Exelixis (EXEL) FY Conference Transcript

Exelixis (EXEL) FY Conference Summary Company Overview - Company: Exelixis (EXEL) - Event: Sixth Annual Oncology Innovation Summit - Date: May 27, 2025 Key Points Commercial Performance - Cabo Performance: Cabo had a strong Q1, with increasing prescriptions and market share in renal cell carcinoma (RCC) [4][8] - Clinical Trials Orders: Clinical trials orders fluctuated between 4 million and 22 million per quarter historically, with a recent order of 12 million [4] - Net Approval: The approval for neuroendocrine tumors (NET) occurred late in the quarter, impacting tracking metrics [5][8] Market Dynamics - IQVIA Tracking Issues: IQVIA's tracking was inaccurate this quarter, attributed to the complexity of real-world data and seasonality [6][12][13] - Gross to Net Dynamics: The gross to net ratio was higher in Q1, influenced by the phase-in of the rebate period under the IRA [14][15] Future Projections - Revenue Growth: Exelixis anticipates Cabo's revenue to grow from approximately $2 billion to$3 billion by 2030, driven by the NET launch and continued momentum in the base business [15] - Rebate Impact: A 1% rebate phase-in under the IRA is expected to have a minimal impact on overall business [16][26] NET Launch Insights - Patient Dynamics: The launch of Cabo for NET is expected to be steady rather than a bolus due to the advanced state of patients [30][31] - Broad Label Impact: The broad label for Cabo is anticipated to positively affect a wide range of patients, with no specific pockets of accelerated uptake identified [32][33] Competitive Landscape - Lutathera Comparison: Lutathera presents unique challenges for patients, and Cabo is positioned to capture market share from oral cytotoxics rather than directly competing with Lutathera [36][37] - Somatostatin Analogs: Cabo is expected to be used alongside background somatostatin analogs, enhancing its therapeutic impact [39] Pipeline Developments - ZENZA Study: The Stellar 303 study has elevated liver metastases patients to a co-primary endpoint due to differentiated event rates observed [40][41] - Head and Neck Cancer Trials: The Stellar 305 study aims to evaluate Zanza in combination with Keytruda, learning from previous trial outcomes [45][46] - Early Pipeline: The bispecific program (628) has generated significant interest, focusing on combining PD-L1 and NKG2A mechanisms [61][62] Regulatory and Market Considerations - Non-Clear Cell RCC Study: The ongoing study aims to establish a new standard of care in the non-clear cell RCC segment, with results expected later this year [55][56] - Collaboration with Merck: Exelixis is collaborating with Merck on various studies, with details to be shared as trials progress [58][60] Additional Insights - Market Research: Continuous market research and KOL engagement are crucial for understanding patient dynamics and optimizing marketing strategies [37][38] - Regulatory Landscape: The evolving regulatory environment, particularly regarding rebates and pricing, will impact future revenue and market strategies [19][20] This summary encapsulates the key insights and developments discussed during the Exelixis FY Conference, highlighting the company's commercial performance, market dynamics, future projections, and ongoing pipeline developments.