Core Insights - Johnson & Johnson announced significant findings from two Phase 3 studies demonstrating that DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) based regimens lead to deep and sustained minimal residual disease (MRD) negativity and improved long-term progression-free survival (PFS) in newly diagnosed multiple myeloma patients, regardless of transplant eligibility [1][2][3] Group 1: Study Findings - In the Phase 3 PERSEUS study, over half of the patients maintained MRD negativity for 24 months or longer with the DARZALEX FASPRO® regimen [1][2] - The addition of DARZALEX FASPRO® to the standard treatment regimen (bortezomib, lenalidomide, and dexamethasone) resulted in a 55.8% sustained MRD negativity rate at the 10⁻⁵ threshold compared to 22.6% with the standard regimen alone [2][4] - The Phase 3 CEPHEUS study showed a 60% overall MRD negativity rate at the 10⁻⁵ threshold in transplant-ineligible patients, indicating significant treatment benefits across different patient populations [1][3] Group 2: Long-term Outcomes - At a median follow-up of 47.5 months, the PFS rate was 95.3% at 48 months for patients receiving the DARZALEX FASPRO® regimen, highlighting its effectiveness in delaying disease progression [2] - The study results indicated that 69% of patients treated with the DARZALEX FASPRO® regimen remained progression-free at 54 months, compared to 48% with the standard regimen [4][5] - The overall survival (OS) favored the DARZALEX FASPRO® group, with a hazard ratio of 0.66, suggesting a potential survival benefit [4] Group 3: Safety and Efficacy - The safety profiles of DARZALEX FASPRO® in the PERSEUS and CEPHEUS studies were consistent with previously known safety data, indicating a manageable safety profile [5] - The studies included diverse patient populations, including those considered high-risk for cytogenetic abnormalities, reinforcing the broad applicability of DARZALEX FASPRO® in treating multiple myeloma [3][5] - The consistent results across different studies support the role of DARZALEX FASPRO® as a cornerstone of frontline therapy for multiple myeloma [5]

Core Insights - The FDA Oncologic Drugs Advisory Committee (ODAC) voted 6-2 in favor of the benefit-risk profile of DARZALEX FASPRO® for treating high-risk smoldering multiple myeloma (HR-SMM), marking a significant step in the treatment landscape for this condition [1][2][3] Company Insights - Johnson & Johnson aims to transform oncology care by advocating for early intervention in high-risk smoldering multiple myeloma, potentially delaying or preventing progression to active multiple myeloma [4][6] - The company emphasizes its commitment to evolving treatment paradigms for multiple myeloma, aligning with its vision for a future where early diagnosis and treatment are standard [4][5] Industry Insights - Currently, there are no approved treatments specifically for HR-SMM, with an estimated 35,000 new multiple myeloma cases expected in the U.S. in 2024, of which approximately 15% are classified as smoldering [3][7] - The standard of care for smoldering multiple myeloma is active monitoring, which may delay therapeutic intervention until significant disease progression occurs [3][8] - The AQUILA study, a Phase 3 trial, demonstrated that early intervention with DARZALEX FASPRO® could reduce the risk of progression or death in patients with HR-SMM [4][6]

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 ...