Core Insights - Kura Oncology's KOMZIFTI (ziftomenib) is generating early revenue momentum and has received positive feedback from the market, emphasizing its differentiated safety and convenience, which supports ongoing development plans targeting up to 50% of AML patients [1][2] Financial Performance - The company reported a net product revenue of $2.1 million in Q4 2025, based on approximately five weeks of commercial sales following the FDA approval on November 13 [5][13] - Collaboration revenue for Q4 2025 was $15.2 million, a decrease from $53.9 million in Q4 2024, reflecting non-cash revenue recognition under the collaboration agreement with Kyowa Kirin [13] - The net loss for Q4 2025 was $81.0 million, compared to $19.2 million for the same period in 2024 [13] Product Development and Pipeline - KOMZIFTI has been granted full FDA approval for adult patients with relapsed or refractory AML with a susceptible NPM1 mutation [5] - The company has initiated pivotal KOMET-017 Phase 3 frontline trials evaluating ziftomenib in combination with chemotherapy for patients with NPM1-m or KMT2A-rearranged AML [4] - Multiple clinical data milestones are expected in 2026 across AML and solid tumor programs, including ziftomenib's development in gastrointestinal tumors and darlifarnib in renal cell carcinoma [2][6] Market Position and Strategy - KOMZIFTI has been added to the NCCN Clinical Practice Guidelines as a Category 2A recommended treatment option for adults with R/R NPM1-m AML [5] - Approximately 80% of private payers established published coverage policies for KOMZIFTI within the first 90 days of its launch, all aligned with the label and without additional restrictions [5] - The company has a strong capital position with $667.2 million in cash and equivalents, expected to support the advancement of ziftomenib through to the topline results from the first pivotal Phase 3 trial anticipated in 2028 [8][9] Future Outlook - Kura expects 2026 to be a data-rich year with multiple potential value inflection points, including ongoing enrollment in pivotal trials and the advancement of next-generation therapies [6][9] - The company aims to establish clear differentiation in the menin inhibitor class and achieve leading class share in the R/R NPM1-m AML setting [7]

Core Viewpoint - Exelixis is a commercial-stage, oncology-focused biotech company that has successfully established its first franchise with cabozantinib and aims to expand its pipeline of franchises [1]. Group 1 - The company has been operational for a significant period and believes it has reached a pivotal point in building its franchises [1]. - Exelixis held an R&D Day in December to discuss strategies for developing a pipeline of franchises and the multi-dimensional approach to franchise building [2].

Exelixis FY Conference Summary Company Overview - Exelixis is a commercial-stage, oncology-focused biotech company with a strong emphasis on building franchises, particularly with its lead product, cabozantinib (Cabo) [9][10] Key Points Discussed Competitive Landscape - The oncology market is described as hypercompetitive, with Exelixis acknowledging the need to navigate this landscape by delivering the best drugs and combinations to improve cancer care [19][20] - Cabo is recognized as the leading TKI (tyrosine kinase inhibitor) in renal cell carcinoma (RCC), with aspirations to maintain its dominance while transitioning to zanzalintinib (Zanza) [20][22] Pipeline Development - Exelixis is focused on expanding its pipeline beyond Cabo, with Zanza expected to launch by the end of the year [26] - The company is conducting pivotal trials for Zanza and exploring its potential in various tumor types, including colon and meningioma [40] Recent Data and Trials - The LITESPARK-011 data from Merck was discussed, indicating competitive dynamics in the RCC market [14][24] - Exelixis is optimistic about Zanza's potential in combination therapies, particularly with belzutifan, to enhance efficacy and safety [37][65] Revenue and Growth Projections - For fiscal year 2026, Exelixis projects revenue growth of 9%-13% year-over-year, driven by both base business and net growth [99][100] - In 2025, revenues increased by 17% year-over-year, with demand up 15% [101] Market Opportunities - The company sees significant potential in the colorectal cancer (CRC) market, with expectations of high interest in the Zanza and atezolizumab combination [103][106] - The total addressable market for net is estimated to be between $500 million and $1 billion [106] Capital Allocation and Share Buybacks - Exelixis emphasizes a disciplined approach to capital allocation, focusing on internal pipeline development while also considering share buybacks as a means to enhance shareholder value [147][150] - The company has repurchased $2.2 billion worth of shares, indicating confidence in its future growth prospects [151] Future Directions - Exelixis is exploring combinations of Zanza with chemotherapy agents, such as docetaxel, to expand its treatment options in prostate and lung cancers [154] - The company aims to build a robust pipeline of franchise molecules, moving away from single compound, single indication strategies [156] Additional Insights - The management team is committed to making strategic decisions based on data and market needs, ensuring that Exelixis remains relevant in the evolving oncology landscape [147][148] - The focus on improving standard of care for cancer patients remains a core mission, with ongoing efforts to enhance treatment paradigms [70][132]

Core Insights - Arcus Biosciences aims to establish casdatifan as a "best-in-class" HIF-2α inhibitor for clear cell renal cell carcinoma (ccRCC) with updated clinical data showing promising efficacy compared to belzutifan [3][5][14] Clinical Data and Development - Updated analysis from the ARC-20 study indicates a median progression-free survival (PFS) of 15.1 months for casdatifan monotherapy, significantly longer than the 5.6-month PFS reported for belzutifan in similar late-line settings [1][2][5] - The confirmed overall response rate (ORR) for casdatifan has risen to 45% in the latest data [5] - The Phase III PEAK-1 trial is actively enrolling patients, comparing casdatifan plus cabozantinib against cabozantinib alone, with a goal to complete enrollment by year-end [6][10] Financial Overview - Arcus ended Q4 with $1.0 billion in cash, following a $288 million financing, and expects to fund operations into at least the second half of 2028 [4][17][18] - The company projects 2026 GAAP revenue between $45 million and $55 million, with anticipated decreases in operating expenses [18] Market Opportunity - The renal cell carcinoma (RCC) market is projected to exceed $10 billion annually, with expectations to grow to $13 billion by 2030, positioning casdatifan as a key player in this competitive landscape [14][15] - Arcus estimates peak sales for casdatifan could reach $2.5 billion in the IO-experienced setting and $3 billion or more in the first-line setting [15] Immunology Pipeline - Arcus is developing an inflammation and immunology (I&I) portfolio, with plans to enter clinical trials for a MRGPRX2 antagonist and a selective TNF receptor 1 inhibitor [16]

Core Insights - Exelixis aims to become a top five solid tumor oncology company, supported by its successful drug cabozantinib, which has significantly boosted its stock performance [1][2] Group 1: Company Overview - Exelixis is a small biotech company with a market capitalization of $11 billion and a gross margin of 96.39% [3] - The company's stock has increased over 20% in the past year and over 97% in the last five years [1] Group 2: Product Pipeline - Cabozantinib, marketed as Cabometyx and Cometriq, is the lead drug, approved for multiple cancer types including kidney, thyroid, liver, and advanced pancreatic neuroendocrine tumors [3][4] - The drug is undergoing a phase 3 trial for advanced neuroendocrine tumors and is protected from generic competition until early 2031 [5] Group 3: Financial Performance - In 2025, Exelixis reported a 7% revenue increase to $2.3 billion, primarily from cabozantinib, with earnings per share rising 57.9% to $2.78 [6] Group 4: New Drug Developments - Zanzalintinib received FDA approval for metastatic colorectal cancer and is involved in multiple phase 3 trials for various cancers [7] - The early-stage pipeline includes antibody-drug conjugates targeting cancer cells with high precision [8] Group 5: Strategic Partnerships - Exelixis collaborates with Takeda Pharmaceutical and Ipsen for cabozantinib sales in Japan [9] - An agreement with Natera will utilize its Signatera assay for enrolling colorectal cancer patients in zanzalintinib's phase 3 trial [10] - The company is also partnering with Merck for zanzalintinib trials in head and neck cancer and kidney cancer [11]

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]