Iovance Biotherapeutics, Inc. (IOVA) Q1 2026 Earnings Call Transcript

Good day and thank you for standing by. Welcome to the IO Vance Biotherapeutics First Quarter 2026 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sarah Pellegrino, SVP of Investor Relations and Corporate Communications. Please go ahead.

Thank you, Operator. Good morning, and 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 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 now turn the call over to Dr. Fred Vose, our Interim Chief Executive Officer and President.

Iovance is the global leader in innovating, developing, and delivering current and future generations of TIL cell therapy in solid tumors. We maximize patient and shareholder value across four pillars, curative platform potential, technology extension, and fully owned manufacturing. During the first quarter of 2026, we drove in Antagomy 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 ICPC. Since resuming full production, Antagony 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 to 2028. Antagamy enrollment and referral trends are at an all-time second quarter total revenue guidance is 86 million to 88 million dollars. Antagamy revenue is expected to grow to 79 million to 81 million dollars 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 2020 and ProLUCIN is 350 to 370 million dollars. The 1 billion dollar peak plus one big dot plus peacock sales trajectory for amtaglium proleukin in the US we expect gross margin to benefit from my financial discipline in-house scale and operational efficiencies shifting to our tilt platform we're expanding the curative potential across solid tumors this morning we announced compelling and clinically differentiated early phase 2 data and metastatic serious 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 US deaths. The second line treatment setting represents a significant unmet medical need with response rates below 15%. We plan to engage with the USFPA to pursue an expedited approval pathway. We highlight additional registrational trials for lifelucil and new indications. To expand the antagonist market potential into advanced frontline melanoma we continue to execute our global TILVANS 301 trial. In previously treated non-squamous non-small cell lung cancer, Leifeloso received FDA fast-track designation following best-in-class unprecedented response rates and strong durability. This US blockbuster market is about seven times larger than our peak opportunity at advanced melanoma. We plan to complete enrollment and provide a clinical update this year, starting accelerated approval and U.S. launch in the second half of 2027 and the difficult to treat soft tissue sarcomas, IOB SAR 201, our new registrational trial, is underway in refractory patients with advanced undifferentiated pleomorphic sarcoma and de-differentiated liposarcoma. The trial is beginning enrollment in the third quarter of 2026. We are building upon the 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 a path expedited approval leader until cell therapy we are making significant progress to our next generation programs IV 5001 is prevalent solid tumors improve clinical efficacy without aisle two and informs how we optimize IV 5001 to enhance efficacy and safety we recently submitted the investigational new drugs or IND application for a phase 1 slash 2 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 and massive commercial opportunities to our strategy. The trial is expected to begin in the second half of 2026. Our next generation IL-2 product, IOB-3001, may optimize the TILT treatment regimen. A phase 1 safety killer using IV-3001 is advancing through multiple dose levels in a phase 1-2 trial. We continue to enroll in our clinical trial with our P1-inactivated TILT therapy, IV-4001, which reduces inhibitory signals to enhance the ability of TILT 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 tilt therapy. We are identifying these enriched populations, such as the serious endometrial cancer population we highlighted today, and our selective populations within soft tissue comas and even within non-small cell lung cancer and other indications, which you will hear more about later this year. Well, Physicians is the only company to have taken Tilt Therapy from concept to commercial scale, with the manufacturing infrastructure, clinical breadth, commercial experience, and operational discipline to back it up. We have momentum, broadening pipelines and 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 Tilt Therapy, but as the backbone of immuno-oncology and solid tumor cancers. To conclude this pipeline update, I would like to extend my sincerest gratitude to Frederick Finkenstein, our Chief Medical Officer, as he prepares to retire in June. During nearly seven years at IAvance, he was instrumental in leading us towards the FDA approval of the first ever Tilt Therapy and our leadership position today. Frederick is available during today's question and answer session, and I wish him the best in his retirement. I want to turn a call over to Corleen Roche, our Chief Financial Officer, who will provide further updates on our first quarter financials and full-year expectations.

Thanks Fred and good morning everyone. Operational excellence, commercial growth and financial discipline drove strong top-line year-over-year growth and meaningful costs. 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 Amtagli demand. Amtagli revenue of $60 million increased by 38% year-over-year on strong demand growth. Our second highest quarterly revenue for Amtagli. We mitigated the first quarter impact from a temporary capacity reduction as we upgraded our facility. Moving to ProLukin, $11 million in first quarter revenue nearly doubled from the year ago period on higher MTAGV adoption. Importantly, gross to net impact remains extraordinary and consistent with past quarters at less than 2%. Margin from cost of sales was about 41% which absorbed one-time non-recurring 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 including optimizing research and development while notably research and development expense for consecutive quarter a reduction of 18% over the prior period and 12% over the prior quarter. Moving to our revenue outlook, after a thorough forecast, we expect total revenue between 86 and $88 million for the second quarter, driven by this momentum carries through into our full year 2026 guidance of $350 to $370 million for the full year. March 31st, 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. 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. 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 TAGV revenue, this performance was achieved with reduced capacity and yielded much better results compared to the first quarter. Demand continued to March was our largest month ever. The second quarter is off to a very strong start, with projections supporting our guidance that this will be our best MTagV quarter to date. In addition to generating demand, our three commercial priorities for patients, 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. Patients are increasingly published real-world evidence combined with published five-year durability data has been very impactful in educating physicians on the value of earlier referrals and optimal treatment with mTagV. Our field teams are committed to educating our physicians up from 50% as more ATCs on board and demand continues to strengthen, being robust demand, driven primarily by its use alongside mTagV. ProLucan sales were $11 million in the first month, a substantial increase. We expect ProLucan to be making meaningful progress. Amtagli has the potential to reach more than 30,000 patients annually with previously treated advanced homes in Canada, officially authorized national private pay patients. At the same time, we are advancing reimbursement in Australia in the first half of this year and in Switzerland next year. We continue making progress with regulatory submissions. May is mellowing with advocacy groups to celebrate the patient experience. Yesterday, the Today Show posted highlighting Jennifer, a mother of three, who is back to enjoying her family after receiving mTagV more than a year ago. A growing network of patients are sharing how this one-time cell therapy has helped their own immune system.

As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. In the interest of time, we ask that you please limit yourself to one question and one follow-up. Please stand by while we compile the Q&A roster.

First question comes from Andrew Tsai with Jeffries.

Your line is open.

Hey, guys. This is John on for Andrew. Congrats on all the progress. So for Q2, if you're in FACV sales guidance of $79 million to $81 million, in, how much can that improve gross margins quarter for quarter as well, and then can we assume that the Q2 gross margins will be better than the Q4 gross margins at 50 percent?

Yeah, thanks, John. Well, obviously, the margins we showed in Q4 at 25 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 depends a lot of the product mix and a lot of other factors but we really do want margins to be better yeah just to emphasize John the margin was impacted like I mentioned from one-time non recurring costs that should not happen again it will be non-recurring so 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 will have economies of scale there we also have um targeted projects focused on

operational excellence in the plant specifically and as you see as revenue grows that also helps does that help you yeah definitely um 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 in 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, thanks.

Yeah, as you can see, we released data in lung only about six 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. is that that's basically what we're looking at for this product and what we think is something that we can get approved and non-sequitur, it's not so long. I can't really say much more about conference stuff except that we've got it, obviously, to 2026 disclosure at a medical meeting and we continue to plan it.

Thanks so much.

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

Hey, good morning, guys. Thanks for taking the questions and congrats on the progress. Maybe two questions. One, you know, as we think about the ATC network, they're now greater than 90. I think you're targeting 110 by the year end. Can you maybe talk to us a little bit about, you know, what the split will be between these academic ATCs and community ATCs, and what do you think will be the max capacity, you know, across these ATCs? And I think Pat maybe mentioned that the sales force is going to be growing, you know, 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 it 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 and 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.

All right, so Remy, thank you very much for the question. I'll start first and hand to Frederick. In regard to the ATC network, we see ATCs now onboarding and starting to treat faster than they were last year. So the ones that onboarded the second half of the year are treating faster. Our academic and community mix is starting to get more balanced, whereas the beginning grew mostly academic, now we're going more into the community hospitals, getting closer where the opportunity is greater for us. So we do see that that is going to, over the year, mix more into a community entering in because we do have the key academics already on board. We did increase our sales force going into this year based on the second half ETS entering into and tag the authorization. We did see and have seen and are seeing 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. Hopefully that answered your question. Yep. Thank you, Beres Remy. I'll hand it over to Frederick for the second.

Yeah, thank you. Thanks for the question, Remy. Yeah, so this is a really, really exciting result that we're seeing there. As you know, in the metrial cancer, the checkpoint emitters are and 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.

Thanks, guys, for taking the questions. Thank you.

Our next question comes from Etzer Derute with Barclays. Your line is open.

Great. Thanks for taking the question.

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 as you're employing for sarcoma in terms of, you know, the regulatory path to accelerated approval?

Yeah, so let me take the second question first, actually, because, yes, correct, we are looking at a similar render-through pad for Cirrus Endometrio versus UPS and DLPS and we'll come back soon after we have some interactions with FBA. We're going to try to optimize as much as we possibly can, so we'll know VLA filings and possibly even combine stuff and work together to make sure that we can get these things approved as quickly as possible with the FBA, so stay tuned for a lot more detail on that. We're very excited, obviously, about all three indications. We think they all significantly add to amplification quite quickly on the back of our commercial expertise and manufacturing expertise. On the QQ guide, you were asking about maintenance versus demand. Demand trends are extremely strong, as Dan highlighted earlier. The issue I think about it is something that we had to address. We fixed it. We won't talk about maintenance ever again. It's now built in our system so we can do it without 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 first quarter and carried into 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.

Thank you.

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

Hey, guys. it's Nick on for Colleen thanks for taking the question and congrats on the progress just so with the new guidance expecting expecting 209 million in product sales in the back half of the year can you just speak to your your confidence in any of that goal and what else needs to be done to get there thanks yeah so right now Nick we're highly confident we can achieve that we've obviously already done a lot of it and we have visibility right now in Q2 to essentially the entire quarter that's why we're giving such strong guidance for Q2 AmtagV revenues as well as ProLukin 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 with some growth as we go from Q2 to Q3 to Q4 that we have line of sight and visibility to. We have a much better understanding of our ATCs and how they perform, how we can produce the product in every step of the process of getting AmtagV to an extremely responsible guidance that we've given. It's guidance that we will we will do everything in our power to beat of course but it's guidance that we can 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 two years since launch so variables such as seasonality etc we have a much better handle on and we can project based on new ATC's coming and growth in the current ATC's where demand is picking up and where demand and that's why we look at the second half of the year is being extremely strong this starts right now at the fourth quarter we're seeing it right now in the demand and what's lining up for this all right thank you thank you as a reminder to ask a question please press star one one on your telephone again that is star

one one to ask a question our next question comes from teller van buren with td cowan your line is open hey guys uh thanks very much for taking the question uh can you talk about the progress you made with the Tilvance 301 enrollment, you know, 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 Nevo IPI in the front line?

Yeah, Todd, I can get that, and then maybe Frederick 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 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 or or and have an early discussion with FDA about confirming impact these approval as well as getting an 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 there's some we're encountering and overcoming I think a lot of those respect good things for Tobans and we We think that pill therapy in the frontline setting can vastly improve the chances of a good overall survival outcome for patients. Comto 218 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 Frederick, 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 COURT 1A from COM202. That is proof for the potential for durable, meaningful benefits for patients in that treatment setting from CHIL therapy when used early. So I totally agree.

Thank you. Our next question comes from Salim Syed with Mizuho. Your line is open.

Thanks for that question, guys. Would love to ask more than two questions here, but I'll limit myself. Coraline, 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. Four of the five quarters, it's been pretty heavy usage. 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, of how much you've accessed 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 the 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, Lee. We don't think the ATM use is egregious at all. We dip 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 more than two 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 2020. That's largely in the back. We're getting internally, we're getting better and better at saving money when we run. So yes, we do have to make use of the ATM. We still explore non-bolutive options. We're still working on them right now, but we think the lowest cost could be here and there to make sure that we are getting closer and closer to that break even. We think this guidance is responsible in possession, of course is a company of detailed information about each ATC, the performance of each ATC, performance of our manufacturing, every aspect of what we do with Amtagby, much more detailed than we were. When we watch the product in the beginning, now we have all the information we need. Amt'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. And so we have internally, I would call them extremely sophisticated, that we are watching. So for example, for Q2, practically every resection that we have for Q2 has already been performed. Now, what's going to happen for Q2? That's why we can give that guidance so tightly, and we really, really, really are giving it. We know investors want it.

Looking at that, I agree. The guidance, as we said, really we've learned a lot about this. Fred said, 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 But we will seek to onboard more ATCs than our goal will exceed to an idea of the mindset from my teams on that.

Appreciate the call, guys.

Thank you. 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 IVANS Biotherapeutics First Quarter 2026 Conference Call on the heels of record high demand for impact, as well as significant progress across our pipeline. As we continue to work on therapies with curative potential and solid tumors, we are energized by the growing number of patient stories reflecting the impact of our health therapies, some benefiting upwards of six years and counting. We remain deeply grateful to the patients, professionals, and advocacy community advance team, our dedicated shareholders, and covering analysts for their continued support and commitment to our mission to innovate, develop, and deliver a current and next generation health self-therapy.

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