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spk08: Good day, ladies and gentlemen. Thank you for standing by. Welcome to Legend Biotech Report's third quarter 2023 financial results conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1-1 on your telephone. You will then hear an automatic message advising your hand is raised. Please note that today's conference may be recorded. I will now hand the conference over to your speaker host, Jessie Yang, Head of Investor Relations and Public Relations, you may begin.
spk16: Good morning. This is Jessie Yang, Head of Investor Relations and Public Relations at Legend Biotech. Thank you for joining our conference call today to review our third quarter 2023 performance. Joining me on today's call are Ying Huang, the company's Chief Executive Officer, and Laurie McComber, the Communist Chief Financial Officer. Following the prepared remarks, we will open up the call for a Q&A. We will be joined by Guo Wei Fan, Chief Scientific Officer, and Steve Scaffold, Head of Commercial Development for the US and Europe. 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 here within. 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 investment section of our company website. Thank you. I will now turn the call over to Ying.
spk10: Good morning, and thank you for joining us today to discuss the third quarter financial and corporate accomplishments of Legend Biotech. We are pleased with the progress we have made over the last quarter to advance our portfolio and pipeline of innovative therapies that are focused on addressing the serious and intractable disease patients face. Last week, we announced that we have entered into an exclusive global licensing agreement with Novartis, which grants Novartis the rights to develop, manufacture, and commercialize LB2102 and other potential CAR T therapies, selectively targeting DLL3. LB2102 is an investigational autologous chimeric antigen receptor T cell therapy for the treatment of adult patients with extensive stage small cell lung cancer. As part of this agreement, we will receive an upfront payment of $100 million and are eligible to receive up to $1.01 billion in milestone payments, as well as tiered royalties on net sales. will also be reimbursed for development costs for the ongoing phase one clinical trial, which will evaluate the safety and efficacy in patients with small cell lung cancer and patients with large cell neuroendocrine carcinoma and to determine the recommended dose for phase two study. We're excited by this transaction and we look forward to seeing how this therapy performs in a clinic. Carvicti, or Siltacel, continues to drive our revenue and direct our priorities. We have worked tirelessly to bring Carvicti to patients who are eligible for treatment, and our efforts are reflected in the total net sales of $152 million in third quarter, bringing total net sales for 2023 to $341 million so far this year. Our third quarter performance was driven by ongoing market launches, expanding market share and capacity improvements, as well as the commercial launch of CARVICTI in Germany, which contributed to quarter-over-quarter ex-U.S. growth of 300%. In the U.S., we have experienced growth of 23% quarter-over-quarter. We remain steadfast in our goal to make CARVICTI available and accessible to patients worldwide, and we look forward to sharing highlights of that journey with you today. We have progressively met strong demand for CARVICTI in collaboration with Janssen. First, Janssen has scaled the in-house production of lentivirus at its factories in Switzerland and has another factory in the Netherlands under construction to complement and support LV supply, which should be online by 2025. LV expansion is crucial because it is often the rate limiting factor in any car team manufacturing and growing LV supply is an important front in our ramp up. Second, we're still on track with our pre-planned capacity increase at our Ryerson site and production from our CDMO is supporting that expansion next year. Third, The first of our state-of-the-art manufacturing facilities in Ghent has received a license from the Federal Agency for Medicines and Health Products in Belgium. This was an important hurdle to clear, and once the Investigational Medicinal Product Dossier is approved by local authorities, we'll begin manufacturing supercells at Ghent for clinical use by end of this year. The Ghent facility will be an important part of the CARVICTI supply chain network. We're committed to bring CARVICTI to more patients who are eligible for this important therapy. Our manufacturing ramp-up supports commercial delivery as well as our ongoing CARTITUDE clinical development program with Janssen. Of the five clinical trials evaluating silted cells, three are ongoing, and CARTITUDE 6, our phase 3 study for frontline patients, enrolled its first patient. The activation of one of our GAND facilities will enable us to continue the commercial ramp we began in the U.S. while onboarding new clinical patients. In addition to making capacity enhancements, we work with roughly 60 certified treatment centers across the U.S. and are expanding access to CARVICTI in select European countries, including Germany. Our teams are working hard on multiple fronts to bring this efficacious one-time treatment to patients in need. We are pleased to share that since trials began in 2018, we have treated more than 2,000 people with Cilta-Cell. Our pipeline is also robust, and we're exploring the potential of cell therapies in both hematologic malignancies and solid tumors. The funds from our transaction with Novartis will primarily be used to develop other promising pipeline assets such as our allogeneic cell therapies. The armoring used in LG2102 can also be deployed in other pipeline programs if validated in a clinic. We continue to explore innovation in our pipeline and are excited about their progression. Now I want to turn this to Laurie.
spk03: Thank you Ying and good morning everyone. As Ying mentioned, we are very pleased with the performance of our commercial product Carvicti this quarter, which generated approximately 152 million in total sales, an increase of 30% over the previous quarter, driven by ongoing market launches, expanding market share, and capacity improvements. That performance also represents 176% year-over-year increase. As a reminder, We share equally in all profits and losses of Carvicti ex-China with our partner Janssen. Starting with cash and cash equivalents, time deposits, and short-term investments of $1.4 billion, this will fund our planned operating and capital expenditures into 2025. Starting with revenue. Total revenues for the third quarter were $96 million consisting of $75.9 million in collaboration revenue from the Salo Carvicti and $20.1 million in license revenue for the achievement of a milestone during the quarter as outlined in the Global Development Plan under the Janssen Agreement for Sit to Sell. Net loss for the three months ended September 30, 2023 with $62.2 million or a loss of 17 cents per share compared to a net loss of 85 million or 26 cents loss per share for the same period last year. For the nine months ending September 30th, 2023, net loss was 373.4 million or a loss of $1.07 per share compared to a net loss of 310.5 million or a loss of 99 cents per share for the nine months ended September 30th, 2022. Moving on to expenses, collaboration cost of revenue for the third quarter 2023 was $43.5 million compared to $25.5 million for the same period last year. These are Legend's portion of collaboration cost of sales in connection with the collaboration revenue under the Janssen Agreement, along with expenditures to support the manufacturing capacity expansion. Research and development expenses for the third quarter 2023 were 95.9 million compared to 104.5 million for the same period last year. The decrease of 8.7 million for the three months ended September 30th, 2023, compared to the three months ended September 30th, 2022, was due to timing of expenses incurred in connection with the master technology transfer, manufacturing and clinical service agreement for BCMA CAR T product with Janssen and Novartis Pharmaceuticals Corporation. Administrative expenses for three months ended September 30 2023 or 28.1 million compared to 23.2 million for the same period last year. The increase of 4.9 million year over year is primarily due to the expansion of administrative functions to facilitate continuous business growth and continue investment in building legend biotech global information technology infrastructure. Selling and distribution expense for the three months ended September 30th, 2023 was $21.1 million compared to $18.9 million for the same period last year. The increase of $2 million year over year due to costs associated with the commercialization of Carvicti. To wrap up, our spending remains on track and we continue to maintain a strong balance sheet. As of September 30th, we had $1.4 billion in cash and equivalents, deposits and investment, which Legend Biotech believes will fund operating and capital expenditures into 2025. Thank you. I will now pass it back to Ying for closing remarks.
spk10: Thank you, Laurie. 2023 continues to be another remarkable year for Legend Biotech, and we look forward to closing out the year strong in the fourth quarter. We have made considerable strides in enhancing our manufacturing capabilities and lowering our out-of-spec rate. We're proud to be a fully integrated cell therapy company focused on both hematology, malignancies, and solid tumors. Looking forward, we'll continue to invest in our manufacturing capacity as we work to deliver Carvicti to patients expeditiously and responsibly. We'll also continue to expand our pipeline. At Legend Biotech, we strive to deliver long-term value to our shareholders and are encouraged by these developments. Thank you for joining us today. We'll now open the call up for questions.
spk08: Thank you. Ladies and gentlemen, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. Please stand by while we compile the Q&A roster. And our first question coming from the lineup, Gina Wang with Barclays, your line is open.
spk06: Thank you for taking my questions. Also, congrats on the great quarter. So maybe I have two questions. One is regarding I think this morning we saw the news that Bristol is a back man now. They will require an ADECOM and a PDUFA got pushed out. And maybe based on that news, what is your interaction with the FDA so far? And are you also anticipating an ADECOM? Second question is regarding the competitive landscape. in terms of the efficacy profile, we will see some update at ASH. You know, what is your thoughts regarding staying competitive? And the other related question is the commercial strategy in the outpatient setting.
spk10: Hi, good morning, Gina. Thanks for the question. So, I'll take the first one first, which is regarding the that will be hosted by FDA ODAC for our computation. So I can tell you that given our interactions with the FDA so far on our CAR T2-4 filing, clearly the agency placed an emphasis on the OS benefit, overall survival benefit. And typically the agent standard is that you have to demonstrate a significant PFS benefit with an overall encouraging trend in survival. So, without disclosing anything further, I can tell you, Gina, that on August 4th, when we received the filing acceptance for a cut report by the agency, we were advised that FDA was not planning to hold an ad hoc or advisory committee to discuss this supplement. That was as of August. Secondly, I'm also very pleased to tell you that as part of our so-called four-month safety update, we did submit to the FDA additional data. And again, we are seeing a stronger trend of overall survival since the last update when the data was presented at ASCO. So that's what I would say about the overall survival from CAR T2-4. And we remain very confident on the profile for CAR T2-4. Secondly, on ASH and competition, I'm not going to comment into any competitive data, but we stand behind the safety and efficacy of CARVICTI, which has been dosed by more than 2,000 patients already since we started the program. And that includes patients with those in the commercial setting after FDA approval last year, and also patients who are dosed in various CARDI-2 programs and also CARDI-3 in China. We are very, very happy to see the very deep, consistent, durable response in every setting of multiple myeloma we have tested so far. With the commercial strategy, I'll ask my colleague, Steve, to comment. Steve?
spk20: Yeah, thanks. Hi, Gina.
spk21: I think your question had to do around outpatient, and maybe I could just give you an update on what's happening in that particular area. We were holding constant at about 30% share in terms of inpatient versus outpatient, and We're also forecasting, as we enter in earlier lines with the Carta 2.4 launch next year, is to exit. We hope to exit next year. I would assume maybe even doubling that. It's really predicated on bringing on board our sites and obviously getting our consistent supply into market. But right now, from a share perspective, that's how our claims data is measuring up.
spk08: Thank you very much. Thank you. One moment for our next question. And our next question coming from the line of Jessica Firewoods, JPM Chase. Your line is open.
spk02: Great. Good morning. Thanks so much for taking my question. On the heels of the Novartis licensing, can you talk about what the next wave of targets Legend is interested in pursuing might be?
spk15: Thanks, Jessica. This is Guowei Yang. So, we have extensive internal pipeline, both in autologous as well as in allogeneic cell therapy front. In autologous space, we continue to focus on blood cancer, building the body-momentum franchise, at the same time also expanding to the solid tumor indications. In the allogeneic space, we have several different platforms, and we have deep investments in gamma delta T allogeneic platform in the past several years. One of our compounds is already tested in the clinical setting, and we are waiting to collect a clinical response profile and expand the allogeneic platform as well. Currently, the allogeneic platform is primarily focused on blood cancer indication.
spk08: Thank you. Thank you. One moment for our next question. And our next question, coming from the line up, Kelly Shee with Jeffery, CLN is open.
spk07: Thank you. Congrats on the great progress. How should we think about the Q over Q growth of Carbic TA into Q4, considering the GMJ and legend manufacturing capacity increase? And also the level of demand in the baseline settings as the Tuck Valley experienced a great launch and also how do you estimate the seasonality impact from holidays and also have a follow up. Thank you.
spk03: Hi Kelly, this is Lori. I'm going to give you just overview quarter over quarter and then I'll turn it over to Steve. As you look at going into Q4, as we talked about before, we are doing a step up. We have gotten that approved, but as we've indicated before, you won't really see the impact of that until Q1 of 2024. And as a reminder, we've also signaled that in Q4 we will be doing some comparability runs as we're getting some of our additional nodes for manufacturing capacity. up and running for 2024 to help support the second line launch. So with that, if you look at Q4, we're not giving specific guidance, but you're not going to see significant growth quarter over quarter because of both of those activities. And with that, Steve, I'll turn it over to you.
spk20: Yeah. Yeah. Hey, Kelly. Yes, Steve. I think your question had to do with the tech launch.
spk21: So what we're seeing in market research that we're running is where you see market share coming out of market in terms of CAR-T therapies has been that from Beckman as opposed to CiltaCell. We're seeing still a robust demand in later line settings, and I think you're going to see that continue in market with the bispecifics. If you see erosion in terms of share erosion, I see it coming from Beckman. At least that's been the latest data we've seen in our research.
spk07: Terrific, thanks. And also regarding the initiation of CARTICUDE 6 trial in the frontline transplant eligible patient population, could you actually share, should we expect the U.S. enrollment to start in the near term? And if the majority of the enrollment comes from Europe, do you consider impact on the enrollment pace compared to CARTICUDE 5 trial? Thank you.
spk10: um thanks kelly so we're very pleased to announce that the first patient has been enrolled last month in spain so we officially have kicked off the initiation of car 2 6 and we are going to initiate the enrollment in the u.s also very soon at this point i can tell you that we will promise to enroll a certain percentage of u.s based patients because We have to submit the data to the agency later to make sure that we have a representative U.S. patient population in the overall patient, although probably the majority of patients will be enrolled ex-U.S. for CARTICUL-6.
spk08: Thank you very much. Thank you. And our next question coming from the line of Vikram Parahit from Morgan Stanley, Yelena Sopin.
spk18: Hi, good morning. Thank you for taking our questions. This is Vikram. We have two. First, assuming you were to obtain approval for CARVIC-D for the expanded label based on the Coditude 4 data by next April, could you just walk us through your latest thinking on what you expect the ramp to look like in earlier line use in 2024 onwards? And then secondly, back to the topic of competition. So Bristol Myers and 270 have mentioned that They're making a bigger commercial push for ABECMA that includes site expansion to broaden out access for the therapy. I wanted to see if you've noticed any competitive impact at this point from those efforts, and if you and J&J feel the need to increase your marketing and promotional spend behind CARVIC in response to the efforts from Bristol-Myers and 270. Thanks.
spk21: Yeah, hi, it's Steve. So let me try to take them. I think the second part of your question had to do with site expansion, also promotional spend. We'll continue to expand sites over time. We'll exit this year, we think, right around 70 sites. I will see, you know, our site expansion is predicated on delivering in our manufacturing capacity increasing. So we are targeting by the end of next year to be exiting at about between 90 to 100. So that hopefully answers your question around site expansion. And as I remember, as I continue to state there, this is more than just site expansion. All these sites are not created equal in terms of the numbers of patients that they treat. Our philosophy is continue to increase our site expansion to ensure that we can accommodate the demand within those sites. I think your second question had to do with Cartitude 4. Can somebody help me here?
spk08: The ramp.
spk21: The ramp. Yeah, so thanks. So how we're planning the Cartitude 4 ramp in terms of the forecast perspective, we were initially and we continue to assume a very quick ramp up, especially in the high-risk population in Second Line Plus. In some of the research that we fielded post-ASCO once we released the CARTITUDE-4 data, we're also seeing high demand also in the standard risk population. So generally speaking, again, we're very excited, as you can imagine, in launching CARTITUDE-4 for our patients. But we see it much broader than we were initially thinking beyond the high-risk group. Got it. Thank you.
spk08: Thank you. One moment for our next question. And our next question coming from the line-off. Leonid Timoshev from RBC Capital Markets, Yolanda Selfin.
spk01: Hi, guys. Thanks for taking my question, and congrats on the quarter. I wanted to stick with the competition discussion for just a little bit. We've been hearing that there's actually been capacity constraints in the CAR T space as a whole, with actually BCMA and CD19-directed CAR Ts competing for beds and infusion capacity. I guess, is this something that you're seeing as you're continuing to launch Carvicti? Do you expect these dynamics to lift or continue?
spk21: Yeah, hi. Steve, I'll take that again. I think that's a very, very good point. So that's why it's so important. This is why you're seeing a large percentage now of sites moving to hospital outpatient for CiltaCell. so yes so to your point it's a very valid point that you cannot continue to uh to treat uh car t therapies as just a single inpatient modality uh we knew that leading into launch and it was the reason why we were continuing to monitor how the market was moving to outpatient to increase capacity to your point so you address capacity in two in essence two ways right so you continue to monitor to see how the market's moving in the outpatient setting and as i stated earlier We're running at about three out of 10 patients now being treated that way, and we see that continuing to grow significantly over time. So that's the first piece of that, of solving that issue. And then the second way you resolve that is by increasing sites themselves, and we'll continue to do that as well. So it's a combination of a number of different moving parts. So we'll see how the market is moving in the outpatient setting, and then we'll also continue to add more and more sites to accommodate, to your point, the patient volume to ensure that we have enough or the sites have enough volume to pull through the volume of patients for our indication.
spk10: And Leonid, this is Ian. Maybe I want to add that, you know, if you look at the number of transplants that are performed in a setting of myeloma, it's about 9,000 transplants that's performed every year in the United States market. So we think at this point, at least for multiple myeloma, we're not approaching that limit in terms of possible beds yet. As you know, if you look at our supply into the market, right, we're nowhere near that 9,000 number yet. Thank you.
spk08: Thank you. One moment, please, for our next question. And our next question coming from the line of Yaron Weber with TD Cowan. Your line is open.
spk19: Great. Thanks for taking my questions. I just have two. The first one, can you give us a little bit of a sense? We're hearing that not now, but potentially later on, a phoresis slot might become more of a bottleneck as you're ramping up capacity. I don't know if you can give us a little bit of a sense how much capacity there is now and what can you do to enhance it? And then secondly, it looks like the facility in Europe, in Belgium, has now got approved on a local basis, and you're noting that you need to wait for investigational medicinal product SCA approval and local authorities. Is that not centralized to the EMA, or is it sort of done differently in Europe? And just reaffirm that you're not foreseeing any sort of... limitation and how many slots you're going to have in that plant in Europe. Thank you.
spk21: Hi there. It's Steve again. Why don't I take a crack at the apheresis question? The apheresis question really varies by site. I know we've been having a number of conversations with our sites as we work collaboratively to onboard them and certify them. So the apheresis question really is being upfront addressed by our sites because what they are doing is forecasting what the volume looks like for them, whether it be for, obviously, the CARTITUDE 1 launch, which they have a pretty good idea, obviously, by now, but more importantly, CARTITUDE 4. So, as I keep mentioning, you know, we are addressing this in a number of different ways, this question around capacity. And right now, like I said, the number that I was guiding earlier in terms of roughly to 90 to 100 that I gave earlier in terms of number of sites is in response to a number of these capacity questions to ensure that the marketplace has enough aggregate capacity to pull this indication through. Dan, you want to take the second question?
spk10: Hey, Aaron. I'll take the question about the European facility. So we did receive a GMP certificate issued by the local FAAG, which is the counterpart of FDA in Belgium. And that is sufficient for us to start the clinical production next month in the U.S. Sorry, in Belgium. And then, specifically, I want to question about the U.S. FDA. So right now, our plan is to start clinical production by end of this year in Belgium for certain clinical trials. And then about mid-year next year in 2024, we're planning to seek regulatory approval for our Obelisk Ghent facility to start produce commercial Corvicti. Initially, we're planning to supply only the European market. So at this point, we would not need FDA approval. In the future, in the case where we do have access capacity that we could use from the Ghent facility, Then we plan to come back and ask FDA approval. So you're right. In the case of commercial production for US patients, we would need SBLA approval by the FDA. But right now, in the very near future, we're only designating the GAN facilities for European commercial demand and also clinical trial demand. But still, that does help our supply in the U.S. because, as you know, right now we're only producing both clinical trial material and commercial CARVICTI from our New Jersey facility. So whenever we can divert some of the demand from European market and also clinical trials to Ghent, that will free up more slots from our Raritan New Jersey facility. I hope that answers your question.
spk08: Thank you. One moment, please, for our next question. And our next question coming from the line of Lynn Heisel from Goldman Sachs. Your line is open.
spk11: Hi. Thanks for taking my question. Two quick questions on the financials. The first one is, as we are still enrolling for CAR 5 and now starting to enroll for CAR 6, and the R&D expenses remain flat for the work quarter, how should we see the R&D spending in fourth quarter and in 2024? And the second question is, it seems that the gross profit margin slightly decreased quarter over quarter. And can you share with us any colors on potential gross profit margin improvement in the near term? Thanks.
spk03: Hi, this is Lori. In regards to the R&D spend, I think you'll see a consistent quarter over quarter. I mean, the activities itself have been pretty consistent with our investment in front lines for the Curvicti program, as well as our pipeline. So we continue going into 2024. We expect to see continual spend consistent with our historic. I'm sorry, can you repeat the second question?
spk11: Yeah, sure. The second question is about the gross profit margin. When do we expect to see a further increase on the profit margin?
spk03: So from a gross margin perspective, we have been seeing improvements from a product perspective. As a reminder for gross margins, we have the product gross margin in there as well as the OPEX related to facility investments. So that's why it's hard for you to see the continual improvement in gross margins, because as we've talked about, we continue to expand our capacity with manufacturing, so we continue to have expenses hitting in that gross margin line. But as our volumes have increased and as we've made also some process improvements, our margins are improving from a product perspective, but we don't give specific guidance on those actual percentages.
spk12: Got it. Thanks.
spk08: Thank you. One moment for our next question. And our next question coming from the lineup, Jonathan Miller from Evercore SI. Your line is open.
spk13: Hi, guys. Thanks for taking my question. I'm going to ask about DLL3, actually, as an entree to solid tumors more broadly. Can you walk us through the dose levels for the DLL3 Phase I versus CARVIC-D and maybe talk a little bit about how that relates to your expectations for dosing in solid tumors more broadly. And I have a follow-up. Thank you.
spk10: Hey, Jonathan. Thanks for the question. So if you look at our disclosure on clinicaltrials.gov, you will see that we're planning to test four different doses, ranging from 0.3 million cells per kilogram body weight up until 1 to 2 million cells per kilogram body weight. So this is a weight-based dosing plan. Because this is a solid tumor, and we foresee that you may need a little bit bigger dose than in the hematology cancers. So if you look at our prior dose ranging finding trials for the hematology, such as multiple myeloma indication, this is a little bit higher starting dose. given that we probably need a larger amount of T cells. But on the other hand, we did put an armor, namely the dominant negative TGF beta armor, to help expansion and penetration into the tumor setting. So that is the dose we're looking at for DL3 in phase one.
spk13: Thank you. And then on the CROTITUDE 4 label, can you remind us how big an impact that will have on out-of-spec rate, assuming it does get approved? And should we expect that out-of-spec rate change to happen immediately on approval, or will there be a ramp period or some sort of recertification for that?
spk10: Sure. In part of our SBLA filing submitted to the FDA, we asked the agency to widen the release back based on the clinical data from the phase three randomized controlled trial in second line beyond population because we provided a significant amount of so-called sensitivity analysis to the agency trying to correlate the release back with the clinical outcomes such as TFS and survival. So based on that data, we and our partner at GNJ are very confident that we should be able to receive a wider release back. And if we do receive such a wider release back from the agency, then eventually we hope that the out-of-spec rate can decrease by additional 5 to 10 percentage points from where it is today. That is our expectation, of course. We have to wait until we see the label and also the FDA-approved release back. next April when the producer date hits. But that is our hope. And to the second part of your question, let's say if we do receive a label and a wider release back today, it is going to take a little bit of time because once we start to roll out the second line in the market and then we start to see more uptake, you will gradually see that lower OS will take place in the manufacturing process.
spk13: Just to clarify what you just said there, when you say you'll take a little time to see that out-of-spect benefit come through, is that because you're only going to see that out-of-spect benefit in the second line plus patients? Is it not going to also apply to manufacturing and later lines?
spk10: You raise a very good question, John. Unfortunately, I don't have an answer to you because we would have to wait and see what the agency gives us. It's possible that we'll get a uniform release back from both the first indication and the second indication, but it's also possible that the agents decided to give us two sets of release bags, which happened before, I'm sure you're aware, to one of the CD19 CAR Ts in the market. So at this point, I actually don't know the answer, but it's a very good question. We'll have to wait and see what the FDA says.
spk12: Thanks so much.
spk08: Thank you. One moment for our next question. And our next question coming from the line of Ash Burma from UBS. Your line is open.
spk17: Hey guys, thanks for taking my question. Good morning. I have two. So just in terms of your partnership with Novartis, could that eventually allow you to use a TCHARGE program to, you know, further lower the carbic DBA into in time and then Second one, just wanted to see where you are on the Cardio 2 study with the cohort E and F. I just wanted to get an idea, is that something that we could see at the ASH abstracts late breaker tomorrow, or is this more for ASCO next year? Thanks.
spk15: So for the T-CHARGER platform, it's a unique manufacturing platform developed by Novartis, and this is only applied for LB2102. Internally, we are also developing a novel manufacturing process, and we are going to move internal developed manufacturing process into other sales IP product in the future. Thank you.
spk10: Ash, this is Ying. I'll take the second part of your question, which has to do with the CART2-2 cohort E and F. So I can tell you that at this point, we have completed enrollment for both CART2-2 cohort E and F in the newly diagnosed patient cohort. But we're not going to release data at this moment because, as you know, typically in the frontline setting, the PFS is relatively low. So, we believe it will be more informative when we present data with a longer follow-up. So, you should stay tuned when we present cohort E and F in the future. Thank you.
spk08: Thank you. One more for next question. And our next question coming from the line of Casas Priotis from BMO Capital Markets,
spk22: Hello, everyone. Thanks for taking our question and congrats on the quarter. One question from us on the clinical ongoing trials. Can you comment on whether the enrollment in Catitude 5 is completed? And given that the Catitude 6 trial is slightly larger than Catitude 5, should we expect any impact from this increase on the commercial slots? All these two are somewhat independent now with the clinical manufacturing support from Novartis and the Gantt sites. Thank you.
spk10: Thank you, Costa, for your questions. So on CART5, we're very much on track to complete the ex-US enrollment of CART5 by end of this year. And now we're looking at potentially over-enrolling CART5 in the US because, as I mentioned previously in this call, we would like to have a very representative US patient population in the overall patient enrolled in CART5. We're going to probably extend the U.S. enrollment by about one quarter into the first quarter of next year. But at this point, I can tell you that we're very pleased with the enrollment status. Like I said, we're pretty much down for the ex-U.S. portion for CARTU5 by end of this year. So everything is going according to plan, but we do want to over-enroll in the U.S. given the demand from patients and also given the fact that we'd like to have a higher percentage of U.S. patients in this trial. On CARTU6, We just started our first patient last month in Spain, and it will probably take us about a couple of years while we enroll. So, regarding to the production, we likely will utilize our Gantt facility that's coming online next month to start production of CardiTube 6. We could also use additional capacity from our CDMO to satisfy that demand for credit use 6 production. That is our current plan now.
spk08: Thank you. One moment for our next question. And our next question coming from the lineup, Justin Zelen with BTIG. The line is open.
spk00: Thanks for taking the questions and congrats on the strong quarter. So can you give us an update on the out-of-spec rate for Carvicti today, just how things have been trending? And second, just on pipeline strategy, will you look to continue to seek partnerships for your pipeline assets in the future, or could you internally develop them and bring them forward? Thank you.
spk10: So Justin, I'll talk about the out-of-spec rate question. We're very pleased where things have been trending in the last six months also. Our out-of-spec rate has been decreasing and also stabilizing, and it's been consistently in the teens range, and right now it does stand below the 18% on-label out-of-spec rate, thanks to the very hard, very much hard work from the Legend team and J&J team in the New Jersey facility. we have really tried very hard to refine our manufacturing protocol by looking at various reasons for OS and also improving OS on various work streams. So that's where we are. I don't think we're very much different from the competitions out of spec rate at this point. So I think we're seeing a very encouraging trend. And like I mentioned, we do expect this to continue to go down, especially after FDA approves the second-line indication. On the pipeline, the BD question, I'm going to refer that to our colleague, Chloe.
spk15: Yeah, thanks for the question. In terms of pipeline development strategy, we are open to both internal development as well as seeking out collaboration partnership. Our goal for pipeline development is to accelerate the development timeline and maximize the value for each individual asset so that we can bring differentiated and potentially transformative therapy to patients sooner. In this particular case for LB2102, we see a unique synergy between ourselves and Novartis. We have a unique product design, a unique construct sequence, and a unique armor mechanism to facilitate immune cell infiltration and overcome the immune suppression in the tumor microenvironment, whereas Novartis has its unique manufacturing process, which is particularly important for a disease of small cell lung cancer. As you know that disease progress very fast, and a fast manufacturing process would add value to the product profile. So in this case, we see the synergy, and then in the future, we will continue to evaluate the asset by asset and try to find the synergy and realize the additional value where it's possible. At the same time, if we have an asset we can develop by ourselves, we will also do it either way.
spk00: Thank you. Thanks for taking my questions.
spk08: Thank you. One moment for our next questions. And our next question coming from the line of Mitchell Kapoor from HC Windride. Your line is open.
spk14: Hi, everyone. Thanks for taking the questions. I just wanted to ask a little bit more about the supply constraints and if you could give kind of a quantitative sense of where we are in terms of meeting demand. I think at one point there was a lot of supply exceeding demand in terms of, you know, I think there was about 15% demand Being able to be met, could you just talk about where we're at today? And if you can't give a quantitative number, could you just kind of help us understand the trend?
spk10: Good morning, Mitch. Thanks for the question and I'm going to answer this 1. so. If you look at the reported revenue last quarter, which was $152 million and $140 million coming from the U.S., you sort of can guesstimate the number of patients we served in the commercial setting last quarter. I cannot give you exactly the percentage of demand we are satisfying, but I can tell you, starting from the beginning of the year, we always track our backlog in terms of patients waiting in the queue every month. And I can tell you from January until now, Really, essentially, we're seeing exactly pretty much the same number of patients in the backlog in the queue. So we're not seeing any difference in terms of demand for this product at this point. And we're working very hard to ensure a robust and reliable supply. So we are going to continue to expand our supply. As you just heard from our colleagues on the call, we did receive the second FDA approval in the increase of our capacity recently. So we're continuing to ramp up given that approval, and then we're planning additional increases in capacity from our New Jersey facility next year as well. If you look at the number of patients we think are within the so-called addressable market in the U.S., about 13,000 patients die every year, unfortunately, from multiple myeloma. And probably around 8,000 to 9,000 patients are eligible for receiving CAR T therapy. So, at this point, given our supply, we think still we're nowhere near being able to supply all the demand for Kavikti at this point.
spk14: Okay, thank you very much. And could you just kind of help us understand what the launch preparation is looking like for moving into earlier lines? Is it mainly just messaging changes with the sales force or what else can you tell us about how you're preparing? Yeah, hey Mitch, I'll take that one, Steve.
spk21: So no, it's a bit different, right? So you're moving from a later line population that was largely, these patients were largely in many of our major academic centers. In the earlier lines from the second line population, this will be a very different type of launch where you're largely reliant on the referral. So what the U.S. team has been working very closely with their partner is working through the models in terms of how to appropriately reach that outpatient clinic to ensure that an appropriate referral is made. to one of our cell-to-cell centers. So it's a bit different. You'll see some increase in FTE expansion on behalf largely of our partner at Janssen because they play largely in that outpatient space. From the U.S. legend perspective, you'll see some increase as we increase sites, but our commercial footprint for legend has been largely built around the inpatient setting as opposed to outpatient. I hope that answers your question.
spk14: It does. Thank you all very much for taking the questions. Thank you.
spk21: Thank you.
spk08: Thank you. And our next question coming from the line of .
spk09: Hello. Well, congrats on the results, and thank you for taking my questions. Well, I just have a follow-up on the gross margin, currently at 43, 44% over the past two quarters. So, and you mentioned about the expanding capacity. So what are the other drivers on the margin, on the gross margin, given we have multiple facilities, both internal and external, coming online, as well as improving our SPAC rate? So what are the key moving parts, actually, and how should we be thinking of the margin profile, maybe even in the longer term as well? Thank you.
spk03: So just on the gross margin again, as we talked about, there's two components in the gross margin. So from your perspective, when you look at quarter over quarter, it's a little bit hard for you to model it out. As I mentioned before, we continue to see improvement in the gross margin from a product perspective. Your gross margins are going to improve as your volumes go up. We also have our out of spec that's gone down based upon also process improvements we've made at the plant. So we're seeing the steady progression of the improvement under the gross margins from a product perspective. But you're going to continually get noise in that number we report externally. Because we have to report the facilities expansion, the expense side of it that cannot be capitalized. And as you know, we have expansion going on in Raritan. We have expansion going on in Belgium. And we also have expansion going on with our CMOs. So you're going to continue to see a lot of facilities expense related to those capital investments. through the end of 2025, so it's going to create noise. Some quarters are going to be higher than others, just depending upon where we are with some of those capital projects. But if there's something specific, if you want to talk and submit more of a question, and we can always set up a call with you and try to go over a little bit more detail, but I can't give any granular numbers. I can't disclose any granular numbers from a product perspective.
spk09: Understood. That's helpful. Thank you.
spk08: Thank you. One moment for our next question. And our next question coming from the line of Kelsey Goodwin with Guggenheim. Your line is open.
spk05: Oh, hey. Good morning. Thanks for taking my question. And congrats on the quarter. I guess two quick ones from me. I guess first, do you have any updated view on how we should think about profitability for the joint venture, maybe kind of building on some of these past questions on gross margin? And then kind of following up on that, I guess, how should we think about the longer-term COGS for Carvicti kind of once these capital expenses are no longer included in those line items? And, yeah, maybe kind of what out-of-spec in manufacturing failure rate do you base in the assumption for longer-term COGS?
spk03: Thank you. Hi, Kelsey. So profitability, the messaging is still consistent with what we signaled before. For the BCMA program, we're looking to have breakeven in profitability by the end of 2025. And from a company perspective, we're striving for profitability by 2026. And I always put a disclaimer in there. It will depend upon what happens with our pipeline development, what we look to do from a business development perspective. But based upon the trajectory of what we know now, that is what we've been signaling. From a longer-term COGS, as I mentioned earlier, you're going to continue to see noise in that COGS line all the way through at the end of 2025 going into 2026. We're not giving any guidance on our actual COGS. I would say for your modeling purposes, you could probably use what's been the standard in the industry. It would be a good proxy for you for your modeling.
spk05: Okay, great. Thanks. And maybe just one quick follow-up then on the profitability. I guess, to what extent is that break-even profitability by 2025? How much is that reliant on hitting that 10,000 commercial doses by the end of the year.
spk10: Hey, Kelsey. I hope you understand that we cannot really disclose our internal modeling. But what I can say is that if you look at the cost for CAR T as a general modality, the cost of goods is probably somewhat higher than the typical cost of goods of monoclonal antibodies. The SG&A, in terms of selling and distribution costs, it will be much lower. You can tell that from our financials, right? While we're almost quadrupling our sales for Carvicti this year versus last year, if you look at quarterly spend in sales and marketing, it's actually slightly lower than what we spent last year. So that gives a hint how we think about the profitability of Carvicti in the Alara. Thank you.
spk05: Got it. Okay. Thank you so much.
spk08: Thank you. One moment for our next question. And our next question, coming from the lineup, Sammy Corwin with William Blair. Your line is open.
spk04: Good morning. Thanks for taking my question. I'm giving you a plan on over-enrolling Heartitude 5 now. Will that delay when we should expect data from that trial? And then do you plan on providing any revenue guidance for CARB-EC at the beginning of 2024? Thanks.
spk10: Thanks for the question, Sammy. So on the first question, no, we don't expect any delay because, like I mentioned, we are pretty much on track to close all the ex-U.S. enrollments for CAR-25, which is the majority of patients by end of this year. That's exactly according to our plan. And then we're only over-enrolling in the U.S. next quarter just to make sure that we have a representative percentage of US patients in this trial. So at this point, we do not expect any delay in terms of readout of CARTITUDE 5. And then on product guidance, we're not really giving product guidance for the year 2024 because our partner, J&J, has this policy of not providing product specific guidance. So unfortunately, we will not be in a position to provide you with guidance for carpet piece sales.
spk08: Gotcha. Thank you.
spk10: Thank you.
spk08: Thank you. And at this time, we have no further questions in the queue. Ladies and gentlemen, this concludes today's conference call. Thank you all for your participation, and you may now disconnect.
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