Financial Data and Key Metrics Changes - For Q2 2025, total revenues were approximately $568 million, including net product revenues from the cabozantinib franchise of $520 million, which represents a 19% year-over-year growth from $438 million in Q2 2024 [6][11][14] - GAAP net income was approximately $184.8 million, or $0.68 per share basic and $0.65 per share diluted, while non-GAAP net income was approximately $212.6 million, or $0.78 per share basic and $0.75 per share diluted [14] - Gross to net for the cabozantinib franchise in Q2 2025 was 30.2%, higher than the previous quarter, primarily due to increased 340B volume, which now accounts for over 24% of total volume [12][13][68] Business Line Data and Key Metrics Changes - The cabozantinib U.S. business showed robust performance, with significant growth in demand and revenue, particularly from the recently approved neuroendocrine tumor (NET) indications, contributing approximately 4% to total net product revenue [5][6][21] - CABOMETYX maintained its position as the leading TKI for renal cell carcinoma (RCC), with TRx volume growing 18% year-over-year, outpacing the market growth rate by 10 percentage points [17][18] - The launch of CABOMETYX in NETs has rapidly established a 35% new patient market share for oral therapies, indicating strong early uptake [20][21] Market Data and Key Metrics Changes - The company anticipates further updates to its 2025 financial guidance as it builds momentum on the NET launch and explores additional revenue opportunities for the second half of 2025 [7][15] - The competitive landscape for cabozantinib remains strong, with the drug being viewed as the best-in-class oral therapy in the NET market shortly after its approval [22][23] Company Strategy and Development Direction - The company aims to solidify its leadership in oncology drug discovery, development, and commercialization through innovation and collaboration, focusing on expanding the number of cancer patients served [4][5] - Zanzalutinib is positioned as the next oncology franchise opportunity, with ongoing pivotal trials and a focus on high-potential indications [7][8][29] - The company is committed to rigorous capital allocation decisions based on clinical and competitive data, prioritizing existing and new indications for zanzalutinib [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth of CABOMETYX and the NET market, highlighting positive prescriber feedback and the drug's potential to become a new standard of care [19][22] - The management team emphasized the importance of continuous assessment of emerging data and the dynamic regulatory environment in guiding future development strategies [39][60] Other Important Information - The company reported a cash and marketable securities balance of approximately $1.4 billion as of June 30, 2025, and continued share repurchases under its authorized plan [15] - The One Big Beautiful Bill Act, signed into law on July 4, 2025, allows for the accelerated deduction of unamortized domestic R&D expenditures, providing a cash tax benefit estimated at $147 million [14] Q&A Session Summary Question: Insights from head and neck data for future studies - Management acknowledged the need for continuous assessments in drug development and indicated that further data will be shared in the future [39][40] Question: Longevity of market share gains for cabozantinib - Management expressed confidence in sustaining market share gains in both RCC and NET, citing strong franchise growth and positive prescriber feedback [42][45] Question: Importance of NLM subset in STELLAR-303 - Management highlighted the significance of overall survival as a gold standard and indicated that they will continue to follow the NLM patient population for further insights [56][57] Question: Pricing dynamics with cabozantinib and 340B volume - Management noted a shift towards the 340B segment, impacting gross to net, and projected gross to net to be closer to 30% [66][68] Question: Future studies for zanzalutinib in CRC - Management confirmed interest in exploring zanzalutinib in earlier lines of therapy, particularly in the adjuvant setting, and emphasized the potential for significant patient impact [84][90]

Core Insights - Exelixis reported Q2 2025 results with non-GAAP EPS of $0.75, exceeding analyst expectations of $0.66, while GAAP revenue of $568.3 million fell short of the $580.05 million estimate, reflecting a 10.8% year-over-year decline primarily due to the absence of a $150 million milestone payment from Q2 2024 [1][2][6] Financial Performance - Non-GAAP EPS was $0.75, down 10.7% from $0.84 in Q2 2024 [2] - GAAP EPS was $0.65, down 15.6% from $0.77 in Q2 2024 [2] - Total revenue was $568.3 million, a decrease of 10.8% from $637.2 million in Q2 2024 [2] - Net product revenue increased by 18.8% year-over-year to $520 million, driven by strong sales of CABOMETYX [2][5] - Collaboration revenue fell to $48.2 million from $199.6 million, a 75.8% decline due to the lack of milestone payments [2][6] Business Model and Strategy - Exelixis focuses on developing targeted small-molecule therapies for cancer, with CABOMETYX as its core product for various cancers [3] - The company aims to diversify its portfolio beyond cabozantinib through strategic partnerships and a robust development pipeline [4] Product Sales and Market Position - CABOMETYX sales accounted for the majority of net product revenue, with $517.9 million from CABOMETYX and $2.1 million from COMETRIQ [5] - The new indication for neuroendocrine tumors now represents about 4% of CABOMETYX's business, with rapid launch efforts following U.S. approval in March 2025 [5][11] Clinical Development and Pipeline - Zanzalintinib showed promising results in the Phase 3 STELLAR-303 trial for colorectal cancer, with a regulatory submission planned [9] - The company is focusing on high-potential projects, having discontinued weaker assets [9][10] Regulatory and Competitive Landscape - Recent approvals for CABOMETYX in neuroendocrine tumors expand market opportunities, although financial contributions will take time to materialize [11] - CABOMETYX remains a leading TKI in renal cell carcinoma, but faces competition from generics in neuroendocrine tumors [12] Future Guidance - Management maintains FY2025 revenue guidance of $2.25 billion to $2.35 billion, with net product revenue expected between $2.05 billion and $2.15 billion [14] - The company will continue to evaluate guidance based on the performance of the NET launch and other new indications [14][15]

Core Insights - Exelixis (EXEL) is expected to report quarterly earnings of $0.63 per share, reflecting a year-over-year decline of 25% [1] - Anticipated revenues are projected at $574.51 million, indicating a decrease of 9.8% compared to the same quarter last year [1] Earnings Projections - The consensus EPS estimate has been revised downward by 0.4% in the past 30 days, indicating a reassessment by analysts [2] - Changes in earnings projections are crucial for predicting investor reactions, with empirical studies showing a strong correlation between earnings estimate trends and short-term stock price movements [3] Revenue Estimates - Analysts expect 'Revenues- Net product' to be $522.61 million, representing a year-over-year increase of 19.4% [4] - The estimated 'Revenues- Collaboration services' is projected at $51.23 million, showing a significant year-over-year change of 1011% [5] - The consensus estimate for 'Revenues- Net product- COMETRIQ' is $3.58 million, reflecting a decline of 15.7% from the previous year [5] - 'Revenues- Net product- CABOMETYX' is expected to reach $527.01 million, indicating a year-over-year increase of 21.6% [5] Stock Performance - Exelixis shares have decreased by 2.7% over the past month, contrasting with the Zacks S&P 500 composite's increase of 5.9% [6] - With a Zacks Rank 2 (Buy), Exelixis is anticipated to outperform the overall market in the near term [6]

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].

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]

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 ...

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]

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].