Iovance Biotherapeutics - Earnings Call - Q2 2025

Executive Summary

• Q2 2025 total product revenue was $59.95M, up 22% q/q and 93% y/y, driven by Amtagvi ($54.1M; 102 commercial patients) and Proleukin ($5.9M).
• The quarter missed Street consensus on revenue and EPS; revenue of $59.95M vs $67.14M* and EPS of -$0.33 vs -$0.276*; management reiterated FY25 revenue guidance of $250M–$300M.
• Gross margin (excl. non-cash items) was 31%; a strategic restructuring targets >$100M annual cost savings from Q4 2025 and lowers next-4-quarters net cash burn to < $245M, extending runway into Q4 2026.
• Catalysts: specialty pharmacy channel with McKesson to unlock community access, Health Canada approval (NOC/c) for Amtagvi on Aug 18, 2025, and multiple clinical data readouts in 2H 2025.

What Went Well and What Went Wrong

What Went Well

• “More than 100 patients treated within a single quarter,” with 102 commercial Amtagvi infusions, demonstrating accelerating adoption across ATCs and the new specialty pharmacy channel.
• Real-world retrospective data: ORR 48.8% overall (20/41) and 60.9% in third-line or earlier, supporting earlier use narratives and community referral initiatives.
• Manufacturing cycle-time improved to 33 days; success rates rebounded vs Q1; management expects margins to improve further as restructuring drives lower cost of sales.

What Went Wrong

• Revenue and EPS both missed consensus; revenue $59.95M vs $67.14M* and EPS -$0.33 vs -$0.276*; cost of sales elevated at $56.66M, including $19.0M period costs tied to drop-offs and success rates.
• EMA marketing application was withdrawn following CHMP interactions; company plans resubmission with additional analyses (e.g., virtual control arm), delaying EU commercialization.
• R&D expense increased 28% y/y to $79.36M in Q2, pressuring the P&L despite SG&A decline y/y; net loss widened to $111.66M.

Transcript

Speaker 3

Good day and thank you for standing by. Welcome to the Iovance Biotherapeutics second quarter 2025 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, Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications.

Speaker 0

Please go ahead.

Speaker 2

Thank you, operator. Good afternoon and thank you for joining the Iovance conference call and webcast to discuss our second quarter and first half 2025 financial results as well as recent updates. Dr. Fred Vogt, our Interim Chief Executive Officer and President, will provide an introduction and brief overview of our key financial results including revenue and revenue guidance, operating expenses, and our strategic restructuring. Dan Kirby, Chief Commercial Officer, will discuss product, revenue, and commercial and regulatory updates for Amtagvi. Dr. Igor Bilinsky, our Chief Operating Officer, will provide a manufacturing update and Dr. Friedrich Graf Finckenstein, our Chief Medical Officer, will summarize our Priority Pipeline program. Additional members of our leadership team, including Dr. Raj Puri, our Chief Regulatory Officer, and Dr. Brian Gastman, our Executive Vice President of Medical Affairs, will be available for the Q&A session.

In addition, our new Chief Financial Officer, Corleen Roche, is joining today's call. Earlier this afternoon, we issued a press release that is available on our corporate website at iovance.com. Before we start, I would like to remind everyone that statements made during 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 and interactions, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interaction, restructuring plans and workforce reductions, licenses and collaborations, 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 statements. With that, I will turn the call over to Fred.

Speaker 0

Thank you, Sara, and welcome to the Iovance second quarter and first half 2025 conference call. We are more than a year into our U.S. launch of Amtagvi for advanced melanoma. The first FDA approved TIL cell therapy adoption continues to grow, and for the first time we surpassed more than 100 patients treated in a single quarter. We're also excited about our first real-world data set for Amtagvi monotherapy in the commercial setting. Top line results showed a nearly 49% response rate among 41 patients after 23 patients treated in third line or earlier treatment settings and approximately 61% response rate, all from patients treated in accordance with their label. We look forward to sharing more detailed real-world data at an upcoming medical meeting. Another important growth driver for Amtagvi is onboarding large community practices to join our ATC network.

We plan to begin treating patients from these practices in the fourth quarter of this year. Patients in the community are generally earlier in their melanoma treatment journey, and we expect that the higher response rates observed in our real-world data set will also be relevant to these patients. Our commercial business is complemented by an exciting pipeline led by our programs to extend the life of the lifileucel franchise in new treatment settings in solid tumor targets as well as next generation approaches. We remain on track for multiple clinical IOV studies in the second half of this year, including updated data from our registrational trial of lifileucel monotherapy in previously treated advanced non-small cell lung cancer, clinical data for lifileucel monotherapy in endometrial cancer, and for IOV4001, our next generation PD-1 inactivated TIL cell therapy.

Today I will cover financial results at a high level, focusing on revenue, expenses, cash runway, and the expected cost savings from our strategic restructuring. I'll begin with revenue and gross margin. In the second quarter, we reported $60 million in total revenue, 22% growth over the prior quarter of this year. Total revenue included approximately $54 million from Amtagvi infusions and approximately $6 million from Proleukin. Based on current growth dynamics and with approximately $109 million in total revenue for the first half of 2025, we are reiterating our full year 2025 revenue guidance of $250 to $300 million inclusive of sales from Amtagvi in the U.S. and Proleukin globally. We continue to see strong demand for Amtagvi and the potential to achieve U.S. peak sales of $1 billion or more. There's also significant opportunity to add to the revenue potential in the international markets.

Gross margin was 31% including non-cash items such as intangible amortization, stock-based compensation, and reserves primarily for excess Proleukin inventory. Our recent restructuring is expected to improve gross margins in the near term to reduce cost of sales. Gross margins are also expected to increase significantly through near-term optimization of manufacturing capacity utilization over the next several years. In summary, we are focused on improving our profitability and are pleased with the strong momentum from our U.S. commercial business. Transitioning to the second quarter 2025 expenses, total operating expenses were approximately $117 million compared to approximately $102 million in the prior year period. This increase was primarily related to higher headcount-related costs and costs for clinical trials and marketing and advertising support for Amtagvi, partially offset by reductions in stock-based compensation.

After experiencing a tremendous period of organizational growth in 2023 and 2024, we are fully committed to streamlining expenses and optimizing business performance through a strategic restructuring announced today. This restructuring includes a workforce reduction of approximately 19% in the third quarter of 2025 and will generate more than $100 million in annual cost savings starting in the fourth quarter of 2025. As I mentioned earlier, in addition to significantly reducing expenses, this restructuring will also significantly reduce our cost of sales and increase gross margins on an ongoing basis. I would like to extend our heartfelt appreciation and best wishes to the employees impacted by the reduction in workforce. Realigning our operating plan and cost structure involves some difficult but necessary decisions to ensure financial discipline while continuing to invest in our commercial launch success.

Notably, our registrational and early phase programs remain on track and no significant changes to our product pipeline are expected. Our net cash burn is significantly reduced from our prior forecast with the next four quarters through the second quarter of 2025. Net cash burn is expected to be less than $245 million excluding one-time charges of less than $6 million associated with the third quarter strategic restructuring. We will continue to optimize and refine our cost structure through operational excellence initiatives over the next two to three quarters, and importantly, we expect ongoing reductions in expenses and improvements in cost of sales. Our current cash acquisition of approximately $307 million in anticipated product revenue, including cost savings from the strategic restructuring, are expected to be sufficient to fund current and planned operations into the fourth quarter of 2026.

I am happy to go into more detail during the Q and A. Notably, we're excited to welcome our new Chief Financial Officer, Corleen Roche, who joined our team this week. We look forward to Corleen covering the financial results in detail from next quarter onwards, and she's available for today's Q and A session. I will now turn the call over to Dan Kirby, Chief Commercial Officer, for a detailed update on our commercial launch and our ex-U.S. regulatory milestones.

Speaker 1

Thanks Fred. I'd like to build on the earlier revenue discussion by highlighting individual product drivers for Amtagvi and Proleukin. I'll also provide an update across our three key focus areas to drive U.S. launch performance as well as our strategy for Amtagvi outside of the United States. Product revenue from U.S. Amtagvi sales was approximately $54 million in the second quarter of 2025, representing a growth of 24% quarter over quarter. A total of 102 commercial patients were treated, representing the highest number of Amtagvi infusions for a single quarter to date. Infusion growth was a direct result of increased field activities in existing ATCs and contribution of new ATCs onboarded earlier this year. Our commercial organization is also dedicated to supporting and growing Proleukin sales. Product revenue from Proleukin was approximately $6 million in the second quarter of 2025, an increase of 2% quarter over quarter.

Two of the three major U.S. wholesalers restocked during the most recent quarter. As a reminder, first quarter Proleukin sales were attributed primarily to manufacturing and clinical uses, not the main channel tied to Amtagvi use. These two channels represent additional revenue growth opportunities for Proleukin. Now that wholesalers are reordering from the main channel, we expect Proleukin revenue to begin to reflect Amtagvi demand. Looking forward to the remainder of the year, we are confident in continued growth from Amtagvi and Proleukin. We are confirming our full year 2025 total revenue guidance of $250 to $300 million. This aligns with our U.S. Amtagvi growth forecast, including expected momentum from community referral activities and large community practices. As a reminder, our 2025 guidance includes sale of Amtagvi only in the United States as well as Proleukin.

Amtagvi has the opportunity to address more than 30,000 patients globally with previously treated advanced melanoma. As Fred stated, we continue to see the potential to achieve Amtagvi U.S. peak sales of equal to or greater than $1 billion. There is also significant opportunity to add to this potential through international sales of Amtagvi. Moving on to key launch performance drivers, our number one goal is to establish Amtagvi as the preferred option for all appropriate patients. Amtagvi is a game changer for melanoma patients who have failed first line treatment for the first time in advanced melanoma and solid tumors. Cell therapy made from the patient's own cells has been shown to induce long term benefit with curative intent. On last quarter's call, I highlighted three key areas to drive performance and would like to comment on our progress.

First, adoption across our Authorized Treatment Center network continues with strong, steady growth at early centers, new centers treating patients, and increased integration with community practices. A second performance driver is engaging medical oncologists to guide earlier consideration for Amtagvi. Our first real-world data shows approximately half of all patients responding, including 60% of patients responding in earlier treatment settings. These results reinforce our messaging in the field and can guide earlier treatment practices within the scope of our label. Our disease education focuses on the benefits of durable responses with one-time cell therapies like Amtagvi versus temporary responses and ongoing side effects seen with other treatments. The third area is to penetrate U.S. community oncology networks and increase the frequency, speed, and overall timeliness of our Authorized Treatment Center referrals.

Last quarter I mentioned that we were working to identify alternative distribution channels on top of our traditional specialty distributor model, such as specialty pharmacy, that may offer flexibility to support community access for one-time therapies like Amtagvi. In direct response to requests from large community practices, we entered our first agreement with McKesson's Biologics Specialty Pharmacy and other transactions are planned. This BIN channel will allow hospitals to have the choice to either buy Amtagvi directly or go through a specialty pharmacy where they do not have to directly purchase the product. Transitioning to our ex-U.S. strategy, we are making progress toward approval in four additional markets. Canadian approval is expected imminently and we are making progress toward approval in the United Kingdom. We gained priority review for our submissions in Australia. We are also in the submission process for Switzerland in the European Union.

As noted in the press release today, we recently withdrew our submission from the European Medicines Agency following lack of alignment during discussions of our clinical data. We are currently evaluating strategic options, such as including a virtual control arm in the submission, to make Amtagvi and TIL therapy broadly accessible to advanced melanoma patients with unmet medical needs in Europe. We look forward to providing updates on our regulatory interactions in the near future. As stated previously, our full year 2025 total revenue guidance does not include Amtagvi sales outside of the U.S. As part of the restructuring, our customer-facing teams remain well resourced and focused to deliver Amtagvi infusions for patients, drive demand, and generate revenue for Amtagvi and Proleukin. To move Iovance Biotherapeutics forward, I'm committed and motivated to lead our commercial organization towards success.

I'm deeply committed to Iovance Biotherapeutics' mission of pioneering a new treatment paradigm for physicians who treat patients with solid tumors, which represent 90% of all cancers. I will now pass the call over to Igor Bilinsky, our Chief Operating Officer, to highlight our manufacturing progress.

Speaker 4

Thank you, Dan. I will focus today's manufacturing update on commercial performance and recent organizational changes. I'll also build on Fred's introductory comments about our ongoing initiatives to improve cost margins. Our internal manufacturing facility, the Iovance Cell Therapy Center, or ICTC, supplies the vast majority of patients today for both commercial and clinical manufacturing. Our contract manufacturer provides second source. Owning our own facility and relying more and more on internal manufacturing provides us with full control to maintain high quality, implement operational efficiencies, and optimize cost of sales. ICTC also offers the flexibility to scale up rapidly when needed. Manufacturing success delivering final product to patients within defined specifications is critical for providing therapies for patients and for recognizing revenue across functional areas of Iovance, from manufacturing to medical affairs and commercial. We have obviously been committed to improving these success rates.

As a result, the success rate in the second quarter rebounded compared to the first quarter with lower patient drop-offs and lower out-of-spec rates, and we continue seeing improvement in the third quarter to date. I'd also like to highlight that, as planned, we delivered on our goal for manufacturing turnaround time, which is now 33 days from receipt of cells at the manufacturing facility to Amtagvi readiness for return shipment to the ATC. Turning to our strategic restructuring, our manufacturing organization has been realigned for operational excellence. We previously staffed our manufacturing network to provide the capacity to meet our prior revenue guidance. Now we have prioritized and optimized the capacity and headcount to align with the revised guidance and growth projections.

Our streamlined manufacturing organization and ongoing implementation of operational efficiencies, I expect to increase capacity utilization, reduce costs, and improve gross margins in the second half of 2025 and beyond. Shifting to the current macroeconomic and geopolitical environment, I will reiterate that Iovance is operating as a strategic advantage within the biopharma industry. We continue to expect Amtagvi and Proleukin to see minimal impact from tariffs. Regarding our intellectual property, our cell therapy expertise and manufacturing capabilities are protected by a robust patent estate that is domiciled in the U.S. We own approximately 280 granted or allowed U.S. and international patents and patent rights for Amtagvi and other TIL-related technologies expected to provide exclusivity through at least 2042. I am available to answer questions during the Q&A session, and I will now hand it off to Dr. Friedrich Graf Finckenstein, our Chief Medical Officer, to discuss our clinical pipeline.

Thank you, Igor. Building on my colleagues' comments about Amtagvi or lifileucel, the durability of responses following one-time treatment is a key differentiator from other available and emerging therapies. This durability message was reinforced in the recent publication of the final five-year analysis from the C-144-01 trial in the Journal of Clinical Oncology and the simultaneous presentation at the American Society of Clinical Oncology Annual Meeting. Unprecedented durability and duration of follow-up were demonstrated in previously treated advanced melanoma patients. 31% of patients responded, with nearly a third of responders ongoing. The five-year overall survival rate was almost 20% in the real-world treatment settings. We are excited to see even better response rates of approximately 50% overall and 60% in less heavily treated patients following lifileucel. We look forward to presenting this real-world data at a future medical meeting following the strategic restructuring.

Our priorities are to expand Amtagvi into additional solid tumor types and earlier lines of therapy and to advance our key next-generation TIL and TIL treatment regimen in frontline advanced melanoma. TILVANCE-301 is our global registrational phase 3 trial designed with FDA and EMA input to show the contribution of components. We are investigating Amtagvi in combination with pembrolizumab compared to pembrolizumab alone. TILVANCE-301 remains on track as the confirmatory trial for Amtagvi monotherapy in our initial indication, and this trial could also support accelerated and full approval of Amtagvi in combination with pembrolizumab in frontline advanced melanoma. We look forward to sharing results from several clinical trials before the end of the year for lifileucel in non-small cell lung and endometrial cancers, as well as on our PD-1 inactivated TIL cell therapy IOV4001.

IOV-LUN-202 is our registrational program intended to extend the label for lifileucel monotherapy to include previously treated advanced non-small cell lung cancer. This trial design aligns with FDA guidance for single-arm trials to support accelerated approvals for single agents in conditions with unmet medical needs. Chemotherapy, the current standard of care in this treatment setting, provides limited rate and duration of responses. The FDA previously provided positive regulatory feedback on the IOV-LUN-202 clinical trial design and the proposed potency assay matrix to support registration. We expect data from IOV-LUN-202 to support a potential regulatory decision on U.S. accelerated approval in 2027 for previously treated non-small cell lung cancer patients. In our IOV-END-201 clinical trial, we've seen promising signs of initial efficacy for lifileucel monotherapy in previously treated patients with advanced endometrial cancer.

Our PD-1 inactivated TIL cell therapy IOV4001 is in a first-in-human trial and reflects our leadership in next generation approaches to optimize TIL and TIL treatment regimen. We are also treating patients in a Phase 1/2 clinical trial of ILV3001, a next generation IL-2 for use with the TIL cell therapy treatment regimen. Finally, we plan to submit an investigational new drug application to FDA early next year for ILV5001. This genetically engineered, inducible and tethered IL-12 TIL cell therapy may expand our development opportunities into a wide range of common solid tumor cancers. I'm happy to address questions during the Q&A session. I now turn the call over to the operator to begin the question and answer session.

Speaker 3

As a reminder to ask a question, please press 11 on your telephone and wait for your name to be announced. To withdraw your question, please press 11 again. In the interest of time, we ask that you please limit yourself to one question. You may rejoin the queue for any additional questions or follow ups. Please stand by while we compile the Q and A roster. Our first question comes from Yanin Zhu with Wells Fargo. Your line is open.

Oh great. Thanks for taking our questions and congrats on the quarter. I was wondering, can you talk about the patient number from 1Q to 2Q? I don't think we had a good sense of exactly how many patients you infused last quarter in 1Q. We wanted to understand the growth in patient number. I also think you might have increased the price, so perhaps talk about the price change and impact for Amtagvi revenue as well. If you can also comment on where you think those infusion numbers will go in the coming quarters relative to your guidance and confidence, that would be super helpful. Thank you.

Speaker 0

Thanks John, I'll start and then I'll ask Dan Kirby to add some comments to this too. The number of fusions we had this quarter was 102. Last quarter it was 83. That was substantial growth over last quarter. There was a price increase that came into effect on April 1, which took the price of the product of Amtagvi to $562,000. We expect growth, and I'll let Dan talk about what we expect in the second half of this year. Go ahead, Dan?

Speaker 1

Sure. For the price increase, I think your question was, did we see any impact of the price increase on demand? We did not see any impact. In fact, demand increased after the price, so we didn't factor that in as being any kind of headwind to follow. With that, we also look in the future and where we see patients coming in. We have our new centers coming on, as we've talked about in previous quarters, and they continue to ramp up demand as well as our existing centers. What we do see in the future happening is we're in the process of opening some ATCs that are closer in the community networks. I mentioned the distribution channel we added, that is specifically at their request, which gives us access to hospitals that normally were not going to purchase.

We do see demand in the second half continuing to be strong to meet the guidance that we provided.

Sorry, if I may quickly follow up. I think I heard the growth in patient number was from 83 to 102.

Speaker 0

Sorry, 85 to 102.

Yeah, 85 to 102. That's pretty good growth. Do you anticipate similar growth going forward, or any color there, just so we have a better sense about what to expect in the coming quarters? Thank you.

Speaker 1

We anticipate demand to continue to be strong. As far as quarter on quarter growth, we don't want to guide to that. We want to still stick to the 250 to 300 range that we have in our guidance, which would indicate second half demand will be strong.

Great, thanks.

Speaker 3

Thank you. Our next question comes from Peter Lawson with Barclays. Your line is open.

Speaker 0

Great.

Thank you so much.

Thanks for the detail on the call. Just as you think about the guidance, just your level of confidence around Proleukin, you know, you mentioned it kind of accelerating in the second half, kind of. What gives you that level of confidence and what do you think the Proleukin number could be and have there been any changes in the number of Proleukin injections?

Thank you.

Hi, Peter.

Speaker 1

I'll take that question. I think for Proleukin in the mainline channel, what we did see as evidenced in the revenue from Q1 was we're seeing the manufacturing and the clinical trial channel that represented the Q1 revenue. In Q2, we started seeing the reordering at regular basis from two of the top three wholesalers in the U.S. What we expect to see moving forward is those orders continuing in from the two and then the third one coming on later this year. It will start to reflect more of the Amtagvi utilization along with that since we are seeing strong demand to use with Amtagvi. We have not seen the number of doses and it's the order to six doses with one dose of Amtagvi. We're not seeing the doses of Proleukin change by center. Each one will do it differently, but the average doses remain consistent.

Finally, we do anticipate those other two channels we've been talking about that we booked revenue in Q1 on continuing to order throughout the year. You'll see some pickup in Proleukin based on the fact that the wholesalers are coming online.

Gotcha.

Speaker 0

Thank you so much.

Speaker 3

Thank you. Our next question comes from Andrew Tsai with Jefferies. Your line is open.

Hey, good afternoon. Thanks for the updates.

Appreciate you taking the question. If the guidance for net cash burned is going to be less than $235 million over the next year and I believe restructuring happens later in the year, it feels as if you're expecting gross margins to improve meaningfully, maybe even as early as Q3 relative to Q2 and Q1. Is that accurate, and if so, can you give us some color why that could be the case in terms of a meaningful margin improvement?

Thank you.

Speaker 0

Yeah, Andrew, thank you for the question. It was 245, not 235. You can see it in the press release and in our remarks there. A few questions.

Speaker 4

Still a good question.

Speaker 0

Yes, we expect all. We expect margins to improve. That's the whole, that's the whole name of the game right now. We're pushing very hard, and a lot of the restructuring activities are really focused on improving margin. Now we're going to enter a phase of operational excellence over the next couple quarters to really tighten down on cost of sales and do a lot of work to improve. As volume ramps up, we'll also see improvements in margins because cost of sales will stay low while revenue goes up, especially as we scale up and use our ICTC facility. You're absolutely right. We expect to see margin growth, and again this quarter we saw a good margin. If you back out the non-cash items and things like that, you see a very good margin on a cash basis as we have already.

Now, as you see more Proleukin sales increase and as you see us do all those things, I think you'll see margins go up significantly.

Thank you.

Speaker 1

Thank you.

Speaker 3

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

Hi, this is Bennett for Salim. Thanks for taking our questions. Could you elaborate on the decision to withdraw the marketing authorization application in Europe, what was the feedback with the European Medicines Agency? What are the steps that you're planning to take to commercialize in Europe? Regarding the announced restructuring, are you also planning to reduce R&D expenses? If so, could you comment on any specific actions you would be planning to take to reduce, for example, clinical expenses? Thank you.

Speaker 0

Yeah, I'll take the second question first. We did reduce some R&D expenses, but we are not expecting any significant changes in our clinical pipeline, as we discussed on the call. With respect to the EMA, we withdrew and we learned late in the review process that we need to include an additional analysis on our submission. What we want to do is go back and resubmit with an additional analysis such as the virtual control arm. Our strategy does not require us to run additional clinical trials and we think that can happen relatively quickly. We'll be seeking scientific advice from the EMA soon to try and get back in there and work on that again with them. That was really what the issue was. It has to do with the data package.

It was submitted, which we submitted, was similar to the FDA package, Health Canada package, and everything else. They would like to see some more, and the easiest route for us to.

Speaker 4

do that is to withdraw and resubmit.

All right, thank you.

Speaker 3

Thank you. Our next question comes from Tyler Van Buren with TD Cowen. Your line is open.

Speaker 0

Great, thanks. This is Nick ONS for Tyler. Thanks for taking that question. Can you provide an update on how infusions are tracking for Amtagvi quarter to date, and then second, in the first quarter earnings call, you noted that 69% of ATCs have infused one patient while 16% infused 10 or more. Can you provide an update on these metrics and the plan to increase prescribing? Thanks, I'll take that one.

Speaker 1

Thanks for the question. For the infusions quarter to date, we do see strong demands. However, we can't comment on how many infusions quarter to date. That's been our policy. As far as the % increase with it, those %s, they have gone up. Obviously, we have not appreciably a lot more centers that came on in the last quarter, however, went up 24% infusion. So those numbers by centers are going up with it. We decided not to continually track those as a metric.

Thank you.

Speaker 3

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

Speaker 2

Hi, good afternoon. Thanks for taking our questions. This EMA feedback on melanoma, do you expect this to impact your path forward in PD-1 treated non-small cell lung cancer?

Speaker 0

No, not right now. Absolutely not. Has nothing to do with the United States whatsoever. Raj Puri can comment on this.

Speaker 1

Yeah, I think Corleen had any impact on the going power continuing.

Great.

Speaker 2

One quick follow up.

Speaker 0

What sort of issues does moving to?

Speaker 2

A specialty pharmacy solve for centers versus just buying through you directly?

Speaker 1

It's a great question. It really solves. You think about the hospitals that are involved with the community clinics and you get close to where the patients are. A lot of times you're dealing with medium sized hospitals that have all the capabilities to administer Amtagvi, however, one-time therapies that have higher price tags. The finance department does not want to bring those in. They would rather go a route where they would go through a specialty pharmacy where the purchase would happen through the specialty pharmacy and the specialty pharmacy would get reimbursed from the payer versus the purchase happening directly from the finance department at the hospital.

Speaker 2

Great. Thank you.

Speaker 3

Thank you. As a reminder to ask a question, please press star 11. Again, that is star 11 to ask a question. You may rejoin the queue for any additional questions or follow ups. Our next question comes from Rennie Benjamin with Citizens. Your line is open.

Speaker 0

Hey guys, thanks for taking the questions. Maybe one, can you just talk a little bit about, you know, the numbers in terms of patient drop offs versus.

Speaker 1

The manufacturing kind of out-of-spec rates? I think Igor, you know, had some prepared remarks regarding that.

Speaker 0

Can you just talk about the specifics?

Speaker 1

From first quarter to second quarter, and how you see that potentially improving throughout.

Speaker 4

The rest of the year?

Speaker 1

Kind of just going back to a previous question regarding McKesson.

Speaker 0

How do you see this potentially improving revenues going forward? Is this something that should kind of minimally increase revenues? How should we be thinking about the.

Speaker 1

Number of patients these one off hospitals.

Speaker 0

You know, how much they might use this?

Speaker 4

Adrian, thanks for the question. On the first part of the question, as I mentioned, the manufacturing success rates normalized in the second quarter compared to the increase in the first quarter. Both the out-of-spec rate and the patient drop-off rates decreased, and we're seeing further improvement in the third quarter so far. As you can see in the Q4, you will see in the queue the scrap costs went down in the second quarter compared to the first quarter. If you want to quantify that beyond that, we're not sharing the exact percentages, but again you can look at the scrap costs and see the decrease in the absolute terms or the relative percentage.

Speaker 1

I'll answer the question regarding both patient drop off as well as the impact of specialty pharmacy, which are a little bit related. Patient drop off does remain somewhat consistent. Although we did see that we were getting patients a bit earlier in this quarter versus previous quarters and we weren't seeing as many patients that were not making an EBITDA tissue procurement. We are making strides in that avenue. The impact of specialty pharmacy allows us to actually get closer to those patients so we can get healthier patients upstream. How we should be thinking about that is we're starting our journey right now. Other cell therapies are following our lead. Gene therapies and other therapies that are higher price have already gone down this road successfully.

As we think about how this can have an impact on it, this could get us next to those clinics that are affiliated with those hospitals inside of network so they can treat patients inside of their network without the call spur. It could have a big impact long term. We already have several accounts right now that have requested that we're opening up this channel for. We will have some impact later this year.

Speaker 0

Got it. If I can just have a quick follow up, just regarding the clinical.

Speaker 1

Trials that are ongoing for Friedrich, just.

Speaker 0

Can you provide us any color in terms of, you know, how many patients?

Speaker 1

Are enrolled in each of these studies?

Speaker 0

How many patients worth of data might we see for non-small cell as.

Speaker 1

As the other ones that we're expecting like endometrial in the second half of this year?

Yeah, happy to respond to that. I think what we said is that we're going to share data by the end of the year. We will provide that information as part of those updates. I don't think that we will predefine at which patient number we would be doing that.

Speaker 0

Okay, thank you.

Speaker 3

Thank you. Our next question comes from David Dye with UBS. Your line is open.

Speaker 0

Hey guys.

Yeah, thanks for taking my questions. First question just around thinking about.

The patient ramp for Amtagvi. Based on current run rate, we calculated that patients need to grow about 26 to 32 patients per quarter over the next couple of quarters and hit midpoint of the guidance.

Could you provide any detail that you're on track to hit that patient growth? Secondly, on the ATCs, you have 80 right now. How many of these ATCs are newly?

Activated compared to last quarter, and how many are still being activated?

Speaker 1

I'll take that question. As far as the patient ramp, just to let you know, the $250 to $300 million is combined revenue between Proleukin and Amtagvi. On the map there, those numbers are in 26 to 30 per quarter each quarter to grow to hit those numbers in the range. We are confident that we are tracking towards that range and seeing Amtagvi demand continue to strengthen and grow towards the end of the year, as well as Proleukin, as we mentioned before, having all three wholesalers starting to order very soon. Two of those doing so currently in the main channel give us our path forward to hit within that guide. The second question regarding how many new ATCs, again we're focusing on quality, not quantity. We happened to open several ATCs in the last quarter.

Each one of those has been carefully vetted to have referral patterns in place so they can get earlier patients in there, and we are seeing, and I'm not going to give the exact numbers here, we are seeing a substantial number of patients coming in the queue, both that have been already infused by them, but also where they're enrolling in there to have manufacturing done for Amtagvi for their basis.

Speaker 3

Thank you. I'm showing no further questions at this time. I would now like to turn it back to Fred Vogt, Interim Chief Executive Officer and President, for closing remarks.

Speaker 0

Thank you again for joining the Iovance Biotherapeutics second quarter 2025 financial results and Corporate Updates Conference Call. We look forward to providing future updates on our growing commercial and clinical portfolio, including our Amtagvi real-world data presentation and planned data updates from our lung, endometrial, and next-generation TIL studies. We're motivated by the stories we continue to hear about the patients who benefit from Iovance TIL cell therapies in our clinical trials and in the commercial setting. I'm confident that Iovance will remain the global leader in innovating, developing, and delivering current and future generations of TIL cell therapies for patients with cancer. As always, we are thankful to the patients, healthcare and advocacy communities, our partners, and our exceptional Iovance team. I'd also like to thank our shareholders and covering analysts for their support. Thank you.

Speaker 3

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