Financial Data and Key Metrics Changes - Total revenue for Q4 2023 was $33.7 million, consistent with Q4 2022, while total revenue for the full year 2023 was $146 million, down from $157.1 million in 2022 [55][56] - Net product revenue from US commercial sales of XPOVIO for Q4 2023 was $25.1 million, compared to $31.1 million in Q4 2022, and for the full year 2023, it was $112 million, down from $120.4 million in 2022 [56][60] - The gross-to-net discount for XPOVIO in Q4 2023 was 23.5%, and for the full year 2023, it was 22%, with expectations for 2024 to be in the 25% to 30% range [68] Business Line Data and Key Metrics Changes - XPOVIO's new patient share in the community setting approached 70% in the second to fourth line, representing double-digit growth year-over-year [44] - The community setting now accounts for two-thirds of the business, with a 20% year-over-year increase in prescribing sites [51][52] - The company expects US XPOVIO net product revenue for 2024 to be in the range of $100 million to $120 million, reflecting a balance of growth conviction and competitive market recognition [60][71] Market Data and Key Metrics Changes - The competitive landscape in the multiple myeloma market has intensified, particularly with the introduction of bispecific therapies in the second half of 2023, impacting demand in the academic setting [12][44] - Despite competition, the company achieved total demand growth year-on-year in the community setting in 2023, which is a key growth driver for 2024 [84] Company Strategy and Development Direction - The company is focused on advancing its late-stage pipeline, particularly in myelofibrosis and endometrial cancer, with three pivotal Phase 3 trials expected to read out results in 2025 [5][17] - The strategy includes shifting the use of selinexor into earlier lines of therapy, where patients tend to stay on treatment longer, thus increasing duration of therapy [95] - The company aims to leverage its existing commercial infrastructure to support rapid launches of selinexor in new indications, with a potential peak annual revenue of approximately $2 billion in the US alone [13][60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing Phase 3 studies and the potential for selinexor to address high unmet needs in cancer treatment [67][73] - The company anticipates a cash runway into late 2025, supported by expected revenues from XPOVIO and partnerships [66][71] - Management highlighted the importance of evolving the regulatory landscape and potential changes in study design to enhance the value proposition of selinexor [105] Other Important Information - The company reported a decrease in R&D expenses due to reduced personnel costs, while SG&A expenses also decreased, reflecting cost optimization efforts [64][69] - The existing cash and investments as of December 31, 2023, totaled $192.4 million, down from $279.7 million in 2022 [70] Q&A Session Summary Question: Can you quantify the community versus academic setting growth in 2023? - The company achieved total demand growth year-on-year in the community setting, with a 20% increase in prescriber base, which is a significant growth driver for 2024 [84][85] Question: What is the impact of BCMA therapies moving into 2024? - The introduction of bispecific therapies posed a significant competitive threat in the academic setting, but the community setting has not seen a major impact yet [78] Question: Can you comment on the enrollment experience of the Phase 3 SPD triplet study in multiple myeloma? - Enrollment is progressing well, with significant interest in the study both in the US and EU, and completion of enrollment is expected later this year [115] Question: What is the company's cash position and runway? - The company finished 2023 with $192 million in cash, with a projected cash runway into late 2025, considering expected revenues and expenditures [119]
Karyopharm Therapeutics(KPTI) - 2023 Q4 - Earnings Call Transcript