Deciphera(US:DCPH)2023-10-30 19:00Financial Data and Key Metrics Changes - The company reported a record QINLOCK sales of $41.8 million for Q3 2023, representing a 29% year-over-year increase and a 12% quarter-over-quarter increase [13][39] - Global net product revenue for QINLOCK included $32.7 million from the U.S., which is a 33% increase year-over-year and a 13% increase quarter-over-quarter [13][39] Business Line Data and Key Metrics Changes - Vimseltinib achieved a 40% overall response rate at week 25 in the MOTION study, compared to 0% for placebo, with a p-value of less than 0.0001 [28][62] - The median treatment duration for Vimseltinib increased to approximately 25.1 months in the Phase I study and 21 months in Cohort A, with the longest patient on treatment for nearly 4 years [33][34] Market Data and Key Metrics Changes - The U.S. market opportunity for Vimseltinib is estimated at $500 million based on 1,400 incident patients, with additional opportunities in the EU where there are no approved therapies for TGCT [8][9] - The company noted a significant overlap of 70% to 80% between oncologists treating TGCT and those treating GIST, which could enhance commercial strategies [7][8] Company Strategy and Development Direction - The company plans to submit a New Drug Application (NDA) for Vimseltinib in the U.S. in Q2 2024 and a Marketing Authorization Application (MAA) in the EU shortly thereafter [4][48] - The strategic focus includes expanding the commercial footprint of QINLOCK and Vimseltinib, with expectations of exceeding $1 billion in peak global revenue from both products [15][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Vimseltinib to change the standard of care in TGCT, highlighting its favorable safety profile compared to existing therapies [12][25] - The company remains committed to advancing its pipeline, with plans to file Investigational New Drug (IND) applications for new candidates in the near future [18][40] Other Important Information - The company ended Q3 2023 with approximately $377 million in cash and cash equivalents, maintaining a cash runway into 2026 [39] - The MOTION study results were described as transformative, with a strong emphasis on patient-reported outcomes and quality of life improvements [60][92] Q&A Session Summary Question: Can you discuss your confidence in the pivotal overall response rate reaching the long-term response rate observed in Phase I? - Management expressed optimism that the response rate could increase over time, citing a starting point of 40% in the MOTION study compared to 38% in previous studies [51][62] Question: Is there a difference between the Phase I and Phase II patient populations that explains the treatment duration delta? - The difference in treatment duration was attributed to the enrollment timing, with Cohort A catching up as more data becomes available [89] Question: Are there plans for trials in neoadjuvant-adjuvant settings for Vimseltinib? - While there is theoretical potential for Vimseltinib in earlier settings, no specific plans have been announced yet [90][94] Question: What are the expectations for off-label use of QINLOCK in the second-line setting? - Management noted that recent data and NCCN listings have positively impacted off-label use, but future trends will need to be monitored [58][99] Question: How does the safety profile of Vimseltinib compare to pexidartinib? - Management highlighted that Vimseltinib does not exhibit the cholestatic hepatotoxicity seen with pexidartinib, which could influence prescribing decisions [97][98]