Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta (Pertuzumab) and Prolia/Xgeva (Denosumab) Biosimilar Candidates

Organon (NYSE: OGN), a global women’s health company with deep expertise in biosimilar commercialization, today announced that it has entered into an agreement with Shanghai Henlius Biotech, Inc. (2696.HK), whereby Organon will license commercialization rights for biosimilar candidates referencing Perjeta (pertuzumab, HLX11) and Prolia/Xgeva (denosumab, HLX14). Organon will acquire exclusive global commercialization rights except for China; including Hong Kong, Macau and Taiwan.

Pertuzumab is used for the treatment of certain patients with HER2+ breast cancer in combinations with trastuzumab and chemotherapy. In the US, 20% of people with breast cancer are HER2+. Denosumab is used for the treatment of certain patients with osteoporosis with high risk of fracture and for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastasis from solid tumors. Osteoporosis affects over 20% of women over the age of 50 globally.

“Biosimilars are a key growth pillar for Organon, and this collaboration represents the successful execution of our strategy to expand our biosimilars portfolio leveraging our strong global footprint and deep commercial expertise,” said Kevin Ali, CEO of Organon. “With our experience in biosimilars and women’s health, our goal is to help more patients gain access to treatments for breast cancer and osteoporosis, two areas that significantly impact the health of women.”

The agreement also includes an option to negotiate an exclusive license for global commercialization rights for a biosimilar candidate referencing Yervoy (ipilimumab, HLX13). Ipilimumab is used for the treatment of certain patients with unresectable or metastatic melanoma, as adjuvant treatment of certain patients with cutaneous melanoma, certain patients with Renal Cell Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma and Esophageal Cancer.

Consideration for the transaction includes an upfront payment of $73 million as well as additional payments upon the achievement of certain development, regulatory and commercial milestones. Henlius will be responsible for development and, if approved, will supply the products to Organon.

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 $73 million upfront payment and an approximate $30 million for milestones expected to be achieved in 2022 were not included in the full year 2022 guidance the company provided on May 5, 2022. The company does not plan to update its guidance inter-quarter based solely on these items.