Latest news with #Exelixis
Yahoo
30-07-2025
- Business
- Yahoo
Exelixis (EXEL) Tumbles 16.8% as Q2 Earnings Disappoint
We recently published . Exelixis, Inc. (NASDAQ:EXEL) is one of the worst-performing stocks on Tuesday. Exelixis nosedived by 16.78 percent on Tuesday to close at $36.94 apiece as investors took path from a dismal earnings performance in the second quarter of the year. In its earnings release, Exelixis, Inc. (NASDAQ:EXEL) said net income during the period dropped by 18 percent to $185 million from $226 million in the same period last year. Photo by National Cancer Institute on Unsplash Revenues, on the other hand, dropped by 10.8 percent to $568 million from $637 million year-on-year. For the full-year period, Exelixis, Inc. (NASDAQ:EXEL) expects total revenues to end between $2.25 billion and $2.35 billion, while net product revenues are projected to settle at a range of $2.05 billion to $2.15 billion. Commenting on the performance, Exelixis, Inc. (NASDAQ:EXEL) said that the company 'continued to execute on our corporate objectives in the second While we acknowledge the potential of EXEL as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the . Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
30-07-2025
- Business
- Yahoo
2 Highly Ranked Stocks to Consider After Q2 Earnings: CLS, EXEL
Among the Zacks Rank #1 (Strong Buy) list, electronics manufacturer Celestica CLS and oncology-focused biotech firm Exelixis EXEL are two highly ranked stocks that are worthy of consideration after exceeding their Q2 earnings expectations on Monday evening. Although Celestica and Exelixis stock moved in different directions in Tuesday's trading session, both have set up intriguing buying opportunities following their Q2 reports. Celestica Stock Hits an All-Time High Exceeding Q2 top and bottom line expectations, the momentum in Celestica stock looks like a buying opportunity after CLS spiked +16% in today's trading session and hit a new all-time high of $208 a share. Appeasing investors, Celestica's strong Q2 results were driven by high demand for its communications and enterprise hardware products, which are heavily sought after by hyperscale clients investing in AI cloud infrastructure. Celestica's Q2 sales came in at $2.89 billion, spiking 21% from $2.39 billion a year ago and comfortably surpassing estimates of $2.67 billion by 8%. More impressive, Celestica's Q2 earnings soared 53% YoY to $1.39 per share from EPS of $0.91 in the prior period and topped expectations of $1.24 by 12%. As one of the stock market's top performers this year, Celestica stock is now up more than +115% in 2025. This comes as CLS shares have rebounded and surged more than +135% in the last three months, which has impressively outpaced the historic recovery among the broader indexes and the Zacks Electronics-Manufacturing Services Market's +58%. Image Source: Zacks Investment Research Exelixis Stock Has Become a Buy-the-Dip Target With Exelixis' stock falling nearly 17% on Tuesday, the post-earnings drop could very well be a long-term buying opportunity. Able to exceed bottom-line expectations, Exelixis posted Q2 EPS of $0.75, beating the Zacks Consensus of $0.65 by 15% despite dipping from $0.84 a share in the comparative period. This came on sales of $568.26 million, which missed estimates of $578.91 million and was down from $637.18 million in Q2 2024. Exelixis' mixed Q2 results were attributed to weaker sales for its flagship cancer drug Cabometyx. The company also announced it will be halting its experimental head and neck cancer drug Zanzalintinib, leading to panic selling after citing competitive pressures and lackluster internal data for the stoppage. However, Exelixis reaffirmed its full-year revenue guidance of $2.25-$2.35 billion (3-8% growth), which is reason to believe there was an overreaction in the market. Exelixis' stock is now down 5% in 2025 after giving up this year's gains on Tuesday. That said, EXEL is up more than +80% in the last two years and now trades under $40 a share and at a reasonable 16.6X forward earnings multiple with double-digit EPS growth currently in the forecast for fiscal 2025 and FY26. Image Source: Zacks Investment Research Summary Investors looking for a momentum stock that could be in store for higher highs may want to consider Celestica (CLS), while those looking for a buy-the-dip target have an intriguing option with Exelixis (EXEL). Most importantly, these highly ranked stocks have proven to be very viable investment options thanks to their prominence among the tech and medical sectors, respectively. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Exelixis, Inc. (EXEL) : Free Stock Analysis Report Celestica, Inc. (CLS) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Yahoo
29-07-2025
- Business
- Yahoo
Exelixis Inc (EXEL) Q2 2025 Earnings Call Highlights: Strong Revenue Growth and Strategic Challenges
Total Revenue: Approximately $568 million for Q2 2025. Cabozantinib Franchise Net Product Revenue: $520 million, with CABOMETYX net product revenues at $518 million. Gross-to-Net Cabozantinib Franchise: 30.2% for Q2 2025. Collaboration Revenues: Approximately $48.2 million, including $43.4 million in royalties from partners Ipsen and Takeda. Total Operating Expenses: $355 million for Q2 2025. GAAP Net Income: Approximately $184.8 million or $0.68 per share basic and $0.65 per share diluted. Non-GAAP Net Income: Approximately $212.6 million or $0.78 per share basic and $0.75 per share diluted. Cash and Marketable Securities: Approximately $1.4 billion as of June 30, 2025. Share Repurchase: Approximately $302 million worth of shares repurchased, retiring approximately 7.5 million shares at an average price of $40.10 per share. Warning! GuruFocus has detected 5 Warning Sign with EXEL. Release Date: July 28, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Exelixis Inc (NASDAQ:EXEL) reported strong second-quarter 2025 financial results with total revenues of approximately $568 million, driven by the cabozantinib franchise. The cabozantinib US business showed robust growth, with revenues increasing 19% year over year to $520 million. The launch of CABOMETYX in neuroendocrine tumors (NETs) is off to a strong start, quickly capturing a 35% new patient share in the oral therapies segment. Positive topline results from the STELLAR-303 trial in colorectal cancer, demonstrating a statistically significant improvement in overall survival. Exelixis Inc (NASDAQ:EXEL) maintains a strong balance sheet with approximately $1.4 billion in cash and marketable securities, allowing for continued R&D investment and share repurchases. Negative Points The decision not to advance the STELLAR-305 trial in head and neck cancer into Phase 3 due to competitive landscape and commercial opportunity concerns. Higher gross-to-net deductions in the second quarter of 2025, primarily related to increased 340B volume, impacting overall profitability. Clinical trial sales were significantly lower in the second quarter compared to the first quarter of 2025, indicating potential volatility in this revenue stream. The competitive landscape in oncology remains challenging, with Exelixis Inc (NASDAQ:EXEL) needing to make tough capital allocation decisions. The regulatory environment is described as highly dynamic, necessitating a conservative approach to data interpretation and communication. Q & A Highlights Q: Can you provide any takeaways from the head and neck study that might be applicable to future studies? A: Amy Peterson, Chief Medical Officer, stated that while they are not sharing data at this time, zanzalintinib is a franchise molecule with much more to be done beyond the initial six pivotal trials. Rigorous drug development requires continuous assessment of emerging data. Q: How sustainable are the market share gains for CABOMETYX, and can you achieve similar market share in neuroendocrine tumors (NET) as in renal cell carcinoma (RCC)? A: Michael Morrissey, CEO, expressed confidence in sustaining market share gains, noting a strong franchise with CABOMETYX in RCC. Patrick Haley, EVP of Commercial, added that the NET launch is off to a strong start with a 35% market share in the second-line-plus oral market, and they expect continued growth. Q: How do you see zanzalintinib positioned in the colorectal cancer landscape, especially with new treatment options emerging? A: Amy Peterson highlighted the significance of the STELLAR-303 trial's positive overall survival results in colorectal cancer, emphasizing it as the first IO TKI combination to show a statistically significant survival benefit. They plan to discuss these results with regulators and share them at a medical conference. Q: Can you comment on the pricing dynamics for cabozantinib, especially with respect to 340B volume and reimbursement? A: Christopher Senner, CFO, noted an increase in 340B volume, which is a highly discounted segment, impacting gross-to-net calculations. They are projecting gross-to-net closer to 30% due to this shift. Q: Regarding STELLAR-303, how important is it to demonstrate a benefit in patients with liver metastases? A: Amy Peterson stated that while they have a positive overall survival readout in the intent-to-treat population, they continue to follow the non-liver metastases subgroup. They look forward to sharing all data once available. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
29-07-2025
- Business
- Yahoo
Exelixis Inc (EXEL) Q2 2025 Earnings Call Highlights: Strong Revenue Growth and Strategic Challenges
Total Revenue: Approximately $568 million for Q2 2025. Cabozantinib Franchise Net Product Revenue: $520 million, with CABOMETYX net product revenues at $518 million. Gross-to-Net Cabozantinib Franchise: 30.2% for Q2 2025. Collaboration Revenues: Approximately $48.2 million, including $43.4 million in royalties from partners Ipsen and Takeda. Total Operating Expenses: $355 million for Q2 2025. GAAP Net Income: Approximately $184.8 million or $0.68 per share basic and $0.65 per share diluted. Non-GAAP Net Income: Approximately $212.6 million or $0.78 per share basic and $0.75 per share diluted. Cash and Marketable Securities: Approximately $1.4 billion as of June 30, 2025. Share Repurchase: Approximately $302 million worth of shares repurchased, retiring approximately 7.5 million shares at an average price of $40.10 per share. Warning! GuruFocus has detected 5 Warning Sign with EXEL. Release Date: July 28, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Exelixis Inc (NASDAQ:EXEL) reported strong second-quarter 2025 financial results with total revenues of approximately $568 million, driven by the cabozantinib franchise. The cabozantinib US business showed robust growth, with revenues increasing 19% year over year to $520 million. The launch of CABOMETYX in neuroendocrine tumors (NETs) is off to a strong start, quickly capturing a 35% new patient share in the oral therapies segment. Positive topline results from the STELLAR-303 trial in colorectal cancer, demonstrating a statistically significant improvement in overall survival. Exelixis Inc (NASDAQ:EXEL) maintains a strong balance sheet with approximately $1.4 billion in cash and marketable securities, allowing for continued R&D investment and share repurchases. Negative Points The decision not to advance the STELLAR-305 trial in head and neck cancer into Phase 3 due to competitive landscape and commercial opportunity concerns. Higher gross-to-net deductions in the second quarter of 2025, primarily related to increased 340B volume, impacting overall profitability. Clinical trial sales were significantly lower in the second quarter compared to the first quarter of 2025, indicating potential volatility in this revenue stream. The competitive landscape in oncology remains challenging, with Exelixis Inc (NASDAQ:EXEL) needing to make tough capital allocation decisions. The regulatory environment is described as highly dynamic, necessitating a conservative approach to data interpretation and communication. Q & A Highlights Q: Can you provide any takeaways from the head and neck study that might be applicable to future studies? A: Amy Peterson, Chief Medical Officer, stated that while they are not sharing data at this time, zanzalintinib is a franchise molecule with much more to be done beyond the initial six pivotal trials. Rigorous drug development requires continuous assessment of emerging data. Q: How sustainable are the market share gains for CABOMETYX, and can you achieve similar market share in neuroendocrine tumors (NET) as in renal cell carcinoma (RCC)? A: Michael Morrissey, CEO, expressed confidence in sustaining market share gains, noting a strong franchise with CABOMETYX in RCC. Patrick Haley, EVP of Commercial, added that the NET launch is off to a strong start with a 35% market share in the second-line-plus oral market, and they expect continued growth. Q: How do you see zanzalintinib positioned in the colorectal cancer landscape, especially with new treatment options emerging? A: Amy Peterson highlighted the significance of the STELLAR-303 trial's positive overall survival results in colorectal cancer, emphasizing it as the first IO TKI combination to show a statistically significant survival benefit. They plan to discuss these results with regulators and share them at a medical conference. Q: Can you comment on the pricing dynamics for cabozantinib, especially with respect to 340B volume and reimbursement? A: Christopher Senner, CFO, noted an increase in 340B volume, which is a highly discounted segment, impacting gross-to-net calculations. They are projecting gross-to-net closer to 30% due to this shift. Q: Regarding STELLAR-303, how important is it to demonstrate a benefit in patients with liver metastases? A: Amy Peterson stated that while they have a positive overall survival readout in the intent-to-treat population, they continue to follow the non-liver metastases subgroup. They look forward to sharing all data once available. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Business Wire
28-07-2025
- Business
- Business Wire
Exelixis Announces Second Quarter 2025 Financial Results and Provides Corporate Update
ALAMEDA, Calif.--(BUSINESS WIRE)--Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the second quarter of 2025, provided an update on progress toward achieving key corporate objectives, and outlined its commercial, clinical and pipeline development milestones. 'Exelixis continued to execute on our corporate objectives in the second quarter of 2025, delivering on key commercial, development and pipeline milestones,' said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. 'While early in the launch, we're very pleased with the reception that CABOMETYX ® has received in advanced neuroendocrine tumors (NET). Our commercial team rapidly mobilized on the U.S. NET launch following approval in March, capturing a leading share of new patient starts among oral therapies in second-line and later settings with NET representing approximately four percent of our overall CABOMETYX business in the second quarter. We will continue to track the launch trajectory and provide updates to our 2025 full year financial guidance, as appropriate.' Dr. Morrissey continued: 'Turning to the zanzalintinib development program, in June, we announced positive topline results from the STELLAR-303 pivotal study in colorectal cancer. We plan to discuss these results with regulators with the intention of filing for approval in this indication as quickly as possible. In May, we completed enrollment into the STELLAR-304 pivotal study in non-clear cell renal cell carcinoma with top-line results expected in the first half of 2026, depending on study event rates. Based on our evaluation of emerging data from the phase 2 portion of the STELLAR-305 study in advanced squamous cell carcinoma of the head and neck, emerging competition in this indication and assessment of other potentially larger commercial opportunities, we have made the decision not to proceed to the phase 3 portion of the trial. We also initiated the STELLAR-311 pivotal study in advanced NET during the quarter and plan to announce an additional wave of zanzalintinib pivotal trials in the coming months. Finally, our early-stage pipeline is advancing quickly with phase 1 clinical studies ongoing for our XL309, XB010 and XB628 programs, and XB371 moving into clinical investigation. As we look ahead to the second half of the year, I'd like to thank the entire Exelixis team for their continued execution across our business, and for their dedication to our mission to help cancer patients recover stronger and live longer.' Second Quarter 2025 Financial Results Total revenues for the quarter ended June 30, 2025 were $568.3 million, as compared to $637.2 million for the comparable period in 2024. Total revenues for the quarter ended June 30, 2025 included net product revenues of $520.0 million, as compared to $437.6 million for the comparable period in 2024. The increase in net product revenues was primarily due to an increase in sales volume. Collaboration revenues, composed of license revenues and collaboration services revenues, were $48.2 million for the quarter ended June 30, 2025, as compared to $199.6 million for the comparable period in 2024. The decrease in collaboration revenues was primarily related to a $150.0 million commercial milestone recognized during the second quarter of 2024 in connection with Ipsen achieving $600 million in cumulative net sales of cabozantinib in its related license territory over four consecutive quarters. Research and development expenses for the quarter ended June 30, 2025 were $200.4 million, as compared to $211.1 million for the comparable period in 2024. The decrease in research and development expenses was primarily related to decreases in manufacturing costs to support our development candidates and clinical trial costs, partially offset by increases in stock-based compensation, consulting and outside services, and personnel expenses. Selling, general and administrative expenses for the quarter ended June 30, 2025 were $134.9 million, as compared to $132.0 million for the comparable period in 2024. The increase in selling, general and administrative expenses was primarily related to increases in marketing expenses, stock-based compensation, and personnel expenses, partially offset by a decrease in corporate giving. Provision for income taxes for the quarter ended June 30, 2025 was $45.6 million, as compared to $66.7 million for the comparable period in 2024. GAAP net income for the quarter ended June 30, 2025 was $184.8 million, or $0.68 per share, basic and $0.65 per share, diluted, as compared to GAAP net income of $226.1 million, or $0.78 per share, basic and $0.77 per share diluted, for the comparable period in 2024. GAAP net income per share for the quarter ended June 30, 2025 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended June 30, 2025, as compared to the comparable period in 2024, as a result of the stock repurchase programs. Non-GAAP net income for the quarter ended June 30, 2025 was $212.6 million, or $0.78 per share, basic and $0.75 per share, diluted, as compared to non-GAAP net income of $245.6 million, or $0.85 per share, basic and $0.84 per share diluted, for the comparable period in 2024. Non-GAAP Financial Measures To supplement Exelixis' financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation, adjusted for the related income tax effect for all periods presented. Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare Exelixis' results from period to period, and to identify operating trends in Exelixis' business. Exelixis has excluded stock-based compensation, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions. These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis' business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release. 2025 Financial Guidance Exelixis is maintaining the previously provided financial guidance for fiscal year 2025. ____________________ (1) Exelixis' 2025 net product revenues guidance range includes the impact of a U.S. wholesale acquisition cost increase of 2.8% for CABOMETYX effective Jan. 1, 2025. (2) Includes $50.0 million of non-cash stock-based compensation. (3) Includes $80.0 million of non-cash stock-based compensation. Expand Second Quarter 2025 Highlights Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the U.S. were $520.0 million during the second quarter of 2025, with net product revenues of $517.9 million from CABOMETYX (cabozantinib) and $2.1 million from COMETRIQ ® (cabozantinib). Based upon cabozantinib-related net product revenues generated by Exelixis' collaboration partners during the quarter ended June 30, 2025, Exelixis earned $43.4 million in royalty revenues. Partner Ipsen Received Approval from the European Commission (EC) for CABOMETYX for Patients with Previously Treated Advanced NET. In July, Exelixis announced that its partner Ipsen received approval from the EC for CABOMETYX for adult patients with unresectable or metastatic, well-differentiated pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues. This approval follows the positive opinion received from the European Medicines Agency's Committee for Medicinal Products for Human Use in June 2025 and allows for the marketing of CABOMETYX in this indication in all 27 member states of the European Union (EU), Norway, Liechtenstein and Iceland. In March, Exelixis received approval from the U.S. Food and Drug Administration (FDA) for CABOMETYX in this setting. These approvals were based on the positive results of the phase 3 CABINET pivotal trial, which evaluated CABOMETYX compared with placebo in two cohorts of patients with previously treated NET: advanced pNET and advanced epNET. Announcement of Positive Top-line Results from the Phase 3 STELLAR-303 Pivotal Trial Evaluating Zanzalintinib in Combination with an Immune Checkpoint Inhibitor in Patients with Metastatic Colorectal Cancer (CRC). In June, Exelixis announced positive top-line results from the phase 3 STELLAR-303 pivotal trial in which the combination of zanzalintinib with atezolizumab (Tecentriq ®) demonstrated a statistically significant improvement in overall survival (OS) versus regorafenib in the intent-to-treat (ITT) population. The STELLAR-303 study is evaluating zanzalintinib in combination with atezolizumab versus regorafenib in patients with metastatic, refractory non-microsatellite instability-high or non-mismatch repair-deficient (non-MSI-H/dMMR) CRC. The ITT population consisted of all randomized patients, regardless of the presence of liver metastases. The top-line findings were from the final analysis conducted by the Independent Data Monitoring Committee of one of the dual primary endpoints of the STELLAR-303 phase 3 trial. The trial will proceed to the planned final analysis for the other dual primary endpoint of OS in patients without liver metastases (non-liver metastases or NLM). The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment. Exelixis plans to discuss these results with regulators with the intention of filing for approval in this indication as soon as possible. Detailed results will be presented at a future medical meeting. Presentation of Encouraging Results from Phase 1b/2 STELLAR-002 Trial Evaluating Zanzalintinib in Combination with Immune Checkpoint Inhibitors in Advanced Kidney Cancer at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025). In June, Exelixis presented results from multiple dose-escalation cohorts of patients with advanced solid tumors, and an expansion cohort of patients with previously untreated advanced clear cell renal cell carcinoma (ccRCC) from the phase 1b/2 STELLAR-002 trial evaluating zanzalintinib in combination with either nivolumab (Opdivo ®) or a fixed-dose combination of nivolumab and relatlimab (Opdualag ™) at ASCO 2025. The results from the ccRCC expansion cohort demonstrated encouraging activity across all efficacy parameters, including objective response rate (ORR), progression-free survival (PFS) and disease control rates. The findings from the dose-escalation cohorts showed that the toxicity profile of these combinations was manageable and consistent with each agent administered as monotherapy. Zanzalintinib Pivotal Development Program Updates. Today, Exelixis announced several updates to the zanzalintinib development program, including: STELLAR-304 study enrollment completed in May 2025. STELLAR-304 is a phase 3 pivotal trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated patients with advanced non-clear cell renal cell carcinoma (nccRCC). The primary endpoints in the trial are PFS and ORR. Top-line results are expected in the first half of 2026, depending on study event rates. Based on the company's evaluation of emerging data from the phase 2 portion of the STELLAR-305 trial in advanced squamous cell carcinoma of the head and neck (SCCHN), emerging competition in this indication, and assessment of other, potentially larger, commercial opportunities, Exelixis has decided not to proceed to phase 3. Initiation of the STELLAR-311 phase 3 pivotal trial in advanced NET. STELLAR-311 is evaluating zanzalintinib versus everolimus as a first oral therapy in patients with advanced NET, regardless of site of origin. The primary endpoint of the trial is PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review. Plans to announce the next wave of zanzalintinib pivotal trials in the coming months. Preclinical Data Presentations from Four Pipeline Programs in Advanced Cancers at the American Association for Cancer Research Annual Meeting (AACR 2025). In April, Exelixis presented preclinical data from four pipeline molecules at AACR 2025. Presentations included data for XL309 and XL495, small molecules that have demonstrated synthetic lethality in the context of certain genetic anomalies found in varying frequencies across a broad array of tumor types. The XL309 findings demonstrated activity of XL309 as monotherapy or in combination with PARP or topoisomerase inhibitors. Data analysis from the XL495 program demonstrated the potential for anti-tumor activity both as monotherapy and in combination with DNA-damaging agents. However, based on early clinical data generated for XL495, Exelixis has discontinued further development of this program. Preclinical data were also presented for the PD-L1 + NKG2A-targeting bispecific antibody XB628 and for the tissue factor (TF)-targeting antibody-drug conjugate (ADC) XB371. Data analysis from the XB628 program demonstrated the molecule's tumor cell killing activity both in vitro and in vivo, supporting advancement of this molecule into clinical development. Findings from XB371 non-clinical experiments demonstrated potent anti-tumor activity in vivo across a range of human tumor xenograft models including colorectal, lung, and pancreatic cancers, supporting the molecule's advancement into phase 1 clinical development. Advancement of XB628 and XB371 Pipeline Programs into Clinical Development. Today, Exelixis provided an update on the recent progress of its early-stage pipeline programs, including XB628 (PD-L1 + NKG2A-targeting bispecific antibody) and XB371 (TF-targeting ADC). In April, Exelixis initiated the phase 1 study of XB628, following the U.S. FDA clearance of its Investigational New Drug (IND) application in March. Exelixis now has three ongoing phase 1 trials for its pipeline programs XL309, XB010 and XB628. Additionally, in July, the U.S. FDA cleared Exelixis' IND application for XB371 and the company plans to initiate the phase 1 study in the coming months. Federal Income Tax Impact from the One Big Beautiful Bill Act. On July 4, 2025, the One Big Beautiful Bill Act was signed into law which, among other provisions, permanently repeals the requirement to capitalize domestic research and experimental (R&E) expenditures for federal income tax purposes for taxable years beginning after December 31, 2024, and allows for the accelerated deduction of any remaining unamortized domestic R&E expenditures. Foreign R&E expenditures are still required to be capitalized and amortized ratably over 15 years. Exelixis estimates its federal cash tax benefit for previously unamortized domestic R&E expenditures is $147 million with no corresponding impact to the federal income tax provision. Positive Developments Across Cabozantinib Patent Estate. Today, Exelixis announced recent positive developments with regards to the company's defense of its cabozantinib patent estate. First, in June and July 2025, the United States Patent and Trademark Office (USPTO) declined to institute Azurity Pharmaceuticals' petitions for inter partes review (IPRs) of U.S. Patent Nos. 11,298,349 and 12,128,039, respectively. Second, in July 2025, Exelixis entered into a settlement agreement with Biocon Pharma Limited, which resolved the patent litigation Exelixis brought in response to Biocon's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of CABOMETYX prior to the expiration of the applicable patents. Pursuant to the terms of the agreement, Exelixis will grant Biocon a license to market its generic version of CABOMETYX in the U.S. beginning on January 1, 2031, if approved by the FDA and subject to conditions and exceptions common to agreements of this type. Stock Repurchase Program. In August 2024, Exelixis' Board of Directors authorized a stock repurchase program to acquire up to $500 million of the company's common stock before December 31, 2025. In February 2025, the Board of Directors authorized the repurchase of up to an additional $500 million of the company's common stock before December 31, 2025. Under these programs, as of June 30, 2025, Exelixis has repurchased $796.3 million of the company's common stock, at an average price of $36.69 per share. Since the approval of the first stock repurchase program in March 2023, the weighted-average diluted common shares outstanding has decreased from 326.3 million shares to 284.4 million shares as of June 30, 2025. Stock repurchases under these programs may be made from time to time through a variety of methods, which may include open market purchases, in block trades, accelerated share repurchase transactions, exchange transactions, or any combination of such methods. The timing and amount of any stock repurchases under the stock repurchase programs will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of our common stock and general market conditions. Basis of Presentation Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31. For convenience, references in this press release as of and for the fiscal periods ended July 4, 2025 and June 28, 2024, are indicated as being as of and for the periods ended June 30, 2025 and June 30, 2024. Conference Call and Webcast Exelixis management will discuss the company's financial results for the second quarter 2025 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Monday, July 28, 2025. To access the conference call, please register using this link. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto and proceed to the Event Calendar page under the Investors & News heading. A webcast replay of the conference call will also be archived on for one year. About Exelixis Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX ® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis' plans to discuss the results of STELLAR-303 with regulators and intention of filing for approval in this indication as soon as possible; anticipated timing for zanzalintinib pivotal data milestones with respect to the STELLAR-304 and STELLAR-311 trials and plans to announce additional zanzalintinib pivotal trials; Exelixis' assessment of other potential commercial growth opportunities; Exelixis' plans to present data from STELLAR-303 at a future medical meeting; Exelixis' plans to initiate the phase 1 study for XB371 in the coming months; the terms of Exelixis' settlement agreement with Biocon Pharma Limited which is subject to FDA approval and subject to conditions and exceptions common to agreements of this type; and Exelixis' scientific pursuit to create transformational treatments that give more patients hope for the future. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis' current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the degree of market acceptance of CABOMETYX and other Exelixis products in the indications for which they are approved and in the territories where they are approved, and Exelixis' and its partners' ability to obtain or maintain coverage and reimbursement for these products; the effectiveness of CABOMETYX and other Exelixis products in comparison to competing products; the level of costs associated with Exelixis' commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; Exelixis' ability to maintain and scale adequate sales, marketing, market access and product distribution capabilities for its products or to enter into and maintain agreements with third parties to do so; the availability of data at the referenced times; the potential failure of cabozantinib, zanzalintinib and other Exelixis product candidates, both alone and in combination with other therapies, to demonstrate safety and/or efficacy in clinical testing; uncertainties inherent in the drug discovery and product development process; Exelixis' dependence on its relationships with its collaboration partners, including their pursuit of regulatory approvals for partnered compounds in new indications, their adherence to their obligations under relevant collaboration agreements and the level of their investment in the resources necessary to complete clinical trials or successfully commercialize partnered compounds in the territories where they are approved; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis' continuing compliance with applicable legal and regulatory requirements; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating cabozantinib, zanzalintinib and other Exelixis product candidates; Exelixis' dependence on third-party vendors for the development, manufacture and supply of its products and product candidates; Exelixis' ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of Exelixis' marketed products; changes in economic and business conditions, including as a result of changing trade policies and tariffs and the related uncertainty thereof; and other factors detailed from time to time under the caption 'Risk Factors' in Exelixis' most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis' other future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law. Exelixis, the Exelixis logo, CABOMETYX and COMETRIQ are registered trademarks of Exelixis, Inc. Opdivo ® is a registered trademark of Bristol Myers Squibb. Opdualag ™ is a trademark of Bristol Myers Squibb. ____________________ (1) Non-cash stock-based compensation used for GAAP reporting in accordance with Accounting Standards Codification Topic 718, Compensation—Stock Compensation. Expand
