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]

Fourth Quarter and FY 2024 Financial & Operating Results Halozyme Therapeutics, Inc. NASDAQ: HALO February 18, 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 d ...

Revenue Growth - Royalties for the year ended December 31, 2024, increased to $570.99 million from $447.87 million in 2023, representing a 27% growth driven by sales of DARZALEX SC and Phesgo[238]. - The company expects further growth in royalty revenue due to anticipated increases in partner product sales, including recently launched products like VYVGART Hytrulo, TECENTRIQ SC, OCREVUS SC, and Opdivo Qvantig[238]. - Proprietary product sales increased by $35,786 thousand, or 27%, to $166,620 thousand in 2024, while total product sales, net rose by $2,638 thousand, or 1%, to $303,492 thousand[239]. - Revenues under collaborative agreements surged by $60,307 thousand, or 75%, to $140,841 thousand, driven by a significant increase in upfront license fees, which rose by $25,000 thousand, or 1,250%[240]. Collaborations and Licensing - The company has collaborations and licensing agreements with major biopharmaceutical companies, including Roche, Takeda, and Pfizer, which generate upfront licensing fees and milestone payments[226]. - In September 2024, Roche's OCREVUS ZUNOVO was approved by the FDA for a ten-minute subcutaneous injection, resulting in a $12 million milestone payment[230]. - The company received $30 million in upfront payments from argenx for the nomination of four additional targets under an expanded collaboration agreement[230]. Financial Performance - Operating expenses decreased overall, with cost of sales down by $32,944 thousand, or 17%, to $159,417 thousand, while research and development expenses increased by $2,685 thousand, or 4%, to $79,048 thousand[241]. - Investment and other income, net increased by $7,435 thousand, or 46%, to $23,752 thousand, primarily due to a rise in the average invested balance[246]. - Income tax expense rose by $46,306 thousand, or 69%, to $113,041 thousand, attributed to higher income before tax and changes in tax benefits[247]. - Net cash provided by operating activities increased by $90,493 thousand, reaching $479,064 thousand, primarily due to higher revenue[257]. Debt and Financing - The company’s long-term debt, consisting of convertible notes, amounted to $1,525.0 million as of December 31, 2024, with future interest payments totaling $30.4 million[251]. - The company completed a share repurchase program of up to $750.0 million in June 2024 and authorized a new program for the same amount in February 2024[261]. - The 2027 Convertible Notes, totaling $805.0 million, have a maturity date of March 1, 2027, and pay interest at an annual rate of 0.25%[269][270]. - The 2024 Convertible Notes, totaling $460.0 million, were converted in full in March 2023, with approximately $13.5 million paid in cash and 288,886 shares issued[276]. Cash Management and Investments - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $596.1 million, expected to fund operations for at least the next 12 months[249]. - Cash, cash equivalents, and marketable securities are deemed to have minimal risk of default or illiquidity, based on discussions with investment advisors[296]. - The primary objective of the company's investment activities is to preserve principal while maximizing income without significantly increasing risk[294]. - The cash management strategy is designed to minimize excessive risk while ensuring liquidity[296]. Risk Management - The company hedges a portion of foreign currency exchange risk related to forecasted royalties revenue in Swiss francs to mitigate earnings and cash flow volatility[295]. - The company does not believe that its results of operations would be materially impacted by an immediate change of 10% in interest rates based on its current investment portfolio[294]. - The company does not engage in speculative trading of derivatives or other financial instruments[295]. - The cash flow hedges are recorded at fair value with gains and losses reflected in AOCI and reclassified to royalty revenue[295].

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]

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]