Latest news with #AdaptimmuneTherapeuticsPLC
Yahoo
14-05-2025
- Business
- Yahoo
Adaptimmune Therapeutics PLC (ADAP) Q1 2025 Earnings Call Highlights: Strong Tecelra Launch ...
Revenue Guidance: Full-year Tecelra sales projected between $35 million and $45 million. Net Sales for Q1 2025: $4 million from Tecelra treatments. Tecelra Treatments Invoiced: 14 treatments in 2025 to date, with 6 in Q1. Authorized Treatment Centers: 28 centers currently accepting referrals, with a target of approximately 30 by the end of 2025. Manufacturing Success Rate: 100% success from the US Tecelra manufacturing center. Average Turnaround Time: 27 days from apheresis to release, beating the target of 30 days. Peak Sales Projection: $400 million from combined Tecelra and Lete-cel sarcoma franchise. Warning! GuruFocus has detected 4 Warning Signs with ADAP. Release Date: May 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Adaptimmune Therapeutics PLC (NASDAQ:ADAP) reported strong momentum with the launch of Tecelra, achieving $4 million in net sales for Q1 2025. The company has successfully apheresed 21 patients in 2025, with 13 in Q1 and 8 in early Q2, supporting their revenue guidance of $35 million to $45 million for the year. Adaptimmune has established 28 authorized treatment centers (ATCs) for Tecelra, with plans to reach 30 by the end of 2025, a year ahead of schedule. The manufacturing success rate for Tecelra has been 100%, with no capacity issues and an average turnaround time of 27 days, beating the target of 30 days. There have been no patient denials for Tecelra, indicating effective patient access and a positive payer environment. Adaptimmune Therapeutics PLC (NASDAQ:ADAP) has a going concern warning, indicating less than 12 months of cash runway, which raises concerns about financial sustainability. The company has not provided detailed cash runway guidance due to various impacting factors, including the success of Tecelra's launch and ongoing cost reduction actions. The cost of goods sold (COGS) is expected to be higher in the initial quarters, affecting margins, although they are projected to normalize over time. There is uncertainty regarding the impact of potential regulatory changes on the business, although the company has not seen any negative indications from the FDA. The company is still exploring strategic options with Cowen, which could imply potential changes or uncertainties in their strategic direction. Q: Can you clarify if the apheresed patients in Q1 have already been treated and invoiced? A: Cintia Piccina, Chief Commercial Officer, explained that of the 21 apheresed patients year-to-date, at least six have been invoiced, with the majority expected to be invoiced in the coming months. Q: Should we expect an acceleration in the number of apheresed patients in Q2? A: Adrian Rawcliffe, CEO, stated that while they are comfortable with the sales guidance of $35 million to $45 million for 2025, they are not providing detailed quarterly breakdowns of apheresis numbers. Q: How has the pace of patient referrals and screening been trending, and do you expect incremental growth? A: Cintia Piccina noted that they expect quarter-over-quarter growth without specific seasonality, driven by increased awareness and the onboarding of more Authorized Treatment Centers (ATCs). Q: What are the key learnings from the early launch of Tecelra? A: Cintia Piccina highlighted the faster-than-expected onboarding of treatment centers and the 100% manufacturing success rate as positive surprises, with patient onboarding and biomarker testing proceeding smoothly. Q: How is the company managing its cash position and what are the implications of the recent debt paydown? A: Gavin Wood, CFO, explained that the debt paydown was part of managing the balance sheet and did not impact cash runway. The company has less than 12 months of cash, with ongoing strategic options being explored. Q: What gives you confidence in providing revenue guidance for the year? A: Adrian Rawcliffe mentioned the visibility into the patient funnel, successful manufacturing, and the increasing number of ATCs as factors supporting the $35 million to $45 million revenue guidance. Q: What is the drop-off rate for patients from apheresis to infusion? A: Adrian Rawcliffe confirmed that so far, 100% of apheresed patients have received infusions. Q: Are there any planned manufacturing maintenance activities this year? A: John Lunger, Chief Patient Supply Officer, stated that maintenance is conducted on a rolling basis without impacting capacity, and no significant shutdowns are planned for the year. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
21-03-2025
- Business
- Yahoo
Adaptimmune Therapeutics PLC (ADAP) (Q4 2024) Earnings Call Highlights: Strategic Growth and ...
Q4 2024 Product Revenue: $1.2 million from Tecelra sales. Authorized Treatment Centers (ATCs): 20 ATCs established, representing 2/3 of the planned network. Patient Apheresis in Q1 2025: 10 patients apheresed with 3 more scheduled, totaling 13 anticipated. Expected Q1 2025 Invoicing: 6 to 8 patients, three to four times the prior quarter. Projected 2025 Sales: Approximately $25 million, aligning with analyst forecasts. Manufacturing Performance: 100% of products manufactured to specification with no failures; turnaround time under 30 days. Reimbursement Success: Over 70% of commercial and Medicare lives covered with no denials. Cost Savings: $75 million to $100 million reduction in forward cash flow demands through 2028 by pausing pre-clinical programs. Cash Savings from Restructuring: $300 million over the period announced previously. Warning! GuruFocus has detected 6 Warning Signs with ADAP. Release Date: March 20, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Adaptimmune Therapeutics PLC (NASDAQ:ADAP) has successfully launched Tecelra, with 20 authorized treatment centers (ATCs) already operational, representing two-thirds of their planned network. The company has seen a significant increase in patient aphereses, with 10 patients apheresed in Q1 2025 compared to three in Q4 2024, indicating strong demand and operational efficiency. Over 70% of commercial and Medicare lives are in plans that cover Tecelra, with no reimbursement denials to date, showcasing effective payer engagement. Manufacturing processes have exceeded expectations, with 100% of products manufactured to specification and no capacity bottlenecks, ensuring reliable supply. The company anticipates achieving US peak sales of approximately $400 million for its sarcoma franchise, supported by strong clinical data and strategic commercial infrastructure. Adaptimmune Therapeutics PLC (NASDAQ:ADAP) has paused spending on pre-clinical programs targeting PRAME and CD70, which may impact future pipeline development. The company has not provided formal revenue guidance for 2025, creating uncertainty about financial projections. Despite the positive launch of Tecelra, the company acknowledges the need for additional capital to achieve profitability by 2027. The ex-US strategy remains unclear, with a focus primarily on the US market, potentially limiting international growth opportunities. The restructuring and cost-saving measures, while beneficial for cash flow, may impact the company's ability to invest in new opportunities or expand its workforce. 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. This article first appeared on GuruFocus. Sign in to access your portfolio
