Release Date: August 07, 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 $40.2 million in net product revenue for OGSIVEO in the second quarter of 2024, indicating strong demand and successful commercial execution.
- OGSIVEO has rapidly become the standard of care systemic therapy for desmoid tumors since its FDA approval, with high patient and physician satisfaction.
- The company completed its NDA submission for mirdametinib, a potential best-in-class therapy for NF1-PN, indicating progress in expanding their product portfolio.
- SpringWorks Therapeutics Inc (SWTX) has a robust balance sheet with $522 million in cash, cash equivalents, and marketable securities, supporting its path to profitability.
- The company is advancing several promising pipeline projects, including a Phase 1 study of TEAD inhibitor SW-682 and expansion opportunities for mirdametinib in various settings.
Negative Points
- Operating expenses increased compared to the previous year, driven by commercial activities for the US launch of OGSIVEO and preparations for mirdametinib.
- There is a significant unmet need for NF1-PN patients, with no FDA-approved therapies for adults, highlighting a gap in current treatment options.
- The company faces challenges in expanding the adoption of OGSIVEO in community centers, despite strong uptake in centers of excellence.
- The market for NF1-PN is minimally penetrated with systemic therapies, indicating potential hurdles in market education and adoption.
- Potential seasonality effects could impact OGSIVEO sales during summer months, as seen with other products in the market.
Q & A Highlights
Q: What are you seeing from both new prescribers and repeat prescribers for OGSIVEO, and how is the wait-and-watch population responding?
A: Bhavesh Ashar, Chief Commercial Officer, explained that there has been a good amount of new prescribers since the launch, with repeat prescriptions coming in regularly. The proportion of business from existing patients is increasing. The wait-and-watch population is expected to decrease over time as more patients seek active treatment with OGSIVEO, supported by treatment guidelines favoring systemic therapy.
Q: Can you provide insights on OGSIVEO inventories and its adoption in community centers?
A: Bhavesh Ashar noted that inventory levels were aligned with demand, and inventory was not a key driver of performance. Adoption in community centers is growing, with efforts to drive both breadth and depth of prescribing. The availability of desmoid tumor-specific ICD-10 codes helps direct sales efforts effectively.
Q: Where do you see the greatest opportunity for growth with OGSIVEO, and how are you reaching that patient population?
A: Saqib Islam, CEO, highlighted the significant opportunity in the desmoid tumor patient population, with more than 7,000 actively managed patients. Efforts focus on driving depth within centers of excellence and expanding reach in community segments. The transformative benefits of OGSIVEO and broad payer access support continued growth.
Q: What are your expectations for the mirdametinib launch next year, and how does it compare to OGSIVEO's launch?
A: Saqib Islam stated that the mirdametinib opportunity is meaningful, with a patient population at least as large as desmoid tumors. The NDA filing covers both pediatric and adult patients, with significant unmet needs in adults. The existing Koselugo revenues indicate a substantial market opportunity, and mirdametinib's data supports a potentially best-in-class profile.
Q: Are you expecting any seasonality effects for OGSIVEO in the third quarter, and how do you anticipate mirdametinib's market penetration?
A: Saqib Islam acknowledged potential seasonality effects in the summer months but emphasized the deep patient pool and significant opportunity. Badreddin Edris, COO, noted that mirdametinib's NDA covers both pediatric and adult patients, with a large portion of the market being minimally penetrated, offering significant growth potential.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
