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Form 8-K · Current Report · Filed 2025-10-14

Halozyme Provides Statement on CMS Medicare Price Negotiation Guidance

Halozyme Therapeutics, Inc. issued a statement on October 14, 2025, addressing the recent final IPAY 2028 guidance for Medicare price negotiations by the U.S. Centers for Medicare & Medicaid Services (CMS). The company's analysis indicates that the CMS final comments suggest no impact to IPAY Part B policy for fixed combination products until 2029 at the earliest, if such a policy were to be finalized. Halozyme demonstrated strong clinical and pharmacoeconomic evidence supporting the benefits of subcutaneous administration of ENHANZE partner products. The company projects zero impact on future partner royalties in 2028, with zero to minimal impact expected from 2029 to 2031, and minimal impact extending to at least 2035.

Filer
Halozyme Therapeutics Inc. HALO · NASDAQ
Filed
Accession
0001159036-25-000039
CIK
0001159036
Signal
Low impactHealthcare

Items reported

Item 7.01

Regulation FD Disclosure

Regulation FD Disclosure
Item 9.01

Financial Statements and Exhibits

Exhibits Furnished

Market reaction

Close before filing

$65.33

Next session

+1.6%

Since filing

+68.7%

Latest close

$110.24

What happened, not what will happen — closing prices around the filing date.

Precedent

Previous filings from HALO reporting the same item, with the next session's move:

Halozyme Announces Merger with Elektrofi-6.6%
Halozyme Therapeutics Announces Acquisition of Elektrofi to Expand Drug Delivery Capabilities-2.2%
Halozyme Therapeutics Raises 2025 Financial Guidance and Reports Strong Q2 2025 Results+3.9%
Halozyme Reports Strong Q1 2025 Results and Raises Financial Guidance+15.7%
Halozyme Therapeutics Reports Strong 2024 Financial Results and Reiterates 2025 Guidance-0.9%

About Halozyme Therapeutics Inc.

Halozyme Therapeutics Inc. is a biopharmaceutical company that specializes in developing and commercializing treatments focused on enhanced subcutaneous drug delivery. The company's proprietary technology, ENHANZE, aims to improve the efficacy and convenience of existing therapies by facilitating faster drug absorption and reducing the need for intravenous administration. Halozyme partners with major pharmaceutical companies to integrate its technology with a variety of treatments, significantly impacting the oncology, immunology, and genetic disorder sectors. This collaboration model helps expand the reach of its technology across multiple therapeutic applications. Based in San Diego, California, Halozyme is noted for its innovative approach to drug delivery, contributing to the broader pharmaceutical industry's efforts to improve patient experiences and optimize medical outcomes. As a significant player in the biopharmaceutical landscape, Halozyme's advancements continue to drive interest and growth within the market, underscoring the vital role of drug delivery technology in modern medicine.

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