Iovance Biotherapeutics Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 8, 2025

There are 16 speakers on the call.

Operator

Good day and thank you for standing by. Welcome to the Iovance Biotherapeutics First Quarter twenty twenty five Financial Results Conference Call. At this time, participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will press 11 on your telephone.

Operator

You will then hear an automated message advising your hand is raised. To withdraw your question, please press 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, Sarah Pellegrino, SVP, IR and Corporate Communications. Please go ahead.

Speaker 1

Good afternoon, and thank you for joining the Iovance conference call and webcast to discuss our first quarter twenty twenty five financial results, as well as recent corporate updates. Doctor. Fred Vo, our Interim Chief Executive Officer and President, will provide an introduction and focus on The US commercial launch of AMTAKVI, including revenue and revenue guidance. Dan Kirby, Chief Commercial Officer, will discuss the EMTAGV commercial launch. Doctor.

Speaker 1

Igor Balinski, our Chief Operating Officer, will provide a manufacturing update. John Mark Belleman, our CFO, will review our financial results, including revenue and revenue guidance, gross margin and cash burn guidance. And Doctor. Fredrik Finkenstein, our Chief Medical Officer, will summarize key pipeline programs. Additional members of our leadership team, including Doctor.

Speaker 1

Raj Puri, our Chief Regulatory Officer Doctor. Brian Gassman, our EVP of Medical Affairs, will be available for the Q and A session. 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, licenses and collaboration, 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.

Speaker 1

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 Brett.

Speaker 2

Thank you, Sarah, and welcome to the Iovance first quarter twenty twenty five conference call. We are four quarters into our U. S. Launch of AMPAGNI, the first FDA approved Till cell therapy and the first treatment for patients with advanced melanoma who progress following anti P1 treatment and, if appropriate, targeted therapy. In the first twelve months of our US launch, we've executed towards our long term adoption goals and generated more than $210,000,000 in revenue.

Speaker 2

This includes infusions from nearly 300 mTagvi patients in the first launch year, starting with our first infusions in April 2024. Total first quarter product revenue was $49,300,000 including $43,600,000 from more than 80 mTagB infusions and 5,700,000 from Proleukin sales. Following steady growth throughout 2024, revenue was lower in the first quarter of this year, driven by three key contributors. First, our internal manufacturing facility, the ICTC, completed annual scheduled maintenance in December of last year, as we previously discussed on last quarter's call. As a result of limited production starts for multi week AMP tagging manufacturing across our network, capacity was reduced by more than half for about one month.

Speaker 2

In addition, volume was impacted by higher rates of patient drop off and lower manufacturing success rates, but has since rebounded. Today we are seeing healthy demand with a record number of production starts in the second quarter. Lower Perleukin sales were the second factor contributing to lower first quarter revenue. We expect two of

Speaker 3

the three largest U. S.

Speaker 2

Ship wholesalers to start replenishing Perleukin in line with growing Mtavi demand in the second quarter. We're also growing the other components of our franchise, including sales of Perleukin to third parties for use with manufacturing and clinical research. The third contributor to first quarter revenue was the variable pace at which ATCs began treating patients, as this differs from centre to centre. For context, sixteen percent of ATCs have treated more than 10 patients. Our ATCs have ample room to grow and we anticipate near term contributions from ATCs that came online in the latter half of twenty twenty four into 2025.

Speaker 2

We are also confident in our growth prospects under our new Chief Commercial Officer, Dan Kirby. Dan brings invaluable leadership experience in cell therapy commercial organisations since the earliest developments in the field. Less than three months, Dan is already strengthening our commercial operations to drive ATC adoption and amplify earlier community referrals to our ATC network. The commercial team is working aggressively to implement key learnings from the first year as we continue to execute our US launch. We are also excited about upcoming milestones related to our ex US launch expansion and pipeline developments in lung cancer and beyond.

Speaker 2

We anticipate three potential approvals for AMPAGNI in The United Kingdom, Canada and the European Union, and additional regulatory submissions are also underway in Australia and Switzerland. We are on track to report updated data from our registrational trial of lefalusol in previously treated advanced non small cell lung cancer and first clinical data in endometrial cancer. And we continue to advance our robust pipeline of next generation total cell therapies for patients with solid tumours. Looking ahead I will briefly comment on our revised full year revenue guidance and cash spend outlook. We revised our guidance to between $250,000,000 and $300,000,000 in total product revenue for

Speaker 4

the full year 2025. We consider our

Speaker 2

experience with growth trajectories at the ATCs, timelines for new ATCs to begin treating their first patients, and expectations for large community practices and community referrals to drive momentum in the second half of twenty twenty five. These demand trends are consistent with the trajectory of other cell therapy launches moving from year one to year two. After aligning our manufacturing slot plans with our new demand forecast, are maintaining our prior cash runway guidance into the second half of twenty twenty six. We remain confident in a peak sales opportunity of more than $1,000,000,000 in The U. S.

Speaker 2

And more than $2,000,000,000 globally for AMPAGNI in the current approved indication. We also continue to expect that gross margin can exceed 70% in the coming years. Amtagni and Perleukin are showing steady growth in the second quarter and will accelerate in the second half of the year. Current momentum is strong and we project between one hundred and one hundred and ten commercial patient infusions in the second quarter. We are also motivated by positive feedback from key opinion leaders and patient success stories that reinforce the unmet medical need and value of Impeg.

Speaker 2

On a macro level, as Igor will describe, we are well prepared to supply ongoing demand to deliver commercial amphagi as well as our investigational Till products to patients around the world. Iovance is competitively positioned with a fully US based patent portfolio and manufacturing network. Tariffs should have a minimal impact on IMPAGNI and Prolukin. I'm happy to go into more detail during the Q and A and will now turn the call to Dan Kirby for a detailed commercial launch update.

Speaker 4

Thank you Fred. Following my first ninety days at IOMAP, I'm excited about the potential for IMTAGNI to benefit patients around the world. I've identified the strengths of our launch as well as opportunities to optimize adoption and accelerate growth. Antagy

Speaker 2

is

Speaker 4

a game changer for patients who have failed first line treatment in melanoma. Antagy is also the first cell therapy for patients with solid tumor cancers. I'll begin with my observations of what is going well. First, I'm very impressed by our competent and dedicated commercial organization and cross functional field teams. These teams have established a solid foundation for mTagV by building awareness of the unmet need in advanced melanoma and strong clinical profile of mTag B, activating our 70 ATCs within our treatment network and preparing for the next wave of new centres, securing early inclusion in the NCCN guidelines and favourable reimbursement access for more than 95 US covered lives.

Speaker 4

As a result of this execution, M type V is a successful cell therapy, the first of its kind in solid tumors. Today, I will discuss status and near term initiatives to improve our performance across three key areas. First, our ATC network expansion and retention strategy to drive adoption. A second area is to address plans to revamp engagements with medical oncologists to guide earlier consideration for Antagy. And the third area is to further establish entagma within The US community oncology networks.

Speaker 4

I'll start with our ATC strategy. In the first year of launch, we strategically prioritized 70 experienced cell therapy centers and most of the major cancer centers, nearly all currently treated melanoma patients and are within a two hour drive of these ATCs. Current metrics amongst these 70 centers demonstrate ample growth performance and potential for mTAC. Seventy nine percent or fifty six ATCs have completed tumor resections, the starting material for Till manufacturing. Sixty nine percent or 48 ATCs have infused one or more patients.

Speaker 4

And sixteen percent or 11 ATCs have infused more than 10 patients. ATC adoption is tracking in the right direction. We expect additional growth from the early launch centers with strong and steady patient volume. Newer centers activated later in the launch are currently contributing as they gain experience. For the next set of ATCs, we are currently in the process of activating more than 10 select high quality centers, including those aligned to large community networks that have premier access to patients needing anti V as their second line treatment.

Speaker 4

This next set of ATCs reflects lessons learned, best practices, and the characteristics that distinguish our top performing ATCs while specifically incorporating clinic referral patterns. Meanwhile, we continuously collaborate with all of our active ATCs to support early referrals and best practices for procuring tumor samples. As we prepare to commercialize Entagney beyond The US, Ten international treatment centers are in process to become DTCs for our planned launches in The United Kingdom, Canada, and Europe. We remain on track to onboard 15 international centres as ATPs by year end. Turning to the second area of focus.

Speaker 4

We have made it our goal in the last three months to better understand our physicians and how they view Antagy. In the initial launch, the team did a great job of educating the cell therapy community and key medical oncologists on the benefits of Antagy. From our market research, we see that those physicians view Antagy as second line treatment. We also saw that there is a disconnect in mTagvi treatment sequencing between our initial target physicians who view mTagvi as a second line treatment and referring medical oncologists in the community who consider mTagvi as third line or leader in therapy. This is a large market opportunity for mTagV.

Speaker 4

Our number one goal is to establish mTagV as the preferred option for all appropriate patients. To this end, we are educating referring medical oncologists to consider mTagB early and bring forth the promise of cell therapy within current solid tumor treatment practices. We have a sizable patient population and we have a tremendous potential to drive earlier patient referrals to our ATC. For example, a portion of our ATC, a portion of patients who initiate the integrity journey die or enter hospice prior to surgery shortly after committing to MCAGD. This is due to late referrals in the community.

Speaker 4

With our updated plans, we are doubling down on initiatives and medical education efforts with community medical oncologists so we can drive earlier patient referrals and shift the treatment sequence. To do this, we will: Educate practitioners on the benefits of durable responses with one time cell therapies like mTagV versus temporary responses and ongoing side effects seen with other treatments. We will roll out new disease state educational efforts and amplify our presence at relevant medical meetings to provide a better understanding around Till and cell therapies. For the first time in advanced melanoma and solid tumors, a cell therapy made from a patient's own immune cells has been shown to induce long term benefit with curative intent. For the third area of focus, we are building relationships within community oncology networks that treat our target mTagD patients.

Speaker 4

We are expanding resources within our community field team to increase frequency, speed, and overall timelines for referrals and to identify new ATC targets. Recently, we have seen increased momentum for patient referrals to current ATCs and identified new ATCs. Since my arrival, we've engaged with executive leadership in every major US community cancer network. We are now collaborating with the top US community clinic networks to identify and onboard several preferred centers for an Antagy. We are also focused on breaking down any remaining access barriers to adoption.

Speaker 4

For example, we are exploring alternative distribution channels that may offer flexibility and broader acceptance of one time therapies like Antagy while maintaining our current pricing strength. In addition to Imtagvi, our commercial organisation is dedicated to supporting Proleukin across three key business lines: use with Imtagvi, use in manufacturing and clinical use. Aside from the main business tied to omegamy, manufacturing and clinical use represent an existing base revenue for Proleukin. My team is focusing on opportunities to increase sales growth in all three areas. As Fred mentioned, strong ProLiquid sales in our main channel will resume throughout the remainder of 2025, including two distributors expected to reorder in the second quarter.

Speaker 4

In summary, I am energized to lead our commercial organization toward a bright future. Launching a first in class therapy entails a unique set of opportunities to make a fundamental difference. I am deeply committed to the I Events vision of pioneering a new treatment paradigm for physicians who treat patients with solid tumours. We have barely scratched the surface of IMTAGI's potential to globally address more than thirty thousand melanoma patients annually. IMTAGI has tremendous promise in solid tumor cancers, which represent ninety percent of all cancers.

Speaker 4

I will now pass the call to Igor Malinski, our Chief Operating Officer, to highlight our manufacturing progress.

Speaker 5

Thank you, Dan. Today I will provide an update on our progress in manufacturing. Our Philadelphia based manufacturing network consists of two FDA approved facilities, our internal manufacturing facility, the Ivant Cell Therapy Center, or ICDC, and an American owned contract manufacturer. This network serves commercial patients in The US, as well as clinical trial patients across Europe, Australia, and Asia. Our experience in supplying Tilt cell therapies to clinical patients around the world provides a strong foundation for delivering commercial product in The EU, UK, and Canada in the near term.

Speaker 5

Today, I'm pleased to report a major step forward in the ongoing review of our marketing authorization application, or MAA, for the European Union approval of Omtagni. Recently, as part of the MAA process, the European Medicines Agency or EMA inspected and confirmed that the ICTC and our contract manufacturer's facility are both GMP compliant. These successful EMA inspections further validate our manufacturing network capabilities to meet regulatory standards from multiple health care authorities as we prepare to serve commercial patients in the European Union. As part of the ongoing launch, we steadily ramped up our staff manufacturing capacity to align with demand, while tightly controlling expenses. As a result of our revised revenue guidance and updated demand forecast, as Fred described, we expect to realize additional cost savings by aligning our manufacturing capacity growth plans with demand.

Speaker 5

Owning our own manufacturing facility provides us with tremendous flexibility to scale up efficiently when needed. As mentioned previously, iCTC conducted and successfully completed annual scheduled maintenance. Given the three week manufacturing process for omtacvi, the network capacity was reduced by more than 50% for approximately one month in December 2024, thus lowering available capacity for Q1 mTagB infusions. Following maintenance, production resumed successfully with full capacity available for Q2 mTagB infusions. I will also comment on our manufacturing success rate in the first quarter.

Speaker 5

Delivering final product within defined specifications is critical for treating patients. Throughout the first nine months of The US launch, our commercial manufacturing experience was consistent with prior clinical experience. The rate of patient drop offs in our SPECT rate increased somewhat in the first quarter, thus impacting our cost of goods and gross margin, as Jean Marc will further discuss. Following Q1, manufacturing success rate has since rebounded. During this year, we also expect to shorten our manufacturing turnaround time, which is currently thirty four days from receipt of sales at the manufacturing facility to MTag being ready for return shipment to the ADC.

Speaker 5

In addition, we continue to be laser focused on driving operational efficiencies and economies of scale to optimize the cost of goods and improve gross margin over time. Shifting to the current macroeconomic and geopolitical environment, Iovance is operating at a strategic advantage within the biopharma industry. We expect on TAGB and Proloquin to see minimal impact from tariffs. Our intellectual property form TAGB and investigational Till cell therapies is domiciled in The US. Antagua manufacturing is based in The US.

Speaker 5

Most of the Antagua cost is US based with direct materials procured from ex US Vendors currently representing less than 5% of the Antagua cost of goods. For Prolukin, we have also brought sufficient Prolukin inventory to The US that we expect to be sufficient for meeting demand into 2027. Our Till cell therapy expertise and manufacturing capabilities are protected by robust patent estate domiciled in The US. We own approximately two eighty granted or allowed US and international patents and patent rights, one tag the another Till related technologies. We expect these patents to provide exclusivity through at least 02/1942.

Speaker 5

I'm available to answer questions during the Q and A, and I will now hand the call to Jean Marc, our Chief Financial Officer.

Speaker 6

Thank you, Igor. Today, I will review our cash position and results for the first quarter of twenty twenty five. I will also highlight our financial outlook, including revenue, expense guidance and gross margin. As of 03/31/2025, our cash position was approximately $366,000,000 Our current cash position is sufficient to fund current and planned operations, including manufacturing expansion into the second half of twenty twenty six. I will now transition to our financial results.

Speaker 6

Net loss for the first quarter of twenty twenty five was $116,200,000 or $0.36 per share compared to a net loss of $113,000,000 or $0.42 per share for the first quarter of twenty twenty four. Total product revenue consists of Emtag B infusion in The US and Proloquine sales. Total product revenue was $49,300,000 for the first quarter of twenty twenty five, including $43,600,000 for Emtac V and $5,700,000 for Proloquine, compared to total product revenue of $700,000 for the first quarter of twenty twenty four for Proloquine. The U. S.

Speaker 6

Commercial launch of EMTAGV and Proloquine sales drove the revenue increase in the first quarter of this year over the prior year period. I will now highlight our cost of sales, which includes cost of inventory, overhead and related cash and non cash expenses that are directly associated with sales of EMTAGV and Proloquine as well as manufacturing costs for EMTAGV. Cost of sales for the first quarter of twenty twenty five was $49,700,000 including 15,000,000 in period costs associated with patient drop off and manufacturing success rates, an increase quarter over quarter as Igor previously described. 5,400,000.0 for non cash expenses, including fair market value step up and intangible asset amortization and $1,300,000 in royalties payable on product sales. During the first quarter of twenty twenty four, cost of sales was $7,300,000 primarily related to non cash amortization for acquired intangible assets.

Speaker 6

The increase in cost of sales in the first quarter of twenty twenty five over the prior year period was primarily attributable to cash and non cash expenses associated with Emtivy product sales tied to The US launch, along with period costs associated with patient drop off and manufacturing success rates. Average standard gross margin is 32% for the first four launch quarters. Standard gross margin for the first quarter of twenty twenty five was 10% or $5,000,000 compared to total product revenue of $49,300,000 First quarter was negatively impacted by lower revenue and higher cost of sales as previously described. As we increase volume and capacity utilization, we expect gross margin to surpass 70% in the coming years. Our priorities are to drive revenue while optimizing our cost of sales with a correspondingly higher gross margin, as we expand our manufacturing, coordinate and continue our focus on ATC engagement and training and realize efficiencies in manufacturing and release testing.

Speaker 6

I will now shift to our operating expenses. Research and development expenses were $76,900,000 for the first quarter of twenty twenty five, a decrease of 4% compared to $79,800,000 for the same prior year period that was primarily attributable to the transition of Emtaglif from clinical to commercial manufacturing. The decrease was partially offset by higher headcount and related costs, including staff based compensation and clinical trial costs resulting from continued enrollment in existing trials. Selling, general and administrative expenses were $43,900,000 for the first quarter of twenty twenty five, an increase of 40% compared to $31,400,000 for the prior year period. Higher selling, general and administrative expenses were primarily attributable to increases in headcount and related costs, including stock based compensation to support the growth in the overall business and related corporate infrastructure, marketing and legal costs and costs to support the commercialization of mTagV and Proloquine.

Speaker 6

Looking ahead, we revised our guidance to between $250,000,000 and $300,000,000 in total product revenue for the full year 2025. After aligning our manufacturing slot expansion strategy with our new demand forecast, we are maintaining our current cash runway guidance into the second half of twenty twenty six. Cash burn for full year 2025 is expected to remain in line with prior guidance of less than $300,000,000 with a strong focus on optimizing spending and reducing expenses throughout the organization, including flat expenses related to Emtiv manufacturing headcount expansion for the latter half of twenty twenty five. As we grow revenue and as gross margin improves, we expect further reduction in our net cash spend with ample flexibility to control both capital and operating expenses as we approach breakeven. For additional information, please see the company's selected consolidated balance sheet and statements of operation in this afternoon's press release and our Form 10 Q to be filed later today.

Speaker 6

I will now hand the call to Frederic, our Chief Medical Officer to discuss our clinical pipeline.

Speaker 3

Thank you, Jean Marc. Building on the team's comments about omtagvi, the durability of responses following a onetime treatment is a key differentiator from other available and emerging therapies. We will present five year results from our C14401 trial at the American Society of Clinical Oncology, or ASCO, annual meeting on June 2. Compared to prior data updates, these results show consistent trends for overall survival and durability over a five year period. Our clinical programs and next generation approaches are the next frontier for Till cell therapy in solid tumors, which represent more than ninety percent of all diagnosed cancers in The US.

Speaker 3

Future growth drivers include global label expansion for lifalusulin to frontline advanced melanoma, other solid tumor types such as non small cell lung cancer, and next generation therapies. Today, I will summarize our latest pipeline updates. First, we are making progress towards the broader commercial opportunity for AMTAGV in frontline and advanced melanoma. Our global registrational phase three trial Tilvan three zero one remains on track to support accelerated and full approvals of IMTAGV in combination with pembrolizumab in frontline advanced melanoma, as well as regular approval of IMTAGRI in our initial indication in post anti PD-one melanoma. The proof of concept cohort is also investigating lisinuslu in combination with nivolumab and relaclimab in The US.

Speaker 3

Our registrational program in advanced non small cell lung cancer, the single arm phase II IOV LUN two zero two clinical study, is designed to show efficacy and safety of liselutone monotherapy in patients progressing after anti PD-one therapy. There's a significant unmet medical need as most patients progress in chemotherapy. The current standard of care in this treatment setting provides limited rate and duration of responses. We remain on track as planned to share additional data from IovLUN-two zero two in the second half of twenty twenty five. The trial is designed with the potential to support a potential regulatory decision on US accelerated approval in post anti PD-one non small cell lung cancer in 2027.

Speaker 3

In frontline non small cell lung cancer, our strategy is to establish a new regimen consisting of lifileutol plus pembrolizumab following standard of care chemotherapy pembrolizumab. Multiple cohorts are investigating patients with EGFR wild type non small cell lung cancer, who are the majority of patients with an unmet medical need in this treatment setting. Turning to another significant opportunity, advanced endometrial cancer, our IOV END two zero one clinical trial is investigating eliseleucel as the frontline standard of care of chemotherapy and anti PD-one. We look forward to sharing initial data from END-two zero one in the second half of this year. As the leader in Till cell therapy, Iovance is also at the forefront of next generation approaches to optimize Till and Till treatment regimens.

Speaker 3

I'll briefly summarize our three lead next generation programs. Our PD-one inactivated Till cell therapy, IOV4001, continues to enroll patients in a trial that previously treated advanced melanoma or non small cell lung cancer. Building on our successful PROLUCON franchise, we are treating patients in the phase onetwo clinical trial of IOV3001, a second generation modified IL-two analog for use with the Till cell therapy treatment regimen. And lastly, ILV-five thousand and one is a genetically engineered, inducible, and tethered IL-twelve Till cell therapy with potential for enhanced activity, which could facilitate expansion into a wide range of common solid tumor cancers beyond our current pipeline with significant market opportunity. We plan to submit an investigational new drug application to FDA this year for ILB five thousand one.

Speaker 3

I'm happy to address questions about these programs and additional trials during the Q and A session. I now turn the call over to the operator to begin the question and answer session.

Operator

As a reminder, to ask a question, please press star Our first question comes from Andrew Tsai with Jefferies. Your line is open.

Speaker 7

Hey, thanks. Good afternoon. Thanks for taking my question. Appreciate the update. My question is around the line of sight you're having amidst the revised guidance.

Speaker 7

Presumably, you do have some direct line of sight, maybe at least a month in advance into the number of patients who are waiting to get dosed in the queue. Can you confirm whether you're seeing or have seen a spike or an inflection in patient uptake as of today to give you the confidence around your guidance of 110 patients for Q2? Thank you.

Speaker 4

So Andrew, this is Dan. Thank you very much. Yes, we're confident in that number and we are seeing demand as we stated in the script in quarter two be strong.

Operator

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

Speaker 8

Hey, guys. Thanks very much for all the information. So for the 11 ATCs that have infused more than 10 patients, were most of them involved in the clinical program, and it's just a matter of getting the other ones that weren't up to speed. Maybe you could discuss the barriers of the other 37 ATCs that have infused more than one patient, but haven't infused ten plus, and what tactics you're employing to get them to increase their utilization.

Speaker 2

Todd, I'll start and I'll pass it over to Dan to give you a little bit more on the second part of that question. On the trial, only a few of those ATCs were actually involved in the trial. It's not necessarily a correlation between the clinical trial unit at a site and their experience and what the site does with commercial antagonists. A lot of times it's different people and we have to work closely with that unit at EJTC to get them up to speed. So there is some learning there, but we're able to overcome it.

Speaker 2

Obviously we're learning quite a bit ourselves about how to do that and we're getting better and better all the time. And that's why we have confidence that many of those other ATCs are going come along quickly. In fact, we're seeing that today. Dan, do you want to

Speaker 4

take the second part of the question? Sure. And looking at just with cell therapy in general, there's actually patients coming in to treat and there's a cell therapy experience level at these centers. So what we'll say is that the larger centers that got off to a quicker start, those are the ones with the infrastructure from various cell therapy launches that were ready for Entegrity to enter in. The other ones are ramping up to speed.

Speaker 4

They're doing this with other cell therapies as well. But infrastructure such as billing mechanisms, cell therapy lab, etcetera are coming online with that. So we are seeing them increase their ramp a lot quicker once they get that infrastructure in place. Does that answer your question?

Speaker 2

Yep, thank you. Thank you.

Operator

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

Speaker 9

Great. Thanks for the question, guys, and the color today. I guess on your guidance kind of going forward here for '25, if I'm doing my math correctly here and assuming something like 20% Prolukin, sort of backing into the balance of the year, you're going have something like two fifty or three twenty five infusions. So roughly like, call it 110, something like that, hundred per quarter roughly. Is that a correct way to sort of think about this which essentially apply no growth versus the 2Q number?

Speaker 5

No, Salim, that's not how you

Speaker 2

want to think about it. We're actually right now, as you know, we did $164,000,000 in revenue last year, including quite a bit of Proleukin, and what we're projecting is $250,000,000 to 300,000,000 this year, which is some growth there obviously. That's fiscal year aligned. If you want to think of it as just infusions though, you can look at the four quarters. We infused our first two patients back in April of twenty twenty four and through to the March we were about two eighty some patients infused.

Speaker 2

Our guidance implies that in this year we'll probably get over 500 patients infused and that's in the four quarters of the fiscal year. And of course there'll be another quarter into 2026 that will grow even more. So you are looking at like a 50% or more growth rate there as you go through this time period year over year and there's a lot of upside there as well. Dave, do want to add to that? Sure.

Speaker 4

So what I would say is the way you can look at this is that we expect continued growth throughout this year. So it will not be flat, it will continue to grow. That's driven by two factors. One, as we talked about the increase of adoption in our centers, both the ones that started in the very beginning and the ones that ramped up through 2024, and the addition of new ATCs that have enhanced referral networks within the community to get patients not only in quantity but also quality, meaning they're getting earlier referrals.

Speaker 9

Okay, thank you so much.

Operator

Thank you. Our next question comes from Andrea Newkirk with Goldman Sachs. Your line is open.

Speaker 10

Good afternoon. Thanks for taking the question. Maybe a follow-up there, Fred, on what your guidance is implying per infusions. I just wanted to make sure I understood this. Are you suggesting that 500 infusions should be on top for 2025?

Speaker 10

And if that's the case, then what are you assuming for Prolukin through the remainder of this year, even after the uptick expected in 2Q?

Speaker 2

So if you just take the guidance we gave, subtract off a number like what Salim just gave you for Prolukin, and divide that through by $5.50 or so, you're going get something in the high 400s, close to 500 depending. If you think

Speaker 5

we just have some upside here, there could be some upside too on top of that. Does that answer the question?

Speaker 10

Okay, thank you. And then just really quickly, Igor, could you just speak to what drove the higher patient drops or lower manufacturing success in the quarter? And what gives you the confidence that this will reverse on the forward?

Speaker 5

So some of this thanks for the question, Andrew. Some of this or much of this is related to patient selection and the tumor procurement technique. And as I mentioned, we already saw the return to normal rebound in the Q2 so far. What gives us confidence is the success rate trends that we see among ATCs who have been up and running for a long time and the experience curve that they've been able to achieve, so that gives us confidence that it's teachable and can be translated to other ATCs across the network.

Operator

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

Speaker 11

Thanks for taking our questions. First, a clarifying question. I must be missing something. So assuming each Empaglutide product is roughly north of $500,000 that's half a million, and then if there's 500 patients infused this year, that alone will be two fifty million, which is the lower bound of the guidance. So if that's the case, then adding IL-two on top of that, the lower bound of guidance should really be above two fifty.

Speaker 11

So I'm trying to see if my assumption for per patient price off, and thank you for clarifying. My actual question is on COGS. Can you talk about the, you know, it seems like COGS as a, you know, ratio of revenue has increased over the last quarter. Just wanted to understand what proportion of the COGS is due to patient attrition, I. E.

Speaker 11

Patient passing away, cannot get the product, or manufacturing failure? If you can give us some color there. Thank you.

Speaker 2

Yes, Ian, on the first part, our guidance we consider this guidance to be fairly conservative. So as you go and do your math there, there is going to be some upside on what we're giving here. But if we get the 500 infusions it might be above 300 on the upper end and that's something that we really want to with this new guidance we really want to show that we can actually exceed guidance here and do well here with this launch. So it's not going to work out exactly to where you might think maybe it's four fifty patients if you want to be more conservative. However, it's still growth.

Speaker 2

It's still growth over the first three quarters of the launch if you want look at it on a fiscal year basis or four quarters if want to look at it on a launch year basis. But again the first four quarters of our launch we treated about two eighty some patients. Now for the COGS question, me ask Annette the ratio of scrap and Jean Marc and maybe Igor might need

Speaker 5

to help out with that one.

Speaker 4

Can I just say one thing first, so one of the things I mean first the quarter the $250,000,000 is a 50% growth over 2024 sales So I should say? So that is definitely a growth in the lower end for it. And yes, we would love to have upside to that. The second part when you talk about patient health, just want to clarify that statement. Those are patients who went to hospice or died prior to the manufacturing process starting, meaning they went there before we had tumor procurement.

Speaker 4

So therefore they would not be affecting COGS. Igor, do you want to take the COGS question? You and John Marc? I think Jean Marc may need to take that.

Speaker 6

Yeah, I'm happy to take the COGS question. So yes, you're correct. We had an increase in the overall cost of sales together. Igbo mentioned during the script is that we see a spike in the out of spec on the first quarter that we know will improve over time, but you have to think also relative to the overall revenue. So yes, the cost of goods and the cost of sales has increased in Q1, particularly related to revenue, but we know this will definitely improve in Q2.

Speaker 6

And our standard gross margin remained positive in Q1, as you heard me saying.

Speaker 11

Got it. Thanks for the color.

Operator

Thank you. Our next question comes from Colleen Cusi with Baird. Your line is open.

Speaker 1

Good afternoon. Thanks for taking our questions. So you report that patient drop on out of spec rate together, but can we assume that that out of spec rate went up? And if so, what drove that? Was it anything to do with the annual maintenance?

Speaker 1

And then would we expect that same one month interruption going forward every year? Thank you.

Speaker 5

Colleen, thanks for the question. So again, regarding the patient drop offs and manufacturing success rate, these closely relate to each ATC's track record and patient selection in tumor tissue procurement, and again, the increase we saw in Q1, we believe it to be transient. It's already normalized in Q2 to date. So that's what we believe is driving it. We have new ATCs, new surgeons, and some of that needs to be optimized over time, which our teams are working on.

Speaker 5

What was the second part of the question?

Speaker 1

Just the annual maintenance, whether that will be a similar one month fifty percent reduction in capacity every year?

Speaker 5

Annual maintenance, so we are now completing build out of the shelf space at ICTC. Once that shelf space is operational, which will not be this year, but should be later on, once that shelf space is operational, then we don't need to the maintenance will only affect part of the ICTC facility, not all.

Speaker 2

So will have less impact.

Speaker 5

It will have less impact.

Speaker 2

But yes, Colleen, it is an annual event that you have to

Speaker 5

do it. But for now, this year, we'll still need to do it. But in the subsequent years, once the ICDC is fully built out and fully up and running, we will not see that effect.

Speaker 1

Helpful. Thank you.

Operator

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

Speaker 12

Great. Thank you so much. Just going back to kind of manufacturing success, has that returned back to normal levels? And was that also related to the I thought you had a problem in 4Q as well associated with the same thing. Is the same thing kind of spread into 1Q or a separate issue?

Speaker 2

I'm not really sure, Peter, what you're asking out there. The important point is we didn't talk

Speaker 5

about that in the last

Speaker 2

quarter at all. What we did mention back then is there was going to be a shutdown, and we were in the process of, at that point, actually hitting the

Speaker 5

shutdown. But no, we don't that doesn't resonate. There was no issue with manufacturing success rates in Q4, no. Q4 was actually a good quarter for us.

Speaker 2

Now the important thing to remember here, Peter, is rebounded already. Again, think it has to do with individual activities in some of the ATCs and how they procure tumor as well as some things that we can learn from throughout the entire process and how we can improve those things. It looks like it's already rebounded pretty well. We're back in the zone where we think we were during the first part of the launch.

Speaker 12

Got you. Thank you. And is there any way of breaking out the revenue weakness you had and lower guidance, kind of how much of that's due to demand uncertainty and or manufacturing uncertainty?

Speaker 2

No, I don't really think there's a way of doing that. No, that would be very complicated to analyze that. Can't think of Dan or Peaker?

Speaker 4

I mean, we see demand being consistent and growing, especially with the new centers coming on with it, not the ones ramping up. So demand is not an issue for that part of it. And I think Igor addressed the manufacturing

Speaker 5

success rate. Success rate, the trend over time from the beginning of launch, the success rates are improving, and we expect that to continue this year.

Speaker 2

The guidance Peter is really driven by ATC launch dynamics more than anything, it's not really about uncertainty in those areas.

Speaker 12

Gotcha. Okay. Thanks so much.

Operator

Thank you. Our next question comes from Reni Benjamin with Citizens. Your line is open.

Speaker 13

Hey, guys. Thanks for taking the questions. Igor, you had mentioned that these different ATCs are doing things slightly different. I'm kind of curious, what are the strategies, the different strategies that you guys are employing right now to kinda get all these ATCs rolling in the same direction to improve all these, improve the various manufacturing things and to help improve the overall processes there? And then just as a second question, it's revised guidance.

Speaker 13

I guess we were all kind of surprised to begin with when last year you provided guidance for this year. I'm kind of curious as I get being conservative now. Why provide guidance for 2025 way back in 2024 to begin with?

Speaker 2

So the first part perhaps Dan can answer. Sure. I can also throw over to Brian for that.

Speaker 4

One of the things we're seeing for the tumor tissue procurement that's happening at the centers and replicating the successes that we're seeing with the surgeons that are doing it better than others, we actually have our field teams out there now that really focus and actually from the medical affairs side, so I'll hand to Brian. But Brian, can you talk about how your field teams are addressing that as the centers to replicate your test? Yeah, think one of the

Speaker 14

things that's happening is we've recognized that these centers continue to grow internally. They keep adding new members and what we've been doing really you call it a white glove service where we're getting in there and actually certainly for the newer surgeons to actually go from we call it the start program or start to finish program where we actually go in and we'll walk through the surgery and beyond with them to try to make sure that every case is as successful as possible. We've had very good feedback they enjoy it especially the new centers and the new surgeons and we're hoping to try to really speed up those learning curves for our newest ADCs so that they can learn from the successes of our best ADCs that have

Speaker 4

been around a long time.

Speaker 2

I guess I can get the second part of your question ready. Back in August we were trying to give investors our best line of sight to what we thought was going to happen. At that point we were very well aware of the high demand for the product and we were ramping up our manufacturing as fast as we could, so we built our model on the back of how many manufacturing slots we would make available at maximum ramp. Now as we've gone, we've learned a lot about the launch, especially recently as we watched some of the dynamics of the ATCs, we looked at our experience with growth trajectories there, we look at the timelines it takes for new ATC's to come on board and begin treating their first patients and how they work through their processes. We're onboarding these large community practices which take some time and we're doing the community referral process which takes a lot of time too.

Speaker 2

And as we looked at that we just decided that it was better and more accurate for us to forecast guidance that

Speaker 5

we gave

Speaker 2

today to show you that we can still make this product grow very substantially, but now what we're going do is we're just going to limit our manufacturing slots. It ends up being essentially almost a neutral one with respect to how we use our cash, and we'll roll forwards and we'll continue to succeed on the launch, but we think we'll do it on terms that are I think a little bit more in line with what we actually see at the ATCs.

Operator

Thank you. Our next question comes from Asthika Goonewarden with Truth. Your line is open.

Speaker 15

This is Karina for Asthika. Thanks for taking the questions. What percentage of the product is currently being manufactured at the ICT versus contract manufacturer? And then also, again, lower manufacturing success rate, some of the clinicians, they noted that there's a need for a larger amount of tissue to improve success rate. Can you comment on that?

Speaker 15

Thanks.

Speaker 5

So I'll take the first part. ICTC, our internal manufacturing facility, is responsible for most of the manufacturing volume and has significantly higher capacity than our contract manufacturer. And then the second part, perhaps I'll turn it over to Brian.

Speaker 14

Yeah, I mean we made a lot of guidance changes in terms of best surgical practices. It goes from volume of tumor to handling of tumor in general and preparing it before it's being sent. To be honest with you, do we need all the tumor that we get sent? Not always, but we generally guide towards what I would call the average ATC, the average surgeon because you know the best surgeons probably don't need any guidance and probably the below average need a lot of guidance and so in general we do try

Speaker 4

to ask them for as much tumour that reasonably fits into our into the vial that we give them. All

Speaker 15

right. Thank you.

Operator

Thank you. I'm showing no further questions at this time. I would now like to turn it back to Fred Boat, interim president and CEO for closing remarks.

Speaker 2

Thank you again for joining the Iovance Biotherapeutics first quarter twenty twenty five financial results and corporate updates conference call. We look forward to providing future updates on our growing commercial and clinical portfolio, including our data presentation and investor event at the upcoming ASCO Annual Meeting in Chicago. We are motivated by the stories we continue to hear about the patients who benefit from Iovance cell therapies in our clinical trials in the commercial setting. I'm confident that Iovance will remain the global leader in innovating, developing and delivering current and future generations of Till cell therapies for patients with cancer. As always, we are thankful to the patients, healthcare, and advocacy communities, our partners, and our exceptional IVANS team.

Speaker 2

I'd also like to thank our shareholders and covering analysts for their support. Thank you. This concludes today's conference call.

Operator

Thank you for participating. You may now disconnect.

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Key Takeaways

  • In Q1 2025, total product revenue reached $49.3 million ($43.6 million from AMTAGV infusions and $5.7 million from Proleukin), down from Q4 due to annual ICTC maintenance, temporary manufacturing dips, patient drop-offs, and uneven ATC pacing, but Q2 production starts hit a record high with Perleukin restocking underway.
  • The company narrowed its 2025 revenue guidance to $250 million–$300 million, expects cash burn below $300 million with runway into H2 2026, and foresees peak AMTAGV sales exceeding $1 billion in the U.S. (>$2 billion globally) and gross margins above 70% in future years.
  • The U.S. commercial network includes 70 ATCs—16% have infused more than 10 patients—with plans to onboard over 10 new high-quality centers and intensified community oncologist education to drive earlier referrals and adoption in second-line melanoma.
  • Iovance’s U.S. manufacturing network—including its internal cell therapy center and a U.S. CMO—recently passed EMA GMP inspections, completed scheduled maintenance in Q1 (temporarily halving capacity), has rebounded manufacturing success rates, and will shorten turnaround times while improving cost-of-goods.
  • Key pipeline milestones include five-year durability data for lifileucel at ASCO, a second-half 2025 readout from the post-PD-1 NSCLC trial, initial endometrial cancer results, and advancement of next-generation TIL therapies (PD-1 inactivated, IL-2 analog, inducible IL-12).
A.I. generated. May contain errors.
Earnings Conference Call
Iovance Biotherapeutics Q1 2025
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