Q1 2025 Adaptimmune Therapeutics PLC Earnings Call
Speaker Change: Hello, and welcome to Adaptimmune's first quarter, 2025 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.
Speaker Change: You may signal the operator by pressing star than zero. I will now turn the call over to Julie Miller of investor relations for Adaptimmune. Julie, please go ahead.
Speaker Change: 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.
Speaker Change: 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 at... and I'll turn the call over to Adrian Rawcliffe at...
Thanks, Juli, and thank you everybody for joining us today.
Adrian Rawcliffe: We now have one full quarter of Giselle Rosales under our belt, and I'm delighted to be able to share with you the momentum that we're seeing with this launch. Thank you very much.
Adrian Rawcliffe: 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 centres that we have up and running.
Adrian Rawcliffe: As of today, we have a total of 28 centres accepting referrals for patients for Tisura, and it's very clear that we will have the full network of approximately 30 ATCs up and running by the end of 2025.
Adrian Rawcliffe: This is approximately a year earlier than we expected, when we launched.
Adrian Rawcliffe: During these first few quarters of digital relaunch, we will continue to share key performance indicators in addition to net sales, such as the number of a Pharisees that I previously mentioned and the number of digital treatments invoiced.
Adrian Rawcliffe: We have invoiced for 14 T-Sour treatments in 2025 to date, with 6 in Q1 resulting in net sales for Q1 of $4 million.
Adrian Rawcliffe: We have since invoiced eight additional treatments in the first few weeks of Q2.
Adrian Rawcliffe: We've also continued to deliver 100% manufacturing success from my US Tissera Manufacturing Centre in Naviard, Philadelphia.
Adrian Rawcliffe: with all Tissera doses released to date, meeting specification, with no capacity issues or constraints, and in the first quarter our average turnaround time from aphoresis to not release was 27 days beating our target of 30 days. [inaudible]
Adrian Rawcliffe: On the payer front, we've seen effective patient access to Zusara with no patient denial of the date.
Adrian Rawcliffe: So, in every aspect, the Tisella launch is progressing exceptionally well, forming the basis for our projected $400 million of peak sales from our combined Tisella and Lettucelle Sarcoma franchise.
Adrian Rawcliffe: The team at Adaptimmune has remained focused, diligent and absolutely committed to this successful law.
Adrian Rawcliffe: Also, I'll remind you that the investments in people and infrastructure that we've put in place for T. Selra will be the same for Letticell when approved, which we anticipate in 2026.
Adrian Rawcliffe: We'll use the same ATC network and work alongside many of the same positions.
Adrian Rawcliffe: Let us now launch readiness activities around our way and we are fully on target for a rolling VLA initiation for the end of the year.
Adrian Rawcliffe: As you know, let yourself have the potential to more than double the addressable patients in our sarcoma franchise, as we anticipate an indication of both synovial sarcoma and Mixoid-Rounsar-Lypa sarcoma patients whose tumour expressed NYESO.
Adrian Rawcliffe: It's worth noting that given the ubiquitous nature of NYU so expression in Mixoid Liversarcoma patients, we do not anticipate the need for NYU so antigen testing in this population further simplifying the patient journey and expanding the patient population.
Adrian Rawcliffe: We continue to review strategic options with Cowper 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?
Adrian Rawcliffe: Thank you. We will now begin the question and answer session.
Speaker Change: To join the question cue, you may press star than one on your telephone keypad. You will hear a tonic acknowledging your request. If you're using a speaker phone, please pick up your hand set before pressing any keys. To answer your question, please press star then two. To answer your question, please press star then two.
Mark: And our first question comes from Marc Frahm from TD Count. Please go ahead.
Mark Fromm: I think we're going to take my questions. You just want to mark, I'll skip some of the numbers you just put up and thanks for all of that clarity. It's just on the Aferist patients, on the Aferist patients in the quarter so far.
Mark Fromm: Difficult for them to have been treated, but it's theoretically possible for some of them to have already been treated and invoiced.
Mark Fromm: Those are all, but none of those are the patients who have been invoiced in the quarter as well, right? Is that correct? [inaudible]
Um...
Mark Fromm: I don't have that but I would doubt it. I think most of those are the patients from the prior court or although there could be one or so. Why don't I ask Cintia to address that? Cintia? I don't know.
Cynthia: Yes, so the A3 is a patient that we've had here today, which is the 21, that includes patients that have been invoiced already in mostly March and April . So, you know, about, you know, at least about... [inaudible]
Cynthia: 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.
Cynthia: Okay. And then, just thinking forward on that Aferesis number, you know, should we, you know, that's roughly half the quarter, so should we be thinking of kind of mid teens total number of patients Aferesis in case you two are there, yes, a reason based on maybe ATC startups and stuff like that, that to think about acceleration of the Aferesis throughout the quarter. The Aferesis number.
Cynthia: I appreciate the voracious appetite for further information, but we're very comfortable with the sales.
Cynthia: 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 Aferesis, 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 to 45 million dollars, but we serve ourselves.
Fair enough, thanks.
Thank you all.
Speaker Change: The next question comes from Michael Schmidt from Guggenheim. Please go ahead.
Speaker Change: Hey, this is Paul from Michael, thanks for taking our questions. So just on to Celra, given that we're about nine months out from the approval, is there anything you can...
Speaker Change: Also, it's painfully told 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 an incremental quarter of a quarter of growth, or would you expect maybe some seasonality coming in in the back half? Thanks.
Yeah.
Speaker Change: Why don't we, when I asked 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.
Cynthia: Yes, thank you, Adrian. We do expect this growth quarter over quarter, and we're not currently anticipating specific visualization.
Cynthia: But more so, the growth based on the increased awareness, the number HLVTCs that are being onboarded and the natural timing from when we have the patient's behavior freeze, and then invoice you can see from the numbers that we had. [inaudible]
Cynthia: in terms of patient's invoice to 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 incredible growth of the time.
Speaker Change: Great, so then if I can have a quick follow-up, so for the 24 patients who have been if-reased to date, anything you can tell us about the average time between when they were confirmed up a positive and when they received the if-resist, and is there any potential to sort of expedite this time as the commercial insurance grows. Thanks.
Speaker Change: Yeah, I can address that, sure. So it varies a lot, and we have, you know, too very few number of patients, if you think about it. [inaudible]
Speaker Change: The main driver of the difference between when the patient is identified double positive and the patient is day-free [inaudible]
Speaker Change: He's 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 UTCs.
Speaker Change: and so that can take some time based on the patient's schedule. So it can take...
Speaker Change: Things 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.
Speaker Change: The patient can be increased at this point.
Speaker Change: Great I appreciate the color.
Speaker Change: Thanks, Paul.
Jonathan Chang: The next question comes from Jonathan Chang from SVP Leerink. Please go ahead.
Jonathan Chang: Hi, guys, Jonathan Chang from Leerink partners, Hi, Thanks for taking my questions.
Jonathan Chang: First question how are you thinking about.
Jonathan Chang: Impact from regulatory changes on your business.
And second question.
Jonathan Chang: What would you say are the key learnings from the early launch to date, what is tracked better in line or worse than your initial expectations. Thank you.
Jonathan Chang: Yeah.
Jonathan Chang: So I'm going to ask Oh.
Jonathan Chang: Dennis Williams to comment on the pro Greg Dilatory progress that we see with left to sell.
Jonathan Chang: And then I.
Jonathan Chang: Going to ask Cynthia to talk about the progress that we've seen since launch and key learnings from that.
Dennis Williams: Over to you Dennis.
Dennis Williams: Yes, Thanks Ed.
Dennis Williams: We like many writer are constantly watching the you know the environment at the FDA and obviously theres a lot of change gallon, what I will say that was we've had three formal meetings with the FDA in the last six months.
Dennis Williams: And we haven't seen any indication that the FDA is not working.
Dennis Williams: Working as diligently as ever and I can say for this program for let us sell they're very engaged.
Cynthia: So so far so good and with that I'll turn it over to Cynthia.
Cynthia: Thank you Dennis and yes, we did learn a lot since we launched the product I think that the main.
Speaker Change: 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 a lot of it is due to the figure.
Speaker Change: And if it can excitement that we're seeing with the sarcoma specialists.
Speaker Change: How close and they've been working together with the cell therapy specialists in the treatment centers to make sure that we can onboard.
Speaker Change: In the sites and it speaks to the high unmet need and the innovation that we're bringing it to <unk>. So that has been.
Speaker Change: Positively.
Speaker Change: Surprising and and you know we we.
Speaker Change: We will be able to complete our full treatment center footprint by the end of the year.
Speaker Change: I think from a.
Speaker Change: <unk>.
Speaker Change: Patients getting on board is pretty much as we expected we treated our first patients.
Speaker Change: At the end of last year and now we're seeing the growth aligns to our regional expectations no denial has been positive.
Speaker Change: The flow from the biomarker testing is also working well, which is something that was new that he had to launch and it has been more seamlessly.
Speaker Change: And I think the other upside has been manufacturing success rate. So we have had 100%.
Speaker Change: <unk> success rate that is as far as I know one hurdle in cellular therapies.
Speaker Change: And we've been able to achieve a turnaround time.
Speaker Change: For further questions.
Speaker Change: Have been trading 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 adapting and with the medical community as well so so far so good.
Speaker Change: Got it thanks for taking my questions.
Speaker Change: Most of them.
Speaker Change: The next question comes from Arthur <unk> from H C. Wainwright. Please go ahead.
Arthur: Hey, good morning, Ed and team congrats on the progress so I would just add the two quick ones. So first.
Speaker Change: For the.
Speaker Change: You mentioned in the last quarter the core debt.
Speaker Change: The patient emphasize the most as Roland already activate a sensors. So could you give us some more color on the current status of that.
Speaker Change: Metrics.
Speaker Change: Yes.
Speaker Change: Youre referring to the.
Speaker Change: The just a clarification about the most of the patients that we had at that point in time.
Speaker Change: <unk> from <unk> <unk> from the centers that was started at the beginning of.
Speaker Change: With that maybe I'll ask I'll ask Cynthia to comment on what.
Speaker Change: What we want to say about the current spread.
Cynthia: Yes. Thank you Adrian so yes, we had the most number of patients being voiced so far from the ones that were activated earlier.
Cynthia: But we have about patients that have been identified right now.
Cynthia: More than 40 patients in more than 40 centers and.
Cynthia: No.
Cynthia: About 80% of the treatment centers have.
Cynthia: They are in the process or at least testing at least one patient. So we are seeing a very good spread across all of the treatment centers in terms of patient identification to be tested then having patients being acre eased and eventually turning into invoices.
Speaker Change: Brad has been fairly consistent across all the treatment centers.
Speaker Change: Thanks, Cynthia and also for <unk>.
Speaker Change: Wanted to follow up on the between the double positive patients two of the patients who get the answer.
Speaker Change: Is that still remain like almost nearly 100% of folio for these cases.
Speaker Change: So we don't have line of sight to all of the patients that have been identified this level positives. We do offer a sponsor casting so we have an approximate a volume of patients.
Speaker Change: <unk> that are going through that route.
Speaker Change: Lee.
Speaker Change: 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.
Speaker Change: Portal and we receive a purchase order from that moment on we have not had any cancellations.
Speaker Change: So far and we have not had any manufacturing failures as well.
Speaker Change: Awesome. Thanks for taking my question.
Speaker Change: Thanks Oliver.
Speaker Change: The next question comes from Craig Susan Eva from Mizuho. Please go ahead.
Speaker Change: Good morning. Thank.
Speaker Change: Thank you for taking my questions and congratulations on a really nice launch so far.
Speaker Change: Two questions if I could.
Speaker Change: And.
One is really.
Speaker Change: With regards to perhaps some recent news on the financing front.
Speaker Change: We chose to pay down two.
Speaker Change: $25 million.
Speaker Change: Sure.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: Wondering how we should think about this.
Speaker Change: The sustainability of operations and cash rent going forward. Thanks.
Kevin: Hi, Hey, Yes, you said, Kevin speaking Hi, Greg.
Speaker Change: With regards to.
Speaker Change: With regards to the pay down debt principal that was actually done in March and we announced that in our.
Speaker Change: 10-K announcement.
Speaker Change: And that was.
Speaker Change: The reasons for that was.
Maybe to continue.
Speaker Change: Continue to manage our balance sheet and leverage and valuation there.
Speaker Change: It wasn't impactful on our cash runway at that time.
Speaker Change: They manage the key stakeholders, we announced that's probably eight nine weeks ago now and continue to.
Speaker Change: Continue to have a good relationship with a debt provider in terms of the cash position, we had a going concern.
Speaker Change: The substantial desktop going concern in the 10-K and that does remain so clearly less than 12 months cash we're not going to give detailed.
Speaker Change: 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 cell that we've just been talking to and how that ramps.
Speaker Change: Secondly is the cost reduction actions that we took we announced a restructuring in November that was executed.
Speaker Change: In February we announced in March further cost reductions associated with our prime $85 20 programs and.
That has impacted on the key one spend so is there a cost associated with that restructuring, which makes the Q1 spend higher than our normalized run rate would look like and finally working through with the TD Cowen strategic options or are they still planning to making given cash runway guidance inappropriate at the moment.
Speaker Change: Thanks could I follow up with additional question.
Speaker Change: Sure sure Greg.
Speaker Change: Thanks, so much.
Speaker Change: Just with respect to the guidance the revenue guidance for the year.
Speaker Change: Very impressive that you were able to provide guidance I don't see many companies in our first year of a launch.
Speaker Change: 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.
Speaker Change: Give you the comfort to indeed be able to provide that guidance for the year, which are which was ahead of our <unk>.
Speaker Change: <unk> so congrats there.
Speaker Change: Yes.
Speaker Change: So I think I think one of the.
Speaker Change: There's a couple of things so one of the advantages that I think you have it in the cell therapy space is that as we referred to we we we can see the bundle of patients coming through.
Speaker Change: From a reasonable perspective, and so if you think about that guidance that guidance looks like it's $35 million to $45 million now thats roughly approximately.
Speaker Change: Between 50, and 70 patients treated for the year and so you think about that in the context of having a <unk> 21 patients seeing an increasing ramp.
Speaker Change: Going into.
Speaker Change: Coming through Q1 and into Q2.
Also now got experience as to what the what.
Speaker Change: The net sales price looks like at least for a relatively small number of patients and you put all of those and the competence and the manufacturing meaning that yes.
Speaker Change: So far we've been able to deliver 100% of the patients that we've we've <unk> switch, which is I think extraordinary Cynthia pointed out for a for a cell therapy launch.
Speaker Change: And a real testament to the to the manufacturing team here you put all of that together and I think you can say that as we go through the remainder of Q2, which we have good visibility to into Q3 and Q4 with the increasing atc's that we have.
Speaker Change: We feel we feel quite comfortable about that $35 million to $45 million range.
Speaker Change: Okay. Thank you very much and congratulations again.
Speaker Change: Thanks, Greg.
Speaker Change: Again, if you have a question. Please press Star then one.
Speaker Change: And our next question comes from Peter Lawson from Barclays. Please go ahead.
Speaker Change: Hey, good morning, it's Alex on for Peter Thanks for taking our questions.
Speaker Change: 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 <unk> does that 100% there.
Speaker Change: It has been so it has been so far.
Speaker Change: Okay, Great and then my other question was just around any manufacturing maintenance work.
Speaker Change: Be required at some point this year and if yes when that could happen.
Speaker Change: Yes.
Speaker Change: It's a pertinent question given given the environment to another.
Speaker Change: Companies.
Speaker Change: John do you want to do you want to talk about.
Speaker Change: Maintenance plans for the year.
Speaker Change: Yeah, absolutely. So this is Jonathan manufacturing group.
Speaker Change: We don't have plans and we managed to defer a significant shutdown like you've maybe seen other places we do a lot of our maintenance on kind of enrolling.
Speaker Change: That and we can we manage did not impact the capacity when we do that so so for this year, we don't have one of those plans.
Speaker Change: Okay, great. Thank you and then just one final one if I may any price increases planned.
Speaker Change: 75.
Speaker Change: We've not made any announcements about price increases.
Speaker Change: Okay, great. Thanks for taking our questions.
Speaker Change: Thanks, Alex.
Speaker Change: The next question comes from <unk> Xu from Wells Fargo Securities. Please go ahead.
Great. Thanks for taking our question.
Speaker Change: Could you comment on Cogs and how it is tracking.
Speaker Change: To your.
Speaker Change: [noise] expectation.
Speaker Change: Yes.
Speaker Change: It's early days actually and we.
Speaker Change: With first quarter in and I think Ive said beforehand Cogs for the first few quarters are going to be a little bit.
Speaker Change: A little bit higher than we think they're going to normalize to because under GAAP, we're consuming pre purchase products.
Speaker Change: Okay.
Speaker Change: You mean, you mean Cogs is going to be high or the margin is going to be higher.
Speaker Change: Yes, love higher margins and margin in Q1 was around about 78%. We think long run average is around about 70%.
Speaker Change: Yes.
Speaker Change: Got it thanks and could you now that you're in a market.
Speaker Change: Could you talk about the annual.
Speaker Change: Incidents right.
Speaker Change: For the eligible patient population any.
Speaker Change: Change compared with when you were.
Speaker Change: Planning the launch thank you.
Speaker Change: I'll ask I'll ask Cynthia to comment on her insights Cynthia.
Cynthia: Yes, Thank you Adrian so.
Cynthia: From the pace that we're seeing there.
Cynthia: Patients being on boarded it is pretty in line to our expectations.
Cynthia: To the literature and the information that we have used for our forecasting.
A thousand patients a year that are being diagnosed with synovial sarcoma and then.
Cynthia: Pretty much all of them are going to be going through.
Cynthia: Around.
Cynthia: Chemotherapy potentially surgery, and we can treat all the patients that has been previously exposed that you're kicking off therapy. So.
Cynthia: It has been quite in line to what we have planned.
Cynthia: Yes.
Cynthia: Maybe lastly, just.
Cynthia: Our balance sheet, the patient you're treating this quarter and in the near term do you feel at this.
Cynthia: Uh huh.
Cynthia: Is there any element of warehouse patients or are these reflecting the.
Cynthia: The incidence rate.
Cynthia: Uh huh.
Up to this point thank you.
Cynthia: Yes, so that is for the <unk>.
Cynthia: <unk> faster launch a good number of patients that I would call more of a prevalent patient population that we're gonna be trading for a while we can see that the pace of these patients being treated.
Cynthia: It depends a little bit on when they are tested.
Kumar: Mr Kumar.
Kumar: Relatively speaking in comparison I'm sure there.
Speaker Change: Hematological malignancies, like four mile or even a L. L. It is a slower progressing.
Kumar: A condition and so.
Kumar: There is a number of patients that we are seeing now that are part of that prevalent pool and eventually then I think we're going to reach.
Kumar: It's kind of to keep more of the incident population I would say that probably by sometime next year that we would see a more I would say.
Kumar: Say steady number of new patients getting.
Kumar: Every.
Kumar: But we didn't see really that bolus of patients that.
Kumar: <unk> seen in other in other therapies, but it is natural that you would expect to treat more of a prevalent patient.
Kumar: In the first months after the launch and then it gets to the incident population.
Kumar: Not a dramatic.
Kumar: Bubble.
Kumar: Great. Thanks.
Kumar: Super helpful. Thank you.
Kumar: This concludes our remarks.
Kumar: Sorry.
Kumar: Concludes our question.
Adrian Rawcliffe: A question and answer session I will turn the conference back over to Adrian Raw Cliff for any closing remarks.
Kumar: Okay.
Speaker Change: Thank you everybody for joining us thank you for your questions.
Speaker Change: Great to be able to update you on the fantastic momentum that we're seeing with the launch of T cell and the progress with the rest of the sarcoma franchise.
Speaker Change: To update you further in due course.
Speaker Change: Yeah.
Speaker Change: This brings to a close today's conference call.
Speaker Change: You may disconnect your lines.
Speaker Change: Thank you for participating and have a pleasant day.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: [music].