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Exelixis(EXEL) - 2025 Q1 - Earnings Call Presentation
2025-05-13 22:33
TUESDAY, MAY 13, 2025 First Quarter 2025 Financial Results Commercial Update Development Update Pipeline & Discovery Update Nasdaq: EXEL Today's Agenda Introduction First Quarter 2025 Highlights Financial Results & Guidance Q&A Susan Hubbard EVP, Public Affairs and Investor Relations Michael M. Morrissey, Ph.D. President and CEO Chris Senner EVP and CFO PJ Haley EVP, Commercial Amy Peterson, M.D. EVP, Product Development and Medical Affairs and CMO Dana T. Aftab, Ph.D. EVP, Discovery and Translational Resea ...
Exelixis (EXEL) Surpasses Q1 Earnings and Revenue Estimates
ZACKS· 2025-05-13 22:20
Exelixis (EXEL) came out with quarterly earnings of $0.62 per share, beating the Zacks Consensus Estimate of $0.42 per share. This compares to earnings of $0.17 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 47.62%. A quarter ago, it was expected that this drug developer would post earnings of $0.51 per share when it actually produced earnings of $0.55, delivering a surprise of 7.84%.Over the last four quarters, the company h ...
Exelixis(EXEL) - 2025 Q1 - Earnings Call Transcript
2025-05-13 22:02
Financial Data and Key Metrics Changes - For Q1 2025, total revenues were approximately $555 million, including cabozantinib franchise net product revenues of $513.3 million, which represents a year-over-year growth of 36% from $378 million in Q1 2024 [9][15] - The company reported GAAP net income of approximately $159.6 million, or $0.57 per share basic and $0.55 per share diluted, while non-GAAP net income was approximately $179.6 million, or $0.64 per share basic and $0.62 per share diluted [17] - Cash and marketable securities at the end of Q1 2025 were approximately $1.65 billion, with share repurchases totaling approximately $289 million during the quarter [18] Business Line Data and Key Metrics Changes - The U.S. cabozantinib business saw strong performance with net product revenues growing 36% year-over-year to $513 million [9][21] - Global cabozantinib franchise net product revenues were approximately $680 million in Q1 2025, compared to $559 million in Q1 2024 [9] - The gross to net for the cabozantinib franchise in Q1 2025 was 28.9%, higher than the previous quarter, primarily due to higher PHS and 340B volumes [15] 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 [22][23] - New prescription share for CABOMETYX increased from 38% to 43%, with NRx volume growing 27% year-over-year [24] - The oral market opportunity for neuroendocrine tumors in 2025 is forecasted to be approximately $1 billion in the U.S. [26] 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 [6][7] - Exelixis plans to advance ZANZA as its next oncology franchise opportunity, with several pivotal trial data milestones expected in the second half of 2025 [11][32] - Business development activities are focused on late-stage assets in GU and GI oncology, with a commitment to high conviction assets that can convert clinical data into commercial success [13][71] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong performance in Q1 2025 and the anticipated busy year ahead, with expectations of continued growth in cabozantinib revenues [6][19] - The approval of CABOMETYX for neuroendocrine tumors is seen as a significant opportunity, with positive prescriber feedback and a strong launch strategy [21][30] - Management is closely monitoring the performance of the NET launch and is confident in the potential for further revenue growth [66][67] Other Important Information - The company has authorized an additional $500 million stock repurchase plan that expires at the end of 2025, with approximately $5.5 million remaining under the previous plan [18] - Exelixis is on track to file up to three new INDs in 2025, with ongoing development of several promising candidates [39][40] Q&A Session Summary Question: What has driven CABOMETYX growth? - Management noted significant market share growth and strong performance in RCC, particularly in frontline settings, with positive feedback from prescribers [46][49] Question: Expectations for the NET launch? - Management indicated it is early days for the NET launch, with positive prescriber excitement and new prescriptions being observed [55][57] Question: Clarification on 2025 guidance increase? - The increase in guidance is primarily driven by strong performance in the RCC business, with some contribution from NET [66][67] Question: Business development plans? - Management remains open to business development opportunities, focusing on high conviction assets that align with their oncology franchise [71][72] Question: Impact of Medicare Part D redesign? - There was minimal impact from the redesign, with a roughly equal split between commercial and Medicare business [80] Question: Expectations for the non-clear cell renal cell carcinoma study? - Management expressed excitement about the study, emphasizing its significance in kidney cancer [99]
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
Core Viewpoint - Exelixis is expected to report significant growth in quarterly earnings and revenues, indicating strong performance compared to the previous year [1][2]. Earnings Estimates - Wall Street analysts predict Exelixis will post quarterly earnings of $0.42 per share, reflecting a 147.1% increase year-over-year [1]. - The consensus EPS estimate has been revised 0.4% higher over the last 30 days, indicating a collective reevaluation by analysts [2]. Revenue Projections - Total revenues are forecasted to be $502.96 million, representing an 18.3% year-over-year increase [1]. - Analysts project 'Revenues- Net product' to reach $448.24 million, indicating an 18.4% year-over-year change [4]. - 'Revenues- Net product- CABOMETYX' is expected to be $433.73 million, reflecting a 15.2% year-over-year increase [5]. - 'Revenues- License' is estimated at $44.61 million, showing a slight decline of 0.2% year-over-year [5]. Market Performance - Exelixis shares have experienced a 4.2% change in the past month, compared to an 11.3% increase in the Zacks S&P 500 composite [6]. - The company holds a Zacks Rank 3 (Hold), suggesting it is expected to mirror overall market performance in the near future [6].
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]