Halozyme Therapeutics, Inc. confirmed on June 15, 2026, that it expects zero to minimal impact on its royalty revenues through at least 2035 based on its analysis of the proposed rule for the Medicare Drug Price Negotiation Program issued by the U.S. Centers for Medicare & Medicaid Services (CMS) on June 12, 2026. The company's analysis indicates that the statutory framework established under the One Big Beautiful Bill Act (OBBBA) safeguards its financial outlook. Consequently, Halozyme stated there is no projected impact on its capacity to execute new ENHANZE partnership agreements, as improving patient treatment experience and competitive differentiation remain primary drivers for the technology's utilization.

Analysis of the Proposed Rule

The company's assessment relies on specific provisions within the CMS proposal. The rule affirms that orphan drug protections remain applicable, a critical factor for Halozyme's revenue projections. Additionally, the proposal addresses the impacts of biosimilar entry on Program eligibility, further supporting the company's stance that its royalty streams are secure.

Strategic Outlook and Engagement

Dr. Helen Torley, President and Chief Executive Officer of Halozyme, emphasized that the analysis confirms the durability of the company's business model despite regulatory changes. She highlighted that the core value propositions of ENHANZE—improving patient experience and providing competitive differentiation—continue to drive partnerships. Halozyme plans to maintain constructive engagement with CMS and other stakeholders to advocate for policies that recognize innovation and preserve patient access to therapies that improve outcomes and reduce the overall burden on the healthcare system.