Karyopharm Therapeutics(KPTI) - 2024 Q3 - Quarterly Report

Revenue Performance - Net product revenue for Q3 2024 was $29.5 million, a decrease of 2$30.2 million in Q3 2023, primarily due to higher gross-to-net discounts driven by increased Medicare rebates and 340B discounts [108]. - For the nine months ended September 30, 2024, net product revenue was $83.6 million, down 4$87.0 million in the same period of 2023, attributed to decreased demand and increased competition [109]. - License and other revenue for Q3 2024 was $9.3 million, a 60$5.8 million in Q3 2023 [107]. - Total revenue for the nine months ended September 30, 2024, was $114.7 million, compared to$112.3 million in the same period of 2023 [107]. - Total license and other revenue for the nine months ended September 30, 2024, increased by $5.8 million to$31.14 billion, a 23% increase year-over-year [111]. Operating Expenses - Operating expenses for Q3 2024 were $38.8 million, an 8$36.0 million in Q3 2023 [107]. - Research and development expenses for Q3 2024 were $36.1 million, a slight increase of 2$35.6 million in Q3 2023 [107]. - Selling, general and administrative expenses for the three months ended September 30, 2024, decreased by $3.2 million to$27.63 billion, a 10% decrease year-over-year [118]. - Personnel costs in selling, general and administrative expenses decreased by $2.4 million to$14.12 billion for the three months ended September 30, 2024, a 15% decrease year-over-year [118]. - The company anticipates a slight decrease in research and development expenses in Q4 2024 due to reduced scope in ongoing trials [117]. Net Loss and Financial Position - The net loss for Q3 2024 was $32.1 million, a decrease of 7$34.5 million in Q3 2023 [107]. - As of September 30, 2024, the company had an accumulated deficit of $1.5 billion [102]. - The company expects to incur significant operating losses in the foreseeable future, raising substantial doubt regarding its ability to continue as a going concern within one year [137]. - The company anticipates that cash, cash equivalents, and investments will be sufficient to fund current operating plans into the fourth quarter of 2025 [137]. Cash Flow and Investments - Cash, cash equivalents, and investments totaled$133.5 million as of September 30, 2024, with a loss of $45.6 million incurred for the nine months ended September 30, 2024 [123]. - Net cash used in operating activities for the nine months ended September 30, 2024 was$(101,676) thousand, an increase of $27,538 thousand or 37$99.6 million for the nine months ended September 30, 2024, driven by a decrease in purchases of investments [125]. - The company has not sold any shares under the 2023 Open Market Sale Agreement, with $100.0 million available for issuance as of September 30, 2024 [130]. - As of September 30, 2024, the company had cash, cash equivalents, and investments totaling$133.5 million [139]. Debt and Future Obligations - The company entered into refinancing transactions in May 2024, borrowing $100 million to limit aggregate indebtedness and provide additional working capital [103]. - Future obligations related to the 2025 Convertible Senior Notes amount to$25.6 million over the next two years [138]. - Future obligations related to the 2029 Convertible Senior Notes total $148.1 million over the next five years [138]. Clinical Trials and Research - The company plans to continue clinical trials and seek additional approvals for selinexor in various cancer indications, focusing on late-stage programs [101]. - Clinical trial costs for Selinexor in myelofibrosis increased by over 100$6.76 billion for the three months ended September 30, 2024 [114]. - The increase in clinical trial costs was primarily driven by heightened activity in pivotal Phase 3 trials, including increased purchases of comparator drugs [116]. Market Risks - The company is primarily exposed to interest rate sensitivity, with an immediate 100 basis point shift in interest rates expected to have no material effect on the fair market value of its investment portfolio [139]. - The company does not believe its cash, cash equivalents, and investments have significant risk of default or illiquidity, but acknowledges potential future adverse changes [140]. - The company is exposed to market risk related to changes in foreign currency exchange rates due to contracts with organizations in Canada, the UK, and Europe [141]. - The company does not currently hedge its foreign currency exchange rate risk, which may lead to fluctuations in costs associated with foreign-denominated agreements [141].