Iovance Biotherapeutics Q4 2023 Earnings Call Transcript

Quartr
Provided by Quartr
February 28, 2024

There are 16 speakers on the call.

Operator

Welcome to

Speaker 1

the Iovance Biotherapeutics Conference Call to discuss the Full Year 2023 Results and Recent Corporate Updates. My name is Kevin, and I'll be your operator for today's call. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session. Please note that this conference is being recorded.

Speaker 1

Will now turn the call over to Sarah Pellegrino, Senior Vice President, Investor Relations and Corporate Communications, Iovance. Sarah, you may begin.

Speaker 2

Thank you, operator. Good afternoon, and thank you for joining our conference call and webcast to discuss full year 2023 results and recent corporate update. Doctor. Fred Vogt, our Interim President and Chief Executive Officer, will provide a brief introduction. Jim Ziegler, EVP Commercial will highlight our initial insights for the U.

Speaker 2

S. Commercial launch of AMTEGVI following the recent U. S. Food and Drug Administration or FDA approval in advanced melanoma Igor Belinsky, Chief Operating Officer will highlight commercial manufacturing and capacity expansion plans Frederic Grassenstein, our Chief Medical Officer, will summarize key clinical pipeline highlights and Jean Marc Bellamy, Chief Financial Officer will review our financial results. Doctor.

Speaker 2

Brian Gasman, EVP, Medical Affairs and Raj Puri, EVP, Regulatory Strategy and Translational Medicine are also on the call and available for the Q and A session. Before we start, I would like to remind everyone that statements made during this call will include forward looking statements regarding Iovance's goals, business focus, business plans and transactions, revenue, 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. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward looking statements.

Speaker 2

With that, I will turn the call over to Fred.

Operator

Thank you, Sarah, and good afternoon, everyone. I'm pleased to host our 2023 full year results conference call. Throughout last year, we executed toward our 1st approval of commercial launch while advancing our pipeline. On today's call, we have a variety of exciting topics to cover on the heels of the U. S.

Operator

FDA's recent approval of Aptagvi, the first one time T cell therapy for a solid tumor. Aptagvi's label allows us to become the first treatment option for advanced melanoma patients after anti PD-one and targeted therapy. The strength of this label also reflects a best case scenario with strong efficacy data from pelvular Cohort 4 as well as pooled Cohorts 2 and 4. In the 1st few days of U. S.

Operator

Launch, we are seeing strong demand and momentum for empagbib. Consequently, we also expect increased demand for Proleukin. 30 authorized treatment centers or ATCs were ready for approval and nearly all have identified a patient. Jim will provide more detail later in the call. The first tumor resection occurred in the 1st business day after approval and commercial manufacturing began the following day at our Iovance cell therapy center or iCTC.

Operator

This is a testament to the high unmet medical need and the great segment around this new therapy as well as our commercial manufacturing readiness. Igor will talk today about our capacity to serve our near term commercial launch clinical trials and ongoing expansion plans. In addition to the U. S. Launch, our near term expansion plans for Emtekivy are focused on addressing many thousands additional patients by entering new geographies browsing the label to include frontline advanced melanoma as well as other indications.

Operator

For example, our planned global expansion has the potential to double the total number of addressable patients for MTAGMI and post anti PD-one melanoma. We remain on track to submit regulatory dossier this year in the European Union in the first half of the year, followed by the United Kingdom and Canada in the second half. In addition, our Phase 3 TilbaS-three zero one trial continues with strong momentum in several countries to support regulatory submissions in frontline advanced melanoma. We are also pleased with the progress with our robust development pipeline across solid tumor cancers. Frederic will speak later about some key highlights in our ongoing clinical trial programs.

Operator

Today, iovance is a fully integrated company and is now the 1st company to commercial a T cell therapy for a solid tumor indication. We are well positioned to execute on our regulatory pipeline, manufacturing commercial launch activities to remain the global leader in Till cell therapy. Jim will now describe the ongoing activities related to our U. S. Launch.

Speaker 3

Thank you, Fred. Each year approximately 8,000 people in the U. S. Die from melanoma. Until now, there have been no FDA approved treatment options for patients with advanced melanoma whose disease progressed following an immune checkpoint inhibitor and if appropriate, a targeted therapy.

Speaker 3

For these patients, eMTAGV ushers in a new era for the melanoma treatment landscape as a one time cell therapy that is manufactured specifically for each patient to address a significant unmet need. Today, I will highlight our launch activities, ATC onboarding, as well as access and reimbursement. There is strong level of ATC commitment with 30 onboard today. These onboarded ATCs are engaged in various stages of the process, including patient identification, reimbursement authorization, scheduling and tumor tissue procurement and manufacturing. In the less than 2 weeks following approval, the majority of our activated ATCs have at least one identified patient and are in the process of establishing financial clearance for reimbursement, including prior authorizations and single case agreements.

Speaker 3

There are at least 20 patients in the process, which includes 10 patients with scheduled or pending manufacturing slots. The number of ATCs engaged in this process reflects the high unmet need and a sense of urgency to offer MTAG V to the for their advanced melanoma patients. In addition, we continue to onboard and remain on track to have approximately 50 active ATCs in total by the end of May. We are also pleased with the initial market access and inpatient reimbursement trends for eMTAGV. These are consistent with approved CAR T products with the benefit of increased speed resulting from both our preparation and the HCC's experience.

Speaker 3

We continue to anticipate prior authorizations to include coverage consistent with label, medical coverage policies within about 90 to 180 days and single case agreements for commercially insured patients. I want to acknowledge our strong cross functional teams who have worked tirelessly to ensure our launch readiness and execution. We are confident in our ability to deliver a successful commercial launch. I will now turn the call over to Igor, who will highlight our manufacturing readiness and capabilities.

Speaker 4

Thank you, Jim. Emtagovy as well as our investigational Till cell therapies are manufactured using our proprietary process to collect the patient's TIL cells from a portion of their tumor, multiply them into billions and return them back to the patients to fight cancer. The U. S. FDA has approved commercial manufacturing at our internal facility, the Iovance Cell Therapy Center or ICTC, as well as at a nearby contract manufacturer.

Speaker 4

These facilities are built to support up to several 1,000 patients annually. As Fred mentioned, the first tumor resection occurred on the 1st business day after approval and commercial manufacturing of ANTOGVI is officially underway. We are currently staffed to meet the anticipated needs of our U. S. Launch as well as our ongoing and planned clinical trials.

Speaker 4

In the BLA submission form tag B, we have included the capacity demonstration study higher than our immediate needs. This means that we can increase near term capacity through increased staffing without requiring additional capacity authorizations. In addition, we're building further capacity to align with our near term and long term manufacturing needs. As we prepare to expand markets and indications and advance our solid tumor pipeline, expansion within the ICDC facility is already starting. Build out of additional clean rooms within the existing shelf space at ICDC can significantly increase capacity to over 5,000 patients annually over the next few years.

Speaker 4

Longer term, our future expansion plans may bring our manufacturing capacity above 10,000 patients annually. In summary, our team is excited to provide EmTagV to patients in need. We are laser focused on the quality of the manufacturing process in the spirit of doing everything right first time at every step from incoming receipt of the tumor sample through the manufacturing and product release process to outbound shipment of the final EmtekVI product to the ATCs and to patients. I'm available to answer additional questions during the Q and A, and I will now hand the call over to Friedrik.

Speaker 5

Thank you, Igor. I'm pleased to speak today about the key highlights within our clinical pipeline in solid tumors, which as you know represent more than 90% of all diagnosed cancers in the U. S. I'll begin with Tillavans 301, our registrational Phase 3 trial in frontline advanced melanoma. TILOVANCE 301 is well underway support accelerated and full approvals of antagvie in combination with pembrolizumab in frontline advanced melanoma.

Speaker 5

Global site activation and patient enrollment continue with strong momentum in the U. S, Europe, Australia, Canada and additional countries. SILVANZ301 is also the confirmatory trial to support full approval of Octagon post anti PD-one advanced melanoma. Shifting to our program in non small cell lung cancer and our single arm registrational Phase 2 trial, IOV LUN202 in post anti PD-one non small cell lung cancer. Enrollment in the registrational cohort is estimated to complete in 2025.

Speaker 5

Following the partial clinical hold for new patients, we are working collaboratively with the U. S. FDA and believe we have provided all the necessary information to resume new patient enrollment in the near future. We are also preparing to start up a new Phase 2 trial in post anti PD-one endometrial cancer, which is expected to include patient populations who are deficient and proficient in mismatch repair. Till cell therapy based on its mechanism of action may benefit both of these patient populations.

Speaker 5

We look forward to providing more details in advancing this trial this year. Iovance is the leader in Till cell therapy, including next generation approaches that have the potential to optimize outcomes for patients. We continue to investigate our genetically modified PD-one inactivated Till therapy IOV-four thousand and one in the GM-two zero one trial. This is the 1st in human trial in previously treated advanced melanoma or non small cell lung cancer patients. This was just a snapshot of the many activities and progress across our forward tumor pipeline and I'm happy to address questions about these programs and additional trials during the Q and A session.

Speaker 5

I will now hand the call to Jean Marc. Jean Marc?

Speaker 6

Thank you, Frederic. Today, I will review our current cash position as well as our full year results for the year ended on December 31, 2023. I will also highlight our 2024 outlook. As of February 22, 2024, our unaudited cash position is approximately $485,200,000 which includes net proceeds of approximately $197,100,000 net of underwriting and other offering expenses from a follow on equity financing in February of 2024. The current cash position and anticipated revenue from both and for looking are expected to be sufficient to fund current and paying the operation well into the second half of twenty twenty five.

Speaker 6

Shifting to our full year financial results. Net loss for the Q4 ended December 31, 2023 was $116,400,000 or $0.45 per share compared to a net loss of $105,300,000 or $0.64 per share for the Q4 ended December 31, 2022. Net loss for the year ended December 31, 2023 was $444,000,000 or $1.89 per share compared to a net loss of $395,900,000 or $2.49 per share for the year ended December 31, 2022. The net loss for the year ended December 31, 2023 includes amortization of intangible assets acquired as part of the forward looking transaction. Revenue from the 4th quarter and year ended December 31, 2023 was $482,000 $1,000,000 respectively, and comprised of product sales of ProLukin following the acquisition in May 2023.

Speaker 6

There were no revenue for the Q4 year ended December 31, 2022. Cost of sales for the 4th quarter year end December 31, 2023, was $4,400,000 $10,800,000 respectively, and comprised of cost of inventory associated with sales of producting as well as $3,900,000 and $9,700,000 respectively of non cash amortization expenses for the acquired intangible assets for developed technology. There were no cost of revenue for the Q4 year ended December 31, 2022. Research and development expenses were $87,500,000 for the Q4 ended December 31, 2023, an increase of $6,900,000 compared to $80,600,000 for the same period ended December 31, 2022. Research and development expenses were $344,100,000 for the year ended December 31, 2023, an increase of $49,300,000 compared to $294,800,000 for the same period ended December 31, 2022.

Speaker 6

The increases in research and development expenses in the Q4 and the year ended December 31, 2023, over the prior year periods were primarily attributable to increases in headcount and related costs to support increased production capacity and commercial manufacturing readiness and clinical trial costs driven primarily by the initiation of our Phase III TLDRAM301 clinical trial. Selling, general and administrative expenses were $29,900,000 for the 4th quarter ended December 31, 2023, an increase of $3,400,000 compared to $26,500,000 for the same period ended December 31, 2022. Selling, general and administrative expenses were $106,900,000 for the year ended December 31, 2023, an increase of $2,800,000 compared to $104,100,000 for the same period ended December 31, 2022. The increase in selling, general and administrative expenses in the 4th quarter and the year ended December 31, 2023, compared to the prior year periods was primarily attributable to increasing headcount and related costs to support the growth in the overall business and related corporate infrastructure, professional fees and travel costs as well as costs associated with pro looking integration activities. This increase was partially offset by the increase in stock based compensation expenses, legal and other costs.

Speaker 6

For additional information, please see this afternoon press release and our annual report on Form 10 ks to be filed later today. Regarding our outlook for this year, we continue to guide towards full year 2024 cash burn in the range of $320,000,000 to $340,000,000 excluding one time expenses. And we will continue to leverage to with the EMTAGVI treatment regimen are expected to drive significant revenue in the second half of twenty twenty four and into 2025 and beyond. Revenue recognition for Emtek V occurs upon infusion like other cell therapies. So we expect to begin recognizing and reporting significant revenue in the Q2 of this year.

Speaker 6

I will now turn the call over to the operator to begin the question and answer session.

Speaker 1

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

Speaker 7

Great. Thanks for taking our questions and congrats on this initial momentum. Just curious about the 10 patients. It sounds like you have 10 patients that are already at the stage of scheduling manufacturing slot. Wondering how long did these patients' reimbursement process took.

Speaker 7

Does that give you any updated thinking, a way of thinking of the average time from patient identification to tumor resection? And also, we see the word, some of these ten patients are pending for manufacturing slots. Just wondering what does that mean and what's behind the word pending? Thank you.

Operator

Yes, hi, Ana. It's Fred. So, they obviously move very quickly for centers that we're able to schedule these patients, the 10 patients that are either scheduled for a slot or soon to schedule for a slot are all moving through the process much more quickly. Some centers move fast, some centers move slow. What we're seeing here I think is some pent up demand and real excitement for the AMPEGGY launch.

Operator

I'll let Jim add. Jim, do you want to add any comments to that?

Speaker 3

Thanks, Fred. I think Yanan, it's still too early to tell what we've guided before based upon our experience in cell therapy approvals. It takes a couple of days for prior authorization and a couple of weeks for single case agreement. As Fred pointed out, there has been some quick movement because of the sense of urgency at these ATCs. To further define what pending means, ATCs basically will schedule a slot once they know they have successful reimbursement.

Speaker 3

So pending is that they're registered, they're ready to go, but they're not quite ready to pull the trigger on that slot yet.

Speaker 7

Great. If I can have a very quick follow-up, namely, you mentioned manufacturing could be conducted at CTC or the CDMO. Just wondering how are you distributing the flow to these two facilities? And if you might if you would mind commenting on the margin for the CDMO? Thank you very much.

Operator

Yes, we can't really say what their margin is. They know that. Obviously, that's their business. We think it's competitive with what we do. So we employ a make versus buy strategy at Ivant and we constantly look at internal manufacturers external that keeps everything in high competition and we think that's the way the best way to run a business.

Operator

Question?

Speaker 7

Right. How would you distribute the flow to ITC to see versus CDMO?

Operator

Yes. So we have internal algorithms for doing that and I can't share the full details, but we distribute the flow somewhat evenly across the two sites. And as we expand and as we grow, I think we'll be able to manage that even more tightly as we learn a little bit more right now about how the sites perform and who's doing the best here. But we run them as an internally competitive process. And again, just to make sure it's really clear, there is no real issue at all with capacity between the 2.

Operator

We have tons of capacity right now for this launch.

Speaker 7

Great. Thanks for all the color and congrats on the progress.

Speaker 8

Thank you.

Speaker 1

One moment for our next question. Our next question comes from Tyler Van Buren with TD Cowen. Your line is open.

Speaker 9

Great. Hey, guys. Thanks for taking the question. The patients in process for MTAGV is very encouraging update given that we're just a week and a half in. But as we think about the 20 MTAGV patients in process, does this constitute the majority of the initial bolus in the 30 ATCs with the majority of sites having at least one patient as you noted?

Speaker 9

Or would you be more likely to characterize it as a fraction? And just as a quick second question, with the MAA to be submitted in the first half and other ex U. S. Submissions, will Iovance be launching Lifeluzole abroad or do you expect to partner?

Operator

Yes, Tyler, that's a tiny fraction we think of the patients out there. It's not the initial bolus. The bolus is going to go on for quite some time and our sales team is out there and they've got a lot of information and it looks like this is going to be sustainable for quite some time. On the MAA front, we intend to do that ourselves. We're not looking for a partner right now to do that.

Operator

We think that could potentially dilute the value of our assets.

Speaker 1

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

Speaker 10

Great. Thank you. Thanks for taking the questions and congrats on the progress. Just wondering if you kind of talk through how you're thinking about how revenue gets booked and the impact of the patients on the IVANS Care program and kind of how you see patients coming in on that program versus not on that program?

Operator

Yes, Peter, in the press release, we talked about IVANS Cares. We're talking about the system that we use to register patients. IVANS Cares also includes patient assistance services. Right now, we're seeing commercial patients come through that are financially able to pay the full amount for OTECHV. But don't confuse the 2.

Operator

IVANS Care, when we say they're registered in the system, that's our system that all the patients track through no matter what they all go to that system. Does that help?

Speaker 10

Got you. Perfect. Thank you. And then how should we think about how long it would take to kind of stop booking revenues? Is that a kind of a 30, 40 day period before we can think about that?

Speaker 10

Or is it longer? So is it kind of beginning of 2Q versus late 2Q?

Operator

So we recognize revenue at the time of infusion. Jean Marc was talking about that earlier and we talked about that last year too. Just like the other cell therapies, we recognize revenue when we actually infuse the antigens into the arm of the patient. So obviously, if we just commence manufacturing, you got to add some for manufacturing release of the product and then the infusion will occur and you'll see us accrue revenue at that point. It's not very far away.

Operator

We're talking weeks now until that starts to happen. But it does there is a time lag and that's why we've been talking about Q1 versus Q2 versus Q3 revenues here. Now Mark, do you want to add anything to that?

Speaker 6

No, I think you characterized it properly. So we will have the first infusion coming sometimes after all the manufacturing process, the release will happen and then we'll book the revenue now. It's a question of several weeks still.

Speaker 10

Got you. And anything you can say about the patients that have already been selected? Do they kind of later line, earlier line? Any details around that

Speaker 7

would be great. Thank you.

Operator

Yes. Jim, could you get this?

Speaker 3

Yes. It's probably not appropriate to comment too much other than this patient had been identified and was ready to go. The center that we're talking about had worked them up and as soon as we got approval moved literally within hours.

Speaker 10

Great. Thanks so much.

Speaker 1

One moment for our next question. Our next question comes from Colleen Cussey with Baird. Your line is open.

Speaker 11

Congrats on the progress and thanks for taking our questions. On the example of the tumor section that happened the next business day, did that patient have reimbursement lined up already or does that speak to the confidence of the center and eventually getting reimbursement? And as an add on to that, can you just speak to the early reimbursement success rate so far?

Operator

Yes, Collyn, you got partially cut off there for the first question, but I think you're asking whether the first patient had their financial clearance already worked up. Is that what you're saying?

Speaker 11

Yes, exactly.

Operator

Yes. So that center, Jim can comment more, but that center basically wanted to get ahead so fast that they are doing it in parallel. And then Jim, do you want to comment on Helane's second question about the health financial clearance is going overall?

Speaker 3

Yes. Colleen, it's still a bit too early to tell, but what I would say is the payers appreciate the unmet need, understand the clinical value of MTAG B and to date, we haven't had any issues. But I would provide the disclaimer that we are very, very early on. Just going back to that first patient and having a very competent experienced team, When this particular ATC reached out to the payer, the payer reached out to our account manager, connected the dots and everything moved very smoothly and very quickly in this particular situation.

Speaker 11

Great. That's really helpful. Thank you. And one quick follow on if I can on Europe. Can you just remind us that have EU regulators historically approached this review similar to U.

Speaker 11

S. Regulators? Is there anything unique about this filing versus the U. S. Filing?

Speaker 11

And just remind us what timelines would be in Europe, please?

Operator

Raj, do you want to take that one? Raj isn't available, I can answer it, Colleen. The accelerated approval like in Europe as well, we won't know that until we actually get further in the MAA process

Speaker 12

and it

Operator

can be a level on 1st of 14 month review period. We will obviously aim for the fastest review as can possibly get with the EMA. EMA is very cooperative and very interested in getting this drug to European patients.

Speaker 11

Great. Thanks for taking our questions and congrats again.

Speaker 1

Thanks. One moment for our next question. Our next question comes from Michael Yee with Jefferies. Your line is open.

Speaker 11

Hi, this is Yna on for Mike. Just wanted to say congrats again on the approval and thanks for the updates today. Just a quick question on, how we should think about the cadence of how patients would be treated in the coming months? I know you mentioned that you have the 20 patients sort of in process and those could be infused weekly. But how can we sort of think about the bolus and the cadence of how many new patients would be identified per site in the next coming months?

Speaker 11

And just quickly on the slots and capacity, how many slots were actually approved by the FDA? And is the manufacturing success rate likely to be in spec of at least 80% or how should we model and assume that?

Speaker 12

Thank you.

Operator

Yes. So on the cadence of treatment, we expect essentially a large bolus to go through. Just as you can see from all the banks and the analysts getting KOL calls and stuff like that, there's a lot of patients waiting for Emtagme. So we think we're going to be really busy here for the next couple of months. And then after that, we think we're

Speaker 8

going to continue to be busy as you

Operator

can see from the same KOL interactions. Most of the sites have several patients a month and when you average that all out across 30 moving to 50 ATCs, that's a very large number of patients every month for us to contend with. So we expect the cadence to essentially be at bolus and then move to a steady state. That's helpful. On slots and capacity, we haven't actually publicly disclosed the total amount of slots that we've got between Wuxi and RICTC facility, but it's enormous.

Operator

And I think be able to handle any load that comes in with what we got and we're very happy with the fact that the FDA gave us a lot of space to be able to manufacture. And then regarding the success rate, we don't really we can't really disclose at this point what the percentages and what's happening. We don't really know yet. We're still working on that and still testing. We think it's going to be quite high.

Operator

We will be successful manufacturing in the vast majority of cases. But again, we're only 12, literally 12 days in the launch right now. So we still need a little bit more time to figure that out.

Speaker 11

Got it. Thank you.

Speaker 1

One moment for our next question. Our next question comes from Joseph Catanzar with Piper Sandler. Your line is open.

Speaker 13

Hey, guys. Appreciate you taking my questions here. I wanted to maybe follow-up on manufacturing capacity, but asset in a slightly different way. So as we think about the dynamic of Ebola and the early indicators of demand you just mentioned today, to what extent if at all will you have to stagger receipt of tumor samples, meaning, the ATC is going to have to dictate the timing of their resection based on your ability to provide a slot or are ATCs able to resect and send sample pretty much at their choosing? And then sort of my second question, I know it's still the early days, but with the 50 ATCs planned to be onboarded by the end of May, are there any plans to add ATCs beyond that?

Speaker 13

And if so, to what extent and what's the timing around that? Thanks.

Operator

Yes. Igor, do you want to take the first part? Maybe Jim, we can talk a little bit about the Plan PAS 50 too.

Speaker 4

Yes. Yes. Great. Joe, thanks for the question. So we have as I mentioned, we have ample capacity to support launch as well as the clinical trials.

Speaker 4

And the way we design our capacity, part of that was extensive research, understanding the preferences of each and every ATC about the typical surgery dates and all of that's accounted for in our plan. So we expect to accommodate basically be completely flexible as to what ATCs need to do and provide all the capacity they need to treat all the patients who are in the queue right now. And as additional ATCs on board, we plan to do the same. And also as I mentioned, the capacity authorization enables us to hire additional staff and increase capacity without conducting additional filings with the agency.

Speaker 3

Joe, this is Jim. The 50 ATCs that we identified by the end of May is going to pick up the significant portion of the treated patients in the country. We will continue to monitor the need to expand from that point, but what we want to do is make sure that with these top centers, we reinforce success, we build their service line and make sure that they're successful in the treatment. And just a reminder, what I had mentioned before, like the CAR T market, there's a concentration of care at the top centers. We expect the top 40 to do about 80% of all the treatments for MTAGP.

Speaker 13

Okay, got it. Thanks. That's helpful and appreciate you taking my question.

Speaker 1

One moment for our next question. Our next question comes from Aspik Gunawarnadee with Truer Securities. Your line is open.

Speaker 11

Hey, guys. I just want

Speaker 8

to maybe ask a little bit more about insurance coverage.

Speaker 2

Could you tell us a

Speaker 8

bit about what proportion of lives in the U. S. Have some degree of coverage right now and what proportion have preferential coverage right now? I know it's only day 12 or 13 up since approval, but just want to get an idea where you are right now. And then if you can also maybe look down into the year, where do you plan on getting that to in the next

Speaker 7

6 months?

Speaker 3

Great. This is Jim. I'll just remind you that in the corporate deck we have our payer mix. About 3 quarters of our payer mix has strong coverage in reimbursement. This includes 55% commercial, and in Medicare 4% are IPPS exempt where these centers are reimbursed at cost and 70% are Medicare Advantage.

Speaker 3

So I would say that we have a lot of tailwinds in terms of coverage. And right now, initial indications granted we're very, very early on in launch is that coverage seems to be appropriate and payers are ensuring access at this moment.

Speaker 8

Great. Thanks for taking my questions.

Speaker 1

One moment for our next question. Our next question comes from Randy Benjamin with Citizens JMP. Your line is open.

Speaker 12

Hey, great guys. Thanks for taking the questions. Maybe just to start off, are you seeing multiple patients potentially getting treated this early in the launch from the same ATC? Do you think this early on maybe it's more of a once the reimbursement and infusion takes place, the next patient will get online. Just trying to understand how you see that developing.

Speaker 12

And then maybe one for Friedrich. You have the cohort 1a data expected at a medical meeting. Would love to know should we just be expecting longer follow-up? Will we have more patients for that update? And related to that, you guys have other trials that are ongoing.

Speaker 12

Could we get additional clinical data from either 4,001 or one of the other studies that's ongoing this year?

Operator

So, Randy, we had a technical issue here. We couldn't hear most of the first question. Can you just we heard the part of the clinical question we asked that, but what was the first question again?

Speaker 12

Yes. So I'm just trying to understand from the ATCs that are on board, are they like you have to have patients going through the process. Is each ATC pretty much putting one patient on and then they're kind of going to wait until an infusion takes place before they bring another patient on? Or are you seeing ATCs like putting 2 or 3 patients on and they've just go ahead and ramping right away?

Operator

They're ramping right away. That's easy question. They're ramping right away. They're not limited in any way by that. And then I guess the second part of the question, Frederic, could you that won't keep you clearly at least here.

Operator

Can you hear can you take that one?

Speaker 5

Yes. I heard that. So thanks, Rene. So your question was about the CORD1a data. So as a reminder for everyone, that's the cohort in the study, ILB COM202 that's involving checkpoint of very naive patients with advanced melanoma to be treated with Till plus pembro.

Speaker 5

So that's our kind of proof of concept to part of study for Tillam. And you were asking is it more patients or more follow-up, it's both. And it's obviously great to bring out some more data here in the context of us having Tillman enrolling. We haven't really said anything about additional publications at this time. So stay posted on that.

Speaker 12

Okay. Can I just ask a follow-up for both those questions again? Do you see any at any point in the process, do you see an area where there could be a potential bottleneck? And then from the clinical trial perspective, is there any color you can provide just regarding the FDA hold? Friedrich, I think you mentioned you've already replied to the FDA, correct me if I'm wrong.

Speaker 12

Do you expect there to be back and forth or do you feel like it was pretty straightforward and you should be the hold should be lifted pretty soon?

Speaker 5

Jim, do you want to go first and then I take the question about IL-two thousand two hundred?

Speaker 3

Sure. Randy, just to circle back on your question about multiple patients, it's still very early on, but we are seeing multiple patients from centers, even multiple patients on a given day in the scheduling calendar. So I think you should expect that as we ramp up and ATCs become more comfortable that you'll see demand with multiple patients from ATCs going forward.

Speaker 5

And on your question regarding the ILU-two zero two studies, so we're confident that we gave them what they needed them being the FDA in this case in order to see what our plans are. We're going to we're expecting a response soon and to start enrolling fairly soon as well.

Speaker 12

Perfect. Thanks for

Speaker 3

taking my question.

Speaker 14

Yes. This is Raj Pui. Can I also add

Speaker 8

that to Frederic's comment regarding the clinical hold? As Frederic mentioned that FDA has everything, they need to leave that clinical hold and we are actually expecting really soon the resolution of this hold to begin enrolling the patients again.

Speaker 12

Thanks for taking the questions.

Speaker 1

One moment for our next question. Our next question comes from Andrea Tan with Goldman Sachs. Your line is open.

Speaker 15

Good afternoon. Thanks for taking

Speaker 2

our question. Friedrich, maybe a follow-up to the last question there, but just wanted to confirm if you could any more details on the basis of the partial clinical hold, if it was any different from your initial thoughts back in December, that would be helpful. Thank you.

Speaker 5

No. So there's nothing there's no information on it, no new aspects that we would have learned in the meantime from our interactions with the FDA. So the basis we discussed in quite a bit of detail in December, we've been working on addressing that. And as we said, we have addressed and are expressing a response about the involvement of new patients. Again, just as a reminder, this was a partial hold, right?

Speaker 5

So we are in agreement with the FDA to be able to offer the therapy to patients who were already enrolled and who had available products. So that also hasn't changed. So again, no new information, no nothing unexpected on you that we didn't know back then.

Speaker 11

Thank you.

Speaker 1

One moment for our next question. Our next question comes from Kelsey Goodwin with Guggenheim. Your line is open.

Speaker 11

Hey, good afternoon. Thanks for taking my questions. I guess just to build a

Speaker 2

bit on some of the prior questions. First, for the app We're not

Operator

able to hear you, Kelsey.

Speaker 11

Okay. Can you hear me better now?

Operator

Hello? Operator, we're unable to hear Kelsey's question, if you can hear us.

Speaker 1

One moment.

Operator

We'll move on

Speaker 1

to the next question and come back to Kelsey. Can you guys still hear me?

Operator

Yes. Operator, we can hear you. You're just having a difficult time hearing the Alice.

Speaker 1

Our next question comes from Ben Burnett with Stifel. Your line is open.

Speaker 8

Great. Thank you very much. I just had just a question to help with the model. Can you talk about price of Proleukin and just how much incremental revenue per patient this will be? And I guess as sort of a follow-up to that, is this handled the same regardless if it's if the patient has commercial insurance versus government insurance?

Speaker 12

And this is the operator.

Speaker 4

Could you repeat the question please? The first part of the question was cut off.

Speaker 8

Apologies. I wanted to ask about Proleukin and how much incremental revenue per patient you might expect on top of the MTAGI price tag? And then sort of the follow-up to that was, would that be handled the same regardless of commercial insurances involved versus government insurance?

Speaker 3

Sure. Why don't I take the first part and then John, Mark, you can jump in. So as you know for the emtagb regimen, I'm

Speaker 2

trying to

Speaker 3

Proleukin would be used 6 doses on average, 18 vials per dose at a WAC of 5,551. What I would share is that the cost would be the same. The reimbursement would be the same whether you are commercial or government at this point, with the exception of mandatory discounts for government sectors.

Speaker 8

I see. Okay. That's helpful. Thank you. And just maybe one question for Jean Marc.

Speaker 8

To what extent does the cash runway assumption that you mentioned earlier incorporate a revenue estimate for MTAGD?

Speaker 1

Hello, Jean Marc, are you there? Could you repeat that question one more time, Ben?

Speaker 8

Certainly. I was just curious to what extent does the cash runway assumption that was mentioned earlier in the prepared remarks, I guess, incorporated revenue estimate for MTAGD, I'm curious if you could maybe speak to that estimate?

Speaker 3

Can you hear me now?

Speaker 9

Yes, we can hear you now.

Speaker 6

Okay. Sorry. We are having some technical difficulties there. So thank you for the question, Ben. So yes, we do have taken into account some revenue from Tagli and looking into a cash runway.

Speaker 6

But of course, obviously, we have been very conservative in the way we have taken those revenues. So I'm not disclosing more. But again, conservatively on the revenue side, we have enough cash well into second half of twenty twenty five.

Speaker 8

Understood. Thanks so much.

Speaker 1

Ladies and gentlemen, this does conclude today's presentation. I would now like to turn the call back over to Fred for any closing remarks.

Operator

And operator, can you confirm that you can hear me just because of the technical difficulties? Yes, I can hear you. Thank you again for joining the IVANS Biotherapeutics 4th quarter and full year 2023 financial results and corporate updates conference call. 2024 is already off to an incredible start for Iovance. Our mission is to remain the global leader in innovating, developing and delivering Till therapies and we've now planted a firm stake in the ground as the pioneers of the first commercial tilt therapy.

Operator

There's also a momentous occasion for the oncology community that's been advancing research cell therapy for solid tumors for decades. We're thankful to all the scientists, researchers, healthcare providers and institutions who have contributed to the field to the patients and their loved ones who have participated in cell therapy clinical trials. It takes a large and coordinated effort to deliver this type of 1st in class category therapy to patients and this achievement is a testament to the unwavering commitment, expertise and collaborative efforts in many. Thank you to those in the healthcare, advocacy and patient communities as well as the regulators, our partners in the local communities in Philadelphia, San Carlos and Tampa that made this U. S.

Operator

Approval possible. I would also like to thank our shareholders and covering analysts for their support. And lastly, I want to thank our exceptional IVANS team. We could not be here without their cross functional efforts and our collective steadfast commitment to following the science. We look forward to providing further updates on the Antagli launch and our pipeline on the Q1 2024 conference call in May.

Operator

Please feel free to reach out to our Investor Relations team for follow-up and apologies for the technical difficulties today. Thank you.

Speaker 11

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

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Key Takeaways

  • FDA approval of EMTEGVI establishes the first one-time T cell therapy for advanced melanoma after anti–PD-1 and targeted therapy, with 30 authorized treatment centers onboarded and nearly all identifying a patient within days of launch.
  • Commercial manufacturing is validated at Iovance’s cell therapy center and a contract site, supporting several thousand patients annually today with plans to expand capacity to over 5,000 patients in the near term and above 10,000 long term.
  • The clinical pipeline is advancing globally, including the Phase 3 TILVANCE-301 trial in frontline advanced melanoma, a registrational Phase 2 NSCLC study resuming enrollment, planned trials in endometrial cancer, and a first-in-human PD-1–inactivated TIL program.
  • With approximately $485 million in cash as of February 22, 2024 (including ~$197 million raised in February), Iovance expects EMTEGVI revenue to begin in Q2 2024 and forecasts a 2024 cash burn of $320–340 million, extending its runway into the second half of 2025.
A.I. generated. May contain errors.
Earnings Conference Call
Iovance Biotherapeutics Q4 2023
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