Financial Data and Key Metrics Changes - For Q4 2025, total revenues were approximately $599 million, including cabozantinib franchise net product revenues of $546.6 million [16] - Full year 2025 US CABO franchise net product revenues grew 17% to approximately $2.12 billion compared to 2024 [10] - GAAP net income for Q4 2025 was approximately $244.5 million, or $0.92 per share basic [18] - Non-GAAP net income for Q4 2025 was approximately $259.5 million, or $0.97 per share basic [19] - Total operating expenses for Q4 2025 were approximately $363 million, up from $341 million in Q3 2025 [18] Business Line Data and Key Metrics Changes - CABOMETYX maintained its position as the leading TKI for renal cell carcinoma (RCC) and neuroendocrine tumors, with a TRX volume growth of 15% in Q4 2025 compared to Q4 2024 [21][22] - CABOMETYX's market share in the oral TKI market increased from 43% to 46% from Q4 2024 to Q4 2025 [21] - The company is preparing to launch zanzalintinib, with a focus on accelerating growth in the GI franchise [11][24] Market Data and Key Metrics Changes - CABOMETYX's US net product revenues exceeded $100 million for the neuroendocrine tumor indication in 2025 [10] - The market basket growth rate for oral TKIs was 7% for the same period, while CABOMETYX outpaced this growth [22] - The company anticipates significant growth opportunities in the community setting for CABOMETYX [52] Company Strategy and Development Direction - The company aims to build a multi-franchise business in solid tumor oncology, focusing on cabozantinib and zanzalintinib [8] - The strategy includes expanding leadership in gastrointestinal (GI) indications and enhancing the commercial footprint for both CABOMETYX and ZANZA [9][11] - Business development activities are focused on late-stage assets in GU and GI spaces, with a commitment to disciplined investment in high-value opportunities [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2026 being a transformational year, with expectations to build on the momentum from 2025 [7][36] - The company is focused on maximizing productivity and advancing its early-stage pipeline while preparing for the potential launch of zanzalintinib [27][36] - Management highlighted the importance of addressing unmet medical needs in the colorectal cancer market with the upcoming STELLAR-303 trial results [25][29] Other Important Information - The company repurchased $954 million of its outstanding common stock in 2025, with approximately $590 million remaining under the stock repurchase plan [19][20] - The gross-to-net for the cabozantinib franchise in Q4 2025 was 28.5%, lower than in Q3 2025, primarily due to lower PHS and 340B volume [16] Q&A Session Summary Question: Duration of small manufacturer discount for Zanza and share repurchase cadence - Management indicated that the small manufacturer exemptions are tied to having a single product as the majority revenue source, which is expected to remain for the foreseeable future [40] - The company plans to continue share repurchases as long as shares are perceived as undervalued, with a commitment to complete the current authorization [41] Question: 340B purchasing behavior and Part D redesign impact - Management noted variability in 340B purchasing behavior and expects this to continue, which could impact gross-to-net [43][44] - The company will design its channel for Zanza to optimize results based on past experiences with CABO [45] Question: STELLAR-316 population size and timeline - The estimated population for STELLAR-316 is approximately 20,000-25,000 patients who are MRD positive after definitive therapy [48] Question: Revenue potential for neuroendocrine tumors - Management expressed confidence in the growth potential for CABOMETYX in neuroendocrine tumors, particularly in the community setting [51][52] Question: Zanza trial design and market expectations - Management emphasized the importance of establishing Zanza as a standard of care in RCC and highlighted ongoing discussions for potential combination trials [56][57] Question: Non-clear cell RCC market size and competition - Non-clear cell RCC represents approximately 20% of the RCC market, and the company sees significant potential for growth in this underserved area [83]

TUESDAY, FEBRUARY 10, 2026 Fourth Quarter & Fiscal Year 2025 Financial Results Nasdaq: EXEL Today's Agenda Introduction Business Update & Highlights Financial Results & Guidance Commercial Update Research & Development Update Andrew Peters SVP, Strategy and Investor Relations Michael M. Morrissey, Ph.D. President and CEO Chris Senner EVP and CFO PJ Haley EVP, Commercial Dana T. Aftab, Ph.D. EVP, Research and Development All Participants 2 Q&A Forward-Looking Statements This presentation, including any oral ...

Group 1: Exelixis Overview - Exelixis has seen a stock increase of +30% over the last year, with Q4 sales expected to rise by 3% year over year to $584.68 million and Q4 EPS projected to increase by 40% to $0.77 compared to $0.55 in the prior year quarter [1][4] - The company received FDA acceptance for a New Drug Application for a combination therapy targeting metastatic colorectal cancer, marking its transition from a single-product biotech to a multi-asset oncology company [2][3] - Exelixis has consistently surpassed Zacks EPS Consensus for six consecutive quarters, with an average earnings surprise of 21.39% in its last four quarterly reports [4][5] Group 2: Gilead Sciences Overview - Gilead Sciences' stock has surged nearly +60% in the last year, with Q4 sales expected to be flat at $7.57 billion and quarterly EPS anticipated to dip 3% to $1.83 [1][10] - The company's HIV franchise, particularly Biktarvy, is highlighted as a primary long-term growth driver, contributing to a "wide moat" for the business [8] - Gilead's robust R&D pipeline, including oncology and virology programs, has been noted as the most extensive in the company's history, fueling investor sentiment [9] Group 3: Financial Projections - For fiscal 2025, Exelixis' annual EPS is expected to increase by 48% to $2.96, while Gilead Sciences' EPS is projected to grow by 76% to $8.14 per share [11] - Exelixis trades at an attractive 12X forward earnings multiple, compared to Gilead's 17X, which is still a slight discount to the Zacks Medical-Biomedical and Genetics Industry average [11] Group 4: Investment Ratings - Exelixis holds a Zacks Rank 1 (Strong Buy), while Gilead Sciences has a Zacks Rank 3 (Hold) ahead of their Q4 reports [12]

Core Insights - Exelixis, Inc. is a biotechnology company focused on developing cancer treatments, particularly known for its innovative therapy cabozantinib [1] - The company is competing with other biotech firms like Amgen and Gilead Sciences in the oncology sector [1] Stock Performance and Analyst Outlook - Robert Burns from H.C. Wainwright set a price target of $52 for Exelixis, indicating a potential upside of 16.1% from the current trading price of $44.79 [2] - Following the announcement of the collaboration with Natera, Exelixis' stock increased by 6% on January 7, reflecting positive market sentiment [4] - Over the past year, Exelixis' shares have risen by 33.9%, significantly outperforming the industry gain of 17.2% [4][6] Collaboration and Clinical Trials - Exelixis announced a collaboration with Natera for the phase III STELLAR-316 study, focusing on the efficacy of zanzalintinib in patients with resected stage II/III colorectal cancer [3][6] - The trial will evaluate zanzalintinib both with and without an immune checkpoint inhibitor, with the primary endpoint being disease-free survival, expected to start in mid-2026 [3] Current Market Data - Exelixis' current stock price is approximately $44.74, showing a decrease of about 3.14% or $1.45 [5] - The stock has fluctuated between a low of $44.39 and a high of $45.84 during the trading day [5] - The company has a market capitalization of approximately $11.99 billion, with a trading volume of 561,415 shares [5]

Financial Performance - Total revenues for Q3 2025 increased by 11% year-over-year to $597.8 million[37], and 5% quarter-over-quarter[37] - Cabozantinib net product revenues were $542.9 million in Q3 2025[22] - GAAP net income for Q3 2025 was $193.6 million, a 64% increase year-over-year[37] - GAAP diluted earnings per share increased by 73% year-over-year to $0.69[37] - The company completed $689.6 million in stock repurchases through Q3 2025, with an additional $750 million SRP authorized through 2026[39, 40] - Full year 2025 total revenue guidance is $2.30 billion - $2.35 billion[41] Research and Development - Positive results were presented from the Phase 3 STELLAR-303 trial of zanzalintinib + atezolizumab in metastatic colorectal cancer (mCRC) at ESMO, with a statistically significant improvement in overall survival (OS) in the ITT population[16, 50] - The company intends to submit an NDA for zanzalintinib in CRC in December 2025[16, 50] - Enrollment was completed in Q2 2025 for the Phase 3 STELLAR-304 trial of zanzalintinib + nivolumab in 1L nccRCC, with top-line results anticipated mid-2026[65] - The Phase 3 STELLAR-311 study in advanced NET was initiated in Q2 2025[116] Commercial Performance - Cabometyx TRx market share reached approximately 46% in Q3 2025[88] - NET contributed approximately 6% to overall CABOMETYX Q3 volume[91] - CABOMETYX captured over 40% of new patient share of the small molecule segment in the 2L+ NET market[102, 104]

Core Insights - Kura Oncology is advancing the use of farnesyl transferase inhibitors (FTIs) in combination with targeted therapies to overcome resistance mechanisms in cancer treatment [2][11] - Preliminary data from ongoing clinical trials indicate promising efficacy of darlifarnib, showing a 50% objective response rate and an 80% disease control rate in renal cell carcinoma when combined with cabozantinib [1][4] - The company is hosting a virtual investor event to discuss these findings and their implications for future cancer therapies [9][10] Clinical Data Highlights - Darlifarnib demonstrated a 50% objective response rate (ORR) and an 80% disease control rate (DCR) in renal cell carcinoma (RCC) patients in an ongoing dose-escalation trial [1][4] - The combination of tipifarnib and alpelisib showed a 47% ORR in heavily pretreated patients with PIK3CA-altered head and neck squamous cell carcinoma (HNSCC) [6][7] - The ongoing studies are assessing the optimal biologically active dose for combinations across various tumor types [6][4] Mechanism of Action - FTIs like darlifarnib block hyperactivated mTORC1 signaling in tumor endothelial cells, which is crucial for enhancing the efficacy of PI3Kα inhibitors [6][11] - The mechanism of FTIs addresses both innate and adaptive resistance pathways common in targeted oncology therapies [2][6] Future Directions - Kura Oncology plans to further evaluate darlifarnib in combination with PI3Kα inhibitors across different solid tumors [6][11] - A Phase 1b dose-expansion study is planned to determine the optimal dosing strategy for the combination therapies [6][4]

Kura Oncology FY Conference Summary Company Overview - Kura Oncology (NasdaqGS: KURA) is focused on developing targeted therapies for cancer treatment, particularly in acute leukemia and solid tumors [2][3] - The company has a strong cash position with $630.7 million as of the last quarter [2] Pipeline and Product Focus - The primary focus is on the Ziftomenib program for genetically defined acute leukemias, with additional efforts in gastrointestinal stromal tumors (GIST) and other cancers [2] - Kura is also exploring therapies for diabetes, indicating a diverse pipeline [2] Market Opportunity - The initial commercial opportunity for Ziftomenib in acute leukemia is estimated at $350 to $400 million, with a potential peak market opportunity of $7 to $10 billion for the class [3] - Kura anticipates capturing up to $3 billion of that market with Ziftomenib [3] Clinical Development - Ziftomenib has an NDA under review with the FDA, with a PDUFA action date set for November 30 [6] - The company is conducting multiple clinical trials, including a phase 1 study (007) and two phase 3 trials (017) for frontline treatment of acute leukemia [9][22] - The trials are designed to assess the efficacy of Ziftomenib in combination with standard therapies, with a focus on measurable residual disease (MRD) negativity as a key endpoint [23][24] Competitive Landscape - Kura believes Ziftomenib has a best-in-class profile due to its safety, tolerability, and lack of significant drug-drug interactions compared to competitors [12][13] - The company is preparing for a competitive market, with multiple menin inhibitors in development [29] Commercial Strategy - Kura has built a robust commercial team and is ready for a potential launch following FDA approval [15][17] - The partnership with Kyowa Kirin Co., Ltd. enhances Kura's commercial capabilities, with shared responsibilities in U.S. commercialization [18][20] Upcoming Milestones - Key upcoming milestones include the FDA decision on the NDA, data presentations at ASH and ESMO, and the initiation of phase 3 studies [45][46] - The company is also focused on advancing its FTI programs and exploring next-generation menin inhibitors for diabetes [33][39] Financial Outlook - Kura is confident in its cash position and has visibility on milestone payments from its partnership with Kyowa Kirin, which supports its development plans through 2029 [19][46] Conclusion - Kura Oncology is positioned for significant growth with its innovative therapies in oncology and diabetes, backed by a strong financial foundation and strategic partnerships [46]

Summary of Arcus Biosciences FY Conference Call (September 10, 2025) Company Overview - **Company**: Arcus Biosciences (NYSE: RCUS) - **Industry**: Biotechnology, specifically focused on oncology Strategic Priorities - **Execution of Phase III Programs**: The primary focus is on the global Phase III program for casdatifan, a HIF2 inhibitor, with two studies targeting earlier line settings in renal cell carcinoma (RCC) [2][3] - **Funding and Partnerships**: The company has received significant funding from partners like Gilead Sciences, AstraZeneca, and Taiho Pharmaceutical, allowing them to operationalize only two of five Phase III studies [2] - **Capital Preservation**: The company has over $900 million in cash and is focused on conserving capital by pausing less strategic initiatives [8] Pipeline Highlights - **Casdatifan**: - Targeting RCC with a market opportunity of approximately $5 billion in G7 countries [4] - Data from 90 patients showed clear differentiation from Merck's belzutifan on efficacy measures [3] - Upcoming data presentation on 120 patients expected to provide more follow-up information [4][12] - **Domvanalimab**: - An Fc-silent anti-TIGIT antibody being evaluated in combination with anti-PD-1 and chemotherapy in first-line gastric cancer [5] - Expected readout in 2026 from a 1,000-patient study [5] - **Quemliclustat**: - A small molecule CD73 inhibitor in combination with chemotherapy for first-line pancreatic cancer, with a 600-patient study expected to provide data soon [5] Competitive Landscape - **FDA Interactions**: The company reports steady communication with the FDA, with no significant impact from recent changes in agency policies [10] - **Benchmarking Against Belzutifan**: - Casdatifan has shown a confirmed overall response rate (ORR) of 33%, significantly higher than belzutifan's 18%-22% [14] - Progression-free survival (PFS) for casdatifan was reported at 9.7 months, compared to belzutifan's 5.6 months [15][16] Market Opportunities - **Gastric Cancer**: The market opportunity for TAP greater than 5 is estimated at $3 billion in G7 countries [70] - **Lung Cancer**: The lung cancer market is projected to exceed $10 billion, with potential for multiple players [77] Collaboration and Partnerships - **Collaboration with AstraZeneca**: AstraZeneca is operationalizing the Evolve study, which is capital-efficient for Arcus, allowing them to retain all economic rights [48] Intellectual Property - **IP Duration**: Casdatifan has a patent life extending to 2041, providing a long-term competitive advantage [51] Conclusion - Arcus Biosciences is strategically positioned with a robust pipeline and significant market opportunities in oncology, particularly with casdatifan and its combination therapies. The company is focused on execution, capital preservation, and leveraging partnerships to enhance its operational efficiency and market presence.

Core Viewpoint - The Schall Law Firm is investigating Exelixis, Inc. for potential violations of securities laws related to misleading statements and undisclosed information affecting investors [1][2]. Group 1: Investigation Details - The investigation centers on whether Exelixis issued false or misleading statements and failed to disclose critical information to investors [2]. - Exelixis reported Q2 2025 financial results on July 28, 2025, indicating product revenue for cabozantinib was below expectations [2]. - The company decided not to proceed to the phase 3 portion of the STELLAR-305 study due to emerging competition and assessment of other commercial opportunities [2]. Group 2: Market Reaction - Following the announcement regarding the phase 3 trial decision, Exelixis shares fell by almost 16.8% the next day [2].

Kura Oncology Conference Call Summary Company Overview - **Company**: Kura Oncology - **Key Product**: Ziftomenib (also referred to as ZYPTOMENIB) - **Upcoming Milestones**: PDUFA for Ziftomenib, data updates at medical conferences, initiation of COMMOD-17 studies Core Industry Insights Ziftomenib Development and Market Position - **PDUFA Status**: Kura is optimistic about the NDA review process for Ziftomenib, receiving positive feedback from Key Opinion Leaders (KOLs) regarding its profile in relapsed/refractory settings [2][3] - **Efficacy and Safety**: The company emphasizes four pillars for Ziftomenib: efficacy, convenience, simplicity of administration, and safety [3] - **Commercial Readiness**: Kura's team is fully trained and prepared for market access and pre-approval information exchange [3] - **Combination Studies**: Data sharing is anticipated at the end of the year for the combination of Ziftomenib with venetoclax and azacitidine [3] Competitive Landscape - **Market Dynamics**: Kura expects to compete effectively against other menin inhibitors in the market, with a focus on strong efficacy and safety profiles [11][12] - **Physician Feedback**: Physicians have shown enthusiasm for Ziftomenib's once-daily oral administration and its potential for combination therapies [11][12] - **Patient Segmentation**: Initial patient starts are expected to be new patients rather than switches from existing therapies [14] Clinical Trials and Data Expectations - **Phase 3 Studies**: Kura is on track to initiate two parallel Phase 3 studies in Q4 [4] - **Combination Therapy Data**: The company aims to improve upon existing combination therapies' outcomes without increasing toxicity [28] - **Enrollment Strategy**: Kura's trial design allows for easier patient enrollment, which is expected to enhance participation rates [30][31] Financial Position - **Cash Reserves**: Kura reported $630.7 million in cash, with expectations of substantial milestone payments to maintain a strong financial position [6] Additional Opportunities Menin Inhibitors in Other Indications - **GIST and Diabetes**: Kura is exploring the use of menin inhibitors in GIST and has nominated a next-gen menin inhibitor for diabetes [45] - **Long-term Vision**: The company aims to lead the discovery and development of menin inhibitors across various oncology applications [45] Future Priorities - **Strategic Goals**: Key priorities include the approval and launch of Ziftomenib, additional combination data, and the start of the COMMOD-17 study [46] Important but Overlooked Aspects - **Collaboration with Kyowa Kirin**: Kura has a strong partnership with Kyowa Kirin for co-development and co-promotion, with Kura leading commercialization efforts in the US [25][26] - **Focus on Safety and Efficacy**: The emphasis on maintaining a favorable safety profile while improving efficacy in combination therapies is crucial for Kura's strategy [28][40] This summary encapsulates the key points discussed during the conference call, highlighting Kura Oncology's strategic direction, product development, and market positioning.