JERSEY CITY, N.J.-- July 29, 2022 -- Organon (NYSE: OGN), a global women’s healthcare company, and Cirqle Biomedical today announced they have entered into a research collaboration and exclusive license agreement for a novel investigational non-hormonal, on-demand contraceptive candidate.

“As a leader in contraception, we believe it is critically important to bring forward new options for women, especially in the space of non-hormonal contraceptives, a category preferred by many with limited available options,” said Sandra Milligan, M.D., Organon’s head of Research and Development. “Organon is committed to driving innovation across women’s health and collaborating with companies like Cirqle Biomedical to support early science and bring forward new solutions that address the unmet needs of women.”

Encouraging preclinical research suggests that Cirqle has discovered a method that has the potential to create a temporary barrier to sperm transport by topically reinforcing the existing cervical mucus barrier.

“This collaboration is an important opportunity to advance our preclinical research exploring this asset’s first-in-class potential,” said Frederik Petursson Madsen, Cirqle Biomedical, CEO. “We are excited to join Organon to leverage Organon’s deep expertise in women’s and reproductive health to drive potential change for women who use contraception everywhere.”

Under the terms of the agreement, Cirqle will be responsible for conducting preclinical studies according to the mutually agreed research plan. Organon will obtain exclusive worldwide rights to develop and commercialize the asset. Cirqle is entitled to receive a $10 million upfront payment, potential milestone payments of up to $360 million and royalties based on net sales.

As stated on Organon’s first quarter conference call, to align with views expressed by the US Securities and Exchange Commission, beginning in 2022 Organon will no longer exclude expenses for upfront and milestone payments related to collaborations and licensing agreements, or charges related to pre-approval assets obtained in transactions accounted for as asset acquisitions, from its non-GAAP results. Organon’s financial guidance does not assume an estimate for these expenses associated with business development not yet executed, and accordingly, the $10 million upfront payment was not included in the full year 2022 guidance Organon provided on May 5, 2022. Organon does not plan to update its guidance inter-quarter based solely on these items.