Iovance Biotherapeutics Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
February 27, 2025

There are 12 speakers on the call.

Operator

Good day and thank you for standing by. Welcome to the Iovance Biotherapeutics Fourth Quarter and Full Year twenty twenty four Financial Results Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer To ask a question during the session, you will need to press 11 on your telephone. You will then enter an automated message advising your hand is raised.

Operator

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 of Investor Relations and Corporate Communications. Please go ahead.

Speaker 1

Thank you, operator. Good afternoon, and welcome to the Iovance conference call and webcast to discuss our fourth quarter and full year '20 '20 '4 financial results as well as recent corporate and development program updates. Doctor. Fred Boat, our Interim Chief Executive Officer and President will provide an introduction and summarize the latest progress with our U. S.

Speaker 1

Commercial launch of AMETAVI, including revenue and revenue guidance and a high level summary of our key pipeline program. Dan Kirby, Chief Commercial Officer, will highlight adoption, market access and demand at authorized treatment centers or ATCs, community outreach initiatives to drive additional growth for The U. S. Commercial launch, as well as our ex U. S.

Speaker 1

Launch expansion plan for Emtekivy and advanced melanoma. Doctor. Igor Balinski, our Chief Operating Officer, will cover our commercial manufacturing experience, available staff capacity and the status of our ongoing capacity expansion. Jean Marc Bellamine, our CFO, will review our financial results, including revenue and revenue guidance, gross margin, cash burn guidance and the strength of our balance sheet. And Doctor.

Speaker 1

Frederick Grafinkenstein, our Chief Medical Officer, will summarize key pipeline programs, including our two registrational programs in frontline melanoma and advanced noncovol cell lung cancer. Additional members of our leadership team, including Doctor. Brian Gasman, our Executive Vice President of Medical Affairs, will be available for the question and answer session. Earlier this afternoon, we issued a press release that can be found 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 technology, manufacturing capabilities, regulatory feedback and guidance, payer interaction, licenses and collaboration, cash position and expense guidance and future updates.

Speaker 1

Forward looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward looking statements. With that, I will turn the call over to Fred.

Speaker 2

Thank you, Sarah. I'm pleased to host this afternoon's conference call to discuss our financial results for the fourth quarter and full year of 2024 as well as our recent corporate highlights. Earlier this month, we marked the one year anniversary of the historic approval of EmTagbi, the first FDA approved Till cell therapy and the first treatment for patients with advanced melanoma progress following anti PD-one treatment and if appropriate targeted therapy. In 2024, iAvance fully transformed into a commercial company. We executed a strong start to the M tag The U.

Speaker 2

S. Launch, reinvigorated global Proluton sales growth and gained significant traction in our efforts to launch in the new markets. Meanwhile, we advanced our robust pipeline of current future generation telesel therapies across all stages of development to address tens of thousands of patients with solid tumors. Today, I'm pleased to highlight continued growth in total product revenue of both AMPEGGY and PROLUCAN. Total product revenue was $73,700,000 in the fourth quarter and $164,100,000 in the full year 2024.

Speaker 2

Importantly, our full year revenue achieved the upper end of our 2024 guidance range of $160,000,000 to $165,000,000 and we finished above the full year Street consensus. Total revenue consisted of $48,700,000 for AMTAGV and $25,000,000 for Prolukin in the fourth quarter with 103,600,000 for AmpTAGV and $60,500,000 for Prolukin in the full year period. Our full year product revenue reflects more than 200 patients already treated with AMPADGI in the partial first year of launch. We are pleased with the robust initial uptake and increasing strong demand for AMPADGI as well as continuing momentum in global Prolukin sales. Our team's successful execution as well as the unmet need, the advanced melanoma, high awareness, broad patient access and a motivated expanding network of authorized treatment centers or ATCs continue to drive increasing demand for AMTAGI and Prolukin.

Speaker 2

Our manufacturing network is well prepared to supply the current anticipated demand for AMTAGMI. Today, we have staffed capacity to supply more than 1,200 patients per year and continue to scale up for additional U. S. And global launch growth. In the back half of last year, we augmented our investment in focused community referral initiatives.

Speaker 2

These efforts in the field are targeted at driving additional demand in our ATCs as they scale up to treat more patients. Looking ahead, we are reiterating our full year 2025 guidance of four fifty million dollars to $475,000,000 in total product revenue. We expect a significant increase in year over year growth in both Antagvion and Prolukin as ATCs broaden utilization. While new ATCs as well as community referral networks are expected to contribute increasing demand through the year. Our fourth quarter gross margin again improved quarter over quarter and is already well over halfway towards our target to surpass 70% over the next several years.

Speaker 2

And continued increases in revenue and gross margin will also correspond with a significant decrease in our annual cash burn while maintaining our pipeline of future indications and products. We were judicious in managing our balance sheet in 2024 and expect cash burn including one time items to continue to decrease as we execute the launch and drive towards breakeven and profitability. Longer term, we remain confident in significant revenue growth in 2026 and beyond. For the currently approved advanced melanoma indication, the peak sales opportunity is more than $1,000,000,000 in The U. S.

Speaker 2

Market alone and more than $2,000,000,000 globally. Our ex U. S. Launch expansion plans are on track with the potential to gain three new approvals and provide early access to IMTAGV in several new markets. IVANS has distinct competitive advantages with the first approval of launch and large scale manufacturing of Till cell therapy combined with strong intellectual property positions and a deep pipeline.

Speaker 2

Future growth drivers include global label expansions into frontline advanced melanoma, other solid tumor types such as non small cell lung cancer and next generation therapies. As we transition to today's commercial update, I would like to welcome and introduce Dan Kirby on his first quarterly call as a member of the iVance team. Dan joined us earlier this month in the newly created role of Chief Commercial Officer. As an instrumental leader in cell therapy commercial organizations since the earliest developments in the field, Dan is a perfect fit for Chief Commercial Officer as we grow the mPADV launch and expand our Prolukin sales. I'm pleased to begin the call to him to discuss our commercial updates.

Speaker 3

Thank you, Fred. I'm very excited to be part of the Iovance team. Like many others in Celentine, I have been following the mTagV launch and I'm incredibly impressed by the progress the team has made in the first year. Entagbe has the potential to improve lives of thousands of patients with advanced melanoma and to advance into other solid tumors as well. I came to Iovance because I believe in Entagbe and the patient focused mission at Iovance.

Speaker 3

My objectives today are to highlight the additional details on the commercial progress that Fred summarized. To begin, favorable medical coverage policies and broad reimbursement is critical for success and patient access for Entagny. Approximately seventy five percent of Entagny patients are covered by private payers and Entagny is also covered under the Medicare cell therapy DRG018. Overall, more than two fifty million lives or greater than ninety five percent of The U. S.

Speaker 3

Covered lives currently have access to reimbursement for NTAGT. Early inclusion in the National Comprehensive Cancer Network or NCCN guidelines combined with strong clinical data have also supported patient access. Throughout 2024, we scaled up our ATC network to meet the growing patient demand and fulfill significant interest among healthcare providers to offer Entag B to their patients. After launching with an unprecedented 30 ATCs on day one, we reached our target of approximately 70 ATCs at the end of twenty twenty four. Our ATC network now spans 32 states and nearly all treated melanoma patients live within a two hour drive of the closest center.

Speaker 3

We treated more than 200 patients with commercial Emtekbee within the first three quarters of launch and Emtekbee is positioned for significant growth across our ATC network in 2025 and beyond. Amongst the 70 current ATCs, seventy six percent completed tumor resection, sixty four percent infused intact, fifty three percent infused two or more patients and thirteen percent infused more than 10 patients. These metrics demonstrate significant growth potential as our ATC scale up to accommodate growing patient demand. New ATCs are preparing to treat initial patients. Our more experienced ATCs are steadily growing or plan to increase utilization throughout 2025 and we expect new ATCs will follow similar trends as we add steadily throughout 2025.

Speaker 3

These additional ATCs will be selected for high quality and volume of eligible patients, including large community practice. To further drive adoption, earlier patient identification and higher referral volume into our ATC network, Iovance field teams are actively engaging top community oncologists and large community practices with a focus on high volume markets. Additionally, we are aligned with leadership at key community organizations on their preferred ATCs for patient referrals. As more patients embark on their treatment journey, we are making steady progress to speed up the time to intact the infusion. Financial clearance currently averages approximately three weeks and continue to improve.

Speaker 3

ATCs are saving up to two additional weeks by scheduling in parallel with financial clearance and or initiating the preconditioning regimen in conjunction with product approval. And we expect a decreased turnaround time for manufacturing and release testing in 2025. Globally, eMTAGV may address more than twenty thousand melanoma patients annually

Speaker 4

in The U. S.

Speaker 3

And are targeted international markets. In all future markets, eMTAGV has the potential to be the first and only improved therapy for the treatment of adult patients with advanced melanoma previously treated with the PD-one and targeted therapy. Three regulatory dossiers are currently under review for potential approvals in 2025, beginning with The United Kingdom in the first half, then Canada in mid year and the European Union in the second half of the year. We also plan to provide early access foreign tag fee in The UK, France, Germany, Canada, Switzerland and Australia. In preparation for our initial ex U.

Speaker 3

S. Launch, we plan to onboard 15 international treatment centers by year end. Additional regulatory submissions remain on track, including Australia in the first half and Switzerland in the second half of twenty twenty five. In addition to IMTAGV, our commercial organization is dedicated to supporting Prolukin across three key lines of business, which include for use in the IMTAGV treatment regimen, for use in manufacturing clinical trials and for clinical trial use where appropriate. During the fourth quarter, we activated and provided initial stock for a third and final plan for Logan distributor.

Speaker 3

Orders are now being fulfilled at all three major U. S. Wholesalers with healthy ordering patterns, including restocking. We expect demand for ProLukin to continue to increase across each of these three key business lines throughout the year. In summary, I am extremely pleased with The U.

Speaker 3

S. Launch performance to date and the momentum we are building to catalyze and expand and tag the adoption while growing Prolukin sales within The U. S. And beyond. I'm fully committed to the opportunity to impact thousands of patients' lives and drive toward 2 plus billion dollar peak sales around the world.

Speaker 3

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

Speaker 5

Thank you, Dem. Today, I would like to build on Fred's introductory comments with an update on our commercial and clinical manufacturing network as well as our capacity expansion. Our manufacturing network consists of our internal manufacturing facility, the Iovance Cell Therapy Center or ICTC and the contract manufacturer, which helps ensure flexibility and ample capacity for both commercial and clinical production. To support growing commercial demand for Entag B, we are steadily ramping up our manufacturing capacity month over month, while actively hiring manufacturing quality control and support staff. Within our manufacturing network, the staff capacity is currently at more than 1,200 patients annually.

Speaker 5

Throughout 2025, we will continue growing staff capacity in alignment with demand, while operating at a high capacity utilization. Each of our facilities is currently required to schedule a brief annual maintenance, which entails a short pause in production. I'm pleased to report that ICDC successfully completed annual maintenance and resumed production promptly at full volume with no issues. We expect the same positive outcome following the upcoming scheduled maintenance at our contract manufacturer. Our commercial manufacturing experience continues to be positive and consistent with prior clinical experience.

Speaker 5

The medical affairs and commercial teams are effectively sharing best practices among ATCs and contributing to improvements in manufacturing success rates and gross margin over time. The turnaround time is consistently thirty four days from receiving sales at the manufacturing facility to Mt. Agribbean ready for return shipment to the ATC. Our team is planning to shorten the turnaround time in 2025. Our Philadelphia manufacturing network currently serves patients in our clinical trials in Europe, Australia and other geographies.

Speaker 5

We are now establishing logistics and distribution to provide access to commercial product in new markets in The EU, UK and Canada in anticipation of potential approvals this year. We are also expanding capacity to fulfill our longer term vision. The ICTC as built today has capacity for more than 2,000 patients annually. Once we complete the ongoing build out of existing shelf space, we expect the ICTC to have total capacity for over 5,000 patients annually within a few years. Additional expansion of our ICTC manufacturing campus along with process optimization and automation is expected to provide capacity for over 10,000 patients annually.

Speaker 5

As we grow our manufacturing we are focused on improving the cost of goods through economies of scale and operational efficiencies as well as by leveraging our unique competitive advantage as the leader in the Till cell therapy. Our Till cell therapy expertise and manufacturing capabilities are protected by a robust intellectual property portfolio. We currently own more than two fifty granted or allowed U. S. And international patents and patent rights for MTAGVI and other TiAL related technologies that are expected to provide exclusivity through at least 02/1942.

Speaker 5

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

Speaker 6

Thank you, Rigor. Today, I will review our current cash position as well as our results for the fourth quarter and full year 2024. I will also highlight our financial outlook, including revenue, expense guidance and gross margin. As of 12/31/2024, our cash position was $330,100,000 As of 02/26/2025, our unaudited cash position was approximately $422,000,000 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 fourth quarter of twenty twenty four was $78,600,000 or $0.26 per share compared to a net loss of $116,400,000 or $0.45 per share for the fourth quarter ended 12/31/2023. Net loss for the full year 2024 was $372,200,000 or $1.28 per share compared to a net loss of $444,000,000 or $1.89 per share for the full year 2023. Total product revenue consists of EmtekV infusion in The U. S. And global sales of Pro Loking within three different lines of business as Dan described.

Speaker 6

Total product revenue was $73,700,000 for the fourth quarter of twenty twenty four, including $48,700,000 for Entagbe and $25,000,000 for Proloki. For the full year 2024, we achieved the higher end of our product revenue guidance range of $160,000,000 to $165,000,000 Total product revenue for the full year 2024 was $164,100,000 and consisted of $103,600,000 for MTACV and $60,500,000 for Proloquine. Revenue increases in the fourth quarter and full year 2024 over the prior year periods were primarily driven by The U. S. Commercial launch of Entagbe and strong demand from global ProLukin sales.

Speaker 6

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 Entagvik and product as well as manufacturing costs for Entyctvie. Cost of sales for the fourth quarter was $45,500,000 including $9,100,000 in period cost associated with patient drop off and manufacturing success rates, which decreased quarter over quarter as a percentage of total revenue $5,900,000 for non cash expenses, including fair market value step up and intangible asset amortization and $6,000,000 in royalty payable on product sales. In the prior year three months period, cost of sales was $4,400,000 primarily related to non cash amortization for intangible assets. Cost of sales for the full year 2024 was $124,000,000 including $26,300,000 in certain costs associated with patient drop off and manufacturing success rates, $26,200,000 in non cash expenses including fair market value step up and intangible asset amortization and $14,200,000 in royalties payable on product sales. In the prior full year, cost of sales was $10,800,000 primarily related to non cash amortization for intangible assets.

Speaker 6

The increase in cost of sales in the fourth quarter and full year 2024 over the prior years periods were primarily attributable to The U. S. Commercialization and sales of Emtekbee as well as pro looking sales growth following the initiation of product sales in The U. S, commercial manufacturing and related cash and non cash expenses tied to MTACV and Pro Looking. Our standard gross margin for the fourth quarter twenty twenty four was 46% or $13,400,000 compared to the total product revenue of $73,700,000 Cost of sales has improved over time as we increased volume and capacity utilization throughout the launch ramp up.

Speaker 6

The higher gross margin over the previous quarters reflect our ongoing focus on profitability and is well over halfway towards our target for gross margin to surpass 70% in the coming years. The ongoing manufacturing expansion, strong coordination with our ATCs and efficiencies in manufacturing and release testing are expected to further optimize our cost of sales with a correspondingly higher gross margin. I will now shift to our operating expenses. For the full year 2024, our total cash burn excluding one time expenses was within our guidance range of $320,000,000 to $340,000,000 Research and development expenses were $72,200,000 for the fourth quarter of twenty twenty four, a decrease of $15,300,000 compared to $87,500,000 for the same period prior year period. Research and development expenses were $282,300,000 for the full year 2024, a decrease of $61,800,000 compared to $344,100,000 for the full year 2023.

Speaker 6

The decrease in research and development expenses in the fourth quarter and full year 2024 over the prior year period was primarily attributable to the transition of Emtekbee from clinical to commercial manufacturing. This decrease was partially offset by increase in headcount and related costs, including stock based compensation and clinical trial costs. Selling, general and administrative expenses were $42,500,000 for the fourth quarter of twenty twenty four, an increase of $12,600,000 compared to $29,900,000 for the prior year period. Selling, general and administrative expenses were $153,000,000 for the full year 2024, an increase of $46,100,000 compared to $106,900,000 for the full year 2023. The increase in selling and general administrative expenses in the fourth quarter and full year 2024 compared to the prior year periods was primarily attributable to increasing net count and related costs including stock based compensation to support our overall growth as well as legal and commercial related costs.

Speaker 6

Looking ahead, we continue to reiterate our prior total product revenue guidance within the range of $450,000,000 to $475,000,000 for the full year 2025. In addition, we anticipate our cash burn for the full year 2025 to be less than $300,000,000 including investment in our ICTC facility expansion. Over time, we expect cash burn to decrease as we continue to grow revenue and as gross margin improves. We also plan to keep leveraging additional opportunities to further optimize spending this year. For additional information, please see the company's selected consolidated balance sheets and statement of operation in this afternoon's press release and our Form 10 K 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 4

Thank you, Jean Marc. We continue to be excited about the potential of Till cell therapy and solid tumors, which represent more than ninety percent of all diagnosed cancers in The U. S. Today, I will summarize key updates for our clinical program as well as our exciting next generation pipeline. Expanding the commercial opportunity for AptagV into frontline advanced melanoma is a top priority at Iovance.

Speaker 4

Our global registrational Phase III trial, TILZAN-three zero one, remains on track to support accelerated and full approvals of EMTAGVI in combination with pembrolizumab in frontline advanced melanoma, as well as regular approval of EmtekVI in our initial indication in post anti PD-one melanoma. Strong momentum with enrollment and high enthusiasm continue among participating in planned clinical sites. As a reminder, till then, three zero one is supported by positive results for lifeluzil plus pembrolizumab from IOV COM202 cohort 1a in patients with advanced melanoma naive to immune checkpoint inhibitors. To explore another potential best in class alternative in frontline advanced melanoma for U. S.

Speaker 4

Physicians and patients, Cohort 1D in IOV COM202 will investigate lifileutol in combination with nivolumab and rolodilumab. Our second registrational program is investigating lifileutal monotherapy in the single arm registrational Phase II IOV LUN202 clinical trial to address unmet medical needs among patients with advanced non small cell lung cancer who progress after anti PD-one therapy. Single agent chemotherapy, the current standard of care in this setting provides limited rate and duration of responses. We expect to share additional data from IOV LUN202 in the second half of twenty twenty five. Enrollment continues with high demand at clinical sites in multiple countries to support a potential accelerated approval of lifileucel in post anti PD-one non small cell lung cancer in The U.

Speaker 4

S. With an anticipated regulatory decision in 2027. We also continue to pursue earlier treatment settings in non small cell lung cancer. In frontline advanced non small cell lung cancer, our strategy is to establish a new frontline regimen of liso neutral plus pembrolizumab following standard of care chemopembrolizumab for patients with EGFR wild type non small cell lung cancer, who represent the majority of patients with an unmet medical needs in this setting. We will investigate this regimen in Cohort three d in the IOVCOM202 clinical trial to inform a registrational and confirmatory trial design in frontline advanced non motor lung cancer.

Speaker 4

Our goal is to further augment the strong efficacy seen in Cohort 3a with liso leucel in combination with pembrolizumab in patients who were not previously treated with immune checkpoint inhibitor therapy. Moving along the pipeline, we are excited about our first clinical trial in advanced endometrial cancer, a significant new opportunity for tilt cell therapy in an additional post anti PD-one setting. Our IOV END-two zero one clinical trial is investigating lifileucel after frontline standard of care of chemotherapy and anti PD-one therapy in patients with endometrial cancer, regardless of mismatch repair or MMR status. Recent approvals of immune checkpoint inhibitors with in combination with chemotherapy for frontline endometrial cancer have created an unmet need. There are no currently approved therapies for patients who progress.

Speaker 4

We look forward to sharing initial data from END-two zero one in the second half of this year. As the leader in tilt cell therapy, Iovance is also at the forefront of next generation approaches to optimize tilt and tilt treatment regimens. I'll briefly summarize our three main programs in this area. Our next generation PD-one inactivated tilt cell therapy, IOV4001, is investigated in the Phase II efficacy stage of our IOV GM1201 clinical trial. Multiple centers are enrolling at an increasing pace across two Phase II cohorts of patients with previously treated advanced melanoma or non small cell lung cancer.

Speaker 4

Building on our successful Prolukin franchise, we recently initiated a Phase onetwo clinical trial of IL-three thousand and one, a second generation modified IL-two analog for use with the tilt cell therapy treatment regimen. IL-three thousand and one may result in a better safety profile and support less frequent dosing compared to proleukin. Lastly, we plan to submit an IND to FDA this year for IOV-five thousand and one, a genetically engineered inducible and tethered IL-twelve tilt cell therapy. A clinical trial of a prior generation IL-twelve tilt therapy at the National Cancer Institute showed improved efficacy with low cell doses without the use of IL-two and provides the rationale for the modifications in IOV5001 to enhance Till efficacy while optimizing safety. IOV5001 could facilitate expansion into wide range of common solid tumor cancers beyond our current pipeline with significant market opportunity.

Speaker 4

I'm happy to address questions about these programs and additional trials during the Q and A session. I look forward to sharing additional updates this year as we continue to work to deliver Till cell therapy to cancer patients in additional therapeutic settings and with additional tumor types. Thank you to the talented multidisciplinary team and research partners who make this possible. I will now turn the call over to the operator to begin the question and answer session. Operator?

Operator

Our first question comes from Andrea Newkirk with Goldman Sachs. Your line is open.

Speaker 7

Good afternoon. Thanks for taking our questions. Fred, on prior calls, you've provided an update on the number of patients infused thus far in the quarter. Just wondering if you'd be willing to share where you stand as of today? And then just remind us or help us understand what gives you the confidence that the range for full year 2025, which was set when you were only one quarter into the launch is still intact?

Speaker 7

Thanks so much.

Speaker 2

Yes, sure, Andrew. We're not from in the press release and on the call, we're not going to be providing the infusions right now. We're not sure how useful that metric was to long investors. And as some of you know, it's prone to over interpretation. We provide some different metrics this time around, including the potential for growth at the ATCs.

Speaker 2

And that actually is a part of the answer to your second question. If you look at our press release and heard Dan's commentary, within the 70 ATCs that we have right now, only thirteen percent of them fuse more than 10 patients, which gives you a very good idea of the upside that we're expecting, the acceleration we're expecting in the second half and second quarter of twenty twenty five years we go through. So we still have confidence in those numbers because the growth curve for this type of product can accelerate quite a bit and we see that happening across our ATC network right now. We see the potential for that in those ATCs.

Speaker 7

Okay. Thank you.

Operator

Thank you. Our next question comes from Peter Lawson with Barclays. Your line is open. Peter, your line is open. Please check your mute button.

Speaker 8

Great. Thank you so much for taking the question. As we think about the IL-two revenues, kind of they had a nice spike this quarter. Is that should we view that as a signal for future TL demand or is that kind of a stock in from distributors? And kind of how should we think about the IL-two sales going forward?

Speaker 8

What component of 2025 revenues could that be?

Speaker 4

Thank you.

Speaker 2

Yes. So we continue to believe and continue to talk about IL-two revenue as being a leading indicator for AMTAPI sales like we've been saying for quite some time now. And I think what you're seeing there is you're seeing the uptake by all the STs now in The United States. As Dan pointed out, we restocked two of them and sold the block to a third. And I think you'll see in 2025, we'll be restocking again and it will represent a significant portion of the four fifty million dollars to $475,000,000 guidance that we have out there at convenience close $80,000,000 to $100,000,000 or more.

Speaker 2

We think it's a fantastic business. That's why we acquired it. It's performing very well right now. So we're very happy with that number.

Speaker 9

Got you.

Operator

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

Speaker 8

Okay, great. Thanks so much.

Speaker 10

I guess, question for us is, what are physicians saying about sort of the evolving landscape and just the potential for a new entrant later this year?

Speaker 2

I think you may or your colleagues have written notes about this lately and there's been a lot of discussion about this. We view the potential entrant as basically being very similar to a currently marketed product known as TBEC. We're not really sure what the differentiation is between that. We've also have seen a lot of information on how that product launched. We view the clinical data is not being comparable to ours.

Speaker 2

Their patient population is much, much earlier. Sixty five percent of their patients have one to two prior lines. They had about a quarter patients with adjuvant PD-one only in the study. And we're looking at sixty five percent of our patients with three or more prior lines, much more real world population of metastatic melanoma. So we we don't really see it as being any kind of significant impact on our launch.

Speaker 2

We're out there with what we think is the premier product and we're looking to grow our market, launching outside The U. S. And get other indications as soon as we can.

Speaker 8

Okay. Appreciate that color. Thank you.

Operator

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

Speaker 1

Great. Thanks for taking our questions. I understand you're not giving intra quarter updates going forward, but since you did provide in 4Q, can you speak was there a slowdown in fusions in the back half of the quarter? And did you see any seasonality in 4Q?

Speaker 2

Collie, no, we don't see any seasonality. As Igor mentioned, we did have a manufacturing maintenance period there. So we have those kind of things in cell therapy. If you look at the launch curves for Beqma, Yescarta and CARVICTI, you'll see there's little peaks and dips and valleys in those as things like that happen. So but nothing in terms of a holiday seasonality, that's what you're asking.

Speaker 1

Great. Thanks for taking our question.

Operator

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

Speaker 8

Great. Thanks very much for taking our question. This is Nick on for Tyler. Thinking about guidance, 2025 guidance, is the potential price increase currently included in that guidance? And also how should we think about the global ex U.

Speaker 8

S. Expansion having a potential impact on guidance? Thanks.

Speaker 2

Yes. The price increase that's coming in April has been factored into that guidance for both Proleukin and TagBe. And right now the guidance doesn't include any contribution from XUS.

Operator

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

Speaker 4

Great. Thanks for taking our questions. I was wondering how many infusions were performed in 4Q and does the quarter over quarter growth over the prior quarter, which was 82 infusions, how does that compare with your expectation? And do you think that growth will either be the same or be different for 1Q over 4Q? Thanks.

Speaker 2

Yes, Jan, it's about 95 revenue infusions. There's other infusions that occur with single patient INDs and that kind of thing that still generate revenue for lubricant sales, for example. That's about 95 revenue infusions is what we're reporting for the fourth quarter. I think the quarter over quarter growth is quite strong. We're seeing the growth that we need to see.

Speaker 2

It's going to go up and down as we go. Just like I said with the CAR T products, if you look back at their growth, there was quarters where they grew 10%, there was quarters where they were flat, there was quarters where they grew 30%. Our intention is to drive growth and we have tremendous opportunity in the ATCs that we have right now to do that as well as we get to the community.

Speaker 4

Great. Thanks for the color.

Operator

Thank you. Our next question comes from Asthika Gooneworton with Truist. Your line is open.

Speaker 8

Hey guys, thanks for taking my question. Fred, if I could ask for the new data that you provide, the end of quarter data that you provided, of the 70 ADCs that are online, what proportion have reached a steady state? I'm wondering, does that align with the thirteen percent of ADCs that have already treated more than 10 patients? Thanks.

Speaker 2

So, I think it's a very low number. I can't tell you exactly, but it's probably ten percent or less have reached steady state at this point. We know that the vast majority of those 70 ATCs have tremendous upside. Maybe I'll ask Dan to comment a little bit on what we've seen so far on the potential upside of those ATCs.

Speaker 3

Sure, Fred. And I think one of the things that you look at

Speaker 4

the ATCs, you look at the ones that are doing 10 plus

Speaker 3

I don't really think they're saturated with it because our strategy is again to increase referrals in the community into those. They're the ones that have developed expertise within Tagby and we have other ones that are inching towards that 10 plus infusion number with it. Those are really our centers of excellence that are leading the way for not only the other centers, but also for our activities in driving referrals to those centers.

Operator

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

Speaker 9

Hey guys, thanks for taking the questions and congratulations on the quarter. Maybe just one from me from the pipeline for Frederick. We have data coming out in the second half of this year. Can you talk a little bit about or set expectations for both non small cell and endometrial? How many patients worth of data?

Speaker 9

And I guess with this data, is this the registrational set? Do we need to enroll even more patients before filing for accelerated approval in both non small cell and endometrial? Or do we need to start another cohort that ultimately becomes the registrational data set? Any color would be great.

Speaker 4

Yes. To start with the 02, thanks for the question. Obviously, we're going to time our data disclosure with an appropriate venue and we'll time our cut with that. Where we are in regards to enrollment will really depend on the timing and I can't really comment on this at this point. This will be an update on what is obviously of the priority interest, which is the data from cohorts one and two, which are the registrational cohorts.

Speaker 4

There's not going to be additional cohorts or anything that we would be reporting out because we think that that is probably not that relevant. About timing of the registrational plan, I said in my script, timing will be that we're expecting a registrational decision by the end of twenty twenty seven. We are enrolling currently. We are seeing good momentum and we are on track with that. I hope that answers your question.

Speaker 4

Around endometrial, similarly, I can't really commit to a specific patient number here, but it's going to be a meaningful number that at least gives you an initial idea around the signals that we're seeing in this trial. We find this important enough to share an early data set this year still.

Speaker 8

Thank you.

Operator

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

Speaker 11

Hi, this is Bennett for Salim. Thanks so much for taking our question and congratulations on the quarter and all the progress. So also on the registration of Phase II trial in post anti PD-one non small cell cancer. So could you remind us what the bog is there? I mean, we believe taxan class anti VEGFR2 response rate is thirty percent, but I'm not sure if that's the best comparative here or if you can just talk a little bit about the BOGI and the bar here?

Speaker 11

Thank you.

Speaker 2

Yes, I can start maybe Frederick can get the rest of that. So we first of all, we can run FDA has told us we can run a single arm trial here. We're not running randomized against docetaxel. What we will look at is with that BLA submission, the FDA would look at available care for those patients and that includes the REBELL study, which is ramiciramap plus docetaxel or docetaxel MOS therapy. And there you're looking at response rates in the low 20s, but very short durability.

Speaker 2

And with tilt therapy, we have much longer durability. So we're thinking if we come in with response rates in the mid-20s like we showed before, with the durability like we've been seeing, we should be fine in terms of getting approval on this product based on what FDA has told us today and they've told us quite a bit about this. And Frederic, if you're online, you can you're welcome to add to that.

Speaker 4

No, that's exactly right. The one thing to add here is it's really the durability that is the limitation here for the standard of care. For docetaxel plus ramul, although again, as Fred mentioned, it's about twenty percent response rate. PFS is about four months and duration of response data has never been shared. So I think that is indicating the limitations and the challenges that we are planning on addressing with lifileucel therapy.

Speaker 4

Just as a reminder, the data that we had previously shared from Elion2 to indicated a response rate in the mid-twenty percent, twenty six percent. And then in a follow-up communication around it, we saw that seventy one percent of the confirmed responders had DORR of more than six months, which in this population is very meaningful.

Speaker 11

Thank you.

Operator

Thank you. Our next question comes from David Dye with UBS. Your line is open. Hey, great. Thanks for taking my question.

Operator

Fred, I know you mentioned that you didn't see any seasonality for the holiday break. I'm just wondering if you see any

Speaker 4

kind of spillover impact from holidays on star forms or receptions?

Speaker 2

Could you repeat that, David, on reception seasonality on receptions?

Operator

No, no, no. Just, yes, wondering if there's any spillover impact from holidays on any kind of start forms or any kind of tumor resections, if that makes sense?

Speaker 2

Yes, I'm not following you. We haven't maybe I can try to just answer more generally. We didn't really see any slowdown in terms of the ATCs just for the holidays, if that's what you're asking for any of their operations, because they are generally running through the Christmas holidays without any interruption for cancer patients. Yes, so of course there could be one or two patients here or there.

Speaker 3

And actually just carrying on top of that Fred, I think for seasonality, we didn't notice it from my understanding in the clinical trials, but as we go commercially, we're just finishing our first year. So we're going to look at those trends and patterns as we go forward to see if there is seasonality. Right now, we're not seeing it in the data. Hopefully that helps you, David. But that is something we're looking at.

Operator

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

Speaker 4

Hey, thanks. Good afternoon. Appreciate the updates. Look forward to 2025. So a quick one is, in terms of the launch uptake, what exactly would you say is the bottleneck at this juncture?

Speaker 4

If it's not patient demand nor supply chain nor even beds at sites, what is the gating factor to seeing an acceleration in sales for 2025 like you guided? Thanks.

Speaker 2

So I think above all the ATCs that are starting up now have to get their feet under them to get running. We've got some ATCs that are performing very, very well right now. We've got a lot more that are working their way up. I think in each ATC there is a difference. Each individual ATC has its own little bottlenecks or whatever it might be.

Speaker 2

Some of them have staffing issues. Some of them have financial clearance challenges that we're helping out with. But all these things are pretty easily resolvable and we've been able to show that a good portion of our ATCs can really fly right now and we think we can get a lot more there pretty soon. Go ahead. And Dan, go ahead.

Speaker 2

Sure.

Speaker 3

And Andrew, I think one other thing to add on top of what Fred said regarding not really a bottleneck, but there's a process they go through. They have to make sure they operationally can do it again. We're the first till in the market. So there's a learning curve there. As you see, we said 13% have hit 10 or more.

Speaker 3

That number continues to grow. So once they hit that wave where they understand how to use the product with it, then the lever really is to pull the referrals and drive more patients in there. And that's where we're working the community, not only at the clinic level, but also the leadership level in community to make sure that those centers are getting to see the most patients.

Speaker 4

Makes sense. Thanks.

Operator

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

Speaker 2

Thank you again for joining the iAdvance Biotherapeutics fourth quarter and full year twenty twenty four financial results and corporate updates conference call. As we close the first calendar year of our first commercial tel cell therapy launch, we look forward to providing future updates on our growing commercial and clinical portfolio. We continue to be motivated as we hear frequent feedback from ACCs about advanced melanoma patients benefiting and finding hope in IMTAG being the commercial setting. I'm confident that IVS is poised to maintain our global leadership in innovating, developing and delivering current and future generations of tel cell therapies for patients with cancer. As always, we are thankful for the patients, healthcare and advocacy communities, our partners and our exceptional iAdvance team.

Speaker 2

I'd also like to thank our shareholders and analysts for their support. Thank you.

Operator

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

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Iovance Biotherapeutics Q4 2024
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