Core Viewpoint - Investors are keenly awaiting Exelixis' first-quarter 2025 results, particularly focusing on the performance of its lead drug, Cabometyx, with sales and earnings estimates at $502.8 million and 42 cents per share respectively [1] Group 1: Financial Performance - Exelixis has a history of earnings surprises, beating estimates in three of the last four quarters with an average surprise of 26.87%, including a 7.84% beat in the last reported quarter [1] - The Zacks Consensus Estimate for Cabometyx sales is $434 million, while the model estimate is $457.3 million, indicating strong sales performance [3] - Collaboration revenues have increased due to higher royalty revenues from cabozantinib sales outside the U.S., a trend expected to continue [4] Group 2: Product Developments - Cabometyx is approved for advanced renal cell carcinoma (RCC) and previously treated hepatocellular carcinoma, maintaining its status as the leading TKI for RCC [3] - Recent FDA approvals expanded Cabometyx's label for treating adult and pediatric patients with previously treated, unresectable, locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumors (pNET) and extra-pancreatic NET (epNET) [5][6] Group 3: Share Repurchase and Financial Strategy - The board has authorized a $500 million stock repurchase program, expected to commence after completing the ongoing $500 million program [7] - Ongoing share repurchases are likely to positively impact the bottom line, although operating expenses may rise due to costs associated with a broader portfolio [7] Group 4: Earnings Prediction - The earnings model predicts a potential earnings beat for Exelixis, supported by a positive Earnings ESP of +7.14% and a Zacks Rank of 3 [8][9] - The Most Accurate Estimate for earnings is 45 cents per share, compared to the consensus estimate of 42 cents [9] Group 5: Stock Performance - Exelixis shares have gained 11.4% year-to-date, contrasting with a 3.7% decline in the industry [12]

Company Overview - Exelixis (EXEL) is expected to report quarterly earnings of $0.41 per share, reflecting a year-over-year increase of +141.2% [3] - Revenues are anticipated to reach $502.8 million, which is an 18.2% increase from the same quarter last year [3] Earnings Estimates and Trends - The consensus EPS estimate has been revised 0.4% lower in the last 30 days, indicating a reassessment by analysts [4] - The Most Accurate Estimate for Exelixis is higher than the Zacks Consensus Estimate, resulting in a positive Earnings ESP of +4.24% [10][11] - Exelixis holds a Zacks Rank of 3, suggesting a neutral outlook [11] Earnings Surprise History - In the last reported quarter, Exelixis exceeded the expected earnings of $0.51 per share by delivering $0.55, resulting in a surprise of +7.84% [12] - Over the past four quarters, Exelixis has beaten consensus EPS estimates three times [13] Industry Context - In the Zacks Medical - Biomedical and Genetics industry, NovoCure (NVCR) is expected to report a loss of $0.47 per share, a year-over-year decline of -30.6% [17] - NovoCure's revenue is projected to be $147.57 million, up 6.6% from the previous year [17] - NovoCure has an Earnings ESP of -6.38% and a Zacks Rank of 3, making it challenging to predict an earnings beat [18]

Core Insights - Exelixis (EXEL) has a strong history of beating earnings estimates and is well-positioned for continued success in upcoming quarterly reports [1][2] Earnings Performance - Exelixis has surpassed earnings estimates by an average of 9.87% over the last two quarters [2] - In the most recent quarter, the company reported earnings of $0.55 per share against an expectation of $0.51, resulting in a surprise of 7.84% [2] - For the previous quarter, Exelixis reported $0.47 per share compared to a consensus estimate of $0.42, achieving a surprise of 11.90% [2] Earnings Estimates and Predictions - Recent estimates for Exelixis have been increasing, indicating a positive outlook for future earnings [4] - The Zacks Earnings ESP for Exelixis is currently +4.24%, suggesting analysts are optimistic about the company's near-term earnings potential [7] - Stocks with a positive Earnings ESP and a Zacks Rank of 3 (Hold) or better have a nearly 70% chance of producing a positive surprise [5] Importance of Earnings ESP - The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate, reflecting the latest analyst revisions [6] - A positive Earnings ESP combined with a Zacks Rank of 3 indicates a strong possibility of an earnings beat [7] - It is crucial to check a company's Earnings ESP before quarterly releases to enhance the likelihood of successful investment decisions [9]

Group 1: Viking Therapeutics - Viking Therapeutics is a mid-cap biotech focused on the weight management market, with positive phase 2 results for its leading candidate VK2735 and plans to move to phase 3 studies soon [2] - The potential for Viking is significant, as its candidate may not need to achieve the same sales as current leaders like Wegovy and Zepbound to be considered a success [3] - Viking is also developing additional candidates, including VK2809 for metabolic dysfunction-associated steatohepatitis and another weight loss candidate in preclinical studies, indicating a diversified pipeline [4] - The company is considered risky due to the lack of approved products, but its innovative approach could lead to substantial long-term gains if mid-stage programs succeed, with shares priced around $25 [5] Group 2: Exelixis - Exelixis is a successful cancer-focused biotech, recently announcing a label expansion for its best-selling product Cabometyx in treating advanced neuroendocrine tumors [6] - Cabometyx has been a significant growth driver, with Exelixis reporting a 18.5% year-over-year revenue increase to $2.2 billion and a 22% growth in adjusted net earnings per share to $2 [7] - The company resolved a legal battle regarding a potential Cabometyx generic, ensuring no competition from MSN Laboratories until 2030, allowing continued revenue growth from new indications [8] - Exelixis is developing new medicines, including zanzalintinib for advanced colorectal cancer, which is in phase 3 studies, addressing a high unmet need in the oncology market [10] - The ongoing performance of Cabometyx and Exelixis' robust pipeline suggest a strong long-term investment opportunity, with shares trading just under $37 [11]

Core Insights - Exelixis, Inc. announced FDA approval for the label expansion of its lead drug Cabometyx for treating adult and pediatric patients aged 12 and older with previously treated, unresectable, locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumors (pNET) [1] - Cabometyx is now the first and only systemic treatment FDA-approved for previously treated neuroendocrine tumors regardless of primary tumor site, grade, somatostatin receptor expression, and functional status [2] - The approval was based on results from the phase III CABINET study, which showed significant improvement in progression-free survival compared to placebo [6] Drug Performance and Market Impact - Cabometyx sales are projected to reach $1.8 billion in 2024, with the label expansion expected to further boost sales [7] - The drug is also approved for other indications, including renal cell carcinoma (RCC) and hepatocellular carcinoma, enhancing its market presence [4][5] Pipeline Development - Exelixis is advancing its oncology portfolio beyond Cabometyx, focusing on developing zanzalintinib, a next-generation oral TKI [9] - The company has other pipeline candidates, including XL495, XL309, and XB010, which could diversify its offerings and reduce dependence on Cabometyx [10][11] Financial Performance - Exelixis shares have increased by 11.1% year-to-date, outperforming the industry growth of 4.7% [13] - The company has authorized a stock repurchase program of up to $500 million, indicating strong financial health and commitment to shareholder returns [14]

Core Viewpoint - Exelixis, Inc. (EXEL) has demonstrated strong stock performance, rising 13.3% year to date, outperforming both the industry and the S&P 500 Index, driven by robust quarterly results, raised guidance, and shareholder return initiatives [1][3]. Financial Performance - The company announced a new share repurchase program worth $500 million, which contributed to a rally in its stock price [4]. - Exelixis reported better-than-expected fourth-quarter results, further driving stock performance [4]. Product Performance - Exelixis' lead drug, Cabometyx, remains the leading tyrosine kinase inhibitor (TKI) for renal cell carcinoma (RCC) treatment, with approvals for use in combination with Bristol Myers' Opdivo [5]. - Cabometyx is also approved for hepatocellular carcinoma and has received orphan drug designation for treating advanced pancreatic neuroendocrine tumors (pNET) [6][7]. Pipeline Development - The company is advancing its oncology portfolio with zanzalintinib, a next-generation oral TKI, showing promising results in combination with Tecentriq for metastatic colorectal cancer [8][9]. - Exelixis is collaborating with Merck to evaluate zanzalintinib in head and neck squamous cell carcinoma (HNSCC) and other studies [10][11]. - The pipeline includes additional candidates like XL495, XL309, and XB010, with plans for clinical development of three biotherapeutics in 2025 [12][13]. Shareholder Value Initiatives - Exelixis has authorized an additional $500 million stock repurchase program, marking the fourth such initiative since March 2023, aiming to complete the ongoing repurchase program by Q2 2025 [14][15]. - The company has returned over $1.2 billion to shareholders through repurchase programs by the end of 2024 [15]. Investment Outlook - The company’s efforts to enhance shareholder value and the potential for Cabometyx's label expansion are viewed positively, although recent stock performance may limit further gains [16][17].

Taking full advantage of the stock market and investing with confidence are common goals for new and old investors, and Zacks Premium offers many different ways to do both.The popular research service can help you become a smarter, more self-assured investor, giving you access to daily updates of the Zacks Rank and Zacks Industry Rank, the Zacks #1 Rank List, Equity Research reports, and Premium stock screens.It also includes access to the Zacks Style Scores. What are the Zacks Style Scores? Developed along ...

Core Viewpoint - The content emphasizes the importance of conducting personal due diligence and consulting competent advisors before making any financial decisions, particularly in the context of investments and trading [1]. Group 1 - The website provides general news, personal analysis, and third-party content intended for educational and research purposes [1]. - It explicitly states that the information should not be interpreted as recommendations or advice for any financial actions [1]. - The content is not tailored to individual financial situations or needs, highlighting the necessity for users to apply their own discretion [1]. Group 2 - The website includes information about complex financial instruments such as cryptocurrencies and contracts for difference (CFDs), which carry a high risk of losing money [1]. - Users are encouraged to perform their own research and understand the risks involved before investing in any financial instruments [1].

Core Viewpoint - Exelixis has announced a new share repurchase program worth up to $500 million, which has positively impacted its stock price amidst a generally declining market [1][2]. Group 1: Share Repurchase Program - Exelixis will initiate a new share repurchase program authorized for up to $500 million before December 31, following the exhaustion of the current buyback program [2]. - The company expects the current buyback program, also capped at $500 million, to be completed in the second calendar quarter of this year [2]. - This new initiative marks Exelixis's fourth share repurchase program, with over $1.2 billion spent on buybacks through the end of 2024 [3]. Group 2: Market Reaction - Following the announcement of the new buyback program, Exelixis's shares rose by 5%, contrasting with a 1.7% decline in the S&P 500 index on the same day [1]. - Investors generally view stock repurchase announcements favorably, as they indicate management's commitment to supporting equity value [4].

Core Insights - Exelixis, Inc. has authorized an additional stock repurchase program of up to $500 million, expected to be completed by Q2 2025 [1] - The company reported a fourth-quarter adjusted EPS of 55 cents, exceeding the consensus estimate of 43 cents, with sales of $566.75 million, also surpassing expectations [2] - Exelixis reaffirmed its 2025 sales guidance of $2.15 billion to $2.25 billion, slightly below the consensus of $2.24 billion [2] Stock Repurchase Program - The new stock repurchase program follows a previous $500 million program announced in August 2024, which is set to be completed in Q2 2025 [1] - As of the end of fiscal year 2024, Exelixis has returned over $1.2 billion to shareholders through its stock repurchase initiatives [1] Financial Performance - The fourth-quarter adjusted EPS of 55 cents beat the consensus estimate of 43 cents, indicating strong financial performance [2] - Sales for the quarter reached $566.75 million, exceeding the consensus of $563.42 million, reflecting robust demand for its products [2] - The company has reaffirmed its sales guidance for 2025, projecting revenues between $2.15 billion and $2.25 billion [2] Clinical Developments - Exelixis announced positive long-term results from the phase 3 CheckMate -9ER trial for Cabometyx in combination with Opdivo, showing sustained efficacy benefits for patients with advanced renal cell carcinoma [3][4] - The trial demonstrated improved progression-free survival and overall survival compared to sunitinib, with a median follow-up of 67.6 months [4] - A subgroup analysis indicated that the combination therapy favored Cabometyx regardless of the IMDC risk group [5] Regulatory Updates - The supplemental New Drug Application (sNDA) for cabozantinib for advanced pancreatic neuroendocrine tumors is still under FDA consideration, with an action date set for April 3 [6] - The sNDA will not be discussed at the upcoming FDA Oncologic Drugs Advisory Committee meeting [6] Stock Performance - Exelixis stock experienced a 3.42% increase, reaching $36.29 at the last check on Friday [6]