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And welcome to Adaptimmune's First Quarter twenty twenty five Business Update Conference Call. As a reminder, all participants are in listen only mode. After the presentation, there will be an opportunity to ask questions. Star then zero. I will now turn the call over to Julie Miller. Of Investor Relations of for Adaptimmune. Julie? Please go ahead.
10m 47s
Thank you.
10m 48s
Good morning, and welcome to Adaptimmune's conference call to discuss our first quarter twenty twenty five business update. 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 and A. With that, I'll turn the call over to Adrienne Rockliffe. [indiscernible] Thanks, Julie.
11m 26s
And thank you, everybody, for joining us today. We now have one full quarter of GESOLMA sales under our belt.
11m 33s
And I'm delighted to be able to share with you the momentum that we're seeing with this launch. With 21 patient A3 so far in 2025, 13 in Q1, and another eight in the first part of Q2, we now feel confident sharing revenue guidance for the full year of between 35,000,000 and $45,000,000 in TISCELRA sales. We believe this is attainable based on the number of patients we've seen through the treatment cycle as well as the number of authorized treatment centers that we have up and running. As of today, we have a total of 28 centers accepting referrals for patients for [indiscernible] and it's very clear that we will have the full network of approximately 30 ATCs up and running by the end of twenty twenty five. Is approximately a year earlier than we expected when we launched. During these first few quarters of the ZESARA launch, we will continue to share key performance indicators in addition to net sales. Such as the number of apheresis that I previously mentioned, and the number of T Cellular treatments invoiced. We have invoiced for 14 T cell retreatment in 2025 to date, with six in Q1, resulting in net sales for Q1 of $4,000,000 We have since invoiced eight additional treatments in the first few weeks of Q2, We've also continued to deliver 100% manufacturing success from our U. S. T Cellular manufacturing center in Navy Yard, Philadelphia.
13m 3s
With all T Cellular doses released to date meeting specification, with no capacity issues or constraints And in the first quarter, our average turnaround time from apheresis to lot release was twenty seven days beating our target of 30 On the payer front, we've seen effective patient access to ZIZARA with no patient denials to date. So in every aspect, the T cell re launch is progressing exceptionally well. Forming the basis for our projected $400,000,000 of of peak sales from our combined Tisera and Letocell sarcoma franchise. The team at Adaptimmune has remained focused diligent and absolutely committed to the successful launch.
13m 52s
Also, I'll remind you that the investments in people and infrastructure that we've put in place for T Cellra will be the same for Letocell when approved. Which we anticipate in 2026.
14m 4s
We will use the same ADC network and work alongside many of the same physicians. Neticel launch readiness activities are underway, and we are fully on target for rolling BLA initiation burdens before the end of the year. As you know, Lettercel has the potential to more than double the addressable patients in our sarcoma franchise. As we anticipate an indication for both synovial sarcoma and myxoid round cell liposarcoma patients whose tumor express NY ESO. It's worth noting that given the ubiquitous nature of NY ESO expression, in myxoid liposarcoma patients, we do not anticipate the need for NY ESO antigen testing in this population. Further simplifying the patient journey and expanding the patient population. Continue to review strategic options with Cowen as our advisors, and are committed to explore all options that benefit patients and shareholders. We look forward to sharing more information on next steps in this process in the upcoming months. And with that, I'll open the call for questions. Operator?
15m 14s
Thank you.
15m 32s
And our first question comes from Mark Frahm from T. B. Cowen. Please go ahead. Hey, thanks for taking my questions. Maybe just one for Mark, housekeeping on some of the numbers just put out and thanks for all of that clarity. Is just on the apheresis patients on the apheresis patients in the quarter so far, I know it's difficult for them to have been treated, but theoretically possible for some of them to have already been treated. And invoiced. Those are all but those eight none of those are the eight patients who have been invoiced in the quarter as well, right? Is that correct? [indiscernible] don't have that, but I would doubt it. I think most of those are the patients from the prior quarter, although there could be one or so. Why don't I ask Cynthia to address that? Cynthia?
16m 26s
Yes. So the A3s is [indiscernible] that we've had year to date, which is the twenty one, that includes patients that have been invoiced already in mostly March and April. So, [indiscernible] at least about six of them probably have been invoiced already. But we would anticipate that the majority of them will be invoiced in the next month or so.
16m 58s
Okay.
16m 59s
And then just thinking forward on that apheresis number, should we that's roughly half the quarter, so should we be thinking of kind of mid teens total number of patients they freeze in Q2? Is there a reason based on maybe ATC startups and stuff like that? That to think about acceleration of the free throughout the quarter?
17m 22s
No, I appreciate the voracious appetite for further information but we're very comfortable with the sales range of guidance that we provided for 2025. And we're very comfortable telling you what we've done. And we're not giving detailed breakdown by quarter of apheresis invoice double positive or anything else. So we'll carry on reporting the metrics that we've got and but we now feel very confident about the guidance that we have for the year of 35% to $45,000,000 for T cellar sales.
17m 58s
Enough.
17m 58s
Thanks.
17m 59s
Thanks, The next question comes from Michael Schmidt from Guggenheim. Please go ahead. This is Paul on for Michael. So just on TESELRA, given that we're about nine months out from the approval, is there anything you can also tell us now about how the pace of patient referrals and screening has been trending in the most recent weeks, especially since you're trending to hit your 30%, 80 goal faster than expected? And generally, would you expect that to translate sort of incremental quarter over quarter growth? Or would you expect maybe some seasonality coming in, in the back half? Thanks.
18m 40s
Ask Cynthia to comment on that ramp up overall think we expect incremental incremental growth quarter on quarter but I'll let Cynthia comment on the the trends as we see them Yes. Thank you, Adrian. We do expect this growth quarter over quarter and we're not currently anticipating specific seasonalization. But more so the growth based on the increased awareness, the number of each that are being onboarded and the natural timing from when we have the patients being a freeze and then invoice you can see from the numbers that we had in terms of patients invoice that we had the six in the first quarter and eight already just at the very first week. Of the second quarter. So we will continue to see that incremental growth over time.
19m 40s
Great. So then if I can have a quick follow-up So for the 24 patients who have been apheresis to date, anything you can tell us about the average time between when they were confirmed double positive and when they received ifresis? And is there any potential to sort of expedite this time as the commercial experience grows? Thanks. Yes, I can address that.
20m 1s
Sure. So it varies a lot, and we have you know, still very few number of patients if you think about it. The main driver of the difference between when the patient is identified double positive and the patient is day freeze, is actually the patient [indiscernible] In many times they need to get closer to the treatment center, About forty percent of our patients today are referral from other sites that are going to the ATCs. And so that can take some time based on the patient schedule. So, it can take a couple of days to a couple of weeks depending on that situation. Everything that we can do on our side to expedite that we certainly do. We don't have any constraints from a capacity perspective. So that is not anything that has been influencing when the patient can be A3 at this point.
21m 3s
Great. Appreciate the color. Thanks, Paul. The next question comes from Jonathan Chang from SVB Leerink.
21m 11s
Please go ahead.
21m 14s
Hi, guys. Jonathan Chang from Leerink Partners. Thanks for taking my questions.
21m 19s
First question, how are you thinking about potential impact from regulatory changes on your business? And second question, what would you say are the key learnings from the early launch to date? What has tracked better in line or worse than your initial expectations? Thank you.
21m 41s
So I'm going to ask So I'm going to ask Dennis Williams to comment on the pro regulatory progress that we see with LetiCell And then I'm going to ask Cynthia to talk about the progress that we've seen since launch and our key learnings from that Over to you, Dennis.
22m 13s
Yes. Thanks, Ed.
22m 16s
We, like many, right, are constantly watching the the environment at the FDA and obviously there's a lot of change going. What I will say though is we've had three formal meetings with the FDA in the last six months We haven't seen any indication that the FDA is not working as diligently as ever I can say for this program, teletasol, they are very engaged. So so far so good. And with that, I'll turn it over to Cynthia.
22m 47s
Thank you, Venice. And yes, we did learn a lot since we launched the product. I think that the main I would say upside we talked about how fast we have been able to onboard the treatment centers. So that has happened even faster than we were anticipating. And a lot of it is due to the significant excitement that we're seeing with the sarcoma specialists how closely they've been working together with the cell therapy specialists in the treatment centers to make sure that we can onboard KESERA in the sites and speaks to the high unmet need and the innovation that we're bringing with Keselra. So that has been positively surprising and and [indiscernible] will be able to complete our full treatment center footprint by the end of the year. The pace from a patients getting on board is pretty much as we expected. We treated our first patients at the end of last year and now we're seeing the growth aligned to our original expectations. No denials has been positive. The flow from the biomarker testing is also well, which is something that was new that we had to launch and it has been working seamlessly. And I think the other upside has been the manufacturing success rates.
24m 13s
We have had % success rate that is as far as I know, unheard of in cellular therapies, And we've been able to achieve a turnaround time for the patients that we have been treating. So so far so good. We're very excited. I think the team has been working really hard to make sure that that cannot take place across all the different functions at Adaptimmune. And with the medical community as well. So, so far so good.
24m 47s
Got it. Thanks for taking my questions. [indiscernible] [indiscernible] The next question comes from Arthur He from H. C. Wainwright. Please go ahead. Hey, good morning, Ed and team. Congrats on the progress. So I just had the two quick ones. So first, for the you mentioned in the last quarter call that [indiscernible] patient emphasize is most shown, they're early activated sensors. So could you give us more color on current status of that metrics Yeah, I think you're referring to the the the just a clarification, you're referring to the fact that most of the that we had at that point in time [indiscernible] the centers that were started at the beginning of that. Maybe I'll ask Cynthia to comment on the we want to say about the current spread.
25m 52s
Yes. Thank you, Adrian. So yes, we had the most number of patients in voice so far from the ones that were activated earlier. But we have about, you know, patients that have been right now in more than 40 patients in more than 40 centers [indiscernible] about eighty percent of the treatment centers have are in the process of at least testing at least one patient. So we are seeing a very good spread across all the treatment centers in terms of patient identification to be tested than having patients being apheres, and eventually turning into invoices. But the spread has been fairly consistent across all the treatment centers.
26m 44s
Thanks, Cynthia. And also for I just want to follow-up on the between the double positive patient to the patient who get anaphoresis, is that still remain like almost nearly one hundred percent for this case?
27m 3s
So we don't have line of sight to all the patients that he's been identified as double positive. We do offer a sponsor testing. So we have an approximate volume of patients that are going through that route. But we really can't know about all the patients that are being tracked across all the different sites. What we do know is that from the moment that the patient gets enrolled in our portal, and we receive a purchase order, from that moment on, we have not had any cancellations so far and we have not had any manufacturing failures as well.
27m 43s
Awesome. Thanks for taking my question.
27m 46s
Thanks, Aldo.
27m 49s
The next question comes from Craig Suvaneva from Mizuho. Please go ahead. Good morning. Thank you for taking my questions and congratulations on a really nice launch so far.
28m 2s
Two questions if I could and one is really with regards to perhaps some recent news on the financing front. You chose to pay down 25,000,000 of the financing obligations you had. It was a bit earlier than we so I was wondering if you could walk us through the thought process there and then just given my second question that is on where the company is on total liquidity relative to the spend we saw on the first quarter and the revenue just wondering how we should think about the sustainability of operations [indiscernible] going forward?
28m 47s
Thanks.
28m 49s
Hi there. Yes, it's Gavin speaking.
28m 51s
Hi, Greg.
28m 52s
With regards to to the paydown of the debt principal, that was actually done in March and we announced that in our ten ks announcement and that was the reason for that was really to continue to manage our balance sheet and leverage and valuation there. It wasn't impactful on our cash runway at that time. And it managed the key stakeholders. Announced that probably eight, nine weeks ago now. And continue to have good relationship with our debt provider. Terms of the cash position, we had a going concern a substantial debt, our going concern. In the 10 ks and that does remain, so clearly less than twelve months cash. We're not going to give detailed cash guidance and cash runway guidance really because it's impacted by a number of factors. One, of course, is the successful launch of t Solar, we've just been talking to and how that ramps.
29m 56s
Second is the cost reduction actions that we took. We announced a restructuring in November that was executed in February.
30m 5s
We announced in March further cost reductions associated with our Frame AD520 programs, And that has impacted on the Q1 spend So there are costs associated with that restructuring, which makes the Q1 spend higher than a normalized run rate would look like. And finally, we're working through the TD Cowen strategic options. So all of those sort of planes making giving cash runway guidance inappropriate at the moment.
30m 35s
Thanks.
30m 36s
Can I follow-up with an additional question? Sure, Greg.
30m 42s
Just with respect to the guidance, the revenue guidance for the year, Very impressive that you were able to provide guidance. I don't see many companies in the first year of a launch feeling comfortable enough to be in a position to do so So my question is, could you just maybe provide some color as to some of the underlying assumptions that give you the comfort to indeed be able to provide that guidance?
31m 9s
For the year, was ahead of our estimates. So congrats there. [indiscernible] there's a couple of things. So one of the advantages that I think you have in the cell therapy space is that as we referred to, we've we can see the funnel of patients coming through from a reasonable perspective. And so if you think about that guidance that guidance looks like it's 35% to $45,000,000 Now that's roughly approximately between fifty and seventy patients treated for the year. And so you think about that in the context of having apheresis 21 patients seeing an increasing ramp going into coming through Q1 and into Q2 We've also now got experience as to what the what the net sales price looks like at least for a relatively small number of patients and the confidence in the manufacturing, meaning that so far we've been able to deliver 100% of the patients that we've we've apherexed, which which is I think extraordinary as Cynthia pointed out for a cell therapy launch and a real testament to the manufacturing team here. You put all of that together and I think you can see that as we go through the remainder of Q2, which we have good visibility to, into Q3 and Q4 with the increasing ATCs that we've got, we feel quite comfortable about that $3,545,000,000 dollars range Okay.
32m 57s
Thank you very much and congratulations again.
33m
Thanks, Greg.
33m 5s
And our next question comes from Peter Lawson from Barclays. Please go ahead. Good morning. It's Alex on for Peter. Thanks for taking my questions. Just a clarification on the question on drop off rate. I guess specifically, percentage of patients end up getting an infusion relative to patients that get apheresis? Is that one hundred percent or It has been so far.
33m 32s
Okay.
33m 33s
Great. And then my other question was just around any manufacturing maintenance work that would be required at some point this year and if yes, when that could happen? [indiscernible] pertinent question given the environment and other other companies. John, do you to talk about maintenance plans for the year?
33m 59s
Yes, absolutely. So, is John. Lead the manufacturing group and We don't have plans and we managed to put a significant shutdown [indiscernible] you've maybe seen other places. We do a lot of our maintenance on kind of a rolling way of doing that and we manage to not impact the capacity when we do that. So for this year, we don't have one of those plans.
34m 18s
Okay, great.
34m 19s
Thank you. And then just one final one, if I may. Any price increases planned 2025?
34m 28s
We've not made any announcements about price increases. [indiscernible] great. Thanks for taking our questions.
34m 36s
Thanks, Alex.
34m 38s
The next question comes from Yanan Zhu from Wells Fargo. Securities. Please go ahead.
34m 45s
Great. Thanks for taking our questions. Could you comment on COGS and how it is tracking? To your expectation? [indiscernible] It's early days actually. And we're first quarter in and I think I said beforehand, COGS for the first few quarters are going to be a little bit a little bit higher than we think they're going to normalize to because under GAAP we're consuming pre purchase products. Got it. You mean COGS is going to be higher or the margin? The margin going be higher, sorry, you can clarify, These lower COGS [indiscernible] Q1 was around about 78%. We think long run average is around about 70%.
35m 38s
Got it. Thanks. And could you now that you're in a market, could you talk about the annual incidence rate for the eligible patient population? Any change compared with when you were planning the launch? Thank you.
36m 1s
I'll ask Cynthia to comment on her insights. Cynthia?
36m 5s
Yes. Thanks, Adrian. So from the pace that we're seeing the patients being onboarded, it is pretty in line to our expectations. And to the literature and information that we have used for our [indiscernible] Of about one thousand patients a year that are being diagnosed with synovial sarcoma and then pretty much all of them are going to be going through a round of chemotherapy, potentially surgery, and we can treat all the patients that have been previously exposed to chemotherapy. So, it has been quite in line to what we have planned.
36m 51s
Maybe lastly, just about the patient you're treating this quarter and in near term, do you feel if this is there any element of warehouse patients or are these reflecting the the incidence rate up to this point? Thank you.
37m 19s
Yes. So there is for the months after launch, a good number of patients that I would call more the prevalent patient population that we're going to be treating for a while. We can see that the pace of these patients being treated depends a little bit on when they're tested, We know that synovial sarcoma is relatively speaking in comparison to other hematological malignancies like lymphoma or even ALL, it is a slower progressing condition. And so there is a number of patients that we are seeing now that are part of the prevalent pool and eventually then I think we're going to reach you know, we start to treat more of the incident population. I would say that probably by sometime next year, that we would see a more I would say, steady number of new patients getting in every month. But we didn't see really that bolus of patients that was seen in other therapies, but it is natural that we would expect to treat more of the prevalent patients in the first month after the launch and then it gets to the incident population. But not a dramatic bubble Great. Thanks. That's super helpful. Thank you.
38m 47s
This concludes our Sorry.
38m 50s
This concludes our question.
38m 52s
Our question and answer session. I will turn the conference back over to Adrian Rawcliffe, for any closing remarks.
39m 1s
Thank you everybody for joining us. Thank you for your questions. And great to be able to update you on the fantastic momentum that we're seeing with the launch of [indiscernible] And the progress with the rest of the sarcoma franchise. Look forward to updating you further in due course. Take care. Bye.
39m 21s
This brings to a close today's conference call. You may disconnect your lines. Thank you for participating and have a pleasant day.
Key Insights
Adaptimmune reported strong initial momentum for its T cell therapy launch, with 21 patients apheresis in 2025 so far (13 in Q1, 8 in early Q2), and 14 treatments invoiced year-to-date (6 in Q1, 8 in early Q2), resulting in Q1 net sales of $4 million.
The company issued full-year 2025 revenue guidance for T cell therapy sales of $35–45 million, based on current patient trends and the rapid onboarding of treatment centers (28 currently active, expecting ~30 by year-end, a year ahead of schedule).
Manufacturing performance has been exceptional, with 100% success rate and no capacity constraints; average turnaround time from apheresis to lot release was 27 days, beating the 30-day target.
No patient denials have occurred to date, and the company expects continued quarter-over-quarter growth without significant seasonality, supported by increasing awareness and treatment center activation.
Adaptimmune remains focused on expanding its sarcoma franchise, with Letocell launch readiness underway (anticipated approval in 2026), ongoing cost reduction efforts, and active review of strategic options; long-term peak sales for the combined franchise are projected at $400 million.
