Iovance Biotherapeutics, Inc. (IOVA) Earnings

Management highlights

- Iovance is the global leader in TIL cell therapy for solid tumors, executing on four pillars: curative platform potential, commercial execution, technology extension, and fully-owned manufacturing. - Drove anti-antagony adoption, advanced development pipeline, and streamlined costs and efficiencies. - Navigated manufacturing capacity reduction, resuming full production with Ampagni exclusively in-house. - Announced early phase two data in metastatic serous endometrial cancer with 40% confirmed objective response rate and 100% disease control rate. - Expanding TIL platform across solid tumors, with ongoing trials for Leifelucel, new indications, and next-generation programs. - Strong commercial progress with expanding ATC network, increasing physician awareness, and robust demand for Prolucan.

Guidance

- Second quarter total revenue guidance is $86 million to $88 million, with MPAGNY revenue expected to be $79 million to $81 million. - Full year 2026 total revenue guidance for Ampagni and Prolucan is $350 to $370 million. - Expect gross margin to benefit from financial discipline, in-house scale, and operational efficiencies moving forward.

Segment performance

First quarter revenue grew approximately 45% year-over-year. Antagony revenue was $60 million, increasing by 38% year-over-year. Prolucan revenue was $11 million, nearly doubling from the year-ago period. Second quarter total revenue guidance is $86 million to $88 million, with MPAGNY revenue expected to be $79 million to $81 million. Full year 2026 total revenue guidance for Ampagni and Prolucan is $350 to $370 million, predominantly fueled by Ampagni. First quarter research and development expenses declined for the third consecutive quarter.

Analyst Q&A

• Q: For Q2, if in sales guidance of 79 to 81 million, how much can that improve gross margins quarter for quarter as well? And can we assume that the Q2 gross margins will be better than the Q4 gross margins at 50%?

  A: Obviously the margins we showed in Q4 of 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. The margin was impacted from one-time non-recurring costs. That should not happen again. It will be non-recurring. So our margins should be continuing to grow.

• Q: 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 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 Pat maybe mentioned that the Salesforce is gonna be growing, throughout this year, can you give us an idea as to what the optimal number of that may be?

  A: In regard to the ATC network, we see ATCs now onboarding and starting to treat faster than they were last year. Our academic and community mix is starting to get more balanced. In regard to Salesforce, we did increase our Salesforce going into this year based on the second half ATCs entering into and tag the authorization.

• Q: 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 the regulatory path to accelerated approval?

  A: For the Q2 guide, demand trends are extremely strong. We don't think about it as a maintenance issue. We 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 into our system. For the endometrial regulatory path, we are looking at a similar regulatory path for Cirrus Endometrial versus UPS and DLPS, and we'll come back soon after we have some interactions with FDA.

• Q: 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 any of that goal and what else needs to be done to get there?

  A: Right now, we're highly confident we can achieve that. We have visibility in Q2 to essentially the entire quarter. The second half of the year is extremely strong as we're over two years since launch and have a much better handle on variables like seasonality.

• Q: Can you talk about the progress you made with the till events 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 Nevo IPI in the front line?

  A: We're seeing good enrollment until mid-year one. We do a lot of it outside the United States. We have very good FDA feedback on the design of the study. We expect good things for TIL bands and think TIL therapy in the frontline setting can improve overall survival outcome for patients.

• Q: On the ATM usage, this is now the fifth quarter you guys have access to ATM in a row. Four of the five quarters has been pretty heavy usage. Could you just outline for us just your financing plans here? And on guidance, could you just outline for us, please, how do you come up with your guidance now?

  A: We don't think the ATM use is egregious. We use it as needed to top up and are disciplined. We're focused on extending cash runway and breakeven. For guidance, we have extremely sophisticated forecasts based on detailed information about ATCs, manufacturing, etc. We have a very good understanding of Q2 as practically every resection for Q2 has already been performed.