Q2 2023 Legend Biotech Corporation Earnings Call

Operator: Thank you for standing by. Welcome to the Legend Biotech report second quarter 2023 financial results.

Speaker 1: Good morning and thank you for standing by. Welcome to the legend biotech report. 2nd, quarter, 2023 financial results at this time. All participants are in the list and only mode. 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.

Operator: At this time, all participants are in the listen-only mode. 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 automated message advising that your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised at today's conference. is being recorded. I would now like to turn the conference over to Jesse Young, head of Investor Relations and Public Relations. Please go ahead.

Speaker 1: So, R11 on your telephone, you would then hear an automated message advising your hand to phrase. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Jesse Young, Head of Invest Relations and Public Relations. Please go ahead. Good morning. This is Jesse Young. Head of Invest Relations and Public Relations and Legend Biotech. Thank you for joining our conference call today to review our second quarter 2023 performance. Joining me on today's call are Ying Huang, our CEO and Lauren Macomba, Legend CFO . Following the prepared remarks, we will open up the call for Q&A. We have Huawei fan, chief scientific officer and Steve Gafel, 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 risk and uncertainties that may cause our actual results to differ materially from those expressed or implied here within. These forward-looking statements are discussed in a greater detail in our SEC following, which we encourage you to read and can be found under the

Jessie Yeung: Good morning. This is Jesse Young, head of investor relations and public relations at Legend Biotech. Thank you for joining our conference call today to review our second quarter, 2023 performance. Joining me on today's call are Ying Huang, our CEO, and Laurie McCumber, Legend's CFO. Following the prepared remarks, we will open up the call for Q&A. We have Huawei Fan, Chief Scientific Officer, and Steve Gavill, head of commercial development for the U.S. and Europe, joining the Q&A session.

Jessie Yeung: During today's call, we will be making forward-looking statements, which are subject to risk and uncertainties that may cause our actual results to differ materially from those expressed or implied herein. These forward-looking statements are discussed in greater detail in our SEC filing, which we encourage you to read and can be found under the Investors' Session section of our company website. Thank you, and I will now turn the call over to Ying.

Ying Huang: Good morning, everyone. Thank you for praying for John yesterday. We have had a very busy first half of the year, and we're excited to be sharing our latest corporate developments with you on a quarterly basis, starting with today's. Over the past six months, our teams have worked incredibly hard to accomplish a number of critical milestones that have set the stage for decisive growth for our company for years to come. First and foremost, as you may have seen, in the report by our partner, JNJ on July

Ying Huang: Our first approved therapy, Karvicti, generated total sales of $170 million in the second quarter of 2023, amounting to $189 million in sales in the first half of 2027. The strong performance in the quarter exceeded our expectations, which was driven by continued strong demand for our product and a meaningful increase in our daily slot capacity.

Ying Huang: We were able to ramp up a lot more quickly than anticipated, and we made continued improvements in our manufacturing process. We're very pleased by the progress made in our commercial launch and remain committed to making Kaviti available and accessible to patients who are eligible for treatment through our ongoing investments to increase capacity and improve efficiency in the second half of 2020. We continue to find success in our portfolio and pipeline, including the Cartitude Clinical Development Program that investigates Carvict in additional patient populations.

Ying Huang: These results demonstrate the strength of our company and our relentless pursuit of novel therapies for patients with unmet needs. This year, at the American Society of Clinical Oncology Meeting in June, we presented new data from our Phase 3 Cartitude 4 study investigating Karviki in Brelap and lenolidomy refractory patients with 1 to 3 prior lines of treatment. In this study, Carvicti reduced the risk of disease progression or death by 74% compared to the standard of care regimen.

Ying Huang: The data were also published in the New England Journal of Medicine and presented at the European Hematology Association 2020 Congress later that month. Based on Cartitude's lore data, our partner Jensen submitted a type 2 variation application to the European Medicines Agency and a supplemental biologics license application to the U.S. Food and Drug Administration to expand the indication for Carvicti for use in earlier stages of mycopomyloma treatment, as early as after the first relapse. We see Karikti as the crux of the new Miloma landscape and have submitted regulatory applications for its expansion from 4 plus lines to 2 plus lines.

Ying Huang: We're excited by the potential to provide treatment options to patients earlier in their treatment journey and are encouraged by the results of the ongoing cardiac flow study. We look forward to working closely with regulatory authorities around the world as we seek to expand the indication. As part of our efforts to expand manufacturing capacity, we signed a three-year contract with Novartis to manufacture additional clinical doses of carvictin in April, and we added additional certified treatment centers this quarter as part of our ongoing efforts to improve efficiencies while expanding capacity and access to this novel therapy.

Speaker 2: We signed a three-year contract with Novartis to manufacture additional clinical doses of carvicties in April and added additional 35 treatment centers this quarter as part of our ongoing efforts to improve efficiencies while expanding capacity and access to this novel therapy. In addition to our success with carvicties, we're also advancing on pipeline of therapies for solid tumors. This quarter, the US Food and Drug Administration granted LB2101, targeting BLL3, our investigational therapy for small cell lung cancer, an often drug designation in which we were able to open a trial site in the US to prepare for patient improvement. Another one of our solid tumor programs, LB1908, targeting clouding 18.2 in gas-free cancer is also progressing on track. We recently opened two clinical trial sites in the US for this program in the second quarter and we anticipate dosing our first patient soon.

Ying Huang: In addition to our success with Carvicti, we're also advancing our pipeline of therapies for solid tumors. This quarter, the U.S. Food and Drug Administration granted LB211, targeting DLL3, our investigational therapy for small-sad lung cancer, an often drug designation, which we were able to open a trial site in the U.S. to prepare for Patient Recruitment.

Ying Huang: Another one of our solid tumor programs, LB1908, targeting clouding 18.2 in gastric cancer, is also progressing on-train. We recently opened two clinical trial sites in the U.S. for this program in the second quarter. And we anticipate dosing our first patient soon. We look forward to reporting all the results across both of these solid tumor programs in the future. And finally, our financial outlook is equally promising and positions us to execute our plans through 2025.

Speaker 2: We look forward to reporting on the programs across both of these 32 programs in the future. And finally, our financial outlook is equally promising and positions us to execute our plans through 2025. On the heels of our strong, cartoon-floor data, we're able to raise approximately $785 million in growth proceeds in a quarter through a registered direct offering, private placements, and the exercise of a warrant. Bringing our cash, cash equivalents deposits and investments to $1.5 billion at quarter end. Further, as part of our collaboration with Janssen for Curvigty and the Cardiff of Clinical Development Program, we received a $15 million milestone payment this quarter at the acceptance of the Type 2 application for Curvigty and achieved another milestone for $20 million at the US SDA acceptance of the SBLA of Cardiff 4. We continue to see additional revenue from Curvigty as we reach additional key data and regulatory milestones. Turning to the next slide, slide 6, a final analysis of data from the Pivotal Phase 1-V2. Partitude 1 study was presented at the ASCO and EATRAE Annual Media this year. That showed sustained, deep, and durable responses in heavily protruded patients with relapsed or refractory multiple maloma. This data showed that Curvigty continues to demonstrate both efficacy and safety years after treatment, which has made our third leading option for adult patients with relapsed or refractory multiple maloma.

Ying Huang: On the heels of our strong Cartitude for data, we were able to raise approximately $785 million in growth proceeds in a quarter through a registered direct offering, a private placement, and the exercise of a warrant, bringing our cash, cash equivalents, deposits, and investments to $1.5 billion at quarter end.

Ying Huang: Further, as part of our collaboration with Jansen for Carvicti and the Cartitude Clinical Development Program, we received a $15 million milestone payment this quarter at the acceptance of the Type 2 application for Carvicti and achieved another milestone for $20 million at the US FDA acceptance of the SBLA for Carditude 4. We continue to see additional revenue from Kraviti as we reach additional key data and regulatory milestones. Turning to the next slide, slide 6, a final analysis of data from the pivotal phase 1d2, Partitude 1 study, which showed sustained deep and durable responses in heavily-pretreated patients with relapsed or refractory mitochondrial maloomaloma.

Ying Huang: This data shows that Carvicti continues to demonstrate both efficacy and safety years after treatment, which has made our therapy a leading option for adult patients with relapsed or refractory mitochondromyalmaeloma. In addition, five-year fall-up data from Legend 2 were presented. It is the longest fall-up data from Annie BCMA Target Cartier South Earth.

Ying Huang: At the five-year fall-up, these data are encouraging and bolster our belief that Scyl Cell or Corvicti is a paradigm-shifting factor. Moving on to slide to 7. As I mentioned earlier, we recently announced the submission of a Supplemental Biologics License application to the U.S. Food and Drug Administration to expand the label for Carvict to include the treatment of adult patients with relapse and laminidomyphratory multomyeloma who have received at least one prior line of therapy, including a proteosum inhibitor and an immunomodulatory agent. With this finding, we hope to move Kavikti into the 2-4-pline lines of therapy setting in myeloma, subject to FDA approval.

Ying Huang: FDA has now accepted this SBA filing and assigned a patent date of April 5th, 2024. In the clinic, we plan to complete enrollment in the ongoing Phase 3-Carditude 5 trial, which evaluates Siltesil in newly diagnosed patients for whom Translent is not intended by the end of this year. Furthermore, we're planning to initiate enrollment in our first-line Cartitude 6th study in the fourth quarter of 2020. Next slide. Flight 8.

Lori A. Macomber: We're pleased to report that Karvigti continues market penetration with sales of $170 million in the second quarter of 2023, consisting of $140 million in the US and $3 million in the EU. The 63% quarter over quarter sequential growth in the US was primarily driven by high demand from physicians and patients, higher slot availability, and lower out-of-spec rate. As of June 30, the number of active U.S. Treatment Sites was 54. On Fly9, our R&D team continues to advance our proprietary pipeline in the second quarter.

Lori A. Macomber: But last quarter, we opened our first clinical trial site for our DR3 program in the US, our second ongoing clinical trial in the US. In addition, a number of patients are being enrolled and dosed in a number of phase one IIT programs in China. I'll now turn the call over to our CFO, Laurie McImberg, to go over our second quarter financial performance in more detail.

Lori A. Macomber: Thank you, Ying, and good morning, everyone. As you mentioned, we are very pleased with the performance of our commercial product Carvicti this quarter, which generated approximately $117 million in total sales, representing a 63% sequential growth and 388% growth over the second quarter of 2022. As a reminder, we share equally in all profits and losses of Kravity, ex-China, with our partner, Jonson. Starting with revenue, total revenues for the second quarter were 73.3 million, consisting of 58.2 million in collaboration revenue from the sales of Carvicti, and 15.1 million in-licensed revenue for the achievement of a milestone during the quarter, as outlined in the global development plan under the Yonson Agreement for Sit to Sell.

Lori A. Macomber: The net loss for the three months ended June 30th, 2023, was $199.1 million, or a loss of 57 cents per share, compared to a net loss of $193.2 million, or a $0.62 loss per share, for the same period last year. For the six months ended June 30, 2023, the net loss was 311.2 million, or a loss of 91 cents per share, compared to a net loss of 225.5 million, or a loss of 73 cents per share, for the six months ended June 30th, 2022.

Speaker 3: Compared to the net loss of $193.2 million or a $0.62 loss per share for the same period last year. For the six months ended June 30th, 2023, net loss was $311.2 million or a loss of $0.91 per share compared to a net loss of $225.5 million or a loss of $0.73 per share for the six months ended June 30th, 2022. Moving on to expenses.

Lori A. Macomber: Moving on to expenses, collaboration cost of revenue for the second quarter, 2023, was 32.7 million, compared to 16.9 million for the same period last year. These are the legend portions of collaboration cost to sales in connection with collaboration revenue under the Yonson Agreement, along with expenditures to support the manufacturing capacity expansion. Research and development expenses for the second quarter, 2023, were 95.8 million, compared to 68.8 million for the same period last year

Speaker 3: Collaboration cost of revenue for the second quarter 2023 was 32.7 million compared to 16.9 million for the same period last year. These are legends portions of collaboration cost of sales in connection with collaboration revenue under the Austin agreement along with expenditures to support the manufacturing capacity expansion. Research and development expenses for the second quarter 2023 were 95.8 million compared to 16.8 million for the same period last year.

Lori A. Macomber: The increase of 27 million year over year is due to higher patient enrollment in phase three clinical development programs for Sit to Cell and increases in R&D activities for other pipeline programs. Administrative expenses for the three months ended June 30th, 2023, were 27.8 million compared to 18.1 million for this same period last year. The increase of 9.7 million year over year is primarily for the further build-out of administrative functions and continued investment in building our global IT infrastructure, along with non-reoccurring financial and legal fees related to the company's restatement of its historical financial statements.

Speaker 3: The increase of 27 million year over year is due to higher patient enrollment for phase three clinical development programs for CITTO-SEL and increases in R&D activities for our other pipeline programs. Administrative expenses for the three months ended June 30th, 2023, for 27.8 million compared to 18.1 million for this same period last year. The increase of 9.7 million year over year is primarily for the further build out of administrative functions and continued investment in building our global IT infrastructure, along with non-reoccurring financial and legal fees related to the company's restatement of its historical financial statements.

Lori A. Macomber: Selling and distribution expense for the three months ended June 30th, 2023, was $21.4 million compared to $27.4 million for the same period last year. The decrease year over year is primarily due to non-reoccurring launch expenses incurred in the first half of last year to support the U.S. launch of Carvict. To wrap up, our spending remains on track, and we continue to maintain a strong balance. As of June 30th, we had $1.5 billion in cash and equivalents, deposits, and investments, extending our cash runway through 2025. Thank you. I will now pass it back to Ying for her closing remarks.

Speaker 3: Selling and distribution expense for the three months ended June thirtieth, twentythousand and 23 was 21.4 million, compared to 27.4 million for the same period last year. The decrease year-over-year is primarily due to nonreoccurring launch expenses incurred in the first half of last year to support the? U's launch of caric teto wrap up. Our spending remains on track and we continue to maintain a strong balance sheet. As of June thirtieth, we had one point five billion in cash and equivalents, deposits and investments, extending our cash runway through thousand and twenty-five.

Speaker 2: Thank you. I will now pass it back to you in for closing remarks. Thanks, Lauren. In closing, we're very encouraged by the performance in this year thus far. Our teams continue to execute making tremendous progress to bring pervicti to more patients while continuing to supply our clinical programs. We have a healthy cash balance to carry out our long-range plans across all areas of the business. We now have cash run with sufficient to form operations throughout 2025. Looking ahead, our priorities include increasing manufacturing capacity, which we will do by continuing to invest in our facilities and working with the FGAT to ramp up, activating more treatment centers in the US and next US.

Ying Huang: Thanks, Lauren. In closing, we're very encouraged by the performance this year thus far. Our teams continue to execute, making tremendous progress to bring her victory to more patients while continuing to supply our clinical programs. We have a healthy cash balance to carry out our long-range plans across all areas of the business. We now have cash flow with sufficient to firm operations throughout 2020. Looking ahead, our priorities include increasing manufacturing capacity, which we will do by continuing to invest in our facilities and working with the FDA to ramp up, activating more treatment centers in the U.S. and XUS, and progressing our frontline studies across Cardiff 5 and 6.

Speaker 2: progressing our frontline studies across hard-to-five and six studies. Last but not least, advancing our pipeline programs. We remain steadfast in our commitment to capturing the full potential of correcting. Our teams across the globe are working tirelessly to enable reliable and consistent product, available to continue with this momentum. I would like to take this opportunity to thank the 1,500 As a reminder to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. The first question comes from Kelly.

Ying Huang: Last but not least, advancing our pipeline program. We remain steadfast in our commitment to capturing the full potential of correct. Our teams across the globe are working tirelessly to enable reliable and consistent product available to continue with this moment. I would like to take this opportunity to thank the more than 1,500 legend team members across the globe for their dedication and effort. Before I get into Ernie's clothes today, this is a picture of our Oblisk facilities in Ghent, Belgium, which we anticipate will be operational for clinical production by the end of 2023. We'll now open up the call to your questions. Thank you. As a reminder,

Operator: As a reminder, to ask a question, please press 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. The first question comes from Kelly She with Jeffries. Congratulations on the progress, and thank you for taking my questions. My first question is regarding the auto-speck rate.

Kelly She: Congratulations on the progress, and thank you for taking my questions. My first question is regarding the out-of-spec rate. I'm curious, is Legend expecting higher project specification limits when it correctly gets approval in earlier lines from second to false-line? And should we expect the out-of-spec rate to improve accordingly for this early-line product? Thank you. Open. Congratulations on the progress and thank you for taking my questions.

Kelly She: My first question is regarding the auto spec rate. I'm curious, is Legend expecting higher project specification limits when corrected get approval in earlier lines from second to fourth one? And should we expect the out of spec rate to improve accordingly for this early long?

Speaker 4: earlier lines from 2nd to 4th floor? And should we expect our stock rate to improve accordingly for this early line product?

Kelly She: holdingly for this early land product.

Ying Huang: Hey, Kelly, thanks for the question. So this is Ian.

Ying Huang: I'm going to answer your questions about auto specs. First of all, after all the work we have done in the last six months, we're very happy to report that today our current auto spec rate is trending down continuously, and it's very close to the labeled rate and not much really higher than our competition's auto spec rate. So we're happy we have made a lot of progress over there thanks to the effort from our riders.

Speaker 2: Hey, Kelly, thanks for the questions. So this is the answer to your questions about out of specs. First of all, after all the work we have done in the last six to 12 months, we're very happy to report that. Today our current out of spec rate is trending down continuously and it's very close to the labeled rate and not much really higher than our competition's out of spec rate. So we're happy we have made a lot progress over there. Thanks to the effort from our right and operation team. And then secondly, transfer question about the widening specs through the cursive for application. We did submit in our SBA package to the FDA when we found in June that a comprehensive correlative analysis that provides data to convince the agency we believe to widen our spec pending FDA approval. So if we do get a wider spec from the agency when we received the cursive for approval on the label, we expect out of spec rate to be down another meaningful month from the current out of spec rate here. Thank you very much. Thank you. Question.

Ying Huang: and operations And then secondly, transfer questions about the widening specs through the Cartesian application. We did submit in our SBLA package to the FDA when we filed in June a comprehensive correlative analysis that provides data to convince the agency we believe to widen our spec pending FDA approval. So if we do get a wider spec from the agency when we receive the Cardiac Initiative for approval, on the label, we expect autospeculation to be down another meaningful amount from the current auto speculation.

Ying Huang: Thank you very much. We have made a lot of mistakes. Go ahead.

Operator: Please stand by for the next question. The next question comes from Terrence Flynn with Morgan Stanley. Your line is open. Great, thanks so much for taking the questions. Maybe two for me. I was just wondering if you could comment at all about the cadence of the slots in the second half.

Terrence Flynn: Great, thanks so much for taking the questions, maybe two for me. I was just wondering if you could comment at all about the pace of slots in the second half of the year, if we should still expect an increase there, or is it more of a steady state until 2024? And then my second one relates to the Ash Conference, obviously always a big event in myeloma. Just wondering, Ying, if you could give us a preview of any potential. data that you guys might plan on submitting. Thank you.

Operator: Stand by for one moment, please. Please stand by.

Lori A. Macomber: Hi Terrence, this is Lori. Thank you for the question.

Lori A. Macomber: So the cadence that you're going to see for the second half of the year, you will see a step up from Q2. We, you know, as you know, we got the capacity ramp in Q2, but we didn't realize that for a full quarter. So you will see somewhat of a step up in Q3, and in Q4, we will continue with that ramp. Regarding the Ash question, I'll turn that over to Ying

Speaker 3: Lori, thank you for the question. So the cadence that you're gonna see for the second half of the year, you will see a step up from Q2. As you know, we got the capacity ramp in Q2, but we didn't realize that for a full quarter. So you will see somewhat of a step up in Q3 and in Q4 we'll continue with that ramp. Regarding the ash question, I'll turn that over to Ying. Hey, Taran, thanks for the questions. So consistent with the JNJ disclosure policy, we do not really comment on the many abstracts.

Ying Huang: Hey, Terrence, thanks for the question. So consistent with JNJ's disclosure policy, we do not really comment on submitted abstracts, but I think given the Cartier 24 data, the initial presentation was made at Ask on the HAA. You should probably expect some, you know, more subgroup analysis coming from Cardiff 4. Other than that, stay tuned until the Ash assets are published. Thank you.

Speaker 1: But I think given the card to fault data, the initial presentation was made at ASCO and the EHA. You should probably expect some more subgroup analysis coming from card to fault. Other than that, stay tuned until the ASHA after service are published. Thank you. Please stand by for the next question. The next question comes from Gina Wang with Faraklays. Your line is open. Thank you for taking my questions. The first question is regarding the manufacturing between the balance between clinical trial enrollment versus commercial patient. So just want to make sure the Belgian site since active by the year end 23 will card to six manufacturing will be all at the Belgian site initially and then you will move to Novartis sites by second half 2024 and also regarding current active sites in the US. Do you still have a slot limitation for each site? And a quickly another set of question regarding Purdue for you announced April 5th, 2024. Just want to confirm this is a standard review and you do not expect an ad account.

Operator: Please stand by for the next question. The next question comes from Gina Wang with Barclays. Your line is open. Thank you for taking my questions. The first question is regarding manufacturing, the balance between clinical trial enrollment versus a commercial patient. So just want to make sure the Belgian site, which will be active by the year end, 23, will

Huidong Wang: Thank you for taking my questions. The first question is regarding manufacturing the balance, you know, the balance between clinical trial enrollment versus a commercial patient. So just want to make sure the Belgian site, since it will be active by the year end, 23, will cartitude 6 manufacturing would be all at the Belgian site initially, and then you will move to Novartis sites by second. have 24. And also regarding current active sites in the U.S., do you still have a slot limitation for each site? And quickly, another set of questions regarding Padufa. You announced April 5th, 24. Just want to confirm this is a standard review, and you do not expect an ad account.

Operator: Please stand by.

Ying Huang: Morning, Gina, thanks for asking me questions. I'll answer the first and the third, and then I'll ask Steve to answer the second question.

Ying Huang: So, on your first question, yes, we fully expect our first stage of our Ghent Belgian facility to come online by the end of this year. And we're planning to start enrollment for Cartier 6, basically around the timing of its launch online for a GEN facility. So we will start clinical production for Cartier's 6 from our GEN facility. I can't comment on Novartis at this point, but suffice to say everything is on track at this point in terms of tech transfer and related activities. And then on your third question on Purdue data, yes, I can confirm that the deadline for data is April 5th, 24 under standard review. Yeah, thanks, Ang, thanks, Gina.

Speaker 2: related activities. And then on your third question on PDUFA data, yes, I can confirm that the PDUFA data is April 5, 2024 under standard review. Yeah, thanks. So the question had to do with allocation for sites. So you're correct. So we launched on an allocated model.

Steven J. Gavel: Yeah, thanks, Ang, thanks, Gina. Yeah, so the question had to do with allocation of sites. So you're correct. So we launched on an allocated model here in the U.S. When we continue to be in an allocated model for the foreseeable future, however, what we did recently as our out of spec sites continued to have significant improvements, we also added a pool concept to the U.S. We have additional slots that our sites can then go into, providing they have, obviously, that level of patient demand. So right now, in the U.S., we have a bit of a hybrid where all sites are being allocated, as well as an open pool approach for some specific sites within the U.S.

Speaker 1: Here in the U.S., when we continue to be in an allocated model for the foreseeable future, however, what we did do recently as our attestpect continued to have significant improvements. We also added a pool concept into the U.S., where we have additional slots that our sites can then go into providing that have obviously that level of a patient demand. So right now in the U.S., we have a bit of a hybrid where we have all sites being allocated as well as an open pool approach for some specific sites within the U.S. Evercore, your line is open. Hi guys, thanks for taking my question. Ying, first, can you remind us what's going on with the board dynamics and Genskripp and what changes may or may not be happening if we can just understand what's happening on the board front and governance front. Secondly, I know you have a DLL 3 CAR T in your phase one right now. Can you remind us a, what did we learn from the DLL 3 CAR T failure at AMGEN? This was a 2019 program.

Operator: Please stand by for the next question. The next question comes from Umar Raffet with Evercore. Your line is open. Hi guys, thanks for taking my question. Ying, first, can you remind us what's going on with the board?

Umar Raffet: Hi guys, thanks for taking my question. Ying, first, can you remind us what's going on with the board dynamics and Genscript and what changes may or may not be happening if we can just understand what's happening on the board front and governance front? Secondly, I know you have a DLL3 car T in your phase one right now. Can you remind us, A, what we learned from the DLL3 car T failure at Amgen?

Umar Raffet: This is a 2019 program. And also, what was the lag between when you were on? I&D was filed or cleared back in the fall last year versus about seven or eight months it took to actually get the first patient recruited. Thank you very much.

Speaker 2: And also, what was the lag between when your IND was filed or cleared back in fall last year versus about seven or eight months it took to actually get the first patient recruited? Thank you very much. Please stand by. Please stand by. I will be. Thanks for the questions. This is Ian. So, I'll answer first about the board. As you know, we have a 10 member board and our shareholder transcript actually has a point is three board members and this is consistent with the 48% equity ownership held by a transcript. I think that board is very productive because we do have a good mix of independent board members, six of those. And one representative from the company and three from our sizable shareholder transcript. So I think in terms of board dynamics, it's a pretty good mix between a large shareholder and the six independent board members. And as you can tell, in terms of CARVICT and the CARVITU program as well as our pipeline company is doing very well in terms of advancing on both fronts and that is the under the gas.

Operator: Please stand by.

Ying Huang: Hi Oomers, thanks for the questions. This is Ian.

Ying Huang: So I'll answer first about the board. As you know, we have a 10-member board, and our shareholder, Jenscript, actually has appointed three board members, and this is consistent with the 48% equity ownership held by Jenscript. I think the board is very productive because we do have a good mix of independent board members, six of those, and one representative from the company, and three from our sizable shareholder list. So I think in terms of board dynamics, it's a pretty good mix between a large shareholder and the six independent board members.

Ying Huang: And as you can see, in terms of Carvicti and the Cartiertytyty program, as well as our pipeline, the company is doing very well in terms of advancing on both fronts, and that is under the guidance of the board of directors. So that's the first question. And what was your second question? One more?

Umar Raffet: My second question was around this.

Unknown Executive: The DL3RT program. Yeah, this is what we found.

Unknown Executive: I can comment on the second question, that is, we regard MGM's DR3 target Kati therapy. As we know, MGM has two different DR3 target products in the clinical trial, and one of them was autogast Cartier therapy, and the second one is the DR3 target, CDC3 bispectin. For the Autokic Carti product, they tried it in several patients; in the second dose cohort, they tested it in two patients; one patient actually gave a fairly durable response. Based on Amigen's communication, their decision on stopping the autops car key product development is certainly based on their portfolio prioritization.

Unknown Executive: They decided to focus on the DR3-CD3 bi-specific entity. We think that the DR3 target autokic therapy could provide substantial benefit to the patient. First, from a disease perspective, this is a disease of high and with highly and mathematical needs. From a targeted perspective, this is also an ideal target for autococcal therapy in solid tumor indications.

Unknown Executive: As we know that DR3 is a limited specific biomark for neuroendocrine cell lineage. And in this aspect, it's very similar to some of the very successful Kati target implants, all of them targeting the lineage-specific biomount. However, our design of the D3 product is quite different from Amg's products. First, we have a unique car design in terms of binder, in terms of the overall architecture of the car structure

Speaker 5: cell lineage. And in this aspect, it's very similar to some of the very successful CUTI target in blood cancer, all of them targeting the lineage-specific biomarkers.

Unknown Executive: Secondly, adding a unique armor mechanism. And currently, this program is already being cleared by R&D, and we have two sides activities, and we have activities moving the program. And Umer, this is him.

Ying Huang: Maybe I want to add the fact that you probably have noticed this. DL3 is the first ever IND and clinical program. We moved into the U.S. Without conducting a first in human study in China.

Ying Huang: So we do believe that the competitive data in DL3 from MNG actually shows very promising data from Phase 2, and I think that's somewhat clinically validated targets. That's why we decided to bring this into IND at risk. Thank you.

Operator: Please stand by for the next question. The next question comes from Erin Werber with Cowan. Your line is open. Hi, good morning, and thanks for taking my questions as well.

Speaker 2: Please stand by for the next question. The next question comes from Aaron Wurber with Cowen. Your line is open. Hi, good morning and thanks for taking my questions as well. So, Ying, it's a little bit about what we're seeing from some of your competitors that they had extra capacity for CAR-T in Q2 and it looks like it was demand driven exactly when you ramped up both your out of spec and your overall capacity. Can you talk a little bit what is your demand backlog looking like? Are you still seeing more demand than you actually have supply? And what are you seeing from Ticveli and now Tovle as they're coming to the market? Have you seen any impact in your...

Erin Werber: Hi, good morning, and thanks for taking my questions as well. So, Ying, it's a little bit about what we're seeing from some of your competitors that they had extra capacity for CART in Q2, and it looks like it was demand driven, exactly when you ramped up both your out-of-spec and your overall capacity. Can you talk a little bit? What is your demand backlog looking like? Are you still seeing more demand than you actually have supply? And what are you seeing from Pickvelli and now Tavlai, are they coming to the market? Have you seen any impact on your demand? And how is Jane J&J going to position itself just sequencing-wise? Thank you.

Operator: Please stand by.

Steven J. Gavel: Leo, thanks for the question. I'll ask my colleague Steve to answer this question. Steve. Yeah, thanks, saying, hi, Leo.

Speaker 2: We stand by. Leo, thanks for the question. I'll ask my colleague Steve to answer this question. Steve? Yeah, thanks. Hi, Leo. Yeah, we've seen just the opposite, especially coming out of ASCO with the release of the CART IV data. We've done a lot of research, as you can imagine, in this space. And market demand has done nothing but increase for some of the other markets. And we've seen just the opposite, especially coming out of ASCO with the release of the CART IV data. We've done a lot of research, as you can imagine, in this space. And market demand has done nothing but increase for silt to sell.

Steven J. Gavel: Yeah, we've seen just the opposite, especially coming out of ASCO with the release of card four data. We've done a lot of research, as you can imagine in this space, and market demand has done nothing but increase for SILT to fill. So in terms of your question, in terms of the backlog that we're seeing, we have seen a reduction for sure since launch in terms of the queue, especially in the later line population.

Steven J. Gavel: And that's largely driven to the fact that, like you mentioned, there has been specific entry into the market. But mostly on our front, it is just in the near term, or I should say, when we launched, our inability, unfortunately, to meet that demand out of the gate. But for sure, we are not seeing any lessening at all in demand in these late lines of treatment, in particular. And just the opposite in these earlier lines of treatment, should we get this indication second line plus, demand there is.

Speaker 6: So in terms of your question, in terms of the backlog that we're seeing, we have seen a reduction for sure since launch in terms of the queue, especially in the later line population. And that's been largely driven to the fact of, like you mentioned, there has been bi-specific entry into market. But mostly on our front, it's just in the near term, or I should say when we launched.

Speaker 6: our inability, unfortunately, to meet that demand out of the gate. But for sure, we are not seeing any lessening at all in demand in these late lines of treatment in particular, and just the opposite in these earlier lines of treatment. Should we get this indication in second line plus, demand there has been very strong, especially in the high-risk population. Of course, the

Steven J. Gavel: has been very strong, especially in the high-risk population. And maybe I want to add Leo that, you know, I talk to our head of technical operations very frequently, and I can confirm that starting from January of this year, we have not seen any meaningful change at all in our backlog in terms of, you know, the backlog for manufacturing operations to process. I think there was a second question about that around Bice.

Speaker 2: And maybe I want to add Leo that I talked to our head of technical operations very frequently. I can confirm that starting from January of this year, we have not seen any meaningful change at all in our backlog in terms of the backlog for our manufacturing operation to process. We have not seen any significant change at all in our backlog in terms of the backlog for our manufacturing operation to process.

Steven J. Gavel: I think there was a second question knowing about that around bi specifics. I didn't, yeah, so let me just address that.

Steven J. Gavel: So I think the question had to do with what's happening with the bi specifics in the market, and also, I think it was a question related to Jansen. So what we're seeing very clearly around the bi specifics is a bridge to get to the Karchi therapies. Again, it's in reaction to our manufacturing constraints that we're working under.

Speaker 6: I think there was a second question going on that around bi-specifics. Yes, let me just address that. I think the question had to do what's happening with the bi-specifics in market, and also I think it was a question related to Janssen. What we're seeing very clearly around the bi-specifics is a bridge to get to the CAR T therapies. Again, it's in reaction to our manufacturing constraints that we're working.

Steven J. Gavel: So for sure, and this is a good situation, obviously, for patients to be able to bridge to car chute therapy, i.e. Silta cell and bridging from whatever that bi-specific may be, you've seen recently a number of bi-specifics being approved. Again, this is a very good situation for patients because they have these different options. And also, most importantly, I think this is a very key point, is that commercial insurers in the U.S. continue to reimburse for car chie therapy once a bi-specific or if a bi-specific is used prior to silt-the-cell therapy. So that, again, speaks to the overwhelming efficacy that we're seeing for this program, even when a prior BCMA therapy is used.

Speaker 6: that bi-specific may be. You've seen recently a number of bi-specifics being approved. Again, this is a very good situation for patients to have these different options. And also, most importantly, I think this is a very key point, is that the commercial insurers in the U.S. continue to reimburse for CAR-T therapy once a bi-specific or if a bi-specific is used prior to silt the cell.

Operator: Please stand by for the next question. The next question comes from Leonid Timashev with RBC Capital. Your line is open.

Speaker 6: So that, again, speaks to the overwhelming efficacy that we're seeing for this program, even when a prior BCMA therapy is used.

Leonid Timashev: Hi Guys, congrats on the progress and thanks for taking my question. I guess I'm going back to the priority review.

Leonid Timashev: priority review and the potential launch in the second to fourth line.

Leonid Timashev: to the launch timing and readiness or

Leonid Timashev: Will you be able to create a backlog of plot for the show?

Leonid Timashev: second through fourth line launches as well. And then, I guess, related to that,

Leonid Timashev: I guess related to that, what are you hearing from the ground about how physicians are thinking about using Carvicti when it becomes available in this second to fourth line indication? Are they going to

Leonid Timashev: Are they going to slowly move up, you know, starting in the fourth line and third line, or would you expect them to jump straight to the second line, given the strength of the data, which might potentially require more supply? Thank you.

Steven J. Gavel: Yeah, hey Leo, excuse me, Steve, why don't I go ahead and answer your question? It's the right question, right?

Steven J. Gavel: So what our models are showing and what the research is showing, and I mentioned this in the earlier response I just made, is that, in particular, in the higher-risk population, we're seeing very quick adoption, regardless of the line of therapy, right? So, and I'm sure you're probably working your models in particular, in the second line setting in particular, we've noticed anywhere between 15 to 20 percent of that second line population is deemed to be at high risk.

Speaker 6: I just made is in particular in the high-risk population. We're seeing very quick adoption regardless of line of therapy. I'm sure you're probably working your models. In the second line,

Speaker 6: setting in particular, we notice between anywhere between 15 to 20 percent of that second line population is deemed to be at high risk. Our research is telling us very clearly based upon the data we presented that is a population that our physicians in the US is at the very much of a treatable population for silt to sell.

Steven J. Gavel: Our research is telling us very clearly, based on the data we presented, that this is a population that our physicians in the U.S. think they're very much a treatable population for silta cell. And that's how we're modeling this as well. As you go into later lines of therapy, you see more aggressive use of silta cell. So that's how we are modeling from our perspective, but you will see across-the-board use for this product. And like I said, in particular in the high-risk population, you'll see very, very high use once we have this approval.

Speaker 6: And that's how we're modeling this as well. As you go in later lines of therapy, you see more aggressive use of cell to cell. So that's how we are modeling it from our perspective, but you will see across the board use for this product. And like I said, in particular, in the high risk population, you'll see very high use once we have this approval.

Operator: Please stand by for the next question. The next question comes from Costas Billerese with BMO Capital. Your line is open.

Speaker 7: Please stand by for the next question. The next question comes from Costas Billeries with BMO Capital. Your line is open.

Konstantinos Biliouris: Congratulations on the progress and thanks for taking out the questions. There are a couple of questions.

Konstantinos Biliouris: Thomas. The first one for Laurie, in the first quarter,

Speaker 8: Congrats on the progress and thanks for taking our questions. A couple of questions from us. The first one for Laurie. In the first quarter of 2023, ABECMA generated a US sale which was similar to George's sale in the second quarter of 2023. Given that ABECMA was a profitable product.

Konstantinos Biliouris: of 2023, a backmark generated US sales, which were similar to George Sales in the second quarter of 2023.

Konstantinos Biliouris: was a profitable product in the first quarter of 2023; can you discuss your timeline to profitability? And the second question is, BMS and

Speaker 2: in the first quarter of 2023. Can you discuss your timeline to profitability? And the second question is, BMS and 270 Bio announced recently a maintenance at one of their manufacturing sites, which has likely impacted the revenues. I was wondering, will you also need this type of maintenance at your manufacturing sites and how frequently would you need that? If at all, thank you. Hey, Kostas, this is Ying. I'll take this part of the question from you on maintenance. So as you know, for any aseptic GMP manufacturer every year, you are required by FDA to do this kind of maintenance. However, our operation from Jensen and Legend teams in New Jersey, we have decided to take a very smart approach, which is to make sure that we have the right maintenance approach, which is we're not gonna shut down facility at all. Instead, we'll do a rotation from all the different suites. So yes, every six months, we will have to do the so-called aseptic.

Konstantinos Biliouris: BMS and 270 bio recently announced maintenance at one of their manufacturing sites, which has likely impacted revenues. I was wondering, will you also need this type of maintenance at your manufacturing site, and how frequently would you need that, if at all?

Konstantinos Biliouris: Thank you.

Lori A. Macomber: Hi Kota, how are you doing? Regarding the question of our sales and profitability, as you know, we've been steadily ramping up, and as our volumes have been increasing, our profitability, particularly our gross margin, is improving. Overall, from a collaboration standpoint, as you know, we're continuing to make significant investments in frontline clinical trial studies as well as manufacturing capacity. So from a program standpoint, it will still be a while before we see overall profitability for the program. But as you saw in Q2, we're making significant strides on the gross margin side. Regarding the second question, I'm sorry. Can you repeat the second question?

Konstantinos Biliouris: The second question has to do with maintenance, so 270 Bio and DMS perform maintenance at one of the ERA-BECMA manufacturing sites, and this slows down the production, and I'm impacted. The revenues of a Bekma, I was wondering whether you will also need to perform maintenance at your manufacturing site at some point for Karvicti and how frequently you would need that, if at all. Thank you.

Speaker 2: simulation rods, but it really wouldn't affect the revenue so much that you're going to see a quarter over a quarter decrease here. So we are planning for this smartly and we will obviously conduct all the required aseptic processes of the rest of the year, but suffice to say we're not planning a shutdown of the facility just to confirm. Thank you.

Speaker 2: But it really wouldn't affect the revenue so much that you're going to see it a quarter over a quarter decrease here. So we are planning for this smartly and we will obviously conduct all the required aseptic processes for the rest of the year. But suffice to say we're not planning a shutdown of the facility just to confirm. Thank you. Thank you. Very helpful. Thank you.

Speaker 7: Please stand by for the next question. The next question comes from Justin Zillin with BTIG. Your line is open. Hi. Congrats on the progress and thanks for taking the questions. Thank you for Steve.

Ying Huang: Hey, Costas, this is being taken from your own maintenance. So, as you know, for any aseptic GMP manufacturer every year, you are required by FDA to do this kind of maintenance. However, our operation from the Jensen and Legend teams in New Jersey has decided to take a very smart approach, which is we're not going to shut down the facility at all. Instead, we'll do a rotation from all the different suites.

Speaker 7: Maybe you could help us understand how slots will be prioritized, whether the line of therapy will make an impact here or whether the high-risk patients may be prioritized for slots. And if you could just also comment on outpatient administration. Thank you.

Ying Huang: So, yes, every six months, we will have to do the so-called aseptic simulation route. But it really wouldn't affect revenue so much that you're going to see a quarter over a quarter decrease here. So we are planning for this smartly, and we will obviously conduct all the required aseptic processes for the rest of the year. But suffice to say, we're not planning a shutdown of the facility just to confirm. Thank you.

Speaker 6: Yeah, hey, Justin. Yeah, in terms of slot priorities or slot prioritizations.

Speaker 6: So a couple things just to kind of maybe rewind in terms of how we allocate and how how things happen, what happens at the site. So we will make our allocations and as I mentioned to you as capacity increases we'll actually be allocating higher amounts as well as increasing what we call this open pool for all sites to to get into.

Ying Huang: Thank you, very helpful. Please stand by.

Operator: Please stand by for the next question. The next question comes from Justin Zillan with BTIG. Your line is open.

Speaker 6: In terms of what types of patients and the allocation in terms of patient type, in terms of who gets what slot, that is basically driven at the site. I know the sites now have different criteria that each of these sites are using in terms of, you know, who will be getting Cilt-2-Cel and other therapies. So that would be driven at the site level, not at our end.

Justin Reid Zelin: Hi, congrats on the progress and thanks for taking the questions. For Steve, so just assuming you get approval in the earlier lines here, maybe you could help us understand how slots will be prioritized, whether the line of therapy will make an impact here, or whether high-risk patients may be prioritized for slots.

Steven J. Gavel: And if you could also comment on outpatient administration, thank you.

Steven J. Gavel: Yeah, hey, Justin. Yeah, in terms of slot priorities or slot prioritizations, a couple things. Just to kind of maybe rewind in terms of how we allocate and how things happen, what happens at the site. So we will make our allocations, and as I mentioned to you, as capacity increases, we'll actually be allocating higher amounts as well as increasing what we call this open pool for all sites to get into.

Speaker 6: we've seen now quarter over quarter, quite a bit of an increase in outpatient use. We've seen in the first quarter for silt to cell, about 18% of the claims that we've analyzed have shown about 18% of the time that these patients are being treated in outpatient clinic within the hospitals. Now for the second quarter, we're seeing quite a bit of a jump now up to 30%.

Speaker 6: So you're seeing this really dynamic move from inpatient to outpatient for CAR T therapy Which is exciting for a number of reasons, especially for patients and also keeping costs down But also the follow-up question you might have is what's happening with the marketplace our competitor

Steven J. Gavel: In terms of what types of patients and the allocation in terms of patient type, in terms of who gets what slot, that is basically driven at the site. I know the sites now have different criteria that each of these sites is using in terms of, you know, who will be getting silt to sell and on other therapies. So that would be driven at the site level, not at RN. In terms of, I think, I get a question on outpatient. Thanks for that question, right?

Speaker 6: we are seeing less than 10% of the time our competitors actually being used in the outpatient setting. So for sure, we believe we have more operational flexibility with Silt to Sell and more importantly now you're starting to see this play out in the market and we believe that again benefits everyone, but most importantly the patient.

Steven J. Gavel: So for those of you who've been following us for quite some time, know that that's an important dynamic, especially as we get larger and larger indications for this therapy. So what we're seeing, and this is interesting.

Speaker 7: Thanks for taking the question. Please stand by for the next question. The next question comes from Mitchell Kapoor with HC Wainwright. Your line is open.

Steven J. Gavel: We've seen now, quarter over quarter, quite a bit of an increase in outpatient use. For example, in the first quarter for Silt to SELF, about 18% of the claims that we've analyzed have shown about 18% of the time that these patients are being treated in outpatient clinics within the hospitals. Now, for the second quarter, we're seeing quite a bit of a jump now up to 30%. So you're seeing this really dynamic move from inpatient to outpatient for CART therapy, which is exciting for a number of reasons, especially for patients, and also keeps costs down.

Speaker 2: Hi, everyone. Thanks for taking the questions. Personally, I just wanted you to comment broadly on the out-of-spec rate when this could virtually not be an issue anymore. And then, secondly, if you could just comment on the earlier pipeline, some of the catalysts and timelines we could expect for the next 12 to 24 months. Thank you. Hi, Mitchell. Thank you for your question. This is Ying. So, on out-of-spec, our quote one industry example.

Steven J. Gavel: But also, the follow-up question you might have is what's happening in the marketplace. Our competitor, you see, less than 10% of the time, our competitor is actually being used in the outpatient setting. So for sure, we believe we have more operational flexibility with SILT to SELTA cell. And more importantly, now you're starting to see this play out in real time. market, and we believe that benefits everyone, most importantly the patient. Excellent. Thanks for taking the question. Please, thank you.

Speaker 2: After about one to two years of improvement in the workstream, Novartis was able to reduce that to now about 2%. So obviously this can be done. And also from our own experience, the Jensen and Legend teams worked really hard in the last year also, and we were also able to see a very meaningful and significant reduction in our OS.

Operator: Please stand by for the next question. The next question comes from Mitchell Kapoor with H.C. Wainwright. Your line is open.

Mitchell Swaroop Kapoor: Hi, everyone. Thanks for taking the questions. Firstly, I just wanted you to comment broadly on the out-of-spec rate when this could virtually not be an issue anymore. And then, secondly, if you could just comment on the earlier pipeline, some of the catalysts and timelines we could expect for the next 12 to 24 months. Thank you. Hi Mitchell, thank you for your question. This is Ying.

Speaker 2: from the beginning of the launch to now in the teens. And we continue to optimize our workstream, and there's a lot of work we can do. As I mentioned previously in this call, we have submitted a lot of data to the agency as part of the SBLA, and we do expect that we can get a wider release back from the agency.

Ying Huang: So in our respect, I'll quote one industry example, which is Kim Raya from Novartis, right? There's a paper out there in public demand that describes how originally the OS rate was probably in the high 20s or 30s, but then after about one or two years of improvement in the world stream, Novartis was able to reduce that to now about 2%. So obviously, this can be done.

Speaker 2: And eventually our goal is to reduce that to low single digit, low to middle single digit out of spec rate. So that's our expectation. That's what we're working towards too. On your second part of the question, in terms of the next six to 12 months, obviously our goal is to reduce that to low single digit.

Speaker 2: First priority is to get the FDA-approved increase in our capacity. We're planning for another one by end of this year, and then we plan to launch the second line indication pending on the FDA approval by or on the particular date of April 5th, 2024. And we continue to work in terms of increasing.

Ying Huang: And also from our own experience, The Jensen and Legend teams worked really hard in the last year, too, and we were also able to see a very meaningful and significant reduction in our OS from the beginning of the launch to now in the teams. And we continue to optimize our work stream, and there's a lot of work we can do. As I mentioned previously in this call, we have submitted a lot of data to the agency as part of the SBLA, and we do expect that we can get a wider release specification from the agency on the CARG-4 data.

Speaker 2: the number of facilities that will supply Carvigty. So we're doing expansion work in Ryerson and we expect the capacity from Ryerson will be a meaningful increase in 25. And then we're opening up our first stage of Belgium facility in Ghent.

Ying Huang: So when that happens, we expect a very meaningful reduction in the out-of-speck rate. And eventually, our goal is to reduce that to, you know, a low single-digit, low-to-middle-single-digit out-of-speck rate. So that's our expectation.

Speaker 2: By end of next year, our large Greenfield facility will be also coming online from Gant. And as you know, we've been working with third-party CMO to expand our network. So all this effort will crystallize into a much higher capacity in the next couple of years. And we have said previously that we aspire to...

Ying Huang: That's what we're working towards. On your second part of question, in terms of the next six to 12 months, obviously, our first priority is to get the FDA-approved increase in our capacity. We're planning for another one by the end of this year, and then we plan to launch the second line indication pending FDA approval on the particular date of April 5th, 24.

Speaker 1: Thank you. Please stand by for the next question. The next question comes from Sammy Corwin with William Blair. Your line is open. Hi, thank you for taking my question. This is Brooke Schuster on for Sammy. We were wondering if you could provide any color on reimbursement and if you saw any changes in security reimbursement, like in comparison to inpatient versus outpatient.

Ying Huang: And we continue to work in terms of increasing the number of facilities that will supply Carvicti. So we're doing expansion work in Raritan, and we expect the capacity, from a riotant world, to meaningful increase by 25.

Ying Huang: And then we're opening up our first stage of our Belgium facility in Ghent. By the end of next year, our large Greenfield facility will also be coming online from Ghent. And as you know, we've been working with third-party CMOs to expand our networks. So all this effort will crystallize into a much higher capacity in the next couple of years. And we have said previously that we aspire to come up with an annual capacity of 10,000 doses or more by the end of 2025.

Speaker 6: or the academic versus community setting? Hi, Brooks. It's Steve again. The short answer is no. As of today, CILPASEL has really enjoyed quite open access from a reimbursement perspective. And as we lead into the second line plus indication, all indications are very positive. As a matter of fact, when you look at the value capture modeling that we've done, insurers love a drug like CILPASEL because of the potential it has in terms of...

Ying Huang: We're very much on track to achieve that goal at this point, given our program in construction and also the other fronts. So that's probably what's really the most important catalyst or priority for us in the next 6 to 12 miles.

Operator: Please stand by for the next question. The next question comes from Sammy Corwin with William Blair. Your line is open.

Speaker 6: cost containment, potentially long-term cost reduction. So, so no, really right now, we'll continue to monitor that area, obviously, it's a very important one for us, but to date, reimbursement has not been a problem. We don't foresee any problems in the future. Thank you. Please stand by for the next question. The next question comes from Kelsey.

Samantha Danielle Corwin: Hi, thank you for taking my question. This is Brooke Schuster on for Sammy. We are wondering if you could provide any commentary on reimbursement, and if you saw any challenges in security reimbursement, like, you know, in comparison to inpatient versus outpatient or the academic setting.

Samantha Danielle Corwin: or the academic versus community setting. Hi Brooks.

Steven J. Gavel: Hi Brooks, it's Steve again. The short answer is no. As to date, Silt to sell has really enjoyed quite open access from a reimbursement perspective, and as we lead into the second line plus indication, all indications are very positive. As a matter of fact, when you look at the value capture modeling that we've done, insurers love a drug like Silt to sell because of the potential it has in terms of cost and potentially long-term cost reduction.

Speaker 4: That last question, could you maybe just provide more color on what you're seeing in terms of community patient mix and referrals from the community? Thanks so much.

Speaker 6: I'll take the question around the commercial cycle time that you referenced. We're seeing the cycle time from receipt to release anywhere between four to five weeks on average, which I think is fairly consistent to what you're seeing in market today with most CAR T therapies. I think if there's a second question, I might refer over to Inc. at this point.

Steven J. Gavel: So, so no, really right now, we'll continue to monitor that, that area. Obviously, it's a very important one for us, but to date, reimbursement has not been a problem. We don't foresee any problems in the future.

Operator: Please stand by for the next question. The next question comes from Kelsey Goodwin with Guggenheim. Your line is open.

Speaker 2: Hi Kelsey, thanks for the question on Cardio 4. So yes, I can confirm that the median time was 79 days cycle time in terms of end-to-end. There are two drivers behind that. Number one is that if you look at the trial sites we opened for Cardio 4, the large majority, I believe about 75 to 80 percent at least.

Kelsey Beatrice Goodwin: Oh, guys, good morning and thanks for taking my question. I guess first, I found cartitude for the median time from A3C2 infusion at 79 days. I guess what you're seeing in the commercial setting and what can be done to speed that up? And then separately, maybe building off that last question, could you maybe just provide more color on what you're seeing in terms of community patient mix and referrals from the community? Thanks so much.

to the cycle time because we had to clear the customs and also unfortunately supply chain was severely disrupted during the COVID outbreak. That's really the major driver behind that. And then secondly, obviously, if you look at the protocol, right, there's all this bridging therapy and the requirement of the standard of care, which is either a PVD or a DP. So,

Unknown Executive: Sure, I'll take the question around the commercial cycle time that you referenced. We're seeing the cycle time from receipt to release anywhere between four to five weeks on average, which I think is fairly consistent with what you're seeing in the market today with most Kartee therapies. If there's a second question, I might refer you over to Inc.

Ying Huang: Hi Kelsey, thanks for the question on Cardi IV. So, yes, I can confirm that the medium time was 79 days cycle time in terms of van to van. There are two drivers behind that.

That's really another reason why we see a higher than normal cycle time of end-to-end for CAR-D4. But as you just heard from Steve today, during our commercialization in the U.S., we can confirm that the typical receipt to a release time is about 35 to 40 days in InSpec samples. And we continue to make improvement on that, and we hope that we can report shorter end-to-end time in the next quarter. Thank you.

Ying Huang: Number one is that if you look at the trial sites we opened for Cardiff 4, the large majority, I believe, about 75% to 80%, at least from Cardi 4, were enrolled in Europe and other international regions outside of the U.S. So if you recall, that was actually conducted during the peak of the COVID outbreak. That contributes significantly to the cycle time because we had to clear customs and also, unfortunately, you know, the supply chain was severely disrupted during the COVID outbreak.

I show no further questions at this time. This concludes today's conference call and thank you for participating. You may now disconnect.

Ying Huang: That's really the major driver behind that. And then secondly, obviously, you know, if you look at the protocol, right, there's all this bridging therapy and the requirement for the assessment. Standard care, which is either PVD or D. Or D2.

Ying Huang: So that's really another reason, a reason why we see a higher than normal cycle time of end-to-end for Cardioux 4. But as you just heard from Steve, right, today, during our commercialization in the U.S., we can confirm that the typical receipt to release time is about 35 to 40 days for inspection samples. And we continue to make improvements on that, and we hope that we can report shorter event-to-end times in the next quarter. Thank you.

Operator: I have no further questions at this time. This concludes today's conference call, and thank you for participating. You may now disconnect.

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