Exelixis(EXEL)2023-08-02 02:20Financial Data and Key Metrics Changes - The company reported total revenues of approximately 409.6 million [116] - GAAP net income for Q2 2023 was approximately 0.25 per share, while non-GAAP net income was approximately 0.31 per share [88] - Cash and investments as of June 30, 2023, were approximately 403.3 million, including approximately $21 million in clinical trial sales [73] - CABOMETYX TRx volume grew by 9% year-over-year in Q2 2023 and 4% compared to Q1 2023 [77] - The cabozantinib franchise net product revenues in the US grew 18% year-over-year in Q2 2023 compared to Q2 2022 [83] Market Data and Key Metrics Changes - CABOMETYX maintained a leading TKI market basket share at 39% [77] - The overall survival data for CABOMETYX plus nivolumab showed a median overall survival of 49.5 months, representing a 14-month improvement over the comparator arm [122] - The company is seeing strong demand and new patient starts, reinforcing its leadership position in the RCC marketplace [121] Company Strategy and Development Direction - The company is focused on building a pipeline of clinically and commercially differentiated medicines for cancer patients with high unmet medical needs [68] - Business development activities remain a priority, with ongoing discussions to access new clinical assets [85] - The company plans to present its R&D efforts at an investor event on December 2, 2023, in New York City [69] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of CABOMETYX into the second half of the year, reiterating full-year 2023 financial guidance [149] - The company is excited about the future and the strength of its balance sheet, which allows for continued investment in R&D and business development [12][75] - Management highlighted the importance of emerging data for both Zanzalintinib and XB002, indicating a positive outlook for these assets [154] Other Important Information - The company entered into a settlement and license agreement with Teva to resolve patent litigation, allowing Teva to market a generic version of CABOMETYX in the US starting January 1, 2031 [70][86] - The gross to net deductions for the cabozantinib franchise in Q2 2023 were 27.3%, lower than the previous quarter, primarily due to lower Medicare Part-D and co-pay assistance expenses [117] Q&A Session Summary Question: Can you comment on the rationale for keeping the original guidance and expectations for cabo growth? - Management reiterated confidence in CABOMETYX's growth potential based on strong performance in the first half of the year [149] Question: What are the scenarios for COSMIC-313 with upcoming data? - Management is focused on the data and its implications for supplemental NDA filing, emphasizing the importance of the upcoming results [5] Question: How does the company view the competitive landscape for TKIs in the RCC market? - CABOMETYX continues to lead the TKI market with strong overall survival data, differentiating it from competitors [122] Question: Are there plans to review the current cost base for efficiencies? - Management indicated that cost efficiencies are being evaluated as part of ongoing strategic discussions [10] Question: What is the company's strategy regarding business development? - The company remains committed to business development activities to access new clinical assets while also focusing on internal R&D efforts [49]