Organon plans to release its second quarter 2026 financial results via a Form 10-Q filing with the Securities and Exchange Commission (SEC). The company also intends to disclose certain non-GAAP financial measures and their reconciliation to comparable GAAP measures in a Form 8-K filing 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.

Organon currently expects to record approximately $1 million of milestone expense in the second quarter of 2026. The company’s second quarter results have not been finalized and are subject to its quarterly financial statement closing procedures. There can be no assurance that actual results will not differ from the preliminary estimates described herein.

IPR&D and Milestones

The anticipated milestone expense of $1 million relates to the second quarter of 2026. This figure is preliminary and subject to change pending the completion of the company's quarter-end closing process, including review by management and the audit committee of the board of directors.

About Organon

Organon 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.

Organon has completed a global licensing agreement with Sebela Pharmaceuticals, securing exclusive rights to MIUDELLA, a hormone-free copper intrauterine device (IUD). The device, approved by the US Food and Drug Administration (FDA) on February 24, 2025, is the first hormone-free copper IUD introduced in the US in over 40 years. This transaction strengthens Organon's contraception portfolio and expands long-acting reversible options for women.

MIUDELLA is indicated for the prevention of pregnancy for up to three years in females of reproductive potential and is 99% effective. The device features proprietary SLIMSERT technology, which includes a highly flexible frame and a fully preloaded inserter with a small, tapered insertion tube diameter of 3.7mm. Commercial availability is anticipated in late 2026.

Regulatory and Safety Profile

The MIUDELLA label includes a Risk Evaluation and Mitigation Strategy (REMS) to manage known or potential risks associated with the product. To mitigate complications due to potential improper insertion, MIUDELLA will only be available in the US through the MIUDELLA REMS program. This restricted program ensures all healthcare providers are trained on proper insertion prior to first use.

Clinical Trial Data

MIUDELLA was investigated in three clinical trials in the US involving 1,904 women aged 17 to 45 years. The Phase 3 study was conducted across 42 centers with a primary endpoint of contraceptive efficacy through 3 years of use.

The most common adverse reactions observed in clinical trials, occurring in 5% or more of participants, included heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post-procedural hemorrhage, and dyspareunia.

Strategic Implications

Joe Morrissey, Chief Executive Officer of Organon, stated that MIUDELLA represents an important hormone-free option that expands choices for women seeking long-acting reversible birth control. He noted that the agreement leverages Organon's deep expertise and capabilities to deliver contraceptive options that meet women's needs.

Alan Cooke, Chief Executive Officer and President of Sebela Pharmaceuticals, expressed that Organon offers the scale, launch readiness, and access capabilities needed to bring the product efficiently into clinical practice. Truist Securities, Inc. acted as the financial advisor to Sebela Pharmaceuticals for the transaction.