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]

Core Viewpoint - Halozyme Therapeutics (HALO) is set to report its fourth-quarter and full-year 2024 results on February 18, with revenue expectations of $284.3 million and earnings of $1.16 per share [1]. Group 1: Financial Performance - In the past year, Halozyme's shares have increased by 65.8%, contrasting with a 3.5% decline in the industry [2]. - The company's revenue for the upcoming quarter is expected to be driven by higher royalty payments from Roche for Phesgo and from J&J for subcutaneous Darzalex due to strong demand [5]. - Revenue from collaborative agreements saw significant growth in the third quarter, a trend likely to continue into the fourth quarter [6]. Group 2: Product and Technology Impact - Halozyme's Enhanze technology is utilized by several companies to develop subcutaneous formulations of their marketed drugs, including J&J's Darzalex and Roche's Phesgo [4]. - The company has two proprietary products, Hylenex and Xyosted, with incremental sales from these products expected to contribute positively to revenues [6]. Group 3: Future Guidance - Due to strong business performance in 2024, Halozyme raised its 2025 revenue guidance to a range of $1.15 billion to $1.22 billion, indicating a year-over-year growth of 16% to 23% [9]. - Royalty revenues for 2025 are now anticipated to be between $725 million and $750 million, reflecting a year-over-year growth of 30% to 35% [9]. Group 4: Earnings Surprise History - Halozyme has a mixed earnings surprise history, beating earnings in three of the last four quarters and delivering an average surprise of 14.86% [11]. - In the last reported quarter, Halozyme achieved an earnings surprise of 28.28% [11].

Company Overview - Halozyme Therapeutics, Inc. is a biopharmaceutical company focused on improving patient experiences and outcomes through innovative solutions [3] - The company is known for its ENHANZE® drug delivery technology, which utilizes the proprietary enzyme rHuPH20 to facilitate subcutaneous delivery of drugs and fluids [3] - Halozyme has impacted over one million patients through its technology, which is used in nine commercialized products across more than 100 global markets [3] Financial Results Announcement - Halozyme will release its fourth quarter and full year 2024 financial and operating results on February 18, 2025, after the market closes [1] - A conference call to discuss these results will take place on the same day at 1:30 p.m. PT/4:30 p.m. ET, with access available via pre-registration [1] Product Development and Partnerships - The company develops, manufactures, and commercializes drug-device combination products, leveraging advanced auto-injector technologies for improved patient convenience and adherence [4] - Halozyme has two proprietary commercial products, Hylenex® and XYOSTED®, and collaborates with several pharmaceutical companies, including Teva Pharmaceuticals and Idorsia Pharmaceuticals, for ongoing product development [4]

Core Viewpoint - Halozyme Therapeutics announced that Janssen-Cilag International NV received a positive opinion from the CHMP for extending marketing authorization for a subcutaneous formulation of RYBREVANT® (amivantamab) in combination with LAZCLUZE® (lazertinib) for treating advanced non-small cell lung cancer (NSCLC) [1][2] Group 1: Product Development and Approval - The subcutaneous formulation of amivantamab, developed using Halozyme's ENHANZE drug delivery technology, was recommended for approval in Europe, highlighting a five-minute administration time and a five-fold reduction in infusion-related reactions [2][3] - The positive opinion from CHMP is supported by results from the Phase 3 PALOMA-3 study, which indicates the efficacy of the treatment [2][4] Group 2: Company Overview and Technology - Halozyme is a biopharmaceutical company focused on improving patient experiences and outcomes through its ENHANZE® drug delivery technology, which facilitates subcutaneous delivery of injected drugs [6][7] - The company has licensed its ENHANZE® technology to several leading pharmaceutical companies, including Roche, Takeda, and Pfizer, and has impacted over one million patients globally [6][7]

Company Performance and Financial Guidance - Halozyme Therapeutics' shares rallied 55.2% in the past year, outperforming the industry's decline of 14.4% [1] - The company raised its 2025 financial guidance, with total revenues expected to be $1.15-$1.22 billion, representing year-over-year growth of 16%-23% [4] - Adjusted EBITDA for 2025 is projected to be $755-$805 million, implying year-over-year growth of 24%-32% [4] - For 2024, preliminary total revenues are expected to be $970 million-$1.02 billion, with royalty revenues anticipated at $550-$565 million [5] - Net income for 2024 is forecasted to be $419-$443 million, with earnings per share expected at $3.22-$3.40 and adjusted earnings at $4.00-$4.20 [6] Revenue Drivers and Partnerships - Halozyme's Enhanze technology is used by several companies to develop subcutaneous formulations of their drugs, including J&J's Darzalex and Roche's Phesgo [1] - The company's top line comprises product sales, royalty payments from Roche for Phesgo and J&J for subcutaneous Darzalex, and revenues from collaborative agreements related to Enhanze technology [9] - Royalty revenues are now anticipated to be $725-$750 million, implying year-over-year growth of 30%-35%, driven by strong growth of J&J's Darzalex SC and Roche's Phesgo [2] Share Repurchase and Market Performance - Halozyme announced a new $250 million accelerated share repurchase program under its previously announced $750 million share repurchase program [3] - The company's shares were up 5% on Jan 8, 2025, following the raised guidance, and gained another 1.8% in after-hours trading [3] Earnings and Adjusted Earnings - Adjusted earnings for 2025 are now expected to be $4.95-$5.35 per share, representing year-over-year growth of 21%-30% [10] - The earnings per share guidance does not consider the impact of potential future share repurchases [11] Industry Comparison - Puma Biotechnology, another top-ranked stock in the biotech sector, has seen its 2025 earnings per share estimates increase from 42 cents to 54 cents in the past 60 days [7] - Puma Biotechnology's shares have declined 25.7% in the past year, despite beating earnings estimates in three of the trailing four quarters with an average surprise of 32.78% [7][8]

Financial Projections for 2025 - Total revenue for 2025 is expected to be $1,150 - $1,225 million, representing YoY growth of 16% - 23%[1][6] - Adjusted EBITDA for 2025 is projected to be $755 - $805 million, with YoY growth of 24% - 32%[1][6] - Non-GAAP diluted EPS for 2025 is estimated at $4.95 - $5.35, reflecting YoY growth of 21% - 30%[1][6] - Royalty revenue for 2025 is anticipated to be $725 - $750 million, showing YoY growth of 30% - 35%[6][8] Financial Projections for 2024 - 2024 preliminary total revenue is estimated at $970 - $1,020 million[4] - 2024 preliminary adjusted EBITDA is projected to be $595 - $625 million[4] - 2024 preliminary non-GAAP diluted EPS is estimated at $4.00 - $4.20[4] Share Repurchase Program - The company announced a new $250 million accelerated share repurchase program[1][2] Revenue Growth Drivers - VYVGART Hytrulo and Darzalex SC are key drivers of 2025 revenue growth[3] ENHANZE Technology - ENHANZE technology has been used in nine commercialized products across over 100 global markets[9] Adjustments and Reconciliations - Adjustments relate to taxes for reconciling items, excess benefits or tax deficiencies from stock-based compensation, and the quarterly impact of other discrete items[22] - Adjustment made for the dilutive effect of Convertible Senior Notes due 2028 when the effect differs on a GAAP and non-GAAP basis for the reporting period[22]

Reports Preliminary 2024 Unaudited Estimated Ranges Consistent with Previous Financial Guidance Raises 2025 Financial Guidance Ranges for Total Revenue to $1,150 - $1,225 million, Representing YoY Growth of 16% - 23%, Adjusted EBITDA of $755 - $805 million, Representing YoY Growth of 24% - 32%, and non-GAAP Diluted EPS of $4.95 - $5.35, Representing YoY Growth of 21% - 30%1,2Announces New $250 million Accelerated Share RepurchaseConference Call Scheduled Today at 5:30am PT/8:30am ETSAN DIEGO, Jan. 8, 2025 / ...

SAN DIEGO, Jan. 6, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced it will host an Investor Conference Call on Wednesday, January 8, 2025, at 5:30 a.m. PT / 8:30 a.m. ET.On the call, Dr. Helen Torley, President and Chief Executive Officer, and Nicole LaBrosse, Chief Financial Officer, will provide preliminary unaudited full year 2024 results and updated 2025 and multi-year financial guidance.Pre-registration of the live call can be accessed via link here: https:/ ...

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