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Organon & (OGN)

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Earnings summaries and quarterly performance for Organon &.

Recent press releases and 8-K filings for OGN.

Organon's NEXPLANON Approved for Five-Year Duration by FDA
OGN
Product Launch
  • Organon (OGN) announced that the US FDA approved a supplemental New Drug Application (sNDA) for NEXPLANON, extending its duration of use for pregnancy prevention from three years to up to five years.
  • Clinical trials for the extended use of NEXPLANON (years 4 and 5) reported no pregnancies and no new safety findings, with the study including women across a wide range of BMIs.
  • This approval also introduces a new Risk Evaluation and Mitigation Strategy (REMS) program in the US, planned to be available starting February 23, 2026, to mitigate complications from improper insertion and removal.
4 days ago
Organon Signs Commercialization Agreement for Nilemdo® in European Markets
OGN
Product Launch
New Projects/Investments
  • Organon has signed a commercialization agreement with Daiichi Sankyo Europe for Nilemdo® (bempedoic acid).
  • Under the terms of the agreement, Organon will distribute and promote Nilemdo® in France, Denmark, Iceland, Sweden, Finland, and Norway.
  • Nilemdo® is a first-in-class therapy indicated for patients with hypercholesterolemia and cardiovascular risk, serving as an alternative for those who cannot be effectively treated with statins.
  • This collaboration aims to address a critical gap in cardiovascular care, particularly for women who have a 47% higher risk of statin intolerance.
Jan 8, 2026, 8:17 PM
Organon Enters Commercialization Agreement for Nilemdo®
OGN
New Projects/Investments
Product Launch
  • Organon has entered into a commercialization agreement with Daiichi Sankyo Europe to distribute and promote Nilemdo® (bempedoic acid).
  • This agreement covers France, Denmark, Iceland, Sweden, Finland, and Norway.
  • Nilemdo® is a first-in-class drug indicated for patients with high cholesterol and cardiovascular disease risk, providing an alternative treatment for those who cannot be effectively treated with statins.
  • The collaboration expands Organon’s cardiovascular disease portfolio and aims to address a critical gap in cardiovascular care, particularly for women who are disproportionately affected by statin intolerance.
Jan 8, 2026, 6:30 AM
Organon Provides 2026 Outlook and Operational Updates
OGN
Guidance Update
Demand Weakening
New Projects/Investments
  • Organon concluded its internal investigation into Nexplanon sales practices, finding issues related to "tone at the top" with a financial impact of less than 1% of annual revenue, and has a detailed remediation plan in place.
  • The company achieved $200 million in operating expense reductions in 2025 but anticipates challenges in meeting its 31% adjusted EBITDA margin target for 2026 due to Nexplanon flattening and continued investment in Vtama.
  • Nexplanon is projected to be flat globally in 2026, with US sales facing headwinds, while Vtama's access is expected to improve significantly to 70%-80% preferred tier access in 2026.
  • Established brands, particularly Respiratory products, face ongoing headwinds, but the overall LOE impact across all established brands in 2026 is expected to be less than $75 million, a significant reduction from over $200 million for Atozet alone in 2025.
  • Emgality and biosimilars are highlighted as key growth drivers, and Organon is pursuing opportunistic divestitures to accelerate deleveraging.
Dec 3, 2025, 3:00 PM
Organon Discusses Investigation Conclusion, 2026 Outlook, and Strategic Priorities at Piper Sandler Conference
OGN
Guidance Update
Demand Weakening
New Projects/Investments
  • Organon concluded its internal investigation into Nexplanon sales practices, finding a revenue impact of less than 1% of annual revenue and 2% in any quarter, with no need to revise financial statements. Remediation efforts are in progress, and the practices are expected to wash out by Q4 2025.
  • While $200 million in operating expenses were removed in 2025, the company anticipates that achieving a 31% adjusted EBITDA margin will be challenging in 2026 due to a flat Nexplanon outlook and ongoing Vtama investments.
  • Nexplanon is projected to be flat globally in 2026, with the U.S. market facing headwinds from Title X funding and macroeconomic factors, while international growth continues.
  • The financial impact from loss of exclusivity (LOE) for established brands is expected to be less than $75 million in 2026, a significant reduction from the over $200 million impact of Atozet alone in 2025.
  • Organon is strategically focusing R&D on existing products and lifecycle management, deprioritizing larger programs to improve leverage, and pursuing opportunistic business development that leverages its established infrastructure, such as the growing Emgality partnership and biosimilar launches.
Dec 3, 2025, 3:00 PM
Organon Discusses 2026 Outlook, Nexplanon Performance, and Cost Discipline
OGN
Guidance Update
Demand Weakening
New Projects/Investments
  • Organon concluded its internal investigation into U.S. sales practices for Nexplanon, confirming that revenue recognition was appropriate and the financial reporting impact was less than 1% of annual revenue.
  • The company achieved $200 million in operating expense reductions in 2025 and plans continued cost discipline, but anticipates its 31% adjusted EBITDA margin target will be challenging in 2026 due to Nexplanon flattening and ongoing Vtama investments.
  • Nexplanon is projected to be flat globally in 2026, with U.S. sales potentially flat to declining due to Title X funding issues and macroeconomic factors.
  • While Established Brands face headwinds from Respiratory products, the impact of Atozet's loss of exclusivity is expected to be significantly reduced to less than $75 million in 2026, with Emgality and biosimilars identified as growth drivers.
Dec 3, 2025, 3:00 PM
Organon Presents Positive VTAMA Cream Data for Pediatric Atopic Dermatitis
OGN
Product Launch
New Projects/Investments
  • Organon will present new sub-analysis data on VTAMA cream at the 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on November 8, 2025, demonstrating early and consistent response in children aged 2-17 with atopic dermatitis, including those with associated comorbidities.
  • The data from Phase 3 ADORING 1 and ADORING 2 trials showed significant improvements in skin clearance (vIGA-AD), eczema severity (EASI scores), patient-reported outcomes (POEM), and itch (PP-NRS).
  • The U.S. FDA approved VTAMA cream for the topical treatment of atopic dermatitis in adults and pediatric patients 2 years and older in December 2024.
  • This sub-analysis represents the largest pediatric data set to date for VTAMA, supporting its favorable safety and efficacy profile for children 2 years and older.
Nov 8, 2025, 1:00 PM
Organon Sells JADA System to Laborie
OGN
M&A
Debt Issuance
  • Organon is divesting its JADA postpartum hemorrhage treatment system to Laborie Medical Technologies for up to $465 million, including $440 million at closing.
  • The transaction, expected to close by Q1 2026, aims to help Organon reduce its $8.9 billion debt and strategically refocus on its women's health biopharma portfolio, moving away from medtech devices.
  • Organon had acquired the JADA system in 2021 for $240 million.
  • JADA sales grew 40% to $61 million in 2024, with the deal valuation representing over six times its annual revenues.
Nov 8, 2025, 2:41 AM
Organon announces agreement to sell JADA® system
OGN
M&A
Debt Issuance
New Projects/Investments
  • Organon has entered into an agreement to sell its JADA® system to Laborie Medical Technologies Corp. for up to $465 million.
  • The net proceeds from this sale will be allocated towards debt reduction, reinforcing Organon's ongoing efforts to lower its debt.
  • This divestiture is intended to position Organon for future investments in growth opportunities, with a focus on women's health biopharmaceuticals and other strategic priorities.
Nov 7, 2025, 11:08 PM
Organon announces agreement to divest JADA system
OGN
M&A
Debt Issuance
New Projects/Investments
  • Organon has agreed to sell its JADA system to Laborie Medical Technologies Corp. for up to $465 million.
  • The transaction includes $440 million payable at closing, with a potential additional $25 million contingent on achieving certain 2026 revenue targets.
  • The net proceeds from the sale will be used for debt reduction and to support future investments in women's health biopharmaceuticals and other strategic priorities.
  • The transaction is expected to close in the first quarter of 2026.
Nov 7, 2025, 11:06 PM