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Halozyme Announces Issuance of New European Patent for ENHANZE® Drug Delivery Platform

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Halozyme Therapeutics announced the issuance of European Patent No. 4269578 for its ENHANZE® drug delivery platform. The patent, covering the ENHANZE® rHuPH20 product, extends protection until March 6, 2029, and will be validated in 37 European countries.

This strengthens Halozyme's patent portfolio and maintains the original royalty rate for DARZALEX SC in Europe through March 2029. The new patent does not impact royalties for other ENHANZE® licenses, as their rates already extend beyond 2029.

Halozyme will discuss the new patent and update its 2024 financial guidance and 5-year financial outlook in a conference call on June 6, 2024, at 8:30am ET.

Positive
  • Issuance of European Patent No. 4269578 strengthens Halozyme's patent portfolio.
  • The patent extends protection for the ENHANZE® rHuPH20 product until March 6, 2029.
  • The patent will be validated in 37 European countries.
  • Maintains the original royalty rate for DARZALEX SC in Europe through March 2029.
Negative
  • The new patent does not impact royalties for other ENHANZE® licenses, as their rates already extend beyond 2029.

The issuance of the new European patent for Halozyme's ENHANZE® platform is a significant development. Patents are important for protecting proprietary technologies and securing revenue streams. This specific patent extends the protection of ENHANZE® for several more years, providing stability and potentially deterring market entry by competitors. By maintaining the original royalty rate for DARZALEX SC in Europe until March 2029, Halozyme ensures a steady income from this high-demand product. For retail investors, this patent extension implies a certain degree of revenue predictability and lowers the risk associated with potential generic competition.

From a financial perspective, the news is quite important. Retaining the original royalty rate for DARZALEX SC in Europe positively impacts Halozyme’s revenue projections. This translates to sustained cash flows, which is beneficial for financial health. While the news may not drastically change short-term earnings, it does solidify long-term revenue streams, an important factor for assessing company stability. Investors should note that this move adds value to Halozyme’s financial outlook and potentially reduces volatility in earnings due to patent expiries.

Conference Call Scheduled for Thursday, June 6 at 5:30am PT/8:30am ET

SAN DIEGO, June 5, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced the grant of European Patent No. 4269578, covering the ENHANZE® rHuPH20 product obtained from Halozyme's ENHANZE® manufacturing methods that the Company provides to its current and future licensees. The new patent is licensed under all of Halozyme's ENHANZE® licenses. It will be validated in 37 European countries and expires on March 6, 2029.

"This new European patent for ENHANZE further strengthens our robust patent estate and extends the durability of our portfolio," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We are pleased to be able to maintain the original royalty rate for DARZALEX SC in Europe through March 2029 based on this new patent."

Under the terms of Halozyme's ENHANZE® license with Janssen, the newly granted patent prevents the reduction in the royalty rate on sales of DARZALEX® SC in the European countries where it is validated until the patent expires. The new patent is not expected to have any impact to royalties under other ENHANZE® licenses with an issued or pending collaboration patent, as current royalty rates for these licenses are already expected to extend beyond expiration of the new patent. 

Webcast and Conference Call

Halozyme will discuss the new European patent and provide an update to its 2024 financial guidance and 5-year financial outlook on a conference call tomorrow, Thursday, June 6 at 5:30am PT/8:30am ET. The call will be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the completion of the call. To access the webcast and presentation, please visit ir.halozyme.com.

The call may also be accessed with the dial-in information below:

Participant Toll-Free Number: 888-632-3384
Participant Direct/International Number: 785-424-1794
Conference ID: HALO0624

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 reducing treatment burden for patients. Having touched more than 800,000 patient lives in post-marketing use in seven 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 recent grant of Halozyme's European Patent No. 4269578 covering Halozyme's ENHANZE® drug delivery technology rHuPH20 product including the expected validation of the patent in thirty-seven European countries, the future expected expiration date of the patent, the expected impact the patent will have on Halozyme's current and future ENHANZE® licenses, including the expected prevention of the reduction in the royalty rate Halozyme receives under the Janssen license on sales of products co-formulated with ENHANZE® in the European countries where the patent is validated. 

These forward-looking statements are typically, but not always, identified through use of the words "believe," "expected," "pending," "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 results or delays in the validation of the recently issued European patent in European countries and termination of the European patent prior to the expected date of expiration. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty or obligation to update forward-looking statements to reflect events after the date of this press 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

Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.) (PRNewsfoto/Halozyme Therapeutics, Inc.)

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SOURCE Halozyme Therapeutics, Inc.

FAQ

What is the new European patent granted to Halozyme for?

Halozyme has been granted European Patent No. 4269578 for its ENHANZE® drug delivery platform.

When does the new Halozyme patent for ENHANZE® expire?

The new patent expires on March 6, 2029.

How many countries will validate the new Halozyme patent?

The new patent will be validated in 37 European countries.

Will the new Halozyme patent affect royalties for other ENHANZE® licenses?

No, the new patent will not impact royalties for other ENHANZE® licenses as their rates already extend beyond 2029.

When is the Halozyme conference call to discuss the new patent?

The conference call is scheduled for June 6, 2024, at 8:30am ET.

Halozyme Therapeutics, Inc.

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