Karyopharm Reports Third Quarter 2024 Financial Results and Highlights Recent Company Progress

Core Insights - Karyopharm Therapeutics reported third quarter 2024 total revenue of $38.8 million, with U.S. XPOVIO® (selinexor) net product revenue of $29.5 million, reflecting continued growth in a competitive market [1][14][4] - The company has narrowed its full-year 2024 total revenue guidance to a range of $145.0 million to $155.0 million, with U.S. XPOVIO net product revenue guidance set at $110.0 million to $115.0 million [1][11][12] - A significant change in the Phase 3 SENTRY trial for myelofibrosis has been made, with the Absolute Change in Total Symptom Score (Abs-TSS) replacing TSS50 as a co-primary endpoint, expected to enhance the evaluation of treatment efficacy [1][6][3] Financial Performance - Total revenue for Q3 2024 was $38.8 million, an increase from $36.0 million in Q3 2023 [14] - U.S. XPOVIO net product revenue for Q3 2024 was $29.5 million, compared to $30.2 million in Q3 2023, indicating a slight decline year-over-year [14][21] - License and other revenue increased to $9.3 million in Q3 2024 from $5.8 million in Q3 2023, primarily due to milestone-related revenue from Menarini [15] Research and Development Highlights - The SENTRY trial's sample size has been increased to approximately 350 patients to enhance statistical power, with top-line data readout expected in the second half of 2025 [7] - Preliminary data from the SENTRY-2 Phase 2 trial of selinexor monotherapy in JAKi naïve patients is anticipated to be presented in late 2024 or early 2025 [7] - Long-term follow-up data from the SIENDO study indicated a significant improvement in quality-adjusted time without symptoms or toxicity for patients with advanced or recurrent TP53 wild-type endometrial cancer [8] Market and Competitive Landscape - Karyopharm continues to experience quarter-over-quarter demand growth for XPOVIO, particularly in community settings, which account for approximately 60% of overall net product revenues [5] - The company has expanded global patient access for selinexor with favorable reimbursement decisions in France and Italy, along with regulatory approvals in several countries [6] Financial Outlook - Karyopharm expects full-year 2024 total revenue to be between $145.0 million and $155.0 million, with U.S. XPOVIO net product revenue guidance adjusted to $110.0 million to $115.0 million [11][12] - R&D and SG&A expenses are projected to be in the range of $255.0 million to $265.0 million for 2024 [12] - The company reported a net loss of $32.1 million for Q3 2024, an improvement from a net loss of $34.5 million in Q3 2023 [21]