Halozyme Therapeutics, Inc. - HALO STOCK NEWS

Halozyme announced that the European Commission has approved Roche's OCREVUS® SC, co-formulated with Halozyme's ENHANZE® enzyme, for treating relapsing and primary progressive multiple sclerosis. This new subcutaneous injection offers a 10-minute administration alternative to the traditional intravenous infusion, maintaining the same twice-yearly schedule. The approval is based on Phase III OCARINA II trial data, demonstrating comparable efficacy and safety between the SC and IV formulations. This new option aims to improve patient accessibility and treatment flexibility.

Halozyme Therapeutics announced that argenx received FDA approval for VYVGART® Hytrulo, co-formulated with Halozyme's ENHANZE®, for treating chronic inflammatory demyelinating polyneuropathy (CIDP). This is the first neonatal Fc receptor blocker approved as a subcutaneous injection for CIDP. The ADHERE study, the largest clinical trial on CIDP, showed a 69% clinical improvement rate and a 61% reduction in relapse risk compared to placebo. This is the second FDA-approved indication for VYVGART® Hytrulo with ENHANZE®, the first being for generalized myasthenia gravis. The safety profile remained generally consistent with previous studies.

Halozyme Therapeutics (NASDAQ: HALO) has raised its full-year 2024 financial guidance and updated its 5-year financial outlook, driven by a new European patent for its ENHANZE® drug delivery platform. The European Patent No. 4269578 will be validated in 37 countries and extends until March 6, 2029. This patent ensures the original royalty rate for DARZALEX SC in Europe, leading to increased revenue projections.

For 2024, Halozyme forecasts total revenue of $935 million to $1.015 billion, up 13% to 22% from 2023. Royalty revenue is expected to reach $520 million to $555 million, a 16% to 24% increase. Adjusted EBITDA is projected between $555 million and $615 million, a 30% to 44% growth, and non-GAAP diluted EPS is anticipated to range from $3.65 to $4.05, representing a 32% to 46% rise. The company's investor call on June 6 will provide further details.

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.

Halozyme Therapeutics (NASDAQ: HALO) announced that CEO Dr. Helen Torley will present and host investor meetings at the Goldman Sachs 45th Annual Global Healthcare Conference.

The presentation is scheduled for June 11, 2024, at 6:20 a.m. PT / 9:20 a.m. ET. A live audio webcast of the presentation will be available on the Investor Relations section of Halozyme's website. Replays will be accessible for 90 days post-conference.

Halozyme Therapeutics announced that Bristol Myers Squibb received an updated Prescription Drug User Fee Act (PDUFA) goal date from the U.S. FDA for their Biologics License Application. This application pertains to the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme's ENHANZE (rHuPH20). The new target date is December 29, 2024. This formulation aims to cover all previously approved adult, solid tumor Opdivo indications, either as monotherapy or in combination treatment. The application is based on the CheckMate-67T Phase 3 trial, which showed noninferior pharmacokinetics, efficacy, and consistent safety compared to the intravenous version. If approved, it will be the first subcutaneous PD-1 inhibitor.

Halozyme Therapeutics, Inc. (NASDAQ: HALO) will be participating in upcoming investor conferences with Nicole LaBrosse, the Chief Financial Officer, presenting and hosting investor meetings. The company will be at The Citizens JMP Life Sciences Conference on May 14, 2024, and the Benchmark 2024 Healthcare House Call Virtual Conference on May 21 and May 22, 2024. The presentations will be available via live audio webcasts on the Company's Investor Relations section.

Halozyme reported strong financial performance for the first quarter of 2024 with revenue increasing 21% YoY to $196 million, net income of $77 million, and adjusted EBITDA of $116 million. The company also announced a $750 million share repurchase program and reiterated its 2024 financial guidance, expecting total revenue of $915 - $985 million, representing YOY growth of 10% - 19%, adjusted EBITDA of $535 - $585 million, and non-GAAP diluted EPS of $3.55 - $3.90, showing YOY growth of 28% - 41%. Halozyme's CEO highlighted ongoing partnerships with argenx and Roche, as well as advancements in its ENHANZE technology.

Halozyme Therapeutics, Inc. announced the election of Mahesh Krishnan, M.D. to its Board of Directors. Dr. Krishnan brings over 20 years of experience in healthcare and biotechnology. He currently serves as Group Vice President of Growth at DaVita, Inc. and has held various key roles at Amgen Inc. Dr. Krishnan's expertise will aid Halozyme in expanding its leadership in innovative drug delivery technologies.