Q1 2024 Legend Biotech Corporation Earnings Call

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Yeah.

Speaker Change: Good day, ladies and gentlemen, thank you for standing by welcome to legend biotech first quarter 'twenty 'twenty four financial results conference call. At this time, all participants are in a listen only mode.

Operator: Good day, ladies and gentlemen. Thank you for standing by. Welcome to the Legend Biotech first quarter 2024 financial results conference call. At this time, all participants are in a listen-only mode.

Operator: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1, 1 on your telephone. You will then hear an automatic message advising your hand is free.

Speaker Change: After the speaker's presentation, there will be a question and answer session to answer question. During the session you will need to press star one and one on your telephone you will then hear an automatic message and fights and you'll have any space. Please note that today's conference maybe recorded I will now hand, the conference I'll, let you speak of House, Jessie Young head of Investor Relations and <unk>.

Operator: Please note that today's conference may be recorded. I will now hand the conference over to your speaker host, Jessie Yeung, Head of Investor Relations and Public Relations.

Jessie Yeung: Public relations. Please go ahead.

Jessie Yeung: Good morning. This is Jesse on head of Investor Relations and public relations I imagine biotech.

Jessie Yeung: Good morning, this is Jessie Yeung, Head of Investor Relations and Public Relations at Legend Biotech. Thank you for joining our conference call today to review our first quarter 2024 performance. Joining me on today's call are Ying Huang, the Communist Chief Executive Officer, and Lori Macomber, the Communist Chief Financial Officer.

Jessie Yeung: Thank you for joining our conference call today to review, our first quarter 'twenty 'twenty fall performance.

Jessie Yeung: Joining me on today's call are <unk>, the company's Chief Executive Officer, and Lori Mccumber, the company's Chief Financial Officer.

Jessie Yeung: Following the prepared remarks, we will open up the call for Q&A, we have quality Fad, Chief Scientific officer, and Steve Gaffle head of commercial development for the U S and Europe, joining in the Q&A session.

Jessie Yeung: Following the prepared remarks, we will open up the call for a Q&A session. We have Guowei Fang, Chief Scientific Officer, and Steve Gavel, Head of Commercial Development for the US and Europe, joining the Q&A session. During today's call, we will be making forward-looking statements, which are subject to risks and uncertainties that may cause our actual results to differ materially from those expressed or implied herewithin.

Jessie Yeung: Joining today's call, we will be making forward looking statements, which are subject to risks and uncertainties that may cause our actual results to differ materially from those expressed or implied here with me.

Jessie Yeung: This forward looking statements are discussed in greater detail in our S. E C filings, which we encourage you to read and can be found under the investors section of our company website.

Thank you.

Jessie Yeung: Yes.

Speaker Change: Hello, everyone and welcome to our first quarter earnings call I am pleased that you could join us.

Jessie Yeung: These forward-looking statements are discussed in greater detail in our SEC filings, which we encourage you to read and can be found under the investor section of our company website. Thank you. Hello everyone, and welcome to our first quarter earnings call. I am pleased that you could join us.

Jessie Yeung: As many of you on this call know, 2024 has been an eventful year for us. Obviously, our major news was the approval of CARVICTI by the FDA and the European Commission for second-line relapse or refractory multiple myeloma. These approvals have the potential to change the treatment paradigm for tens of thousands of patients in the United States and Europe. The feedback from key opinion leaders, oncologists, advocates, patients, and caregivers has been tremendous. On March 15, we received international media attention when the FDA's Oncologic Drug Advisory Committee, or ODAC, meeting raised awareness about multiple myeloma and the positive benefit risk profile of COVID-19. ODAC's unanimous 11-to-0 recommendation in favor of CARVICTY was an independent and objective validation of its value proposition.

Speaker Change: As many of you on this call know 'twenty 'twenty four has been an eventful year for us.

Speaker Change: Obviously, our major news with the approval of tour victory by the FDA and European Commission for second line relapsed or refractory multiple myeloma.

Speaker Change: These approvals have the potential to change the treatment paradigm for tens of thousands of patients in the United States and Europe.

Speaker Change: The feedback from key opinion leaders oncologists advocates patients and caregivers has been tremendous.

Speaker Change: On March 15th we received international media attention when the Fda's Oncologic drugs Advisory Committee or <unk> meeting.

Speaker Change: Meeting raised awareness about multiple myeloma and the positive benefit risk profile of correcting.

Speaker Change: I would ask unanimous 11, two zero recommendation in favor of Kovykta was independent and objective validation of its value proposition.

Speaker Change: We also added another noteworthy approval to our growing list the Brazilian health regulatory agency has approved car victory for second line multiple myeloma.

Jessie Yeung: We also added another noteworthy approval to our growing list. The Brazilian Health Regulatory Agency has approved Corvicti for second-line multiple myeloma. I am pleased to report that Corvicti is now available by prescription in Brazil.

Speaker Change: I'm pleased to report that conflict is not available by prescription in Brazil.

Speaker Change: Our patient facing colleagues and those working in manufacturing are energized and eager to share our transformative therapy with more patients around the world.

Jessie Yeung: Our patient-facing colleagues and those who work in manufacturing are energized and eager to share our transformative therapy with more patients around the world. As you will see on our addressable market slide, our second line indication translates to an addressable patient population of 80,000 across three major markets. Turning to financial developments, CARVICTY net trade sales for the first quarter were $157 million, which is a 100% increase year over year. However, sequentially, net sales decreased by $2 million from $159 million in the fourth quarter of last year.

Speaker Change: You will see on our addressable market slide our second line indication translates to an addressable patient population of 80000 across three major markets.

Speaker Change: Turning to financial developments correcting that trade. So for the first quarter were $157 million, which is 100% increase year over year.

Speaker Change: Sequentially net sales decreased by $2 million from $159 million in the fourth quarter of last year.

Jessie Yeung: This was the result of phasing due to the timing of orders and when they were delivered and billed for, as well as manufacturing testing needed for the upcoming expansion. Importantly, there was growth in patient demand, and obviously, that was before the recent second line approach. So, we do anticipate continued growth for Curvicti, particularly in the second half of the year, as we continue to add more slots and expand our capacity. Right now, there's no higher priority in the company than making more supply available to the market and reducing the vent-to-vent time.

Speaker Change: This was a result of phasing due to the timing of orders and when they were delivered and billed for.

Speaker Change: As well as manufacturing testing needed for the upcoming expansion.

Speaker Change: Importantly, there was growth in patient demand and obviously that was before the recent second line approvals.

Speaker Change: So we do anticipate continued growth for kovykta, particularly in the second half of the year as we continue to add more slots and expand our capacity.

Speaker Change: Right now there is no higher priority in the company that makes you more supply available to the market and reducing the vantiv and time.

Jessie Yeung: We're working to expand production from every angle. We're continually increasing production at our Raritan, New Jersey facility, where we have doubled cell processing capacity since the beginning of 2023. We are laser focused on completing the physical expansion of our Raritan site. We plan to double corrective capacity by the end of 2024 compared to the end of 2023. Our production capacity will be augmented later in the year when our Obelisk facility in Ghent, Belgium, is approved for commercial production.

Speaker Change: We're working to expand production from every angle.

We're continuing to increasing production at our Raritan, New Jersey facility, where we have doubled cell processing capacity since the beginning of 2023.

We're laser focused on completing physical expansion of our route inside this year, we plan to double convicted capacity by the end of 2024 compared to the end of 2023.

Speaker Change: Our production capacity will be augmented later in the year when our oldest facility in Ghent, Belgium is approved for commercial production.

Jessie Yeung: Clinical production already started back in January. With the second-line FDA approval, the specifications for manufacturing Carvicti were widened, which should give us greater yield going forward. Finally, Legend and J&J expanded a previous agreement with Novartis to perform commercial manufacturing for Carvictis through the end of 2029. The increases to our production capacity will help ensure we meet our target of annualized capacity of 10,000 patient slots by the end of 2025. Our cash balance now stands at $1.3 billion, which we believe provides us with the resources needed to increase production and gives us financial runway into 2026, when we expect to begin to achieve an operating profit. In other developments, we continue to bring more hospitals online as authorized treatment centers. We now have a total of 72 U.S. hospitals certified to treat CARB-Active patients.

Speaker Change: Clinical production already started back in January.

Speaker Change: With the second line FDA approval the specification for manufacturing Kovykta were widened, which should give us greater yield going forward.

Speaker Change: Finally legend and J&J expanded a previous agreement with Novartis to perform commercial manufacturing for <unk> through the end of 2029.

Speaker Change: The increases to our production capacity will help ensure we meet our target of annualized capacity of 10000 patients' lives by the end of 2025.

Speaker Change: Our cash balance now stands at $1 $3 billion, which we believe provides us the resources needed to increase production and gives us financial runway into 2026, when we expect to begin to achieve an operating profit.

Speaker Change: In other developments, we continue to bring more hospitals online as authorized treatment centers.

Speaker Change: We have now a total of 72 U S hospitals certified to treat <unk> patients.

Jessie Yeung: So our reach in the community is growing in parallel with the increase in eligible patients. Outpatient treatment comprises approximately one-third of our volume and remains an important differentiator for us. Due to the longer onset of CRS for CARVICTI patients, this side effect can potentially be managed in the outpatient setting, which allows those hospital beds to be utilized for other patients who need them. Finally, since our last earnings call in March, we published our first ESG report. Not only does it summarize our achievements as responsible corporate citizens, but the report provides a great overview of the company and transparency into how we conduct our business. To sum up,

Speaker Change: So our reach in the community is growing in parallel with the increase in eligible patients.

Speaker Change: Outpatient treatment comprises approximately one third of our volume and remains an important differentiator for us.

Due to the longer onset of Crs for car victory patients. This side effect can potentially be managed in the outpatient setting which allows those hospital beds to be utilized for other patients who need them.

Speaker Change: Finally, since our last earnings call in March we published our first ESG report not only does it summarize our achievements as a responsible corporate citizen. The report provides a great overview of the company and transparency into how we conduct our business.

Speaker Change: To sum up so far in 2024, we have achieved a significant regulatory goals and are working to execute with excellence to meet the growing demand for car victory now I would like to turn the call over to Laura to walk you through the financials for the first quarter.

Lori A. Macomber: So far in 2024, we have achieved our significant regulatory goals and are working to execute with excellence to meet the growing demand for Corvette. Now, I would like to turn the call over to Lori to walk you through the financials for the first quarter.

Speaker Change: Laurie.

Laura: Thank you Jim and good morning, everyone.

Lori A. Macomber: Thank you, Ying, and good morning, everyone. As Ying mentioned, we generated approximately $157 million in total net sales for CARB-50 during the first quarter, an increase of 118% year over year. Sequential growth was roughly flat due to the timing of orders and when they were delivered and billed for, as well as manufacturing testing needed for the upcoming expansion. As a reminder, we share equally in all profits and losses for Kravity ex-China with our partner Yandex.

Laura: As Jim mentioned, we generated approximately $157 million in total net sales for perfect day during the first quarter, an increase of 118% year over year.

Laura: Sequential growth was roughly flat due to the timing of orders and when they were delivered and build for as well as manufacturing testing needed for the upcoming expansions.

Laura: As a reminder, we share equally in non profits and losses for gravity ex China with our partner Johnson.

Laura: Turning to revenue total revenues for the first quarter were 94 million consisting of $78 5 million of collaboration revenue from the Silicon Vicky and license revenue of $12 2 million and the recognition of deferred revenue in connection with our agreement with Novartis to develop manufacture and commercialize.

Lori A. Macomber: Turning to revenue, total revenues for the first quarter were $94 million, consisting of $78.5 million of collaboration revenue from the sale of CAR-VIC-T and license revenue of $12.2 million from the recognition of deferred revenue in connection with our agreement with Novartis to develop, manufacture, and commercialize LV2102 and other potential CAR-T therapies selectively targeting DL3. The net loss for the quarter ending March 31st, 2024 was $59.8 million, or a loss of $0.16 per share, compared to a net loss of $112.1 million, or a loss of $0.34 per share, for the same period last year.

Lori A. Macomber: Moving on to expenses, the collaboration cost of revenue for the first quarter of 2024 was $49.1 million, compared to $35.6 million for the same period last year. These are Legend's portion of the collaboration cost of sales in connection with the collaboration revenue under the Janssen Agreement, along with expenditures to support the manufacturing capacity expansion. Additionally, cost of license and other revenue for the first quarter of 2024 was $5.6 million, compared to no cost of license and other revenue for the first quarter of 2023.

Laura: L B 21, or two and other potential car T therapies selectively targeting D. L. Three.

Laura: Net loss for the quarter ended March 31, 2024 was $59 8 million or a loss of <unk> 16 per share compared to a net loss of $112 1 million or a loss of 34 per share for the same period last year.

Laura: Moving on to expenses collaboration cost of revenue for the first quarter 2024, It was $49 1 million compared to $35 6 million for the same period last year.

Laura: These are legends portion of collaboration cluster cells in connection with the collaboration revenue under the Onsen agreement along with expenditures to support the manufacturing capacity expansions.

Laura: Additionally cost of license and other revenue for the first quarter 2024 was $5 6 million compared to no cost of license and other revenue for the first quarter of 2023.

Lori A. Macomber: These costs are in connection with our agreement with Novartis to develop, manufacture, and commercialize LV2102 and other potential CAR T therapies selectively targeting DL3. Research and development expenses for the first quarter of 2024 were $101 million, compared to $84.9 million for the same period last year. The increase of $16.1 million for the three months ending March 31, 2024 compared to the three months ending March 31, 2023 was due primarily to research and development activities in CITISEL, including higher patient enrollment in Phase III clinical trials and continued investment as well in our solid tumor programs, which include two IND approvals that advanced into phase one development. Administrative expenses for the three months ending March 31, 2024 were $31.9 million compared to $22.2 million for the same period

Laura: These costs are in connection with our agreement with Novartis to develop manufacture and commercialize L. B 20, 102, and other potential car T therapies selectively targeting D. L. Three.

Laura: Research and development expenses for the first quarter 'twenty 'twenty four for $101 million compared to $84 9 million for the same period last year.

Laura: The increase of $16 1 million for the three months ending March 31, 2024 compared to three months ended March 31, 2023 was due to primarily to research and development activities and sit yourself, including higher patient enrollment for phase III clinical trials and continued investment as well in our solid.

Laura: Tumor programs, which includes two anda approvals that advanced into phase one development.

Laura: Administrative expenses for three months ended March 31, 2024 were $31 9 million compared to $22 2 million for the same period last year.

Lori A. Macomber: The increase of $9.7 million year-over-year is primarily due to the expansion of administrative functions and infrastructure to increase manufacturing capacity. Selling and distribution expense for the three months ending March 31st, 2024 was $24.2 million compared to $18 million for the same period last year. The increase of $6.3 million, year-over-year, due to the cost associated with the commercialization of cars, including the expansion of the Salesforce and preparation for the second line indication launch. To summarize, our spending remains on track, and we continue to maintain a strong balance. As of March 31st, we had $1.3 billion in cash and equivalents, deposits, and investments.

Laura: The increase of $9 7 million year over year is primarily due to the expansion of the administrative functions and infrastructure to increase manufacturing capacity.

Laura: Selling and distribution expense for three months ended March 31, 2024 was $24 2 million compared to $18 million for the same period last year the.

The increase of $6 3 million year over year due to the costs associated with the commercialization of <unk>, including the expansion of the sales force in second line indication in launch preparations.

Laura: To summarize our spending remains on track and we continue to maintain a strong balance sheet as of March 31, we have $1 3 billion in cash and equivalents deposits and investments. Additionally, we earned in April a milestone payment of $45 million in connection with the Fda's approval of <unk> label.

Lori A. Macomber: Additionally, we earned in April a milestone payment of $45 million in connection with the FDA's approval of CARB-50's label expansion to treat second-line multiple myeloma in accordance with the Janssen Agreement. Thus, we believe we have sufficient capital to fund our operating and capital expenditures into 2020, when we expect to begin to achieve an operating profit. Thank you. I will now pass it back to Ying for closing remarks. Thank you

Laura: Expansion to treat second line multiple myeloma in accordance with the Nansen agreement.

Laura: Thus, we believe we have sufficient capital to fund our operating and capital expenditures into 2026, when we expect to begin to achieve an operating profit.

Speaker Change: Thank you I will now pass it back to you for closing remarks.

Speaker Change: Yeah.

Speaker Change: Thank you Laurie to sum up 2024 has already been a monumental year for legend with a stream of regulatory successes.

Ying Huang: To sum up, 2024 has already been a monumental year for Legend with a string of regulatory successes. CARVICTE continues to be the fastest-launched CAR T therapy, and now we have new opportunities to serve even more patients. I want to thank each of our 1,900 employees for their commitment and dedication that will ensure patients who need Carvicti are able to access it. And with that, we'd like to take your questions. Operator, we're ready for the first question. Ladies and gentlemen, as a reminder, to ask a question, you will need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, simply press star 1-1 again.

Speaker Change: <unk> continues to be the fastest launched car T therapy, and now we have new opportunities to serve even more patients.

Speaker Change: I want to thank each of our 90 to 100 employees for their commitment and dedication that will ensure patients who need car victim are able to access it and with that we'd like to take your questions.

Speaker Change: Operator, we're ready for the first question.

Speaker Change: Thank you, ladies and gentlemen, as a reminder to ask a question you will need to press star one on your telephone and wait for your name to be announced to withdraw your question simply press Star One again, please standby, while we compile the Q&A roster.

Speaker Change: No first question coming from the line of Jessica Fye with Jpmorgan. Your line is open.

Operator: Please stand by while we compile the Q&A roster. Now, the first question coming from the lineup is Jessica Fye with JPMorgan New London. Hey, guys. Good morning. Thanks so much for taking my questions. I have two, please, sort of related.

Jessica Macomber Fye: First, I know 1Q was impacted by a number of non-revenue batches for comparability. What should we think about the scale of that work in 2Q and beyond? And then second, when you talk about doubling capacity, from the end of 23 to the end of 24. But I think you mentioned that Obelisk commercial production is going to be kind of back half-weighted or back end-weighted. What does that mean for how we should think about revenue year-over-year in 24 relative to 23? Trying to figure out, kind of, is it one-to-one on that doubling year-end?

Good morning, Thanks, so much for taking my questions.

Jessica Macomber Fye: Two please sort of related first <unk> was impacted by a number of non revenue batches for comparability work.

Jessica Macomber Fye: How should we think about the scale of that work into <unk> and beyond.

Jessica Macomber Fye: And then second when you talk about doubling capacity.

Jessica Macomber Fye: From the end of 'twenty three to the end of 'twenty or do you think.

Jessica Macomber Fye: You mentioned that the obelisk commercial production.

Gonna be kind of back half weighted or back end weighted.

Jessica Macomber Fye: What does that mean for how we should think about <unk>.

Jessica Macomber Fye: Revenue year over year, and 24 relative to 'twenty three.

Jessica Macomber Fye: I'm just trying to figure out kind of is it one to one on that doubling year end.

Ying Huang: of Premier Ontario Endow Capacity, or are there other factors we should think about when we're thinking about revenue this year? Thank you. Hey, good morning, Jess.

Jessica Macomber Fye: Premier onto your under capacity or are there. Other factors, we should think about when we're thinking about revenue. This year. Thank you.

Jessica Macomber Fye: Hey, good morning, Jess Thanks for the question. This is Ian I will help answer those two so first on the <unk>.

Ying Huang: Thanks for the questions. This is Ying. I'll help answer those two. So first on the manufacturing investments, I would tell you that qualitatively, in the first quarter of this year, we did have a number of non-revenue generating runs. And that includes bringing in the CMO from Novartis and also bringing in a couple other additional nodes, including our facilities in Ghent for production, including clinical, and then, in the future, also for commercial production. So I cannot disclose exactly the number of the non-revenue-generating runs, but it is on a similar order of magnitude compared to, for example, clinical runs.

Ian: Manufacturing investments.

Ian: I would tell you that quantitatively in first quarter of this year. We did have a number of non revenue generating wrong and that includes bringing up the CMO from Novartis and also bring up a couple of other additional notes, including our facilities you can get up to full production, including <unk>.

Ian: Clinical and then.

Ian: The future also for commercial production.

Ian: I cannot disclose exactly the number of the non revenue generating Ross, but it is on a similar order of magnitude compared to for example, clinical Ross and we do expect that for the rest of the year in the next three quarters that number will come down the reason this.

Ying Huang: And we do expect that for the rest of the year, in the next three quarters, that number will come down. The reason is that we are pretty much complete in terms of the work we're doing with Novartis. So we believe that Novartis is in a position to file an IND very soon. And, you know, assuming the IND is cleared by the FDA, we expect Novartis to start clinical trial production in the third quarter, followed by commercial production in the first quarter of next year. And then, of course, we also have two other facilities in Ghent. The first one, phase one, is called Obelisk, and Obelisk is already producing for CARTITUDE 6, as we speak.

We are pretty much complete in terms of the work we're doing with Novartis. So we believe that Novartis is in a position to file <unk> very soon.

Ian: Sure.

Ian: Assuming the IND is cleared by the FDA, we expect Novartis to start clinical trial production in the third quarter and then followed by commercial production first quarter of next year.

Ian: And then of course, we also have two other facilities and get the first one in phase one is called the <unk> and <unk> is already producing fault Carter to six as we speak and we expect pending regulatory approval probably around late third quarter or early fourth quarter. This year overlay school has started commercial.

Ying Huang: And we expect, pending regulatory approval, probably around the late third quarter or early fourth quarter this year, Obelisk will start commercial production, followed by our much larger facility in Belgium called Techland. Techland, right now, is on track to complete physical construction and validation by the end of this year, so we expect that facility to start clinical trial production early next year, followed by commercial production in the second half of 2025. So that's kind of like the rhythm.

Ian: Production and then followed by a much larger facility in Belgium called the Turkmen Tech land right now is on track to a complete physical construction and validation by end of this year. So we expect that.

Ian: Facility to start clean.

Ian: Clinical trial production early next year, followed by commercial production in the second half of 2025, So that's kind of like the cadence and then to address your second question.

Ying Huang: And then, to address your second question, as I just mentioned, Obelisk is expected to start commercial production late 3Q or early 4Q this year. So, in general, I think we have said that, you know, we are looking at a roughly doubling of our capacity from 2023 to 2024. We don't provide guidance for the product itself, but I think the capacity expansion gives you a good idea of where the revenue would lie.

Ian: As Jeff mentioned overlap is expected to start commercial production late <unk> or early <unk> this year.

Ian: So in general I think we have said that we are looking at a roughly a doubling of our capacity from 2023 to 2024.

Ian: We don't provide guidance for the product itself, but I think the capacity expansion gives you a good idea of where the revenue would lie.

Ian: Consistent with our policy.

Ying Huang: Consistent with our policy to have similar or same disclosure from J&J, which does not provide product-specific guidance, we cannot guide the product itself. But I think that doubling of expansion gives you confidence about where the revenue would be in terms of growth year over year. Thank you. Can I just clarify, when you say doubling of capacity, there are other factors as it relates to revenue, whether it's kind of like in spec, out of spec, the amount going to clinical trials, the amount going to these comparability batches or what have you.

Ian: Similar or same culture disclosure from J&J.

Ian: Which does not provide product specific guidance, we cannot guide product sales, but I think that doubling of expansion gives you confidence that where the revenue would be in terms of growth year over year. Thank you.

Speaker Change: Can I just clarify when you say doubling of capacity.

Speaker Change: Other factors as it relates to revenue, whether it's kind of like in stack out of spec the amount going to clinical trials I'm not going to these comparability batches or what have you. So when you say doubling of capacity is that just like total total capacity inclusive of all these.

Ying Huang: So when you say doubling of capacity, is that just like total, total capacity inclusive of all these other things that may not generate revenue, or is that commercial? That is correct. When we talk about capacity, that includes the number of total slots from all nodes of production. That includes clinical production, that includes non-revenue manufacturing investment funds, that includes commercial production. And then when you think about commercial production, Jeff, of course, you have to make assumptions about the InSpec success rate, right?

Speaker Change: Other things that may not generate revenue or is that commercial capacity.

Speaker Change: That is correct. When we talk about capacity that includes the number of total slot from all notes off production that includes clinical production that includes non revenue manufacturing investment Ralph that includes commercial production and then when you think about commercial production jet of course, you have to make the assumption of the <unk>.

Speaker Change: <unk> success rate right.

Ying Huang: I mean, we're encouraged by the trend so far this year because given what we're seeing in Q1 and now in Q2, that continues to improve. So then there's, of course, the net pricing. So audits will figure into the revenues.

Speaker Change: I mean, we're encouraged by the trends so far this year because given what we're seeing in Q1 and now in Q2 that continue to improve.

Speaker Change: So then there is of course, the net pricing so audits will figure into the revenues, but when we talk about total capacity, we're talking about all the capacity orders slot from different nodes and that includes everything.

Operator: But when we talk about total capacity, we're talking about all the capacity, all the slots from different nodes, and that includes everything. And our next question comes from the line-up: Gina Wang with Barclays and Yolanda Soto.

Speaker Change: Thank you.

Speaker Change: And our next question coming from the line of Gena.

Speaker Change: Gena Wang with Barclays. Your line is open.

Gena Wang: Thank you for taking my questions, maybe I'll just follow Jessica's questions. So should we still expect revenue growth in second quarter, 'twenty four or should we wait into second half 'twenty four when uplift commercial production onboard in through Q4, Q and then another.

Unknown Attendee: Maybe I'll just follow Jessica's questions. So, should we still expect revenue growth in the second quarter, 24, or should we wait until the second half, 24, when a blitz commercial production onboarding 3Q, 4Q? And another related question is regarding Quarter 2, 5, and 6, now mainly 6, you still have maybe roughly 700 patients that need to be enrolled. Where do you expect these 700 patient enrollments mainly at? Would that be on the New Jersey site, or would that be on? Hi Gina, this is Lori.

The questions is regarding credit your five and six now mainly six.

Gena Wang: But you still have maybe roughly 700 patients that need to be in road.

Where do you expect these 700 patient enrolment, mainly at would that be in new Jersey side or would that be in.

Gena Wang: Yes.

Gena Wang:

Gena Wang: <unk> site.

Gena Wang: Hi, Dana this is Lori I'll take your first question on revenue, we do expect to see some growth in Q2, but as we've talked about we expect pronounced growth in the second half of the year as gene mentioned, we have different factors coming into play in the second half of the year with our Raritan ramp we expect our second capacity ramp.

Lori A. Macomber: I'll take your first question on revenue. We do expect to see some growth in Q2. But as we've talked about, we expect pronounced growth in the second half of the year. As you mentioned, we have different factors coming into play in the second half of the year with the Raritan ramp; we expect a second capacity ramp coming on there. Again, the facility is the largest driver with that coming online in order to do some commercial production.

Lori A. Macomber: Coming on there against facility is the largest driver without coming online in order to do some commercial production and then we do have a CMO that we anticipate clinical production can shift there that will free up some commercial capacity at Raritan. So in addition to that as we start to get these additional notes that come online.

Lori A. Macomber: And then we do have a CMO that we anticipate clinical production can shift to there, that'll free up some commercial capacity at Raritan. So in addition to that, as we start to get these additional nodes that come online, we will have some multiple country launches we anticipate in the back half of the year.

Lori A. Macomber: We will have some multiple country launches, we anticipate in the back half of the year and as you know with the complexity and cell therapy. Some of the achieving those sales will depend upon.

Lori A. Macomber: How those launches so and you've seen in prior launches we tend to get a lot of the acute patients first so we want to be conservative, but we do anticipate a more pronounced growth in the second half of the year.

Ying Huang: And as you know, with the complexity and cell therapy, some of the success of those sales will depend upon how those launches go. And you've seen in prior launches, we tend to get a lot of the acute patients first. So, you know, we want to be conservative, but we do anticipate more pronounced growth in the second half of the year. Ying, do you want to take the CAR-T5 and CAR-T6 questions? Yeah, Gina.

Lori A. Macomber: Tim do you want to take the 102036 question Gena. So on car two five we have completed all international enrolment already for a cartoon.

Ying Huang: So on CAR-T5, we have completed all international enrollment for CAR-T5, and that's actually above our pre-planned number. Right now, we're just enrolling additional U.S.-based patients so that we satisfy the minimum number of U.S. patient representation by the FDA. So by now, we have manufactured a significant portion of CAR-T5 patients. Now, on CAR-T6, since we opened enrollment in October last year, right now, it's enrolling really fast. It's actually faster than our plan. So in terms of where we're manufacturing for those trials, I can tell you that right now, Raritan, New Jersey, is the main site for CAR-T5 manufacturing.

Tim: And that's actually above our pre plan number right now we're just enrolling additional U S based.

Tim: Patients so that we satisfy the minimum of the U S patient representation by the FDA. So by now we have manufactured a significant portion of cartons of five patients now on car two six since we opened enrollment in October last year right now, it's enrolling really fast it's actually faster than our plan.

Tim: So in terms of where we're manufacturing for those trials I can tell you that.

Tim: Ryan now Raritan, New Jersey is the men's side.

Tim: Five manufacturing four <unk> six right now actually.

Ying Huang: For CAR-T6, right now, actually, Ghent, our first facility called Obelisk, is the main site for that trial now, and it will shift to other sources, but we're trying to really, you know, save the Raritan facility for commercial production for the rest of 2024. So that's where we're manufacturing for CAR-T5 and CAR-T6 for now. Thank you everyone for your questions, and our next question comes from the line of... Kelly Xu with Jeffrey C. Alanisopoulos.

Tim: Again, our first facility called <unk> is the men's side for that trial now and always shift to other sources of but we're trying to really.

Tim: Save the Raritan facility for commercial production for the rest of 'twenty 'twenty four.

Tim: That's where we're manufacturing for cardiac <unk>.

Speaker Change: Thank you.

Speaker Change: Thank you.

Our next question and our next question coming from the line up.

Speaker Change: Kelly <unk> with Jefferies. Your line is now open.

Thank you congrats on achieving great milestones early life full volatile for the launch in the U S.

Ying Huang: Thank you. Congratulations on achieving a great milestone in early line approval. So for the launch in the U.S., could you talk about the current launch activities? Have you started treating patients in the second to fourth line? And do you see a switch from the last line?

Steven J. Gavel: And also have a follow-up. Thank you. Yeah, why don't I take that question? This is Steve Gavel.

Kelly: Could you talk about the kinds of launch activity have you started treating patients in a second offline and do you see switch off on Oh.

Last one and also has a lot. Thank you.

Speaker Change: Yes, why don't you take that.

Steven J. Gavel: So I think the question had to do with Cartitude and its status and patients and so forth and so on. One of the things I do want to just piggyback a little bit on Lori's response earlier concerning the second half component of this year. Even though the product was approved in earlier lines in April, there's just a natural lag in the market, especially with a Cartitude 4 launch, where we are looking to get patients referred into our institutions. So I think this is one of the key differences with the Cartitude 1 launch versus 4, that there will be a natural lag, and it's just because of the referral piece of this.

Speaker Change: That question. This is Steve <unk>. So I think the question has to do with harder.

Steven J. Gavel: Harder to for the status of it and patients and so forth and so one of the things I do want to just piggyback a little bit to Lori's response earlier concerning the second half component of this year, even though the product was approved in earlier lines. In April there is just a natural lag in the market, especially with a quarter or two for launch we are looking for.

Steven J. Gavel: We're getting patients referred into our institutions. So I think this is one of the key differences with the card issued one launch versus four that there will be a natural lag and it's just because of the peripheral piece of this now.

Steven J. Gavel: Now, Also, to Lori's point, there are a number of patients that meet the eligibility criteria today in our hospitals that are moving very quickly through the approval processes and so forth. So, again, we continue to move very quickly in terms of patient identification and apheresis, but I did want to caution you all that it's just a natural phenomenon of referral, then manufacturing, and ultimately to revenue recognition. That's why we're basing our assumption on a really strong second half.

Steven J. Gavel: Also to Larry's point, there are a number of patients that meet the eligibility criteria today in our hospitals that are moving very quickly through the approval processes and so forth for it so.

Steven J. Gavel: Again, we continue to have very quickly as quickly in terms of patient identification and <unk>, but I did want to caution you all that it's just the natural phenomenon of.

Steven J. Gavel: Of referrals in manufacturing and ultimately to revenue.

Steven J. Gavel: Revenue recognition, that's why we're basing our assumption on a really strong second half.

Speaker Change: Thanks, and also to reach the goal of the 10000 doses by the end of 2025, what do you need to consider to sign up for additional city ammo contract also what percentage of the patients would be needed to trade it in outpatient setting.

Steven J. Gavel: And also, to reach the goal for 10,000 doses by the year end of 2025, we do need to consider signing up for additional CDMO contracts. Also, what percentage of patients would be needed to treat it in all patient settings to reach the 10,000 doses goal if we're assuming, like on the hospital side, there are also capacity constraints. Thanks.

Speaker Change: To reach that 10000 doses if are we assuming like on the hospital side, there's also capacity constraints.

Speaker Change: Yeah.

Speaker Change: So Kelly, let me take the first part of your question and then I'll ask Steve to talk about your allocation to administration of <unk>.

Ying Huang: So, Kelly, let me take the first part of the question, and I'll ask Steve to talk about the allocation demonstration of Curvetti. So when we look at the goal of reaching 10,000 annualized capacity by the end of 2025, we believe that with existing nodes, four nodes, right, that includes our own site in Ryerton, New Jersey, our two sites in Ghent, Obelisk and Techland, plus the Vardy site here, that should pretty much give us the reach that number. Of course, we're continuing to evaluate the CDMO of other companies that could potentially give us a boost as well. So stay tuned on that front.

Steven J. Gavel: So when we look at the goal of reaching 10000 annualized capacity by the end of 2025, we believe that with existing notes four notes right that includes our own siding right with the New Jersey, our two sites in Ghent or Blizzcon Tech land plus on Novartis side here that should be pretty much give us the reach.

Steven J. Gavel: To that number of course, we're continuing to evaluate the CMO of other companies that could potentially give us a boost as well so stay tuned on that front.

Steven J. Gavel: And then I'll ask Steve to talk about the outpatient administration of CAR-VIC-T. All right, thanks, Singh. So, you heard Ying at the top talking about roughly a third of all patients now being treated in the outpatient setting. And that's grown quite a bit. I mean, to give you a comparator versus other CAR-Ts in the market that we compete with, they're right around 15%

Steven J. Gavel: Then I'll ask Steve to talk about the.

Steven J. Gavel: Ah patient illustration of perfect day, alright, thanks, Tim So you're hurting us at the top talking about roughly about a third of all patients now are being treated in the outpatient setting.

Steven J. Gavel: That has grown quite a bit I mean, thats to give you a comparator versus other car Ts in the market that we compete with as they are right around 15%. So I think the question was what from an outpatient perspective, what would we need to see in order to achieve that.

Steven J. Gavel: So, I think the question was, from an outpatient perspective, what would we need to see in order to achieve the target doses that you referenced earlier? We expect by the end of 2025 to be at least doubled from where we are today. And it's reflective of the growth in the outpatient sector that we are seeing today. So, we are relatively confident that we are going to be there. I think the one wrinkle, and you're seeing a number of our sites investigating this today, is the partnerships that they are going to be, and they're currently embarking on, with other outpatient players, whether it be in the community setting, or I'm talking now about pure community retail setting.

Steven J. Gavel: The target doses that you referenced earlier, we expect by the end of 2025 to be at least double to where we are today.

Steven J. Gavel: And it's reflected in the growth in the outpatient sector that we are seeing today. So we are relatively confident that we are going to be there I think the one wrinkle and youre seeing now a number of our sites investigating this today is the partnerships that they are going to be and they are currently embarking with with other <unk>.

Steven J. Gavel: Outpatient players whether it be in the community setting I'm talking now pure.

Steven J. Gavel: Community retail setting and actually if you haven't seen a good example of that is back in 2022 acre healthcare announced a partnership with Mckesson, which is U S oncology and I know that they are very interested in leveraging assets outside of their own hospitals to bring these therapies out to as many patients that are eligible to receive them. So youll see.

Steven J. Gavel: And actually, if you haven't seen a good example of that, in 2022, ACA Healthcare announced a partnership with McKesson, which is U.S. Oncology. And I know that they are very interested in leveraging assets outside of their own hospitals to bring these therapies out to as many patients that are eligible to receive them. So, you'll see the definition of outpatient will change quite a bit over the next couple of years, not just hospital outpatient.

Steven J. Gavel: The definition of outpatient will change quite a bit over the next couple of years, not just hospital outpatient but in the next few years, you will start to see community administration of <unk>.

Steven J. Gavel: But in the next few years, you will start to see community administration of our program. Terrific. Thanks. And our next question comes from the line of John Miller with EverCrySci. Your line is open. Hi guys, this is Omer filling in for Jon.

Steven J. Gavel: Our program.

Speaker Change: Terrific. Thanks.

Speaker Change: Okay.

Speaker Change: Thank you.

Speaker Change: And our next question coming from the line of Jon Miller with Evercore ISI. Your line is open.

Speaker Change: Hi, guys. This is omar filling in for John.

Omer: Ying, I don't have any single question on CAR-VIC-T today. Instead, I want to focus on a very important area in the CAR-T space, which I don't think has come up in Legend conversations. So, you have this triple-targeted CAR-T ongoing in China since March 22. I think it's wrapping up now.

Yeah, I don't have any single question on corvid today, instead I want to focus on the very important area and our in car T space, which I don't think Thats come up in conversations. So you have this triple targeted car T ongoing in China. Since March 22, I think it's wrapping up now that's 18 1920 22 on autologous and separately.

Ying Huang: That's CD19, CD20, CD22 on autologous. And separately, you have this Leucar G39P, which is the dual-targeting CD19, CD20 allo, that I think you just started phase one of. Both of these in China. My question is, shouldn't those trials have been in autoimmune diseases, and or is that a plan that you're intending to do near-term? Hey, Umer,

Speaker Change: You have this lukehart G 39, P, which is a dual targeting CD 19 cities 20, allo that I think he just started phase one both of these in China. My question is should on those trials have been an autoimmune and or is that a plan that you're intending to do near term.

Speaker Change: Yeah.

Speaker Change: Hey.

Guowei Fang: I will ask our CSO, Dr. Guowei Fang, to answer your question. Oh, yeah. Thank you for the question. This is an important question.

Speaker Change: Good morning, I will ask Rcs, our doctor I'm going to answer your question.

Guowei Fang: And our disease-focused areas are both oncology and autoimmune diseases. For both, as I said, we have plans to develop those autoimmune disease indications as well, and that's in the process. And when would that start, Ying? And would it be a U.S. trial?

Rcs: Thanks, John for the question.

Rcs: This is Adam questioning and our disease focus area, both oncology and <unk>.

Rcs: Our auto immune diseases for both as said that.

Rcs: We have plans to radically those in autoimmune disease indication as well and it's in process.

Speaker Change: And when would that start doing.

Speaker Change: And would it be a U S trial I think that's the other very important question obviously.

Ying Huang: I think that's the other very important question, obviously. Currently, All-in-One is in the process of initiating the autoimmune IAT study in China across multiple disease indications. For U.S. autoimmune diseases, as I said, our current strategy is focusing on the allogeneic approach, given some of the key challenges associated with autologous treatment options.

Speaker Change: Currently.

Speaker Change: One is in the process of.

Speaker Change: Initiating.

Speaker Change: What you mean.

Speaker Change: Studying china across multiple disease indications.

Speaker Change: For the U S.

Speaker Change: Auto immune diseases.

Speaker Change: Said, all kind of strategies focusing on the allogeneic approach given some of the key challenge associated with our targets.

Speaker Change: Treatment options for example, the requirement of LIFO depletion and refinement of our manufactured at the individual patient level high cost et cetera.

Guowei Fang: For example, the requirement for lipid depreciation and the requirement for manufacturing at the individual patient level, high cost, et cetera. We are, as said, in the process of initiating the U.S. anti-abnormality study. And we will disclose additional information in the future. Thank you. And if I may clarify, sorry, one last one. If I may just clarify, in that Allo trial for the U.S., I'm assuming that's your CD19, CD20 dual targeting, is it safe to assume that you would not need the Fluci loading? Preconditioning, for what autoimmune disease?

Speaker Change: We have.

Speaker Change: As said.

Speaker Change: In the process.

Speaker Change: Initiating.

Speaker Change: Yes, R&D, enabling studies and we got it.

Speaker Change: Additionally, information.

Speaker Change: In the future. Thank you and if I may clarify sorry, one last one if I may just clarify and that allo trial for U S. I'm, assuming that's your CD 19020 dual targeting is it safe to assume that you would not need the flu Si loading.

Speaker Change: The pre conditioning.

Speaker Change: What I mean.

Guowei Fang: That's an open question, and I think we will make a decision based on the clinical data we are collecting. In terms of targeting mechanisms, we think that autoimmune diseases cover a very broad spectrum of different diseases, and we want to have options and choices for patients.

Speaker Change: That's an open question and I think we will.

Speaker Change: Make a decision based on the clinical data we are collecting in terms of targeting mechanism and we have we think that auto immune disease I'll cover a very broad spectrum of different diseases, and we wanted to have akshay on the choice for patients.

Guowei Fang: In terms of targeting mechanisms, CD90 and CD20 certainly are valid targeting mechanisms. I think plasma cells may also play a major component in BCI-driven disease pathology, so we're also considering the BCMA as an additional targeting opportunity. And Umer, I know you had a question about the disclosure and also moving to USIND. So I'll just add that.

Speaker Change: <unk>, a CD 19, <unk> suddenly that is tightening mechanism and I see the plasma Sam. They also play a major component of the Eep's adjuvant disease pathology. So we're also considering the PMA as additional attractive opportunities.

Speaker Change: And <unk>.

Speaker Change: I know you had a question about the disclosure and also moving into the U S and I'll just add that you see that we already initiated the chip Pacific CD 19, <unk> 'twenty to 'twenty, two clinical program and it will probably start dosing for autoimmune by end of this year. So based on that clinical data, we will make the decision when and how to move assets into the <unk>.

Ying Huang: You see, we have already initiated the triple specific CD90, CD20, CD20 clinical program, and it will probably start dosing for autoimmune by the end of this year. So based on that clinical data, we will make the decision when and how to move assets into the USIND process. And of course, like Dr. Fang just mentioned, we are very interested in whether we can either bypass or lower the dose intensity of the flu-like lymphodiptycin regimen.

Speaker Change: U S R&D process and of course like Dr. Francis mentioned, we are very interested in whether we can either bypass a lower the dose intensity for fluids LIFO depletion rates, but that is one goal of our Iot trial in China, It's always lost or the trial, we're conducting for the dual targeting allo.

Guowei Fang: That is one goal of our IIT trials in China, and so is also the trial we're conducting for the dual targeting allo-CD90, CD20 gumdality program. Sounds great. Thank you very much. Ying, it sounds like you could have some autoimmune data next year. Is that a reasonable conclusion from all this?

Speaker Change: 19% to 20 comes out of our T program.

Speaker Change: It sounds great. Thank you very much so it sounds like you could have some auto immune data next year does that a reasonable conclusion from all of this.

Ying Huang: Without officially guiding, yes, that is a possibility. Excellent. Thank you so much for this.

Speaker Change: Without officially guiding yes that is our ability.

Speaker Change: Excellent. Thank you so much for this.

Speaker Change: Thank you.

Speaker Change: And our next question coming from the line of.

Operator: And our next question, coming from the lineup: Yaron Werber with TD Colony. Line is open. Great. Let me maybe just follow Umar's last question, and then I have a question on Corvicti. Can you just discuss a little bit the concept of autologous with a triple CD19, CD20, and CD22 versus ALO. It looks like you're doing dual targeting. Can you just help us understand kind of your thoughts? Why not do triple on both?

Speaker Change: Brian Weber with TD colony. Your line is open.

Yaron Benjamin Werber: And then I have a follow-up on Corvicti. So for triple targeting, the design principle is to drive a deeper response by targeting multiple B-cell biomarkers, and so for that, we are currently initiating the IIT study and collecting predicted data. So for the ELO, we are going to have different targeting mechanisms, and based on the IIT study, we will have additional insight in terms of which disease we should target among different autoimmune indications. Okay, with the duel, but they'll keep that as a duel 1920 only because you don't need to drive deeper responses. Is that the thinking? You just need to reset the immune system?

Brian Weber: Great. Let me maybe just follow rumors last question and then I have a question on court victory.

Brian Weber: Can you just discuss a little bit the concept of autologous with a triple C 19, two to 20 and <unk> 22 versus with although it looks like youre doing dual targeting.

Brian Weber: Just help us understand kind of your thoughts why not do triple in both and then I have a follow up on court victory.

Brian Weber: So her tumor targeting.

Speaker Change: Got it.

Speaker Change: The design principle is to drive deeper responses by targeting multiple piece out by Marcus and.

Speaker Change: So for that we are currently.

Speaker Change: Initiating the study in the clinic and predictive data portal ad load.

Speaker Change: We have we are going to have different types of mechanism and based on the <unk> study.

Speaker Change: Additional insight in terms of which disease, we should target among different auto immune indications.

Speaker Change: Okay with the dual but you'll keep that as a dual 19 'twenty only because you don't need to drive deeper responses.

Thinking they just need to reset the immune system.

Guowei Fang: Yeah, so we're talking about CD19 and CD20 as well. So it's different, as I said, talking to CD19 and BCN, having different aspects. Okay, got it.

Speaker Change: Yes, so we're talking about CD 19.

Speaker Change: <unk> and <unk> as well as that was different asset targeting CD 19 <unk>.

Speaker Change: How many different aspects.

Speaker Change: Okay got it.

Speaker Change: Okay, maybe just to move back I have a quick question on <unk> can you give us a little bit of a sense now that second line is approved.

Yaron Benjamin Werber: Okay, maybe just to move back, I have a quick question on COVID-19. Can you give us a little bit of a sense now that the second line is approved? Is the out of specs now different, pretty much easier across the board? Or is the FDA still keeping a certain bar sort of on fourth line onwards and a different bar in the second line? Yeah, Yaron. Good morning. This is Ying.

Speaker Change: The other specs now different pretty much.

Speaker Change: Easier across the board or is the FDA still keeping a certain bar sort of on fourth line onwards on a different bar in the second line.

Speaker Change: Yes.

Ying Huang: I'll answer your question. So the answer is that when we received FDA approval on April 5th for the second line, we did receive one label with one specification. So as of today, right, if we treat any patient on label, the release spec is the same for second-line patients versus the fifth line and beyond. And also, by the way, it is a wider release specification. So I know it's early days, but based on the data from the full month of March production, which we tested in April, so far, we're seeing an encouraging trend in OS, based on either, you know, probably the wider release spec approved by the FDA, and also potentially, once we start to see more second line patients rolling in, the natural evolution of a better baseline for those patients. And those release picks, how do they compare with Becma and maybe Kymriah and Yaskarta, as far as you can tell?

Good morning. This is Ian I'll answer your question. So the answer is that when we received FDA approval on April 5th for second line. We did receive one label with one spec so as of today right. If we treat any patient own label. The release back is the same for second line patients versus the fixed line and beyond and also by the way it is.

Wider release back so I know, it's early days, but based on the data from the full month of March production, which we testing.

Speaker Change: April so far we're seeing encouraging trends in Oss sofa.

Speaker Change: Based on either probably the.

Speaker Change: Wider release back approved by the FDA and also potentially.

Speaker Change: Once we start to see more second line patients rolling in the natural evolution of a better baseline for those patients.

Speaker Change: And those really expects how do they compare with our beckmann, maybe Kim Ryan as hard as far as you can tell.

Ying Huang: Um, without disclosing a number, I can tell you that, based on the late data we have on AutoSpec, I think our success rate is approaching that of our competition at this point. Of course, like I said, it's very early days; we have only, you know, March production data; we have only a little bit of the April production data. Okay, and maybe just final, you know, I think you talked about a 100 ATC target for the year. What's the gating kind of rate to open all of those? Is it capacity, or are there other factors as well? Thank you. Yeah, no, it's fine, Steve Gavel.

Speaker Change: Without disclosing the number I can tell you that based on latest data we have on our spec I think our success rate is approaching that of our competition. At this point of course like I said, it's very early days we've only.

Speaker Change: No.

Speaker Change: March production data, we have only a little bit partial of the April production data.

Okay, and maybe just final I think you talked about 100 ATC target for the year.

What's the gating kind of race to open all of those is it capacity or are there other factors as well. Thank you.

Speaker Change: Yes.

Steven J. Gavel: The, I mean, the gating element is really the site certification process. One thing to take note, and I've talked about this on previous calls, is as we add more and more sites, you don't see nearly the volume that you see in our initial phase one sites, but we will continue to certify sites, and our intent is to get between 90 and 100 this year. The key metric, just so you know what we look at, is because there's so much outpatient administration of CARBICTE in our facilities now, on a per-site basis, we're seeing much more throughput per site versus what you would see, for example, with the BECMA.

Speaker Change: It will be.

Speaker Change: I mean, the gating element is really the site certification process.

Speaker Change: One thing to take note and I've talked about this on previous calls is as we add more and more sites.

Speaker Change: You don't see nearly the volume that you see in our initial phase or phase one site. So, but we will continue to to certify sites and our tenants to get between 90 to 100. This year. The key metric just so you know what we look at is because theres. So much outpatient now administration of cart.

Speaker Change: And our facilities on a per site basis, we're seeing much more throughput per site versus what you would see for example, with the back book. So I just wanted to make to make sure we're kind of viewing the same way.

Steven J. Gavel: So I just wanted to make sure we're kind of viewing this the same way. Next question coming from the line-up: Ziyi Chen with Goldman Sachs, Elon. Hey, thank you for taking my questions. Just two questions.

Thank you.

Speaker Change: And our next question coming from the line of.

Speaker Change: Chen with Goldman Sachs. Your line is open.

Speaker Change: Okay.

Ziyi Chen: One is on the EU launch. Well, I think the U.S. has been down quarter over quarter, but the EU has been increasing 23%, which is still growing nicely. So could you share a bit more color on the European pricing and also how the reinvestment coverage is in your countries? And also, any updates on the commercial launch in the UK and in Japan? And a small financial question is really regarding the DLL3 partnerships. So we understand that for the upfront payment, you just recognize about U.S. dollar 12 million in the first quarter out of the 100 million upfront payment.

Chen: Hey, Thank you for taking my questions.

Chen: Just two questions one is on the.

Chen: The EU launch well I think the U S. That's being down quarter over quarter, but you have Spain increased 23, 23%, which is still growing nicely. So could you share a bit more color on the Europe pricing and also how is the reimbursement coverage in Europe countries.

Chen: And also any updates on our commercial launch in UK and in Japan.

Chen: And a small financial question is really regarding the DIR through partnerships.

Ziyi Chen: So is that the specific accounting treatment for that? So it's going to be spread out over the next few quarters. And secondly, there is a cost of license related to connection to that. So could you help me help us to unpack this? A lot of things from that. Why don't I take the first European question?

Chen: So we understand that for the appropriate upfront payment you just recognize about USD 12 million in the first quarter out of the 100 million upfront payment so that.

Chen: Specific accounting treatment for that so it's going to be spread out over next few quarters and secondly, there is a cost of license related and collection to that so could you help me, helping us to understand a bit more about.

Where does this cost coming from thank you.

Speaker Change: Yes, we are going to try to unpack. This a lot of a lot of things from that why don't I take the first the European question. So I think the folks on the line are aware of our partner is responsible for all ex U S promotional activity specifically in Europe I can't tell you I think you are aware there is already a year into our partner in Germany, Austria, and both card in Q1 and four.

Steven J. Gavel: So I think folks on the line are aware of a partner who is responsible for all ex-U.S. promotional activities, specifically in Europe. I can tell you, I think you're aware of this already, we are an inter-partner in Germany and Austria, in both Carta 2.1 and 4. The other thing to take note from a global allocation perspective, even though we are in those countries, the majority of the global slot allocation is coming into the United States.

Speaker Change: The other thing to take note from our global allocation.

Speaker Change: Even though we are in those countries. The majority of the global slot allocation is coming into United States.

Steven J. Gavel: I think you had a question around pricing. Pricing has not been disclosed as yet in Europe, so we can't unfortunately provide information on that until it becomes publicly disclosed. I'm trying to think of the other European questions that are out there.

Speaker Change: Thank you had a question around pricing pricing has not been disclosed as of yet in Europe. So we can't Unfortunately provide information around that until it becomes publicly disclosed.

Speaker Change: I'm trying to think of the other European questions that were out there.

Lori A. Macomber: Oh, let's see here. [inaudible] So for deal three, as you guys saw on how we recognize on the P&L, there are actually three different locations of what we're recognizing there. And then on our balance sheet, as you guys remember, and we disclosed, we received 100 million upfront payment. However, we have to defer that revenue, the recognition of that 100 million over time, for the activities that we're performing, that we're obligated to perform as part of the collaboration agreement.

Speaker Change: Let's see here.

Speaker Change: Part of the pricing and reimbursement piece.

Speaker Change:

Speaker Change: Yes.

Speaker Change: Yes, so we're not comment again, we aren't commenting yet.

Speaker Change: We have received approvals, obviously in Japan, but we have yet to launch there.

Speaker Change: And again I'm going to defer to my partner on that one because they have not disclosed their intention on timing there nor as far as in the UK as well, so Florida, indicating excellent.

Speaker Change: For deal III as you guys saw on the highly recognized on the P&L, there's actually three different locations that we're recognizing there and then on our balance sheet. As you guys remember and we disclosed we received a $100 million upfront payment. However, we have to defer that recognition of that $100 million over time for the activity.

Lori A. Macomber: So to your question of how will that spread out? Yes, it will spread out over various quarters in the future, as we continue to do our activities that we're obligated to perform for that study. Now we do have a pass-through; there are certain material costs that we will pass through to our collaboration partner. So we recognize that as other income. So that is actually separated out, and then the cost of the license is the actual cost that triggers that revenue recognition is the cost that we've incurred based upon those obligations that we have to perform.

Speaker Change: That were performing that we're obligated to perform as part of the collaboration agreement. So to your question of how will that spread out, yes that will spread out over various quarters into the future as we continue to do our activities that we're obligated.

Speaker Change: To perform for that study now we do have a pass through there are certain material costs that we will pass through those costs to our collaboration partner. So we recognize that as other income so that is actually separate it out and then the cost of the license is the actual what triggers of that revenue.

Speaker Change: Recognition is the cost that we've incurred based upon those obligations that we have to perform so that's the actual costs that we're incurring for the clinical study.

Speaker Change: Great. Thank you, Steve and Laurie Thank you.

Lori A. Macomber: So that's the actual cost that we're incurring for the clinical study. Great. Thank you, Steven and Lori. Thank you. And our next question comes from the line of Leonid Timashev with RBC Capital Markets. Hey guys, thanks for taking my question. Why don't I maybe talk, ask on..., and I'm curious about cohorts ENF, when we might see that data, what level of follow-up, and what efficacy measures we should be focusing on. Related to that, I guess the question is, What in your mind is the PFS benchmark? Samantha Aaron, you know, for CARTiTUDE 5 as well.

Speaker Change: Thank you.

Speaker Change: And our next question coming from the line of Liana <unk> with RBC capital markets. Your line is open.

Liana: Hey, guys. Thanks for taking my question I wanted to maybe talk ask on sort of cadence of data that we should expect for the rest of the year and specifically Im curious on cohorts TNF.

Liana: When we might see that data what level of follow up and sort of efficacy measures, we should be focusing on.

Liana: And then related to that I guess.

Liana: What in your mind is the PFS benchmark that we should be looking forward there and for <unk> five at all thanks.

Speaker Change: Hello, This is <unk> so.

Leonid Timashev: Hello, this is Ying. First, maybe I can give you a quick preview of ASCO. We expect to present some data from one cohort, cohort B. These are the patients who did not achieve an optimal response to the standard care regimen in the front line.

First maybe I can give you a quick preview of <unk>, we expect to present some data from one cohort cohort D. These are the patients who did not achieve optimal.

Speaker Change: In response to.

Speaker Change: Standard care of resident in the frontline.

Speaker Change: And then for.

Ying Huang: And then for cohort E and F, we enrolled and dosed a total of roughly 60 patients with newly diagnosed multiple myeloma. So right now, we're expecting to release and publish the data at a major medical meeting towards the end of the year. So that's roughly the timing for cohorts E and F. And in terms of the level of follow-up, I think you should expect to see, you know, a year of follow-up or maybe even longer than that. If you talk about the PFS benchmark, so for cohorts 3 to 5, as you know, the standard of care regimen we use here is RVD or RevLimit, Velcade, and dexamethasone.

Speaker Change: For cohort E and F. We enrolled and dosed a total of roughly 60 patients in the newly diagnosed multiple myeloma. So right now we're expecting to release and published a data at a major medical meeting towards the end of the year.

Speaker Change: So that's roughly the timing of four cohorts.

Speaker Change: And in terms of the level of follow up I think you should expect to see a year of follow up or maybe even longer than that.

Speaker Change: If you talk about the PFS benchmarks, so from car T to five as you know.

Speaker Change: The standard of care regimen, we use here is <unk> or revlimid and Velcade and dexamethasone.

Ying Huang: If you look at the registration study for that regimen in frontline, the median PFS is about 34, 35 months, and that is the benchmark we're looking at to beat, right? I just want to remind you that this is a superiority trial. And then for cohort 6, I think you got the answer from the PERSUSE trial that was presented at ASH last year. That is a DRVD regimen combined with a stem cell transplant. So there, you're looking at a 4-year PFS rate of 84%, and that's the benchmark we're looking at, right?

Speaker Change: At a registration study for that regimen in frontline. The median PFS is about 30 535 months.

Speaker Change: And that as a benchmark we look at to beat right I just want to remind you that this is a superiority trial.

Speaker Change: And therefore Carter to six.

Speaker Change: I think you've got the answer from the persist trial that was presented at Ash last year.

Speaker Change: That is a Dr vd regimens.

Speaker Change: In combination of stem cell transplant. So there you look at the four year PFS rate of 84% and Thats. The benchmark, we're looking at right.

Ying Huang: Again, we are looking at superiority in PFS as a primary endpoint. Now, given the recent ODAC vote, we will be engaging with the agency to talk about the potential of using MRD as an endpoint to accelerate the approval timeline. So if you look at cohort 5, MRD inactivity is already a secondary endpoint. And then for cohort 6, if you look at our clinicaltrials.gov, the co-prime endpoint is PFS and MRD inactivity. So we will follow all the patients with MRD inactivity. And at the same time, we plan to engage the FDA and the EMA to talk about the potential of using MRD as an endpoint as well. They're very helpful.

Speaker Change: Again, we are looking at is superiority in PFS as a primary endpoint now given the recent <unk> vote.

We will be engaging with the agency to talk about potential for using Mardi is endpoint to accelerate the approval timeline.

Speaker Change: So if you look at cartoon five margin activities already a secondary endpoint and therefore <unk> six if you look at our clinical trials Dot Gov actually a co primary endpoint is PFS and margin activity. So we will follow all the patients who are margin activity and at the same at the same time, we've had to engage.

The FDA and DMA to talk about the potential of using MRV as endpoint as well.

Speaker Change: That's very helpful. Thank you.

Speaker Change: Thank you.

Ying Huang: Thank you. Thank you. And our next question comes from the line up. Vikram Purohit, Paul Morgan, Stanley Yelanisovan, Hi, good morning. Thanks for taking our questions. We just had two on Carbicti. The first on...

Speaker Change: Our next question coming from the line of the.

Speaker Change: Nick <unk> from Morgan Stanley Your line is open.

Nick: Hi, good morning, Thanks for taking our questions. We just had two one on correcting the first on.

Vikram Purohit: The topic of future disclosures, Ying and team, do you anticipate providing kind of a split of patients by line of therapy or any directional sense of, um, how patient use in the quarter has trended between earlier line versus later line in the coming quarters of performance data? And secondly, I know you don't provide long-term guidance, but looking a couple years out, how do you expect the CARB-XE sales base to perform? Print, U.S. vs. Mexico.

Nick: The topic of future disclosures.

Nick: Do you anticipate providing kind of a split of patients by line of therapy or any directional sense of.

Speaker Change: How kind of patient use in a quarter has trended between earlier line versus later lines.

Speaker Change: Coming quarters of performance data and then secondly.

Speaker Change: I know you don't provide long term guidance, but.

Speaker Change: A couple of years out how do you expect.

Speaker Change: Perfect sales basis.

Speaker Change: France U S respectively.

Speaker Change: Okay.

Steven J. Gavel: So I'll ask Steve to take your first question. Yeah, so thanks for that question. And it's an important metric. It's your question around looking at line of therapy use. It's an important question.

Speaker Change: So I'll ask Steve to take your first question.

Steven J. Gavel: Yes. So thanks for that question and it's an important metric because it's your question around looking at line of therapy use.

Steven J. Gavel: It's an important question that's a very difficult question detract from so just because of the available data thats in the public domain right now around that so let me give you a way how we're thinking about this so we're assuming any.

Steven J. Gavel: It's a very difficult question to track from. So, just because of the available data that's in the public domain right now around that. So let me give you a way of how we're thinking about this. So, we're assuming that in a year plus time, about 70% of our product use is going to be in earlier line therapies, or earlier line treatments, I should say. And that's going to increase over time. It's because the market is so large, and obviously there's high demand to use this in patients that are doing quite well.

Steven J. Gavel: Year, plus time about 70% of our product use is going to be in earlier lines of therapies early line treatments I should say and thats going to increase over time.

Steven J. Gavel: It's because the market is so large and obviously there is high demand to users and patients that are doing quite well.

Steven J. Gavel: But we will not, per se, teasing that out by line of therapy, not because we don't want to. But like I said, you get that data through different sources. One of the big sources is claims data, but the source information is a bit choppy.

Steven J. Gavel: But we will not be per se teasing that out by line of therapy, not because we don't want to but like I said, you get that data through different sources. One of the big sources is claims data, but the source source information is a bit choppy. So no to answer your question directly we will not be disclosing that by line.

Ying Huang: So no, to answer your question directly, we will not be disclosing that by line. Things that are a second follow-up. Yeah, so Vikram, on your second question, I mean, again, we're not in a position to provide guidance for CARVICTY, but as you know, typically when you launch a new indication, it takes about three years to get to peak sales. And as of now, we are not changing the projection that CARVICTY will peak at $5 billion plus.

Steven J. Gavel: <unk>, yes, so vikram on your second question.

Vikram: Again, we're not in a position to provide guidance for.

Vikram: Correct.

Vikram: But as you know typically when you launch a new indication.

Vikram: About three years.

Vikram: To get to that peak sales and as of now we are not changing.

Vikram: No.

Vikram: <unk>.

Vikram: Projection that <unk> 5 billion plus and by the way that is really on a stipulation that we'll have a healthy market share in second line for which we already have received official approval from both FDA and the U S and in Europe. So we feel confident about the growth potential for <unk> in the <unk>.

Ying Huang: And by the way, that is really on the stipulation that we'll have a healthy market share in the second line, for which we already have received official approval from both FDA in the U.S. and EMA in Europe. So we feel confident about the growth potential for CARVICTY in the second line over the next few years.

Vikram: One line in the next few years.

Speaker Change: Got it thank you.

Speaker Change: Yeah.

Speaker Change: Thank you one moment, our next question and our next question coming from the line of.

Operator: Thank you. Thank you. One moment for our next question coming from the line-up. Kostas Biliouris from BMO Capital Markets, Yolanda St. Good morning, everyone.

Speaker Change: <unk> <unk> from BMO capital markets. Your line is open.

Speaker Change: Good morning, guys and thanks for taking our question one question from us on the guidance out on the 10000 slot production by.

Konstantinos Biliouris: Thanks for taking our question. One question from us on the guidance around the 10,000 slot production by year 2025. Can you maybe provide some color around the number of FDA approvals for manufacturing capping creams you will need to be able to manufacture these slots by year-end 2025? Thank you. Kalani Kostas, thanks for the question.

Speaker Change: <unk> five.

Speaker Change: Can you maybe provide some color around the number of FDA approvals on manufacturing top increase you would need to be able to manufacture the slots by year end 2025.

Speaker Change: Yeah.

Speaker Change: Good morning constant thanks for the question. So let me just give you the little bit more details about how we think about all the different nodes right. So obviously right now the only commercial production side is rather than new Jersey facility.

Ying Huang: So, Let me just give you a little more details about how we think about all the different nodes, right? So obviously, right now, the only commercial production site is the Raritan facility in New Jersey. And we are implementing an FDA-approved increase as of now, and then we expect to have another increase toward the second half of the year. So that's what we're doing with Raritan.

Speaker Change: And we are implementing an FDA approved increase as of now and then we expect to have another increase towards the second half of the year. So that's what we're doing with routing and then Meanwhile, we and our partner Johnson <unk> Johnson are conducting a physical expansion of the Oregon facility.

Ying Huang: And then, meanwhile, we and our partner, Johnson & Johnson, are conducting a physical expansion of the Raritan facility. So that physical expansion should be completed by the end of this year. So over the course of next year, we are going to validate the equipment and then bring all the briefs up to GMP facility standards. So sometime next year, towards the second half, we expect that doubling of the manufacturing area in Raritan to start to contribute to additional capacity. So that's what we're doing for Raritan.

Speaker Change: So that essentially should complete by end of this year.

Speaker Change: So over the course of next year, we are going to validate the equipment and then bring on a brief up to the GMP facility.

Speaker Change: Standards. So sometime next year towards the second half, we expect that double.

Speaker Change: Doubling of the manufacturing.

Speaker Change: Area in Raritan to start to contribute to additional capacity. So that's what we're doing for our Raritan and then for the two facilities in Ghent.

Ying Huang: And then for the two facilities in Ghent, the first one, Obelisk, right now is already manufacturing for clinical trials, and I just said in the call that, towards late 3Q or early 4Q, we expect that facility to receive regulatory approval for commercial production. The much larger Techland facility in Ghent, right now, we're on track to complete all the validation work by the end of this year, so we expect clinical trial production to start early next year in 2025.

Speaker Change: The first one.

Speaker Change: Right now is already.

Speaker Change: Manufacturing for clinical trial, and I, just said in the call that towards property late <unk> or early <unk>, we expect that facility to receive the regulatory approval for our commercial production there.

Speaker Change: The much larger tech lab facility in <unk> right now we're on track to complete all the validation work by end of this year. So that we expect clinical trial production to start early next year in 2025 and in the second half of next year that facility will also come online pending regulatory approval for commercial <unk>.

Ying Huang: And in the second half of next year, that facility will also come online pending regulatory approval for commercial production. And then, of course, we talked about Novartis as a CMO. Again, we expect commercial production to start early next year. So if you look at those four nodes, right, we're adding three additional nodes for commercial production starting in the second half of this year and then throughout 2025. That's how we can achieve the 10,000 dose capacity by end of next year, all these four nodes together.

Speaker Change: Reduction and then of course, we talked about in Novartis as CMO again, we expect commercial production to start early next year. So if you look at those four nodes right, we're adding three additional assets for our commercial production starting second half of this year and then throughout 2025, that's how we can achieve.

Speaker Change: The 10000 dose capacity by end of next year Audis, four notes together and I can tell you that without disclosing all the technical details if we track as of last Friday, we are on track to achieve that 10000 total capacity by end of next year, given where we are in Raritan, where we arent in the again facilities and where we are.

Ying Huang: And I can tell you that, without disclosing all the technical details, if we track, you know, as of last Friday, we're on track to achieve that 10,000 total capacity by the end of next year, given where we are in Raritan, where we are in the Ghent facilities, and where we are with Novartis. Thank you. Very helpful. And our next question comes from the line of George Farmer with Scotiabank. Your line is

Speaker Change: With Novartis.

Speaker Change: Thank you very helpful.

Speaker Change: Thank you.

Speaker Change: And our next question coming from the line of George Farmer with Scotiabank. Your line is open.

George Farmer: Hi, Thanks for taking my question can you comment a little bit about how the this wider release spec approval translates may translate into.

George Farmer: Hi, thanks for taking the question. Ying, can you comment a little bit about how this wider release spec approval may translate into top-line sales, number one? Number two, also recognizing that Carvicti is moving into second-line primarily, at least in the relapse of Crater, you know, fourth-line plus. Can you talk a little bit about the dynamics of how Carvicti is being positioned against BiSpecifics? It looked like there was a bit of a surprise number from J&J when they reported. And also, finally, can you go into a little bit more detail on how you get to your CAHPS Youth Spend out to 2026? Thanks. Good morning, Josh.

George Farmer: And to top line sales number one number two also recognizing that <unk> is moving into second line, primarily at least in the relapsed refractory fourth line plus can you talk a little bit about the dynamics between how <unk> is being positioned against bi specifics. It looked like there was a bit of a surprise number from J&J.

George Farmer: When they reported and then also finally.

George Farmer: Can you go into a little bit more detail on how you get to your cash usage.

George Farmer: Spend out to 2026.

George Farmer: Yes.

Good morning, Josh I'll take the first question and then ask Steven Lori to provide answers for the second or third line.

Ying Huang: I'll take the first question and then ask Steve and Lori to provide answers for the second and third one. So on the wider release spec granted by the FDA in April, I think what we have said previously is that, based on our modeling and also the data from the Cartagena Clinical Program, we believe this widened spec should result in an additional 5 to 10 percentage points lower OS compared to before the wider release spec was approved by the FDA.

Speaker Change: So on the wider release spec granted by the FDA in April I think.

Speaker Change: What we have said previously is that based on our modeling and also the data from <unk> clinical program. We believe this widened spec should result in additionally, five to 10 percentage points lower Oss compared to before the writer Relief Act was approved by the FDA.

Ying Huang: So right now, like I said, it's still very early days, but based on what we are seeing so far, the OS is already coming down by roughly 5% from last month. So that is very encouraging, and we're going to have a little bit longer follow-up data to provide you with better confidence about where exactly the OS will be. But so far, things are trending very positively. Steve?

Speaker Change: So right now like I said, it's still very early days, but based on what we're seeing so far the OSC is already coming down by roughly 5% last month. So that is very encouraging and we're going to have to have.

I have a little bit longer follow up data to provide you with better.

Speaker Change: Confidence about where exactly the OS will be but so far things are trending very positively Steve yes. So why don't I take the question around how we're positioning the assets specifically for the quarter to four launch in second line and then I'll get into a little bit around later lines and by specific so it.

Steven J. Gavel: Yeah, so why don't I take the question around how we're positioning the assets specifically for the CARTA 2.4 launch and second line, and then I'll get into a little bit about later lines and bi-specifics. So it is our number one promotional focus to launch CARTA 2.4 in the second line plus setting. There's clearly a clear differential there versus standard of care, and it's going to be basically a single-minded focus for my team.

Speaker Change: It is our number one promotional focus to launch card of two four in the second line plus setting.

Speaker Change: There is clearly there.

Speaker Change: Clear differential there versus standard of care alone and it's going to be basically a single minded focus from my team. The other thing in terms of the bi specific question because it is the appropriate one and later lines of therapy, you are hurting in the opening talk about speed.

Steven J. Gavel: The other thing, though, in terms of the bi-specific question, because it's the appropriate one in later lines of therapy, you heard Aang in the opening talk about speed. One of the things that is clearly apparent to us, and you mentioned, I think, a Janssen surprise around the bi-specific, what's happening there, and this is honestly something that we could foresee coming, is that one of the things that's a key focus for us, you heard Aang talking about it, is not only generate more slots in the market but get faster into the market.

One of the things that is clearly apparent to us and you mentioned I think janssen surprise surrounded by specific.

Speaker Change: What's happening there and this is honestly something that we could foresee coming is that one of the things that is a key focus for us you're hurting talking about it not only generate more slots in the market, but get faster into the market and that's extremely important in later line disease, where patients are progressing very rapidly. So that's where you saw the growth happening with the <unk>.

Steven J. Gavel: And that's extremely important in later-line diseases, where patients are progressing very rapidly. So that's where you saw the growth happening with the bi-specifics as Clistimat hit the market and then was followed by Talc. One of the things I do want to point out to you, and it's something we talked to our partner quite a bit about, is that now that Talc has entered the market in fifth line plus in the U.S., what you're starting to see is a shift in the dynamic in terms of what bi-specific is used in front of one another. What we're seeing, and this makes sense, is that with Talc coming on board now, you're seeing a shift where Talc is actually being used first in front of Teq.

Speaker Change: Specifics as <unk> hit the market and then we followed by top one of the things I do want to point out to something that we talk to our partner quite a bit about it.

Speaker Change: As now talc has entered into the market in <unk> plus in the U S. What youre starting to see is a share shift in that guidance, but the dynamic in terms of what by specific is used in front of one another.

Speaker Change: What we're seeing and it makes sense is with <unk> coming onboard now youre seeing a shift where textbook talc is actually being used first in front of tech and the reason for that and this is bearing out in research.

Steven J. Gavel: And the reason for that, and this is bearing out in research, is this is a very effective bridging strategy to also get the cell to cell. So in the past, with Talc not being around, obviously, the market had no other option but to use Teclistimat if they needed it to bridge a patient. The challenge there is you're also targeting the same BCMA target. We know there's efficacy there, but by using Talc instead, you're obviously targeting a different target.

Speaker Change: This is a very effective bridging strategy to also get the cell itself. So in the past with tough not being around obviously.

Speaker Change: The market had no other option, but to use it.

Speaker Change: If they needed to do to bridge a patient the challenge there as you are also targeting the same BCA may target.

Speaker Change: We know theres efficacy, there, but by using talc instead, you're obviously targeting a different target. So they wanted to preserve the DCM a target to get to <unk>.

Steven J. Gavel: So they want to preserve the BCMA target to get CAR-50. So maybe it's a little bit more than you had asked for, but I did want to just point that out to you that even though, in this case, Talc might be used with some of these quicker-progressing patients, we anticipate them to get to cell at a later point in time. I'll take the question on cash and the runway into 2026. As you guys know, we ended Q1 with $1.3 billion in cash.

Speaker Change: So maybe it's a little bit more than you had asked for but I did want to at this point that out to you that even though in this case <unk> might be used with some of these quicker progressing patients we anticipate them to get to sell at a later point in time in Florida.

Speaker Change: I'll take the question on cash and the runway into 2020.

Speaker Change: We ended Q1 with $1 3 billion in cash if we take a look over the next two to three years.

Lori A. Macomber: If we take a look over the next two to three years, that'll be adequate cash to bridge us until we get to profitability from the BCMA program. But what I do want to say is, you know, that doesn't preclude us from potentially looking at additional capital raises. And that's really going to be dependent upon pipeline advancement, if there's something that we want to do from a business development perspective, and also if there's a certain level of working capital that we want to maintain.

Speaker Change: That'll be adequate cash to bridge us until we get to profitability from the BC MMA program, but what I do want to say is.

Speaker Change: That doesn't preclude us from potentially looking at additional capital raises and thats really going to be dependent upon pipeline advancement. If we if there is something that we wanted to do on a business development perspective, and also if there is a certain level of working capital that we want to maintain so yes, we do see us having adequate cash to get to profitability, but there are.

Lori A. Macomber: So, yes, we do see us having adequate cash to get to profitability, but there are other factors that will come into play if we decide that we do want to raise additional capital. Okay, thanks very much. And our next question comes from the line-up: Justin Zelin with BTIG, Elan is open.

Speaker Change: Our other factors that will come into play if we decide that we do on the raise additional capital.

Speaker Change: Okay. Thanks very much.

Speaker Change: Thank you.

Speaker Change: And our next question coming from the lineup.

Speaker Change: Justin Zelman with <unk> Your line is open.

Justin Reid Zelin: Thanks for taking the question. And it's great to see the outpatient administration usage pick up here. Steve, can you talk about some of the factors that are constraining outpatient administration and just the dynamic that centers decide on whether to offer outpatient administration? Yeah, sure. Thanks for that question. There are a number of different factors.

Justin Zelman: Thanks for taking the question and it's great to see the outpatient administration usage here pick up Steve can you talk about some of the factors that are constraining outpatient administration and just the dynamic that centers decide on whether to offer outpatient administered.

Speaker Change: Administration. Thanks.

Justin Zelman: Yes sure. Thanks for that question, there's a number of different factors the.

Steven J. Gavel: The challenge in later-life disease is the fact that you're dealing with a very difficult to treat patient to begin with, right? So I think just from a patient perspective, it's a challenge. However, as we see in our trends, you know, we're seeing almost 30% of the time, our facilities are working quite effectively to treat those very difficult-to-treat patients. What you're going to see, though, in an earlier line mobile patient, often many of these patients are often working, is it become much easier for the sites. And that's what we are projecting as well, right?

Steven J. Gavel: The challenge in later line disease is the fact that youre dealing with a very difficult to treat patient to begin with right. So I think just from a patient perspective.

Steven J. Gavel: So from a patient selection point of view, these are more mobile patients, and some of the patient-related issues that the sites were challenged with will get a bit easier for them. So that's, that's the first thing.

Speaker Change: It's a challenge however, as we see in our trends we are seeing almost 30% of the time.

Speaker Change: Our facilities are working quite effectively to treat those very difficult to treat patients, which youre going to see though in an earlier line more bolt mobile patient optum entities. These patients are often working.

Speaker Change: <unk> become much easier for the sites and that's what we're projecting as well right. So from a patient selection.

Speaker Change: These are more mobile patients and some of the patient related issues that the sites were challenged with will get a bit easier for them. So that's the first thing.

Steven J. Gavel: And the other thing that we keep an eye on is their intent to move forward. The question was asked earlier around capacity, right? So, you know, the sites recognize this, and they also want to use outpatient CAR T administration as a strategy to reduce the amount of resources to treat the number of patients that are eligible for this therapy. So, just from a resource perspective, sites also look at this as a very effective strategy to do so.

Speaker Change: The other thing that we keep an eye on is their intent to move forward.

Speaker Change: The question was asked earlier around capacity right.

Speaker Change: So.

Speaker Change: The sides recognize this and they also want to use outpatient car T administration as a strategy to reduce the amount of resources to treat the numbers of patients that are eligible for the therapy. So just from a resource perspective sites also look at this as a very effective strategy to do so so we're very very excited about this and you've heard me talk.

Steven J. Gavel: So we're very, very excited about this. And you've heard me talk about a little bit on the back end of one of the questions around outpatient. You will see with this program, a very different type of migration to full outpatient use. Our strategy, we've been very deliberate in how we went to market with this program.

Speaker Change: A little bit on the back end of the one of the questions around outpatient you will see with this program a very different type of migration to full outpatient use our strategy. We've been very deliberate in how we went to market with this program.

Speaker Change: Thank you.

Speaker Change: I'm proud of in terms of what's gone on in the marketplace in terms of the introducing this into the hospitals, having the hospitals moved into the outpatient clinics and like you said over time, our hospitals are looking at other third party partners on how to take this even further out to the community.

Steven J. Gavel: And I think I'm proud of how it's gone in the marketplace, in terms of introducing this into the hospitals, and having the hospitals move it to their outpatient clinics. And like I said, over time, our hospitals are looking at other third-party partners, how to take this even further out to the community, to ensure that these numbers that we talked about earlier, 10,000 doses, etc., we can meet that, that potential. So it's, it's very exciting stuff.

Speaker Change: To ensure that these numbers that we talked about earlier 10000 doses et cetera, we can meet that that potential so it's very exciting stuff.

Great. Thanks for taking the question.

Operator: Great, thanks for taking the question. And our next question comes from the line of Asperma with UBS. The line is open. Hi, good morning.

Speaker Change: Thank you.

Speaker Change: And our next question coming from the lineup.

UBS: <unk> with UBS Your line is open.

UBS: Hi, good morning, Thanks for taking our questions. So.

Ashwani Verma: Thanks for taking our question. So, in terms of this like double the capacity by year-end 24 versus 23, what is the respective annualized dose goal for this? Just to make sure we understand the apples to apples comparison to your year-end 25 goal of 10,000 doses capacity. And then second, I wanted to ask, like this Perseus quad regimen adoption in the first line setting, eventually, do you think that this delays or shrinks the second line pool of patients for curvity in the long run? Effectively, these patients can have several years of progression-free survival, which could arguably impact the downstream market opportunity for curvity. Yeah, so Ash, let me help with your first question.

UBS: In terms of this bank doubling capacity by adding 24 versus <unk> like what is the respective annualized dose goal is just to make sure we understand the Apple to Apple comparison to your.

Speaker Change: <unk> 25 will have 10000 doses capacity and then second I wanted to ask it's Perseus quad regimen adoption in the first line setting eventually do you think that this delayed.

Speaker Change: Thanks, The second line pool of patients for <unk>.

Speaker Change: In the long run effectively these patients.

Speaker Change: And have several years of progression free survival, which could arguably.

Speaker Change: In fact, the downstream market opportunity for <unk>.

Speaker Change: Thanks.

Speaker Change: Yeah. So let me help with your first question.

Ying Huang: So yes, by the end of 2025, we have this goal of reaching 10,000 annualized dose capacity, right? But that is when we exit 2025. So I just want to remind you that when we go into 2025, right, we are not going to be at 10,000. But then, because of the introduction of additional sites into the commercial production mode, we'll be able to end the year in 2025 with that capacity. And it doesn't stop there, because we'll continue to maximize the capacity of each of those nodes I mentioned.

Speaker Change: So yes.

Speaker Change: By end of 2025, we have this goal of reaching 10000 annualized.

Speaker Change: Those capacity right, but that is when we exit 2025, so I just want to remind you that when we go into 2025, we are not going to be at.

10000, but then because of the introduction of additional sites into the commercial production will be able to end the year in 2025 with that capacity and it doesn't stop there because we will continue to maximize the capacity from each of those notes I mentioned.

Speaker Change: So we believe that we will be able to actually get to a much higher number than that $10000. Once we complete all the expansion in farming additional nodes with the investment here.

Ying Huang: So we believe that, you know, we'll be able to actually get to a much higher number than that 10,000 dose once we complete all the expansion from the additional nodes with the investment here. So it's going to be hard for me to give you any quantitative distribution among the three, sorry, the four different nodes we mentioned. But I can tell you that Raritan, New Jersey, remains our biggest facility.

Speaker Change: So it's going to be hard for me to give you any quantitative.

Speaker Change: Distribution amount of <unk> III I'm, sorry, the four different notes, we mentioned, but I can tell you that Raritan, New Jersey remains our biggest facility and in the foreseeable future right and will be the most productive side in terms of the total output probably followed by our site in <unk>.

Ying Huang: And in the foreseeable future, Raritan will be the most productive site in terms of total output, probably followed by our site in Techland, Belgium. So that is how we think about the total peak capacity and then how we would plan to distribute the capacity among the different nodes. With regard to your second question, how DRVD getting into the front line would potentially affect the second opportunity, I'll ask Steve to answer that.

Speaker Change: <unk>, Belgium.

Speaker Change: So that is how we think about the.

Total peak capacity and then how we would plan to distribute capacity among the different nodes with regarding your second question, how the arvida getting into the frontline with potentially.

The second opportunity I'll ask Steve to answer.

Ying Huang: Yeah, so I thank you for the question. So we've just, so you know, we've been modeling certain assumptions in terms of, you know, in terms of eligible patient populations progressing on the quad. So I guess from an eligible patient population, it's been accounted for in our forecast and that forecast, and we've obviously communicated that with the manufacturing counterpart. So, from my perspective, again, we've accounted for that, and we've accounted for it in our supply plan. And then, Ash, maybe I'll just add to Steve's answer that, number one, you do have this 20-25% so-called patient with a high-risk cytokinetic mutation, and those patients, unfortunately, do not respond well, so they'll relapse.

Steven J. Gavel: Yes, so thanks for the question.

Steven J. Gavel: So just so you know we've been we've modeled certain assumptions in terms of how in terms of eligible patient populations progressing on the quad so.

Steven J. Gavel: I guess from an eligible patient population it's.

Steven J. Gavel: It's been accounted for in our forecast and that forecast and we have obviously communicated that with the manufacturing counterpart. So.

Steven J. Gavel: I guess from my perspective again, we've accounted for that and we've accounted for in our supply plan.

Speaker Change: And then maybe I'll just add to Steve So that number one you do have this 20% to 25% so called <unk> patients with high risk cytogenetics mutation and those patients. Unfortunately do not respond well so they will relapse and that is why we are releasing the data at <unk> for cohort D. These patients do not achieve a sub op.

Steven J. Gavel: And that is why, you know, we are releasing the data at ASCO for COPOR-D. These patients do not achieve a suboptimal or a complete response from DRVD. They need second-line therapy, right?

Speaker Change: T Mo or a complete response from <unk> they need a second line therapy right that it's your early adoption market.

Ying Huang: That is your early adoption market. And then, obviously, you know, we are conducting CAR-T5 trials. If you look at clinicaltrials.gov disclosure, we expect the primary conclusion in the year 2026. So, hopefully, within a couple of years, we'll have the first-line label, and then, obviously, we are going to pivot from second-line to front-line when that happens. Thank you. Thank you. And our next question comes from the lineup, Sean McKittin with Raymond James. Your line is open.

Speaker Change: And then obviously.

Speaker Change: We are conducting cartoon five trial, if you look at clinical trials dug up disclosure, we expect the primary competition.

Speaker Change: Year of 2026, so hopefully within a couple of years, we won't have the first line label and then obviously, we're going to pivot from second line too from that when that happens.

Speaker Change: Thank you.

Speaker Change: Thank you.

Speaker Change: And our next question coming from the line of Sean Mcgowan with Raymond James Your line is open.

Sean McGowan: Hey, guys. Thanks for taking the question maybe to put a finer point on that <unk> negativity Exxon outcome.

Sean McCutcheon: Hey guys, thanks for taking the question. Maybe to put a finer point on that MRD negativity adcom outcome. What do you think are the implications here for, I guess, Predatude 5 and Predatude 6? Timelines.

Sean McGowan: What do you think the implications here for I guess trying to two 5 million credit to six.

Ying Huang: And do you suppose the official draft guidelines will come in, you know, in time to be impactful there, or a bit too late? And what's your view on what the details for that MRD negativity requirement could be? So in Partitude 6, there is a 12-month sustained MRD negative CR. Do you think that's likely to be the bar, or do you think maybe an earlier landmark could be informative or acceptable? And then, just as a follow-on to that, you know, what do you think is the impact on the competitive dynamic for your earlier competitors if they're able to utilize MRD across different lines of therapy? Thanks.

Sean McGowan: Timeline.

Sean McGowan: And do you suppose the official draft guidelines will come in in time to be impactful there or are there too late.

Sean McGowan: And what's your view on what the details for that <unk> negativity requirement could be so im trying to just say for the 12 months sustained <unk> negative CR do you think that's likely to be the bar or do you think maybe an earlier landmarks could be informative are acceptable and then just as a follow on to that.

Speaker Change: Thank you.

Speaker Change: Impact on the competitive dynamics for your earlier competitors.

Speaker Change: They're able to utilize MRV.

Speaker Change: Across different lines of therapy.

Speaker Change: Hey, Mitch Thanks for all the questions about <unk>. So first of all we have all along.

Ying Huang: Amish, thanks for all the questions about MRD. So first of all, we have all along worked with the MRD endpoint, right? If you look at all the CAR-2 program trials, everyone has MRD measurement in the trial built-in. As I mentioned just on the call today, in CAR-2-6, we actually have already designed the trial with MRD inactivity as a co-primary endpoint with others in our minds. So if you look at the ODAC recommendation, the ODAC voted to recommend a 12-month period of MRD inactivity as a potential endpoint.

Mitch: Worked with MLD endpoint right. If you look at all of the car T program trials, everyone has <unk> measurement in the trial <unk> like I mentioned just on the call today in cartoon six we actually have already designed the trial with a margin activity as a co primary endpoint with others in our mind. So if you look at it all of that.

Mitch: <unk> voted to recommend a 12 month margin activity as a potential endpoint.

Ying Huang: Right now, we don't expect FDA to publish official guidance documents, but we do plan to engage with the agency to talk about the endpoints for CAR-2-5 and 6-12. And for CAR-2-5, you know, it probably would make a small difference.

Mitch: Now, we don't expect FDA to publish official guidance documents, but we do plan to engage with the agency to talk about the endpoints for <unk>, five and six trials and for cardiac <unk>.

Mitch: It probably would make us more difference because anyway, we expect the readout to be in 2026 now for currency six it could make a big difference because if you look at our disclosure on clinical trials Gov primary completion is estimated at 2033 now if FDA does agree upon that.

Ying Huang: Because anyway, we expect the readout to be in 2026. Now, for CAR-2-6, it could make a big difference. Because if you look at our disclosure on clinicaltrials.gov, primary completion is estimated at 2033. Now, if FDA does agree upon the 12-month MRD inactivity in combination, for example, with CR or any other endpoint as a potential endpoint for accelerated approval, then we can do that much, much faster in terms of the process, right?

Mitch: 12 months marketing activity in combination for example, with CR or any other endpoint as a potential endpoint for accelerated approval. Then we can make that much much faster in terms of the process that because if we can complete Audi enrollments Mccarthy six by end of next year, which is end of 'twenty five.

Ying Huang: Because if we can complete all the enrollments for CAR-2-6 by the end of next year, which is the end of 2025, then if, you know, the 12-month MRD inactivity is amenable at the endpoint, that means, potentially, by the end of 2026, we could have that kind of readout, right? So it does help a lot for frontline trials. Now, if you look at the competition, I mean, I think in the second line, based on our experience, it doesn't change too much, right?

Mitch: Then if the 12 months and margin activity is amenable as endpoint that means potentially by end of 2026, we could have that kind of readout. So it does help a lot for frontline trials now if you look at competition I mean, I think in second line based on our experience.

Mitch: It doesn't change too much right because the median PFS for our control arm was about 12 months. So I wanted to completing enrollment the redox shouldnt take that much longer. So I don't think theres a huge difference. If you look at a second line third line, but for frontline it does make a significant difference here.

Ying Huang: Because the median PFS for our control arm was about 12 months, so once you complete the enrollment, the readout shouldn't take that much longer. So I don't think there's a huge difference if you look at second line or third line, but for frontline, it does make a significant difference here.

Mitch: Yeah.

Ying Huang: In terms of the bar, you know, I don't think there is a quantitative bar here that the regulators have already determined at this point. But you can follow our disclosure from the CAR-T2-4, CAR-T2-2, and CAR-T1 trials, right? In general, we achieve a very high MR-gene activity rate.

Mitch: In terms of the bar.

Mitch: I don't think there is a quantitative bar here that the regulators have already tightened determine at this point, but you can follow our disclosure from cartoon for car T.

Mitch: Two car to one trial right in general we achieve a very high.

Mitch: And margin activity rate in fact at Ash last year, we even published the data from <unk>. One if you look at patients who achieved 612 months or even longer than 12 months margin activity in combination of CR. Those patients tend to have a very good prognosis in terms of longer term PFS and survival. So we do have data from.

Ying Huang: In fact, at ASH last year, we even published data from CAR-T2-1. If you look at patients who achieve six, 12 months, or even longer than 12 months of MR-gene activity in combination with CR, those patients tend to have a very good prognosis in terms of longer-term PFS and survival. So we do have data from the CAR-T2 program to show that if a patient can achieve complete response in combination with some sort of longer-term MR-gene activity, that is a very good predictor of long-term outcome here. Thank you. And our next question coming from the line of Mitchell Kapoor with HCWen Regulon is open. Everyone, thanks for taking the questions. I have two.

Mitch: The card program.

Program to show that if a patient can achieve complete response in combination with some sort of longer term margin activity that is a very good predict marker for long term outcome here. Thank you.

Mitch: Thank you and our next question coming from the line of Mitchell Kapoor with H C. Wainwright. Your line is open.

Mitchell Swaroop Kapoor: Everyone. Thanks for taking the questions I have two the first one I wanted to ask a bit on the second line launch.

Mitchell Swaroop Kapoor: The first one I wanted to ask a bit about the second line launch and the pair discussions. Can you just talk about the color of the pair discussions in the second line, the second line population? And how did those second line reimbursement discussions compare to those that you've had previously for later line reimbursement discussions? And then the second question is on COGS. Could you just talk about the trend in COGS and any impacting factors or levers that could influence COGS? Yes, it's Steve. So who am I?

Mitchell Swaroop Kapoor: The pair discussions can you just talk about kind of the color of payer discussions in the second second line population.

How did those second line reimbursement discussions compare to those that you've had previously for later line reimbursement discussions and then the second question is on Cogs could you just talk about the trend in Cogs and any impacting factors or levers that could influence the cogs in the future.

Steven J. Gavel: Yes, it's Steve so.

Steven J. Gavel: Okay, good. Why don't I take the first question around payer and contrast Artitude 4 versus 1? So it all comes down to these payer conversations around the value proposition associated with treatment per interval. The obvious data, the CAR-T4 data, is significant in terms of our fee of death improvement. So payers, the net of this, in an earlier line setting, payers love a product like SiltaCell in terms of the benefit that we are able to give, not only from a financial perspective but also from a patient perspective in terms of the patient-related metric.

Steven J. Gavel: Okay great.

Steven J. Gavel: Why don't I take the first question around Payor in contrast, our Q4 versus one.

Steven J. Gavel: So it all comes down with this payer conversations around the value proposition associated with treatment free intervals.

Obviously part of Q4 data.

Speaker Change #102: As significant in terms of our PFS improvement.

Speaker Change #103: So payers.

Speaker Change #103: The net of this in an earlier line setting payers love a product like silk yourself in terms of the benefit that we are able to give not only from a financial perspective, but also from a patient perspective in terms of.

Speaker Change #103: The patient related metrics.

Steven J. Gavel: So all systems are a go in terms of early line approvals. In terms of reimbursement, we have had no issues at all. As a matter of fact, the payers, the privates, in particular, are one of our biggest advocates out there. I'll take the COGS, actually.

Speaker Change #103: All systems are go in terms of early line approvals in terms of from a reimbursement perspective, we have had no issues at all as a matter of fact.

Speaker Change #103: Payers are privates in particular, our one of our biggest advocates out there.

Lori A. Macomber: So as you move into the second line and the payer structure changes to your question, where you're going to see that is in the growth to net adjustment. On the COGS line, the reason that you see variability actually has to do with the manufacturing capacity investments that we're making. So you will continue to see COGS variability as we start to bring these in, finalize the capital investments, and bring these nodes online in 24 and, actually, 25.

Speaker Change #103: Laurie and I will take the Cogs actually so as you move into the second line and the payer structure changes to your question, where youre going to see that is in the gross to net adjustment.

Lori A. Macomber: So you will continue to see that noise. It's the revenue line and the growth net where you'll see the impact of the second line launch. Lori, mind if I come back to that first point that just occurred to me?

Speaker Change #103: On the Cogs line. The reason that you see variability actually has to do with their manufacturing capacity investments that we're making so you'll continue to see.

Speaker Change #103: Cause variability as we start to bring these.

Speaker Change #103: Finalize the capital investments and bringing these nodes online in 'twenty, four and actually 25, so youll continue to see that noise.

Speaker Change #103: It's the revenue line and the gross to net where youll see the impact for the second line launch.

Speaker Change #104: Sure My if I come back to that first point that just occurred to me one more thing that around the payers piece of this it ties back into the crux of the issue around outpatient administration as well I mean other than the treatment free interval component of this as you can imagine private insurers loved the fact of a now a car T therapy that can be given by by hospitals.

Steven J. Gavel: One more thing around the payer piece of this. It ties back into the issue around outpatient administration as well. I mean, other than the treatment-free interval component of this, as you can imagine, private insurers love the fact that analog RT therapy can be given by hospitals very safely in the outpatient setting, just purely from a cost-reduction point of view, as opposed to admitting these patients, keeping them in for some time for weeks to reduce costs and continue to maintain these patients safely.

Speaker Change #104: Safely in the outpatient setting just purely from a cost reduction as opposed to as many of these patients keeping them and sometimes for weeks.

Speaker Change #104: To reduce costs and continue to maintain these patients safely and then also benefit.

Speaker Change #104: Benefit from that long term treatment free interval is a very good and very compelling story to private insurers.

Speaker Change #105: Great. Thank you for taking the question.

Lori A. Macomber: And then also benefit from that long-term treatment-free interval is a very good and very compelling story to private insurers. Great, thank you for taking the question. And our next question comes from the line-up: Rick Bienkoski with Cancer First Gerald, Yolanda Soltman, Hey, good morning, everyone.

Speaker Change #106: Thank you.

Speaker Change #106: And our next question coming from the line of Rick.

Dan Calfskin with Cantor Fitzgerald. Your line is now open.

Speaker Change #107: Hey, good morning, everyone and thanks for taking our questions.

Rick Stephen Bienkowski: And thanks for taking our questions. For the CARVICTI launch in Europe, could you comment on the number of certified treatment centers that are open in Germany and Austria, and how many are expected to be certified by the end of the year? And as a second question, Ying, I was hoping you could expand on the prepared comments around reducing the curvicty vein to mean time.

Rick: <unk> launch in Europe could you comment on the number of certified treatment centers that are opening in Germany, and Austria and how many are expected to be certified by the end of the year.

Dan Calfskin: As a second question Yang I was hoping you could expand on the prepared comments around reducing the perfect is anchored in time.

Ying Huang: Could you talk about the work that's being done here and if there are any internal targets for how much this could be improved? Why don't I take the first question about Germany and sites. Unfortunately, I cannot get into the details about sites and the rollout plan in Germany. I can tell you this, it's very robust.

Dan Calfskin: Could you talk about the work that's being done here and if there are any internal targets for how much this could be improved.

Speaker Change #110: Why don't I take the first question around Germany around sites. Unfortunately, I cannot get into the details around sites.

Yang: The rollout plan in Germany, I know I can tell you. This it's very robust and I can also tell you the fact that in any country.

Steven J. Gavel: And I can also tell you the fact that, in any country, the site certification process is often somewhat lengthy. So I'm bringing that up because I know our partners are working very hard to bring more and more sites on board. But I can't, unfortunately, get into specifics around the number of sites.

Certification process is oftentimes somewhat Wednesday, so I bring that up because I know our partners working very hard to bring more and more sites onboard.

Yang: But I can't unfortunately get into specifics around numbers of sites.

Yang: Okay. So on the question about <unk> I can tell you that our goal is to get to a median of Latam four weeks by end of this year and also we are a new metric to measure which is <unk> 90 <unk>.

Ying Huang: Okay, so on the question about van to van, I can tell you that our goal is to get to a median of less than four weeks by the end of this year. And also, we have a new metric to measure, which is P90. That means 90% of all the sellbacks we shift out will fall into what we call apheresis to receipts in less than five weeks. So that is our goal by the end of this year. That means an average of four weeks or shorter, and then pretty much all the patients will be able to receive it within five weeks.

Yang: 90% of all the setbacks, we shipped out.

Yang: Fall into the.

What we call.

Yang: <unk> has two receipts to less than five weeks. So that is our goal by end of this year that means average, while we saw shorter and then pretty much.

Yang: All the patients will be able to receive that within five weeks that is our goal here.

Speaker Change #112: Alright, great. Thanks for taking the questions.

Operator: That is our goal here. All right, great. Thanks for taking the questions. I'm showing up for the questions at this time. Ladies and gentlemen, this concludes today's telecon... Thank you for your participation and you may now disconnect. Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music, ?? ?? ?? ??

Speaker Change #113: Thank you.

Speaker Change #114: I'm showing no further questions at this time, ladies and gentlemen. This concludes today's teleconference. Thank you for your participation and you may now disconnect.

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