Core Insights - Roche, in collaboration with the Breast International Group (BIG) and other partners, announced significant overall survival results from the phase III APHINITY study for HER2-positive early-stage breast cancer, showing a 17% reduction in the risk of death after ten years for patients treated with a Perjeta-based regimen compared to those receiving Herceptin and chemotherapy [1][2][6]. Study Results - The APHINITY study demonstrated that 91.6% of patients treated with the Perjeta-based regimen were alive at ten years, compared to 89.8% for the control group, with a hazard ratio of 0.83 [6]. - A 21% reduction in the risk of death was observed in the subgroup of patients with lymph node-positive disease, with a hazard ratio of 0.79 [6][5]. - The previously reported invasive disease-free survival benefit was maintained, reinforcing earlier analyses [6][5]. Treatment Implications - The results validate the Perjeta-based regimen as a standard-of-care treatment for high-risk HER2-positive breast cancer patients, particularly those with lymph node-positive disease [2][4]. - Roche's commitment to improving outcomes for HER2-positive breast cancer patients is evident through the development of targeted therapies like Herceptin and Perjeta, which have transformed survival rates [11][10]. Future Presentations - Full results from the APHINITY study will be presented as a late-breaking abstract at the 2025 European Society for Medical Oncology Breast Cancer Congress [3].

Core Insights - Roche, in collaboration with Breast International Group (BIG) and other partners, announced significant overall survival results from the phase III APHINITY study for HER2-positive early-stage breast cancer, showing a 17% reduction in the risk of death after ten years for patients treated with a Perjeta-based regimen compared to standard treatment [1][5][6] Group 1: Study Results - The APHINITY study demonstrated that after ten years, 91.6% of patients treated with the Perjeta-based regimen were alive, compared to 89.8% of those receiving standard treatment, with a hazard ratio of 0.83 [6] - A 21% reduction in the risk of death was observed in the subgroup of patients with lymph node-positive disease, with a hazard ratio of 0.79 [6] - The previously reported invasive disease-free survival benefit was maintained, reinforcing earlier analyses [6] Group 2: Treatment Implications - The results validate the Perjeta-based regimen as a standard-of-care treatment for early-stage HER2-positive breast cancer, particularly for high-risk patients [1][3] - Roche's commitment to improving outcomes for HER2-positive breast cancer patients is evident through the development of targeted therapies like Herceptin and Perjeta, which have transformed survival rates [8][9] Group 3: Future Directions - Full results from the APHINITY study will be presented at the 2025 European Society for Medical Oncology Breast Cancer Congress, indicating ongoing research and collaboration in the field [2][5] - The collaborative efforts in the APHINITY study have led to pivotal trials that continue to enhance understanding and treatment of HER2-positive breast cancer [3][4]

Halozyme Therapeutics (HALO) reported first-quarter 2025 adjusted earnings of $1.11 per share, which comprehensively beat the Zacks Consensus Estimate of 95 cents. Earnings rose 41% year over year.Total revenues in the first quarter increased 35% year over year to $264.9 million. Revenues too surpassed the Zacks Consensus Estimate of $239 million. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)The top-line growth was primarily driven by higher royalty payments from Roche (RHHBY) fo ...

Halozyme Therapeutics, Inc. First Quarter Financial & Operating Results NASDAQ: HALO May 6, 2025 1 Forward-Looking Statements In addition to historical information, the statements set forth in this presentation include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance and growth rates (including the Company's 2025 financial guidance and longer term financial outlook through 2028 and the assumptions used in deriving such guidan ...

Announcing New $250M Share Repurchase Total Revenue Increased 35% YOY to $265 million and Royalty Revenue Increased 39% YOY to $168 million Net Income Increased 54% YOY to $118 million; Adjusted EBITDA Increased 40% YOY to $162 million; GAAP Diluted EPS Increased 55% YOY to $0.93; non-GAAP Diluted EPS Increased 41% YOY to $1.111 Raising 2025 Financial Guidance Ranges for Total Revenue to $1,200 - $1,280 million, Representing YOY Growth of 18% - 26%, Adjusted EBITDA to $790 - $840 million, Representing YOY G ...

Basel, 30 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an update to the European Union (EU) label for Phesgo®, a subcutaneous (SC) fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab), for human epidermal growth factor receptor 2 (HER2)-positive breast cancer. If approved, administration of Phesgo outside of a clinical setting (such ...

Positive recommendation based on clinical, real-world and bioequivalence data supporting feasibility and safety of Phesgo’s administration outside of clinical settings, for example at home1-4 Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings3Phesgo has the potential to reduce treatment administration costs by up to 80% in Western Europe, and 85% of patients prefer SC over IV administration.7,3 B ...

Halozyme Therapeutics, Inc. (NASDAQ:HALO) Q4 2024 Earnings Conference Call February 18, 2025 4:30 PM ET Company Participants Tram Bui - Vice President, Investor Relations & Corporate Communications Helen Torley - President & Chief Executive Officer Nicole LaBrosse - Chief Financial Officer Conference Call Participants Sean Laaman - Morgan Stanley Brendan Smith - TD Cowen Mohit Bansal - Wells Fargo Jessica Fye - JPMorgan Michael DiFiore - Evercore ISI Jason Butler - Citizens JMP Operator Good afternoon. My n ...