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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SAN DIEGO, Dec. 30, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Takeda received regulatory approval for HYQVIA® [Immune Globulin Infusion 10% (Human) with Halozyme's Recombinant Human Hyaluronidase] by the Japanese Ministry of Health, Labour and Welfare (MHLW) for patients with agammaglobulinemia or hypogammaglobulinemia, disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primar ...

SAN DIEGO, Dec. 30, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that argenx's VYVDURA (efgartigimod alfa and hyaluronidase-qvfc), which is co-formulated with Halozyme's ENHANZE® drug delivery technology, was granted regulatory approval by Japan's Ministry of Health, Labour and Welfare (MHLW) for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVDURA was approved for CIDP as a once weekly 30-to-90 second subcutaneous injection, which can b ...