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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].
Exelixis (EXEL) Q1 Earnings: Taking a Look at Key Metrics Versus Estimates
ZACKS· 2025-05-13 23:01
Core Insights - Exelixis reported a revenue of $555.45 million for the quarter ended March 2025, marking a 30.6% increase year-over-year and exceeding the Zacks Consensus Estimate by 10.44% [1] - The company's EPS for the quarter was $0.62, significantly up from $0.17 in the same quarter last year, resulting in an EPS surprise of 47.62% compared to the consensus estimate of $0.42 [1] Revenue Breakdown - Net product revenues reached $513.28 million, surpassing the average estimate of $448.24 million by nine analysts, reflecting a year-over-year increase of 35.6% [4] - CABOMETYX generated $510.87 million in net product revenues, exceeding the estimated $433.73 million by seven analysts, with a year-over-year growth of 35.7% [4] - COMETRIQ's net product revenues were $2.41 million, compared to the estimated $3.39 million, showing a year-over-year increase of 14.5% [4] - License revenues totaled $42.48 million, falling short of the average estimate of $44.61 million, representing a year-over-year decline of 4.9% [4] - Collaboration services reported a loss of $0.32 million, significantly below the average estimate of $2.43 million, indicating a drastic year-over-year change of -115.6% [4] Stock Performance - Over the past month, Exelixis shares have returned +3.5%, while the Zacks S&P 500 composite has increased by +9.1%, suggesting underperformance relative to the broader market [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating it may perform in line with the market in the near term [3]
Exelixis(EXEL) - 2025 Q1 - Earnings Call Presentation
2025-05-13 22:33
Financial Performance - U S cabozantinib franchise net product revenues grew 36% year-over-year to $513 3 million in Q1 2025, compared to $378 5 million in Q1 2024[15, 27] - Total revenues for Q1 2025 were $555 4 million, a 31% increase compared to $425 2 million in Q1 2024[27, 40] - GAAP net income for Q1 2025 was $159 6 million, a significant increase from $37 3 million in Q1 2024[36, 40] - GAAP diluted earnings per share (EPS) increased to $0 55 in Q1 2025, compared to $0 12 in Q1 2024[39, 40] - The company increased its full-year 2025 financial guidance for net product revenues to $2 05 billion - $2 15 billion and total revenues to $2 25 billion - $2 35 billion[15, 43] - Approximately $1 5 billion of stock has been repurchased since March 2023, at an average price of $24 62 per share[42] CABOMETYX Performance - CABOMETYX holds approximately 44% TRx market share in Q1 2025[55] - CABOMETYX new patient starts reached an all-time high in Q1 2025[56, 62] - CABOMETYX in combination with nivolumab is the 1 prescribed TKI+IO regimen in 1L RCC[50, 56, 62] Pipeline and Development - The company anticipates pivotal data milestones for zanzalintinib in the second half of 2025, including top-line results for STELLAR-303 in CRC and STELLAR-304 in nccRCC[22]
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]