Iovance Biotherapeutics, Inc. (IOVA) Q1 2026 Earnings Report, Transcript and Summary

Good day, and thank you for standing by. Welcome to the Iovance Biotherapeutics first quarter 2026 financial results conference call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sara Pellegrino, SVP of Investor Relations and Corporate Communications. Please go ahead.

Thank you, operator. Good morning, welcome to the Iovance webcast to discuss our first quarter 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 collaboration, cash position and expense guidance, 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 SEC filings. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statement. I will now turn the call over to Dr. Fred Vogt, our Interim Chief Executive Officer and President.

Thank you, Sara. Iovance is the global leader in innovating, developing, and delivering current and future generations of TIL cell therapy in solid tumors. We are executing to maximize patient and shareholder value across four pillars: curative platform potential, commercial execution, technology extension, and fully owned manufacturing. During the first quarter of 2026, we drove Amtagvi adoption, advanced our development pipeline, and streamlined costs and efficiencies. First quarter revenue grew approximately 45% year-over-year. Owning manufacturing is critical for our success. We navigated a temporary capacity reduction to complete maintenance upgrades at our internal manufacturing facility, the iCTC. Since resuming full production, Amtagvi is now exclusively manufactured in-house, and our modular facility can provide uninterrupted supply while supporting global demand and scale. Research and development expenses declined for the third consecutive quarter, helping to extend our cash runway into 2028. Looking ahead, Amtagvi enrollment and referral trends are at an all-time high in support of our second quarter and full year 2026 guidance issued today. Second quarter total revenue guidance is $86 million to $88 million. Amtagvi revenue is expected to grow to $79 million to $81 million in the second quarter. This is an increase of approximately 23% over our highest quarterly revenue to date in the fourth quarter of last year. For the full year 2026, total revenue guidance for Amtagvi and Proleukin is $350 million to $370 million, predominantly fueled by Amtagvi. Over time, we project we project a $1 billion peak -- $1 billion plus peak sales trajectory for Amtagvi and Proleukin in the U.S. For the rest of 2026 and beyond, we expect gross margins to benefit from our financial discipline, in-house scale, and operational efficiencies. Shifting to our TIL platform, we're expanding the curative potential across solid tumors. This morning, we announced compelling and clinically differentiated early Phase II data in metastatic serous endometrial cancer. The confirmed Objective Response Rate was 40% with a 100% disease control rate in the first five patients. Metastatic serous endometrial cancer is difficult to treat with an estimated 5,000 annual U.S. deaths. The second-line treatment setting represents a significant unmet medical need with response rates below 15%. We plan to engage with the U.S. FDA to pursue an expedited approval pathway. I will now highlight additional registrational trials for lifileucel in new indications. To expand the Amtagvi's market potential into advanced frontline melanoma, we continue to execute our global TILVANCE-301 trial. In previously treated non-squamous, non-small cell lung cancer, lifileucel received FDA Fast Track Designation following best-in-class unprecedented response rate and strong durability. This U.S. blockbuster market is about 7x larger than our peak opportunity in advanced melanoma. We plan to complete enrollment and provide a clinical update this year, targeting accelerated approval and U.S. launch in the second half of 2027. In advanced and difficult to treat soft tissue sarcomas, IOV-SAR-201, our new registrational trial, is underway in refractory patients with advanced undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma. The trial is beginning enrollment in the third quarter of 2026. We are building upon positive early clinical results with a 50% confirmed response rate in comparison to the abysmal response rates of less than 5% with current standard of care. We are actively engaging with FDA soon on path to expedited approval. As the global leader in TIL cell therapy, we are making significant progress to our next generation programs. IOV-5001 is our IL-12-tethered TIL therapy for highly prevalent solid tumors. A prior generation IL-12 TIL therapy at the National Cancer Institute improved clinical efficacy without IL-2 and informs how we optimize IOV-5001 to enhance efficacy and safety. We recently submitted the investigational new drug or IND application for a Phase I/II clinical trial, which includes indications that represent more than 15% of U.S. cancer deaths annually. Among these indications are advanced colorectal cancer as well as triple-negative and estrogen receptor-low breast cancers, adding large populations of massive commercial opportunities to our strategy. The trial is expected to begin in the second half of 2026. Our next generation IL-2 product, IOV-3001, may optimize the TIL treatment regimen. A Phase I safety cohort using IOV-3001 is advancing through multiple dose levels in a Phase I/II trial. We continue to enroll in our clinical trial with our PD-1-inactivated TIL therapy, IOV-4001, which reduces inhibitory signals to enhance the ability of TIL therapies to fight and kill cancer. We are initially exploring melanoma and non-small cell lung cancer. We look forward to reporting data and updates soon. As we expand our clinical strategy in solid tumor cancers, we now have the opportunity and capability to identify enriched patient populations that are highly responsive to TIL therapy. We are identifying these enriched populations such as the serous endometrial cancer population we highlighted today and our selected populations within soft tissue sarcomas and even within non-small cell lung cancer and other indications, which you will hear more about later this year. Iovance is well-positioned as the only company to have taken TIL therapy from concept to commercial scale with the manufacturing infrastructure, clinical breadth, commercial experience and operational discipline to back it up. We have momentum, a broadening pipeline and an improving line of sight to profitability. The foundation is built, and as we continue to expand across indications, our ambition is clear. To extend our leadership not just in TIL therapy, but as the backbone of immuno-oncology and solid tumor cancers. As I conclude this pipeline update, I would like to extend my sincere gratitude to Friedrich Finckenstein, our Chief Medical Officer, as he prepares to retire in June. During nearly 7-years at Iovance, he was instrumental in leading us towards the FDA approval of the first-ever TIL therapy and our leadership position today. Friedrich is available during today's question-and-answer session, and I wish him the best in his retirement. I will now turn the call over to Corleen Roche, our Chief Financial Officer, who will provide further updates on our first quarter financials and full year expectations. Corleen?

Thanks, Fred, and good morning, everyone. Our commitment to operational excellence, commercial growth, and financial discipline drove strong top-line year-over-year growth and meaningful cost containment in the first quarter. We transformed our internal manufacturing facility to meet demand growth and scale for the future without major additional capital investment. First quarter revenue of $71 million grew roughly 45% year-over-year, driven by strong Amtagvi demand. Amtagvi revenue of $60 million increased by 38% year-over-year on strong demand growth, our second-highest quarterly revenue for Amtagvi. We mitigated the first quarter impact from a temporary capacity reduction as we upgraded our facility. Moving to Proleukin, $11 million in first quarter revenue nearly doubled from the year ago period on higher Amtagvi adoption. Importantly, gross-to-net impact remains extraordinary and consistent with past quarters at less than 2%. Our first quarter gross margin from cost of sales was about 41%, which absorbed one-time nonrecurring costs related to our facility upgrades. Margin is expected to trend higher for the rest of 2026, excluding one-time items, as we operate our in-house capabilities more efficiently. We continue to manage our operating expenses carefully, including optimizing research and development while expanding our pipeline. Notably, research and development expense declined for the third consecutive quarter, a reduction of 18% over the prior period and 12% over the prior quarter. Moving to our revenue outlook. After thorough analysis of demand trends and internal forecasts, we expect total revenue between $86 million and $88 million for the second quarter, driven by strong Amtagvi demand. This momentum carries through into our full year 2026 guidance of $350 million to $370 million for the full year. As of March 31, we had approximately $319 million in cash and equivalents. Thanks to careful cost management and financial discipline, we expect to fund our operations into 2028. In closing, we are building momentum and focusing on operational excellence to grow revenue, manage expenses, and improve margins. We are on a clear path to profitability and remain committed to creating lasting value for our shareholders. I will now turn the call to Dan Kirby, our Chief Commercial Officer, to review our strong commercial progress.

Thank you, Corleen. Building on Corleen's comments, strong demand in the first quarter culminated in our second-highest quarter of Amtagvi revenue. This performance was achieved with reduced capacity and yielded much better results compared to the first quarter of 2025. Demand continued to increase throughout the quarter. March was our largest month ever for reported Amtagvi revenue. Second quarter is off to a very strong start with projections supporting our guidance that this will be our best Amtagvi quarter to-date. In addition to generating demand, our three commercial priorities are further solidifying Amtagvi as the choice for patients. First, our expanding ATC network of academic ATCs together with new community ATCs are creating more patients, establishing both a reliable base of business as well as driving additional growth in 2026. Second, patients are increasingly referred for Amtagvi earlier in the treatment cycle. The recently published real world evidence combined with published 5-year durability data has been very impactful in educating physicians on the value of earlier referrals and optimal treatment with Amtagvi. Our field teams are committed to educating our physicians while advocating for our patients. Third, Amtagvi awareness continues to build among our key target physicians. Our latest market research shows physician awareness increased to 70%, up from 50% over the last 6-months. Earlier this year, we further expanded our field sales force with plans for additional increases in field staff as more ATCs onboard and demand continues to strengthen. Proleukin is seeing robust demand, driven primarily by its use alongside Amtagvi. Proleukin sales were $11 million in the first quarter, down from the prior quarter due to wholesale buying patterns, but a substantial increase from the prior year as all 3 wholesalers ordered. We expect Proleukin to stabilize and grow throughout the year with increasing Amtagvi demand. Globally, we are making meaningful progress on [ ex-U.S. expansion ]. Amtagvi has the potential to reach more than 30,000 patients annually with previously treated advanced melanoma. Following Amtagvi approval in Canada, the first ex-U.S. treatment center is officially authorized to support international [ private-pay ] patients. At the same time, we are advancing reimbursement discussions with the Canadian government. Regulatory decisions are anticipated in Australia in the first half of this year and in Switzerland next year. We continue making progress with regulatory submissions in other markets as well. Finally, May is Melanoma Awareness Month. We are collaborating with advocacy groups to celebrate the patient experience while spreading awareness of Amtagvi. Yesterday, the Today Show posted an inspiring story highlighting Jennifer, a mother of 3, who is back to enjoying her family after receiving Amtagvi more than a year ago. Her story is one of many that represents the hope of Amtagvi. Jennifer is now also featured on our website, amtagvi.com. A growing network of patients are sharing how this one-time cell therapy has helped their own immune system, fight cancer. I will now hand the call back to the operator to begin question and answer session.

[Operator Instructions] Our first question comes from Andrew Tsai with Jefferies.

Hey, guys. This is John on for Andrew. Congrats on all the progress. For Q2, if your Amtagvi sales guidance of $79 million to $81 million, how much can that improve gross margins quarter-over-quarter as well? And then can we assume that the Q2 gross margins will be better than the Q4 gross margins at 50%?

Yeah. Thanks, John. Well obviously, the margins we showed in Q4 of 2025 were really where we aspire to be or above that. We can't say just yet where our margins are going to be exactly. But I would expect generally that they will trend upwards throughout the year. We're working very hard on that. It depends a lot on the product mix and a lot of other factors. So we really do want margins to be better throughout the year and then of course, in 2027 and beyond, we're driving towards higher and higher margins all the time.

Yeah. Just to emphasize, John, the margin was impacted, like I mentioned, from one-time nonrecurring costs. That should not happen again. It will be nonrecurring. Our margins should be continuing to grow. As i keep mentioning, we have a lot of efforts. We brought everything in-house, right? So we use the capacity of our own facility. We'll have economies of scale there. We also have targeted projects focused on operational excellence in the plan specifically. And as you see, as revenue grows, that also helps. Does that help you?

Yes, definitely. And then also maybe just a quick follow-up, if I can. Is it fair to assume that the lung data would come at a major medical meeting in the second half of 2026 versus something like Q2 at ASCO? And then would you be inclined to press release the data before? Any timing granularity would be helpful. And maybe also just remind us your expectations on ORR and potentially even DOR?

Yes. As you can see, we released data in lung only about 6 months ago that had excellent durability, which is typical of immuno-oncology approaches that work really well. So you can go back and look at our November press release, that's basically what we're looking at for this product and what we think is something that we get approved for non-squamous non-small cell lung. I can't really say much more about conference stuff except that we've guided, obviously, to 2026 disclosure at a medical meeting, and we continue to plan to do that.

Our next question comes from Reni Benjamin with Citizens.

Congrats on the progress. Maybe two questions. One, as we think about the ATC network and now bringing to the 90, I think you're targeting 110 by the year-end. Can you maybe talk to us a little bit about what the split will be between these academic ATCs and community ATCs? And what do you think will be the max capacity across these ATCs? And I think, Fred, you mentioned that the sales force is going to be growing throughout this year. Can you give us an idea as to what the optimal number of that may be? That's the commercial question. One for Friedrich because this will be the last time that we're speaking to him. Congratulations, Friedrich, on retirement. Kind of wanted to just get a sense as to the 40% confirmed ORR in endometrial, kind of your thoughts and any kind of details you can provide us in terms of depth of response or durability and how it compares to what's already out there?

So Remi, thank you very much for the question. I'll start first and hand to Friedrich. In regard to the ATC network, we see ATCs now on-boarding and starting to treat faster than they were last year. So the ones that on-boarded in the second half of the year are treating faster. Our academic and community mix is starting to get more balanced, whereas at the beginning, we were mostly academic. Now we're going more into the community hospitals, and getting closer to the patients, where the opportunity is greater for us. So we do see that, that is going to, over the year, mix more into a greater percentage of community entering-in because we do have the key academics already onboard and treating. In regard to sales force, we did increase our sales force going into this year based on the second half ATCs entering into Amtagvi authorization. We did see and have seen and are seeing increased demand from those ATCs. The new reps are being very impactful in the field with it, and we have a plan now to expand in Q2 as well as looking at later this year based on the timing and pace of both demand in our current ATCs and on-boarding new ATCs. Hopefully, that answers your question. I'll hand over to Friedrich for the second half.

Yes. Thank you. Thanks for the question, Remi. Yes, so this is a really, really exciting result that we're seeing there. As you know, in endometrial cancer, the checkpoint inhibitors are -- have moved into frontline therapy. So standard of care or really available therapy, if you want, in second line is dire. Usually, these patients are being treated with monotherapy, chemotherapy and response rates are usually below 10%, 15% highest when you look at control arms of randomized trials. So that's not good enough. These patients have highly unmet medical need and seeing another immunotherapy come through with these response rates and typically durability that is differentiated from chemotherapy, that's really important. That's why we're planning on jumping on this and taking this further.

Our next question comes from Etzer Darout with Barclays.

Congrats on the quarter. Just looking again at your 2Q guide, just wondered how much of this rebound with the step-up from the first quarter is maintenance disruption versus maybe underlying demand trends, and what the key assumptions are behind the outlook there? And then maybe secondly, on the pipeline, just as you think about the endometrial regulatory path, should we think about a potentially similar framework for -- as you're employing for sarcoma in terms of the regulatory path to accelerated approval?

Yes. So let me take the second question first actually because, yes, that's correct. We are looking at a similar regulatory path for serous endometrial versus UPS and [ DDPS ], and we'll come back soon after we have some interactions with FDA. We're going to try to optimize as much as we possibly can to supplemental BLA filings and if possibly, we combine stuff and work together to make sure that we can get these things approved as quickly as possible with the FDA. So stay tuned for a lot more detail on that. We're very excited, obviously, about all 3 indications. We think they all significantly to Amtagvi's potential, and we're currently built to launch all these indications quite quickly on the back of our commercial expertise and manufacturing. On the Q2 guide, you were asking about maintenance versus demand. Demand trends are extremely strong, as Dan highlighted earlier. I really don't think about it as a maintenance issue. I think about it as something that we had to address. We fixed it, it's done. We won't talk about maintenance ever again. It's now built in our system so we can do it without any kind of -- any kind of impact whatsoever. Demand is very, very, very strong for the product right now. So Dan, do you want to emphasize again some of the points you made during the prepared remarks on demand trends?

We continue to see demand increase. This has happened through fourth quarter and the first quarter and carried into the second quarter. I mentioned before that March was our largest reported month to date. We continue to see a strong start to Q2, which is why we have the guidance set.

Our next question comes from Colleen Kusy with Baird.

It's Nick on for Colleen. Congrats on the progress. Just -- so with the new guidance, expecting $209 million in product sales in the back half of the year, can you just speak to your confidence in hitting that goal? And what else needs to be done to get there?

Yes. So right now, Nick, we're highly confident we can achieve that. We've obviously already done a lot of it. We have visibility right now in Q2 into essentially the entire quarter. That's why we're giving such strong guidance for Q2 Amtagvi revenues as well as Proleukin. And then the back end of the year, we can see very clearly, too. And when you look at the guidance that we gave today, it's easily achievable with some growth as we go from Q2 to Q3, Q4 that we have line of sight and visibility to. We have a much better understanding of our ATDCS and how they perform, how we can produce the product and every step of the process of getting Amtagvi to the patient. And I think it's extremely responsible guidance that we've given -- its guidance that we will do everything in our power to beat, of course, but it's guidance that we can stand by and live with and it's quite strong compared to where we were last year.

And I would just add on to that, Nick, that this is our second full year on the market. We're over 2 years since launch. So variables such as seasonality, et cetera, we have a much better handle on. And we can project based on new ATCs coming and growth in the current ATCs where demand is picking up and where demand continues to increase. And that's why we look at the second half of the year as being extremely strong. It starts right now in the fourth quarter. We're seeing it right now in the demand and what's lining up for the centers.

[Operator Instructions] Our next question comes from Tyler Van Buren with TD Cowen.

Can you talk about the progress you made with the TILVANCE-301 enrollment, where you are in terms of percent enrollment? And what's been working to enroll patients? And what are some of the hurdles that you've had to overcome like sites in the U.S. using Nivo Ipi in the front line?

Yes, I can get that and then maybe Friedrich can add a little bit to it, too. We're seeing good enrollment in TILVANCE-301. Obviously, we do a lot of it outside the United States because it's easier outside the United States with standard of care. But it's a study that we think is well designed. We have very good FDA feedback on the design of the study. We're very focused on getting to the interim read where we can read ORR and have an early discussion with FDA about confirming Amtagvi's approval as well as getting additional approval. You can go on clinicaltrials.gov and see the vast scope of sites that we're running right now. It's all over the place. There's -- obviously, with any trial, there's things that you have to do to pound through it and succeed. Every company has to deal with this, and we're encountering and overcoming, I think, a lot of those right now, with this trial. So we expect good things for TILVANCE, and we think that TIL therapy in the frontline setting, especially combined with pembrolizumab can vastly improve the chances of a good overall survival outcome for patients. Our COM-202-1A data shows that. You've seen that publicly. We'll talk about that more this year, but that's really what's driving the study right now. Friedrich, do you want to add anything?

No, I think you've said it. I think it's important to remind folks that pembrolizumab is standard of care, and there are some geographic differences around this and not everyone believes that everyone should be getting -- frontline combination therapy. And then, Fred, you already highlighted the data from Cohort 1A from COM-202 that is proof for the potential for durable meaningful benefit for patients in that treatment setting from TIL therapy when used as early. So I totally agree.

Our next question comes from Salim Syed with Mizuho.

Would love to ask more than two questions here, but I'll limit myself. Corleen, Fred, maybe just one -- I'll limit myself to two here. On the ATM usage, this is now the fifth quarter you guys have access to ATM in a row, 4 of the 5 quarters, it's been pretty heavy usage. What -- could you just outline for us just your financing plans here? I mean this seems to be egregious at this point beyond any biotech company that I'm aware of how much you've access to your ATM. Why don't you just do a more traditional sort of financing path here? Or what are your financing plans going forward, should we expect this continued sort of practice? And then just second, on guidance, could you just outline for us, please, how do you come up with your guidance now? Like is it -- you have your sort of internal forecast and it's a plus/minus when you get to that? Or is it just downside? Just how conservative is this guidance?

Yes, we don't think the ATM usage is egregious at all. We dipped on the ATM occasionally, and we use it as needed to sort of top up where we are, and we've been really, really disciplined in how we use it. We're really driving the cash runway extension and now we pushed the cash runway out 2 quarters, more than 2 quarters in this most recent. By the way, every single quarter, we're pushing it out a quarter. So we're now all the way well into 2026, as you can see in the press release today. That's largely on the back of cost discipline. And we're getting -- internally, we're getting better and better at saving money when we run our trials, and we're obviously boosting margins and we're making more revenue to the top line. Everything is coming together to really extend our runway. And we are very, very focused on breakeven and any dilution for the shareholders. So yes, we do have to make use of the ATM. We still explore non-dilutive options. We're still working on them right now, but we think the lowest cost of capital right now for the company is to do a little bit of equity here and there, to make sure that we are getting closer and closer to that breakeven every quarter. On the guidance, we think this guidance is responsible. We are in possession, of course, as a company of detailed information about each ATC, the performance of each ATC, performance of our manufacturing, every aspect of what we do with Amtagvi, much more detailed than we were when we launched the product in the beginning. Now we have all the information we need. Dan's team is doing a great job identifying all the trends. As we onboard new ATCs, we have a much better understanding of what they're going to add to the picture. We know which ATCs to focus our sales teams on and which ATCs can produce for us reliably -- product that is the highest quality that we can make very reliably for them. And so we have internally, I would call them extremely sophisticated forecasts that we are watching every day to make sure that they are accurate in the launches. So for example, for Q2, practically every resection that we have for Q2 has already been performed. So we already have a very good understanding right now of what's going to happen for Q2. That's why we can give that guidance so tightly. And we're really, really comfortable in that guidance. That's why we're giving it. We know investors want it. And like I said earlier, we're going to do our absolute best to beat it.

I'll just add on to that, Fred. Looking at that, and I agree that the guidance that we said, I've been here over a year and really, we've learned a lot about this market and how to forecast and understanding it. So that's responsible, as Fred said. But I would also say that my teams are focused on beating that. That is our mission. That's what we're going to do and our expectations are higher than that. But again, the guidance is responsible, what we believe we're going to do based on the current information we have, but we will seek to onboard more ATCs than our goal. We'll seek to treat more patients than our goal. So I hope that gives you an idea of the mindset from my teams on that, but also to what we issued publicly is what we believe is responsible and what we are going to do based on the information we have today.

I'm showing no further questions at this time. I would now like to turn it back to Fred Vogt for closing remarks.

Thank you again for joining the Iovance Biotherapeutics First Quarter 2026 Conference Call on the heels of record high demand for Amtagvi as well as significant progress across our pipeline. As we continue to work on therapies with curative potential in solid tumors, we are energized by the growing number of patient stories reflecting the impact of our TIL therapies, some benefiting upwards of 6 years and counting. We remain deeply grateful to the patients, partners, health care professionals and advocacy communities we serve. Finally, I want to thank our exceptional Iovance team, our dedicated shareholders and covering analysts for their continued support and commitment to our mission to innovate, develop and deliver current and next-generation TIL cell therapies for patients with cancer. Thank you.

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