Q4 2024 Iovance Biotherapeutics Inc Earnings Call
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Good day, and thank you for standing by.
Welcome to the Io Vance Biotherapeutics fourth quarter and full year 2024 financial results Conference call.
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After the speaker's presentation, there will be a question and answer session.
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Speaker Change: I would now like to hand, the conference over to your speaker today.
Speaker Change: Ara Pellegrino SVP of Investor Relations and corporate Communications. Please go ahead.
Speaker Change: Thank you operator, good afternoon, and welcome to the <unk> conference call and webcast.
Speaker Change: Our fourth quarter and full year 2024 financial result, as well as recent corporate and development program updates.
Doctor friend: Doctor friend, though our interim Chief Executive Officer, and President, who will provide an introduction and summarize our latest progress with our U S commercial launch of <unk>, including revenue and revenue guidance at a high level summary of our key pipeline programs.
Doctor friend: Dan Kirby Chief commercial officer will highlight adoption market access and demand if authorized treatment centers or ATC community outreach initiatives to drive additional growth in the U S commercial launch as well as our ex U S launch expansion plan for <unk> in advanced melanoma.
Speaker Change: Dr. Igor for Lindsay, our Chief operating officer will cover our commercial manufacturing experience available debt capacity and the status of our ongoing capacity expansion.
Speaker Change: John <unk>, our CFO will review, our financial results, including revenue and revenue guidance gross margin cash burn guidance and the strength of our balance sheet.
Speaker Change: And Dr. Frederic graph Finkelstein, our Chief Medical Officer will summarize key pipeline programs, including our two Registrational program in frontline melanoma and advanced non small cell lung cancer additional members of our leadership team, including Doctor Brion Johnson, our executive Vice President of Medical Affairs will be available for <unk>.
Speaker Change: The question and answer session.
Speaker Change: Earlier. This afternoon, we issued a press release it can be found on our corporate website at <unk> Dot com.
Speaker Change: Before we start I would like to remind everyone that statements made during this conference call will include forward looking statements regarding IOM goal is this focus and this plan in transaction revenue and revenue guidance commercial activities clinical trials and results regulatory approvals and interaction plans and.
Speaker Change: <unk> research and preclinical activities potential future applications of our technologies manufacturing capabilities regulatory feedback and guidance payer interaction licenses in collaboration cash position an expense garden future update.
Speaker Change: 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 Change: 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.
Fred: 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.
Fred: Earlier this month, we marked the one year anniversary of the historic approval of impact first.
Fred: The first FDA approved till cell therapy, and the first treatment for patients with advanced melanoma progressed, following anti PD, one treatment and if it's appropriate targeted therapy.
Fred: In 2004, I think it's fully transformed into a commercial company.
Fred: We executed a strong start to the impact of the U S launch reinvigorated global Proleukin sales growth and gained significant traction in our efforts to launch the new markets.
Fred: While we advanced our robust pipeline of current and future generations host cell therapies across all stages of development to address tens of thousands of patients with solid tumors.
Fred: Today Im pleased to highlight continued growth in total product revenue, both Mpeg VM proleukin.
Fred: Total product revenue was $73 $7 million in the fourth quarter and $164 $1 million in the full year of 2020 for.
Fred: Importantly, our full year revenue achieved the upper end of our 2024 guidance range of $160 million to $165 million and we finished above the full year Street consensus.
Fred: Total revenue consisted of $48 7 million SRAM pegged at $25 million for Proleukin into fourth quarter with $103 6 million SRAM pagni at $60 $5 million for Proleukin and the full year period.
Fred: Our full year product revenue reflects more than 200 patients already treated with <unk> and the partial first year of launch.
Fred: We're pleased with the robust initial uptake and increase and strong demand for impact as well as continuing momentum global Proleukin sales. Our team's successful execution is well beyond met need in advanced melanoma high awareness broad patient access and a motivated expanding network of authorized treatment centers or ATC.
Fred: Continue to drive increasing demand for <unk> and for Luka.
Fred: Our manufacturing network is well prepared to supply the current and anticipated demand for <unk>.
Fred: Today, we are staffed capacity of supply more than 1200 patients per year and continue to scale up for additional U S and global launch growth.
Fred: In the back half of last year, we augmented our investment and focus community referral initiatives.
Fred: These efforts in the field are targeted at driving additional demand and our ACC as they scale up to treat more patients.
Fred: Looking ahead, we are reiterating our full year 2025 guidance of $450 million to $475 million and total product revenue.
Fred: We expect a significant increase in year over year growth in both and Tagmeme Proleukin is atc's brought in utilization.
Fred: While new Atc's as well as community referral networks are expected to contribute increasing demand through the year.
Fred: Our fourth quarter gross margin again improved quarter over quarter and is already well over halfway towards our target surpassed 70% over the next several years.
Fred: And continued increases in revenue and gross margin were also correspond with a significant decrease in our annual cash burn.
Fred: Maintaining our pipeline of future indications in products we.
Fred: We were judicious in managing our balance sheet 2020 forward expect cash burn excluding one time items to continue to decrease as we execute the launch and drive towards breakeven and profitability.
Fred: Longer term, we remain confident significant revenue growth in 2026 and beyond.
Fred: For the currently approved advanced melanoma indication the peak sales opportunity of more than 1 billion of the $1 billion in the U S market alone and more than $2 billion globally.
Fred: Our ex U S. Ex launch expansion plans are on track with the potential to keep three new approvals and provide early access to <unk> in several new markets.
Fred: I've answered as distinct competitive advantages with the first approval launch and large scale manufacturing until cell therapy, combined with strong intellectual property position and a deep pipeline.
Fred: Growth drivers include global label expansions into frontline advanced melanoma, and other solid tumor types, such as non small cell lung cancer and next generation therapies as.
Speaker Change: As we transition today's commercial update I would like to welcome and introduce Dan Kirby on his first quarterly call as a member of the <unk> team.
Dan Kirby: I'm joined US earlier this month to the newly created role of Chief Commercial Officer.
Dan Kirby: As an instrumental leader in cell therapy commercial organization since the earliest developments in the field.
The perfect fit for Chief commercial officer, as we grow the <unk> launch and expand our <unk> sales.
Dan Kirby: Please begin the call to him to discuss our commercial updates.
Speaker Change: Thank you Fred I am very excited to be part of the <unk> team like many others in cell and gene I have been following the impact of the launch and I'm incredibly impressed by the progress. The team has made in the first year.
Dan Kirby: <unk> has the potential to improve lives.
Dan Kirby: One of the patients with advanced melanoma and to advance into other solid tumors as well I came to <unk>, because I believe in impact and the patient focused mission at <unk> Bye.
Dan Kirby: By objective today is to highlight the additional detail on the commercial progress that Fred summarized.
Dan Kirby: To begin favorable medical coverage policies and broad reimbursement is critical for success in patient access were impacted approximately 75% of the type of patients are covered by private payers and <unk> has also covered under the Medicare cell therapy Dr. Giovanni.
Dan Kirby: Overall more than 250 million lives are greater than 95% of the U S. Covered lives currently have access to reimbursement for impact.
Dan Kirby: Early inclusion in the National comprehensive cancer network or <unk> CCN guidelines combined with strong clinical data have also supported patient access.
Dan Kirby: Throughout 2024, we scaled up our ATC network to meet the growing patient demand and fulfill a significant interest among health care providers to offer <unk> to their patients.
Dan Kirby: After launching with an unprecedented 30 atc's on day, one we reached our target of approximately 78 at.
Dan Kirby: At the end of 2024.
Dan Kirby: Our ACC network now spans 32 states and nearly all treated melanoma patients live within a two hour drive of the closest that.
Dan Kirby: We treated more than 200 patients with commercial <unk> within the first three quarters of launch and in Cagny is positioned for significant growth across our atg network in 2025 and beyond.
Dan Kirby: Amongst the 70 current atc's, 76% completed tumor resection, 64% in Qs and tagging, 53% in Q2 or more patients and 13% and <unk> more than 10 patients.
Dan Kirby: These metrics demonstrate significant growth potential as our ADC scale up to accommodate growing patient demand.
Dan Kirby: New Adcs are preparing to treat initial patients are more experienced adcs are steadily growing our plan to increase utilization throughout 2025.
Dan Kirby: And we expect new Adcs will follow similar trends as we add steadily throughout 2025. These additional atc's will be selected for high quality and volume of eligible patients, including large community practices.
Dan Kirby: To further drive adoption earlier patient identification and higher referral volume into our DTC network.
Dan Kirby: <unk> field teams are actively engaging top community oncologist and large community practices with a focus on high volume markets.
Dan Kirby: Additionally, we are aligned with leadership and key community organization on their preferred adcs for patient referrals as more patients embark on their treatment journey, we are making steady progress to speed up the time to impact the infusion.
Dan Kirby: Financial clearance currently averages approximately three weeks and continuing to improve.
Dan Kirby: Atc's are saving up to two additional weeks by scheduling in parallel with financial clearance.
Dan Kirby: Or initiating the pre conditioning regimen in conjunction with product arrival.
Dan Kirby: And we expect to decrease turnaround time for manufacturing and release testing in 2025.
Dan Kirby: Globally, and Taghavi may address more than 20000 melanoma patients annually in the U S and our targeted international markets and.
Dan Kirby: And all future markets.
Dan Kirby: And <unk> has the potential to be the first and only approved therapy for the treatment of adult patients with advanced melanoma previously treated with a PD one and targeted therapy.
Dan Kirby: Three regulatory dossiers are currently under review for potential approvals in 2025, beginning with the United Kingdom in the first half than Canada in mid year and the European Union in the second half of the year.
Dan Kirby: We also plan to provide early access for impacting in the UK, France, Germany, Canada, Switzerland, and Australia and.
Dan Kirby: In preparation for our initial ex U S launch, we plan to onboard 15 international treatment centers by year end.
Dan Kirby: Additional regulatory submissions remain on track, including Australia in the first half and Switzerland in the second half of 2025.
Dan Kirby: In addition to <unk>, our commercial organization is dedicated to supporting Probuphine across three key lines of business, which include for use and the impact of the treatment regimen for use and manufacturing clinical trial and for clinical trial use where appropriate during.
Dan Kirby: During the fourth quarter, we activated and provided initial stock for our third and final planned provoking distributor.
Dan Kirby: Orders are now being fulfilled at all three major U S wholesalers with healthy ordering patterns, including restocking.
Dan Kirby: We expect demand for propylene going to continue to increase across each of these three key business lines throughout the year.
Dan Kirby: In summary, I am extremely pleased with the U S launch performance to date and the momentum we are building to capitalize and expand in cagny adoption, while growing probably can sales within the U S and beyond.
We committed to the opportunity to impact thousands of patients' lives and drive towards $2 billion in peak sales around the world I will now pass the call over to <unk>, Our chief operating officer to highlight our manufacturing progress.
Speaker Change: Thank you Tim.
Speaker Change: Today, I would like to build on <unk> introductory comments with an update on our commercial and clinical manufacturing network as well as our capacity expansion.
Speaker Change: Oh manufacturing network consists of over internal manufacturing facility, either in cell therapy center, or CTC and the contract manufacturer, which helps ensure flexibility and ample capacity for both commercial and clinical production.
Speaker Change: To support growing commercial demand from Doug.
Speaker Change: Steadily ramping up manufacturing capacity month over month.
Speaker Change: While actively hiring manufacturing quality control and support staff.
Speaker Change: There are no manufacturing this work the stuff capacity is currently more than 200 patients annually.
Speaker Change: Throughout 2025, we will continue growing stuff capacity in alignment with demand while operating at high capacity utilization.
Speaker Change: Each of our facilities are currently required to schedule, a brief annual maintenance, which entails a shortfall in production.
Speaker Change: Pleased to report that <unk> successfully completed its 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.
Speaker Change: Our commercial manufacturing experience continues to be positive in <unk>.
Speaker Change: Systems with prior clinical experience the.
Speaker Change: The medical affairs and commercial teams are effectively sharing best practices, among adcs and contributing to improvements in manufacturing success rates and gross margin over time.
Speaker Change: The turnaround time is consistently 34 days from receiving cells of the manufacturing facility to <unk> being ready for return shipments to the Hec.
Speaker Change: Our team is planning to shorten the turnaround time in 2025.
Speaker Change: Our Philadelphia manufacturing currently serves patients and all clinical trials in Europe, Australia and other geographies.
Speaker Change: We are now establishing logistics and distribution to provide access to commercial product in new markets in the EU. The U K in Canada in anticipation of potential approvals this year.
Speaker Change: We are also expanding capacity to fulfill our longer term vision.
Speaker Change: Icd's <unk> built today has capacity for more than 2000 patients annually.
Speaker Change: Once we complete the ongoing build out of existing shelf space, we expect the ICC to a total capacity for over 5000 patients annually within a few years.
Speaker Change: Additional expansion of <unk> manufacturing campus, along with process optimization and automation is expected to provide capacity for over 10000 patients.
Speaker Change: As we drove our manufacturing network, 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 cell therapy.
Speaker Change: Our til therapy expertise and manufacturing capabilities are protected by a robust intellectual property portfolio we.
Speaker Change: We currently own more than 250 and granted or allowed U S and international patents and patent rights for <unk> and other <unk> related technologies.
Speaker Change: I expect it to provide exclusivity through at least 2042.
Speaker Change: I am available to answer additional questions during the Q&A and I will now hand, the call to Mark our Chief Financial Officer.
Mark: Thank you Rocco.
Mark: Today, I will review, our current cash position as well as our results for the fourth quarter and full year consequences.
Mark: And we'd also highlight their financial outlook, including revenue expense guidance and gross margin.
Mark: As of December 31st 2024, our cash position was $313 4 million.
Mark: As of February 26, 2025.
Mark: <unk> cash position was approximately 422 million barrels.
Mark: Our current cash position is sufficient to fund current and planned operations, including manufacturing expansion into the second half of 2020.
Mark: I will now transition to our financial results.
Mark: Net loss for the fourth quarter of 2024 was $78 6 million.
Mark: <unk> <unk> per share.
Mark: Compared to a net loss of $116 4 million.
Mark: <unk> 45 per share for the fourth quarter ended December 31st 2020.
Mark: Net loss for the full year of 2024 was $372 2 million.
Mark: $1 28 per share compared to a net loss of <unk>.
Mark: $444 million.
Mark: <unk> 89 per share for the full year of 2020.
Mark: Total product revenue consisted of integra intrusion in the U S and global sales of polluting resumed through different lines of business.
Mark: None of this growth.
Mark: Total product revenue was $73 7 million.
Mark: For the fourth quarter of 2024, including $48 7 million growing segment.
Mark: And $25 zero million cocoa Luke.
Mark: For the full year of 2020 full we achieved.
Mark: Handle for a product or a new guidance range of 160 to 165 million barrels.
Mark: Total product bookings for the full year of 2024 was $164 1 million.
Mark: And consisted of $103 6 million foreign taxes and $65 million per quarter.
We're renewing cruises in the fourth quarter and full year 2024 over the prior year periods were primarily driven by the U S commercial launch of <unk>.
Mark: Strong demand from global protein sales.
Mark: I will now highlight our cost of sales, which includes cost of inventory overhead and related cash and noncash expenses that are directly associated with sales of anti VEGF protein as well as manufacturing costs for <unk>.
Mark: Cost of sales for the fourth quarter.
Mark: $45 5 million.
Mark: Including $9 $1 million in period costs associated with suspicion robo for manufacturing success rates, which decreased quarter over quarter.
Mark: On page of total revenue.
Mark: $5 9 million for noncash expenses, including fair market value step up in terms of go asset amortization and $6 million in royalty payable on product sales.
Mark: And the prior in Europe, three months period cost of sales was $4 4 million primarily related to noncash amortization point in terms of collections.
Mark: Cost of sales for the full year of 2020 pool was $124 million.
Mark: Including $26 3 million and certain cost associated with patients who are both in manufacturing success rates.
Mark: $26 2 million in.
Mark: Non cash expenses, including fair market value step up and tangible asset amortization.
Mark: And $14 2 million.
<unk> payable on product sales.
Mark: In the prior year for Euro cost of sales was.
Mark: <unk> four 8 million.
Mark: Primarily related to noncash amortization for intangible assets.
Mark: The increase in cost of sales from the fourth quarter and full year 2024 over the prior year periods.
Mark: Were primarily attributable to the U S commercial instrument sales of impact.
Mark: As well as Proleukin sales growth.
Mark: Following the initiation of product sales in the U S commercial manufacturing and related cash and noncash expenses tied to <unk>.
Mark: I'll start milk gross margin for the fourth quarter of 2020 goal was 4% to 6%.
Mark: All 13 4 million compared to the total product renewals and $3 7 million.
Mark: Cost of sales has improved over time, as we increase volume and capacity utilization throughout the launch ramp.
Mark: <unk> gross margin over the previous quarters reflect our ongoing focus on profitability.
Mark: Well over off with towards our targets for gross margin to surplus severance 2% in the coming years.
Mark: Our ongoing manufacturing expansion strong coordination reserve <unk> and.
Mark: Efficiency in manufacturing and release testing are expected to further optimize our cost of sales was a correspondingly higher gross margin.
Mark: I will now shift to our operating expenses.
For the full year of 2020 for a total cash burn excluding onetime expenses was within our guidance range of $2 $20 million to $340 million.
Mark: Research and development expenses were $72 2 million for the fourth quarter of 2024, a decrease of $15 3 million compared to <unk>.
Mark: $7 5 million for the same period prior year period.
Mark: Research and development expenses were $200 to $2 3 million for the full year of 2024, a decrease of 61.
Mark: <unk> compared to $344 1 million for the full year 2020.
Mark: The decrease in research and their brokerage expenses in the fourth quarter and full year 2024 over the prior year period was primarily attributable to the transition of <unk> from clinical to commercial manufacturing.
Mark: This decrease was partially offset by increasing the charter and related costs, including stock based compensation and clinical trial costs.
Mark: Selling general and administrative expenses were $42 5 million for the fourth quarter of 2024, an increase of $12 6 million.
Mark: Compared to $29 9 million will be part of our your peer group.
Mark: Selling general and administrative expenses were 163 million.
Mark: Euro 2024.
Mark: The increase of $46 1 million compared to $106 9 million for the full year of 2023.
Mark: The increase in selling and general.
Mark: <unk> expenses in the fourth quarter and full year of 2024 compared to the prior year periods was primarily attributable to increasing headcount and related costs, including stock based compensation to support global growth as well as legal and commercial related costs.
Mark: Looking ahead, we continue to in our prior total product revenue guidance within the range of 450 to 475 million.
Mark: For the full year 2025.
Mark: In addition, we anticipate the accounts per barrel for the full year 2025 to less than 300 million.
Mark: Including investment in our <unk> expenses.
Mark: Overtime, we expect cash burn to decrease as we continue to grow revenue and gross margin improves.
Mark: We also plan to keep leveraging additional opportunities to further optimize spending this year.
Mark: For additional information please see the company's selected consolidated balance sheets and statements of operation in this afternoon's press release, and our Form 10-Q to be filed later today.
Speaker Change: I will now hand, the call to our.
Speaker Change: Chief Medical officer to discuss our clinical pipeline.
Speaker Change: Thank you so much.
Speaker Change: We continue to be excited about the potential of til cell therapy in solid tumors, which represent more than 90% of all diagnosed cancer in the U S.
Speaker Change: Today, I will summarize key updates on our clinical program as well as our exciting next generation pipeline.
Speaker Change: Expanding the commercial opportunity for our Cagny into frontline advanced melanoma is a top priority at <unk>.
Speaker Change: Our global Registrational phase III trial till them 301 remains on track to support accelerated and full approval pathway in combination with <unk> in frontline melanoma as well as regular approval of <unk> in our initial indication post anti PD one melanoma.
Speaker Change: Strong momentum with enrollment and high enthusiasm continue among participating unplanned clinical site.
Speaker Change: As a reminder, so that 301% supported by positive results for Liza neutral plus timberlands them up from <unk> Com 202 cohort one eight in patients with advanced melanoma naive to immune checkpoint inhibitors.
Speaker Change: To explore another potential best in class alternative in frontline advanced melanoma for U S physicians and patients cohort <unk> and ILD come to two with investigate likelihood planned combination with new volume at <unk>.
Speaker Change: Our second Registrational program is investigating likelihood for monotherapy and this single arm Registrational phase III IOP Edu in 202 clinical trial to address unmet medical need among patients with advanced non small cell lung cancer, who progressed after anti PD one therapy.
Speaker Change: Single agent chemotherapy. The current standard of care in this setting provides limited rate and duration of responses.
Speaker Change: We expect to share additional data from <unk> in the second half of 2025 and enrollment continues with high demand at clinical sites in multiple countries to support a potential accelerated approval of LIFO neutral and potent anti PD, one non small cell lung cancer in the U S with an anticipated regulus.
Speaker Change: Sorry decision in 2027.
Speaker Change: 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 LIFO neutral plus Pembina, Vermont following standard of care chemo <unk> patients with Egfr wild type non small cell lung cancer, who.
Speaker Change: At present, the majority of patients with an unmet unmet medical need in this setting.
Speaker Change: We will investigate this regimen in cohort three D and the ILB come 202 clinical trial to inform a registrational and confirmatory trial design in frontline advanced non small cell lung cancer.
Speaker Change: Our goal is to further augment the strong efficacy seen in cohort three eight with <unk> in combination with <unk> in patients who were not previously treated with immune checkpoint inhibitor therapy.
Speaker Change: Moving along the pipeline we're excited about our first clinical trial in endometrial cancer, a significant new opportunity for <unk> cell therapy, and an additional post anti PD one setting.
Speaker Change: Our <unk> <unk> clinical trial is investigating less a neutral after frontline standard of care of chemotherapy and anti PD, one therapy in patients with endometrial cancer.
Speaker Change: Regardless of mismatch repair or MMR status.
Speaker Change: Recent approvals of immune checkpoint inhibitors in combination with chemotherapy for frontline endometrial cancer has created an unmet need.
Speaker Change: There are no currently approved therapies for patients who progress.
Speaker Change: We look forward to sharing initial data from <unk> hundred one in the second half of this year.
Speaker Change: As the leader until cell therapy <unk> also at the forefront of next generation approaches to optimize till until treatment regimen.
Speaker Change: If we summarize our three main programs in this area.
Speaker Change: Our next generation PD, one and activated T cell therapy <unk> 4001 is investigated in the phase II efficacy stage of our <unk> hundred one clinical trial.
Speaker Change: Multiple centers that are enrolling at an increasing pace across two phase II cohorts of patients with previously treated advanced melanoma.
Speaker Change: Small cell lung cancer.
Speaker Change: Building on our successful Proleukin franchise, we recently initiated a phase one two clinical trial of ILD Sweetveld with one a second generation modified IL two analog for use with the cell therapy treatment regimen.
Speaker Change: <unk> 3001 May result, in a better safety profile and support net frequent dosing compared to Proleukin.
Speaker Change: Lastly, we plan to submit an IND to FDA for <unk>.
Speaker Change: <unk> 5001, and genetically engineered inducible <unk> IL 12 'til cell therapy.
Speaker Change: The clinical trial of our prior generation of IL 12, IL 12 til 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 and <unk> five one to five til efficacy while optimizing safety.
Speaker Change: <unk> 5001 could facilitate expansion into a wide range of comments on the tumor cabin size beyond our current pipeline with significant market opportunity.
Speaker Change: I'm happy to address questions about these programs and additional trials.
Speaker Change: Q&A session.
Speaker Change: I look forward to sharing additional updates this year as we continue to work to deliver till cell therapy to cancer patients and additional therapeutic settings with additional tumor types.
Speaker Change: Thank you to the talented multi disciplinary team and research partners, who make this possible.
Speaker Change: I will now turn the call over to the operator to begin the question and answer session operator.
Speaker Change: As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced.
Speaker Change: With your all your question. Please press star one again.
Speaker Change: In the interest of time, we ask that you. Please limit yourself to one question and.
Speaker Change: And you may rejoin the queue. If you have any additional questions.
Speaker Change: Please standby, while we compile the Q&A roster.
Speaker Change: Our first question comes from Andrea <unk> with Goldman Sachs. Your line is open.
Andrea: Good afternoon, Thanks for taking my questions.
Speaker Change: 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 2005, which was set when you are only one quarter into the launch is still intact. Thanks. So much.
Andrea: Yeah sure Andrew we're not.
Andrea: 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 too long investors.
Andrea: Assuming no it's prone to over interpretation.
Andrea: We provide some different metrics this time around including the potential for growth and to Atc's net actually as a <unk>.
Andrea: Part of the answer to your second question. If you look at our press release and our advanced commentary.
Andrea: Within the 786 that we have right now only 13% of infuse 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.
Andrea: And second quarter of 2025 years, we go through so we still have confidence in those numbers because of the growth curve for this type of product can accelerate quite a bit and we see that happening across our ACC network right now we see the potential for that in those cities.
Speaker Change: Okay. Thank you.
Speaker Change: Thank you.
Operator: Our next question comes from Peter Lawson with Barclays. Your line is open.
Operator: Peter Your line is open please check your mute button.
Peter Lawson: Great. Thank you so much for taking the question.
Operator: As we think about Iot revenues.
Speaker Change: Have a nice spike this quarter.
Operator: Is that should.
Operator: Should we view that as a signal for future till demand or is that kind of stuck in from distributors and kind of.
Operator: How should we think about the other two sales.
Operator: Going forward what component of 2020.
Operator: Five revenues could that be.
Operator: Thank you.
Operator: Yes, so we.
Operator: We continue to believe and continue to talk about IL two revenue as being a leading indicator for <unk> sales like we've been saying for quite some time now and I think what youre seeing there is youre seeing the uptake by all of the seasonality that states.
Dan Kirby: Dan pointed out.
Dan Kirby: We restocked two of them and sold total block to a third.
Speaker Change: I think youll see in 2025 will be restocking again and it will represent.
Speaker Change: Is that a significant portion of the 450 to 475 guidance that we have out there could be as close to $100 million or more.
Speaker Change: We think it's a fantastic business, that's why we acquired it and it's performing very well right now so we're very happy with that number.
Speaker Change: Okay.
Speaker Change: Got you.
Speaker Change: Thank you. Our next question comes from Ben Burnett with Stifel. Your line is open.
Ben Burnett: Okay, great. Thanks, so much I guess a 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.
Ben Burnett: I think many of your colleagues are written notes about this lately and there's been a lot of.
Ben Burnett: Discussion about this we view the potential entrant is basically being very similar to a currently marketed product noticed feedback we're not really sure. What the differentiation is between that we've also has been a lot of information on how that product launched with.
Ben Burnett: The clinical data has not been comparable to ours their patient population is much much earlier.
Ben Burnett: 65% of their patients have one or two prior lines ahead about quarter patients with adjuvant PD one only in the study and we're looking at 65% of our patients with three or more prior lines much more real world population of metastatic melanoma. So.
Ben Burnett: We don't really see it as being any kind of significant impact on our launch.
Ben Burnett: We're out there with what we think is the premier product and we're looking to grow our market launch outside the U S and other indications as soon as we can.
Ben Burnett: Okay I appreciate that color. Thank you.
Speaker Change: Thank you. Our next question comes from Colin <unk> with Baird. Your line is open.
Speaker Change: Great. Thanks for taking our questions I understand you're not giving inter quarter updates going forward, but you did provide in for Keith can you speak was there a slowdown infusions in the back half of the quarter.
Speaker Change: And did you see any seasonality in <unk>.
Speaker Change: Calling it out we don't see any seasonality as Igor mentioned, we did have a manufacturing.
Speaker Change: Manufacturing maintenance period, there. So we have those kind of things and cell therapy. If you look at the launch curves for Beckman, I guess quarter and carpet Youll see theres theres little peaks and dips and valleys in those as things like that happen, so, but nothing in terms of our holiday seasonality Thats, what youre asking.
Speaker Change: Great. Thanks for taking my question.
Speaker Change: Thank you. Our next question comes from Tyler Van Buren with TD Cowen Your line is open.
Speaker Change: Great. Thanks, very much for taking our question. This is Nick on for Tyler.
Speaker Change: Thinking about guidance or anything five guidance as the potential price increase currently included in that guidance and also how should we think about.
Speaker Change: Global ex U S expansion, having any potential impact on guidance.
Speaker Change: Yes, the price increase that's coming in April has been factored into that guidance for both pro <unk> and right now the guidance doesn't include any contribution from ex U S.
Speaker Change: Thank you.
Thank you. Our next question comes from Giannis Zoom with Wells Fargo Securities. Your line is open.
Speaker Change: Great. Thanks for taking our questions.
Speaker Change: Was wondering how many infusions or pro forma for Q and that the quarter over quarter growth over the prior quarter, which was the 83 infusions.
Speaker Change: How does that compare with your expectations and do you think.
Speaker Change: That growth will.
Speaker Change: Either either claim R b.
Speaker Change: Different before lunch you color for Q.
Speaker Change: Yeah.
Speaker Change: Yes, it's about 95 revenue infusions theres other impurities that occur with single patient IMD isn't that kind of thing Thats still generate revenue Proleukin sales for example, it's about 95 revenue infusions.
Speaker Change: Our reporting for the fourth quarter.
Speaker Change: The quarter over quarter growth is quite strong we're seeing the growth that we need to see 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.
Speaker Change: They were they were there were quarters, where they grew 10 percentage careers, where they were flat to scores with over 30%.
Speaker Change: Our intention is to drive growth and we have tremendous opportunities vlccs that we have right now to do that as well as as we get into the community.
Speaker Change: Great. Thanks for the color.
Speaker Change: Thank you. Our next question comes from Africa, Gordon with Truth. Your line is open.
Gordon: Hey, guys. Thanks for taking my question.
Speaker Change: All right.
Speaker Change: <unk>.
Speaker Change: Data that you provided in the quarter to date that you've provided.
Speaker Change: 70, <unk> ADC is that our online what proportion have reached a steady state I'm wondering does that align with the 13% of ADC instead of all recruited more than 10 patients.
Speaker Change: So I think it's a very low number I can't tell you exactly but it's probably 10% or less of reach steady state at this point.
Speaker Change: We know that the vast majority of those 70 adcs have tremendous upside.
Dan Kirby: Maybe I'll ask Dan to comment a little bit only seen so far.
Dan Kirby: On the potential upside of those Atc's sure Fred and I think one of the things that you look at the fees you look at the Wassa reviewing patents plus.
Dan Kirby: I don't really think theres saturated with it because our strategy is again to increase referral to the community and of those they are the ones that are.
Dan Kirby: Developed expertise within <unk> and we have other ones that are they're entering towards that 10, plus confusion 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 and driving referrals to those centers.
Reni Benjamin: Thank you. Our next question comes from Reni Benjamin with citizens JMP. Your line is open.
Reni Benjamin: Hey, guys. Thanks for taking the questions and congratulations on the quarter.
Speaker Change: Maybe just one for me from the pipeline for Frederic we have data coming out in the second half of this year can you talk a little bit about our set expectations for both non small cell and endometrial how many patients worth of data and then I guess with this data is this the registrational set do we need to enroll.
Speaker Change: I'll, even more patients before filing for accelerated approval in both non small cell and in endometrial or do we need to start another cohorts that ultimately becomes the registrational dataset.
Speaker Change: Any color would be great.
Speaker Change: Yes.
Speaker Change: To start with <unk>. Thanks for the question.
Speaker Change: Obviously, we're going to we're going to time, our R. R data data disclosure with with an appropriate venue in real time, our cup with that.
Speaker Change: Where we are in regards to enrollment.
Speaker Change: It will really depend on the timing and I can't really comment on that at this point.
Speaker Change: This will be.
Speaker Change: An update on what what.
Speaker Change: As of itself the priority interests, which is the data from cohorts, one and two which are the registrational cohort.
Speaker Change: There is not going to be additional cohorts or anything that.
Speaker Change: That we would be reporting out because we think that that is.
Speaker Change: Really not that relevant.
Speaker Change: <unk>.
Speaker Change: Timing of the debt.
Speaker Change: The Registrational plan.
I said in my script.
Speaker Change: Timing will be that we are expecting a registrational decision by the end of 2027.
Speaker Change: We are enrolling currently.
Speaker Change: <unk> seen good momentum.
Speaker Change: And we are on track with that I hope that.
Speaker Change: And your question around endometrial.
Speaker Change: Similarly, I can't really commit to a specific page.
Speaker Change: Patient number here, but it's going to be a meaningful number that's at least an initial idea around the signals that we're seeing in this trial. We find this important enough to share an early dataset.
Speaker Change: Yourself.
Speaker Change: Thank you.
Speaker Change: Thank you. Our next question comes from Salim Sayed with Mizuho. Your line is open.
Speaker Change: Hi, This is bennett for clean thanks, so much for taking our question congratulations on the quarter and our progress. So also on the Registrational phase III trial in post anti PD, one non small cell lung cancer. So could you remind us what's the target there.
Speaker Change: We will expect sand plants, MTBE part to responsive rate at 30%, but I mean, not sure. If that's the best comparator here or if you can just talk a little bit about the bogey at the buyer here. Thank you.
Speaker Change: Yes, I can I can start maybe fredrik can get the get the rest of that so.
Speaker Change: First of all we can run FDA has told US we can run a single arm trial here, we're not running randomize against Docetaxel, but we will look at it.
Speaker Change: The BLA submission the FDA would look at available care for those patients and that includes the rebel study, which is very much to your map with docetaxel or Docetaxel monotherapy. There youre looking at response rates in the low twenties, but very short durability with til therapy, we have much longer durability. So were thinking it would.
Speaker Change: Come in with response rates in the mid Twenty's like we showed before with the durability like we've been saying we should be fine.
Speaker Change: 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 in Frederick if you're online you can you're welcome to add to that.
Speaker Change: No thats exactly right. The one thing to add here is it's really the it's really the durability.
Speaker Change: The limitation here.
Speaker Change: For the for the standard of care.
Speaker Change: For Docetaxel plus plus <unk>.
Speaker Change: Although again as Fred mentioned it.
Speaker Change: It's about 20% response rate PFS is about four four months.
Speaker Change: <unk>.
Speaker Change: Duration of response data has never been being shared so I think that that is indicating.
Speaker Change: Yeah.
Speaker Change: The limitations of the challenges that we are that we are planning on addressing with license.
Speaker Change: <unk> therapy, just as a reminder.
Speaker Change: The data that we had previously shared.
Speaker Change: <unk> two indicators.
Speaker Change: Response rates in the mid 20%, 26% and then a follow up communication around it we saw that 71% of the contract responders had <unk> of more than six months, which in this population is very meaningful.
Speaker Change: Thank you.
David Dye: Thank you. Our next question comes from David Dye with UBS. Your line is open.
David Dye: Okay, great. Thanks for taking my question, Brian I know you mentioned that you didn't see any seasonality.
David Dye: Or the holiday break, but I'm just wondering if you see any spillover impact from holidays on star forms are receptions.
David Dye: Could you repeat that David.
David Dye: Resection seasonality on receptions.
David Dye: No no I was just wondering if theres any has still an impact.
David Dye: From holidays.
David Dye: Start forms or any kind of tumor resection, if that makes sense.
David Dye: Yes, I am not following you we havent, maybe I can try to answer more generally.
David Dye: We didn't really see any slowdown in terms of the ATC just for the holidays, if thats, what youre asking for any of their operations because they are generally running.
Through the Christmas holidays, without any interruption for cancer patients.
David Dye: Yes, so of course, there could be one or two patients who are there.
David Dye: And actually just carrying on top of that Fred I think for seasonality, we didn't notice that from my understanding 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.
David Dye: But that is something we're looking at.
David Dye: Alright, thank you so much.
Speaker Change: Thank you. Our next question comes from Andrew Tsai with Jefferies. Your line is open.
Andrew Tsai: Hey, Thanks, Good afternoon I 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, if it's not patient demand and our supply chain or even beds at sites.
Speaker Change: What is the gating factor to sing.
Speaker Change: An acceleration in sales and 25% like you got it thanks.
Speaker Change: So I think above all the adcs that are starting up now have to get their feet under them and get them running we've got some accs are performing very very well right now we've got a lot more that are working their way up.
Speaker Change: I think in each ATC there is a difference.
Speaker Change: Okay.
Speaker Change: Each individually <unk> is its own little bottlenecks or whatever it might be some of them have staffing issues. Some of them have financial clearance challenges that were helping out with it but all of these things are pretty easily resolvable and we've been able to show that a good portion of our Acc's can really fly right now and we think we can get a lot more there pretty soon.
Speaker Change: Sure Andrew I think one thing to add on top of what Fred said regarding not really a bottleneck, but theres a process. They go through they have to make sure. They operationally enjoyed again, where the first oil on the market. So there's a learning curve. There as you see we said 13% of head count or more that number continues to grow so once they hit.
Speaker Change: That wave, where they understand how to use the product with it than a lever excuse me really is to pull the referrals and drive more patients in there and that's where we're working with community not only at the clinic level, but at the leadership level and community to make sure are those centers are getting to see the most patients.
Speaker Change: Makes sense. Thanks.
Speaker Change: Thank you.
Speaker Change: I'm showing no further questions at this time.
Fred Vote: I would now like to turn it back to Fred vote.
Fred Vote: Interim president and CEO for closing remarks.
Fred Vote: Thank you again for joining the <unk> biotherapeutics fourth quarter and full year 2024 financial results and corporate update conference call. As we closed the first calendar year of our first commercial <unk> 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 a frequent feedback from ACC is about advanced melanoma patients benefiting and finding hope entangled in the commercial setting.
Fred Vote: I'm confident that <unk> is poised to maintain our global leadership in innovating developing and delivering current and future generations he'll cell therapies for patients with cancer.
Fred Vote: As always we are thankful for the patients health care and advocacy communities, our partners and our exceptional Ian's team I'd also like to thank our shareholders and analysts for their support thank you.
Fred Vote: This concludes today's conference call. Thank you for participating you may now disconnect.
Fred Vote: Yes.
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