Release Date: November 05, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Karyopharm Therapeutics Inc (KPTI, Financial) reported a favorable regulatory update for their phase three trial in Myelofibrosis, increasing confidence in their trial outcomes.
- The company achieved its third consecutive quarter of net product revenue growth in the US, indicating strong commercial performance.
- Karyopharm Therapeutics Inc (KPTI) has a promising late-stage pipeline with three ongoing phase three studies, potentially establishing new standards of care in solid and hematologic malignancies.
- The company has expanded its global footprint with continued reimbursement and regulatory approvals for XPOVIO in countries like Italy and France.
- Karyopharm Therapeutics Inc (KPTI) has a strong commercial infrastructure with significant overlap in community-based physicians treating multiple myeloma and myelofibrosis, positioning them well for future launches.
Negative Points
- The gross to net discount for XPOVIO increased to 31% in Q3 2024, up from 21% in Q3 2023, driven by increased 340 B utilization and Medicare rebates.
- Cash and cash equivalents decreased significantly from $192.4 million at the end of 2023 to $133.9 million as of September 30, 2024.
- The company faces a highly competitive marketplace, particularly in the multiple myeloma space, which could impact future growth.
- Karyopharm Therapeutics Inc (KPTI) is still awaiting regulatory feedback on their phase three trials, which could affect timelines for top-line data.
- The company anticipates lower operating expenses in 2025, but ongoing cost-saving measures may impact their ability to invest in new opportunities.
Q & A Highlights
Q: How does the change to the absolute total symptom score (TSS) as a co-primary endpoint affect the powering assumptions for the Myelofibrosis trial?
A: Reshma Rangwala, Chief Medical Officer & Head of Research, explained that the absolute TSS is a more sensitive and comprehensive method to assess symptom improvement. The data suggests a significant improvement, potentially leading to a higher statistical significance in the phase three trial. The co-primary endpoints will now be SPR 35 followed by absolute TSS, replacing TSS 50.
Q: Can you provide an update on the international launch and outlook for 2025?
A: Sohanya Cheng, Executive Vice President & Chief Commercial Officer, stated that Karyopharm continues to see approvals for reimbursement and regulatory approvals globally. The company anticipates increased royalties from ex-US Selinexor revenues in 2025, following major market reimbursement approvals achieved in 2024.
Q: What are the challenges of entering the maintenance therapy market for endometrial cancer, and how is Karyopharm addressing them?
A: Sohanya Cheng highlighted that Selinexor offers a novel, biomarker-specific oral maintenance therapy for TP53 wild-type and PMMR subgroups. The product profile is compelling, and there is strong overlap with treating physicians in multiple myeloma and endometrial cancer, enabling effective market entry.
Q: What are the underlying trends contributing to the consecutive quarters of growth for XPOVIO?
A: Sohanya Cheng noted that growth is driven by strong demand in both community and academic settings, with XPOVIO being positioned as a flexible, combinable, and manageable drug. The team is focused on driving demand and positioning XPOVIO as a differentiated mechanism of action in a competitive market.
Q: How is enrollment progressing for the endometrial cancer trial, and what is the regulatory stance on MMR proficient patients?
A: Reshma Rangwala confirmed that enrollment is on track, with strong enthusiasm for the data. The regulatory agencies recognize TP53 wild-type status, which includes multiple molecular subgroups, so specific MMR proficient status does not need to be called out separately.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
