able to," "intend," or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to uncertainties as to the timing of the merger; the risk that the merger may not be completed on the anticipated terms in a timely manner or at all; the failure to satisfy any of the conditions to the consummation of the merger, including receiving, on a timely basis or otherwise, the minimum vote required by Organon’s stockholders to approve the merger; the possibility that competing offers or acquisition proposals for Organon will be made; the possibility that any or all of the various conditions to the consummation of the merger may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable governmental entities (or any conditions, limitations or restrictions placed on such approvals); the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive agreement, including in circumstances which would require Organon to pay a termination fee; the effect of the announcement or pendency of the merger on Organon’s ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, or its operating results and business generally; risks related to diverting management’s attention from Organon’s ongoing business operations; the risk that stockholder litigation in connection with the merger may result in significant costs of defense, indemnification and liability; certain restrictions during the pendency of the merger that may impact Organon’s ability to pursue certain business opportunities or strategic transactions; the risk that any announcements relating to the merger could have adverse effects on the market price of Organon’s common stock, including if the merger is not consummated; risks that the benefits of the merger are not realized when and as expected; and legislative, regulatory and economic developments. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the SEC, including the company’s most recent Annual Report on Form 10-K, Current Report on Form 8-K, filed by the company on April 27, 2026, and other SEC filings, available at the SEC’s Internet site (www.sec.gov). Additional Information and Where to Find It This press release may be deemed to be solicitation material in respect of the proposed merger. In connection with the merger, Organon intends to file relevant materials with the SEC, including Organon’s proxy statement in preliminary and definitive form on Schedule 14A (the "Merger Proxy Statement"). Organon will mail the Merger Proxy Statement and a proxy card to its stockholders in connection with the merger. INVESTORS AND STOCKHOLDERS OF ORGANON ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING THE MERGER PROXY STATEMENT (WHEN THEY ARE AVAILABLE), BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT ORGANON, SUN PHARMA AND THE MERGER AND RELATED MATTERS. Investors and stockholders of Organon are or will be able to obtain these documents (when they are available) free of charge from the SEC’s website at www.sec.gov, or through the investor relations section of Organon’s website, https://www.organon.com. Participants in the Solicitation Organon and its directors, executive officers and other members of management and employees, under SEC rules, may be deemed to be "participants" in the solicitation of proxies from stockholders of Organon in favor of the proposed acquisition. Information about Organon’s directors and executive officers is set forth in the 2026 Annual Meeting Proxy Statement, filed with the SEC on April 24, 2026, and which is available at https://www.sec.gov/ix?doc=/Archives/edgar/data/0001821825/000119312526177411/ogn-20260423.htm. To the extent holdings of Organon’s securities by its directors or executive officers have changed since the amounts set forth in the 2026 Annual Meeting Proxy Statement, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC, which are available at https://www.sec.gov/edgar/browse/?CIK=1821825. Additional information concerning the interests of Organon’s participants in the solicitation, which may, in some cases, be different than those of Organon’s stockholders generally, will be set forth in the Merger Proxy Statement when it becomes available. View source version on businesswire.com: https://www.businesswire.com/news/home/20260430180575/en/ Contacts Media Contacts: Felicia Bisaro (646) 703-1807 Kate Vossen (732) 675-8448 Investor Contacts: Jennifer Halchak (201) 275-2711 Renee McKnight (551) 204-6129
Related articleQuarter not tagged2026-04-30Organon (OGN) Q1 Earnings and Revenues Miss Estimates
Zacks
Organon (OGN) Q1 Earnings and Revenues Miss Estimates
Organon (OGN) came out with quarterly earnings of $0.71 per share, missing the Zacks Consensus Estimate of $0.83 per share. This compares to earnings of $1.02 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -14.87%. A quarter ago, it was expected that this pharmaceutical company would post earnings of $0.73 per share when it actually produced earnings of $0.63, delivering a surprise of -13.7%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Organon, which belongs to the Zacks Medical Services industry, posted revenues of $1.46 billion for the quarter ended March 2026, missing the Zacks Consensus Estimate by 0.48%. This compares to year-ago revenues of $1.51 billion. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Organon shares have added about 86.1% since the beginning of the year versus the S&P 500's gain of 4.2%. While Organon has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Organon was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It wil…Read full documentShow less
Organon (OGN) came out with quarterly earnings of $0.71 per share, missing the Zacks Consensus Estimate of $0.83 per share. This compares to earnings of $1.02 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -14.87%. A quarter ago, it was expected that this pharmaceutical company would post earnings of $0.73 per share when it actually produced earnings of $0.63, delivering a surprise of -13.7%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Organon, which belongs to the Zacks Medical Services industry, posted revenues of $1.46 billion for the quarter ended March 2026, missing the Zacks Consensus Estimate by 0.48%. This compares to year-ago revenues of $1.51 billion. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Organon shares have added about 86.1% since the beginning of the year versus the S&P 500's gain of 4.2%. While Organon has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Organon was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.87 on $1.54 billion in revenues for the coming quarter and $3.37 on $6.11 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical Services is currently in the top 39% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Pediatrix Medical Group (MD), is yet to report results for the quarter ended March 2026. The results are expected to be released on May 5. This physician group is expected to post quarterly earnings of $0.37 per share in its upcoming report, which represents a year-over-year change of +12.1%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Pediatrix Medical Group's revenues are expected to be $466.99 million, up 1.9% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Organon & Co. (OGN) : Free Stock Analysis Report Pediatrix Medical Group, Inc. (MD) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Related articleQuarter not tagged2026-04-30Organon (OGN) Q1 Earnings: Taking a Look at Key Metrics Versus Estimates
Zacks
Organon (OGN) Q1 Earnings: Taking a Look at Key Metrics Versus Estimates
For the quarter ended March 2026, Organon (OGN) reported revenue of $1.46 billion, down 3.5% over the same period last year. EPS came in at $0.71, compared to $1.02 in the year-ago quarter. The reported revenue represents a surprise of -0.48% over the Zacks Consensus Estimate of $1.47 billion. With the consensus EPS estimate being $0.83, the EPS surprise was -14.87%. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health. Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance. Here is how Organon performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenue- Established Brands- U.S.- Respiratory- Other: $11 million versus the three-analyst average estimate of $9.57 million. The reported number represents a year-over-year change of +10%. Revenue- Women's Health- Int'l- Nexplanon/Implanon NXT: $74 million compared to the $78.51 million average estimate based on three analysts. The reported number represents a change of +2.8% year over year. Revenue- Women's Health- U.S.- NuvaRing: $6 million versus the three-analyst average estimate of $3.51 million. The reported number represents a year-over-year change of 0%. Revenue- Women's Health- Int'l- Follistim AQ: $39 million versus $35.59 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a +14.7% change. Revenue- Women's Health- Nexplanon/Implanon NXT: $201 million compared to the $219.22 million average estimate based on three analysts. The reported number represents a change of -19% year over year. Revenue- Established Brands Total: $880 million versus $868.4 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a -0.8% change. Revenue- Women's Health- NuvaRing: $24 million versus $19.75 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a +9.1% change. Revenue- Women's Health- Follistim AQ: $61 million versus $67.09 million estimated by three…Read full documentShow less
For the quarter ended March 2026, Organon (OGN) reported revenue of $1.46 billion, down 3.5% over the same period last year. EPS came in at $0.71, compared to $1.02 in the year-ago quarter. The reported revenue represents a surprise of -0.48% over the Zacks Consensus Estimate of $1.47 billion. With the consensus EPS estimate being $0.83, the EPS surprise was -14.87%. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health. Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance. Here is how Organon performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenue- Established Brands- U.S.- Respiratory- Other: $11 million versus the three-analyst average estimate of $9.57 million. The reported number represents a year-over-year change of +10%. Revenue- Women's Health- Int'l- Nexplanon/Implanon NXT: $74 million compared to the $78.51 million average estimate based on three analysts. The reported number represents a change of +2.8% year over year. Revenue- Women's Health- U.S.- NuvaRing: $6 million versus the three-analyst average estimate of $3.51 million. The reported number represents a year-over-year change of 0%. Revenue- Women's Health- Int'l- Follistim AQ: $39 million versus $35.59 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a +14.7% change. Revenue- Women's Health- Nexplanon/Implanon NXT: $201 million compared to the $219.22 million average estimate based on three analysts. The reported number represents a change of -19% year over year. Revenue- Established Brands Total: $880 million versus $868.4 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a -0.8% change. Revenue- Women's Health- NuvaRing: $24 million versus $19.75 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a +9.1% change. Revenue- Women's Health- Follistim AQ: $61 million versus $67.09 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a -11.6% change. Revenue- Biosimilars Total: $173 million compared to the $163.68 million average estimate based on three analysts. The reported number represents a change of +22.7% year over year. Revenue- Women?s Health Total: $389 million versus the three-analyst average estimate of $413.45 million. The reported number represents a year-over-year change of -16%. Revenue- Other Total: $18 million versus $22.43 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a -18.2% change. Revenue- Biosimilars- Renflexis: $57 million versus the three-analyst average estimate of $52.32 million. The reported number represents a year-over-year change of 0%. View all Key Company Metrics for Organon here>>> Shares of Organon have returned +117.3% over the past month versus the Zacks S&P 500 composite's +12.2% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Organon & Co. (OGN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

