HALOZYME RAISES 2025 FINANCIAL GUIDANCE RANGES AND REPORTS STRONG FIRST QUARTER 2025 RESULTS
- Strong Q1 2025 financial performance with 35% revenue growth and 54% net income growth
- Raised 2025 guidance with projected revenue growth of 18-26% YOY
- New $250M share repurchase program announced
- Expanded portfolio with multiple new product approvals and launches
- Strong royalty revenue growth of 39% YOY
- Robust cash position of $747.9M, up from $596.1M in December 2024
- Patent infringement lawsuit filed against Merck regarding SC Keytruda development
- Increased selling, general and administrative expenses by 20.8% YOY
- Higher cost of sales, up 71% compared to Q1 2024
Insights
Halozyme delivered exceptional Q1 with 35% revenue growth, raised 2025 guidance, and announced $250M share repurchase, showing financial strength.
Halozyme's Q1 2025 results demonstrate remarkable financial strength across all key metrics. Total revenue surged
The company's capital-light business model is generating substantial cash flow, with cash and investments increasing to
Particularly significant is Halozyme's decision to raise full-year 2025 guidance across all financial metrics:
- Total revenue guidance increased to
$1,200-$1,280 million (from$1,150-$1,225 million ) - Royalty revenue guidance increased to
$750-$785 million (from$725-$750 million ) - Adjusted EBITDA guidance increased to
$790-$840 million (from$755-$805 million ) - Non-GAAP EPS guidance increased to
$5.30-$5.70 (from$4.95-$5.35 )
The revised guidance represents impressive year-over-year growth projections of
The only potential concern worth monitoring is the patent infringement lawsuit against Merck regarding subcutaneous Keytruda. While litigation outcomes are inherently unpredictable, Halozyme's proactive defense of its intellectual property is prudent for long-term value protection.
Halozyme's ENHANZE platform drives growth across multiple blockbuster drugs with numerous catalysts from approvals and label expansions expected.
Halozyme's robust Q1 performance highlights the growing adoption of its ENHANZE drug delivery technology across the pharmaceutical industry. The company's three established blockbuster partner products - Darzalex SC (daratumumab), Phesgo (pertuzumab/trastuzumab), and VYVGART Hytrulo (efgartigimod) - continue showing strong growth in their approved indications, forming a solid foundation for royalty revenue.
The recent launches of four additional ENHANZE-enabled products - Ocrevus Zunovo (U.S./Europe), Tecentriq Hybreza (U.S./Europe), Opdivo Qvantig (U.S.), and Rybrevant SC (Europe) - represent significant revenue growth opportunities as these products gain reimbursement coverage and market penetration. Notably, Rybrevant SC with ENHANZE marks Halozyme's 10th partnered commercial product.
The quarter featured numerous regulatory achievements strengthening Halozyme's market position:
- CHMP recommendation for Phesgo administration outside clinical settings
- CHMP recommendation for VYVGART with ENHANZE for CIDP
- FDA approval of VYVGART Hytrulo prefilled syringe for self-injection
- European Commission approval of Rybrevant SC with ENHANZE for first-line EGFR-mutant NSCLC
- European Commission approval of DARZALEX SC for newly diagnosed multiple myeloma patients
- CHMP recommendation for Opdivo with ENHANZE across multiple solid tumors
Pipeline advancements include BMS's nivolumab plus relatlimab SC and Takeda's 20% immune globulin SC in Phase 3 development. Additionally, promising data from ViiV's N6LS with ENHANZE for HIV and Acumen's sabirnetug with ENHANZE demonstrate the platform's versatility across diverse therapeutic areas.
The patent infringement lawsuit against Merck regarding Keytruda SC underscores the value of Halozyme's intellectual property portfolio. As subcutaneous administration becomes increasingly preferred for many biologics due to convenience and reduced administration time, Halozyme's proprietary technology maintains significant competitive advantages.
Halozyme's mention of its first HVAI (Halozyme Volume Augmentation Injection) development agreement and progress with SVAI (Small Volume Access Injection) further demonstrates the company's continued innovation beyond its core ENHANZE platform.
Announcing New
Total Revenue Increased
Net Income Increased
Raising 2025 Financial Guidance Ranges for Total Revenue to
"2025 is off to a strong start with our current three blockbuster brands, Darzalex SC, Phesgo and VYVGART Hytrulo, continuing to demonstrate strong growth in their currently approved indications. Our four recently launched products, Ocrevus Zunovo in
"In addition, our long-term growth prospects have never been better with additional growth opportunities projected to result from our pipeline, where two products, BMS' nivolumab plus relatlimab SC and Takeda's
First Quarter and Recent Corporate Highlights:
- On May 6, Halozyme announced a second
share repurchase under the$250 million approved program from February 2024.$750 million - In April 2025, Halozyme filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. ("Merck") in the
U.S. District Court inNew Jersey alleging that Merck is using Halozyme's patented MDASE™ subcutaneous drug delivery technology to develop Subcutaneous ("SC") Keytruda. Halozyme is seeking damages and injunctive relief to stop Merck's infringement of Halozyme's MDASE™ intellectual property. - In March 2025, Halozyme completed the first
Accelerated Share Repurchase of its common stock under the$250 million approved program from February 2024.$750 million
First Quarter and Recent Partner Highlights:
- In April 2025, Roche received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use ("CHMP") recommending an update to the European Union ("EU") label for Phesgo® for human epidermal growth factor receptor 2 ("HER2")-positive breast cancer. Administration of Phesgo® outside of a clinical setting (such as in a person's home) by a healthcare professional will be possible, once safely established in a clinical setting.
- In April 2025, argenx received a positive opinion from the CHMP recommending European Commission approval of VYVGART® 1000mg (efgartigimod alfa) developed with ENHANZE® for SC injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy ("CIDP") after prior treatment with corticosteroids or immunoglobulins.
- In April 2025, argenx received
U.S. Food and Drug Administration ("FDA") approval of VYVGART® Hytrulo prefilled syringe for self-injection for the treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive and adult patients with CIDP. - In April 2025, Janssen received European Commission marketing authorization of the SC formulation of RYBREVANT® (amivantamab) with ENHANZE®, in combination with LAZCLUZE® (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer ("NSCLC") with epidermal growth factor receptor ("EGFR") exon 19 deletions or exon 21 L858R substitution mutations. Additionally, RYBREVANT® (amivantamab) is approved as a monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after the failure of platinum-based therapy. This represents the 10th partner product with ENHANZE® to be commercialized.
- In April 2025, Janssen received European Commission approval for an indication extension of DARZALEX® SC in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma regardless of transplant eligibility.
- In March 2025, Bristol Myers Squibb received a positive CHMP opinion recommending approval of Opdivo® (nivolumab) with ENHANZE® across multiple solid tumor indications.
- In March 2025, Acumen announced top-line results from a Phase 1 study of sabirnetug (ACU193) with ENHANZE® comparing the pharmacokinetics between SC and intravenous administrations in healthy volunteers that demonstrated weekly SC administration of sabirnetug was well-tolerated with systematic exposure supporting further clinical development.
- In March 2025, ViiV announced results from a Phase 2b study demonstrated N6LS administered every four months SC with ENHANZE® in combination with cabotegravir successfully maintained viral suppression in adults living with HIV who were already stable on treatment.
- In March 2025, Takeda announced Health Canada expanded the marketing authorization for HYQVIA® to include CIDP as a maintenance therapy after stabilization with intravenous immunoglobulin to prevent relapse of neuromuscular disability and impairment in adults.
First Quarter 2025 Financial Highlights:
- Revenue was
, compared to$264.9 million in the first quarter of 2024. The$195.9 million 35% year-over-year increase was primarily driven by royalty revenue growth and an increase in sales of bulk rHuPH20. Revenue for the quarter included in royalties, an increase of$168.2 million 39% compared to in the first quarter of 2024, primarily attributable to increases in revenue of VYVGART® Hytrulo, DARZALEX® SC, and Phesgo®.$120.6 million - Cost of sales was
, compared to$48.4 million in the first quarter of 2024. The increase in cost of sales was primarily due to an increase in product sales.$28.3 million - Amortization of intangibles expense remained flat at
, compared to the first quarter of 2024.$17.8 million - Research and development expense was
, compared to$14.8 million in the first quarter of 2024. The decrease in research and development expense was primarily due to lower compensation expense driven by resource optimization and labor allocation initiatives, and timing of planned investments in ENHANZE® related to the development of our new high-yield rHuPH20 manufacturing process.$19.1 million - Selling, general and administrative expense was
, compared to$42.4 million in the first quarter of 2024. The increase was primarily due to an increase in consulting and professional service fees and compensation expense.$35.1 million - Operating income was
, compared to$141.5 million in the first quarter of 2024.$95.5 million - Net income was
, compared to$118.1 million in the first quarter of 2024.$76.8 million - EBITDA and Adjusted EBITDA were
, compared to$162.0 million in the first quarter of 2024.1$115.7 million - GAAP diluted earnings per share was
, compared to$0.93 in the first quarter of 2024. Non-GAAP diluted earnings per share was$0.60 , compared to$1.11 in the first quarter of 2024.1$0.79 - Cash, cash equivalents and marketable securities were
on March 31, 2025, compared to$747.9 million on December 31, 2024. The increase was primarily a result of cash generated from operations.$596.1 million
Financial Outlook for 2025
The Company is raising its financial guidance for 2025. Note that the guidance reflects tariffs that are currently implemented.
For the full year 2025, the Company expects:
- Total revenue of
to$1,200 million , representing growth of$1,280 million 18% to26% over 2024 total revenue, primarily driven by increases in royalty revenue. Revenue from royalties of to$750 million , representing growth of$785 million 31% to37% over 2024. - Adjusted EBITDA of
to$790 million , representing growth of$840 million 25% to33% over 2024. - Non-GAAP diluted earnings per share of
to$5.30 , representing growth of$5.70 25% to35% over 2024. The Company's earnings per share guidance does not consider the impact of potential future share repurchases.
Table 1. 2025 Financial Guidance | |||
Previous Guidance Range | New Guidance Range | ||
Total Revenue | |||
Royalty Revenue | |||
Adjusted EBITDA | |||
Non-GAAP Diluted EPS |
1 | Adjusted EBITDA and non-GAAP Diluted EPS are non-GAAP financial measures. See "Note Regarding Use of Non-GAAP Financial Measures" below for an explanation of these measures. |
Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the first quarter ended March 31, 2025 today, Tuesday, May 6, 2025, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: https://registrations.events/direct/Q4I7813723. The call will also be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com.
About Halozyme
Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc.
Halozyme is headquartered in
For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.
Note Regarding Use of Non-GAAP Financial Measures
In addition to disclosing financial measures prepared in accordance with
The Company evaluates other items of income and expense on an individual basis for potential inclusion in the calculation of Non-GAAP financial measures and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company's ongoing business operations and (iii) whether or not the Company expects it to occur as part of the Company's normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP, and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures, and the Company may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures.
The Company considers these non-GAAP financial measures to be important because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company's core business over time and with respect to other companies, as well as assessing trends and future expectations. The Company uses non-GAAP financial information in assessing what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establishing portions of our performance-based incentive compensation programs.
Safe Harbor Statement
In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's financial performance (including the Company's expected financial outlook for 2025) and expectations for future growth, profitability, total revenue, royalty revenue, EBITDA, Adjusted EBITDA, and non-GAAP diluted earnings-per-share and potential share repurchases under its share repurchase program. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible benefits and attributes of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery and the expected expiration date of our ENHANZE® patent in
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-333-7668
tbui@halozyme.com
Samantha Gaspar
Teneo
212-886-9356
samantha.gaspar@teneo.com
Footnotes:
1. Reconciliations between GAAP reported and non-GAAP financial information for actual results are provided at the end.
Halozyme Therapeutics, Inc. Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except per share amounts) | ||||
Three Months Ended | ||||
2025 | 2024 | |||
Revenues | ||||
Royalties | $ 168,192 | $ 120,593 | ||
Product sales, net | 78,041 | 58,583 | ||
Revenues under collaborative agreements | 18,628 | 16,703 | ||
Total revenues | 264,861 | 195,879 | ||
Operating expenses | ||||
Cost of sales | 48,403 | 28,329 | ||
Amortization of intangibles | 17,762 | 17,763 | ||
Research and development | 14,799 | 19,111 | ||
Selling, general and administrative | 42,362 | 35,134 | ||
Total operating expenses | 123,326 | 100,337 | ||
Operating income | 141,535 | 95,542 | ||
Other income (expense) | ||||
Investment and other income, net | 6,818 | 4,993 | ||
Interest expense | (4,525) | (4,507) | ||
Income before income tax expense | 143,828 | 96,028 | ||
Income tax expense | 25,733 | 19,205 | ||
Net income | $ 118,095 | $ 76,823 | ||
Earnings per share | ||||
Basic | $ 0.96 | $ 0.61 | ||
Diluted | $ 0.93 | $ 0.60 | ||
Weighted average common shares outstanding | ||||
Basic | 123,215 | 126,941 | ||
Diluted | 126,644 | 128,887 |
Halozyme Therapeutics, Inc. Condensed Consolidated Balance Sheets (Unaudited) (In thousands) | ||||
March 31, | December 31, | |||
ASSETS | ||||
Current assets | ||||
Cash and cash equivalents | $ 176,328 | $ 115,850 | ||
Marketable securities, available-for-sale | 571,594 | 480,224 | ||
Accounts receivable, net and contract assets | 304,621 | 308,455 | ||
Inventories | 164,868 | 141,860 | ||
Prepaid expenses and other current assets | 44,617 | 38,951 | ||
Total current assets | 1,262,028 | 1,085,340 | ||
Property and equipment, net | 72,816 | 75,035 | ||
Prepaid expenses and other assets | 55,609 | 80,596 | ||
Goodwill | 416,821 | 416,821 | ||
Intangible assets, net | 384,068 | 401,830 | ||
Deferred tax assets, net | 5,190 | 3,855 | ||
Total assets | $ 2,196,532 | $ 2,063,477 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
Current liabilities | ||||
Accounts payable | $ 20,074 | $ 10,249 | ||
Accrued expenses | 130,305 | 128,851 | ||
Total current liabilities | 150,379 | 139,100 | ||
Long-term debt, net | 1,507,447 | 1,505,798 | ||
Other long-term liabilities | 56,436 | 54,758 | ||
Total liabilities | 1,714,262 | 1,699,656 | ||
Stockholders' equity | ||||
Common stock | 123 | 123 | ||
Additional paid-in capital | 7,596 | — | ||
Accumulated other comprehensive income (loss) | (3,413) | 3,829 | ||
Retained earnings | 477,964 | 359,869 | ||
Total stockholders' equity | 482,270 | 363,821 | ||
Total liabilities and stockholders' equity | $ 2,196,532 | $ 2,063,477 |
Halozyme Therapeutics, Inc. GAAP to Non-GAAP Reconciliations EBITDA (Unaudited) (In thousands) | ||||
Three Months Ended | ||||
2025 | 2024 | |||
GAAP Net Income | $ 118,095 | $ 76,823 | ||
Adjustments | ||||
Investment and other income, net | (6,819) | (4,993) | ||
Interest expense | 4,525 | 4,507 | ||
Income tax expense | 25,733 | 19,205 | ||
Depreciation and amortization | 20,449 | 20,206 | ||
EBITDA | 161,983 | 115,748 | ||
Adjustments | — | — | ||
Adjusted EBITDA | $ 161,983 | $ 115,748 |
Halozyme Therapeutics, Inc. GAAP to Non-GAAP Reconciliations Diluted EPS (Unaudited) (In thousands, except per share amounts) | ||||
Three Months Ended | ||||
2025 | 2024 | |||
GAAP Diluted EPS | $ 0.93 | $ 0.60 | ||
Adjustments | ||||
Share-based compensation | 0.08 | 0.08 | ||
Amortization of debt discount | 0.01 | 0.01 | ||
Amortization of intangible assets | 0.14 | 0.14 | ||
Income tax effect of above adjustments(1) | (0.07) | (0.04) | ||
Non-GAAP Diluted EPS | $ 1.11 | $ 0.79 | ||
GAAP Diluted Shares | 126,644 | 128,887 | ||
Adjustments | ||||
Adjustment for dilutive impact of Senior 2028 Convertible Notes(2) | (458) | — | ||
Non-GAAP Diluted Shares | 126,186 | 128,887 |
Dollar amounts, as presented, are rounded. Consequently, totals may not add up. |
(1) | Adjustments relate to taxes for the reconciling items, as well as excess benefits or tax deficiencies from share-based compensation, and the quarterly impact of other discrete items. |
(2) | Adjustment made for the dilutive effect of our Convertible Senior Notes due 2028 when the effect is not the same on a GAAP and non-GAAP basis for the reporting period. |
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SOURCE Halozyme Therapeutics, Inc.