Iovance Biotherapeutics, Inc.

Welcome to the Iovance Biotherapeutics second quarter 2026 conference call. My name is Daniel, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. Please note that this conference call is being recorded. I will now turn the call over to Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications at Iovance. Sara, you may begin.

Thank you, operator. Good morning, and welcome to the Iovance webcast to discuss our second quarter of 2026 financial results, business achievements, and corporate updates. This morning, we issued a press release that is available on our corporate website at iovance.com. This conference call will include forward-looking statements regarding Iovance's goals, business focus, business plans and transactions, revenue and revenue guidance, commercial activities, Clinical Trials and Results, Regulatory Approvals, Submissions, Feedback and Guidance, Plans and Strategies, Research and Preclinical Activities, Potential Future Applications of Our Technologies, Manufacturing Capabilities, Payer Interactions, Licenses and Collaborations, Cash Position and Future Updates. Forward-looking statements are subject to numerous risks and uncertainties. Many of which are beyond our control, including the risks and uncertainties described from time to time in our FTC filing. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements. I will turn the call over now to Dr. Fred Vogt, Interim CEO and President.

Thank you, Sara. IVANCE is the global leader in innovating, developing, and delivering tilt therapy for solid tumors. Today and for the next generation. The second quarter of 2026 was our strongest yet. We delivered record revenue and margin, advanced our pipeline, and secured important new regulatory approvals and designations. I'll start by highlighting a few notable achievements. First, our commercial launch reached new heights in the second quarter, while our foundation for growth expanded. More authorized treatment centers, or ATCs, are activating, enrolling, and infusing patients than ever before. We reported $99.3 million in revenue, driven by record Ampagni demand. We also greatly exceeded both our Ampagni and total revenue guidance ranges for the second quarter. Second quarter margin also reached an all-time high of 56%. We expect margin to keep expanding as we increase revenue, fine-tune execution, and gain efficiency and scale. Looking ahead, we maintain our peak assumptions for Ampagni and Perlucan of more than $1 billion in U.S. sales from advanced melanoma alone. The opportunity and other indications is significantly larger. Our third quarter performance of data is very strong. Once we fully assess increasing growth trends, we expect to provide an update to our four-year guidance during the third quarter. We are now providing commercially untagged to more than 50 patients a month on top of increasing numbers of clinical patients, which demonstrates both our manufacturing scale and how broadly accessible our cell therapies have become. We are not choosing between growth and discipline. This quarter, we delivered both. Research and development expenses improved for the fourth consecutive quarter, even as every lead program advanced and our pipeline grew. We are closing in on our pursuit of the largest opportunities for cancer patients who have the greatest on that need. Our technology platform is scaling quickly. Recent regulatory and clinical milestones bring teletherapy forward for more patients in the U.S., as well as new markets and additional solid tumor indications. Nearly 2,000 patients have received Iovance pill therapies in commercial and clinical settings across hundreds of centers in the U.S. and in 30 countries. Over the coming years, our vision is to reach tens of thousands of patients. In our registrational trials, enrollment is nearly complete in our Lung 202 trial in the pivotal cohorts in non-squamous, non-small cell lung cancer. This indication represents a blockbuster opportunity that is roughly seven times that of advanced melanoma. We look forward to providing program updates in the fourth quarter as we work toward a supplemental biologics license application in 2027. We're moving quickly with our registrational Saratoga trial for SAR201 and two advanced soft tissue sarcomas. As we announced today, the US FDA granted fast track designation in undifferentiated pleomorphic sarcoma and de-differentiated liposarcoma, validating the promise of the initial clinical data for lifelucel as well as the substantial unmet medical need in both indications. In a pilot study with one-time life elusal therapy, the objective response rate was an unprecedented 50% in the first six valuable patients compared with abysmal response rates of less than 5% using current standard of care in these refractory treatment settings. Our translational data and state-of-the-art technologies are uncovering the next frontier in TIL therapy. We are now able to identify highly responsive patient populations across solid tumor indications Thank you for joining us. Tilt therapy includes continuous investment in next-generation programs. A new trial, known as G1-Tilt-1, is using IOB5001, our next-generation IL-12 tethered tilt therapy. This Phase 1-2 BASCA trial will run across prevalent solid tumors representing more than 100,000 U.S. deaths annually, including metastatic colorectal, triple negative breast, and estrogen-receptor low breast cancers. We expect to provide more updates this year. Today, profitability is the site, and with it, lasting value for patients and shareholders alike. iAdvance is the first and only company in the world to take pill therapy from concept to commercial treatment for patients, supported by our scalable manufacturing infrastructure, clinical breadth, commercial experience, and operational discipline. With healthy commercial momentum, broadening pipeline, and solid execution, iAdvance has never been better positioned for long-term success. I'll now ask Corleen Roche, our Chief Financial Officer, to detail our financial results.

Thanks, Fred, and good morning, everyone. Our highest ever quarterly revenue and margin clearly demonstrate our commitment to top-line growth, operational excellence, and financial discipline as we build a sustainable, self-funded business. Second quarter total revenue was more than $99 million. That is up 66% year over year and 39% sequentially from the first quarter. which have included one-time non-recurring impact from our internal manufacturing upgrades. MPagD was the key growth driver, reaching a new high of approximately $91 million in the quarter. We exceeded our second quarter MPagD guidance range of $79 to $81 million, and second quarter MPagD revenue increased roughly 51% over the first quarter of 2026 and 68% year-over-year. reflecting a robust increase in patient demand and adoption. Prolucan contributed about $9 million in the second quarter, slightly down from $11 million in the prior quarter due to timing of wholesaler inventory stocking. For the full year of 2026, we anticipate that Prolucan as a percentage of total revenue will be in line with 2025. Consistent with the prior quarters, Overall gross to net impact remains minimal at less than 2%. Margin increased to approximately 56%, up from 41% in the first quarter, and above our previous all-time high of 50% in the fourth quarter of 2025. With the year-to-date 2026 margin of 50%, the second quarter benefited from higher MTAG re-volume, continued cost optimization, and Maturing Internal Efficiencies during our first full quarter of manufacturing exclusively in-house. We are also deploying and advancing artificial intelligence tools to drive significant future cost efficiencies and new product pipeline insights. As we expand our business as well as our development pipeline, we are very closely managing offering expenses. Research and development expenses were about $59 million, down from $62 million in the prior quarter, reflecting ongoing efficiency gains as we progress all of our programs. This marks the fourth consecutive quarter of cost savings through R&D optimization. Selling general and administrative expenses held essentially flat at about $39 million, even as revenue grew roughly 39%. With clear operating leverage from our commercial infrastructure, we expect to gain further efficiency with targeted investment across the business. I will now cover our outlook for the rest of the year. Based on strong second quarter sales, we are reviewing our previously issued full year 2026 total revenue guidance of $350 to $370 million and plan to share more detail in the third quarter. We are well capitalized to fund both the launch and barrel pipelines. As of June 30, 2026, we had approximately $304 million in cash, cash equivalents, and short-term investments. This cash position is now expected to fund operations into the second half of 2028. When I joined IVAN, the priorities were clear. Grow revenue. Thank you Corleen. As mentioned, anti-degenerative record revenue

More patients treated than in any prior order. This commercial momentum is carrying into the third quarter. Adoption isn't just growing, it's broadening into new ATCs and earlier lines of treatment. Today, I will highlight three commercial priorities powering that trajectory for MTAC to grow, which are rising physician awareness, continued expansion of our ATC network, and a deepening body of clinical evidence. The first priority is to continue to increase awareness of antagonists. Among both treating and referring physicians, unaided awareness has increased nearly threefold over the past year, driven by two factors. One, a new marketing campaign unveiled at ASCO, and two, improvement in sales force effectiveness, measured by meaningful growth in both number of treaters and referrers. The second priority is increasing our footprint across both academic and community settings. With more than 95 total ATCs today, we are on track to reach at least 110 by year's end. Community ATCs now represent a third of our network and are expected to increase significantly over the next several quarters. Each new ATC is widening our commercial reach to the patients who need it. The third priority is the continued expansion of our already deep, industry-leading clinical evidence. The published five-year durability data and real-world response rates of greater than 50% in patients with two or fewer lines of therapy are convincing physicians to adopt MTAGV earlier. In addition, at ASCO, we released a new survival analysis from our clinical trial. This analysis estimated that the MTAGV 10-year overall survival for responders would be 46.7% or almost half. Independently, a growing number of our ATCs are publishing their own real-world experience. Across these studies, response rates and patient outcomes consistently meet or exceed what we observed in our clinical trials, which support the emerging practice pattern of treating patients with MTAGV as soon as possible after checkpoint inhibitor therapy. These aggregated, real-world evidence data are being deployed across our sales This information can be found on the publications page of our website at iovance.com for those interested. Underpinning all three priorities is ensuring coverage and access. Antagni has strong payer coverage. More than 75% of Antagni patients are covered by private payers. Payers and plans that cover more than 250 million lives have added Antagni to their policies. Our U.S. ATCs are strategically located in proximity to most addressable patients. More than 95% of patients live within 200 miles, and 80% of patients live within 100 miles of an ATC. With our rapidly expanding ATC network and increased community presence, we expect even broader access to MTAGI throughout 2026. Importantly, we are also proving we can deliver on our promise to patients. with a turnaround time of 31 days or less using the only scaled centralized commercial manufacturing process approved by the FDA for till therapy. Demand for Prolucan, our second product, remains strong. All three wholesalers have sold through their previous stocking inventory in the second quarter and are currently ordering in line with MTAGV demand. For the rest of the year, we expect quarter-on-quarter Prolucan growth tied to MTAGV growth on a steady basis of approximately 16% of total revenue. Outside of the U.S., with two approvals of Empagni in Canada and Australia, we are continuing to expand in the new markets for previously treated melanoma patients, a globally addressable population of more than 30,000 patients. Our first ATC in Canada is ready to support international private pay patients while we work toward public reimbursement. In Australia, I recently visited several of our onboarding ATCs as we collaborate to raise awareness and expand access to MTAGV. Australia has the highest rate of melanoma in the world. We are opening our first ATCs for private pay patients while we work with the government on pricing. Looking ahead, regulatory approvals are pending in the United Kingdom and Switzerland. Elsewhere, we continue to work closely with health authorities and the European Union towards resubmission. Together, these foundational international markets augment our growing U.S. franchise for MTAG. In summary, demand for MTAG-B is strong and continues to grow. Rising physician awareness is accelerating referrals. A growing network of ATCs is broadening access that is converting into more patients treated. And the deepening clinical evidence is expanding the adjustable patient population. iAdvance is committed to serving patients. with a one-time cell therapy that delivers meaningful, validated, systemic clinical benefits. I will now hand the call back to the operator to begin question and answer session.

To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. Our first question comes from Andrew Tsai with Jeffries. Your line is open.

Hey, good morning. Thanks. Congrats on a great quarter. So can you talk about this large upswing in Q2 that even came out well ahead of your guidance? Was it purely due to underlying demand or was there kind of any one-offs in the timing of shipments maybe being more favorable in Q2? Just wanted to check the box on that. And then secondly, on the long update later in Q4, Just wanted to clarify on the cadence of events we can expect here. Is it fair to assume you would first need to complete enrollment in this pivotal cohort first and then generate follow-up data on every enrolled patient before you top-line the data? Or can the top-line data be on the majority of patients, not necessarily all patients with follow-up? Thank you.

So I'll take the first part on demand. It's a great question. What we saw on demand was, as I said on the call script, essentially we saw that awareness is increasing among our physician base, both treaters and referrers. We are expanding our ATC network, and then the clinical data is evidence of MTAGV's efficacy. One thing that did happen in the first quarter that helped us in the second quarter have the manuscript published on our real-world evidence data that showed over 50% of the patients with two or fewer lines of therapy were responding. That data helped propel our sales force and our commercial efforts to raise awareness further and encourage more patients to be treated. We expect this to continue, and we are seeing this in the third quarter.

I'll just add to Dan, just to be very clear, Andrew, there's not a timing issue or anything. This is organic demand for the product. It's looking very good right now. based on all the factors that Dan described and more that we really do expect that demand is going to continue to increase significantly for Ampag throughout the coming quarters. On your question about the Lung 202 update, yes, I think it's fair to assume we're going to complete enrollment very soon and we would want to finish that process before we put any kind of material update out. Obviously, for FDA purposes, we want to do that But I don't think it's fair to assume that we would wait for every single patient to become evaluable. We really want to make sure the integrity of the trial is clean and we have all the patients in before we put some data out. Some of the patients may still be coming for their first evaluation, that kind of thing. Will we put that out or maybe not? It depends on the timing and how the data looks. So just stay tuned. The lung is looking very positive right now. We feel very good about where we stand with the study, and we will have a lot, I think, to say about that. I know that's a very key thing for investors, and I really urge everybody to watch carefully as we talk about that, and maybe even more than what people are expecting in this space.

Thanks so much. Congratulations. Thank you. Our next question comes from Yanen Zhu with Wells Fargo. Your line is open.

Great, great. I'll add my congrats on a very strong quarter. Maybe from Fred's comment, it sounds like for the next two quarters, you expect the sales or the demand to further build upon the current demand level or the second quarter demand level. Just want to see if that's the correct interpretation. and in terms of you know given your visibility into the third quarter and perhaps also into the fourth quarter can you talk about your expectation and also the guidance sounds like it's going to come during the third quarter is that the case rather than at the next quarter's earnings call and perhaps also a question on TILVAN 301. Can you give an update on where you are? And it sounds like you have a presentation at ESMO. Yeah, can you talk about what can we expect the data there? Thanks.

Sure, yeah. Let me cover the first two and then Dan can comment and I'll come back to TILVAN at the end. Yes, I think you heard correctly. Demand trends are very positive right now for the Empagni product, and we expect increasing demand Q3 and Q4. We're obviously seeing quite a bit of Q3 right now. We want to just evaluate the whole situation because we really focus on long-term guidance here, and we want to make sure we can give good guidance for the full year before we announce it. But you are correct. We are intending to make a separate announcement of guidance. So, you know, one morning, You'll wake up to some hopefully very positive news, I think, from my advance on the guidance as we get that visibility. Can't tell you exactly when, but obviously sometime in the third quarter. But yes, that's very strong and tagging strong, and as we pointed out, for looking to be very strong. Dan, do you want to comment and add some detail to that? Sure.

For Q3 right now, as you mentioned, Jan, and we have a pretty good sight into Q3 and what's going on right now, the demand continues to grow. And so we're very confident that Q3 will build upon the success in Q2 and then Q4, of course, following from that. You know, we've expanded our sales force. We continue to evaluate, putting promotional activities in place, such as new campaigns, et cetera, to continue that growth driving not only through 2026, but 2027, you know.

and then I'll come back and answer your question about Tilvansia-1. That study continues to run well. We're very happy with the performance of the study. At ESMO, we're going to, again, in an oral session there, highlight some of the compelling clinical characteristics of Ampagni plus Pembrolizumab in the frontline setting, including the fact that almost a third of patients go into a complete response. We have a very rapid velocity of response, meaning we can drive patients into a response much faster than other alternative therapies, we think, and we'll show much more insight, I think, from the The predecessor Phase II study, obviously TILVANCE is a randomized trial that we can't look at right now. It's blinded. We'll read that at the interim point hopefully relatively soon, although these trials take a long time to run, as you know. But we're going to show the compelling clinical characteristics, and I think it's going to be a very important output for people in the field, especially since some of the excitement around LANG3 has faded, especially post-ASCO with Regeneron's results. and, you know, off the lag is still in some cases being questioned is whether it's the right combination in the frontline setting and there really is an extremely large need for something, some alternative to ipinevo in the frontline setting for these patients. We think Leifelusil's characteristics are perfect for this with the one-time therapy combined with what may end up being fairly limited PEMBRA dosing and the fact that we can drive a large percentage of patients into what's effectively a cure.

Great.

Thanks for the update. Thank you. Our next question comes from Etzer Darut with Barclays. Your line is open.

Great. Thanks for taking the question and congrats on the strong second quarter. One question on margins and then one on long. You had a meaningful step up, obviously, in gross margin in the second quarter. Maybe if you could talk about the remaining opportunities to improve margins further relative to current levels and where you think Thank you. Hi, answer is Corleen.

So I'll answer your margin question. The driver is a number of things, and as you know, we've been focusing on this internally, and we've been talking about it. Obviously, higher volume, which you can see, but we have all of our manufacturing in-house, and those efficiencies are also helping margin, as well as these projects that we have where we're continuing to focus on margin improvement and operational efficiencies within the plant. I would think about that in terms of process, automation, things like that.

And one other point, I'll just add to what Corleen said. As Dan and others pointed out here already, with Perlucan now normalizing and then Perlucan sales expected to increase this year and then stabilize at the right percentage going forwards, Perlucan is a very high margin product, so you can expect a little bit of tailwind there as well. On Lung 202, I just want to ask two questions there. One was... Do we, is our internal goal to replicate the durability? It's to actually exceed the durability, because when we reported the durability earlier, we had a shorter follow-up, and I think what we're seeing right now, although we're not going to pre-release the results here, obviously, right now, we're seeing very strong durability, I think very similar in overall outcome to what we saw in melanoma. It's effectively the same type of product. When we get a response, it's usually pretty durable. whether it ends up being two years, three years, whatever it's going to be, we'll find that out when we do the ultimate stats analysis at the end, but it looks pretty good. I think any of those options are going to be successful in the marketplace in terms of a product that will attract a lot of prescribers and patients to a one-time therapy like that. And then you mentioned with enrollment nearly complete, you asked about the baseline characteristics of the patients. I think we are seeing similar baselines where we don't have a lot of heterogeneity in our population. We're very comfortable with how we enroll these studies. We've spent a lot of time on our protocols to make sure we get things right. And yes, I think we're seeing similar patients come through right now than we were throughout the study. Obviously, we changed our limit of depletion to make it a little less burdensome on patients, and we're seeing really good results with that right now in terms of the safety profile and the overall risk-benefit profile of the product.

Great. Thanks for the color, and congrats again.

Thank you. Our next question comes from Renny Benjamin with Citizens. Your line is open.

Hey, good morning, guys. Thanks for taking the questions and congratulations on an amazing quarter. Just two questions from us. One regarding the outlook and the fact that you're reviewing guidance. Can you talk a little bit about what factors go into providing this reviewed outlook and kind of what prevents you from providing that guidance now? and related to that, does Replimune's recent positive FDA Advisory Committee feedback and maybe even the Obsidian going public, does that kind of impact guidance? And if not, what are your thoughts regarding at least Replimune's agent coming into the marketplace? And just as a final question, the endometrial study, Fred, you had mentioned, You know, it's histology-based patient selection and that there are protocol amendments going on right now. Can you talk a little bit or provide some color regarding the protocol amendments and, you know, how that study will ultimately reach conclusion? Thanks.

Let me take the last one first, Rennie, because it's fast. It's a protocol amendment to focus on the serous subtype. and it really links up with the disclosure we had last quarter about the response rate that we're seeing and that precise approach to how we deliver teletherapy to certain histological subpopulations in our studies. We have a lot more to say about that across all the indications soon. On the guidance, what we're doing with the guidance internally is we're going to make sure we understand Q3, but really we want to understand full year. We're not looking to give guidance that is just sort of short-term. We're really focused on long-term guidance to show the strength of the product overall. We really, obviously, we cater to long investors, long holders of the stock, and we want to make sure they have the information they need to understand the overall trajectory. So what we're going to do is make sure we have our demand understood fully. Obviously, it's very good, and then we will come back out at some point, which I can't tell you exactly when it's going to be during the third quarter, and we will announce something that I think everybody will find very positive and persuasive. On the competitor front, obviously there's a lot of noise out there. I just want to stress that we stay out of this. This is not our situation. Other people have their drama that's going on with the FDA. Obviously, that product could get approved or not get approved. We don't really know. But if it does get approved, we view it as primarily competitive with TVEC, which is the product that's on the market today that's also an oncolytic virus, very similar to that product. as well as products like Opti-Lag that are being recycled in the community right now. It has a lot of barriers like TVEC did, and honestly, when a company goes to launch a product, they have to perform, and we expect the MTAGB is a much more compelling option, I think, for patients with its long-time profile and really fantastic efficacy and tons of real-world experience now, and so we think that'll be good. And with the other company, Obsidian, it's a tilt competitor. I think people should look very hard Thank you for joining us today. Thanks for taking the questions. Thank you. Our next question comes from David Dye with UBS. Your line is open.

Great. Thanks for taking my questions and also add my congratulations on a great quarter. I have two questions. So on topic demand, can you just talk more about the demand across different ATCs? Do you see more demand concentrating in large ATCs or do you see increasing demand in smaller and newly activated ATCs? And then I'll have a follow-up.

Thanks for the question. And what we are seeing right now is the ATCs that we originally opened in 2024 are starting to grow based on patient type and based on the information that we have that's been published recently. The ATCs that we onboarded last year in 2025, those are continuing to accelerate. Some of them are hitting their stride, so to speak. and getting mature and treating their patients. And then in the first half of this year, we've been opening ATCs at a pretty substantial pace. And those are starting to contribute now. So we do see there's a few months between an ATC activation to them starting to treat patients and then comfort level goes up. So we are seeing growth across the different segments. In regard to larger ATCs and whether they're contributing to more, I think our larger ATCs are still growing. We still haven't had an ATC that we can So we are seeing across our subset of ATCs, all of them.

Great. Thanks for the color. And then on community ATCs, which now represent roughly one-third of the network, how does patient volume, referral behavior, and reimbursement experience differ between community and academic centers?

Great question. So for patient volume, they have the patients there, and it's really not The number of patients, it's what time we're getting these patients. So as we said in the real world data that got published earlier this year, is that patients that are on two or fewer lines of therapy have an over 50% response rate. Those patients reside primarily in the community setting before referred to the academic. So we see referral barriers go down. The volume of patients are there and they're there earlier. We do see the community ETCs are having learning curves So again, it takes a little while for them to ramp up. They're doing so now. Most of the community ATCs we started to onboard in the second half of last year. I joined in the first half, and that was one of the things that we said would be in focus. We've come through on that focus, and now a third of our ATCs. And we do see that they can have a higher ceiling than the academics because, again, it's organic referral patterns within network, which are much easier to maximize than referring to the academics.

Thank you so much.

Thank you. Our next question comes from Colleen Cousy with Baird. Your line is open.

Hey, everyone. It's Nick on for Colleen. Thanks for taking the question. Congrats on the quarter. Just wondering if you could provide any color on how the conversion rate from referrals that treated patients has changed over the last few quarters. And then also just on just growth bottlenecks like patient identification referrals, et cetera, what do you expect to be the biggest constraint on growth going forward? And just wondering if you could talk about how you plan on addressing that. Thank you. Sure.

So as we look at this, the conversion to referrals, what we do see is earlier patients and earlier patients coming in. We're using that data in both non-personal media as well as in face-to-face with our field forces to get that word out. So again, we are seeing the referrals come in earlier, which means we have time to treat the patients. So that is the change in the referral pattern with an earlier patient. and that gets into patient ID as well. We have gone after, I've mentioned in previous calls, the BRAF mutated patients, because that is a very important patient type, 40% of our market That is helping us ID these patients earlier to get tissues so we can manufacture for infusion at the right time. And then as far as constraints with it, the constraints that we're working on is really more penetration into the larger community networks. And we see that as an opportunity. We've made a lot of strides over the last six to eight months. with other entities, Florida Cancers, etc., where we're getting the referral pattern up or we're looking to establish ATCs within their own networks. We've got some up right now in those areas. We're looking to get more up. Fred, did you have anything to add? No. Yeah, I think that's pretty accurate.

Thank you. This concludes the question and answer session. I would now like to turn it back to Fred Vogt for closing remarks.

Thank you for joining us. This was a record quarter for revenue infusions and margin. Our pipeline is advancing rapidly with new registrational trials, next-generation clinical programs, and new approvals outside the United States. We are energized by the growing number of patient stories that show the power of our pill therapies. We remain deeply grateful to the patients, partners, healthcare professionals, and advocacy communities we serve. Finally, I want to thank our exceptional high-advance team, our dedicated shareholders, are covering analysts for their continued support. We remain committed to our mission to innovate, develop, and deliver current and next-generation cell therapies for patients with cancer. Thank you.

This concludes today's conference call. Thank you for participating. You may now disconnect.