Karyopharm Therapeutics(KPTI)2023-11-02 18:25Financial Data and Key Metrics Changes - Total revenue for Q3 2023 was $36 million, slightly down from $36.1 million in Q3 2022 [36] - Net product revenue from U.S. sales of XPOVIO was $30.2 million in Q3 2023, compared to $32 million in Q3 2022, impacted by higher patient assistance program utilization and increased gross to net discounts [37] - Cash and cash equivalents totaled $209.2 million as of September 30, 2023, down from $279.7 million at the end of 2022, with a cash runway expected through late 2025 [39][40] Business Line Data and Key Metrics Changes - XPOVIO delivered $30.2 million in net sales in Q3 2023, with total demand year-over-year declining 3% compared to Q3 2022, primarily due to increased competition in late lines [17][32] - The utilization of the patient assistance program (PAP) contributed to 9% of total demand in Q3 2023, up from 4% in Q3 2022, reflecting higher patient engagement [18] - The NCCN has updated guidelines to recommend switching classes of therapy, enhancing XPOVIO's positioning in the treatment landscape [20] Market Data and Key Metrics Changes - The company expects total revenues in 2023 to be between $145 million and $160 million, with XPOVIO net U.S. product revenue projected between $110 million and $125 million [40] - The new patient share mix for XPOVIO in the second to fourth line was over 60%, representing approximately 20% growth year-over-year [49] Company Strategy and Development Direction - The company is focused on advancing its mid and late-stage pipeline, with three pivotal Phase 3 trials expected to read out data through 2024 and 2025 [4][90] - There is a strong emphasis on cost management, with a 12% reduction in R&D and SG&A expenses year-over-year for the first nine months of 2023 [38] - The company aims to leverage its commercialization capabilities and relationships in the community to drive growth across multiple indications [52] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for selinexor to change treatment paradigms in multiple myeloma and endometrial cancer [42][90] - The company is optimistic about the upcoming data readouts and the impact of recent guideline updates on XPOVIO's market positioning [60][76] Other Important Information - The company has reduced its workforce by approximately 20% to strengthen its financial position for ongoing Phase 3 studies [36] - The collaboration with BMS to evaluate selinexor in combination with mezigdomide is expected to enhance treatment options for multiple myeloma patients [93] Q&A Session Summary Question: Contextualizing new IMF data and Phase 3 top line data expectations - Management highlighted the impressive efficacy of the combination of selinexor and ruxolitinib in JAK naive patients, with a focus on the durability of responses [46] Question: Update on eltanexor development plans - Management remains enthusiastic about eltanexor's data in hard-to-treat patient populations, with encouraging survival rates observed [47] Question: Enrollment progress and repo rates in early line patients - Enrollment is proceeding well, driven by enthusiasm around new data, with a noted increase in new patient starts in earlier lines [57] Question: Impact of NCCN guideline updates on XPOVIO - The elevation of XPOVIO to category one in NCCN guidelines is expected to strengthen its position in the community and drive steady growth [60] Question: Overall survival data from the SIENDO Phase 3 study - Initial overall survival data is anticipated to be presented later this year, with ongoing monitoring of patient populations [71] Question: Impact of foundation closures on PAP - The impact of PAP is expected to remain similar in Q4 as in Q3, with anticipated changes in Medicare Part D design expected to reduce reliance on PAP in 2024 [85]