Iovance at Barclays Conference: Strategic Growth and Expansion

On Thursday, 13 March 2025, Iovance Biotherapeutics (NASDAQ: IOVA) participated in the Barclays 27th Annual Global Healthcare Conference. The company presented a strategic overview that highlighted both achievements and challenges. Key topics included the launch of their cell therapy product IMTAGVI, supply chain resilience, and future growth prospects. The company expressed confidence in its current strategies while acknowledging areas needing further development.

Key Takeaways

• Iovance is focusing on the commercialization of IMTAGVI, with 70 authorized treatment centers (ATCs) actively participating.
• A 9% price increase for IMTAGVI and Proleukin is set for April 1.
• The company plans to expand its cell therapy center capacity to over 5,000 patients annually.
• Anticipated approvals in Canada, the U.K., and the EU for EMTAGVI by the end of the year.
• Iovance is optimistic about completing lung cancer trial enrollment and submitting for FDA accelerated approval.

Financial Results

• Minimal impact from tariffs due to U.S.-based manufacturing.
• Proleukin is projected to contribute 10-15% of long-term revenues.
• Current network capacity supports over 1,200 patients annually, with expansion plans underway.
• Cash burn guidance for 2025 is projected to remain under $300 million, despite expansion costs.

Operational Updates

• The company has strengthened its supply chain resilience, particularly during COVID.
• Focus remains on maximizing the potential of existing ATCs, with plans to elevate their expertise.
• Annual maintenance at the Iovance cell therapy center (ICTC) was completed in Q4, with limited impact expected on Q1 operations.
• Proleukin sales have increased, supported by major U.S. wholesalers.

Future Outlook

• Iovance anticipates regulatory approvals for EMTAGVI in Canada, the U.K., and the EU, potentially boosting market presence.
• The company aims to complete lung cancer trial enrollment by year-end and pursue FDA accelerated approval.
• Expansion of ICTC aims to increase patient capacity significantly, aligning with strategic growth goals.

Q&A Highlights

• The launch phase has been strong, with ATCs demonstrating proficiency in cell therapy treatments.
• Several new centers are expected to reach expert treatment levels soon.
• The company acknowledges that cell therapy launches may not follow a linear growth pattern.

Iovance Biotherapeutics remains committed to its strategic initiatives, with a focus on expanding its treatment capabilities and market reach. For further details, readers are encouraged to refer to the full transcript.

Full transcript - Barclays 27th Annual Global Healthcare Conference:

Peter Wilson, Biotech Analyst, Barclays: My name is Peter Wilson. I’m one of the biotech analysts at Barclays. I had a great pleasure for covering IVANS for at least five, six years, I think, maybe longer.

And up on stage with me, I’ve got, Igor Balinski, Chief Operating Officer Brian Gasman, EVP of Medical Affairs and Dan Kirkby, Chief Commercial Officer. And first question I’ve been asking and really just been around kind of the impact of the broader economy and change in government and cost cutting. If there’s been if there’s any longer term worries you’re thinking about through supply chain and if that impacts the business in any way whether it’s the near term or longer term as we think about tariffs etcetera?

Igor Balinski, Chief Operating Officer, Iovance: Yes. Thanks, Peter. Good question. So we don’t anticipate any meaningful impact. We’ve made our supply chain quite robust during COVID.

And as you know we manufacture MTAGVI in The U. S. In Philadelphia and most of the raw materials come from The U. S. So the impact on tariffs if any we would expect to be very minimal.

Peter Wilson, Biotech Analyst, Barclays: Got it. Thank you. And then as we think about the FDA potential cuts and disruptions, have you seen any kind of slowdown in communication patterns whether it’s with existing products or products in front of the FDA etcetera, whether it’s a dialogue and or if you’re even seeing inbound resumes that suggest there’s a disruption?

Igor Balinski, Chief Operating Officer, Iovance: Well, I don’t want to comment on the resumes. But as far as the interactions with the FDA, we have not seen any impact, not at this point. We have a very active pipeline. We have a number of ongoing positive discussions with the agency and the FDA is there in full force and being very active and very supportive. So no change so far that we can report.

Peter Wilson, Biotech Analyst, Barclays: Okay. Is there any longer I guess I assume there’s a longer term impact of NIH cuts, but any other near midterm effects that could trickle through to whether it’s clinical trial sites or other things we’re not really thinking about?

Igor Balinski, Chief Operating Officer, Iovance: Well, Emtekivy is a very unique product. I mean, it’s for patients who really have no other treatment options. So it positions it in a way that’s for example, we expect approvals in Canada and U. K. And EU this year.

And I would say regardless of any macroeconomic trends, we expect EMTAGVI to be well received in those markets because these patients have no other option. So again, I don’t think we anticipate any significant impact from geopolitical trends.

Peter Wilson, Biotech Analyst, Barclays: Okay. Perfect. And then just as we have you’ve mentioned the product and the launch, just how should we think about the factors influencing guidance? What brings you to the top and bottom end of those ranges? And what are the moving parts?

Dan Kirkby, Chief Commercial Officer, Iovance: Sure. So, the factors for the guidance really are our existing ATCs. We have 70 ATCs that are stood up right now. And of those over three quarters have done a tumor tissue procurement, over two thirds have done an actual infusion to a patient and over half of them have infused multiple patients, thirteen percent are at that expert level of 10 plus Our guidance really is about maximizing for this year their progress through that spectrum to keep treating more and more patients and to maximize the potential inside of those accounts. We also simultaneously this year with the upper end, we have other initiatives that are getting into the referral patterns with the community and looking at where they’re sending patients, sending those to the expert accounts and standing up new ATCs where we know patients are flowing in.

So that’s the perspective on the guidance with it. We can do it with our existing ATCs, but we’re also being opportunistic to see if we can get more volume of patients by increasing the referral patterns into them.

Peter Wilson, Biotech Analyst, Barclays: Got you. How should we think about what’s the right number of ATCs? Where does it kind of tap out where you’d get kind of diminishing returns?

Dan Kirkby, Chief Commercial Officer, Iovance: It’s a great question. If you look at the cell therapy launches mainly the CAR Ts, about 75 centers make up the majority of the volume for them patient wise. There are roughly 175 to 200 centers inside of The U. S. That could treat, but the tail is very long.

So as you look at it, we have a core of 70, which are the bigger cell therapy centers that are already ATCs are authorized to give IMTAGV. And so maximizing those give us our best chance. As we look at adding additional ATCs, as I mentioned before, it’s quality over quantity. We want to make sure the patient flow is coming into them. So if we were to go and spend effort to put twenty, thirty more ATCs on, if they’re not the right ATCs, that’s a lot of focus for our field and resources that may not yield the return that we want.

So we believe we have the core right now and we’ll add strategically.

Peter Wilson, Biotech Analyst, Barclays: Got you. What’s the overlap we should think around ATCs for Teal versus

Dan Kirkby, Chief Commercial Officer, Iovance: CAR T cell? I think at the initial phase of launch, it’s quite strong because those are the centers that have almost like an IQ for treating cell therapies. And that’s not only the cell therapy lab and the cell therapy physicians that are advanced, but they’re the infrastructure with the finance and the POs. They’re used to working with that. So in the initial phase of launch, what we saw was that those were the centers that were easily accessible for launch.

As we branch out the differences between liquid tumor and solid tumor, we feel are going to make a difference in some of the centers and that’s just based on geography, referral patterns, etcetera. But I think we’ll start to deviate the liquid and solid tumor as we get into future years of launch, but initially it was very similar.

Peter Wilson, Biotech Analyst, Barclays: And so over time you think there’s going to be areas where they’re not doing CAR T and that’s what you’re breaking to or?

Dan Kirkby, Chief Commercial Officer, Iovance: We’ll eventually get into that and we’re starting to see some conversations where there are some entities that want to stand up in ATC for Till because they see the fact of the matter that we’re in melanoma right now as we get future indications that’s where their patients are. Whereas with liquid tumor patients, they have a tendency to send those quicker to the academic institution based on the stem cell transplant experience.

Peter Wilson, Biotech Analyst, Barclays: Got it. Thank you. And then as we think about the number of infusions, I mean, there was kind of seemed to be around thirteen percent incremental number of infusions from 3Q to 4Q. How should we think about that rate of growth changing over time? Is it kind of plateau in any way?

Is it slowing down in the rate of growth?

Dan Kirkby, Chief Commercial Officer, Iovance: What you see with cell therapy launches, it’s not linear quarter to quarter. So as you look at ATCs coming on board, you’ll see ebbs and flows as far as the quarters go. So looking at smoothing out a four quarter rolling average over time is the better way of looking at it than looking at it from quarter to quarter.

Peter Wilson, Biotech Analyst, Barclays: Okay. Got you. Thank you. So the idea of kind of, I mean, things positioned where 1Q could show acceleration of growth or is it more backend loaded? How should we be thinking about?

Dan Kirkby, Chief Commercial Officer, Iovance: It’s a great question with it. We don’t want to talk about first quarter right now until we have the earnings call. But what I would say is, if you look at our initiatives with the accounts that are ramping up, we’re having more enter into that expert level of 10 plus infusions. And then the other ones are ramping along and progressing with it. We’re expecting significant growth in the second half of this year with it, but we do feel that it’ll be more of a yearly look than a quarterly look.

Peter Wilson, Biotech Analyst, Barclays: Got you. Thank you. And then what are the positives and negatives that kind of came out from the launch? What surprised you negatively or positively? Well,

Dan Kirkby, Chief Commercial Officer, Iovance: based on the fact I’m newer with the company, I think the most impressive thing watching this being in cell therapy for over nine years is how many ATCs were stood up at day one. There were 30 ATCs at the launch of Entagnet, which was extremely impressive. I don’t think any other cell therapy company had that many stood up in the initial phases with it. And then the progression as looking at the launch and where the patients went into and the fact that the company was able to supply where the demand was very impressive with it. As far as the challenges, I’ll hand over to Peter, sorry to Brian to talk about that since he was there.

Brian Gasman, EVP of Medical Affairs, Iovance: Well, I would like to start first with and thank you, Peter, for having us. With some of the positive surprises, one of the biggest for me personally as someone who just treat patients recently was the fact that we’re seeing this refocus of young medical oncologists wanting to become cell therapists in solid tumor. And we’re the only company that provides that route for them. I’m hearing about hirings and job postings all over the country right now merely be or I shouldn’t say merely, but because of what we are accomplishing. So, that to me is not only a big surprise, but it’s wonderful to watch us be part of shaping the medical field.

In terms of some of the challenges, I think some of it is just getting and I’m guilty of it too as a physician, getting physicians to listen. And sometimes it takes another physician to explain to the physician what we’re saying. Once it resonates, we see incredible positive changes. I mean, some of the trends we saw from that were challenges are now of successes. And I think that gives me a lot of enthusiasm because that represents our future.

And if what we’re if those positive changes persist and continue as we’re seeing right now, I mean, we should be able to hit all the marks that you and your and the people listening to you would be would want to see from us.

Peter Wilson, Biotech Analyst, Barclays: Gotcha. What percentage of the ATCs are driving like 80% of the volume? Is it kind of is it like 10 major centers or 20 major centers we should be thinking about? Really, as we look at

Dan Kirkby, Chief Commercial Officer, Iovance: it, the centers that hit that 10 plus as we’ve talked about are the expert level for us. So we had 13% at the end of last year with it. We’ve added to that Q1. We have several others that are ramping to that. So when you think about where the volume is, as you get to that expert level, you figured out tumor tissue procurement, you figured out the POs and the financial aspect of it.

And then you have a comfort level on the patients with MTAG V. So as we look at it, those centers are leading the way, but other ones are catching up to them very quickly.

Peter Wilson, Biotech Analyst, Barclays: Got you. Is over the short period of time that’s been launched, do you see insights getting better at delivering the product or delivering tissue to you and getting better response rates?

Dan Kirkby, Chief Commercial Officer, Iovance: The short answer is yes. Brian works with the surgery side of it. I think that’s one of the keys. So, I’ll hand over to him.

Brian Gasman, EVP of Medical Affairs, Iovance: Yes. We actually track ATC by ATC performance. We actually we now have on-site business reviews where a cross functional team meets with their cross functional team and gives them sort of a scorecard, so they can understand where they’re at and where we think they could be. But there are centers that have just, I would call it, knocking out of the park already. We’re very excited and a lot of those are some of our best volume centers as well.

And I think ultimately when you start hearing from them about the responses they’re seeing and how that’s driving their enthusiasm, that tells me that there’s been a big impact. But there were some infrastructure things. For example, one hospital, they wanted only pathology to do the prosection after the tumor resection. And once they realized the surgeon was the best person to do it, that was an automatic change, for example. And there’s been other just sort of coordination things that once we got the surgeon to talk to the cell therapy coordinator, we fixed internal issues within those centers they didn’t even know they had.

But because they’re engaging and having bilateral communication and what I would call true partnership with Iovance, we are able to make distinct changes and I think they’ve I think ubiquitously appreciated that.

Peter Wilson, Biotech Analyst, Barclays: Got you. So you kind of use those higher volume centers to kind of essentially teach the lower volume centers. So over time their experience gets day one experiences better and better.

Dan Kirkby, Chief Commercial Officer, Iovance: Yes. And then one of the things to think about when you look at the other cell therapy launches, they’re relying on apheresis to get the raw material. So our process is different because we’re doing tumor tissue procurement. So that was an educational curve that as they get better and Brian’s team has done a great job, they teach each other, where the experts start bringing the other ones along and of course we have staff there with them on the medical affairs side helping them do that.

Peter Wilson, Biotech Analyst, Barclays: Okay. So it’s like the quality of the tumor sample improves over time from sites?

Brian Gasman, EVP of Medical Affairs, Iovance: Well, it’s the choosing the tumor. It’s being willing to go after tumors that weren’t necessarily the lowest tree the lowest fruit on the tree. It’s the preparation because the better they prepare it for our technicians the better we can do for them. And I think that and what we actually do is bring back pictures of the tumors they sent us. And that bilateral exchange, you can see that in their eyes like, wow, I really realized I could have done a little differently there, a little differently there.

And it really tightens things up and we’ve seen a great improvement. And just to add one more thing in our new centers, not just our existing centers that makes the lower volume centers better, but the new ones before they even get started, we’re applying those year long knowledge that we have. Remember, we’ve done way more probably than our clinical trials in just a short period of time. We’ll be able to get some things at a much higher level on day one than we ever have before. And that continues to get better and better.

Peter Wilson, Biotech Analyst, Barclays: Do you think the real world response rates are going to be higher than the clinical trial or lower? Or how do you think that shakes out with that experience curve?

Brian Gasman, EVP of Medical Affairs, Iovance: Well, you and I have discussed this before. If you look at the data, we presented our 1A data, which is the naive population with a nearly sixty seven percent response rate, thirty percent of patients had complete responses. And in the JASON similar trial, if you got a CR, you had a ten year survivability of almost one hundred percent. You go in the second line, again, it’s a similar not our product, but very similar, it was a fifty percent response rate. And in our three up to 10 lines of therapy, we had 31.

So I really think it depends on where they choose the patients along that spectrum. But I think the physicians are starting to get it. And as they get these patients the same exact patients just earlier in their journey, and now it’s easier to give the drug, but also they’re going to see those kind of increased responses. And that’s the exciting part, because a lot of patients come in having been terrific IMTAGMI patients, doctor just waited too long post progression and once they get it and they see what we can bring to those patients, you’re going to see that shift to the left so to speak. And that’s where you’re going to see those response rates go up and up.

And that’s why I do believe in the real world as time goes on, we should outpace what we saw in our trials.

Peter Wilson, Biotech Analyst, Barclays: Thank you. And then how should we think about in 4Q you had this manufacturing maintenance work that was conducted. So that kind of slowed you down somewhat. At least that was our impression. Did it slow you down and that something going to happen regularly on every Q4 you go through maintenance?

Igor Balinski, Chief Operating Officer, Iovance: So, yes, our Iovance cell therapy center, ICTC completed its annual scheduled maintenance in Q4. It went well. No surprises. We restarted production promptly at full volume. And it was well managed from the standpoint of ATCs.

I mean, all the slots are in the system and they just saw that there were fewer slots for a period of time. So it will have some limited impact on the Q1. But again, this is something that you see cell therapy companies do routinely and we manage it well from the standpoint of the ATCs, make sure they’re prepared, the patients still get care because as you know we have a contract manufacturing side as well. And so some of the volume was shifted to the CMO during that time.

Peter Wilson, Biotech Analyst, Barclays: Okay. And sorry, your comment, it won’t have an impact in Q1?

Igor Balinski, Chief Operating Officer, Iovance: It didn’t have much of an impact in Q4. We expect it to have some limited impact in Q1, yes.

Peter Wilson, Biotech Analyst, Barclays: And that’s because you shift over to the external

Igor Balinski, Chief Operating Officer, Iovance: But because the total capacity of our internal manufacturing site ICTC is higher than the contract manufacturer. So when we have maintenance of the internal site it will have some impact on the total network capacity.

Peter Wilson, Biotech Analyst, Barclays: Is there any way of quantifying how much of it impact? We don’t want to go

Igor Balinski, Chief Operating Officer, Iovance: there quite yet. So we’ll report that with the Q1 earnings.

Peter Wilson, Biotech Analyst, Barclays: Okay. And I mean do you make up that delta with running longer shifts or how are you kind of thinking about managing that kind of dip especially if it’s maybe on an annual basis?

Igor Balinski, Chief Operating Officer, Iovance: So in the future, as you know, we’re expanding the ICTC. We’re building out the shelf space in the existing building that will take our internal site capacity to over 5,000 patients per year. The design, when that’s completed, we can operate half of the facility and do maintenance in the other half. So that’s the design. As soon as that capacity is up in operation for commercial production, we should not have this maintenance issue anymore that impacts scheduling.

Peter Wilson, Biotech Analyst, Barclays: Got it. And then, wonder if you could remind us the current capacity and where you think that can go over the next couple of years?

Igor Balinski, Chief Operating Officer, Iovance: So the with the total network capacity to the staff capacity that actually we operate at is more than 1,200 patients per year, more than 100 per month across commercial and clinical. That’s the staff capacity. The build capacity is more than 2,000 patients per year at ICTC today and we’re expanding building that out to more than 5,000 patients. And most of that construction will be completed actually this year and that’s included all of that’s included in our cash burn guidance for the year under $300,000,000 total for 2025.

Peter Wilson, Biotech Analyst, Barclays: Got you. Thank you. And then ProLukin kind of how should we read the revenue number coming from Proleukin as kind of a forward projector? And I know there was an additional distributor that came online in 4Q and would we see other additional distributors we should think about and how should we think about the flow? So if

Dan Kirkby, Chief Commercial Officer, Iovance: you look at Prolukin, and Proluk is a it was a great acquisition from the company with it and it really was to augment and to not only control, but grow Prolukin regarding the MTAG utilization with it. With the three wholesalers that we have, if you look in The U. S, really it’s Sankora, which is AmerisourceBergen for a long time with the name change Sankora, Cardinal and McKesson. All three of those were not holding ProLikin in the past with it. So in Q4, we fixed that and we had them all three stock and there’s some advantages at the center level that they can pick because again it’s a biologic not a cell therapy.

So, we were easier to work with by going with all three of the distributors. I don’t see us really adding on in The U. S. More distributors as we come on because those are the three that deal with all the centers and their preference is one of the three usually.

Peter Wilson, Biotech Analyst, Barclays: Got you. Thank you. And what’s the revenue number you’re kind of thinking or percentage of revenues do you think

Dan Kirkby, Chief Commercial Officer, Iovance: will come from ProLukin over the long run and how quickly does it kind of get to that? I think we’ve stated 10 to 15% on the long run with it. So looking at that, that is the consistent contribution from Prolukin. There are three channels that we sell Prolukin. One is the channel that goes and that’s the commercial channel that goes along with emTagb.

So as emTagb grows, Prolukin grows. We also have it in clinical trials and we also have it in manufacturing of cell therapies with it. All three have revenue changed for us, but it usually has been 15% is what we project Prolukin’s contribution.

Peter Wilson, Biotech Analyst, Barclays: Got you. Thank you. And then price increases for the tool and IL2 products?

Dan Kirkby, Chief Commercial Officer, Iovance: We’ve announced previously that we have a 9% price increase both for MTAGD and Prolukin effective April 1.

Peter Wilson, Biotech Analyst, Barclays: Okay. Is there anything

Dan Kirkby, Chief Commercial Officer, Iovance: the distributors kind of pre order ahead of those increases typically? I think they have their own algorithms when they order with it. A lot of it has to do with existing stock on hand, how they forecast demand. And then if there is an opportunity for them to make a buy in before price increase, they have done that with other products. I can’t comment on anything that they would do with ProLukin, but it all depends on the other two factors.

They don’t just buy to buy. So they want to make sure that they have the stock on hand that they need. If they have an order that they’re going to place in the near future and they see a price for any product that’s a biologic that they stock, they will factor that into their buying decisions.

Peter Wilson, Biotech Analyst, Barclays: Got you.

Dan Kirkby, Chief Commercial Officer, Iovance: Thank you.

Peter Wilson, Biotech Analyst, Barclays: And then how should we think about the expansion internationally of the time course around when we get the approvals and when you actually get to market? Well,

Dan Kirkby, Chief Commercial Officer, Iovance: we’re right now pending in The UK, Canada and EU as Egor mentioned. And we have not baked that into our forecast. So we do see from the history and looking at the Yescarta launch for instance, where they started early, but didn’t really generate revenue for the first few quarters and then it ramped up. They’ve been the most successful outside of The U. S.

So, we want to follow that pattern. So, we went for earlier approvals in those regions. After you receive approval, then you have to negotiate price. So, health technology assessments that you submit to the government and then you have your price negotiations with single payer countries or single payer entities with it. That process has already started in those regions.

So we will see patients coming online. You’ll have named patient programs, some private pay while we’re getting those decisions outside of The U. S. With it, but we did not put that in our forecast for this year. Anything that we would see from that would be upside.

Peter Wilson, Biotech Analyst, Barclays: Got you. Thank you. And then just quickly moving on to the lung data in the second half of this year, kind of what we should expect to see?

Brian Gasman, EVP of Medical Affairs, Iovance: Yes. So we expect to complete enrollment by the end of the year. As you know, one of our strengths is duration of response. So, we won’t be able to report on all aspects of the trial by the end of the year. But we do intend to have enough data to have it large enough to be stable that it should persist to the end of the actual registrational package that we submit to the FDA.

We fully intend that this will be a positive package that we can apply for full approval well, excuse me, accelerated approval similar as an SBLA that we did for LN-one 44 and ultimately MTAGVI.

Peter Wilson, Biotech Analyst, Barclays: What’s the buffer success in lung?

Brian Gasman, EVP of Medical Affairs, Iovance: Well, it actually is quite low to be frank. But if you look at the comparator that usually people use like docetaxel as a very short durability and the response rates that we need to be are somewhere in the 20s. The early data that we presented over a year ago to the street was already there. And our median duration of response, although it was early, had not been reached, which is similar to what we saw in melanoma. More than seventy percent of patients already had a duration response over six months.

And some weren’t in that category because they were so early on the trial. So, again, we know this is a living therapy and we are very enthusiastic because we also know these responses tend to deepen. And one other comment I should make based on what we heard before is some centers are so enthusiastic about it in their minds, it is actually used as a therapy because it’s the trial is not just a research tool, but they believe in it enough already to have it as an option because there’s really no options for the second line patients.

Peter Wilson, Biotech Analyst, Barclays: Perfect. With that, we’ve got like twenty seconds on the clock. So thank you so much. Always a pleasure speaking to you. Thanks for having me.

Thank you for having us.

Brian Gasman, EVP of Medical Affairs, Iovance: As always, thank you.

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