Exelixis(EXEL)

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Exelixis(EXEL) - 2025 Q1 - Earnings Call Transcript
2025-05-13 22:00
Financial Data and Key Metrics Changes - The company reported total revenues of approximately $555 million for Q1 2025, which included cabozantinib franchise net product revenues of $513.3 million, a 36% year-over-year increase from $378 million in Q1 2024 [7][13] - Non-GAAP net income for Q1 2025 was approximately $179.6 million, or $0.64 per share basic, compared to $159.6 million GAAP net income [16] - The company increased its full-year 2025 net product revenue guidance to $2.05 billion to $2.15 billion, reflecting a $100 million increase from previous guidance [18] Business Line Data and Key Metrics Changes - The U.S. cabozantinib franchise net product revenues grew 36% year-over-year to $513 million [7] - Global cabozantinib franchise net product revenues were approximately $680 million in Q1 2025, compared to $559 million in Q1 2024 [7] - The gross-to-net for the cabozantinib franchise in Q1 2025 was 28.9%, higher than the previous quarter, primarily due to increased PHS and 340B volumes [13] Market Data and Key Metrics Changes - CABOMETYX grew its market share from 40% to 44% in the TKI market basket, with TRx volume growing 18% year-over-year [20][21] - New prescription share for CABOMETYX increased from 38% to 43%, with NRx volume growing 27% year-over-year [22] - The oral market opportunity for neuroendocrine tumors in 2025 is forecasted to be approximately $1 billion in the U.S. [24] Company Strategy and Development Direction - The company aims to build a multi-compound, multi-franchise oncology enterprise, focusing on improving the standard of care for cancer patients [4][5] - The launch of CABOMETYX in neuroendocrine tumors is seen as a significant commercial opportunity, with expectations of rapid establishment as a market leader [20][25] - The company is advancing ZANZA as its next oncology franchise opportunity, with several pivotal trials expected to report data in the second half of 2025 [10][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong performance of CABOMETYX and the potential for new indications to drive further growth [6][9] - The company is focused on advancing new molecules from its pipeline and expects to file up to three new INDs in 2025 [11][34] - Management highlighted the importance of capital allocation, balancing investments in R&D, business development, and share repurchases [12][86] Other Important Information - The company repurchased approximately $289 million of its shares during Q1 2025, with a remaining authorization of $5.5 million under the previous buyback plan [17] - The company is focused on late-stage assets in GU and GI oncology for business development opportunities [72] Q&A Session Summary Question: What has been driving CABOMETYX growth? - The company noted significant growth in market share and volume, particularly in frontline RCC, driven by positive physician feedback and updated data from CheckMate 9ER [42][46] Question: What are the expectations for the NET launch? - Management indicated that it is early days for the NET launch, with positive prescriber excitement and new prescriptions being tracked closely [49][54] Question: What is the impact of Medicare Part D redesign? - The company reported minimal impact from the redesign, with a roughly equal split between commercial and Medicare business [74][78] Question: What is the company's approach to business development? - The company remains open to business development opportunities, focusing on high-conviction assets that align with its oncology franchise [68][70]
Exelixis(EXEL) - 2025 Q1 - Quarterly Results
2025-05-13 20:10
Exhibit 99.1 Contacts: Chris Senner Chief Financial Officer Exelixis, Inc. 650-837-7240 csenner@exelixis.com Susan Hubbard EVP, Public Affairs & Investor Relations Exelixis, Inc. 650-837-8194 shubbard@exelixis.com Exelixis Announces First Quarter 2025 Financial Results and Provides Corporate Update - Total Revenues of $555.4 million, Cabozantinib Franchise U.S. Net Product Revenues of $513.3 million - - GAAP Diluted EPS of $0.55, Non-GAAP Diluted EPS of $0.62 - - Increasing 2025 Full Year Net Product Revenu ...
Ahead of Exelixis (EXEL) Q1 Earnings: Get Ready With Wall Street Estimates for Key Metrics
ZACKS· 2025-05-08 14:21
In its upcoming report, Exelixis (EXEL) is predicted by Wall Street analysts to post quarterly earnings of $0.42 per share, reflecting an increase of 147.1% compared to the same period last year. Revenues are forecasted to be $502.96 million, representing a year-over-year increase of 18.3%.The consensus EPS estimate for the quarter has been revised 0.4% higher over the last 30 days to the current level. This reflects how the analysts covering the stock have collectively reevaluated their initial estimates d ...
Exelixis' Q1 Earnings: Will Cabometyx Maintain Momentum?
ZACKS· 2025-04-25 18:30
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]
Exelixis (EXEL) Earnings Expected to Grow: What to Know Ahead of Q1 Release
ZACKS· 2025-04-22 15:06
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]
Will Exelixis (EXEL) Beat Estimates Again in Its Next Earnings Report?
ZACKS· 2025-04-11 17:16
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]
The Smartest Biotech Stocks to Buy With $50
The Motley Fool· 2025-04-03 10:15
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]
FDA Expands Exelixis Cabometyx Label for Neuroendocrine Tumors
ZACKS· 2025-03-27 20:00
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]
Exelixis Stock Rises 13.3% Year to Date: Buy, Sell or Hold?
ZACKS· 2025-03-26 20:01
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].
Here's Why Exelixis (EXEL) is a Strong Growth Stock
ZACKS· 2025-03-26 14:45
Company Overview - Exelixis, Inc. is an oncology-focused biotechnology company based in Alameda, CA, specializing in the discovery, development, and commercialization of new drugs for difficult-to-treat cancers [11] - The company is leveraging investments, expertise, and strategic partnerships to target a growing range of tumor types and indications with its differentiated pipeline of small molecules, antibody-drug conjugates (ADCs), and other biotherapeutics [11] Investment Potential - Exelixis has a Zacks Rank of 3 (Hold) and a VGM Score of A, indicating a solid investment profile [12] - The company is particularly appealing to growth investors, with a Growth Style Score of B, forecasting a year-over-year earnings growth of 15.5% for the current fiscal year [12] - Seven analysts have revised their earnings estimates higher in the last 60 days for fiscal 2025, with the Zacks Consensus Estimate increasing by $0.17 to $2.31 per share [12] - Exelixis has an average earnings surprise of 26.9%, further enhancing its attractiveness to investors [12] Conclusion - With a strong Zacks Rank and top-tier Growth and VGM Style Scores, Exelixis is recommended for investors' consideration [13]