Adaptimmune Therapeutics plc (ADAPY) Earnings Call Transcript & Summary

Hello, and welcome to Adaptimmune's First Quarter 2025 Business Update Conference Call. [Operator Instructions] and the conference is being recorded. [Operator Instructions] I will now turn the call over to Juli Miller of Investor Relations for Adaptimmune. Juli, please go ahead.

Thank you. Good morning, and welcome to Adaptimmune's conference call to discuss our first quarter 2025 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 Rawcliffe, 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 Rawcliffe. Ad?

Thanks, Juli, and thank you everybody for joining us today. We now have 1 full quarter of TECELRA 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 apheresed so far in 2025, 13 in Q1 and another 8 in the first part of Q2, we now feel confident sharing revenue guidance for the full year of between $35 million and $45 million in TECELRA 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 TECELRA, and it's very clear that we will have the full network of approximately 30 ATCs up and running by the end of 2025. This is approximately a year earlier than we expected when we launched. During these first few quarters of TECELRA 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 TECELRA treatments invoiced. We've invoiced for 14 TECELRA treatments in 2025 to date, with 6 in Q1, resulting in net sales for Q1 of $4 million. We have since invoiced 8 additional treatments in the first few weeks of Q2. We've also continued to deliver 100% manufacturing success from our U.S. TECELRA manufacturing center in Navy Yard, Philadelphia, with all TECELRA 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 27 days, beating our target of 30 days. On the payer front, we've seen effective patient access to TECELRA with no patient denials to date. So in every aspect, the TECELRA launch is progressing exceptionally well, forming the basis for our projected $400 million of peak sales from our combined TECELRA and lete-cel sarcoma franchise. The team at Adaptimmune has remained focused, diligent and absolutely committed to this successful launch. Also, I'll remind you that, the investments in people and infrastructure that we've put in place for TECELRA will be the same for lete-cel when approved, which we anticipate in 2026. We'll use the same ATC network and work alongside many of the same physicians. Lete-cel launch readiness activities are underway, and we are fully on target for a rolling BLA initiation before the end of the year. As you know, lete-cel 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. We continue to review strategic options with Cowen, as our adviser 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 Instructions] And our first question comes from Marc Frahm from TD Cowen.

Maybe just a one quick, March, 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 is it theoretically possible for some of them to have already been treated and invoiced? Those are all -- but those -- none of those are the 8 patients who have been invoiced in the quarter as well, right? Is that correct?

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 Cintia to address that? Cintia?

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, about at least about 6 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. 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, a reason based on maybe ATC start-ups and stuff like that to think about acceleration of the apheresis throughout the quarter?

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. But we now feel very confident about the guidance that we have for the year of $35 million to $45 million for TECELRA sales.

The next question comes from Michael Schmidt from Guggenheim.

This is Paul on for Michael. So just on TECELRA, given that, we're about 9 months out from the approval, is there anything you can qualitatively 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 to translate to sort of incremental quarter-over-quarter growth, or would you expect maybe some seasonality coming in, in the back half?

Why don't I ask Cintia to comment on that ramp-up. Overall, I think we expect incremental growth quarter-on-quarter, but I'll let Cintia comment on 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 ATCs that are being onboarded and the natural timing from when we have the patients being apheresed and then invoiced. You can see from the numbers that we had in terms of patients invoiced that we had the 6 in the first quarter and 8 already just at the very first weeks of the second quarter. So we will continue to see that incremental growth over time.

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

Yes, I can address that. Sure. So it varies a lot, and we have 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 apheresed is actually the patient schedule. In many times, they need to get closer to the treatment center. About 40% 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 apheresed at this point.

The next question comes from Jonathan Chang from SVB Leerink.

Jonathan Chang from Leerink Partners. 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?

So, I'm going to ask Dennis Williams to comment on the pro-regulatory progress that we see with lete-cel. And then I'm going to ask Cintia to talk about the progress that we've seen since launch and our key learnings from that. Over to you, Dennis.

Yes. Thanks, Ad. 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 3 formal meetings with the FDA in the last 6 months. We haven't seen any indication that the FDA is not working as diligently as ever. I can say, for this program, for lete-cel, they are very engaged. So, so far so good. And with that, I'll turn it over to Cintia.

Thank you, Dennis. 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 what 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 TECELRA in their sites, and it speaks to the high unmet need and the innovation that we're bringing with TECELRA. 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 onboard 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. And I think, the other upside has been the manufacturing success rate. We have had 100% success rate, that is as far as I know and heard of in cellular therapies. And we've been able to achieve a turnaround time for the patients that we have been treating. So far so good, we're very excited. I think the team has been working really hard to make sure that that can now take place across all the different functions at Adaptimmune, and with the medical community as well. So, so far so good.

The next question comes from Arthur He from H.C. Wainwright.

Congrats on the progress. So I just had 2 quick ones. So first, for the -- you mentioned in the last quarter call that the patient emphasize is mostly from the early activated centers. So could you give us more color on current status of that metrics?

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, apheresed were from the centers that were started at the beginning of that. Maybe I'll ask Cintia to comment on what we want to say about the current spread.

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 is more than 40 patients -- in more than 40 centers, and about 80% of the treatment centers 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, then having patients being apheresed and eventually turning into invoices. But the spread has been fairly consistent across all the treatment centers.

And also, I just want to follow up on the -- between the double positive patient to the patient who get the apheresis. Does that still remain like almost nearly 100% for this case?

So, we don't have line of sight to all the patients that have been identified as double positives. We do offer sponsored 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.

The next question comes from Graig Suvannavejh from Mizuho.

Congratulations on a really nice launch so far. 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 million of the financing obligation that you had. It was a bit earlier than we anticipated. And so I was wondering if you could walk us through the thought process there. And then just given my second question then 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 and cash going forward?

Yes, it's Gavin speaking, Graig. With regards to the paydown of the debt principal, that was actually done in March and we announced that in our 10-K 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. We announced that probably 8, 9 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 doubt about our growing concern in the 10-K, and that does remain. So clearly, less than 12 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 TECELRA just been talking to and how that ramps. Second is the cost reduction actions that we took. We announced a restructuring in November that was executed in February. We announced in March further cost reductions associated with our PRAME ADP-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 the TD Cowen strategic options. So all of those are playing into making giving cash runway guidance inappropriate at the moment.

Can I follow up with an additional question?

Sure, sure.

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, which was ahead of our estimates? So, congrats there.

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. So, if you think about that guidance, that guidance looks like it's $35 million to $45 million. Now that's roughly approximately between 50 and 70 patients treated for the year. And so you think about that in the context of having apheresed 21 patients, seeing an increasing ramp going into -- coming through Q1 and into Q2. 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 the 100% of the patients that we've apheresed, which is, I think, extraordinary, as Cintia 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 $35 million to $45 million range.

[Operator Instructions] And our next question comes from Peter Lawson from Barclays.

It's Alex on for Peter. 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 apheresed? Is that 100%? Or is there --?

It has been so far.

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 could happen?

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

Yes, absolutely. So this is John, I lead the Manufacturing Group. And we don't have plans, and we managed to 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 managed to not impact the capacity when we do that. So for this year, we don't have one of those plans.

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

We've not made any announcements about price increases.

The next question comes from Yanan Zhu from Wells Fargo Securities.

Could you comment on COGS and how it is tracking to your expectation?

It's early days actually, and we're the 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.

You mean COGS is going to be higher or the margin?

The margin is going to be high. Sorry, to clarify, yes, lower COGS, higher margins. The margin in Q1 was around about 78%. We think long-run average is around about 70%.

Got it. And could you -- now that you're in the market, could you talk about the annual incidence rate for the eligible patient population? Any change compared with when you were planning the launch?

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

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 1,000 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.

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

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 -- 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, a 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.

This concludes our -- this concludes our question-and-answer session. I will turn the conference back over to Adrian Rawcliffe for any closing remarks.

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

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