Efgartigimod/Hyaluronidase

Total revenues grew 9% y-o-y to $110.0 million for the second quarter of 2025; reaffirming full-year 2025 revenue guidance of $560 million to $590 million VYVGART reached record patient utilization in the second quarter; updated national guidelines elevate VYVGART’s role as a treatment for both acute and maintenance gMG Operating loss improved by 28% year-over-year to $54.9 million for the second quarter of 2025, and by 37% to $34.2 million on an adjusted basis1; on track to achieve profitability1 in the fourth quarter of 2025 ZL-1310 (DLL3 ADC) data presented at ASCO 2025 showed a 67% ORR across all doses (n=33) and 79% at 1.6mg/kg (n=14) in 2L ES-SCLC, with a differentiated safety profile; registrational study to be initiated in the second half of 2025 The success of the global Phase 3 FORTITUDE-101 study of bemarituzumab highlighted its potential as a first-line treatment for gastric cancer patients with FGFR2b overexpression; China regulatory submission expected in the second half of 2025 EAACI Congress 2025 presentation of ZL-1503 (IL-13/IL-31R) underscores its promising potential as a novel treatment option for moderate-to-severe atopic dermatitis Conference call and webcast today, August 7, 2025 , at 8:00 a.m. ET ( 8:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass. --(BUSINESS WIRE)--Aug. 7, 2025-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the second quarter of 2025, along with recent product highlights and corporate updates. “Zai Lab is entering a pivotal period – defined by innovation, scale and strong execution,” said Dr. Samantha Du , Founder, Chairperson, and CEO of Zai Lab . “We are making meaningful progress throughout our business – expanding patient impact, accelerating global innovation, and operating with financial discipline. Updated ASCO data for ZL-1310 (DLL3 ADC) reaffirm its best-in-class potential in second-line SCLC, and we are moving swiftly into pivotal development while exploring opportunities in first-line SCLC and other neuroendocrine carcinomas. We were also encouraged by positive data for bemarituzumab in first-line gastric cancer and by emerging preclinical results for our IL-13/IL-31 bispecific antibody in atopic dermatitis, reinforcing both our near-term commercial opportunities and the potential of our global pipeline, respectively. With multiple launches ahead, a robust pipeline, and profitability1 within reach, Zai Lab is executing on its vision to become a leading global biopharma company.” “VYVGART continues to lead our commercial momentum, with record patient utilization driven by longer treatment durations and growing adoption in the maintenance setting,” said Josh Smiley , President and COO of Zai Lab . “The July update to national MG guidelines further strengthens VYVGART’s role in both acute and chronic care, and we expect momentum to accelerate in the second half. We are also preparing for several high-impact launches – including KarXT and bemarituzumab – that, together with pipeline-in-a-product assets like VYVGART and povetacicept, will fuel our next wave of growth. With a 28% year-over-year reduction in operating loss and a 37% improvement on an adjusted basis, we are on track to achieve profitability1 in the fourth quarter. Backed by a strong cash position2, a growing commercial business, and an advancing global pipeline, Zai Lab is well equipped to deliver long-term shareholder value.” 1 Refers to adjusted income (loss) from operations (non-GAAP), calculated as GAAP income (loss) from operations adjusted to exclude certain non-cash expenses, including depreciation, amortization, and share-based compensation. For additional information on this adjusted profitability measure, refer to the “Non-GAAP Measures” section. 2 Cash position includes cash and cash equivalents, current restricted cash, and short-term investments. Second Quarter 2025 Financial Results Product revenue, net was $109.1 million in the second quarter of 2025, compared to $100.1 million for the same period in 2024, representing 9% y-o-y growth, 10% y-o-y growth at constant exchange rate (CER). This increase was primarily driven by increased sales for VYVGART, XACDURO, and NUZYRA, partially offset by softer sales for ZEJULA: VYVGART and VYVGART Hytrulo were $26.5 million in the second quarter of 2025, compared to $18.1 million in the first quarter of 2025. Sales grew 46% quarter over quarter driven by an extension of duration of therapy and increasing market penetration. ZEJULA was $41.0 million in the second quarter of 2025, compared to $45.0 million for the same period in 2024. Sales were softer due to evolving competitive dynamics within the PARPi class. XACDURO, which was launched since the fourth quarter of 2024, was $4.6 million in the second quarter of 2025. NUZYRA was $14.3 million in the second quarter of 2025, compared to $12.3 million for the same period in 2024. This growth was supported by increasing market coverage and penetration. Research and Development (R&D) expenses were $50.6 million in the second quarter of 2025, compared to $61.6 million for the same period in 2024. The decrease reflects reduced personnel and clinical trial costs, driven by ongoing resource prioritization and efficiency efforts. Selling, General and Administrative expenses were $71.0 million in the second quarter of 2025, compared to $79.7 million for the same period in 2024. The decrease was primarily driven by reduced personnel costs because of resource prioritization and efficiency efforts. Loss from operations was $54.9 million in the second quarter of 2025, $34.2 million when adjusted to exclude certain non-cash expenses including depreciation, amortization, and share-based compensation. A reconciliation of loss from operations (GAAP) to adjusted loss from operations (non-GAAP) is included at the end of this release. Net loss was $40.7 million in the second quarter of 2025, or a loss per ordinary share attributable to common stockholders of $0.04 (or loss per American Deposit Share (ADS) of $0.37 ), compared to a net loss of $80.3 million for the same period in 2024, or a loss per ordinary share of $0.08 (or loss per ADS of $0.82 ). These decreases in net loss were primarily due to product revenue growing faster than net operating expenses. Cash and cash equivalents, short-term investments, and current restricted cash totaled $832.3 million as of June 30, 2025 , compared to $857.3 million as of March 31, 2025 . VYVGART and VYVGART Hytrulo were $26.5 million in the second quarter of 2025, compared to $18.1 million in the first quarter of 2025. Sales grew 46% quarter over quarter driven by an extension of duration of therapy and increasing market penetration. ZEJULA was $41.0 million in the second quarter of 2025, compared to $45.0 million for the same period in 2024. Sales were softer due to evolving competitive dynamics within the PARPi class. XACDURO, which was launched since the fourth quarter of 2024, was $4.6 million in the second quarter of 2025. NUZYRA was $14.3 million in the second quarter of 2025, compared to $12.3 million for the same period in 2024. This growth was supported by increasing market coverage and penetration. Recent Pipeline Highlights Below are key product updates since our last earnings release: Oncology Pipeline ZL-1310 (DLL3 ADC): In June 2025 , Zai Lab presented positive data from an ongoing, global Phase 1a/1b clinical trial of ZL-1310 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. In second-line (2L) SCLC, objective response rate (ORR) was 67% across all dose levels (n=33) and 79% at 1.6 mg/kg dose (n=14). ZL-1310 demonstrated a well-tolerated safety profile at target doses of less than 2.0 mg/kg, with Grade ≥3 treatment-related adverse events (TRAEs) of 6%, no Grade ≥2 interstitial lung disease, and no drug discontinuations. In May 2025 , the U.S. Food and Drug Administration (FDA) granted Fast Track designation to ZL-1310 for treatment of ES-SCLC. Bemarituzumab (FGFR2b): In June 2025 , Zai Lab announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim analysis.​ At the interim analysis, bemarituzumab plus chemotherapy significantly improved OS in patients with FGFR2b overexpression compared to chemotherapy alone. The most common treatment-emergent adverse events (>25%) in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anemia, neutropenia, nausea, corneal epithelium defect and dry eye. While ocular events were consistent with the Phase 2 experience and observed in both arms, they occurred with greater frequency and severity in the Phase 3 bemarituzumab arm. Detailed results from FORTITUDE 101 will be shared at a future medical meeting. Zai Lab plans to move rapidly toward regulatory submission in China in the second half of 2025. Tumor Treating Fields (TTFields): In May 2025 , Zai Lab partner Novocure presented results from the Phase 3 PANOVA-3 trial for pancreatic cancer as a late-breaking oral presentation at the 2025 ASCO Annual Meeting. The data demonstrated that TTFields therapy, when added to standard of care, achieved an OS benefit supported by significantly improved quality of life and extended pain-free survival, a key outcome for patients with pancreatic cancer. Zai Lab participated in the study in Greater China (mainland China , Hong Kong , Macau and Taiwan , collectively) and plans to file for regulatory approval in China in the second half of 2025.​ In June 2025 , Zai Lab presented positive data from an ongoing, global Phase 1a/1b clinical trial of ZL-1310 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. In second-line (2L) SCLC, objective response rate (ORR) was 67% across all dose levels (n=33) and 79% at 1.6 mg/kg dose (n=14). ZL-1310 demonstrated a well-tolerated safety profile at target doses of less than 2.0 mg/kg, with Grade ≥3 treatment-related adverse events (TRAEs) of 6%, no Grade ≥2 interstitial lung disease, and no drug discontinuations. In May 2025 , the U.S. Food and Drug Administration (FDA) granted Fast Track designation to ZL-1310 for treatment of ES-SCLC. Immunology Pipeline Efgartigimod (FcRn): In July 2025 , the China Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (MG) (2025) was published, emphasizing the importance of Minimal Symptom Expression (MSE), as the primary treatment goal in MG. The guidelines have highlighted VYVGART’s ability to achieve MSE rapidly and provide durable benefit. VYVGART is now recommended for early use in mild-to-moderate and highly active patients, and for sustained long-term treatment to maximize potential benefit. ZL-1503 (IL-13/IL-31R): In June 2025 , Zai Lab announced new preclinical data highlighting the potential of ZL-1503 as a promising treatment for moderate-to-severe atopic dermatitis and other IL-13 and IL-31-driven diseases. Its favorable preclinical safety profile, prolonged half-life and durable suppression of both inflammatory and pruritogenic pathways support the continued advancement of ZL-1503 toward clinical development. Anticipated Major Milestones in 2025 and the First Half of 2026 Upcoming Potential NMPA Submissions Bemarituzumab (FGFR2b) in first-line gastric cancer in the second half of 2025 Tumor Treating Fields (TTFields) in first-line pancreatic cancer in the second half of 2025 Efgartigimod (FcRn) for prefilled syringe in generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) in the second half of 2025 Upcoming Potential NMPA Approvals Xanomeline-Trospium (or KarXT) (M1/M4-agonist) in schizophrenia Tisotumab Vedotin (Tissue Factor ADC) in recurrent or metastatic cervical cancer following progression on or after chemotherapy Repotrectinib (ROS1/TRK) in NTRK+ solid tumors Expected Clinical Developments and Data Readouts Global Pipeline ZL-1310 or Zocilurtatug pelitecan (DLL3 ADC) Second-Line ES-SCLC: Zai Lab to provide data update and to initiate a global registrational study of ZL-1310 monotherapy in the second half of 2025. First-Line ES-SCLC: Zai Lab to provide data readout for dose escalation of ZL-1310 doublet in combination with atezolizumab. Other neuroendocrine carcinomas: Zai Lab to provide data readout from the global Phase 1/2 study in patients with selected solid tumors. ZL-1503 (IL-13/IL-31R) Zai Lab to advance into a global Phase 1 study in moderate-to-severe atopic dermatitis in the second half of 2025. ZL-6201 (LRRC15 ADC) Zai Lab to advance into global Phase 1 development for patients with sarcoma and potentially other LRRC15-positive solid tumors, such as breast cancer and other malignancies. Regional Pipeline Bemarituzumab (FGFR2b) Zai Lab partner Amgen to provide detailed results from the Phase 3 FORTITUDE-101 study of bemarituzumab combined with chemotherapy versus chemotherapy alone in first-line gastric cancer at an upcoming medical meeting. Zai Lab participated in the study in Greater China . Zai Lab partner Amgen to provide potential data readout from the Phase 1b/3 FORTITUDE-102 study of bemarituzumab plus chemotherapy and nivolumab versus chemotherapy and nivolumab in first-line gastric cancer. Zai Lab participated in the study in Greater China . Xanomeline-Trospium (or KarXT) (M1/M4-agonist) Zai Lab partner Bristol Myers Squibb to provide data readout from the Phase 3 ADEPT-2 study of KarXT in Alzheimer’s Disease Psychosis in the second half of 2025. Zai Lab participated in the study in Greater China . Efgartigimod (FcRn) Lupus Nephritis (LN): Zai Lab and partner argenx to provide topline results from the Phase 2 study in LN in the fourth quarter of 2025. Seronegative gMG: Zai Lab partner argenx to provide topline results from the global Phase 3 ADAPT-SERON study in seronegative gMG in the second half of 2025. Zai Lab participated in the study in Greater China . Ocular myasthenia gravis: Zai Lab partner argenx to provide topline results from the global Phase 3 ADAPT-OCULUS study in the first half of 2026. Zai Lab participated in the study in Greater China . Sjogren's disease: Zai Lab to join the registrational UNITY study of efgartigimod subcutaneous given by prefilled syringe in Sjogren’s disease in Greater China in the third quarter of 2025. Povetacicept (APRIL/BAFF) Primary Membranous Nephropathy (pMN): Zai Lab plans to partner with Vertex to execute the global pivotal Phase 2/3 study of povetacicept in pMN in Greater China . The study is expected to start in the second half of 2025. IgA Nephropathy (IgAN): Zai Lab partner Vertex will conduct an interim analysis of the global Phase 3 RAINIER study following 36 weeks of treatment with the potential to file for U.S. accelerated approval in the first half of 2026. VRDN-003 (IGF-1R, subcutaneous) Zai Lab to initiate a registrational study in thyroid eye disease in Greater China in the second half of 2025. Zai Lab partner Viridian to provide topline results from the global registrational REVEAL-1 and REVEAL-2 studies in the first half of 2026. Conference Call and Webcast Information Zai Lab will host a live conference call and webcast today, August 7, 2025 , at 8:00 a.m. ET ( 8:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at http://ir.zailaboratory.com. Participants must register in advance of the conference call. Details of registration links are as follows: For webcast: https://edge.media-server.com/mmc/p/5xsbgbn3 For dial-in: https://register-conf.media-server.com/register/BI52be4f1f4178480fa60b0d17b5c6ae3d All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering. A replay will be available shortly after the call and can be accessed by visiting the Company’s website. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States . We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide. For additional information about Zai Lab , please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global. Non-GAAP Measures In addition to results presented in accordance with GAAP, we disclose growth rates that have been adjusted to exclude the impact of changes due to the translation of foreign currencies into U.S. dollars. We have also presented a measure of adjusted loss from operations that adjusts GAAP loss from operations to exclude the impact of certain non-cash expenses including depreciation, amortization, and share-based compensation, which we refer to as “profitability.” These adjusted growth rates and adjusted loss from operations are non-GAAP financial measures. We believe that these non-GAAP financial measures are important for an understanding of the performance of our business operations and financial results and provide investors with an additional perspective on operational trends and greater transparency into our historical and projected operating performance. Although we believe the non-GAAP financial measures enhance investors’ understanding of our business and performance, these non-GAAP financial measures should not be considered an exclusive alternative to the corresponding GAAP financial measures. Zai Lab Forward-Looking Statements This press release contains certain forward-looking statements, including statements relating to our strategy and plans; potential of and expectations for our business, commercial products, and pipeline programs; our goals, objectives, and priorities and our expectations under our growth strategy (including our expectations regarding our commercial products and launches, clinical stage products, revenue growth, profitability, and cash flow); clinical development programs and related clinical trials; clinical trial data, data readouts, and presentations; risks and uncertainties associated with drug development and commercialization; regulatory discussions, submissions, filings, and approvals and the timing thereof; the potential benefits, safety, and efficacy of our products and product candidates and those of our collaboration partners; the anticipated benefits and potential of investments, collaborations, and business development activities; our profitability and timeline to profitability; our future financial and operating results; and financial guidance, including with respect to our capital allocation and investment strategy and our expected path to profitability. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “poised,” “positioned,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products; (2) our ability to obtain funding for our operations and business initiatives; (3) the results of our clinical and pre-clinical development of our product candidates; (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates; (5) risks related to doing business in China ; and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.SEC.gov. Zai Lab Limited Unaudited Condensed Consolidated Balance Sheets (in thousands of U.S. dollars ($), except for number of shares and per share data) June 30 , 2025 December 31 , 2024 Assets Current assets Cash and cash equivalents 732,159 449,667 Restricted cash, current 100,111 100,000 Short-term investments — 330,000 Accounts receivable (net of allowance for credit losses of $26 and $25 as of June 30, 2025 and December 31, 2024 , respectively) 88,499 85,178 Notes receivable 10,843 4,233 Inventories, net 61,700 39,875 Prepayments and other current assets 40,750 41,527 Total current assets 1,034,062 1,050,480 Restricted cash, non-current 1,114 1,114 Property and equipment, net 50,160 47,961 Operating lease right-of-use assets 16,787 21,496 Land use rights, net 2,860 2,907 Intangible assets, net 56,519 56,027 Other non-current assets 2,599 5,768 Total assets 1,164,101 1,185,753 Liabilities and shareholders’ equity Current liabilities Accounts payable 107,357 100,906 Current operating lease liabilities 5,584 8,048 Short-term debt 174,509 131,711 Other current liabilities 44,051 58,720 Total current liabilities 331,501 299,385 Deferred income 29,233 31,433 Non-current operating lease liabilities 11,307 13,712 Other non-current liabilities 325 325 Total liabilities 372,366 344,855 Commitments and contingencies Shareholders’ equity Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized; 1,104,032,910 and 1,082,614,740 shares issued as of June 30, 2025 and December 31, 2024 , respectively; 1,099,112,890 and 1,077,702,540 shares outstanding as of June 30, 2025 and December 31, 2024 , respectively) 7 7 Additional paid-in capital 3,308,491 3,264,295 Accumulated deficit (2,542,248 ) (2,453,083 ) Accumulated other comprehensive income 46,348 50,515 Treasury Stock (at cost, 4,920,020 and 4,912,200 shares as of June 30, 2025 and December 31, 2024 , respectively) (20,863 ) (20,836 ) Total shareholders’ equity 791,735 840,898 Total liabilities and shareholders’ equity 1,164,101 1,185,753 Zai Lab Limited Unaudited Condensed Consolidated Statements of Operations (in thousands of $, except for number of shares and per share data) Three Months Ended June 30 , Six Months Ended June 30 , 2025 2024 2025 2024 Revenues Product revenue, net 109,085 100,106 214,735 187,255 Collaboration revenue 892 398 1,729 398 Total revenues 109,977 100,504 216,464 187,653 Expenses Cost of product revenue (43,003 ) (35,148 ) (81,455 ) (68,767 ) Cost of collaboration revenue (217 ) (85 ) (412 ) (85 ) Research and development (50,614 ) (61,625 ) (111,343 ) (116,270 ) Selling, general, and administrative (71,038 ) (79,710 ) (134,460 ) (148,904 ) Loss from operations (54,895 ) (76,064 ) (111,206 ) (146,373 ) Interest income 8,843 9,330 17,449 18,988 Interest expenses (1,262 ) (492 ) (2,449 ) (605 ) Foreign currency gains (losses) 2,837 (4,108 ) 3,488 (6,176 ) Other income (expense), net 3,750 (8,943 ) 3,553 418 Loss before income tax (40,727 ) (80,277 ) (89,165 ) (133,748 ) Income tax expense — — — — Net loss (40,727 ) (80,277 ) (89,165 ) (133,748 ) Loss per share - basic and diluted (0.04 ) (0.08 ) (0.08 ) (0.14 ) Weighted-average shares used in calculating net loss per ordinary share - basic and diluted 1,091,933,150 975,937,790 1,086,413,130 974,541,780 Zai Lab Limited Unaudited Condensed Consolidated Statements of Comprehensive Loss (in thousands of $) Three Months Ended June 30 , Six Months Ended June 30 , 2025 2024 2025 2024 Net loss (40,727 ) (80,277 ) (89,165 ) (133,748 ) Other comprehensive (loss) income, net of tax of nil: Foreign currency translation adjustments (2,955 ) 3,605 (4,167 ) 5,147 Comprehensive loss (43,682 ) (76,672 ) (93,332 ) (128,601 ) Zai Lab Limited Non-GAAP Measures (unaudited) ($ in thousands) Growth on a Constant Exchange Rate (CER) Basis Three Months Ended June 30 , Year over Year % Growth Six Months Ended June 30 , Year over Year % Growth 2025 2024 As reported At CER* 2025 2024 As reported At CER* Product revenue, net 109,085 100,106 9 % 10 % 214,735 187,255 15 % 16 % Loss from operations (54,895 ) (76,064 ) (28 )% (28 )% (111,206 ) (146,373 ) (24 )% (24 )% * The growth rates at CER were calculated assuming the same foreign currency exchange rates were in effect for the current and prior year periods. Reconciliation of Loss from Operations (GAAP) to Adjusted Loss from Operations (Non-GAAP) Three Months Ended June 30 , Six Months Ended June 30 , 2025 2024 2025 2024 GAAP loss from operations (54,895 ) (76,064 ) (111,206 ) (146,373 ) Plus: Depreciation and amortization expenses 3,735 2,941 7,193 5,953 Plus: Share-based compensation 16,973 18,638 32,773 36,618 Adjusted loss from operations (34,187 ) (54,485 ) (71,240 ) (103,802 ) View source version on businesswire.com: https://www.businesswire.com/news/home/20250807049974/en/ For more information, please contact: Investor Relations: Christine Chiou / Lina Zhang +1 (917) 886-6929 / +86 136 8257 6943 christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com Media: Shaun Maccoun / Xiaoyu Chen +1 (415) 317-7255 / +86 185 0015 5011 shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com Source: Zai Lab Limited

Total Revenue Increased 41% YOY to $326 million and Royalty Revenue Increased 65% YOY to $206 million Net Income Increased 77% YOY to $165 million; Adjusted EBITDA Increased 65% YOY to $226 million; GAAP Diluted EPS Increased 85% YOY to $1.33; Non-GAAP Diluted EPS Increased 69% YOY to $1.541 Raising 2025 Financial Guidance Ranges for Total Revenue to $1,275 - $1,355 million, Representing YOY Growth of 26% - 33%, Adjusted EBITDA to $865 - $915 million, Representing YOY Growth of 37% - 45% and Non-GAAP Diluted EPS to $6.00 - $6.40, Representing YOY Growth of 42% - 51%1 Announcing Third $250 million Share Repurchase Tranche Under $750 million Authorized Plan SAN DIEGO, Aug. 5, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the second quarter ended June 30, 2025, provided an update on its recent corporate activities and raised its 2025 financial guidance. "We are very excited to report another quarter of exceptional growth with a 65% increase in royalty revenue driven by our current three blockbuster therapies, DARZALEX SC, Phesgo, and VYVGART Hytrulo. In the second quarter, four notable approvals include RYBREVANT SC in Europe, VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy in Europe and the VYVGART Hytrulo pre-filled syringe for gMG and CIDP in the U.S and Europe. Additional regulatory milestones were achieved with ENHANZE, including new indications and geographic expansion for DARZALEX SC, Opdivo SC, HYQVIA and Phesgo, which will further accelerate our future growth trajectory and enhance patient access. Based on the strong performance and growth trends, we are pleased to increase our full-year 2025 financial guidance ranges for the second time this year," said Dr. Helen Torley, President and CEO, Halozyme. "The strong results highlight the momentum and durability across our business, powered by high-margin royalty streams and increasing global demand for our industry-leading ENHANZE drug delivery technology. In the quarter, we completed a total of $303 million in share repurchases, including the $250 million program that we announced in May. Our outperformance and strong cash generation supports a balanced capital allocation strategy, including investing in growth through M&A and returning capital to shareholders," concluded Dr. Torley. Second Quarter and Recent Corporate Highlights: In June 2025, Halozyme initiated the third $250 million share repurchase tranche under the $750 million approved program from February 2024, of which $53.5 million was used to repurchase approximately 1.0 million shares at an average price of $52.40 per share in June 2025 for a total of $303.4 million of share repurchases in the second quarter. In May 2025, Halozyme announced a second $250 million share repurchase under the $750 million approved program from February 2024. The second $250 million share repurchase was completed in June 2025, resulting in a total purchase of 4.8 million shares at an average price of $52.09 per share. In April 2025, Halozyme filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. ("Merck") in the U.S. District Court in New Jersey alleging that Merck is using Halozyme's patented MDASE™ subcutaneous ("SC") drug delivery technology to develop SC Keytruda. Halozyme is seeking damages and injunctive relief to stop Merck's infringement of Halozyme's MDASE™ intellectual property. Second Quarter and Recent Partner Highlights: In July 2025, Janssen announced the European Commission approved a new indication for DARZALEX® SC as a monotherapy for the treatment of adult patients with smouldering multiple myeloma ("SMM") at high risk of developing multiple myeloma. In June 2025, Takeda announced the Ministry of Health, Labour and Welfare in Japan approved HYQVIA® SC with ENHANZE® for treatment of patients with chronic inflammatory demyelinating polyneuropathy ("CIDP") and multifocal motor neuropathy. In June 2025, argenx announced European Commission approval of VYVGART® SC with ENHANZE® for the treatment of adult patients with progressive or relapsing active CIDP after prior treatment with corticosteroids or immunoglobulins. VYVGART® SC injection is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional. In May 2025, Bristol Myers Squibb received European Commission approval of Opdivo® SC, the SC formulation of Opdivo® (nivolumab) developed with ENHANZE® for use across multiple adult solid tumors, resulting in the recognition of $12.0 million in milestone revenue. In May 2025, argenx initiated a Phase 1 study to evaluate ARGX-213 with ENHANZE®. In May 2025, Janssen announced the U.S. Food and Drug Administration ("FDA") Oncologic Drug Advisory Committee voted in favor of the benefit-risk profile of DARZALEX Faspro® for the treatment of adult patients with high risk SMM. In April 2025, Roche received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending an update to the European Union ("EU") label for Phesgo® for human epidermal growth factor receptor 2-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 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 tenth partnered product with ENHANZE® to be commercialized. In May 2025, amivantamab was made available to patients in the EU resulting in a $10.0 million milestone payment. 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. Second Quarter 2025 Financial Highlights: Revenue was $325.7 million, compared to $231.4 million in the second quarter of 2024. The 41% year-over-year increase was primarily driven by royalty revenue growth and an increase in milestone revenues. Revenue included $205.6 million in royalties, an increase of 65% compared to $124.9 million in the second quarter of 2024, primarily attributable to increases in revenue of DARZALEX® SC, VYVGART® Hytrulo and Phesgo®. Cost of sales was $46.4 million, compared to $39.6 million in the second quarter of 2024. The increase in cost of sales was primarily due to an increase in product sales and labor allocation initiatives. Amortization of intangibles expense remained flat at $17.8 million, compared to the second quarter of 2024. Research and development expense was $17.5 million, compared to $21.0 million in the second 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. Selling, general and administrative expense was $41.6 million, compared to $35.7 million in the second quarter of 2024. The increase was primarily due to an increase in consulting and professional service fees, including $2.6 million of litigation costs incurred in connection with a patent infringement litigation case, and an increase in compensation expense. Operating income was $202.4 million, compared to $117.2 million in the second quarter of 2024. Net income was $165.2 million, compared to $93.2 million in the second quarter of 2024. EBITDA was $222.9 million, compared to $137.0 million in the second quarter of 2024. Adjusted EBITDA was $225.5 million, compared to $137.0 million in the second quarter of 2024.1 GAAP diluted earnings per share was $1.33, compared to $0.72 in the second quarter of 2024. Non-GAAP diluted earnings per share was $1.54, compared to $0.91 in the second quarter of 2024.1 Cash, cash equivalents and marketable securities were $548.2 million on June 30, 2025, compared to $596.1 million on December 31, 2024. The decrease was primarily a result of share repurchase activities during the year, partially offset by cash generated from operations. 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 $1,275 million to $1,355 million, representing growth of 26% to 33% over 2024 total revenue, primarily driven by increases in royalty revenue. Revenue from royalties of $825 million to $860 million, representing growth of 44% to 51% over 2024. Adjusted EBITDA of $865 million to $915 million, representing growth of 37% to 45% over 2024. Non-GAAP diluted earnings per share of $6.00 to $6.40, representing growth of 42% to 51% over 2024. The Company's earnings per share guidance does not consider the impact of potential future share repurchases. Table 1. 2025 Financial Guidance Webcast and Conference Call Halozyme will host its Quarterly Update Conference Call for the second quarter ended June 30, 2025 today, Tuesday, August 5, 2025, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: . 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 San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit 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 U.S. generally accepted accounting principles ("GAAP"), this press release and the accompanying tables contain certain Non-GAAP financial measures. The Company reports earnings before interest, taxes, depreciation, and amortization ("EBITDA"), adjusted EBITDA, Non-GAAP diluted earnings per share, Non-GAAP diluted shares, and guidance with respect to those measures, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates Non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discounts, intangible asset amortization, one-time items, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges and intellectual property litigation costs, and certain adjustments to income tax expense. The Company calculates Non-GAAP diluted shares excluding the dilutive impact of convertible notes which is used in calculating Non-GAAP diluted earnings. The Company calculates EBITDA excluding interest, taxes, depreciation and amortization. The Company calculates adjusted EBITDA excluding one-time items, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges, transaction costs for business combinations and intellectual property litigation costs. Reconciliations between GAAP and Non-GAAP financial measures are included at the end of this press release. The Company does not provide reconciliations of forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in share-based compensation expense and the effects of any discrete income tax items. For the same reasons, the Company is unable to address the probable significance of the unavailable information. The Company provides Non-GAAP financial measures that it believes will be achieved; however, it cannot accurately predict all of the components of the adjusted calculations and the GAAP measures may be materially different than the Non-GAAP measures. 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, potential share repurchases under its share repurchase program and potential expansion of the Company's platform through acquisitions. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible benefits and attributes of ENHANZE® and 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. Forward-looking statements regarding the Company's business may include potential growth and receipt of royalty and milestone payments driven by our partners' development and commercialization efforts, potential new clinical trial study starts and clinical data, regulatory submissions and product launches, the size, demand and growth prospects of our partners' drug franchises, potential new or expanded collaborations (including potential HVAI and SVAI collaborations) and collaborative targets and regulatory review, and potential approvals of new partnered or proprietary products, and the potential timing of these events. These forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected delays in the execution of the Company's share repurchase program or planned platform expansion through acquisitions, unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered or proprietary products, regulatory approval requirements, uncertainties related to tariff, trade and pharmaceutical pricing policies and tax legislation, unexpected adverse events or patient outcomes and competitive conditions. In addition, there can be no assurance as to developments related to the litigation referred to in this press release, the outcome of the litigation or any remedies that could be awarded in connection with the litigation. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-333-7668 [email protected] Sydney Charlton Teneo 917-972-8407 [email protected] SOURCE Halozyme Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED