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Exelixis Gains 15.6% YTD: How Should You Play the Stock?
ZACKS· 2025-08-14 14:16
Core Insights - Exelixis (EXEL) has shown strong year-to-date performance with a 15.6% increase in share price, significantly outperforming the industry growth of 2.9% [1] - Despite reaching a 52-week high of $49.62 on June 23, 2025, shares dipped following mixed quarterly results reported on July 28 [1][4] - The company’s lead drug, Cabometyx, continues to perform well in the renal cell carcinoma (RCC) market, supported by strong demand and recent label expansions [5][6] Company Performance - Exelixis' stock has outperformed both the sector and the S&P 500 Index during the year [1] - The company reported a revenue miss in the second quarter, which has affected investor sentiment [8][20] - Cabometyx remains the leading tyrosine kinase inhibitor (TKI) for RCC, with strong sales driven by its combination with Bristol Myers' Opdivo [5][6] Drug Pipeline and Developments - Zanzalintinib, an investigational TKI, has shown positive results in the STELLAR-303 study, meeting a key endpoint for overall survival in metastatic colorectal cancer [10][12] - The company has decided not to proceed with the phase III portion of the STELLAR-305 trial for zanzalintinib due to emerging competition and a focus on larger commercial opportunities [14] - Exelixis is actively expanding its pipeline with three ongoing phase I studies and has received FDA clearance for a new IND application [15] Financial Outlook - Exelixis shares are currently trading at a price/sales ratio of 4.14x forward sales, higher than the biotech industry average of 1.59x [16] - The bottom-line estimate for 2025 has increased slightly from $2.64 to $2.68, while the estimate for 2026 has decreased from $3.13 to $3.09 [17] Competitive Landscape - Cabometyx faces significant competition in the RCC market, particularly from Merck's Keytruda and Pfizer's Inlyta [20][21] - Keytruda is a leading drug in the RCC space, accounting for approximately 50% of Merck's pharmaceutical sales [21]
Will Zanzalintinib Ease Out EXEL's Reliance on Cabometyx for Growth?
ZACKS· 2025-08-13 13:55
Core Insights - Exelixis is developing zanzalintinib, a next-generation oral investigational tyrosine kinase inhibitor (TKI) targeting receptor tyrosine kinases involved in cancer growth, with recent studies showing positive data [1] Study Results - In June 2025, Exelixis announced positive top-line results from the STELLAR-303 study, a phase III trial involving 901 patients with metastatic colorectal cancer, comparing zanzalintinib plus Tecentriq against regorafenib [2] - The STELLAR-303 study met one of its dual primary endpoints, showing a statistically significant improvement in overall survival (OS) for the intent-to-treat population treated with zanzalintinib plus Tecentriq compared to regorafenib [3] - Enrollment for the STELLAR-304 study was completed in May 2025, evaluating zanzalintinib in combination with Opdivo versus sunitinib in advanced non-clear cell renal cell carcinoma [4] - Exelixis has opted not to proceed with the phase III portion of the STELLAR-305 trial based on emerging data and competition in advanced squamous cell carcinoma [5] - The company initiated the phase III STELLAR-311 study in advanced neuroendocrine tumors, comparing zanzalintinib to everolimus [6] Competitive Landscape - The competitive environment for renal cell carcinoma (RCC) is intensifying, with significant competition for Exelixis's lead drug, Cabometyx, from various immunotherapy-TKI combinations [7] - Keytruda, approved for advanced RCC, accounts for approximately 50% of Merck's pharmaceutical sales, highlighting the competitive pressure in the market [10] Financial Performance - Exelixis shares have increased by 14% year-to-date, contrasting with a 0.9% decline in the biotech industry [11] - The company's shares are currently trading at a price/sales ratio of 4.09x forward sales, above its historical mean of 3.64x and the biotech industry's average of 1.59x [13] - The bottom-line estimate for 2025 has risen from $2.64 to $2.68, while the estimate for 2026 has decreased from $3.13 to $3.09 over the past 30 days [14]
EXEL Q2 Earnings Top, Sales Miss on Lower Collaboration Revenues
ZACKS· 2025-07-29 14:42
Core Viewpoint - Exelixis, Inc. reported mixed results for Q2 2025, with adjusted earnings beating estimates but revenues missing expectations, leading to a decline in stock price in pre-market trading [2][3][25] Financial Performance - Adjusted earnings were 75 cents per share, exceeding the Zacks Consensus Estimate of 65 cents, but down from 84 cents in the same quarter last year [2][8] - Net revenues totaled $568.3 million, missing the Zacks Consensus Estimate of $579 million and reflecting a 10.8% year-over-year decline [3][8] - Net product revenues were $520 million, marking an 18.8% increase year-over-year, primarily driven by increased sales volume [5][8] Product Performance - Cabometyx generated revenues of $517.9 million, falling short of the Zacks Consensus Estimate of $527 million but surpassing the model estimate of $511.3 million [6][8] - The demand for Cabometyx's new indication for neuroendocrine tumors accounted for just over 4% of total demand in Q2, with expectations for growth [9][25] Collaboration and Revenue Sources - Collaboration revenues plummeted 70% to $48.2 million from $199.6 million in the prior year, largely due to a significant milestone payment recognized in the previous quarter [10][25] Expenses - Research and development expenses were $200.3 million, down 5.1% year-over-year, while selling, general, and administrative expenses rose 2.1% to $134.9 million [11][25] Stock Repurchase Program - Exelixis has repurchased $796.3 million of its common stock at an average price of $36.69 per share, with $204 million remaining under the current repurchase plan [12][13] Guidance - The company maintains its 2025 revenue guidance of $2.25 billion to $2.35 billion, with net product revenues expected between $2.05 billion and $2.15 billion [14][15] Pipeline Developments - Exelixis is advancing its pipeline with zanzalintinib, which has shown promising results in the STELLAR-303 study for metastatic colorectal cancer [16][18] - The company has three ongoing phase I studies and plans to initiate a phase I study for XB371 soon [23] Legal Settlement - In July 2025, Exelixis settled patent litigation with Biocon Pharma, allowing Biocon to market a generic version of Cabometyx in the U.S. starting January 1, 2031, if approved [24]
Here's Why This $50 Healthcare Stock Could Be the Next $200 Winner
The Motley Fool· 2025-07-20 10:30
Core Viewpoint - Exelixis has shown significant stock price growth over the past decade, with shares increasing from under $10 to approximately $45, indicating strong market performance and potential for further growth [1] Group 1: Company Performance - Exelixis is primarily recognized for its cancer drug, Cabometyx, which was first approved in the U.S. in 2016 for renal cell carcinoma (RCC) and has demonstrated significant improvements in overall survival, progression-free survival, and objective response rate [3] - The company's revenue for the first quarter increased by 30.6% year over year to $555.4 million, with adjusted earnings per share (EPS) more than tripling to $0.62 [4] - Cabometyx has become the most prescribed tyrosine kinase inhibitor among RCC patients and is expanding into other markets, including hepatocellular carcinoma [6] Group 2: Future Growth Potential - Exelixis is preparing for the anticipated generic competition for Cabometyx expected by 2030, indicating proactive strategic planning [7] - The company aims to replicate its past success by developing new cancer medicines that address high unmet needs, with zanzalintinib showing promising phase 3 results for metastatic colorectal cancer (CRC) [8][10] - Zanzalintinib is projected to generate approximately $5 billion in sales, significantly surpassing Cabometyx's current revenue, suggesting strong future growth potential [12] Group 3: Market Position and Strategy - Exelixis is reinforcing its leadership in oncology with several early-stage candidates in development, which could help mitigate the impact of generic competition for Cabometyx [13] - To reach a stock price of $200, Exelixis would need a compound annual growth rate (CAGR) of at least 16.1% over the next decade, a target that, while ambitious, aligns with the company's historical performance [14] - The company is well-positioned to deliver market-beating returns, even if it does not reach the $200 target, indicating a strong investment outlook [15]
Tempus AI Raises 2025 Financial Outlook: What's Backing It?
ZACKS· 2025-07-15 14:20
Core Insights - Tempus AI (TEM) has raised its full-year 2025 revenue guidance to $1.25 billion, reflecting an 80% annual growth, and expects adjusted EBITDA of $5 million, an improvement of approximately $110 million over 2024 [2][9]. Financial Performance - In Q1, Tempus reported total sales of $255.7 million, a year-over-year increase of 75.4%, with gross profit rising 99.8% to $155.2 million [3][9]. - The adjusted EBITDA loss narrowed to $16.2 million from $43.9 million a year ago, indicating improved operational efficiency [3]. Strategic Collaborations - Tempus entered a three-year, $200 million agreement with AstraZeneca and Pathos to develop a multimodal foundation model in oncology, utilizing over 300 petabytes of healthcare data [4]. - This collaboration has increased the total remaining contract value to over $1 billion as of the end of April [4]. Growth in Hereditary Testing - Revenues from hereditary testing reached $63.5 million, driven by a 23% volume growth, surpassing initial guidance [5]. - The acquisition of Ambry Genetics is expected to enhance long-term growth potential in this segment, extending beyond oncology to other genetic predispositions [5]. Competitor Outlook - Exact Sciences (EXAS) anticipates 2025 revenues between $3.070 billion and $3.120 billion, with an adjusted EBITDA forecast of $425-$455 million, driven by the successful launch of Cologuard Plus [6]. - Exelixis (EXEL) raised its 2025 revenue guidance to $2.25-$2.35 billion following strong demand for CABOMETYX and recent FDA approvals [7]. Stock Performance - Tempus AI shares have increased by 58.6% over the past year, outperforming the industry growth of 16.8% and the S&P 500's 11% [10]. Valuation Metrics - Tempus currently trades at a forward Price-to-Sales (P/S) ratio of 7.09, compared to the industry average of 5.82 [11].
Exelixis Surges 35.2% in Three Months: Buy or Sell the Stock?
ZACKS· 2025-07-07 14:26
Core Viewpoint - Exelixis (EXEL) has demonstrated strong performance in the biotech sector, with a 35.2% increase in stock price over the past three months, significantly outperforming the industry growth of 11.8% [1][7]. Pipeline and Study Updates - The stock received a boost from positive results in the late-stage STELLAR-303 study for zanzalintinib, a promising pipeline candidate [2][3]. - The STELLAR-303 study involved 901 patients with previously non-microsatellite instability-high metastatic colorectal cancer, comparing zanzalintinib in combination with Tecentriq against the standard drug regorafenib [4][5]. - Zanzalintinib is a third-generation oral TKI that targets various receptor tyrosine kinases involved in cancer progression [5]. - The study met one of its primary endpoints, showing a statistically significant improvement in overall survival for the treatment group [5][6]. - Exelixis plans to continue the trial for further analysis of the second primary endpoint related to patients without liver metastases [6]. Product Performance and Revenue Guidance - Exelixis' lead drug, Cabometyx, remains a top TKI for renal cell carcinoma, with strong sales driven by label expansions and high demand [10][11]. - The company raised its 2024 revenue guidance by $100 million, supported by Cabometyx's momentum and pipeline advancements [8][11]. - Recent label expansions for Cabometyx are expected to further enhance sales, particularly in treating neuroendocrine tumors [12][13]. Collaborative Efforts - Exelixis is collaborating with Merck to evaluate zanzalintinib in combination with Keytruda for head and neck squamous cell carcinoma in a late-stage study [9]. Pipeline Expansion - The company is making significant progress in expanding its oncology portfolio beyond Cabometyx, with plans to submit an investigational new drug application for XB371 to the FDA in 2025 [14][15]. Valuation and Estimates - Exelixis shares are currently trading at a price/sales ratio of 5.03x forward sales, higher than the biotech industry's average of 1.57x [16]. - The bottom-line estimate for 2025 has increased to $2.64 per share, with a positive trend in earnings estimates over the past 60 days [18][19]. Investment Outlook - Exelixis is viewed as a strong investment opportunity due to its robust fundamentals, growth prospects, and efforts to enhance shareholder value [20].
2 Stocks to Buy With Less Than $50
The Motley Fool· 2025-07-04 11:45
Group 1: Investment Strategy - A formula for generating strong returns involves investing small amounts in top stocks regularly over long periods, with fractional shares being one method to apply this strategy [1] - Attractive corporations can be found at affordable prices, particularly in the healthcare sector [2] Group 2: Pfizer - Pfizer's shares have significantly declined due to reduced revenue and earnings post-coronavirus success, with a notable patent cliff approaching for Eliquis [4] - The company has improved its pipeline and received major approvals, which are expected to positively impact revenue over time [5] - Pfizer is engaged in cost-cutting efforts, planning to reduce expenses further through 2027 [5] - The company offers a strong dividend program, having increased payouts by 19.45% over the past five years, with a forward yield of 7.1% [6] - Pfizer's forward price-to-earnings ratio is 8.3, significantly below the healthcare industry average of 16.1, indicating it is reasonably valued [6] - While recovery may take time, it is considered a worthwhile investment for patient, income-seeking investors [7] Group 3: Exelixis - Exelixis specializes in oncology, with its top-selling product, Cabometyx, approved for various cancers, contributing positively to revenue and earnings [9] - The company won a patent litigation case, ensuring Cabometyx's generic version will not enter the market until early 2030, which is crucial for financial stability [10] - Cabometyx received a label expansion for treating pancreatic neuroendocrine tumors, maintaining a strong market share in renal cell carcinoma treatments [11] - Exelixis announced positive results for its next-gen cancer medicine, zanzalintinib, in a phase 3 study for metastatic colorectal cancer, addressing an unmet need [12] - With these developments, Exelixis's future appears promising, with shares currently priced at $44, suggesting potential for solid returns if held for five years or more [13]
Exelixis (EXEL) Surges 7.4%: Is This an Indication of Further Gains?
ZACKS· 2025-06-24 15:46
Company Overview - Exelixis (EXEL) shares increased by 7.4% to close at $43.37, supported by high trading volume, contrasting with a 4.8% decline over the past four weeks [1] - The company announced that the late-stage STELLAR-303 study met one of its dual primary endpoints, showing a statistically significant improvement in overall survival for patients treated with zanzalintinib in combination with Tecentriq compared to regorafenib [2] - The consensus EPS estimate for Exelixis is $0.63 for the upcoming quarter, reflecting a year-over-year decrease of 25%, with expected revenues of $571.08 million, down 10.4% from the previous year [3] Earnings and Estimates - The consensus EPS estimate for Exelixis has been revised 0.8% higher in the last 30 days, indicating a positive trend that may lead to price appreciation [4] - Exelixis holds a Zacks Rank of 2 (Buy), suggesting favorable market sentiment [4] Industry Context - Exelixis operates within the Zacks Medical - Biomedical and Genetics industry, where Cartesian Therapeutics, Inc. (RNAC) also competes, having closed 0.7% higher at $9.83 [4] - Cartesian Therapeutics has a consensus EPS estimate of -$0.77, representing a significant year-over-year change of -242.6%, and currently holds a Zacks Rank of 3 (Hold) [5]
Exelixis Stock Surges 28% YTD: Should You Buy Now or Sell?
ZACKS· 2025-06-04 15:21
Core Viewpoint - Exelixis (EXEL) has shown strong performance in 2023, with shares increasing by 28.1% year-to-date, outperforming the industry and the S&P 500 Index, which declined by 3.5% [1][2]. Group 1: Company Performance - The positive performance of Exelixis is attributed to strong quarterly results, raised guidance, label expansion of its lead drug Cabometyx, and efforts to enhance shareholder returns [4]. - The FDA expanded Cabometyx's label for patients with previously treated advanced neuroendocrine tumors (NET), which is expected to further drive sales [6][7]. Group 2: Product Strengths - Cabometyx remains the leading tyrosine kinase inhibitor (TKI) for renal cell carcinoma (RCC) and is also approved for use in combination with Bristol Myers' Opdivo, contributing to strong sales [5][6]. - The recent label expansion for Cabometyx makes it the first and only systemic treatment FDA-approved for previously treated NET, regardless of tumor site or grade [7]. Group 3: Pipeline Development - Exelixis is advancing its oncology pipeline, focusing on zanzalintinib, a next-generation oral TKI, with promising results from studies in metastatic colorectal cancer [8][9]. - Collaboration with Merck to evaluate zanzalintinib in combination with Keytruda for head and neck squamous cell carcinoma is also underway [10]. Group 4: Shareholder Value Initiatives - The company has authorized stock repurchase programs totaling $1 billion to enhance shareholder value, with significant repurchases already completed [12]. - These efforts are expected to boost returns for shareholders [17]. Group 5: Valuation and Estimates - Exelixis shares are currently trading at a price/sales ratio of 4.75x forward sales, which is higher than the biotech industry's average of 1.69x [13]. - Earnings estimates for 2025 and 2026 have increased, indicating positive growth expectations [15][16].
EXEL Q1 Earnings Beat, 2025 Sales View Up as Cabometyx Drives Top Line
ZACKS· 2025-05-14 14:01
Core Viewpoint - Exelixis, Inc. reported strong first-quarter 2025 results, exceeding earnings expectations and showing significant revenue growth driven by its lead drug, Cabometyx [1][2]. Financial Performance - Adjusted earnings were 62 cents per share, surpassing the Zacks Consensus Estimate of 42 cents, and up from 17 cents per share in the same quarter last year [1][2]. - Net revenues reached $555.4 million, exceeding the Zacks Consensus Estimate of $503 million, and reflecting a 31% year-over-year increase [2]. - Net product revenues were $513.3 million, a 36% increase year-over-year, primarily due to higher sales volume and average net selling price of Cabometyx [3]. Product Performance - Cabometyx generated revenues of $510.9 million, beating the Zacks Consensus Estimate of $433.7 million and the model estimate of $457.3 million [4]. - Collaboration revenues totaled $42.2 million, a decrease of 10% from $46.7 million in the previous year, attributed to lower royalty revenues from collaboration partners [5]. Expense Management - Research and development expenses amounted to $212.2 million, down 7% year-over-year, due to reduced collaboration costs and lower clinical study costs [6]. - Selling, general and administrative expenses increased by 20% year-over-year to $137.2 million, driven by higher personnel and marketing expenses [6]. Guidance and Future Outlook - Exelixis raised its 2025 sales guidance, now expecting total revenues between $2.25 billion and $2.35 billion, up from the previous range of $2.15 billion to $2.25 billion [8]. - The company anticipates research and development expenses in the range of $925 million to $975 million and selling, general and administrative expenses between $475 million and $525 million for 2025 [10]. Regulatory and Pipeline Updates - In March 2025, Exelixis received FDA approval for the label expansion of Cabometyx for treating neuroendocrine tumors, making it the first systemic treatment approved for this indication [11][12]. - The company is also developing zanzalintinib, with promising results from a phase Ib/II trial showing better efficacy when combined with Tecentriq [13][14].