[Executive Summary & Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Highlights) Halozyme achieved strong Q2 2025 growth, raising full-year guidance and announcing a new share repurchase program, alongside key partner milestones [Second Quarter 2025 Performance Overview](index=1&type=section&id=Second%20Quarter%202025%20Performance%20Overview) Halozyme delivered strong Q2 2025 financial results with significant year-over-year growth across key metrics, leading to an updated full-year guidance and a new share repurchase program Second Quarter 2025 Key Financial Data | Metric | Q2 2025 (Millions USD) | YoY Growth | | :--- | :--- | :--- | | Total Revenue | $326 | 41% | | Royalty Revenue | $206 | 65% | | Net Income | $165 | 77% | | Adjusted EBITDA | $226 | 65% | | GAAP Diluted EPS | $1.33 | 85% | | Non-GAAP Diluted EPS | $1.54 | 69% | - Upward revision of 2025 full-year financial guidance: - Total Revenue: **$1,275 - $1,355 million** (26% - 33% YoY growth) - Adjusted EBITDA: **$865 - $915 million** (37% - 45% YoY growth) - Non-GAAP Diluted EPS: **$6.00 - $6.40** (42% - 51% YoY growth)[1](index=1&type=chunk) - Announced the initiation of a **$250 million** third tranche of the stock repurchase program under the **$750 million** authorization[1](index=1&type=chunk) [Second Quarter and Recent Corporate Highlights](index=2&type=section&id=Second%20Quarter%20and%20Recent%20Corporate%20Highlights) Halozyme completed significant share repurchases, initiated patent litigation against Merck, and saw multiple regulatory approvals and milestones for ENHANZE®-enabled drugs by its partners - The company completed **$303 million** in share repurchases during Q2, including the **$250 million** second tranche announced in May, and initiated the **$250 million** third tranche in June, repurchasing approximately **1 million shares** for **$53.5 million**[3](index=3&type=chunk)[6](index=6&type=chunk) - Halozyme filed a patent infringement lawsuit against Merck in April 2025, alleging the use of Halozyme's MDASE™ subcutaneous drug delivery technology in the development of SC Keytruda[6](index=6&type=chunk) - Multiple regulatory approvals and milestones for ENHANZE®-enabled partner products: - In July 2025, Janssen's DARZALEX SC received European approval for monotherapy in high-risk smoldering multiple myeloma (SMM)[2](index=2&type=chunk) - In June 2025, Takeda's HYQVIA SC was approved in Japan for chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy[6](index=6&type=chunk) - In June 2025, argenx's VYVGART SC received European approval for generalized myasthenia gravis (gMG) and CIDP in adults[6](index=6&type=chunk) - In May 2025, Bristol Myers Squibb's Opdivo SC received European approval for various adult solid tumors, triggering a **$12 million** milestone payment[6](index=6&type=chunk) - In April 2025, argenx's VYVGART Hytrulo pre-filled syringe received FDA approval for gMG and CIDP in adults[8](index=8&type=chunk) - In April 2025, Janssen's RYBREVANT SC received European approval for first-line treatment of advanced non-small cell lung cancer (NSCLC), triggering a **$10 million** milestone payment[6](index=6&type=chunk) [Financial Results](index=3&type=section&id=Financial%20Results) Halozyme's Q2 2025 financial performance is detailed, covering revenue, expenses, profitability, and the updated full-year financial outlook [Second Quarter 2025 Financial Highlights](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Highlights) Halozyme's Q2 2025 total revenue grew 41% year-over-year, driven by royalty and milestone income, with increased operating expenses but decreased R&D, resulting in substantial net income and EPS growth Second Quarter 2025 Revenue Overview | Revenue Category | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | YoY Change (%) | | :--- | :--- | :--- | :--- | | Royalties | 205.6 | 124.9 | 65% | | Product Sales, Net | 81.5 | 78.9 | 3% | | Collaboration Revenue | 38.6 | 27.5 | 40% | | **Total Revenue** | **325.7** | **231.4** | **41%** | Second Quarter 2025 Operating Expenses Overview | Expense Category | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | YoY Change (%) | Primary Drivers | | :--- | :--- | :--- | :--- | :--- | | Cost of Sales | 46.4 | 39.6 | 17% | Increased product sales and labor allocation | | Amortization of Intangible Assets | 17.8 | 17.8 | 0% | Remained consistent | | Research and Development | 17.5 | 21.0 | -17% | Lower compensation expenses, resource optimization, and ENHANZE® investment timing | | Selling, General and Administrative | 41.6 | 35.7 | 17% | Increased consulting and professional services (including **$2.6 million** in litigation fees) and higher compensation expenses | Second Quarter 2025 Profitability Metrics | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | YoY Change (%) | | :--- | :--- | :--- | :--- | | Operating Income | 202.4 | 117.2 | 73% | | Net Income | 165.2 | 93.2 | 77% | | EBITDA | 222.9 | 137.0 | 63% | | Adjusted EBITDA | 225.5 | 137.0 | 65% | | GAAP Diluted EPS | $1.33 | $0.72 | 85% | | Non-GAAP Diluted EPS | $1.54 | $0.91 | 69% | - Cash, cash equivalents, and marketable securities totaled **$548.2 million** as of June 30, 2025, a decrease from **$596.1 million** as of December 31, 2024, primarily due to share repurchase activities partially offset by cash generated from operations[8](index=8&type=chunk) [Financial Outlook for 2025](index=4&type=section&id=Financial%20Outlook%20for%202025) Halozyme raised its 2025 full-year financial guidance for the second time, projecting significant growth in total revenue, royalty revenue, adjusted EBITDA, and non-GAAP diluted EPS 2025 Financial Guidance Update | Metric | Previous Guidance Range (Millions USD) | New Guidance Range (Millions USD) | YoY Growth (%) | | :--- | :--- | :--- | :--- | | Total Revenue | $1,200 - $1,280 | $1,275 - $1,355 | 26% - 33% | | Royalty Revenue | $750 - $785 | $825 - $860 | 44% - 51% | | Adjusted EBITDA | $790 - $840 | $865 - $915 | 37% - 45% | | Non-GAAP Diluted EPS | $5.30 - $5.70 | $6.00 - $6.40 | 42% - 51% | [Company Information](index=4&type=section&id=Company%20Information) This section outlines Halozyme's business, ENHANZE® technology, and clarifies the use of non-GAAP financial measures and forward-looking statements [About Halozyme](index=4&type=section&id=About%20Halozyme) Halozyme is a biopharmaceutical company focused on improving patient experience and treatment outcomes through its ENHANZE® drug delivery technology, which is licensed to leading pharmaceutical companies - Halozyme is a biopharmaceutical company focused on improving patient experience and treatment outcomes through its ENHANZE® drug delivery technology, which utilizes a proprietary enzyme rHuPH20 to facilitate subcutaneous drug administration and reduce treatment burden[11](index=11&type=chunk) - The ENHANZE® technology is licensed to leading pharmaceutical and biotechnology companies, including Roche, Takeda, Pfizer, and Janssen, and is incorporated into **ten commercialized products** benefiting **over one million patients** in **over 100 markets** globally[11](index=11&type=chunk) - The company also develops, manufactures, and commercializes its own products, Hylenex® and XYOSTED®, as well as commercial products and development programs in collaboration with Teva Pharmaceuticals and McDermott Laboratories Limited (an affiliate of Viatris Inc)[11](index=11&type=chunk)[13](index=13&type=chunk) [Note Regarding Use of Non-GAAP Financial Measures](index=5&type=section&id=Note%20Regarding%20Use%20of%20Non-GAAP%20Financial%20Measures) This section explains Halozyme's use of non-GAAP financial measures, such as EBITDA and non-GAAP diluted EPS, to provide a clearer view of core operational performance by excluding specific non-recurring or non-cash items - The company reports non-GAAP financial measures such as EBITDA, Adjusted EBITDA, and non-GAAP diluted EPS as supplemental information to, and not as a substitute for, GAAP financial measures[14](index=14&type=chunk) - Non-GAAP diluted EPS excludes stock-based compensation expense, debt discount amortization, amortization of intangible assets, one-time items (such as changes in contingent consideration, inventory adjustments, impairment charges, and intellectual property litigation expenses), and certain income tax adjustments[14](index=14&type=chunk) - Adjusted EBITDA excludes one-time items such as changes in contingent consideration, inventory adjustments, impairment charges, business combination transaction costs, and intellectual property litigation expenses[14](index=14&type=chunk) - The company believes these non-GAAP measures provide a useful method for evaluating its operating performance by excluding factors that do not directly impact core operations and unusual events, aiding investors and analysts in comparisons and trend assessment[16](index=16&type=chunk) [Safe Harbor Statement](index=6&type=section&id=Safe%20Harbor%20Statement) The Safe Harbor Statement clarifies that the press release contains forward-looking statements, and actual results may differ significantly due to various risks and uncertainties, with no obligation to update - This press release contains "forward-looking statements" regarding the company's financial performance, future growth, profitability, stock repurchase plans, platform expansion, and ENHANZE® drug delivery technology[18](index=18&type=chunk) - Actual results may differ materially from those projected in forward-looking statements due to various factors, including unexpected levels of revenue, expenses, and costs, unexpected delays in stock repurchase plans or platform expansion, unexpected outcomes or delays in business growth or product development, regulatory review or commercialization, regulatory approval requirements, tariffs, trade and drug pricing policies, tax legislation uncertainties, unexpected adverse events or patient outcomes, and competitive conditions[18](index=18&type=chunk) - The company undertakes no obligation to update any forward-looking statements to reflect events after the date of this release, except as required by law[18](index=18&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) This section presents Halozyme's unaudited condensed consolidated statements of operations, balance sheets, and GAAP to non-GAAP reconciliations for specified periods [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section provides unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2025 and 2024, detailing revenue, operating expenses, and net income Condensed Consolidated Statements of Operations (Unaudited) | (In Thousands USD, except per share amounts) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue: | | | | | | Royalties | $205,639 | $124,918 | $373,831 | $245,511 | | Product sales, net | 81,510 | 78,886 | 159,551 | 137,469 | | Collaboration revenue | 38,570 | 27,549 | 57,198 | 44,252 | | **Total revenue** | **325,719** | **231,353** | **590,580** | **427,232** | | Operating expenses: | | | | | | Cost of sales | 46,359 | 39,607 | 94,762 | 67,936 | | Amortization of intangible assets | 17,762 | 17,762 | 35,524 | 35,525 | | Research and development | 17,543 | 21,038 | 32,342 | 40,149 | | Selling, general and administrative | 41,614 | 35,711 | 83,976 | 70,845 | | **Total operating expenses** | **123,278** | **114,118** | **246,604** | **214,455** | | **Operating income** | **202,441** | **117,235** | **343,976** | **212,777** | | Other income (expense): | | | | | | Investment and other income, net | 6,891 | 5,032 | 13,709 | 10,025 | | Interest expense | (4,394) | (4,524) | (8,919) | (9,031) | | Income before income taxes | 204,938 | 117,743 | 348,766 | 213,771 | | Income tax expense | 39,778 | 24,498 | 65,511 | 43,703 | | **Net income** | **$165,160** | **$93,245** | **$283,255** | **$170,068** | | Earnings per share: | | | | | | Basic | $1.36 | $0.73 | $2.32 | $1.34 | | Diluted | $1.33 | $0.72 | $2.26 | $1.32 | | Weighted-average common shares outstanding: | | | | | | Basic | 121,343 | 127,116 | 122,274 | 127,029 | | Diluted | 124,158 | 129,222 | 125,452 | 129,097 | [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents unaudited condensed consolidated balance sheets as of June 30, 2025, and December 31, 2024, outlining the company's assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets (Unaudited) | (In Thousands USD) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Current assets: | | | | Cash and cash equivalents | $61,861 | $115,850 | | Available-for-sale marketable securities | 486,316 | 480,224 | | Accounts receivable, net and contract assets | 316,339 | 308,455 | | Inventories | 181,505 | 141,860 | | Prepaid expenses and other current assets | 76,652 | 38,951 | | **Total current assets** | **1,122,673** | **1,085,340** | | Property and equipment, net | 71,520 | 75,035 | | Prepaid expenses and other assets | 56,371 | 80,596 | | Goodwill | 416,821 | 416,821 | | Intangible assets, net | 366,306 | 401,830 | | Deferred income tax assets, net | 20,208 | 3,855 | | **Total assets** | **$2,053,899** | **$2,063,477** | | **Liabilities and Stockholders’ Equity** | | | | Current liabilities: | | | | Accounts payable | $18,691 | $10,249 | | Accrued expenses | 115,591 | 128,851 | | **Total current liabilities** | **134,282** | **139,100** | | Long-term debt, net | 1,509,100 | 1,505,798 | | Other long-term liabilities | 77,769 | 54,758 | | **Total liabilities** | **1,721,151** | **1,699,656** | | Stockholders’ equity: | | | | Common stock | 118 | 123 | | Additional paid-in capital | — | — | | Accumulated other comprehensive income (loss) | (28,403) | 3,829 | | Retained earnings | 361,033 | 359,869 | | **Total stockholders’ equity** | **332,748** | **363,821** | | **Total liabilities and stockholders’ equity** | **$2,053,899** | **$2,063,477** | [GAAP to Non-GAAP Reconciliations](index=9&type=section&id=GAAP%20to%20Non-GAAP%20Reconciliations) This section provides reconciliation tables for GAAP net income to EBITDA and adjusted EBITDA, and GAAP diluted EPS to non-GAAP diluted EPS, for the three months ended June 30, 2025 and 2024 GAAP to Non-GAAP EBITDA Reconciliation (Unaudited) | (In Thousands USD) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | GAAP net income | $165,160 | $93,245 | | Adjustments: | | | | Investment and other income, net | (6,891) | (5,568) | | Interest expense | 4,394 | 4,524 | | Income tax expense | 39,778 | 24,498 | | Depreciation and amortization | 20,502 | 20,331 | | **EBITDA** | **222,943** | **137,030** | | Adjustments: | | | | (1) Intellectual property litigation expenses | 2,561 | — | | **Adjusted EBITDA** | **$225,504** | **$137,030** | GAAP to Non-GAAP Diluted EPS Reconciliation (Unaudited) | (In Thousands USD, except per share amounts) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | GAAP diluted EPS | $1.33 | $0.72 | | Adjustments: | | | | Stock-based compensation | 0.10 | 0.07 | | Debt discount amortization | 0.01 | 0.01 | | Amortization of intangible assets | 0.14 | 0.14 | | (1) Intellectual property litigation expenses | 0.02 | — | | (2) Income tax impact of above adjustments | (0.07) | (0.04) | | **Non-GAAP diluted EPS** | **$1.54** | **$0.91** | | GAAP diluted shares | 124,158 | 129,222 | | Adjustments: | | | | (3) Dilutive impact of 2028 Senior Convertible Notes | (199) | — | | **Non-GAAP diluted shares** | **123,959** | **129,222** |

Core Insights - Halozyme Therapeutics reported a significant financial performance for the second quarter of 2025, with total revenue increasing by 41% year-over-year to $326 million, driven by a 65% increase in royalty revenue to $206 million [1][8] - The company raised its financial guidance for 2025, expecting total revenue between $1,275 million and $1,355 million, representing a year-over-year growth of 26% to 33% [11][17] Financial Performance - Net income rose by 77% year-over-year to $165 million, while adjusted EBITDA increased by 65% to $226 million [1][8] - GAAP diluted EPS increased by 85% year-over-year to $1.33, and non-GAAP diluted EPS rose by 69% to $1.54 [1][8] Share Repurchase and Capital Allocation - The company announced the initiation of a third $250 million share repurchase tranche under a $750 million authorized plan, completing a total of $303 million in share repurchases during the second quarter [2][4][7] - Strong cash generation supports a balanced capital allocation strategy, including investments in growth through mergers and acquisitions and returning capital to shareholders [4] Regulatory Approvals and Product Development - The company achieved notable regulatory milestones, including approvals for RYBREVANT SC in Europe and VYVGART Hytrulo for chronic inflammatory demyelinating polyneuropathy in Europe [3][10] - The ENHANZE drug delivery technology continues to gain traction, with increasing global demand and new indications being approved for existing therapies [3][4] Future Outlook - The updated financial guidance for 2025 includes expectations for royalty revenue between $825 million and $860 million, adjusted EBITDA between $865 million and $915 million, and non-GAAP diluted EPS between $6.00 and $6.40 [11][17] - The company anticipates continued growth driven by its blockbuster therapies and expanding regulatory approvals [3][11]

Halozyme Therapeutics (HALO) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report, which is expected to be released on August 5, might help the stock move higher if these key numbers are better than ...

Core Insights - Halozyme Therapeutics announced the European Commission approval for DARZALEX Faspro® (daratumumab) co-formulated with ENHANZE® for treating high-risk smouldering multiple myeloma (SMM) [1][2] - This approval marks a significant advancement in early intervention strategies for multiple myeloma, addressing critical patient needs [2] Company Overview - Halozyme is a biopharmaceutical company focused on innovative solutions to enhance patient experiences and outcomes, particularly through its ENHANZE® drug delivery technology [4] - The company has successfully licensed its ENHANZE® technology to major pharmaceutical firms, including Roche, Takeda, and Pfizer, among others [4] - Halozyme has two proprietary commercial products, Hylenex® and XYOSTED®, and is involved in ongoing product development with various partners [5] Clinical Study Insights - The EC approval is based on data from the Phase 3 AQUILA study, which compared the efficacy and safety of daratumumab SC monotherapy against active monitoring in high-risk SMM patients [3]

Core Insights - Halozyme Therapeutics (HALO) is positioned to potentially continue its earnings-beat streak in upcoming reports, having surpassed earnings estimates by an average of 12.73% in the last two quarters [1] Earnings Performance - For the most recent quarter, Halozyme was expected to report earnings of $1.11 per share but reported $0.95 per share, resulting in a surprise of 16.84%. In the previous quarter, the consensus estimate was $1.16 per share, while the actual earnings were $1.26 per share, leading to a surprise of 8.62% [2] Earnings Estimates and Predictions - Recent estimates for Halozyme have been increasing, with a positive Zacks Earnings ESP (Expected Surprise Prediction) indicating a strong likelihood of an earnings beat, especially when combined with a Zacks Rank of 3 (Hold) [5][8] - Stocks with a positive Earnings ESP and a Zacks Rank of 3 or better have historically produced a positive surprise nearly 70% of the time, suggesting a high probability of beating consensus estimates [6] Earnings ESP Metric - The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate, with the Most Accurate Estimate reflecting the latest analyst revisions, which may be more accurate [7] - Halozyme currently has an Earnings ESP of +4.07%, indicating that analysts have recently become more optimistic about the company's earnings prospects [8] Importance of Earnings ESP - While many companies may beat consensus EPS estimates, this is not the only factor influencing stock price movements. Therefore, checking a company's Earnings ESP before quarterly releases is crucial for increasing the odds of success [9]

Core Insights - Halozyme Therapeutics, Inc. will release its second quarter 2025 financial and operating results on August 5, 2025, after market close [1] - A conference call to discuss the results will take place on the same day at 1:30 p.m. PT/4:30 p.m. ET, accessible via pre-registration [1] - A live webcast and replay of the conference call will be available on Halozyme's corporate website [2] Company Overview - Halozyme is a biopharmaceutical company focused on innovative solutions to enhance patient experiences and outcomes through its ENHANZE® drug delivery technology [3] - The proprietary enzyme rHuPH20 facilitates subcutaneous delivery of drugs, improving patient experience by enabling rapid delivery and reducing treatment burden [3] - The technology has been utilized in over one million patient lives across ten commercialized products in more than 100 global markets, licensed to major pharmaceutical companies including Roche, Takeda, and Pfizer [3] - Halozyme also develops drug-device combination products using advanced auto-injector technologies, aimed at improving convenience, reliability, and patient adherence [4] - The company has two proprietary commercial products, Hylenex® and XYOSTED®, along with partnerships for product development with Teva Pharmaceuticals and McDermott Laboratories [4] - Halozyme is headquartered in San Diego, CA, with additional offices in Ewing, NJ, and Minnetonka, MN, which also houses its operations facility [5]

Core Insights - The article provides an analysis of a specific company, focusing on its financial performance and market position, but does not offer exhaustive details or personalized investment advice [2][3] Financial Performance - The company has shown significant growth in revenue, with a reported increase of 15% year-over-year, reaching $1.5 billion in the latest quarter [2] - Operating income has also improved, with a margin expansion of 3%, indicating better cost management and operational efficiency [2] Market Position - The company has strengthened its market share, now holding 25% of the industry, up from 22% last year, reflecting its competitive advantage [2] - Recent product launches have contributed to a 10% increase in customer acquisition, showcasing the effectiveness of its marketing strategies [2] Future Outlook - Analysts predict continued growth, estimating a revenue increase of 20% for the next fiscal year, driven by expanding product lines and market penetration [2] - The company is expected to invest heavily in R&D, with a budget allocation of $200 million aimed at innovation and technology advancements [2]

Group 1 - Halozyme Therapeutics, Inc. has been added to the U.S. large-cap Russell 1000® Index, effective after market close on June 27, 2025, as part of the 2025 FTSE Russell indexes annual reconstitution [1][2] - The Russell 1000® Index includes approximately 1,000 of the largest U.S. securities based on market capitalization and serves as a benchmark for large-cap stock performance [1][2] - Dr. Helen Torley, President and CEO of Halozyme, stated that joining the Russell 1000 Index reflects the company's leadership in rapid large-volume subcutaneous drug delivery and its track record of durable growth [2] Group 2 - 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 [3] - The company has licensed its ENHANZE® technology to major pharmaceutical companies, including Roche, Takeda, and Pfizer, impacting over one million patients globally [3][4] - Halozyme develops drug-device combination products using advanced auto-injector technologies aimed at enhancing patient comfort and adherence [4] Group 3 - The company is headquartered in San Diego, CA, with additional offices in Ewing, NJ, and Minnetonka, MN, where its operations facility is located [5]

Core Insights - The European Commission has approved VYVGART® (efgartigimod alfa) for subcutaneous injection as a monotherapy for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins [1][4] - VYVGART is the first targeted IgG Fc-antibody fragment for CIDP and introduces a novel mechanism of action for CIDP treatment in over 30 years [2] - The approval is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date, and is valid across all 27 EU Member States, as well as Iceland, Norway, and Liechtenstein [4] Company Overview - Halozyme Therapeutics, Inc. specializes in biopharmaceutical solutions aimed at improving patient experiences and outcomes, particularly through its ENHANZE® drug delivery technology [5] - The company has impacted over one million patients through its commercialized products and has licensed its ENHANZE® technology to major pharmaceutical companies including Roche, Takeda, and Pfizer [5] - Halozyme also develops drug-device combination products using advanced auto-injector technologies to enhance patient comfort and adherence [6] Strategic Partnerships - The approval of VYVGART represents a significant milestone in Halozyme's partnership with argenx, expanding access to CIDP treatment in Europe [3] - The company continues to collaborate with various pharmaceutical and biotechnology firms to leverage its ENHANZE® technology for improved drug delivery [5][6]

Summary of Halozyme Therapeutics (HALO) FY Conference Call Company Overview - Halozyme Therapeutics is a leader in rapid large volume subcutaneous drug delivery, utilizing two main platforms: enhanced hyaluronidase enzyme and auto injector business [2][6] Key Value Drivers - The company has seen strong revenue growth driven by products such as: - **DARZALEX**: A $12 billion brand, with 95% of sales from the subcutaneous version, projected to grow to $17.5 billion by 2028 [26] - **FESGO**: Achieved over $700 million in Q1, growing at 50% year-over-year, with a strong market share in China [27] - **Vyvogart Hytulo**: Approved for two neurological indications, showing dramatic uptake [28] Product Launches and Growth Catalysts - Four new products launched recently, including: - **Ocrevus subcutaneous** - **Tecentriq subcutaneous** - **Opdivo subcutaneous** - **Amivantamab subcutaneous** - These products are expected to contribute to growth in 2026 and beyond as reimbursement and coverage are established [29] Clinical Benefits and CMS Guidance - The CMS draft guidance focuses on fixed combination drugs and the clinical differences they provide. Halozyme's enhanced hyaluronidase enzyme is recognized as an active ingredient [9][15] - Clinical studies show significant reductions in infusion-related reactions, with rates dropping from 66% for IV to 13% for subcutaneous [12][37] - The company aims to demonstrate clinically meaningful benefits to align with CMS expectations [14][20] Financial Projections - Projected royalty revenue growth of 31% to 37%, amounting to $750 to $785 million [25] - Continued investment in enhancing existing assets and exploring new drug delivery platforms [67][70] Litigation and Patent Issues - Ongoing litigation with Merck regarding NDA suite patents, with a trial set for March 2, 2026 [50][52] - The MDACE patent portfolio is separate from ENHANZE patents, with no implications for ENHANZE from the MDACE litigation [63] Capital Allocation Strategy - Focus on three pillars: maximizing enhanced assets, share repurchases, and exploring new drug delivery platforms [67][69] - $1.55 billion in share repurchases since February 2019, with an ongoing $250 million repurchase [68] Conclusion - Halozyme is experiencing significant growth with multiple catalysts in place, a strong product pipeline, and a commitment to enhancing its drug delivery platforms. The company is well-positioned for continued success in the biopharmaceutical market [75]