Exelixis(EXEL) - 2025 Q2 - Quarterly Results

Exelixis Q2 2025 Financial Results and Corporate Update Financial Performance Exelixis reported decreased total revenues in Q2 2025 due to lower collaboration revenues, despite strong net product revenue growth Q2 2025 vs. Q2 2024 Financial Results (in millions, except EPS) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenues | $568.3 | $637.2 | -10.8% | | Net Product Revenues | $520.0 | $437.6 | +18.8% | | Collaboration Revenues | $48.2 | $199.6 | -75.8% | | GAAP Net Income | $184.8 | $226.1 | -18.3% | | GAAP Diluted EPS | $0.65 | $0.77 | -15.6% | | Non-GAAP Net Income | $212.6 | $245.6 | -13.4% | | Non-GAAP Diluted EPS | $0.75 | $0.84 | -10.7% | - The decrease in total revenues was primarily due to a $150.0 million commercial milestone from a collaboration partner recognized in Q2 2024, which did not recur in Q2 2025[5] - The increase in net product revenues was mainly driven by a rise in sales volume[4] Q2 2025 Operating Expenses (in millions) | Expense Category | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Research & Development (R&D) | $200.4 | $211.1 | -5.1% | | Selling, General & Administrative (SG&A) | $134.9 | $132.0 | +2.2% | Corporate and Pipeline Update Exelixis reported successful CABOMETYX® launch in NET, positive zanzalintinib STELLAR-303 results, and advancements in its early-stage pipeline Cabozantinib Franchise Highlights - The U.S. launch of CABOMETYX® in advanced neuroendocrine tumors (NET) was well-received, capturing a leading share of new patient starts in second-line and later settings and accounting for about 4% of the overall CABOMETYX business in Q2[3] Q2 2025 Cabozantinib Franchise Revenues (in millions) | Revenue Source | Amount | | :--- | :--- | | U.S. Net Product Revenues (CABOMETYX & COMETRIQ) | $520.0 | | Royalty Revenues from Partners | $43.4 | - In July, partner Ipsen received approval from the European Commission for CABOMETYX for patients with previously treated advanced NET, following the U.S. FDA approval in March, allowing marketing in all 27 EU member states, Norway, Liechtenstein, and Iceland[17] Zanzalintinib and Early-Stage Pipeline - Positive top-line results from the phase 3 STELLAR-303 trial showed that zanzalintinib with atezolizumab significantly improved overall survival versus regorafenib in patients with metastatic colorectal cancer (CRC), with Exelixis planning to discuss these results with regulators for potential approval[19] - Key updates on the zanzalintinib pivotal program include: - STELLAR-304 (nccRCC): Enrollment completed in May 2025, with top-line results expected in H1 2026 - STELLAR-305 (SCCHN): The company decided not to proceed to the phase 3 portion due to emerging data, competition, and other opportunities - STELLAR-311 (NET): Initiated a phase 3 pivotal trial evaluating zanzalintinib versus everolimus[22] - The early-stage pipeline is advancing, with three ongoing phase 1 trials for XL309, XB010, and XB628, and the IND for XB371 (a TF-targeting ADC) was cleared by the FDA, with a phase 1 study planned to start soon[24] - Based on early clinical data, Exelixis has discontinued further development of the XL495 program[23] 2025 Financial Guidance Exelixis has maintained its previously provided financial guidance for the full fiscal year 2025, projecting total revenues between $2.25 billion and $2.35 billion and net product revenues between $2.05 billion and $2.15 billion - Exelixis is maintaining its previously provided financial guidance for fiscal year 2025[15] Full Year 2025 Financial Guidance | Metric | Guidance Range | | :--- | :--- | | Total revenues | $2.25 billion - $2.35 billion | | Net product revenues | $2.05 billion - $2.15 billion | | Cost of goods sold | 4% - 5% of net product revenues | | Research and development expenses | $925 million - $975 million | | Selling, general and administrative expenses | $475 million - $525 million | | Effective tax rate | 21% - 23% | Other Corporate Developments The company highlighted a $147 million federal cash tax benefit from the repeal of R&E capitalization requirements, announced positive developments in its cabozantinib patent defense, and continued its stock repurchase program - Due to the One Big Beautiful Bill Act, which repeals the requirement to capitalize domestic R&E expenditures, Exelixis estimates a federal cash tax benefit of $147 million[25] - Exelixis settled patent litigation with Biocon Pharma, granting Biocon a license to market a generic version of CABOMETYX in the U.S. beginning January 1, 2031, subject to FDA approval and other conditions[26] - As of June 30, 2025, Exelixis has repurchased $796.3 million of its common stock at an average price of $36.69 per share under its authorized programs[27] Financial Statements This section provides the detailed, unaudited financial tables for the three and six months ended June 30, 2025, compared to the same periods in 2024, including the Condensed Consolidated Statements of Income and a reconciliation of GAAP to Non-GAAP net income Condensed Consolidated Statements of Income Condensed Consolidated Statements of Income (in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Total revenues | $568,261 | $637,178 | $1,123,708 | $1,062,404 | | Net product revenues | $520,014 | $437,581 | $1,033,297 | $816,104 | | Collaboration revenues | $48,247 | $199,597 | $90,411 | $246,300 | | Total operating expenses | $354,685 | $361,304 | $723,273 | $757,068 | | Income from operations | $213,576 | $275,874 | $400,435 | $305,336 | | Net income | $184,848 | $226,116 | $344,464 | $263,433 | | Diluted Net income per share | $0.65 | $0.77 | $1.20 | $0.88 | Reconciliation of GAAP to Non-GAAP Net Income Reconciliation of GAAP to Non-GAAP Net Income (in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | GAAP net income | $184,848 | $226,116 | $344,464 | $263,433 | | Stock-based compensation (R&D) | $14,143 | $9,178 | $23,665 | $13,070 | | Stock-based compensation (SG&A) | $21,928 | $16,176 | $38,336 | $31,397 | | Income tax effect of adjustments | ($8,355) | ($5,841) | ($14,348) | ($10,289) | | Non-GAAP net income | $212,564 | $245,629 | $392,117 | $297,611 | | Non-GAAP diluted EPS | $0.75 | $0.84 | $1.37 | $0.99 |