Release Date: November 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- SpringWorks Therapeutics Inc (SWTX, Financial) reported $49.3 million in net product revenue for the third quarter, representing a 23% growth quarter over quarter.
- The company has successfully launched 100 mg and 150 mg strength tablets in blister packaging, improving patient convenience and adherence.
- The addressable patient population for desmoid tumors is larger than initially estimated, with 10,000 unique patients identified through new diagnosis codes.
- SpringWorks Therapeutics Inc (SWTX) has a strong balance sheet with $498 million in cash, cash equivalents, and marketable securities, expected to fund operations through profitability by the first half of 2026.
- The NDA for nirogacestat for NF1-PN has been granted priority review, with potential FDA approval anticipated in early 2025, positioning it as a first-in-class treatment for adults and a best-in-class option for children.
Negative Points
- The transition to blister packs caused short-term delays in prescription refills, impacting patient adherence temporarily.
- There was some summer seasonality that affected new patient starts in July, although demand returned in August and September.
- The introduction of new ICD-10 codes for desmoid tumors is still in the early stages, and full adoption may take several years.
- Operating expenses increased compared to the third quarter of 2023 due to commercial activities supporting product launches.
- Despite strong growth, the company acknowledges that it has only reached a small portion of the potential patient population for its therapies.
Q & A Highlights
Q: Could you give us more color on how the blister pack transition progressed over Q3 and how should we think about the remaining 35% progressing through Q4?
A: We made the choice to transition this quarter, knowing it would pose challenges. We saw about a two-week delay for many patients in getting their prescriptions refilled as they transitioned from bottle to blister pack refills. We finished with our strongest month ever in August and an even stronger month in September. The transition improves patient convenience and adherence, and we expect to be through it by the end of the year. - Unidentified_8
Q: Your ICD-10 data suggests you've underestimated the desmoid tumor population. Could you elaborate on this?
A: Between the introduction of the desmoid tumor-specific ICD-10 codes in October 2023 and August of this year, 10,000 patients were identified, which is higher than our previous estimate of 5,500 to 7,000. This number is an undercount since new codes take years to be fully adopted. Many desmoid tumor patients are still being coded under the old general soft tissue neoplasms code. - Unidentified_4
Q: What does demand look like beyond September, and did you see month-over-month growth in Q3?
A: We are poised for acceleration. Our largest ever month was August, followed by an even larger September. We have 800 unique prescriptions in September and are steadily adding patients. The blister pack transition is expected to improve refill rates and compliance. We believe the physician satisfaction and likelihood to treat will drive continued growth. - Unidentified_8
Q: How are prescribers approaching IV discontinuation, and what percentage of patients have had dose reductions?
A: Discontinuation rates have been low, with fewer than 10% of patients discontinuing a year into launch. We are starting to get more visibility with patients switching to the blister packs. A majority of patients are still on the 150 mg dose, indicating good tolerability. We expect better transparency into dosing patterns by the end of Q4. - Unidentified_4
Q: For Ocib, looking forward to 2025, how should we think about the trajectory for the second year of launch relative to the first year?
A: We are positioned well for 2025 and beyond. We have a larger patient population than initially estimated, high physician enthusiasm, and systemic standard of care status. The blister pack transition will improve refill rates and compliance. We have clinical data supporting long-term dosing benefits, setting us up for continued growth. - Unidentified_8
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
