Halozyme Sees Zero to Minimal Royalty Revenue Impact Through 2035 Under Proposed CMS Rule
HALO•Halozyme projects zero to minimal impact to royalty revenues through at least 2035 based on CMS’s June 12 proposed Medicare Drug Price Negotiation Program rule for IPAY 2029. The company also expects no hindrance to future ENHANZE partnerships thanks to preserved orphan drug protections and biosimilar eligibility criteria.
1. Projected Royalty Revenue Impact
Halozyme’s analysis of CMS’s June 12 draft Medicare Drug Price Negotiation Program rule for IPAY 2029 under the One Big Beautiful Bill Act framework projects zero to minimal royalty revenue impact through at least 2035.
2. Orphan and Biosimilar Exclusions
The draft rule maintains orphan drug protections and excludes drugs facing biosimilar competition from Program negotiations, shielding Halozyme’s licensed products from royalty reductions.
3. ENHANZE Partnership Outlook
With royalty structures intact, Halozyme expects no barrier to future ENHANZE® collaboration agreements, emphasizing the technology’s role in enhancing patient treatment experience and market differentiation.
4. Continued CMS Engagement
The company intends to engage with CMS and other stakeholders to advocate for policies that support innovation, protect patient access, and manage overall healthcare costs.
