Release Date: March 20, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Could you comment on the pace of apheresis during Q1, specifically were patient numbers higher in March versus January? And how many patients per year do you think you'll need to treat to achieve profitability in 2027? A: The pace of apheresis has been increasing as we onboard more treatment centers. We had a greater number of apheresis in February and March than in prior months. Regarding profitability, we haven't provided specific revenue guidance for 2027, but the combination of Tecelra and Lete-cel sales will drive us to operating profitability.
Q: Can you confirm what proportion of the 15 confirmed double positive patients as of November went on to undergo apheresis this year? A: The majority of the double positive patients have started the treatment journey, with 10 patients apheresed so far. Most of the others are still in the process, and while some dropouts are expected, we haven't seen many to date.
Q: What are the assumptions and considerations for achieving profitability in 2027? A: We plan to reduce spending by about $50 million in 2025 and by $70 million to $80 million in 2026 and 2027. This will bring our cost base down significantly. The approval and launch of Tecelra and Lete-cel will offset these costs, with anticipated US peak sales of $400 million for our sarcoma franchise.
Q: Do you have sufficient cash to reach profitability in 2027, or does it assume additional funding? A: We are exploring strategic options with TD Cowan to ensure we can finance the company appropriately to reach profitability in 2027.
Q: What is the commercial strategy for Tecelra outside the US, and are there any timelines for filing in Europe? A: Our primary focus is establishing a commercially viable business in the US. We are exploring opportunities for ex-US commercialization, either independently or through partnerships. We haven't provided specific timelines for European filings.
Q: How do the incremental savings from pausing PRAME and CD70 impact the timeline for reaching profitability? A: These savings will help accelerate the timeline to profitability, but other variables, such as the successful launch of Tecelra and Lete-cel, are also crucial.
Q: How many ATCs have infused more than one patient, and are there any capacity constraints that could limit patient infusions? A: Several ATCs have infused more than one patient, and the pace of onboarding ATCs has been faster than expected. We have not encountered any capacity constraints in manufacturing or site capacity.
Q: What is the conversion rate from double positive patients to those who get apheresed? A: It's more a matter of time than percentage, as each patient's journey varies. Most double positive patients are progressing through the treatment journey over time.
Q: Are there any plans to file for Tecelra approval in the EU, and what is the interest level in PRAME and CD70 programs? A: We are part of the PRIME scheme in Europe and plan to report confirmatory evidence later this year. PRAME and CD70 are of interest to several pharma companies, and we are exploring all opportunities to support our sarcoma franchise.
Q: How will the experience with Tecelra drive efficiencies for Lete-cel's approval and launch? A: Learnings from Tecelra's BLA review are being applied to Lete-cel's BLA preparation. We have breakthrough therapy designation for Lete-cel, allowing for expedited development and review. The established commercial infrastructure for Tecelra will also support Lete-cel's launch.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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