Halozyme Therapeutics, Inc. - HALO STOCK NEWS

Halozyme Therapeutics (NASDAQ: HALO) announced that Janssen-Cilag International NV received a positive CHMP opinion recommending marketing authorization for a subcutaneous formulation of RYBREVANT® (amivantamab) in Europe. The recommendation covers two treatments: combination therapy with LAZCLUZE® for first-line treatment of advanced NSCLC with specific EGFR mutations, and monotherapy for advanced NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy failure.

The subcutaneous formulation, developed using Halozyme's ENHANZE® technology, demonstrates significant advantages with an approximate five-minute administration time and a five-fold reduction in infusion-related reactions. The recommendation is supported by positive results from the Phase 3 PALOMA-3 study.

Halozyme (NASDAQ: HALO) has reiterated its 2024 financial guidance and raised its 2025 and multi-year financial outlook. The company projects 2025 total revenue of $1,150-$1,225 million (16-23% YoY growth), adjusted EBITDA of $755-$805 million (24-32% growth), and non-GAAP diluted EPS of $4.95-$5.35 (21-30% growth).

The growth is primarily driven by VYVGART Hytrulo's strong acceptance in generalized myasthenia gravis and CIDP, along with continued growth of Darzalex SC and Phesgo. Three additional products - Ocrevus Zunovo, Tecentriq Hybreza, and Opdivo Qvantig - are expected to contribute modestly in 2025 with meaningful growth from 2026.

The company has also announced a new $250 million accelerated share repurchase program under its previously announced $750 million share repurchase program.

Halozyme Therapeutics (NASDAQ: HALO) has announced an upcoming Investor Conference Call scheduled for Wednesday, January 8, 2025, at 5:30 a.m. PT / 8:30 a.m. ET. During this call, Dr. Helen Torley, President and CEO, and Nicole LaBrosse, CFO, will present preliminary unaudited results for the full year 2024 and provide updated financial guidance for 2025 and beyond.

Investors can pre-register for the live call through a provided registration link. The presentation will also be accessible via webcast through the 'Investors' section of Halozyme's website, with presentation materials becoming available 15 minutes before the call. A recording of the call will be made available afterward.

Halozyme Therapeutics (NASDAQ: HALO) announced that Takeda received regulatory approval from Japan's MHLW for HYQVIA®, a combination therapy using Halozyme's ENHANZE® technology, for patients with agammaglobulinemia or hypogammaglobulinemia.

HYQVIA® is Japan's first plasma-derived subcutaneous therapy combining Immunoglobulin 10% with Recombinant Human Hyaluronidase PH20. The therapy allows for reduced dosing frequency (every 3-4 weeks) compared to conventional treatments (weekly/bi-weekly).

The approval is based on two Phase 3 studies in Japan involving 16 patients aged 2+ years. The trials showed maintained IgG trough levels of 9.494g/L, comparable to traditional treatments. Main adverse reactions included pyrexia (31.3%) and various injection site reactions (12.5%).

Halozyme Therapeutics (NASDAQ: HALO) announced that argenx's VYVDURA, co-formulated with Halozyme's ENHANZE® drug delivery technology, received regulatory approval in Japan for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. The treatment, administered as a weekly 30-90 second subcutaneous injection, is the first FcRn blocker approved for CIDP.

The approval is based on the ADHERE Study, which showed 69% of patients demonstrated clinical improvement, with a 61% reduction in relapse risk versus placebo. VYVDURA was previously approved in Japan for generalized myasthenia gravis (gMG) in January 2024 and received Orphan Drug designation for CIDP in March 2024.

Halozyme (NASDAQ: HALO) announces FDA approval of Bristol Myers Squibb's Opdivo Qvantig™, the first and only subcutaneously administered PD-1 inhibitor co-formulated with ENHANZE® technology. The approval covers most previously approved adult solid tumor Opdivo® indications. The key advantage is faster administration time (3-5 minutes vs. 30 minutes for IV Opdivo).

The approval is based on the Phase 3 CheckMate-67T trial, which demonstrated noninferiority to IV Opdivo. The overall response rate was 24% for Opdivo Qvantig compared to 18% for IV Opdivo. The safety profile was comparable to IV Opdivo, with serious adverse reactions occurring in 28% of patients.

Halozyme Therapeutics (NASDAQ: HALO) has announced its executive leadership team's upcoming presentations at two major investor conferences on December 4, 2024. Chief Financial Officer Nicole LaBrosse will present at the Piper Sandler 36th Annual Healthcare Conference in New York at 10:30am PT, while President and CEO Helen Torley will speak at the 7th Annual Evercore ISI HealthCONx Conference in Miami at 9:30am PT.

Both events will feature fireside chats and one-on-one meetings. Live audio webcasts will be available on the company's Investor Relations website, with replays accessible for 90 days after the conferences.

Halozyme Therapeutics (NASDAQ: HALO) has withdrawn its non-binding proposal to acquire Evotec SE (NASDAQ: EVO) for €11.00 per share in cash, which valued Evotec at €2.0 billion. The withdrawal comes after Evotec's unwillingness to engage in discussions about the potential combination. Despite Halozyme's attempts to engage with Evotec's leadership, including informal discussions with a Supervisory Board member, their requests were not accepted. Halozyme maintains its 2024 guidance with revenue of $970-$1,020 million and adjusted EBITDA of $595-$625 million, and projects 10 approved products with ENHANZE® by 2025 and $1 billion in royalty revenue by 2027.

Halozyme (NASDAQ: HALO) has provided an update on its non-binding proposal to acquire Evotec SE for €11.00 per share in cash, valuing the company at €2.0 billion. The proposed combination would create a leading global innovative pharma services company with projected annual revenue of $2 billion in 2025. The acquisition would combine Evotec's drug discovery and biologics manufacturing capabilities with Halozyme's ENHANZE® drug delivery technology. The all-cash transaction would be funded through cash reserves and new debt, with projected net leverage less than 2x within two years post-close. Halozyme expects to have over $800 million in cash by year-end 2024, maintaining a 15-20%+ revenue CAGR through 2023-2028 and achieving 45-50% adjusted EBITDA margin by 2026.