Iovance Biotherapeutics, Inc. (IOVA) Q3 2026 Earnings Call Transcript

Welcome to the Iovance Biotherapeutics Third 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 would now turn the call over to Jen Saunders, Senior Director, Investor Relations and Corporate Communications at Iovance. Jen, you may begin.

Thank you, Daniel. Good morning, and welcome to the Iovance webcast to discuss our third 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 Regulation results, regulatory approvals, submissions, feedback and guidance, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, hair 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 SEC filings. 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 Boath, interim CEO and President. Thank you, Jen.

Good morning, everyone. Our third quarter delivered outstanding record-setting results for IVANs. Our highest ever revenue and margin and strong financial performance across the board. Total revenue of about $122 million surged 80% over the prior year. U.S. Antagny revenue increased 77% over the prior year and crossed $100 million in a single quarter for the first time. We also passed an important landmark this quarter with more than 1,000 commercial Antagny pages now infused in the U.S. since launch. Based on this strong performance, we remain on track to achieve our full-year revenue guidance of $410 to $420 million. Our authorized treatment center, or ATC, network continues to expand rapidly, and we fully expect to reach 110 or more authorized treatment centers by year end. Third quarter margin of about 60% also set a new all-time high for the second consecutive quarter, and we expect it to expand further over time. Our cash runway is now expected to fund operations well into 2029. The strong performance reflects the financial health of IAvance and the strong platform that we can build upon for upcoming launches. The third quarter and recent updates also reflect major progress across our TIL platform and pipeline programs. In metastatic non-small cell lung cancer, LIPOLUSO continues to demonstrate a potentially best-in-class clinical profile. Earlier this year, the FDA granted FastTrack designation based on the strength of our data And the high unmet need. Last week, we reported positive updated results from our Registrational Lung 202 trial that included 69 patients with previously treated non-squamous metastatic non-small cell lung cancer. The objective response rate, or ORR, by Resist-1-1 was 24.6%, consistent with our prior results in 39 patients. Durability, while still maturing, was also consistent with our prior results and has already greatly surpassed the current standard of care, Sosetaxel. which has a response rate of only 12.8%, short durability of 5.6 months, and median overall survival of just 12.3 months. Safety in Lung 202 is consistent with our lifolucyl experience to date across our clinical trials of multiple solid tumors. Encouragingly, the safety profile in Lung 202 improves using the updated Reduced Dose Length of Depletion Regimen. Efficacy, including durability. Remains comparable and consistent in Lung 202 before and after the change to reduce this lump of depletion. We will provide more details on Lung 202 as the study completes with potential presentations at medical meetings in 2027. Looking ahead, we are confident in our plans to submit a Supplemental Biologics License Application, or SBLA, in 2027. We are completing enrollment in cohorts 1 and 2 with a target of approximately 80 patients for the SBLA. In parallel, we are advancing independent review committee assessments, FDA discussions, and other pre-submission activities, including preparation for a confirmatory trial. Alongside our latest Lung 202 update, we launched an innovative precision TIL strategy. We identified a biomarker-enriched subgroup of non-squamous, non-small cell lung cancer patients in Lung 202 that demonstrated a remarkable 59.1% response rate. Nearly 6 in 10 patients showed a deep and durable response. These results are the foundation for Positility, a first-in-class, prospectively-defined, biomarker-enriched cohort with registrational intent that we will pursue in addition to our initial SVLA in 2027 in non-squamous, non-small-cell lung cancer. Positility is targeting 80 patients and will begin enrollment this month. Utilizing the existing Lung 202 site footprint to speed enrollment is part of a planned transition. In 2027, we are also planning our OPTILISM trial to investigate this population in the frontline setting. Together, these biomarkers selected front and second-line settings representing U.S. opportunity about 10 times the size of advanced melanoma. At the ESMO Congress in late October, two-world presentations showcased the broader potential for lipolucyl to demonstrate deep, durable responses in soft tissue sarcomas and frontline advanced melanoma. Following one of the oral sessions at ESMO, this morning's press release included our most recent updates in soft tissue sarcoma. The confirmed ORR by Resist1-1 for lipolucyl and refractory undifferentiated pleomorphic sarcoma, or UPS, and de-differentiated liposarcoma, or DDLPS, has climbed to 55.6%, five of nine patients. Multiple durable responses have already been observed, including two ongoing more than a year from infusion. Save the endosarcoma trial is consistent with our lipolucil experience to date across our clinical trials and multiple solid tumors. These powerful results in heavily pretreated patients are the basis for Saratoga, our registrational trial that is actively enrolling to support tumor approvals for lipolucil. After failing chemotherapy, second-line response rates are typically below 5%. Median survival is about 9 to 10 months, and there are no approved immunotherapies. In recognition of this unmet need, as well as our initial results, the FDA granted fast-track designation in both UPS and DDLPS. In addition, we have aligned with the agency on the design and a potential accelerated approval pathway based on the Saratoga trial with 40 patients expected in each cohort and SBLA submissions planned for 2028 or 2029. In our second world session at ESMO, we focused on frontline advanced melanoma. Where about half of patients do not achieve long-term benefit with today's standard combination checkpoint inhibitors. In our Phase II cohort, Frontline Advanced Melanoma, 62.5% of patients responded, including complete responses in 29.2% of patients where tumors disappeared completely and did not return. Median overall survival was not reached after more than four years of follow-up. Safety was consistent with the known safety profiles of one-time lipoluzil and paparalizumab. These results reinforced Telvans-001, our Phase III trial enrolling in more than 80 sites, and expanding, designed to support both the frontline approval and serve as the confirmatory trial for full U.S. approval of MPAG. In summary, IVans is focused on growing revenue, expanding in the new indications of markets, Broadening pill therapy and the solid tumor indications, including biomarker-selective populations, and collectively represent tens of thousands of cancer patients with poor prognosis and limited available options. I am also thrilled to welcome our new chief medical officer, Dr. Noah Berkowitz, to his first quarterly call at Iovance to discuss additional details about our pipeline. His valuable expertise in global drug development across cancer and blood disorders led to approvals for the CAR-T cell therapies of Beckman-Brianzi, Wall of Bristol-Myers Squibb. As the first and only company in the world to take pill therapy from concept to commercial treatment, we are forging ahead with tremendous momentum to our profitability and long-term value for patients and shareholders alike. Perlene Roche, our Chief Financial Officer, will now highlight our financial results.

And good morning, everyone. The third quarter was another record quarter for Iovance, combining strong revenue, record margin, and disciplined spending. Revenue is up 80%, that's 8-0, year-over-year. Margin is at an all-time high of 60%, 6-0, and operating expenses reflected disciplined, intentional allocation of capital to our highest return priorities. And now, our cash runway is expected to fund operations well into 2029. Total revenue, once again, achieved a new quarterly record of about $122 million, up 80% year-over-year, as I mentioned, and 22% sequentially. And PAGD powered that revenue growth by reaching more patients than ever before. AmtagVee sales of around $102 million represent a 77% increase year-over-year and a 12% increase sequentially, reflecting strong patient demand and broad adoption. ProBucan revenue contributed approximately $20 million in the third quarter, more than double the second quarter level as wholesaler ordering patterns are realigning with AmtagVee demand. As expected, the quality of our revenue remains high, with gross-to-net deductions around 1%, consistent with prior quarters. That high-quality revenue is flowing through to margin, which reached an all-time high for the second consecutive quarter of approximately 60%, up sequentially from our previous record of 56%, and that brings our year-to-date margin to 54%. Amtagdi growth, operational efficiencies, and investment discipline contributed to this margin gain and remain powerful levers for continued expansion as we drive further efficiencies across the company. Turning to operating expenses. Third quarter R&D expenses were down approximately 16% sequentially to about $49 million, marking the fifth consecutive quarter of reduced R&D expense. This trend reflects efficiency of our operations, including clinical and manufacturing, which allows us to advance multiple registrational programs at greater scale and much less cost than any TIL competitor. Total selling general and administrative expenses held flat at about $39 million sequentially, even as revenue grew about 22%. We continue to make targeted investments in revenue-generating activities that drive the greatest commercial return. We are reaffirming our recently updated full-year revenue guidance range of $410 to $420 million. At the midpoint, that is nearly 60% growth over last year. Through the first three quarters of 2026, we have already delivered $292 million of revenue, expanded margin, and controlled operating expenses. We end the quarter in a strong financial position with approximately $382 million in cash, cash equivalents, short-term investments, and restricted cash on September 30th. Together, with robust revenue and careful capital allocation, this cash position is now expected to fund operations well into 2029, giving us the runway to execute on our growth plan from a position of strength. In closing, we again delivered strong revenue, improved margin, and intentional capital allocation this quarter. With a strong balance sheet supporting us, we are well positioned as we build a valuable, self-sustaining business that delivers lasting value for patients and our shareholders. And behind these record results are the patients we serve. For more on how we are reaching them, here's Dan Kirby, our Chief Commercial Officer, to review our commercial progress in more detail.

Thank you, Corleen. Third quarter was the strongest quarter of the MTAGITY launch. Amtagne revenue surpassed $100 million for the first time, and we treated more patients than in any prior quarter. Together with proleukin sales of approximately $20 million, we are confident in achieving our updated full year guidance of 410 to 420. We also achieved two milestones this quarter. We have now treated more than 1,000 commercial patients, and we have more than 100 ATCs. Access is expanding, and more patients are able to receive a one-time cell therapy that can deliver long-term... I'll cover how we got here through our three priorities, physician awareness, growing our ATC network, and clinical data. Our latest market research shows durability of response is the leading reason physicians choose mTagV over other treatments. Durability was rated highly by more than 80% of our target physicians and was cited by nearly two-thirds as the key driver. Early with mTagney is measured in years, with over three years of median duration, while other options, both on the market and in trials, measure durability in weeks and months. Last week, Fox News covered a story about one of our patients, Patty Garcia, who is experiencing a long-term durable response to mTagney after a single infusion two years ago. Patient stories like Patty's are increasingly being featured across media outlets. And continue to reinforce the promise of our TIL therapy. Also, our expanded sales force returned clear value on investment as they logged more customer interactions than in any quarter since launch, which translated into more patients treated We now have more than 100 ATCs and are on track to reach at least Most of the centers we onboarded in Q3 were community-based, and community ATCs represent over a third of our network. New centers are also getting started faster at the time between authorization. Behind these numbers is reliable delivery to patients. For the majority of lots, turnaround time is 30 days or less, using the only scaled, centralized commercial manufacturing. iAdvance's manufacturing capabilities are faster and more reliable than any tilt area. Real-world studies show response rates of 50% or greater in second-line patients, supported by five-year durable responses. These results are the standard in second-line-class metastatic melanoma, where patients get better and more durable responses. Indirect comparison suggested that Lipelucil may approximately double four-year overall survival compared with standard of care and anti-PD-1 resistant advanced melanoma. Our teams also met with U.S. and international thought leaders at ESMO who were excited about the data and what it means for their patients. Turning to ProLukin, third quarter sales were about $20 million, driven by mTagV demands. We expect that trend to continue in Q4. We have approved in Canada and Australia for previously treated melanoma with our first ATCs ready in Canada and onboarding in Australia. We are progressing reimbursement discussions in both countries. These ATCs will initially treat private pay patients while we work towards public reimbursement, which is key to broad access. The UK application is under expedited review and the Swiss medic process is moving smoothly with potential approvals in both markets by the first quarter of 2020. Also in 2027, we plan to submit an application in Brazil where expedited review is available and to resubmit our application in the European Union. Looking beyond today's indication, in frontline advanced melanoma, the population is more than twice the size of the previously treated population we serve today. In metastatic non-small cell lung cancer with KRAS wild types, the first and second line addressable market is at least 10 times. In soft tissue sarcomas, the U.S. market opportunity in UPS and DDLPS is approximately the same as the current second-line metastatic melanoma. Cross-indications, these patients are concentrated at centers of excellence that are already ATCs, which we believe positions us well to quickly reach. To close, we had a record third quarter, approximately $122 million in total revenue, including more than $100 million in MTAGD revenue, reaching more patients than ever. We are on track to reach at least 110 ATCs with community centers and faster onboarding driving growth. And the call off to NOAA.

Thank you, Dan, and hello, everyone. My name is Noah Berkowitz. Having joined the company a month ago, this is my first iAvance earnings call, and I am incredibly happy to be here. I joined iAvance because TIL is the first single administration cell therapy that achieves deep and lasting responses in a significant proportion of patients. That may derive the greatest Toga Registrational Trial at major U.S. cancers. Thank you. It will be 5,000. Thank you. Thank you. Thank you. Collaboration with regulators and letting the data... to the operator to begin the Q&A session.

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. Please stand by while we compile the Q&A roster. Our first question comes from Andrew Tsai with Jefferies. Your line is open.

Hi there. Good morning. Great execution. Thanks for the updates. My question is about the commercial franchise right now. So traditionally, you guys have seen some impacts due to maintenance of your facility around the December and January timeframe, I think. This time around, is it fair to assume everything will be smooth and good to go because you've switched to the modular manufacturing early in the year? And if that's the case, you know, the guidance implies maybe a flattish to slightly up quarter-over-quarter growth for Q4. Is that really going to be the case? Can you maybe then talk about any other potential headwinds we should think about for Q4 as it relates to your guidance? Thank you.

Yeah, thanks, Andrew, for the question. You're correct. The maintenance is no longer an issue. That will not affect our earnings going forward. That was primarily affecting us in Q1 in the first quarter of each year, and that effect has gone away. We just issued this guidance five weeks ago, and so, yes, obviously... We would like to have growth quarter over quarter, and we expect that, and that's something we would aim to do, but just keep in mind that the guidance really just came out five weeks ago, and right now we're tracking to achieve it, and of course, of course, of course, if we can beat our guidance, we're very happy to do so, as we just did.

Great. Thanks.

Thank you. Our next question comes from Edsar Darute with Barclays. Your line is open.

Great.

Thanks for taking the question.

I guess, you know, with quarterly operating loss of about approximately $24 million, I guess, is profitability achievable before launches in lung cancer or sarcoma? And I guess, what remaining revenue scale or course margin improvements do you think Are needed to reach operating cash flow break even given, you know, the momentum we're seeing in second line melanoma alone. Thank you.

The answer is yes. So, I mean, if you look at the EPS, it's only five cents loss, and that's the best it's ever been. And so we are on our way to profitability. I'm not guiding when, but if we continue on this path of revenue growth and disciplined investments, we'll get there.

Great. Thank you. Thank you. Our next question comes from Yanan Zhu with Wells Fargo. Your line is open.

Hi. Thanks for taking our questions. This is Quan An for Yanan, and congrats on another strong quarter. For per looking, the sales increased from $9 million to $20 million, and you mentioned the ordering patterns are realigning with the integrity of events. So, can you share how much does that reflect the expected use of mTagV? And is there an estimation on the average delay between producing cells and the use for mTagV? Thank you.

Thank you, Connie. Great question with it. Proleucan is in line with MTAGME demand. So we had said before about 16% of the demand was represented by Proleucan. That is what this quarter represented. We're seeing the orders in line. One of the things that the teams are doing to ensure that there's supply at the wholesaler is we're communicating planned orders at the hospitals that pull from that wholesaler. So we're tracking in line with demand in real time. Thank you.

Got it. And a quick question on Lung 202. When do you think we may see a mature median DOR data from this study? Thank you.

Well, it's possible that when we complete this study, we may be not reached, so that we may have mature but not reached like we did with some other reports that we've done, so just bear that in mind. But as we mentioned a couple of times now, We expect to finish the study imminently at 80 patients. We will report, as I mentioned, the prepared remarks. We'll report data on that at some point next year. And then at that point, you should see what you might, I think, what you mean by mature, be the DOR. But just don't be surprised if it's not reached at that point with a lot of follow-up.

Got it. Thank you for all the colors. Thank you. Our next question comes from Nick LaRusso with TD Cowan. Your line is open.

Hey, guys. Thanks for taking my question. You noted that community ATCs represent about a third of the current network, which is impressive. Can you discuss the current prescribing patterns and maybe the proportion of patients coming from the community versus academic centers and how we I should think about this ramping over time. Thanks.

Sure. Great question, Nick. So, we are focused, we've been focused for over a year now on opening community hospitals and ATCs to service MTGV. What we're seeing is, in general, we've gotten better at opening accounts. So, as I mentioned in the prepared comments, we're seeing a quicker activity. Come up. Our business still is concentrated. The community ATCs are growing over time, so it's about a little over a third.

Thanks very much for the call. Thank you. And our final question comes from Joe Pagenis with H.C. Wainwright. Your line is open.

Hi, this is Josh on for Joe. Thanks for taking our question. So I just wanted to follow up on LUN 202 if there's any additional color you can provide with the discussions you've been having with the FDA about the SBLA submission.

Yeah, I'm happy to provide that. We're very focused right now on those discussions with the FDA, and we're having productive discussions right now, and we believe that this data set that we have right now should be registrational and should be approvable. I'll ask Raj Khoury here, who's with me, to make some comments on this as well. He's our head of Chief Registrarial Office.

Yes, I agree with Fred's comment that the FDA, we are on track to get VLA from Nathan to end And based on our data, we are confident that FDA will consider the accelerated approval based on the prior approvals in this space with about 80 subjects' trials.

And just to clarify, we're planning to submit that BLA in 2027.

Perfect. Thank you so much.

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 is another record-breaking quarter, and our pipeline is advancing rapidly. We remain deeply grateful to the patients, partners, healthcare professionals, and advocacy communities we serve. Finally, I want to thank our exceptional I-Advanced team, our dedicated long-term shareholders, and our covering analysts for their continued support. We remain committed to our mission to innovate, develop, and deliver current and next-generation cell cell therapies for patients with cancer. Thank you.

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