Under the terms of the license agreement, Richter will grant Lilly exclusive, worldwide rights to develop, manufacture and commercialize medicine(s) containing E4 in combination with Lilly compound(s) for the treatment of women’s health conditions and cardiometabolic diseases.
Richter will also grant Lilly an option to co-commercialize its orally administered E4-based estrogen monotherapy in the United States (U.S.) upon obtaining regulatory approval in the U.S. The product is approved in the European Economic Area as FYLREVY® for hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women. In the U.S., it is investigational and under review by the FDA for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.
Under a separate supply agreement, Richter would supply Lilly with the active pharmaceutical ingredient E4 and, in case Lilly exercises its co-commercialization option, the estrogen monotherapy product.
Upon the closing of the transaction, Lilly will make an upfront cash payment to Richter, and will acquire ordinary shares of Richter. Richter will be eligible for regulatory and commercial milestone payments and tiered royalties on net sales of combination products.
Under the share purchase agreement, Lilly will acquire 381,354 pieces of Richter ordinary shares from Richter (currently held in treasury) for a total consideration of approximately USD 15 million, at a per share price of approximately USD 39.33, determined as a volume-weighted average price (VWAP) of Richter ordinary shares on the Budapest Stock Exchange over the 30-trading day period immediately preceding the signature date of this agreement.
The agreements are subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.
Gábor Orbán, CEO of Richter, commented: “We are extremely proud to announce this strategic collaboration with Lilly, one of the world’s leading pharmaceutical companies. This partnership recognizes our longstanding commitment to women’s health and the potential of our proprietary Estetrol platform. Women now live around a third of their lives after menopause yet their needs in these years have long been overlooked and remain largely unmet. This partnership has the potential to address that unmet medical need and meaningfully improve the treatment paradigm for millions of women worldwide.”
About Estetrol (“E4”)
Estetrol (“E4") is a native and selective estrogen produced by the fetal liver during pregnancy and is synthesized from plant sources for pharmaceutical purposes. Preclinical and clinical data for E4 points to a tissue-specific activity and a more selective pharmacological profile compared to other estrogens, including a low impact on the liver, hemostasis balance, and breast cell proliferation. The efficacy and safety of E4 in alleviating VMS were evaluated in two independent, confirmatory, pivotal phase 3 studies (E4COMFORT I and E4COMFORT II) having enrolled a total of 2,576 postmenopausal women in Europe, Russia, the United States, Canada and Latin America. E4 has marketing authorization in over 50 countries worldwide as the estrogen component of a combined oral contraceptive with drospirenone (marketed as DROVELIS® in the E.U. and NEXTSTELLIS® in the U.S.). In the therapeutic field of menopause E4 (marketed as FYLREVY®) as a monotherapy was also granted a marketing authorization by the European Commission for all member states of the European Economic Area as HRT for estrogen deficiency symptoms in non-hysterectomized postmenopausal women with at least 12 months since last menses (FYLREVY® 14.2 mg and 18.9 mg) and as HRT for estrogen deficiency symptoms in hysterectomized postmenopausal women (FYLREVY® 18.9 mg). To date, FYLREVY® is commercialized in Hungary, the Czech Republic, Slovakia, Finland and Sweden.
About Richter
Richter aspires to be a global innovator in some key scientific fields, while dedicated to making medicines more accessible worldwide. Founded in 1901, headquartered in Hungary, with a market capitalization of EUR 4.8bn and sales of EUR 2.3bn in 2025, it operates Central Europe's largest R&D hub. Its research drives breakthroughs in Neuropsychiatry and Women's Healthcare, while Biotechnology and General Medicines strengthen its affordable treatment portfolio. Committed to sustainable growth, Richter invests in R&D, manufacturing excellence, and digitalization to advance medical innovation. Learn more at www.gedeonrichter.com