Financial Data and Key Metrics Changes - In Q3 2025, the company generated $13.1 million in total revenue, including $7.7 million in net product revenue from ATROSY, marking a strong performance for the first full quarter as a commercial stage company [36][40]. - The gross-to-net ratio is approximately 20%, with expectations for slight increases over time as the payer mix stabilizes [50]. Business Line Data and Key Metrics Changes - The launch of ATROSY has seen 204 new patients starting treatment in Q3, averaging over 15 new patient starts per week, significantly higher than previous benchmarks [5][26]. - The company reported a median duration of response (DOR) of 50 months for TKI-naive patients, indicating strong efficacy [9][30]. Market Data and Key Metrics Changes - ATROSY is now covered by payers representing over 80% of covered lives, up from 58% two months prior, reflecting effective market access efforts [28][37]. - The company anticipates an increase in the annual addressable population for ROS1-positive non-small cell lung cancer patients due to the shift towards RNA-based testing, potentially expanding from 3,000 to 4,000 patients annually in the U.S. [32][58]. Company Strategy and Development Direction - The company is focused on deepening adoption of ATROSY in the U.S. and raising awareness of oncogenic driver testing, which is crucial for identifying eligible patients [31][34]. - The initiation of the TRUST-4 study aims to evaluate ATROSY as an adjuvant therapy for early-stage non-small cell lung cancer, addressing a significant unmet need [15][33]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong early adoption of ATROSY and its potential to become the new standard of care for ROS1-positive non-small cell lung cancer [44]. - The company is optimistic about the future growth trajectory, supported by a robust cash balance and a disciplined approach to resource allocation [41][43]. Other Important Information - The company has received regulatory approval for ATROSY in Japan, expanding its market reach [16]. - The company plans to submit a supplemental NDA to update the label for ATROSY by the end of the week [50]. Q&A Session Summary Question: Guidance on sales for this year and trends in usage between treatment lines - The company is not providing specific sales guidance but is comfortable with current consensus estimates, noting strong Q3 performance [46]. Question: Expanded access program details - Only six patients were converted from the expanded access program to commercial ATROSY, with expectations for more patients to generate full commercial revenue soon [47]. Question: Gross-to-net and payer mix insights - The gross-to-net ratio is around 20%, with a payer mix expected to stabilize over time [50]. Question: First line versus second line patient usage - The company expects to capture a significant number of treatment-naive patients and is already seeing switches from other therapies due to ATROSY's superior efficacy [58]. Question: European partnership timeline - Advanced discussions are ongoing, with expectations to finalize details in Q4 [55].

Financial Data and Key Metrics Changes - For Q1 2025, the company reported R&D expenses of $24.6 million, reflecting continued investments in lead assets and clinical stage pipeline [31] - SG&A expenses were $35.4 million, primarily driven by pre-commercial build-out, including personnel-related expenses tied to commercial hiring [31] - The net loss for the quarter increased compared to the prior year, with a cash position of $461.7 million at the end of the quarter, not including proceeds from a recent financing agreement [32][34] Business Line Data and Key Metrics Changes - The company is preparing for the potential approval of telotrectinib, a next-generation ROS1 inhibitor for non-small cell lung cancer, with a PDUFA date set for June 23, 2025 [6][18] - Telotrectinib has demonstrated a confirmed overall response rate (ORR) of 89% in treatment-naive patients and a median progression-free survival (PFS) of 46 months [10][12] - The drug's safety profile is favorable, with a low discontinuation rate of 6.5% due to treatment-emergent adverse events [16] Market Data and Key Metrics Changes - ROS1 positive non-small cell lung cancer is estimated to affect approximately 2% of newly diagnosed non-small cell lung cancer patients, translating to about 3,000 new patients each year in the U.S. [24] - First-generation ROS1 TKIs like crizotinib and entrectinib generate less than $150 million in annual U.S. net sales, indicating significant unmet needs in the market [25] Company Strategy and Development Direction - The company aims to challenge the status quo in cancer treatment by providing better drugs that impact efficacy, safety, and convenience [7] - The commercial strategy focuses on ensuring quick access to telotrectinib for patients and maximizing long-term value through its impressive clinical profile [24][30] - The company has secured a $250 million non-dilutive financing agreement to support the launch of telotrectinib and advance its broader pipeline [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the data supporting telotrectinib and the readiness of the team for the upcoming launch [39] - The new NCCN guidelines are expected to serve as a tailwind for the drug, emphasizing the need for ROS1 therapies over traditional IO chemotherapy [49] - The company believes that the market is ready for new alternatives, with telotrectinib positioned to reshape the ROS1 landscape if approved [19] Other Important Information - The company is also developing saclucitanib for diffuse IDH1 mutant glioma, with early clinical data suggesting deeper responses than other agents in this class [20][21] - The company is preparing to move saclucitanib into pivotal development this year, indicating a strong pipeline beyond telotrectinib [21] Q&A Session Summary Question: Can you discuss the tailwinds for the launch and how you prioritize them? - Management highlighted that duration of response and progression-free survival are key metrics for patients and physicians, positioning telotrectinib favorably against historical oncology agents [44] Question: What is the pricing strategy for telotrectinib? - Management indicated that pricing discussions are ongoing, with plans to announce the price shortly after the anticipated approval [50] Question: What is the targeted account strategy for ROS1 patients? - Management refrained from disclosing specific strategies but expressed confidence in their approach and the team's experience [58] Question: How does the company plan to address physician education regarding telotrectinib? - Management acknowledged the importance of physician education and emphasized that the drug's compelling data will incentivize prescriptions [70] Question: What are the expectations for the expanded access program (EAP)? - Management does not expect a large bolus from the EAP but remains confident in the overall launch strategy [85]