Earnings summaries and quarterly performance for Organon &.
Executive leadership at Organon &.
Joseph Morrissey
Interim Chief Executive Officer
Aaron Falcione
Executive Vice President and Chief Human Resources Officer
Daniel Karp
Executive Vice President, Corporate Development
Juan Camilo Arjona Ferreira
Executive Vice President, Head of Research & Development and Chief Medical Officer
Kirke Weaver
Executive Vice President, General Counsel and Corporate Secretary
Matthew Walsh
Executive Vice President and Chief Financial Officer
Rachel Stahler
Executive Vice President and Chief Digital & Growth Officer
Vittorio Nisita
Executive Vice President and Head of Enterprise Services & Solutions
Board of directors at Organon &.
Alan Ezekowitz
Director
Carrie S. Cox
Executive Chair
Cynthia M. Patton
Director
Deborah Leone
Director
Grace Puma
Director
Helene Gayle
Director
Philip Ozuah
Director
Ramona A. Sequeira
Director
Robert Essner
Lead Independent Director
Rochelle B. Lazarus
Director
Shalini Sharp
Director
Research analysts who have asked questions during Organon & earnings calls.
Umer Raffat
Evercore ISI
6 questions for OGN
Ethan Brown
JPMorgan Chase & Co.
4 questions for OGN
Jason Gerberry
Bank of America Merrill Lynch
4 questions for OGN
Michael Nedelcovych
TD Cowen
4 questions for OGN
David Amsellem
Piper Sandler Companies
3 questions for OGN
Terence Flynn
Morgan Stanley
3 questions for OGN
Balaji Prasad
Barclays
2 questions for OGN
Pavan Patel
Bank of America
2 questions for OGN
Alex Riesemann
Piper Sandler Companies
1 question for OGN
Christopher Schott
JPMorgan Chase & Co.
1 question for OGN
Mike Nedelcovic
TD Cowen
1 question for OGN
Recent press releases and 8-K filings for OGN.
- Organon has entered into a global exclusive licensing agreement with Sebela Pharmaceuticals for MIUDELLA®, a hormone-free copper intrauterine device (IUD).
- MIUDELLA® was FDA-approved on February 24, 2025, for contraception in women of reproductive age for up to three years, and is the first of its kind approved in the US in nearly 40 years.
- Organon will make an upfront payment of $27.5 million upon closing, with potential future sales-based milestone payments up to $505 million and tiered double-digit royalties on net sales.
- The transaction's effectiveness is subject to regulatory approvals, including HSR Act review and FDA approval for MIUDELLA®'s alternative supply chain entity.
- Organon (NYSE: OGN) has entered into an agreement with Sebela Pharmaceuticals for the global exclusive license of MIUDELLA®, a non-hormonal copper intrauterine contraceptive device (IUD).
- The agreement includes an upfront payment of $27.5 million upon closing, with potential sales-based milestone payments of up to $505 million and tiered double-digit royalties on net sales.
- MIUDELLA® received FDA approval on February 24, 2025, for contraception in women of reproductive age, effective for up to three years, and is the first non-hormonal copper IUD approved in the U.S. in nearly 40 years.
- The transaction is contingent on regulatory approvals, including HSR Act review and FDA approval of MIUDELLA®'s alternative supply chain master file.
- Organon (OGN) has entered into an agreement to obtain the exclusive global license for MIUDELLA, a hormone-free intrauterine device (IUD) from Sebela Pharmaceuticals.
- Under the terms of the agreement, Organon will pay $27.5 million at closing, with potential sales-based milestone payments up to $505 million, and tiered double-digit royalties based on net sales.
- MIUDELLA, which was approved by the FDA on February 24, 2025, for pregnancy prevention for up to three years, is the first hormone-free copper IUD approved in the U.S. in 40 years. It is not yet commercially available.
- The transaction's validity is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act and FDA approval of alternative supply chain entities for MIUDELLA.
- Organon has entered into an exclusive global licensing agreement with Sebela Pharmaceuticals for MIUDELLA®, a hormone-free copper intrauterine device (IUD).
- The financial terms include an upfront payment of $27.5 million at closing, potential sales-based milestone payments of up to $550 million, and tiered royalties in the low double-digits on net sales.
- MIUDELLA® received FDA approval on February 24, 2025, for up to three years of pregnancy prevention, but is not yet commercially available.
- This product is the first hormone-free copper IUD approved in the U.S. in over 40 years and strategically expands Organon's women's reproductive health portfolio.
- The deal is contingent on Hart-Scott-Rodino Act review, FDA approval of an alternative supply chain, and other customary closing conditions.
- Organon has entered into an exclusive licensing agreement for the worldwide rights to MIUDELLA, a hormone-free copper intrauterine device (IUD) from Sebela Pharmaceuticals.
- The agreement includes an upfront payment of $27.5 million upon closing, with potential revenue-based milestone payments of up to $505 million and tiered double-digit royalties on net sales.
- MIUDELLA, approved by the FDA on February 24, 2025, is the first hormone-free copper IUD approved in the U.S. in 40 years and is not yet commercially available.
- The transaction's effectiveness is subject to regulatory review, including the Hart-Scott-Rodino Antitrust Improvements Act, and FDA approval of MIUDELLA's alternative supply chain companies.
- A Organon (NYSE: OGN) firmou um acordo para licenciar com exclusividade os direitos globais de MIUDELLA®, um dispositivo intrauterino (DIU) de cobre sem hormônios da Sebela Pharmaceuticals.
- A Organon pagar\u00e1 US$ 27,5 milh\u00f5es no fechamento do neg\u00f3cio, com potenciais pagamentos por metas de vendas de at\u00e9 US$ 505 milh\u00f5es, al\u00e9m de royalties escalonados de dois d\u00edgitos com base nas vendas l\u00edquidas.
- O MIUDELLA® foi aprovado pela FDA em 24 de fevereiro de 2025, para a preven\u00e7\u00e3o da gravidez em mulheres em idade f\u00e9rtil por at\u00e9 tr\u00eas anos, sendo o primeiro DIU de cobre sem horm\u00f4nios aprovado nos EUA nos \u00faltimos 40 anos.
- O produto ainda n\u00e3o est\u00e1 dispon\u00edvel comercialmente, e a efic\u00e1cia da transa\u00e7\u00e3o est\u00e1 sujeita \u00e0 revis\u00e3o de acordo com a Lei Hart-Scott-Rodino de Melhorias Antitruste e \u00e0 aprova\u00e7\u00e3o da FDA para as entidades alternativas da cadeia de suprimentos do MIUDELLA®.
- Organon reported $6.2 billion in revenue and $1.9 billion in adjusted EBITDA for the full year 2025, with revenue down 3% on both a reported and ex-FX basis.
- The company provided 2026 guidance, expecting revenue and adjusted EBITDA to be approximately $6.2 billion and $1.9 billion, respectively, consistent with 2025.
- Key product performance in 2025 included Vtama revenue of $128 million and HADLIMA growth of 61% ex-FX, which helped offset challenges in Nexplanon and the loss of exclusivity (LOE) of Atozet.
- Organon is committed to debt reduction, having retired approximately $530 million of debt in 2025 and expecting to achieve net leverage below 4x by the end of 2026, aided by $390 million in net proceeds from the JADA System divestiture.
- The FDA approved an sNDA to extend the duration of Nexplanon from three to five years, a significant milestone despite expected volume headwinds in 2026 due to the transition and policy changes.
- Organon reported $6.2 billion in revenue and $1.9 billion in adjusted EBITDA for full year 2025. The company recorded a net loss of $205 million, or $0.79 per diluted share, for Q4 2025, which included a $301 million goodwill impairment.
- For 2026, Organon expects revenue and adjusted EBITDA to be flat with 2025, at approximately $6.2 billion and $1.9 billion respectively, with adjusted gross margin projected to be 75-100 basis points lower than the prior year.
- The company aims to achieve net leverage below 4x by the end of 2026, supported by approximately $390 million in net proceeds from the JADA System divestiture and the retirement of approximately $530 million of debt in 2025.
- Key product performance in 2025 included $128 million in global revenue from VTAMA and 61% ex-FX growth for the biosimilar Hadlima, while Nexplanon revenue decreased 4% ex-FX for the full year.
- Organon reported full-year 2025 revenue of $6.2 billion, Adjusted Diluted EPS of $3.66, and Adjusted EBITDA of $1.9 billion.
- For full-year 2026, the company expects results to be in-line with 2025, projecting approximately $6.2 billion in revenue and approximately $1.9 billion of Adjusted EBITDA. Revenue growth is anticipated to be ~flat as reported and ~(1.5%) at constant currency.
- The Adjusted Gross Margin for FY 2026 is expected to be ~75-100 basis points lower than 2025.
- Organon generated $659 million in Free Cash Flow for full-year 2025.
- The company's net leverage ratio was ~4.3x at December 31, 2025 , and the divestiture of Jada® was completed in January 2026.
- Organon reported $6.2 billion in revenue and $1.9 billion in adjusted EBITDA for full year 2025, with revenue down 3% on both a reported and ex-FX basis.
- For 2026, the company expects revenue and Adjusted EBITDA to be about $6.2 billion and $1.9 billion, respectively, with revenue projected to be about flat on a constant currency basis pro forma for the JADA System divestiture.
- Key product updates include the FDA approval to extend Nexplanon's duration from 3 to 5 years, VTAMA delivering $128 million in global revenue in 2025, and biosimilars performing better than expected, driven by Hadlima's 61% ex-FX growth.
- Organon divested the JADA System for approximately $390 million in net proceeds and reduced debt by approximately $530 million in 2025, with a goal to achieve net leverage below 4x by the end of 2026.
Quarterly earnings call transcripts for Organon &.
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