Halozyme Thrp Stock Price, News & Analysis

Halozyme Therapeutics (NASDAQ: HALO) has announced its participation in three upcoming investor conferences in September 2024. The company's leadership, including Dr. Helen Torley, President and CEO, and Tram Bui, VP of Investor Relations, will be presenting and hosting investor meetings at these events.

The conferences include the 2024 Wells Fargo Healthcare Conference in Boston on September 4, the Morgan Stanley 22nd Annual Global Healthcare Conference in New York on September 5, and the H.C. Wainwright 26th Annual Global Investment Conference in New York on September 10. Presentations at Wells Fargo and H.C. Wainwright will be in a fireside chat format, while the Morgan Stanley event will feature 1x1 meetings only.

Live audio webcasts of the presentations will be available on Halozyme's website, with replays accessible for 90 days after each conference.

Halozyme Therapeutics reported strong Q2 2024 financial results, with total revenue of $231 million, a 5% year-over-year increase. Royalty revenue grew 12% to $125 million. The company maintained its recently increased 2024 financial guidance, projecting total revenue of $935-$1,015 million (13-22% YOY growth) and adjusted EBITDA of $555-$615 million (30-44% YOY growth).

Key highlights include partner approvals for Ocrevus SC in Europe and the UK, and VYVGART Hytrulo for CIDP in the U.S. Halozyme expects 10 approved products with ENHANZE by 2025, including potential U.S. approvals for Roche's Tecentriq SC and Ocrevus SC in September 2024.

Halozyme Therapeutics (NASDAQ: HALO) has announced the upcoming release of its second quarter 2024 financial and operating results on Tuesday, August 6, 2024, after the market closes. The company will host a conference call on the same day at 1:30 p.m. PT/4:30 p.m. ET to discuss the results. Investors and interested parties can pre-register for the call using a provided link. Additionally, a live webcast and replay of the conference call will be available through the "Investors" section of Halozyme's corporate website.

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.