SAN DIEGO - Halozyme (NASDAQ:HALO) Therapeutics, Inc. (NASDAQ: HALO), a biopharmaceutical company, announced the issuance of European Patent No. 4269578, which pertains to its ENHANZE® drug delivery technology. The patent, validated in 37 European countries, extends the company's intellectual property rights until March 6, 2029.
The newly granted patent is expected to maintain the original royalty rate for DARZALEX SC, a subcutaneous treatment for multiple myeloma, in Europe without reduction until the patent's expiration. According to Dr. Helen Torley, president and CEO of Halozyme, this development strengthens the company's patent portfolio and the longevity of its royalty streams.
The ENHANZE® technology, which uses the proprietary enzyme rHuPH20, is designed to facilitate the subcutaneous delivery of injected drugs, potentially reducing the treatment burden for patients. Halozyme has licensed this technology to several top pharmaceutical and biotechnology companies.
The impact of the new patent on royalties from other ENHANZE® licenses is expected to be minimal, as the current royalty rates under these licenses are already set to continue beyond the new patent's expiration date.
Halozyme will provide further details on the implications of the patent and update its 2024 financial guidance and 5-year outlook in a conference call scheduled for Thursday. Investors can access the webcast through the "Investors" section of Halozyme's corporate website or via the provided dial-in information.
The company's portfolio includes more than 800,000 patient lives impacted post-marketing across over 100 global markets. Halozyme's technology has been incorporated into seven commercialized products and the company continues to develop drug-device combination products offering potential commercial or functional advantages.
This announcement is based on a press release statement from Halozyme Therapeutics , Inc. The forward-looking statements in the press release involve risks and uncertainties that could cause actual results to differ materially from those projected. Halozyme cautions against placing undue reliance on these forward-looking statements, which reflect current views but are not guarantees of future performance.
In other recent news, the U.S. Food and Drug Administration (FDA) has updated the review date for Halozyme Therapeutics' Biologics License Application (BLA) of a subcutaneous formulation of Opdivo, co-formulated with Halozyme's proprietary ENHANZE® technology.
The new goal date is set for December 29, 2024. The BLA submission is backed by data from the CheckMate-67T trial, which aims to demonstrate the efficacy, safety, and noninferior pharmacokinetics of this formulation in adult patients with solid tumors.
In financial developments, Halozyme reported strong Q1 results and maintained a positive outlook for the year. The company saw a 15% year-over-year royalty growth for the 15th consecutive quarter, driven by their Wave 2 products.
Halozyme anticipates a 10-19% increase in total revenue for the year, projecting amounts between $915 million and $985 million. EBITDA is expected to grow by 26-37%, reaching $535 million to $585 million, while non-GAAP EPS growth is forecasted at 28-41%, resulting in $3.55 to $3.90 per share.
Further, Halozyme announced a new $750 million share repurchase program, following a $250 million Accelerated Share Repurchase in the previous quarter. The company is also actively pursuing new partnerships and advancing their product pipeline, including the Wave 3 and Wave 4 products with significant sales potential.
InvestingPro Insights
Halozyme Therapeutics, Inc. (NASDAQ: HALO) recently celebrated a boost to its intellectual property portfolio with a new European patent for its ENHANZE® drug delivery technology. This development is poised to enhance the company's financial stability and extend the profitability of its royalty streams. In light of this news, let's delve into some key financial metrics and insights from InvestingPro that could be of interest to investors.
InvestingPro data indicates that Halozyme has a market capitalization of $5.81 billion, reflecting a robust presence in the biopharmaceutical industry. The company's P/E ratio stands at 18.62, with a slight adjustment to 19.25 when considering the last twelve months as of Q1 2024. This valuation suggests that the company is trading at a reasonable price relative to its near-term earnings growth. Moreover, Halozyme's revenue growth is impressive, with a 22.41% increase over the last twelve months as of Q1 2024, showcasing the company's ability to expand its financial top line.
Two InvestingPro Tips that are particularly relevant given the context of the patent announcement are:
- Halozyme is trading at a low P/E ratio relative to near-term earnings growth, which could indicate a potentially undervalued stock in light of its recent positive developments.
- The company's strong free cash flow yield, as implied by its valuation, suggests that Halozyme is generating sufficient cash from its operations, which could be a positive sign for investors looking for companies with healthy financials.
For investors seeking a deeper dive into Halozyme's financials and future outlook, InvestingPro offers additional tips and metrics. There are currently 13 more InvestingPro Tips available for HALO, which can be accessed at InvestingPro. To enrich your investment research, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
These insights and data points could be particularly valuable for investors as they assess the potential impact of Halozyme's latest patent on the company's future revenue and earnings potential.
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