HALOZYME PROVIDES UPDATE ON LICENSEE CO-FORMULATION PATENT HEARING IN EUROPE

Rhea-AI Summary

Halozyme Therapeutics (NASDAQ: HALO) announced that the European Patent Office (EPO) revoked one of Janssen's co-formulation patents for DARZALEX® SC. The company affirms this decision will not impact its 2024 royalty revenue guidance of $520-555 million or its projection to exceed $1 billion in royalty revenues by 2027. The company maintains that U.S. and European royalty revenues from DARZALEX FASPRO® and SC will remain unaffected through 2032. The decision does not affect Halozyme's composition of matter patents for ENHANZE® or other licensees' ability to obtain co-formulation patents.

Positive

• 2024 royalty revenue guidance maintained at $520-555 million
• Projected to exceed $1 billion in royalty revenues by 2027
• No impact on U.S. or European royalty revenues through 2032
• Company has 8 approved partner products, expected to reach 10 by 2025
• ENHANZE® composition patents remain unaffected

Negative

• EPO revocation of Janssen's co-formulation patent for DARZALEX® SC

Insights

Legal Expert

The EPO's decision to revoke Janssen's co-formulation patent for DARZALEX SC appears largely inconsequential to Halozyme's business model and revenue projections. The key points supporting this assessment include:

• The company's core ENHANZE composition of matter patents remain unaffected in both the U.S. and Europe
• The decision is to a single co-formulation patent in Europe
• Janssen can appeal, which would suspend the revocation
• Other licensees' ability to obtain co-formulation patents remains intact

The company's confident stance is backed by solid projections, including $520-555 million in 2024 royalty revenue and expectations to exceed $1 billion in 2027. This patent decision doesn't affect royalty revenues from DARZALEX FASPRO and SC through 2032, preserving the company's core revenue streams.

Company Projects No Impact on U.S. or European Royalty Revenues from DARZALEX FASPRO^® and SC through 2032

Reiterates 2024 Royalty Revenue Guidance of $520-555 million and Expectations to Generate >$1 billion in 2027

Conference Call Scheduled Today, Thursday, October 24 at 5:30am PT/8:30am ET

SAN DIEGO, Oct. 24, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today provided an update following a decision by the Opposition Division of the European Patent Office ("EPO") to revoke one of the Janssen Biotech, Inc. (Janssen) co-formulation patents for DARZALEX^® (daratumumab) SC (Patent EP 3827845).

"We remain confident in our strong royalty revenue projections with 8 approved partner products on the market today, which is expected to reach 10 by 2025. The EPO decision on a single co-formulation patent in Europe has no impact on our 2024 royalty revenue projections and expectations to exceed $1 billion in royalty revenues in 2027. We also project no impact on our U.S. or European royalty revenues on sales of DARZALEX FASPRO and SC through 2032.  Additionally, this decision has no impact on the ability of any other Halozyme licensee to obtain co-formulation patents for their innovations," said Dr. Helen Torley, president and chief executive officer.

"While we are disappointed with the EPO's decision today, if Janssen files an appeal in the case, today's decision would be suspended and the patent would remain in force until the case is finally decided," Dr. Torley concluded.

Today's decision by the EPO has no impact on Halozyme's composition of matter patents in the U.S. and Europe for ENHANZE^®.

Halozyme will provide additional details on today's EPO decision and its intellectual property portfolio during an Investor Update conference call today, Thursday, October 24 at 5:30am PT/8:30am ET.  A webcast of the live call and presentation will be available through the "Investors" section of Halozyme's corporate website at ir.halozyme.com.

About Halozyme

Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched more than 800,000 patient lives in post-marketing use in eight commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.

Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals.

Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility.

For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.

Safe Harbor Statement

In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance (including the Company's royalty revenue projections for 2024, 2027 and through 2032). Forward-looking statements regarding the Company's business may include statements about the expected number of future approved partnered products, potential growth and receipt of royalty payments driven by our partners' development and commercialization efforts and the potential impact of the decision on a co-formulation patent referenced in this press release on the Company's 2024 royalty revenue guidance and future royalty revenues through 2032, and the ability of our licensees to obtain co-formulation patents and on certain composition of matter patents and the impact of appealing the decision. These forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected impact of the co-formulation patent decision referenced in this press release including unexpected results or delays in our licensees' ability to obtain co-formulation patents or in appealing the decision, unexpected impacts on our composition of matter patents, unexpected results regarding the growth of the Company's business or number of future approved partnered products, or in the development, regulatory review or commercialization of the Company's partnered or proprietary products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.  Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Contacts:

Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com

Samantha Gaspar
Teneo
212-886-9356
samantha.gaspar@teneo.com

 

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SOURCE Halozyme Therapeutics, Inc.

FAQ

What happened to Halozyme's (HALO) patent in Europe on October 24, 2024?

The European Patent Office revoked one of Janssen's co-formulation patents for DARZALEX® SC (Patent EP 3827845).

Will the EPO patent decision affect Halozyme's (HALO) 2024 revenue guidance?

No, Halozyme maintains its 2024 royalty revenue guidance of $520-555 million despite the EPO decision.

How many approved partner products does Halozyme (HALO) currently have?

Halozyme currently has 8 approved partner products and expects to reach 10 by 2025.

What is Halozyme's (HALO) projected royalty revenue for 2027?

Halozyme projects to exceed $1 billion in royalty revenues by 2027.