Organon (NYSE: OGN) plans to release its third quarter 2026 financial results through a regularly scheduled Form 10-Q filing with the Securities and Exchange Commission. The company will also disclose non-GAAP financial measures in a Form 8-K filed on the same day.

The disclosure comes as Organon navigates the pending acquisition by Sun Pharmaceutical Industries Limited, announced on April 26, 2026. Due to the transaction's pendency, the company has suspended its quarterly earnings calls for this period.

Regulatory filings and disclosures

Investors should note that the Q3 results have not been finalized and remain subject to standard quarterly financial statement closing procedures. The company explicitly states there can be no assurance that actual results will not differ from preliminary estimates.

Key procedural details include:

• Form 10-Q: Contains the primary financial statements for the quarter ended September 30, 2026.
• Form 8-K: Will provide reconciliation of non-GAAP measures to comparable GAAP measures.
• Earnings Call: Suspended during the pending acquisition period.

IPR&D and milestone expenses

Regarding specific expense categories, Organon does not currently expect to record any milestone expense in the third quarter of 2026. This indicates a stable outlook for In-Process Research and Development costs related to milestones for this reporting period.

Company profile

Headquartered in Jersey City, New Jersey, Organon is a global healthcare company focused on Women’s Health and General Medicines. Its portfolio includes over 70 products, including biosimilars, across more than 140 markets. The company’s mission centers on delivering medicines that address health needs disproportionately affecting women while expanding access to essential treatments.

Organon & Co (NYSE: OGN) announced that Sebela Women’s Health will present interim results from an ongoing Phase 3 study evaluating MIUDELLA, a hormone-free copper intrauterine device, through six years of use. The presentation is scheduled for the 2026 Society of Family Planning Annual Meeting in San Francisco from October 17 to 19, 2026.

The prospective, single-arm study was conducted at 42 sites in the United States. The cumulative six-year Pearl Index was 0.93 (95% CI, 0.62 to 1.34), while the cumulative Kaplan-Meier pregnancy rate stood at 3.9% (95% CI, 2.7% to 5.8%). These findings support the company's ambition to expand hormone-free contraceptive options and are scheduled for presentation at the 2026 Society of Family Planning Annual Meeting.

Clinical efficacy and safety profile

The study evaluated efficacy and safety in two distinct populations: 465 of 1,397 participants in the evaluable-for-pregnancy group and 592 of 1,601 in the safety population. Treatment-emergent adverse events included heavy menstrual bleeding, dysmenorrhea, and pelvic discomfort.

Notably, adverse events leading to study discontinuation decreased significantly over time. In year one, 8.7% of participants (139 individuals) discontinued due to bleeding- and pain-related events, whereas this figure dropped to 1.9% (11 participants) by year six.

Regulatory status and licensing

Organon holds exclusive global licensing rights to MIUDELLA, acquired from Sebela Women’s Health in June 2026. The U.S. Food and Drug Administration has accepted for review a supplemental New Drug Application (sNDA) for MIUDELLA, seeking approval for an extended duration of use up to six years. A Prescription Drug User Fee Act (PDUFA) action is expected in the second quarter of calendar year 2027.

Juan Camilo Arjona Ferreira, Head of Research & Development and Chief Medical Officer at Organon, stated that the interim results add to the clinical evidence for MIUDELLA and represent an important milestone in the ongoing study. Kelly Culwell, Chief Medical Officer at Sebela Women’s Health, emphasized that reaching six years of follow-up reflects the commitment of participants and investigators.

What the numbers show

The data reveals a distinct trend in user retention relative to initial side effects. While the cumulative Pearl Index remained low at 0.93 over six years, indicating high contraceptive efficacy, the discontinuation rate due to bleeding and pain fell from 8.7% in year one to 1.9% in year six. This suggests that while initial tolerability issues drive early dropouts, long-term users experience significantly fewer adverse events leading to removal, supporting the viability of the extended-use indication.

About MIUDELLA

MIUDELLA is currently indicated for the prevention of pregnancy in females of reproductive potential for up to three years. It is a hormone-free, low-dose copper intrauterine system. The product is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) to ensure healthcare providers are trained on proper insertion, mitigating risks of complications such as perforation or infection.