Adaptimmune Therapeutics Q1 2025 Earnings Call Transcript

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May 13, 2025

There are 12 speakers on the call.

Operator

and welcome to Adaptimmune's First Quarter twenty twenty five Business Update Conference Call. As a reminder, all participants are in listen only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. I will now turn the call over to Julie Miller of Investor Relations for Adaptimmune. Julie, please go ahead.

Speaker 1

Thank you. 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.

Speaker 1

With that, I'll turn the call over to Adrian Rockliffe. Ad?

Speaker 2

Thanks, Julie, and thank you, everybody, for joining us today. We now have one full quarter of TESULRA sales under our belt, and I'm delighted to be able to share with you the momentum that we're seeing with this launch. With 21 patients 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 TESELRA 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 TISELRA, 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.

Speaker 2

This is approximately a year earlier than we expected when we launched. During these first few quarters of the T 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 Cellra treatments invoiced. We have invoiced 14 T Cellular treatments 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.

Speaker 2

T Cellular manufacturing center in Navy Yard, Philadelphia, 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 not release was twenty seven days, beating our target of thirty days. On the payer front, we've seen effective patient access to TYSARA with no patient denials to date. So in every aspect, the TYSARA launch is progressing exceptionally well, forming the basis for our projected $400,000,000 of peak sales from our combined T cellra and Letocell sarcoma franchise. The team at Adaptimmune has remained focused, diligent and absolutely committed to the successful launch.

Speaker 2

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 Leticel when approved, which we anticipate in 2026. We'll use the same ADC network and work alongside many of the same physicians. Letocell launch readiness activities are underway, and we are fully on target for rolling BLA initiation before the end of the year. As you know, lettucel 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.

Speaker 2

We 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?

Operator

Thank you. We will now begin the question and answer session. And our first question comes from Mark Fromm from TD Cowen. Please go ahead.

Speaker 3

Hi, thanks for taking my questions. Maybe just one, Mark, housekeeping on some of the numbers you just put out and thanks for all of that clarity. It's 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 it's theoretically possible for some of them to have already been treated and invoiced. Are all but none of those are the eight patients who have been invoiced in the quarter as well, right? Is that correct?

Speaker 2

I 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?

Speaker 1

Yes. So the apheresis patients that we've had year to date, which is the 21, that includes patients that have been invoiced already in mostly March and April. So, you know, 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. Okay.

Speaker 3

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 apheresis in Q2? Or is there, I guess, reason based on maybe ATC start ups and stuff like that to think about acceleration of the apheresis throughout the quarter?

Speaker 2

No, I appreciate the voracious appetite for further information, but we're very comfortable with the sales range of guidance that we've 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 thirty five million dollars to $45,000,000 for T Cellar sales.

Speaker 3

Fair enough.

Speaker 2

Thanks, Mark.

Operator

The next question comes from Michael Schmidt from Guggenheim. Please go ahead.

Speaker 4

Hey, this is Paul on

Speaker 5

for Michael. Thanks for taking our questions. 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 ATC goal faster than expected? And generally, would you expect that

Speaker 6

to translate to sort of

Speaker 5

incremental quarter over quarter growth? Or would you expect maybe some seasonality coming in, in the back half? Thanks.

Speaker 2

Why don't we why don't I ask Cynthia to comment on that ramp up. Overall, I think we expect incremental growth quarter on quarter, but I'll let Cynthia comment on the trends as we see them.

Speaker 1

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 ATTs 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 invoiced that we had the six in the first quarter and eight already just at the very first weeks of the second quarter. So we will continue to see that incremental growth over time.

Speaker 5

Great. So then if I can have a quick follow-up. So for the 24 patients who have been ifferees to date, anything you can tell us about the average time between when they were confirmed double positive and when they received ifpheresis? And is there any potential to sort of expedite this time as the commercial experience grows? Thanks.

Speaker 1

I can address that. Sure. It varies a lot and we have you know, still very few number of patients if we think about it. The main driver of the difference between when the patient is identified double positive and the patient is day free is actually the patient schedule. In many times they need to get closer to the treatment center.

Speaker 1

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.

Speaker 1

So that is not anything that has been influencing when the patient can be apheres at this point.

Speaker 6

Great. Appreciate the color.

Speaker 7

Thanks, Bob.

Operator

The next question comes from Jonathan Chang from SVB Leerink. Please go ahead.

Speaker 8

Hi, guys. Jonathan Chang from Leerink Partners. Thanks for taking my questions. 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?

Speaker 8

What has tracked better in line or worse than your initial expectations? Thank you.

Speaker 2

So I'm going to ask Dennis Williams to comment on the regulatory progress that we see with Leticel. 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.

Speaker 9

Yes. Thanks, Ed. We like many, right, are constantly watching 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 and I can say for this program, teletasol, they are very engaged.

Speaker 9

So far so good. And with that, I'll turn it over to Cynthia.

Speaker 1

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 TESERA in their sites and it speaks to the high unmet need and the innovation that we're bringing with TESERA.

Speaker 1

So that has been positively surprising and we 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 working well, which is something that was new that we had to launch and it has been working seamlessly.

Speaker 1

And I think the other upside has been the manufacturing success rates. We have had 100% 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.

Speaker 1

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.

Speaker 8

Got it. Thanks for taking my questions.

Speaker 2

Thanks, gentlemen.

Operator

The next question comes from Arthur He from H. C. Wainwright. Please go ahead.

Speaker 7

Hey, good morning, Ed and team. Congrats on the progress. So I just had two quick ones. So first, for the you mentioned in the last quarter that the patient emphasize is mostly from the early activated sensors. So could you give us more color on current status of that metrics?

Speaker 2

Yes. I think you're referring to the just for clarification, you're referring to the fact that most of the patients that we had at that point in time, Afer East, were from centers that were started at the beginning of that. Maybe I'll ask Cynthia to comment on what we want to say about the current spread.

Speaker 1

Yes. Thank you, Adrian. So yes, we had the most number of patients invoiced so far from the ones that were activated earlier. But we have about patients that have been identified right now in more than 40 patients in more than 40 centers. And, know, about eighty percent of the treatment centers have are in the process of at least testing at least one patient.

Speaker 1

So, we are seeing a very good spread across all the treatment centers in terms of patient identification to be tested, then having patients being A3s and eventually turning into invoices. But the spread has been fairly consistent across all the treatment centers.

Speaker 7

Thanks, Cynthia. And also for I just want to follow-up on the between the double positive patient to the patient who get the amphorisis. Is that still remain like almost nearly one hundred percent for this case?

Speaker 1

So we don't have line of sight to all the patients that have 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.

Speaker 7

Awesome. Thanks for taking my question.

Operator

Arthur. The next question comes from Greg Suvaneva from Mizuho. Please go ahead.

Speaker 3

Yes. Good morning. Thank you for taking my questions and congratulations on a really nice launch so Two questions if I could. And one is really with regards perhaps some recent news on the financing front. You chose to pay down $25,000,000 of the financing obligations you had.

Speaker 3

It was a bit earlier than we anticipated. 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 in the first quarter and the revenue. Just wondering how we should think about the sustainability of operations cash rent going forward? Thanks.

Speaker 6

Hi, Yes, it's Gavin speaking. Hi, Greg. With regards to the paydown of the debt principal, that was actually done in March and we announced that in our 10 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.

Speaker 6

We announced that probably eight, nine weeks ago now and continue to have a good relationship with our debt provider. In terms of the cash position, we had a going concern a substantial debt about a 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. Second is the cost reduction actions that we took.

Speaker 6

We announced a restructuring in November that was executed in February. We announced in March further cost reductions associated with our Frame 8,520 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 with TD Cowen strategic options. So all of those sort of planes making giving cash runway guidance inappropriate at the moment.

Speaker 3

Thanks. Can I follow-up with an additional question?

Speaker 7

Sure, sure, Greg.

Speaker 3

Thanks so much. 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 for the year, was ahead of our estimates. So congrats there.

Speaker 2

Yes. So I think one of the 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 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 35,000,000 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 twenty one patients, seeing an increasing ramp going into coming through Q1 and into Q2.

Speaker 2

We've also now got experience as to what the net sales price looks like at least for a relatively small number of patients. And you put all those and the confidence in the manufacturing, meaning that so far we've been able to deliver one hundred percent of the patients that we've apheresis, which is I think extraordinary, as Cynthia pointed out, for a cell therapy launch and a real testament to 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 35,000,000 to $45,000,000 range.

Speaker 3

Okay. Thank you very much and congratulations again.

Speaker 6

Thanks, Greg.

Speaker 10

And

Operator

our next question comes from Peter Lawson from Barclays. Please go ahead.

Speaker 10

Hey, good morning. It's Alex on for Peter. Thanks for taking our questions. Just a clarification on the question on drop off rate. I guess specifically what percentage of patients end up getting an infusion relative to patients that get apheresis, is that one hundred percent or

Speaker 2

is there a level of It been so far.

Speaker 10

Okay, 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's going to happen?

Speaker 2

Yes. That's a pertinent question given the environment in other companies. John, do you to talk about our maintenance plans for the year?

Speaker 4

Yes, absolutely. So this is John. I lead the manufacturing group. And we don't have plans and we managed to put a significant shutdown like 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.

Speaker 4

For this year, we don't have one of those plans.

Speaker 10

Okay, great. Thank you. And then just one final one, if I may. Any price increases planned in 2025?

Speaker 2

We've not made any announcements about price increases.

Speaker 10

Okay, great. Thanks for taking our questions.

Speaker 7

Thanks, Alex.

Operator

The next question comes from Yanan Zhu from Wells Fargo Securities. Please go ahead.

Speaker 11

Great. Thanks for taking our questions. Could you comment on COGS and how it is tracking to your expectation?

Speaker 6

Yes. Hi, there. It's early days actually. And with first quarter in, and I think I said beforehand, COGS for the first few quarters are going to be a little bit higher than we think they're going to normalize to because under GAAP, we're consuming pre purchased products.

Speaker 3

Got it.

Speaker 2

You mean COGS is going be higher or the margin?

Speaker 6

The margin is going be higher, sorry, clarify, yes. It's lower COGS, higher margins. The margin in Q1 was around about 78%. We think long run average is around about 70%.

Speaker 11

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.

Speaker 2

I'll ask Cynthia to comment on her insights. Cynthia?

Speaker 1

Yes. Thank you, Adrian. So, we from the pace that we're seeing the patients being onboarded, it is pretty in line to our expectations and to the literature and the information that we have used for our forecasting 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.

Speaker 11

Maybe lastly, just about the patient you're treating this quarter and in the near term, do you feel if this is there any element of warehouse patients or are these reflecting the incidence rate up to this point? Thank you.

Speaker 1

Yes. So that 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.

Speaker 1

I would say that probably by sometime next year that we would see a more, I would say, a steady number of new patients getting in every month. But we didn't see really that bolus of patients that we've 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.

Speaker 11

Great. Thanks. That's super helpful. Thank you.

Speaker 4

Concludes our question

Operator

and answer

Operator

will turn the conference back over to Adrian Rawcliffe for any closing remarks.

Speaker 2

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 T Cellra and the progress with the rest of the sarcoma franchise. We look forward to updating you further in due course. Take care. Bye.

Operator

This brings to a close today's conference call. You may disconnect your Thank you for participating and have a pleasant day.

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Key Takeaways

  • Teselra launch momentum: 21 apheresis procedures in 2025 (13 in Q1, 8 in early Q2) and 14 doses invoiced to date, resulting in Q1 net sales of $4 M and full-year revenue guidance of $35 M–$45 M.
  • Rapid network expansion: 28 authorized treatment centers (ATCs) are accepting referrals today, with the full 30-center network expected by end of 2025—one year ahead of plan.
  • Manufacturing excellence: Achieved 100 % success at the Philadelphia facility with an average 27-day turnaround from apheresis to release, beating the 30-day target and facing no capacity constraints.
  • Unrestricted patient access: No payer denials to date and a seamless NY-ESO testing process are supporting effective reimbursement and patient uptake.
  • Leticel launch readiness: Rolling BLA submission for Lete-cel is on track by year-end ahead of an anticipated 2026 approval, leveraging the same ADC network to potentially double the sarcoma franchise’s addressable patients.
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Earnings Conference Call
Adaptimmune Therapeutics Q1 2025
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