Core Insights - Halozyme Therapeutics announced that Janssen-Cilag International NV received European Commission approval for an indication extension of DARZALEX® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients [1] - The approval allows newly diagnosed patients to receive daratumumab subcutaneously, avoiding lengthy intravenous infusions, thus enhancing patient experience [1] - This approval follows a previous indication extension for daratumumab-VRd in October 2024, based on the Phase 3 PERSEUS study results [1][2] Company Overview - Halozyme is a biopharmaceutical company focused on improving patient experiences and outcomes through innovative drug delivery solutions, particularly with its ENHANZE® technology [4] - The company has successfully licensed its ENHANZE® technology to major pharmaceutical companies, including Roche, Takeda, and Pfizer, among others [4] - Halozyme also develops drug-device combination products aimed at enhancing patient comfort and adherence, with two proprietary commercial products, Hylenex® and XYOSTED® [5]

Core Points - Halozyme Therapeutics announced the European Commission's marketing authorization for the subcutaneous formulation of RYBREVANT® (amivantamab) in combination with LAZCLUZE® (lazertinib) for first-line treatment of advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations [1] - The approval also includes amivantamab as a monotherapy for advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy [1] - The subcutaneous formulation utilizes Halozyme's ENHANZE® drug delivery technology, which aims to improve patient experience by reducing administration time and infusion-related reactions [2][3] Company Overview - Halozyme is a biopharmaceutical company focused on innovative solutions to enhance patient experiences and outcomes, particularly through its ENHANZE® drug delivery technology [4] - The company has successfully licensed its ENHANZE® technology to major pharmaceutical companies, impacting over one million patients globally [4] - Halozyme also develops drug-device combination products aimed at improving convenience, reliability, and patient adherence [5]

Core Insights - Halozyme Therapeutics announced that Bristol Myers Squibb received a positive opinion from the CHMP for the subcutaneous formulation of Opdivo, which is expected to be approved by the European Commission by June 2, 2025 [1][2][4] - The subcutaneous delivery of Opdivo is anticipated to provide cancer patients with a faster and more flexible treatment option, potentially alleviating pressure on healthcare resources [3][4] - The positive opinion from CHMP is supported by results from the Phase 3 CheckMate -67T trial [4] Company Overview - Halozyme is a biopharmaceutical company focused on improving patient experiences and outcomes through its ENHANZE® drug delivery technology, which utilizes the proprietary enzyme rHuPH20 [5] - The company has licensed its ENHANZE® technology to several leading pharmaceutical and biotechnology companies, including Roche, Takeda, and Pfizer, among others [5] - Halozyme also develops drug-device combination products and has two commercial proprietary products, Hylenex® and XYOSTED®, along with ongoing partnerships and product development programs [6]

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Core Viewpoint - Halozyme Therapeutics reported strong fourth-quarter results for 2024, with adjusted earnings and revenues exceeding expectations, driven by increased royalty payments and milestone revenues from partnerships with Roche and Johnson & Johnson [1][2][5]. Financial Performance - Adjusted earnings for Q4 2024 were $1.26 per share, surpassing the Zacks Consensus Estimate of $1.16, and up from $0.82 per share in the same quarter last year [1]. - Total revenues for Q4 2024 reached $298 million, a 30% increase year over year, exceeding the Zacks Consensus Estimate of $284 million [2]. - Royalty revenues amounted to $170.4 million, a 40% increase from the previous year, driven by strong demand for Phesgo and subcutaneous Darzalex [5]. - Product sales were $79.4 million, nearly matching the previous year's figures, and also beating the model estimate of $77 million [6]. - Revenues from collaborative agreements increased by 69.7% year over year to $48.2 million [8]. - Adjusted EBITDA for Q4 was $195.8 million, reflecting a 60.9% increase from the prior year [8]. Annual Results - For the full year 2024, Halozyme generated revenues of $1.02 billion, marking a 22% increase year over year and the first time surpassing the $1 billion mark [9]. - Adjusted earnings for the full year were $4.23 per share, up from $2.77 per share in the previous year [9]. Future Guidance - For 2025, total revenue is expected to be between $1.15 billion and $1.22 billion, indicating a year-over-year growth of 13% to 21% [10]. - Royalty revenues are projected to be in the range of $725 million to $750 million, reflecting a growth of 27% to 31% [11]. - Adjusted earnings per share for 2025 are anticipated to be between $4.95 and $5.35, representing a growth of 17% to 26% year over year [11]. Stock Performance - Shares of Halozyme increased by 1.9% in after-hours trading following the earnings report [3]. - Over the past year, Halozyme's shares have risen by 60.8%, contrasting with an 8.5% decline in the industry [4].

Financial Data and Key Metrics Changes - Total revenue exceeded $1 billion for the first time, growing 22% year-over-year to $1.15 billion in 2024 [7][54] - Royalty revenue grew 27% to $571 million, contributing significantly to total revenue growth [10][54] - Net income increased 58% year-over-year to $444 million [10] - Adjusted EBITDA increased 48% to $632 million from $426 million in 2023 [55] - Non-GAAP diluted earnings per share rose to $4.23 from $2.77 in 2023 [56] Business Line Data and Key Metrics Changes - DARZALEX subcutaneous sales represented 95% of total DARZALEX sales in the U.S., with worldwide sales growing almost 24% to $3.1 billion in Q4 2024 [12][13] - Phesgo revenue reached approximately $2 billion for full year 2024, growing 72% year-over-year [16] - VYVGART, including VYVGART Hytrulo, achieved fourth quarter sales of $737 million, with full year revenue of $2.2 billion [18] Market Data and Key Metrics Changes - The U.S. market for DARZALEX is projected to grow significantly, with analyst projections estimating over $17 billion in total revenue by 2028 [14] - Phesgo is expected to reach $3.4 billion in revenue by 2028 [17] - Ocrevus Zunovo sales reached approximately $7.7 billion in 2024, with significant growth potential [29] Company Strategy and Development Direction - The company aims to maintain strong revenue and earnings growth through continued expansion of ENHANZE partnerships and product approvals [9][38] - New product launches and regulatory approvals are expected to contribute to revenue growth through 2030 and beyond [64] - The company is actively pursuing new nominations and deals for ENHANZE, with a focus on expanding its pipeline [44][45] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving another record year in 2025, projecting total revenue growth of 13% to 21% [11][57] - The company anticipates strong growth from DARZALEX, Phesgo, and VYVGART Hytrulo, with VYVGART expected to be the largest growth driver in 2025 [57] - Management highlighted the importance of maintaining operational efficiencies to support continued profitability [56] Other Important Information - The company extended patent protection for ENHANZE in Europe until 2029, maintaining royalty rates for key products [9] - A development agreement for a small-volume auto-injector was signed with a current partner, indicating ongoing innovation in delivery methods [44][80] Q&A Session Summary Question: What is the confidence around new uses and argenx-related programs beyond 2028? - Management indicated that current approved products will continue to contribute significantly post-2028, with multiple opportunities for new nominations and pipeline products [70][72] Question: What does the integration of the small-volume auto-injector mean for partnerships? - The small-volume auto-injector deal will create new revenue streams through development and commercial agreements, enhancing existing partnerships [78][81] Question: What are the dynamics behind the expected decrease in royalties for Q1? - The decrease is attributed to annual rate resets in contracts, particularly impacting DARZALEX, but growth is expected to resume quickly [91][92] Question: How is the pre-filled syringe transition incorporated into guidance? - The guidance reflects potential increases from the pre-filled syringe, which is expected to enhance patient access and adoption [98] Question: Will VYVGART subcutaneous sales exceed IV sales in 2025? - While management is optimistic about the growth of VYVGART, they cannot provide a specific timeline for when subcutaneous sales will surpass IV sales [113] Question: What do the undisclosed products on Slide 23 represent? - The undisclosed products are from current partners, with opportunities for new deals expected to be announced separately [115]

Financial Data and Key Metrics Changes - Total revenue exceeded $1 billion for the first time, growing 22% year-over-year to $1.15 billion in 2024 [7][54] - Royalty revenue grew 27% to $571 million, contributing significantly to total revenue [10][54] - Net income increased 58% year-over-year to $444 million [10] - Adjusted EBITDA rose 48% to $632 million from $426 million in 2023 [55] - Non-GAAP diluted EPS increased to $4.23 from $2.77 in 2023 [56] Business Line Data and Key Metrics Changes - DARZALEX subcutaneous sales represented 95% of total DARZALEX sales in the U.S., with worldwide sales growing almost 24% to $3.1 billion in Q4 2024 [12][13] - Phesgo revenue reached approximately $2 billion for full year 2024, growing 72% year-over-year [16] - VYVGART and VYVGART Hytrulo sales reached $737 million in Q4 2024, with full year revenue of $2.2 billion [18] Market Data and Key Metrics Changes - The U.S. market for DARZALEX is projected to grow significantly, with analyst projections estimating over $17 billion in total revenue by 2028 [14] - Phesgo is expected to reach $3.4 billion in revenue by 2028 [17] - Ocrevus Zunovo sales reached approximately $7.7 billion in 2024, with significant growth opportunities anticipated [29] Company Strategy and Development Direction - The company aims to maintain strong revenue growth through existing products and new approvals, with a focus on expanding the ENHANZE platform [9][64] - The strategy includes extending patent protections and securing new partnerships to enhance revenue streams [9][44] - The company is actively pursuing new nominations and deals to drive future growth [45][47] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving another record year in 2025, projecting total revenue growth of 13% to 21% [11][57] - The company anticipates continued strong growth from DARZALEX, Phesgo, and VYVGART Hytrulo, with VYVGART expected to be the largest growth driver in 2025 [11][57] - Management highlighted the importance of new product approvals and ongoing partnerships in sustaining long-term growth [64] Other Important Information - The company maintained a strong balance sheet with cash and marketable securities totaling $596 million as of December 31, 2024 [52] - A $250 million accelerated share repurchase program was initiated, with a total of $1.55 billion returned in share repurchases since 2019 [60][62] Q&A Session Summary Question: What is the confidence around new uses and argenx-related programs beyond 2028? - Management indicated high confidence in existing products continuing to contribute significantly post-2028, with multiple opportunities for new nominations and pipeline products [70][72] Question: Can you elaborate on the small-volume auto-injector's impact on partnerships? - Management explained that the small-volume auto-injector deal will create new revenue streams through development and commercial agreements, enhancing existing partnerships [80][82] Question: What are the dynamics behind the expected decrease in royalties for Q1? - Management clarified that annual rate resets and seasonality in certain products, particularly DARZALEX, contribute to the expected decrease in royalties for the first quarter [91][93] Question: How is the pre-filled syringe transition being incorporated into guidance? - Management confirmed that the guidance reflects the potential increase from the pre-filled syringe, which is expected to enhance patient access and adoption [98] Question: Will VYVGART subcutaneous sales exceed IV sales in 2025? - Management expressed excitement about the growth of VYVGART but refrained from commenting on specific timelines for when subcutaneous sales might exceed IV sales [113] Question: Are the three undisclosed products on Slide 23 new deals expected this year? - Management clarified that the three products are from current partners, with new deals expected to be over and above these nominations [115]

Core Insights - Halozyme Therapeutics reported revenue of $298.01 million for the quarter ended December 2024, marking a year-over-year increase of 29.6% and an EPS of $1.26 compared to $0.82 a year ago [1] - The reported revenue exceeded the Zacks Consensus Estimate of $284.02 million, resulting in a surprise of +4.93%, while the EPS also surpassed the consensus estimate of $1.16 with a surprise of +8.62% [1] Revenue Breakdown - Product sales, net amounted to $79.36 million, slightly below the average estimate of $75.16 million, reflecting a year-over-year change of -0.3% [4] - Royalties generated $170.42 million, exceeding the average estimate of $159.68 million, and showing a significant year-over-year increase of +39.6% [4] - Revenues from collaboration agreements reached $48.23 million, slightly below the average estimate of $49.20 million, but representing a substantial year-over-year increase of +69.9% [4] Stock Performance - Over the past month, shares of Halozyme Therapeutics have returned +6.4%, outperforming the Zacks S&P 500 composite's +4.7% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]

Group 1 - Halozyme Therapeutics reported quarterly earnings of $1.26 per share, exceeding the Zacks Consensus Estimate of $1.16 per share, and showing an increase from $0.82 per share a year ago, representing an earnings surprise of 8.62% [1] - The company achieved revenues of $298.01 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 4.93%, and up from $230.04 million in the same quarter last year [2] - Halozyme Therapeutics has outperformed the S&P 500, with shares increasing approximately 21.9% since the beginning of the year compared to the S&P 500's gain of 4% [3] Group 2 - The earnings outlook for Halozyme Therapeutics is mixed, with the current consensus EPS estimate for the upcoming quarter at $1.01 on revenues of $247.73 million, and for the current fiscal year at $5.01 on revenues of $1.19 billion [7] - The Medical - Biomedical and Genetics industry, to which Halozyme belongs, is currently ranked in the top 27% of over 250 Zacks industries, indicating a favorable outlook for the sector [8]

Core Insights - Nexalin Technology, Inc. has received Institutional Review Board (IRB) approval from the University of California, San Diego (UCSD) for clinical testing of its HALO™ Clarity headset in human subjects, marking a significant milestone for the company [1][4] - The independent study at UCSD will evaluate the efficacy of HALO in treating mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD), particularly in military personnel [2][4] Company Overview - Nexalin Technology specializes in Deep Intracranial Frequency Stimulation (DIFS) technology, which provides non-invasive deep-brain stimulation without drugs or invasive procedures [3][7] - The HALO device is designed to be a drug-free alternative for mental health care, reducing the risk of side effects associated with pharmacological treatments [5][7] Clinical Trial Details - UCSD has requested and will receive 50 HALO devices from Nexalin for the independent research project, with the initial shipment already in preparation [2][4] - The clinical trials will utilize a virtual clinic model that incorporates artificial intelligence (AI) and a proprietary Electronic Data Capture (EDC) platform to enhance patient care and ensure real-time monitoring of treatment progress [3][5] Technology and Innovation - The HALO device allows for at-home use, providing comfort and convenience for patients while enabling remote monitoring by physicians [5][6] - The integration of AI facilitates real-time data acquisition and analysis during clinical trials, improving efficiency and compliance [5][6] Future Outlook - The independent study at UCSD aims to provide essential data to further establish HALO as a revolutionary treatment option for mTBI and PTSD, building upon prior research that has shown DIFS technology's ability to modulate neural activity [4][6] - Nexalin remains committed to pioneering neuromodulation technologies to address unmet needs in mental health and neurological care [4][7]