Earnings Call Transcript - IOVA Q2 2025

Operator, Operator

Good day, and thank you for standing by. Welcome to the Iovance Biotherapeutics Second Quarter 2025 Financial Results Conference Call. 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. Please go ahead.

Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications

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 Finckenstein, our Chief Medical Officer, will summarize our priority pipeline programs. 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 interactions, 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.

Frederick G. Vogt, Interim Chief Executive Officer and President

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 are 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, and for 23 patients treated in third line or earlier treatment settings, an approximately 61% response rate, all from patients treated in accordance with the 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 lifileucel franchise in new treatment settings in solid tumor types as well as next-generation approaches. We remain on track for multiple clinical milestones 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 IV-4001, our next-generation PD-1 and activated 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, a 22% growth over the prior quarter of this year. Total revenue included approximately $54 million for 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 million 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 a significant opportunity to add to the revenue potential in the international markets. Gross margin was 31%, excluding 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 through reduced 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 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 and 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 over our prior forecast. For 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 position 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&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&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.

Daniel G. Kirby, Chief Commercial Officer

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 contributions from 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 for Amtagvi and Proleukin. We are confirming our full year 2025 total revenue guidance of $250 million 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 sales 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 a significant opportunity to add to this potential through international sales of Amtagvi. Moving on to key launch performance drivers. Our #1 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 ATC 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. The third area is to penetrate U.S. community oncology networks and increase the frequency, speed, and overall timeliness for Amtagvi referrals. Last quarter, I mentioned that we are 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 new 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 U.K. We gained priority review for our submission 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 United States. 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 forward. I am committed and motivated to lead our commercial organization towards success. I'm deeply committed to Iovance's 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.

Igor P. Bilinsky, Chief Operating Officer

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 gross 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 a 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 are focused and committed to improving 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 to see an improvement in the third quarter to date. I'd also like to highlight that as planned, we delivered on our goal to shorten manufacturing turnaround time, which is now 33 days from receipt of sales 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 rightsized 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 are expected 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'll 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 TIL 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'm available to answer questions during the Q&A session, and I will now hand the call to Dr. Friedrich Finckenstein, our Chief Medical Officer, to discuss our clinical pipeline.

Friedrich Graf Finckenstein, Chief Medical Officer

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 5-year analysis from our 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 1/3 of responders ongoing. The 5-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 regimens. In frontline advanced melanoma, TILVANCE-301 is our global registrational Phase III 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 approvals 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, IOV-4001. 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 need. Chemotherapy, the current standard of care in this treatment setting, provides a 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, IOV-4001, is in a first-in-human trial and reflects our leadership in next-generation approaches to optimize TIL and TIL treatment regimens. We are also treating patients in a Phase I/II clinical trial of IOV-3001, 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 the FDA early next year for IOV-5001. 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. And I'll now turn the call over to the operator to begin the question-and-answer session.

Operator, Operator

Our first question comes from Yanan Zhu with Wells Fargo.

Yanan Zhu, Analyst

Congratulations on the quarter. Could you share details about the patient numbers from the first quarter to the second quarter? I don't think we had a clear idea of how many patients were infused in the first quarter, so I'm interested in understanding the growth in patient numbers. Additionally, I believe there may have been a price increase, so could you discuss that change and its impact on Amtagvi revenue? It would also be helpful if you could comment on your expectations for infusion numbers in the upcoming quarters in relation to your guidance and confidence.

Frederick G. Vogt, Interim Chief Executive Officer and President

Thanks, Yan. I'll begin, and then I'll invite Dan Kirby to share some additional insights. This quarter, we had 102 infusions, compared to 83 last quarter. This represents significant growth over the previous quarter. We implemented a price increase on April 1st, which raised the price of Amtagvi to USD 562,000. We anticipate continued growth, and I will let Dan elaborate on our expectations for the second half of the year. Go ahead, Dan.

Daniel G. Kirby, Chief Commercial Officer

For the price increase, did we see any impact on demand? We did not see any impact; in fact, demand increased after the price change. Therefore, we didn't consider it a hindrance. Looking ahead, we anticipate more patients as our new centers come online, and they are helping to boost demand alongside our existing centers. Additionally, we are in the process of opening some ATCs that will be more accessible within community networks. I mentioned the new distribution channel we added at their request, which allows us to reach hospitals that previously weren't purchasing Amtagvi. We expect strong demand in the second half to meet our guidance.

Yanan Zhu, Analyst

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

Frederick G. Vogt, Interim Chief Executive Officer and President

Sorry, 85 to 102, Yan.

Yanan Zhu, Analyst

That's a 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?

Daniel G. Kirby, Chief Commercial Officer

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 stick to the $250 million to $300 million range that we have in our guidance with it, which would indicate second half demand will be strong.

Operator, Operator

Our next question comes from Peter Lawson with Barclays.

Peter Richard Lawson, Analyst

Just as we think about the guidance, just your level of confidence around Proleukin. 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 has there been any changes in the number of Proleukin injections?

Daniel G. Kirby, Chief Commercial Officer

Peter, 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 a regular basis from two of the top three wholesalers in the U.S. So 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. So it will start to reflect more of the Amtagvi utilization. Along with that, we are seeing strong demand to use with Amtagvi. So we have not seen the number of doses. Again, it's zero 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. And then 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, so you'll see some pickup in Proleukin based on the fact that the wholesalers are coming online.

Operator, Operator

Our next question comes from Andrew Tsai with Jefferies.

Lin Tsai, Analyst

So if the guidance for net cash burn is going to be less than $245 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 on why that could be the case in terms of meaningful margin improvement?

Frederick G. Vogt, Interim Chief Executive Officer and President

Yes, Andrew, thank you for the question. It was $245 million, not $235 million. You can see it in the press release and in our remarks there, but your question is still a good question. Yes, we expect margins to improve. 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 of quarters to really tighten down on cost of sales and do a lot of work to improve margins even more. And 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. So 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 that 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.

Operator, Operator

Our next question comes from Salim Syed with Mizuho.

Unidentified Analyst, Analyst

This is for Salim. Could you elaborate on the decision to withdraw the marketing authorization application in Europe? What was the feedback with the EMA? And what are the steps that you're planning to take to commercialize in Europe? And regarding the announced restructuring, are you also planning to reduce R&D expenses? And if so, could you comment on any specific actions you would be planning to take to reduce, for example, clinical expenses?

Frederick G. Vogt, Interim Chief Executive Officer and President

I will address the second question first. We did reduce some research and development expenses, but we do not expect any significant changes in our clinical pipeline as we mentioned earlier. Regarding the EMA, we learned late in the review process that we need to include an additional analysis in our submission. Our plan is to go back and resubmit with this additional analysis, like the virtual control arm. Our strategy does not necessitate running additional clinical trials, and we believe this can be accomplished relatively quickly. We will be seeking scientific advice from the EMA soon to re-engage with them on this matter. The issue primarily relates to the data package we submitted, which was similar to what we provided to the FDA and Health Canada, but the EMA would like to see more. The simplest approach for us is to withdraw and resubmit.

Operator, Operator

Our next question comes from Tyler Van Buren with TD Cowen.

Nicholas Lorusso, Analyst

This is Nick for Tyler. Can you update us on how infusions are performing for Amtagvi this quarter so far? Additionally, in the first quarter earnings call, you mentioned that 69% of ATCs have infused patients, while 16% have infused 10 or more. Can you provide an update on these figures and the plan to increase prescribing?

Daniel G. Kirby, Chief Commercial Officer

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

Operator, Operator

Our next question comes from Colleen Kusy with Baird.

Colleen Margaret Kusy, Analyst

So this EMA feedback on melanoma, do you expect this to impact your path forward in PD-1 treated non-small cell lung cancer?

Frederick G. Vogt, Interim Chief Executive Officer and President

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

Raj K. Puri, Chief Regulatory Officer

Yes. I think, Colleen, any impact on continuing non-small cell lung cancer.

Colleen Margaret Kusy, Analyst

Great. And one quick follow-up. What sort of issues does moving to a specialty pharmacy solve for centers versus just buying through you directly?

Frederick G. Vogt, Interim Chief Executive Officer and President

It's a great question. It really addresses the situation with hospitals involved in community clinics and their proximity to patients. Often, these are medium-sized hospitals that can administer Amtagvi. However, for high-cost one-time therapies, their finance departments prefer not to bring them in directly. Instead, they opt to work through specialty pharmacies, where the purchase occurs via these pharmacies, which then get reimbursed by the payer, rather than having the finance department at the hospital handle the transaction directly.

Operator, Operator

Our next question comes from Reni Benjamin with Citizens.

Reni John Benjamin, Analyst

Maybe one, can you just talk a little bit about the numbers in terms of patient drop-offs versus the manufacturing kind of out-of-spec rates? I think Igor had some prepared remarks regarding that. Can you just talk about the specifics from first quarter to second quarter and how you see that potentially improving throughout the rest of the year? And then kind of just going back to a previous question regarding McKesson, how do you see this potentially improving revenues going forward? Like is this something that should kind of minimally increase revenues? Like how should we be thinking about the number of patients these one-off hospitals, how much they might use this?

Friedrich Graf Finckenstein, Chief Medical Officer

Reni, thanks for the question. Regarding the first part, the manufacturing success rates returned to normal in the second quarter after an increase in the first quarter. Both the out-of-spec rate and patient drop-off rates decreased, and we are observing further improvements in the third quarter so far. In the earnings report, you will notice that scrap costs declined in the second quarter compared to the first quarter, if you want to quantify that. We’re not disclosing the exact percentages, but you can see the decrease in both absolute terms and percentage of scrap costs.

Daniel G. Kirby, Chief Commercial Officer

And I'll answer the question regarding both patient drop-off as well as the impact of specialty pharmacy, which are a little bit related. So 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 even the tissue procurement. So 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. And 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 priced have already gone down this road successfully. So as we think about how this could have an impact on it, this could get us next to those clinics that are affiliated with those hospitals inside of the network that they can treat patients inside of their network without the cost burden. So it could have a big impact long term. We already have several accounts right now that have requested it that we're opening up this channel for. So we will have some impact later this year.

Friedrich Graf Finckenstein, Chief Medical Officer

Yes. Happy to respond to that. So 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.

Operator, Operator

Our next question comes from David Dai with UBS.

Xiaochuan Dai, Analyst

So first question is just around thinking about the patient ramp for Amtagvi. Based on the current run rate, we calculated that the patients need to grow about 26 to 32 patients per quarter over the next couple of quarters to hit the midpoint of the guidance. Could you just provide any detail that you're on track to hit that patient growth? And 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?

Daniel G. Kirby, Chief Commercial Officer

I'll address that question now. As for the patient ramp, the combined revenue for Proleukin and Amtagvi is projected to be between $250 million and $300 million. This means that to reach those figures, we are looking at a growth of 26 million to 30 million each quarter for both products. However, I want to emphasize that we are confident we are moving towards that target, especially with the increasing demand for Amtagvi. Additionally, Proleukin has all three wholesalers ready to start ordering soon, with two already active in the main channel. This positions us well to meet our guidance. Regarding the new ATCs, we are prioritizing quality over quantity. We opened several ATCs last quarter, each thoroughly vetted to ensure they have the right referral pathways to introduce patients early. We are seeing a significant number of patients entering the queue, including those who have already received treatment and others enrolling for Amtagvi manufacturing for their patients.

Operator, Operator

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.

Frederick G. Vogt, Interim Chief Executive Officer and President

Thank you, again, for joining the Iovance Biotherapeutics Second Quarter 2025 Financial Results and Corporate Update 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 long endometrial and next-generation TIL studies. We are 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 would also like to thank our shareholders and covering analysts for their support. Thank you.

Operator, Operator

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