Iovance Biotherapeutics, Inc. Q3 FY2025 earnings call

• Revenue and Margin Focus: Continued progress to increase revenue and margins, with third quarter revenue up 13% over prior quarter and gross margin at 43% post-restructuring.
• Pipeline Advancements: Interim clinical data in previously treated non-squamous non-small cell lung cancer showed a best-in-class profile with an objective response rate of 26% and long duration of response. Plan to complete enrollment in LUN-202 registrational trial in 2026 with ~80 patients for potential accelerated approval and launch in H2 2027.
• ATC Expansion: Added community and academic authorized treatment centers (ATCs), with community ATCs beginning to treat patients and specialty pharmacy agreement enhancing access to Amtagvi. Educating oncologists on earlier treatment with Amtagvi.
• Manufacturing Centralization: Planning to centralize manufacturing at internal facility starting early 2026 to improve cost of sales and gross margin further.

Total product revenue increased approximately 13% over the prior quarter to about $68 million in the third quarter. This included Amtagvi sales of approximately $58 million and global Proleukin revenue of nearly $10 million. Gross margin improved to 43% following the initial results of strategic restructuring and cost optimization. The revenue contribution of Amtagvi was significant at around 85% of total product revenue ($58M out of $68M), and Proleukin contributed nearly 15% ($10M).

• Full year 2025 revenue guidance remains in the range of $250 million to $300 million, on track.
• Expect a strong fourth quarter for Amtagvi alongside increasing Proleukin sales.
• Aim to quickly complete enrollment in LUN-202 trial in 2026 and advance toward a supplemental biologics license application in non-squamous non-small cell lung cancer with a potential launch in H2 2027.

• Forward-looking statements subject to numerous risks and uncertainties, including those detailed in SEC filings, such as risks related to clinical trial outcomes, regulatory approvals, market adoption, and competition.

Q: Nice execution this quarter. Great to see various dynamics improving. So my question this quarter is on the lung cancer data update that you had. It's interesting that the signal did not necessarily degrade compared to the prior data cut. In fact, maybe the efficacy on DOR seemed to get better. So for the remaining batch of patients, would you expect the third data cut to be also similar or even better than what we're seeing in this interim that you just had? Or would you expect some kind of efficacy degradation on a larger sample size?

A: Thanks, Andrew. I can start and then maybe Friedrich can chime in here. I don't -- we don't expect any degradation in the efficacy signal. We're getting very good within the LUN-202 trial at making sure our investigators identify the right patients for the trial. And we are obviously going to be cutting the data with longer and longer follow-ups. And with ongoing responders, as you can see in the swimmers plot from that data cut, we would expect to see that durability improve even beyond what we have today. I'll let Friedrich comment a little bit on the details of how we think that study is going to play out, but that's the big picture view.

Q: Congrats on the quarter. Just a quick one on the lung cancer. Can you talk about when did you touch base with FDA regarding the path and the regulatory path? And you did mention 80 patients. I wanted to hear your confidence that 80 patients is enough for the lung cancer filing. Then on Amtagvi in melanoma, can you talk about infusion growth into fourth quarter and into 2026, your confidence for inflection point in the patient infused? And lastly, sorry, if I may, on the improved gross margin, great to see that result. Can you comment on how much of it is coming from patient dropout and manufacturing success rate improvements versus how much is coming from cost reduction measures?

A: Thanks, Yanan. Why don't I start on the FDA point and then Raj Puri will jump in, and I'll ask Dan and Corleen to help out with the Amtagvi, the inflection point as well as the gross margin questions here. We've engaged heavily with FDA on the LUN-202 trial and gotten guidance from them, feedback on the trial design, patient population, CMC, things like the potency assay. We feel very comfortable that we're on the right track here. Obviously, engagement with FDA is a continuous process during the trial. As I'm sure investors know, we have to engage frequently and we do engage frequently. A lot of it doesn't get talked about. So we'll continue to do that on this trial, but we're very comfortable with where we stand right now in the trial design and what we need to do to get a supplemental BLA submitted on time. On the sample size for the patient -- for the 80 patients, we pointed out during a lot of our calls earlier this week as well as during our prepared remarks here that we think 80 patients will be sufficient based on the precedent of Amtagvi with 73 patients which led to the approvals on label in melanoma as well as a lot of recent FDA meeting the last couple of months, FDA approvals in non-small cell lung. So I'll let Raj and maybe Mark comment on that on what they've seen with the FDA and why they think that's reasonable.