Adaptimmune Therapeutics plc

Hello, and welcome to the Adapt Immune's Q4 and full-year 2024 Business Update conference call. As a reminder, all participants are in a listen-only mode. The conference is being recorded. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star and then one on a telephone keypad. Should you need assistance during the conference call, you may signal the operator by pressing star and zero. I would now like to turn the floor over to Julie Miller, Investor Relations for Adaptimmune. Julie, please go ahead.

Good morning, and welcome to Adaptimmune's conference call to discuss our full year and fourth quarter 2024 business updates. I would ask you to review the full text of our forward-looking statements from this morning's press release. We anticipate making projections during this call, and actual results could differ materially due to several factors. including those outlined in our latest filings with the SEC. Adrian Rockliffe, our Chief Executive Officer, is here with me for the prepared portion of the call, and other members of our leadership team will be available for Q&A. With that, I'll turn the call over to Adrian Rockliffe.

Thanks, Julie, and thank you, everybody, for joining us on today's call. I'd like to begin by discussing the T-cellular launch and the fantastic momentum that we've seen building since our approval late last year. This launch, as you know, has been our top priority, and we have provided some updated performance metrics in this morning's press release. But I'm going to go into more details on this call so that you can see why we're so excited that our long-range forecast of at least $400 million in combined synovial sarcoma sales seems very achievable given these early success indicators. Currently, we have 20 authorized treatment centers, or ATCs, available through our network, which you can find on T-Cellular.com, and that's pretty much updated in real time for the most part. These 20 ATCs represent a full two-thirds of our planned treatment network of approximately 30 sites. So we are very much ahead of schedule in setting up these ATCs. When we launched last year, we intended to have the full network established by late 2026. And our Q3 earnings in November, and based on enthusiasm from sites and the progress that we've seen up to that point, we accelerated that timeline to the end of this year. Now, having two-thirds of these sites up and running already, we are very much on track to have the full network by the end of the year. Now onto patients being treated with T-Sauer. In Q4 last year, we A4Eased three patients and two of those were invoiced, resulting in Q4 recorded product revenue of $1.2 million. In Q1 2025, as of today, we have A4Eased 10 more patients and we have three additional A4Eases scheduled by the end of March for an anticipated total of 13 patients A4Eased in Q1 2025. This means we're likely to A4Ease more than four times as many patients in Q1 as we did in the prior quarter. Furthermore, we anticipate that the majority of the 10 patients A4Eased in Q1 to date will be invoiced in Q1, with the remainder in Q2. As such, we anticipate invoicing three to four times as many patients in Q1, i.e. approximately six to eight patients as we did in the prior quarter. We can see this launch is accelerating rapidly. And our KPIs are in line with or indeed exceeding our projections, which is a testament to the team's hard work and to the unmet need of sarcoma patients and the recognition from their treating physicians that T-cell offers a real solution. And we anticipate the acceleration of these numbers will continue. We have an additional pool of around 20 patients who are biomarker positive. And we expect the majority of these patients to be treated in Q2 and Q3 this year. And behind that, we estimate that approximately 30 patients are in various stages of testing. Now, we don't have full visibility into all of the MAGE A4 testing that occurs, but more than 80 patients have completed testing for MAGE A4 using our sponsored testing program since launch, with a positivity rate which is, as expected, around 65%. On the payer front, we've had tremendous success with reimbursement, over 70% of commercial and Medicare lives are in plans that already have established policies in place to cover T-cells. To date, we haven't experienced a single denial, which is a great accomplishment for the team and even greater outcome for patients, obviously. Before we move off launch performance, I'd be remiss not to discuss manufacturing, since this is so important for cell therapies. As you know, an effective, efficient delivery of autologous cell therapies is, in our view, a critical, indeed, a defining characteristic for successful commercialization campaigns. De-cellular manufacturing has exceeded all of our goals and expectations. Although the numbers so far are small, 100% of the released products were manufactured to specification with no manufacturing failures. Our average turnaround time from apheresis to product release has been less than our target of 30 days. We've had no capacity bottlenecks so far. and we have a robust supply of all the key materials, including, importantly, vector already in place. We should have no trouble meeting the anticipated accelerating demand in the coming quarters that I referenced earlier. The net result of everything we're seeing across our treatment network, our commercial and manufacturing teams, is that we anticipate sales of T-cellerol will continue to accelerate in each quarter this year as the pipeline of new patients flows through, as new ATCs come online, and as the timelines for each patient moving through the process becomes more efficient and more streamlined. As of now, we have good visibility of the patients we expect for delivery in April. And although we're not yet in a position to provide formal revenue guidance, we feel very confident that the current consensus analyst forecast of approximately $25 million of sales in 2025 is very achievable. This is a testament to the commercial and CMC capabilities we've thoughtfully and strategically built, and which are now firing on all cylinders. Most importantly, though, it's a testament to the strength of the clinical data, as reflected in the approved label, which has provided patients and their treating oncologists with the confidence that T-cell array is the right choice. Now we've built this commercial infrastructure not only for T-Celera, the first product in the Sarcoma franchise, but also for the next product, Leticel, which we expect to be on the market in 2027. The data we've generated for Leticel is as strong as that for T-Celera and will be the basis for the BLA filing, which is on track for submission later this year. T-Celera and Leticel form the basis of our Sarcoma franchise and As stated previously, we expect to see US peak sales of approximately $400 million. Since Lettucelle will use the same commercial footprint as T-Cellera, we will achieve significant operational channel and cost synergies. Put another way, the incremental cost to launch Lettucelle is minor, given that most of the capabilities will already be in place by the time of launch in 2027. Now I'm going to elaborate a little more on Leticel and, in particular, on the IGNITE-ESO pivotal data that met its primary endpoint and was presented at CTOS last year. Efficacy is similar to what we saw with Afamacel, which was the basis for approval of T-Cellera. And in the 64 patients treated with Leticel in the IGNITE-ESO trial, there is a 42% overall response rate. This also included six complete responses. And that's a complete response rate of almost 10% in these advanced metastatic synovial sarcoma and myxoid liposarcoma patients. For these patients with few other options, this is a transformational advance. As I mentioned, these data will serve as the basis for the rolling BLA filing plan to begin later this year. And I also want to point you to a KOL event we previously hosted, which we've linked in our PR this morning. that Dr. Sandra D'Angelo from Memorial Sloan Kettering Cancer Center led after CTOS. Dr. D'Angelo, who has been the lead investigator in our trials, framed Letticelle from the perspective of the provider. She was enthusiastic not only about the data but also about having another future treatment option. She speaks compellingly about her patients who often in the prime of their lives receive a devastating diagnosis of synovial sarcoma or myxoid liposarcoma and have limited treatment options. Dr. D'Angelo highlighted Leticel's significant improvement over standard of care and described the treatment journey from screening to dosing as streamlined. If you want to understand the transformative nature of these therapies in this space, I encourage you to listen to her presentation, which is on our website. Leticel will expand our sarcoma franchise into NYESO-expressing synovial sarcoma and myxoid liposarcoma, which we anticipate will more than double the number of treatable patients in the U.S. each year. We estimate that Lettucell will eventually make up over 60% of our combined Sarcoma franchise revenue. Switching gears a little, last quarter we shared the key priorities for our restructuring and for the company going forward. These were, one, to build a successful business with what we anticipate will be two FDA approved products in Sarcoma. to substantially reduce the need to bring in additional capital before becoming cash flow positive, and three, to achieve our objective to be cash flow break-even in 2027. The update of the launch of TESORA and the progress with Letticelle demonstrates we are well on track to meet the first of these objectives, building our sarcoma business. On the capital reductions and the cash flow break-even in the 2027 objectives, we have two updates for you today. First, we are pausing spending on our preclinical programs targeting PRAME and CD70. This decision reduces our forward cash flow demands in the period through 2028 by approximately $75 to $100 million. This is in addition to the $300 million of full cash savings over this period we announced at the end of last year as a result of our restructuring. Secondly, we've engaged TD Cowen to help us explore all the strategic options and evaluate every financial opportunity to ensure we achieve our goals and optimize value for our shareholders. This includes potential partnerships or collaborations, strategic combinations, various financial transactions, and multiple pipeline monetization opportunities. We won't say much more beyond this, and while we appreciate all your questions, we will only provide an update on the progress of these initiatives when we have something meaningful to discuss. We have a lot of options and financial levers we can pull while we continue to execute our commercial strategy from a position of strength with the early success of the TESELRA launch. In summary, we have great traction and acceleration on the launch of TESELRA, and we'll continue to provide updates on this and the progress of Lettucell towards enrolling BLA submission later this year. We will continue to effectively manage our costs as we push towards profitability in 2027. And in the context of the current capital markets, we will leave no stone unturned to enable us to achieve our objectives. And with that, I'll open the call out for questions. Operator?