Q4 2024 Legend Biotech Corp Earnings Call
R.I.P.
Unknown Speaker 00.00.00.00.
Speaker Change: Good day, and welcome to the Legend Biotech 4th quarter of full year 2024 earnings call. At this time, all participants are in a listening mode.
Speaker Change: After the speaker's presentation, there'll be a question and answer session. Instructions will be given at that time.
Speaker Change: As a reminder, this call may be recorded. I would like to turn the call over to Caroline Paul, Associate Director of Master Relations. Please go ahead.
Speaker Change: Good morning. This is Caroline Paul, Associate Director of Investor Relations at Legend Biotech. Thank you for joining our conference call today to review our fourth quarter of 2024 performance.
Speaker Change: Prior to this call, we issued a press release announcing our financial results for the quarter. You can find the press release on our IR website at legendbiotech.com
Speaker Change: Joining me on today's call are Ying Huang, the company's chief executive officer and Jessie Yeung, the company's interim chief financial officer.
Speaker Change: Following the prepared remarks we will open up the call for Q&I. We will open up the call for Q&I.
Speaker Change: We have our President of Carvecty, Alan Bash, President of R&D, Goway Fang, and Chief Medical Officer, Mitchell Lee Koneru, joining the Q&A session.
Speaker Change: 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 defer materially from those expressed or implied here with them.
In addition, adjusted net loss is a non-IFRS metric.
Speaker Change: This non-IFRS financial measure is in addition to and not a substitute for or superior to measures of financial performance prepared in accordance with IFRS.
Speaker Change: There are a number of limitations related to the use of these non-IFRS financial measures versus their closest IFRS equiplets.
Speaker Change: However, we believe that providing information concerning adjusted net loss and adjusted net loss for share enhances and investors understanding of our financial performance.
Speaker Change: We use adjusted net loss as a performance metric that guides management in its operation of and planning for the future of the business.
Speaker Change: We believe that adjustment loss provides a useful measure of our operating performance from period to period by excluding certain items that we believe are not representative of our core business.
Speaker Change: Our press release includes IFRS to non IFRS reconciliations for these measures.
Yeung: With that, I will now turn the call over to Ying.
Yeung: Hello everyone, I am glad that you are able to join us and hear about our recent accomplishments as the largest standalone cell therapy company.
Yeung: As you can see on slide 6, we have been executing against our strategic priorities, paving the way for us to achieve blockbuster status and operational break-even for Kervicti by the end of 2025.
Yeung: and Anticipated Company-wide Profitability in 2026, excluding unrealized foreign exchange gans or losses.
Yeung: I would like to start by expanding on Carvector's unique profile, which is the first and only CARTY Immortable Myeloma to cleanically demonstrate a survival benefit versus standard of care.
Yeung: At the Ash 2024 annual meeting, we shared new results from the Phase III Cartoon Force study that show 89% of valuable patients achieved minimal residual disease negativity with a single infusion of
Compared to 38% for those treated with standard of care. [inaudible]
Yeung: As you may know, the FDA ODAC committee recently recommended the uses of MRG negativity as discretion as a potential surrogate endpoint in multiple myeloma trials, which creates other potential opportunities for approval in the future.
Yeung: Additionally, we're pleased to see that Carvegti Alcomstata is reaching the broader Markoma Iloma community.
Yeung: The International Miloma Working Group recently published a series of core recommendations on sequencing therapy for the treatment of multiple Miloma.
Yeung: Notably, one of these recommendations in patients who are reasonable candidates for both DCMA CAR-T therapy and by specific T-cell engages is to pursue CAR-T therapy first.
Speaker Change: Our sales trajectory since our launch is no doubt due to Carvictus unique profile along with strong manufacturing and commercial execution.
Speaker Change: Remember, Legend and J&J are pioneering and undertaking at a scale that we believe has never been down before in the field of multiple myeloma for Carti.
Speaker Change: On this note, on slide 7, we would like to highlight how the FDA has approved our CMO Novartis facility for commercial production of Carvecte in New Jersey
Speaker Change: This is another critical component of our plans for serving patients in Europe and beyond to meet the increasing demand.
Speaker Change: We are thrilled with our industry leading early launch performance and we're not stopping there. We're continuing our commitment to bring
Speaker Change: were pleased that Carvicky recently received approval for reimbursement in Spain.
Speaker Change: Moving to Slide 9, in the fourth quarter of 2024, net trade sales of CarvegTV were approximately $334 million, which is a 110% increase year-over-year and a 17% increase from third quarter.
Speaker Change: This performance was aligned with our expectation for accelerating growth in the second half of last year and was driven by strong demand continued to have expansion and the cartoon for labor launch, for use as early as the second line
Speaker Change: Regarding OUS performance, sales of $31 million increased 138% year-over-year and 15% quarter-over-quarter.
Speaker Change: Owen to our recent increases in capacity and launches in Germany, Austria, Switzerland and Brazil.
Speaker Change: In the United States, we continue to certify more hospitals as authorized treatment centers. The total number of US hospitals that are certified to treat with Carvicti is now 102.
Speaker Change: We believe all patient administration remains another key competitive advantage for us.
Speaker Change: Carvector is the only approved CARTI in multiple myeloma, data seen significantly used in our patient studies.
Speaker Change: Because of the delayed onset of CRS, with CARVEGT, providers are able to utilize outpatient
Speaker Change: We are pleased with the progress we have made since one year ago when our patient treatment accounted for 30% of our overall volume and anticipate.
Speaker Change: A majority of our volume coming from our patient use by end of this year.
Unknown Speaker 0.
Speaker Change: We're also committed to facilitating best practice sharing as we treat more and more patients.
Speaker Change: We have now treated over 5,000 patients with carvictive, which has created the most comprehensive CAR-T patient data set in multiple myeloma.
Speaker Change: New data is constantly being generated about carvictives' benefit over risk profile, for example, at the tender meeting in February , as you can see on slide 10, real-world data was presented on risk mitigation strategies for carvictives.
Speaker Change: On the clinical front, for CARVITY, as you may know, CARVITY 5 is fully enrolled and we expect to complete enrollment for CARVITY 6 this year.
Speaker Change: We believe these trials are key to moving gravity into the frontline setting.
Speaker Change: We believe the studies we have underway and our manufacturing and commercial execution will enable us to maximize carvictive potential. As you can see on slide 12, carvictive the proven leader forging the past to cure in multiple myeloma.
Speaker Change: Turning to our upcoming company milestones on slide 14, as we continue to work toward doubling Kharvek's supply in 2025. We anticipate growth to be driven by capacity expansion in Belgium and New Jersey.
Speaker Change: In addition to increasing our manufacturing capacity, we're working to include our overall survival benefit in Carvictus Label, which is the gold standard that doctors want for their patients.
Speaker Change: Looking at long-term growth for legend, we're building out our pipeline programs and we love to use the successful model we have pioneered with Carvicti and take it to other therapeutic areas where options are limited.
Speaker Change: These include blood cancers and next generation model for myeloma 30s, solid tumor programs, and autoimmune diseases.
Speaker Change: The new research facility we're building in Philadelphia is a testament to our commitment to pipeline investments and that we are looking forward to opening it later this year.
Speaker Change: To sum up, Carvecte is the market leader in multiple myeloma CAR-T therapies. We have scaled up our business and delivered on our commitment to doubling Carvecte's supply.
Speaker Change: We have continued to expand the body of evidence on targeted differentiated clinical profile and we continue to build up our pipeline to leverage our end to end expertise and ensure long-term growth.
Speaker Change: Now it's time to take a closer look at the financials, so I'll turn that call over to Jessie.
Thank you, Ying, and good morning, everyone.
Speaker Change: As Ying mentioned, we generated approximately $334 million in total net sales for Kaffirty during the fourth quarter, an increase of 110% year-over-year As a reminder, we share equally in all profits and losses of Kaffirty with our partner, Jensen Kaffir.
R.T. for a piece selectively targeting D.O.L.F. III.
Speaker Change: Net profit for the fourth quarter was $26 million or $7 cents per share compared to net loss of $145 million or $0.40 per share for the same period
Speaker Change: The increase was primarily driven by an unrealized foreign exchange game of $110 million for the quarter due to our treasury center base in Ireland.
Speaker Change: We have US dollars in not-delaminated deposits, while the functional currency in Ireland is your role.
Speaker Change: For the same period last year, $38 million in unrealized forward exchange loss was reported. As we have said in past quarters, largest fluctuations in unrealized gains and losses can occur from quarter to quarter due to our Treasury center base in Ireland.
Speaker Change: Moving on to expenses, collaboration cost of revenue for the fourth quarter 2024 was $69 million, compared to $32 million for the same period last year
Speaker Change: These expenses are a legend portion of collaboration costs of sales in connection with collaboration revenue under the Jensen's agreement, along with expenditure to support the manufacturing capacity expansion
Speaker Change: Additionally, costs of license and other revenue for the fourth quarter of 2024 was $5 million, compared to no cost of license and other revenue for the fourth quarter of 2023.
Speaker Change: These costs are in connection with our license agreement with Novartis for the development, manufacture and commercialization of LB-20102, and other potential-cardi therapies, selectively targeting DLL-3
Speaker Change: Selin and distribution expense for the fourth quarter was $49 million compared to $34 million for the same period last year.
Speaker Change: The increase of $50 million a year over a year was due to costs associated with the commercial activities for Kaffirty, including the expansion of the self-force and second-line indication launch.
Speaker Change: Other income were $125 million for the fourth quarter compared to $10 million for the same period last year.
Speaker Change: The increase was almost entirely different by an unrealized foreign exchange game for the three months and December 31, 2024. In the same period last year, there was an unrealized foreign exchange loss of $38 million.
Speaker Change: The unrealized forward exchange gains and losses were primarily driven by our Treasury center-based in Ireland. We have US dollars denominated deposits, while the functional currency in Ireland is euro .
Speaker Change: On this note on slide 18, you'll notice we are introducing non-IFRS earnings measures to to provide more insight into our financial performance.
Speaker Change: After excluding certain items that are not representative of the Communist Corps of Business,
Speaker Change: Our adjusted net loss of $59 million or $16 per share for the fourth quarter compared to an adjusted net loss of $89 million or $24 cents per share for the same period.
Speaker Change: Finally, we entered the year with $1.1 billion in cash and equivalence and time deposits. Our spending remains on track and we continue to maintain a strong balance sheet.
Speaker Change: Thus, we believe we have sufficient capital to fund our operating and capital expenditures until we anticipate rich and profitability in 2026, excluding unrealized forward exchange gains
Speaker Change: Our profitability guidance implies further growth acceleration, which shows that we are making good progress towards our long-term goals. I will now pass it back to Ying for closing remarks.
Yeung: Unknown Speaker 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27
Speaker Change: Thank you, Jessie. Carvict is the fastest-launched Carty Therapy. The achievements of our global teams have set us up for great success in 2025, and we are poised to provide Carvict to even more patients around the world. I want to thank each of our 2600 employees for their commitment and dedication to a legend.
Yeung: Now it's time to take your questions. Operator, we're ready for the first question, please.
Speaker Change: Thank you. If you'd like to ask a question, please press star 1-1. If your question has been answered and you'd like to remove yourself from the queue, please press star 1-1 again. Our first question comes from John Miller with Evercore. Your line is open.
John Miller: Hi guys, thanks for taking my question and congrats on all of the progress and a great fourth quarter.
I would love to ask more about...
John Miller: the safety profile and the your plans to develop a trial that more aggressively manages
John Miller: in a more trial-like setting. I think we all saw the IST posters that came out a month ago, that's great, but being you've spoken in the past to running your own phase to using a more Arcelix-like management system, where are the plans for that trial, and when is the earliest we could see data from that? Thank you.
John Miller: Sarah, thank you for your questions. So regarding the posters that were presented at
John Miller: These were single-centered studies, but I think they represent a promising start to the risk mitigation strategies we've discussed recently using absolute lymphocyte count or ALC as a predictive biomarker for patients who are at higher risk for MNTs or Parkinsonism.
John Miller: In those posters, C-D-C-I, chose that threshold of 5,000, where as Mayo Clinic actually used the threshold of 3,000, as predictive cutoff.
John Miller: I think our Carbitude Studies, our internal programs, indicate that it's actually probably more consistent with the 1000s, just try to capture as many of these patients as possible.
John Miller: We actually had a discussion with the investigators at CBCI and they're planning on moving forward with the 3000 as a cutoff for future investigation.
John Miller: But regardless of the cutoff, I think it's clear that ALC is a predictive biomarker and when you use in conjunction with the dexamethasone treatment with the goal of decreasing
John Miller: or potentially preventing Parkinsonism altogether. So, going forward, I think we've harmonized these ALC cutoffs within the Cardiff Youth Studies and have ongoing enrollment as the year continues. I think
John Miller: It's also important to mention the prospective study that you're referring to, which will be an investigator-initiated trial by some of these investigators that presented their information at Tandem.
John Miller: I think with the conjunction of the internal efforts, as well as the external efforts with the investigator-initiated trial using the cut-off that I just mentioned, I think we'll have some data that will be presented throughout this year and as well as into next year, that will address the-
the MNTs in the Parkinsonism. [inaudible]
John Miller: The poster also, the Mayo Clinic mentioned the cranial nerve palsies. I think it's important to highlight that cranial nerve palsies tend to be reversible in a majority of cases. In fact, the two cases that
John Miller: presented the Cranelo Paul V from the CBCI, actually a show complete resolution of their symptoms using the Cardinist's own paper, as well as this that nib for seven days.
Speaker Change: and in general, as I mentioned, the Pringles and Colesies tend to be irreversible.
Speaker Change: The ICANN and M&Ts are the most notable, but we have clear mitigation strategies for these going forward and we're confident in the benefit risk profile that is overall positive for Carv safety.
Speaker Change: Thanks, Mai. And then, Yaron, maybe I'll just add a comment about our own sponsor trials. So,
We have...
Speaker Change: Already amanded all the protocols for the Cartoon Program, including ongoing Cartoon 6 and also ongoing Cartoon 2, including additional new cohorts for Cartoon 2.
Speaker Change: So that will be with a cutoff of 3,000 cells per microliter for ALC monitoring.
Speaker Change: and then a three-day flat dosing of 10-metre grand, twice daily for three days. So that's already being implemented at all the Cartesian program sites.
Speaker Change: Excellent, thanks so much. If I could get one follow-up, I'm very curious to hear about your plans for Ashgo this year. Are you going to have meaningful updates to your existing trials at the new data in early lines this year? Thank you.
Speaker Change: So, John , as you know, the typical policy for both J&J and Legend's social policies that we cannot comment until the abstract is officially accepted by any major medical meeting. But suffice to say that, you know, both Legend and J&J are very excited about the data we're presenting at ASCO Potentially this year, so stay tuned.
Unknown Speaker 0 Transcription by Trans-Express Transcription by Trans-Express
Thank you very much.
Speaker Change: Thank you. Our next question comes from Gina Wang with Barclays. Your line is open.
Speaker Change: Hi, thank you for taking our question. This is Han Kuo on behalf of Jina Wenzh.
Speaker Change: So our questions about commercial, so first one is what's the culturally revenue breakdown in terms of the...
Second line to sub-line patients versus four-class line patients.
Speaker Change: The second one is a watcher, thousands of minds for cardiovascular therapy in multiple manoma, which is higher than the number of patients we've been treatment now. Could you give more colors on that, for instance, what kind of leg?
Speaker Change: and the physician capacity. And also, for the additional patients, could be treated with the cardiotherapy, whether they're from the academic center. Yeah, thanks.
Speaker Change: All right, thanks for the question. So with respect to market demand and commercial uptake, we continue to get good receptivity to the card to four data and I'll just share a little bit more about what we're hearing from customers and then go into some of the numbers.
Speaker Change: We're here in very positive receptivity to the clinical profile, inclusive of obviously the PFF and the overall survival data that's now in the public domain, all from a one-time treatment.
Speaker Change: and as you mentioned, education in earlier lines specifically the second through fourth line opportunity. And at this point we're about three quarters plus into the launch of the cardotune for education and we've already converted nearly 60% of our usage.
Speaker Change: to that in the second through fourth-line populations. That's a very strong evolution quarter on quarter of bringing our total revenue across two earlier lines. And it sets up well to maintain leadership in these earlier line opportunities. [inaudible]
Speaker Change: Thank you, Alan. And I will also add that, you know, both our commercial field forces and also from our partner, JNJ, are now targeting 8,000 hematologist in about 3,000 clinics. So we're working very hard to penetrate deeply into the community setting. [inaudible]
Thank you so much for your answers. I appreciate that.
Speaker Change: Thank you. Our next question comes from Yaron Werber with TD Cowan. Your line is open.
Yaron Werber: Right. Thanks for taking my question. It may be a couple. The first one just housekeeping the the share count.
Yaron Werber: I noticed that you're using the fully diluted 402, which is up from 367 last quarter.
Yaron Werber: Is this the run rate we should use from now on, or is there kind of a one-time or an anti-delusion kind of measures, and that's why you're using that?
Yaron Werber: And then the second one is more about the pipeline. Can you give us a sense what data can we expect from sort of the early pipeline and maybe some of the INI programs that you have going on and anything this year? Thank you.
Speaker Change: Hi, Yaron. So, for this time, we actually recorded a map profit with the IFRS measure, and then with map profit, we have to calculate, using all the, I mean, fastest share as well. So, you see a different number with the other value to numbers. But going forward, if we switch back to that law, then you will see the same collection as before again.
Go to Beadaholique.com for all of your beading supply needs!
Speaker Change: Sarah T. Taken, Card 18.4 for Gertrigg, as well as Taken DL3 for Smoth and Uncancel, we will have the dose excretion readout on this year and then decide to the next phase of development.
Speaker Change: On the IT Tri-Side from China, we have multiple results on heterogeneous progress and targeting different diseases. We expect to have those results before end of this year as well.
Speaker Change: That's in communicated that we just about to initiate a new research center at Philadelphia.
focusing on disruptive technology, including the interview or self-self approach. [inaudible]
Speaker Change: We expect to see, as said, moving through clinical development with that particular platform.
Speaker Change: And lastly, I think, on the autoimmune front, we have Michael Progwen currently undergoing IT T-Try, including both our targets as well as energetic approach. In particular, we have a triple targeting our targets to our self-selfie product.
Speaker Change: targeting CD-19, CD-20, CD-22. And this asset is being tested across a very broad spectrum of autoimmune diseases. In fact, more than 10 different disease indications. We expect to have a initial clinical readout. [inaudible] We expect to have a final clinical read out. We expect to have a final clinical read out.
for this particular asset as well.
Speaker Change: Thank you. Our next question comes from Jessica Fye with JP Morgan. Your line is open.
Jessica Fye: Hey guys, good morning. Thanks for taking our question. With all the various sources of capacity, slots, et cetera, kind of coming online, cute.
Speaker Change: Just give us a little color about how to think about the cadence of revenue growth this year. Thank you.
Speaker Change: Yeah, so overall we're feeling reasonably confident about doubling capacity and achieving the consensus number. And as our partner, Jane J, has said previously, and as we'll share a little bit more here, our growth over 2025 will not be perfectly linear. So just the way to think about it is coming off of a strong Q4 in the back at 2024, we anticipate a Q1 that's more modest growth compared to the Q4. And that's really because of seasonality.
Speaker Change: and the fact that in November , December , during the holiday, we took the opportunity to do some important and regulatory required facility maintenance.
So that will actually lag into revenue in Q1.
Speaker Change: Following that, we expect step-ups in our manufacturing due to the rarerning step-up, as well as the approval of the Novartis commercial operations, and so that will have a more meaningful impact in Q2 and Q3, as we see, for meaningful close in those two quarters.
Thank you.
Speaker Change: Thank you. Our next question comes from Zhe Chen with Goldman Sachs. Your line is open.
Hey, thank you for taking my questions.
Speaker Change: Well, since you mentioned about our stage pipelizing, including the Al-3 and the Call of the Ending Point 80s, the CAR-T, I'm kind of wondering, could you share more color on the expected data for both SSS this year and also the future clinical development strategies?
Speaker Change: and I'm trying to understand what is your perspective on a position in the Carti therapies and solid tumor trimmings, and based on the data you have seen, you know, are there any obstacles you have been seeing in solid tumor Carti development? Thank you.
Speaker Change: Thank you for your question. So, as Goa mentioned earlier, both the LL3 and the Cloud in 18.2 Carti.
Speaker Change: are currently in dose isolation. We actually are making good progress on both studies.
Speaker Change: and we look forward to presenting the safety dose escalation data and some preliminary efficacy this year at multiple different conferences. Safety, preliminary efficacy as well as actually biomarker data that's actually quite interesting for both programs.
Speaker Change: I think the whole three, we hope to complete the dose escalation and the entirety of 20 patients as planned. As you probably know this study is
Speaker Change: Under a collaboration with Novartis and so they are looking to continue the development of this and it's clear that [inaudible]
Speaker Change: This construct is of particular interest and as you'll see throughout this year, really exciting data will be discussed in various venues.
Speaker Change: Regarding the cloud in 18.2, similarly, we are planning to complete the dose escalation this year and begin dose expansion.
Speaker Change: Currently, Club in 18.2 is an appropriate target in pancreatic cancer and gastrocancer among others.
Speaker Change: That's my iPhone. Yeah, I can also add a bit more color in terms of our wall.
Speaker Change: Early Pipeline Strategy for Saudi Truma. There are certain disease indications where a medical need is tremendous such as pancreatic cancer and small cell lung cancer.
Speaker Change: Good efficacy at this manageable safety profile would have a commercial pass forward. We are seeing other disease indications, probably additional new innovation is required. [inaudible]
Speaker Change: who really drives the commercial success of South-South-European Saudi-Tuma space.
Speaker Change: engineering, more compact sales of the products we constitute both the innate as well as the adaptive immunity.
Speaker Change: and the engineering varies the email mechanism to promote the email product infiltration into two-monthly environment exception. So stay tuned, and we will have a more additional
Innovation Insighting Timaspace.
Thank you so much Stucked Phones. Looking forward to that.
[inaudible]
Speaker Change: Thank you. Our next question comes from Kelly Shee with Jeffers. Your line is open.
Huang Fei-Fu: Hi, thanks for taking my question. This is the health-based calling for Kali Shi.
Speaker Change: I just have one quick question. We know that two BCMA bi-specific expected to report second to fourth-line data in 2025 from Dan Day and Pfizer, and both trials exclude patients with prior BCMA agents.
Speaker Change: So my question is how do you see by specifics competing with carvictine general? And as you mentioned that I am WG recommended using car T ahead of by specifics.
Speaker Change: Based on existing data, what could we learn from this new upcoming data from those two by specifics? Thank you.
Speaker Change: As you mentioned, the BCMAD by specifics do include prior BCMAD agents and they're approved in the later lines of therapy compared to the current approval for Carvicky in second line and beyond.
Speaker Change: and so we hope to also continue not only in the academic centers but also in the community setting. So we hope to continue to show this by our stale and growth for
Speaker Change: and thank my conference. Maybe I'll add a couple of points about this. I think...
Speaker Change: Both street modalities all have its place in the market. On the other hand, I do not emphasize some of the unmatched benefits offered by Carti.
especially Karvechti. [inaudible]
Speaker Change: First of all, as you can see from both late line and now second line data that Kabuki offers unmatched depth and durability or response in even late line.
Speaker Change: Patients in Card 2-1. We've demonstrated the media and PFS of nearly three years, and so far the media and PFS has not been reached yet in the second line trial of Card 2-4.
Speaker Change: on their appreciated by investors, but when we talk to physicians and customers such as and user patients
Speaker Change: They do appreciate the fact that Carvicti offers the Communion of one-time treatment, and that offers patients a very long treatment-free period which translates into an improved quality of life. So I think that's another significant benefit offered by Cartier therapy.
Thank you.
Speaker Change: Thank you. Our next question comes from Leonid Timashev with RBC Capital Markets. Your line is open.
Speaker Change: Thank you guys, thanks for taking my questions. I want to follow up on Jessica's question, but maybe it was a bit longer of a time horizon, you know?
Joseph talked about exiting 2025 with...
Speaker Change: 10,000 doses. And I guess historically, people have been assigning what they think that might be in revenues, but consensus for 2026 is well below.
Speaker Change: What people historically thought that number could be? I guess, what do you think the street is missing about, you know, 2026, you know, are you going to be able to utilize the full 10,000 doses in 2026, the 2026 sort of a point where you're no longer going to be supply cap?
That's that time period and beyond. Thanks.
Unknown Speaker 0
Speaker Change: Yeah, hi. So as we exit 2025 with 10,000, that's an annualized number, so that's an annualized run rate. So as we think about 2026, we will be in a position to supply the market. And we're seeing very good evolution of our shares as well as our uptake in the community. We're really just at the very beginning of what we think
Speaker Change: We're in 102 centers, actually now we're up to 104 certified sites as of today.
Speaker Change: We continue to expect that the number of sites will expand significantly as Ying mentioned, we're also now have a very significant presence in the community and our partner, J&J is very much a leader in the community setting.
Speaker Change: So by reaching all of those referrals and then ultimately having Carvicti administered even closer to the patient in more centers and into the community setting, we expect that there's significant upside there.
Speaker Change: You know, from a manufacturing standpoint, we're very comfortable with the supply network that we've built across the four knowns. So, as mentioned, Rariton will continue to have step-ups and then a physical planning expansion in the second half of this year.
to support the European launches.
Speaker Change: Both the Ovalist Facility is at capacity and continuing to deliver as well as by the end of 2025 that will have our Tech Lane Facility. And those will be supporting our XUS markets and that will continue to be a meaningful contributor.
Speaker Change: to our top line. Right now, the X-US is about 10% of our revenue, but we continue to see that that will grow Germany, the demand is strong, and we have the additional European markets. And as was mentioned today, Spain now has national reimbursement. So,
Speaker Change: As you know, J&J is our partner in Europe and they take the lead on commercialization but we're very comfortable with the fact that there's going to be continued demand from Europe as well.
Speaker Change: Thank you, Alan. And Leo, maybe I'll just add a couple of points here. Number one, you heard from Alan that we're very pleased. Recently, Novartis did receive the FDA approval for commercial production in the US. And also, we did receive the span reimbursement of pricing. [inaudible]
Speaker Change: Lastly, I also want to emphasize another fact which is that [inaudible]
based on our internal projection for the demand. Now, let's get started.
Legend End
Speaker Change: J&J have decided to jointly invest in expansion of tech man facility. So that has received the Executive Committee from J&J's approval and also Legend's Board of Director of Proof of
Speaker Change: and we should expect additional capacity coming online in 2028 from our Tech Land Facility in Belgium. That shows you that both partners are very confident about the demand.
Got it, thanks.
Speaker Change: Thank you. Our next question comes from Vikram Purohit with Morgan Stanley . Your line is open.
Speaker Change: Hi, good morning. Thanks for taking your question. We just wanted to revisit the topic of
Vikram Parowit: Expanded Use for Carvict in the Community Setting. You spoke about this a little bit, but I was wondering if you could unpack in a bit more detail. What some of the key inflection points are that you're looking for throughout the course of this year, to ensure that I'll take in the community setting is, in the second line, plus setting is...
Vikram Parowit: Fending how you would want it to trend. And also, if you go through the year, what you will be looking to learn to better understand how I guess first line uptake potentially could look for
Vikram Parowit: Yes, so as it relates to adoption of the community, we look at it in terms of the three states plan and right now we're in the first stage.
Speaker Change: which is to educate community physicians that being mentioned, we are reaching over 8,000 community oncologists who treat myeloma, educating them on the profile and supporting them as they refer patients into the certified treatment centers.
Speaker Change: And that's going very well, and everything we're out there, we're getting more support for referring those patients in the IMWG.
Speaker Change: Recommendation around considering referral for a party is supportive of that. We're also building connections between the treaters in the sort of like treatment centers and the refers that there refers know where and how to send patients.
Speaker Change: The second stage will be, as we initiate this later this year, will be to identify certain regional hospitals and community accounts.
Speaker Change: who are closely affiliated with hospitals who can actually go ahead and administer a
Speaker Change: and I'll think about outpatient in a moment. But then the third stage is really bringing COVID-19 even closer to the patient and having it more widely administered in the community oncology practices. We expect that to be an effort that will really begin in earnest next year and carry us through kind of the next few years as COVID-19 gets administered into the community setting.
Speaker Change: As mentioned, we're obviously partnered with the leader in my element in J&J. They have outstanding capabilities in terms of reimbursement and access.
and Commercial Footprint.
Speaker Change: and both companies are now deploying commercial sales, field medical, nurse educators in the community. In terms of outpatient, just to share a little bit about that, we currently see that a little over half of our business right now is administered in the outpatient setting. That's really driven by the fact that we have a unique profile, our meeting onset of CRF, as you know, is seven days, and so that enables patients to be more comfortably administered in the outpatient setting, and then monitor more
Speaker Change: Publicly, and that's a better experience for patients, and importantly, it expands the capacity for the treatment centers because they don't have to use inpatient beds for the administration of perfection. And that's a unique aspect of our profile that is gaining good receptivity both at the treatment centers we're in as well as in the community. [inaudible]
Costas Delores: Thank you. Our next question comes from Kostas Biliouris with BMO Capital Markets. Your line is open.
Costas Delores: Thanks for taking our question and congrats on the progress. Two quick questions from us. One on the activated.
Sandwich, you mentioned there are currently 102 activated sandbags [inaudible]
Speaker Change: Can you break this number down to how many of these standards can do both outpatient and inpatient administration, only outpatient or only inpatient?
Costas Delores: And the second question is on currently ongoing clinical trials, which in vivo-cardi therapy is multiple myeloma. How are you thinking about...
Speaker Change: Competition from Envivo, Cardi, Product, Given the convenience that they could potentially offer. Thank you.
Speaker Change: Yes, so as we put on the slide deck 102 centers in the US have been activated and actually has today that number is 104, so we continue to add centers each day. And I should mention that across globally, across Europe there are another 40 or so centers activated, but just to answer your second part, while we don't break it down specifically center by center, we can say that the majority of patients are receiving, curfew in the outpatient setting. And we look at that through plain data and we have a number of others.
Speaker Change: Sources, so again, a little over half of the patients right now are being administered to the outpatient setting. Newer centers just to just add one more point as you bring centers on. Newer centers sometimes start in the inpatient until they get a little bit more experience. [inaudible]
Speaker Change: and then they gained the comfort to start it in outpatients. So, as we bring new centers on, sometimes it's a start in the inpatient but they very quickly realize that they based on the profile and based on the logistics and based on their capacity they're able to implement an outpatient protocol.
Speaker Change: Yeah, so on the individual front, we are close to the monitoring and the paying attention. It's a new technology, certainly bringing potential advantage.
Speaker Change: and also potential liability. It's in early days, and so far, one patient data was released from S.O.Y. Tech Company, and we are closing the monitor of CT as well as the durability of the response.
Speaker Change: On the evil front, we also have our own differentiated platform, and we are actually pursuing the evil treatment option for various diseases as well.
Speaker Change: Thank you. Our next question comes from Mitchell Kapoor with H.C. Wainwright. Your line is open.
Mitchell Kapoor: Everyone, thanks for taking the questions. First one is I wanted to ask if you could give an update on your demand relative to supply. When do you expect that all supply constraints could be potentially alleviated for supply to be able to outpace demand?
Mitchell Kapoor: And then secondly, could you just talk about demand increasing on a per-center basis? Is this, you know, on a per-center basis, are you seeing more demand there? Or is it coming from more centers coming offline generally? [inaudible]
Mitchell Kapoor: As we said before, we're executing well on both the demand and supply, and really by the end of this year we'll be in a situation where supply is fully meeting the demand where we are and then we'll be able to keep pace with that. To answer your question, we don't break it down in terms of specific sources, but I'll just share a little bit on that.
Mitchell Kapoor: The predominant growth will be coming from the existing centers and the referral base into those centers.
Mitchell Kapoor: and so, as I mentioned before, as we reach out into the community and as we educate on the earlier line approval for Carvitti, the main source of growth will be in those referrals coming into the 104 activated centers.
Great, thank you very much.
Thank you. Thank you.
Speaker Change: Thank you. Our next question comes from James Shin, with Debi. Your line is open.
James Shen: Hey, morning guys, thanks for the question. Are there any updates on removing factor accreditation to broaden out outpatient and car to use? And then secondly, given car to five and six protocols now include ALC, have you decided whether there will be a breakout for those that reach 3000 cells per ML requiring intervention versus those that do not? Thank you very much.
I'm sorry. I'm sorry. I'm sorry. I'm sorry. I'm sorry.
Speaker Change: It's sort of the fact that accreditation, the plan that we've heard from some centers is to really do more of an affiliation.
James Shen: Where they can be part of a fact accreditation umbrella from a larger institution. Rather than removing wholesale, it's more about leveraging the fact accreditation from a larger center.
Speaker Change: I think regarding your ALC question, I think we just want to clarify that the ALC mitigation strategy was only incorporated into studies that are ongoing enrollment.
So as you know, as Ying mentioned in his earlier.
That...
Partist 5 has completed enrollment last year. [inaudible]
Speaker Change: So therefore, that wouldn't be involved with the additional mitigation strategies that we've incorporated, how we will report it, I think remains to be seen, but I think it's clear that it's something that we've incorporated in
Speaker Change: That study as well as Ying mentioned in our study in courtitude to in the in that cohort G. So we look forward to presenting some of this data in the at the appropriate time this year next year.
Mitch, I know you asked about the breakouts, right? So...
Speaker Change: Based on the biomarker data we collected from the nearly 1,000 patients database on CAR2 program, we believe about 20% of patients could potentially reach that threshold and therefore could be benefiting from this L.C. monitoring and the Dexamation Proflax treatment.
Speaker Change: Thank you. Our next question comes from Justin Zelin with BTIG. Your line is open.
Speaker Change: Great. Thanks for taking the question. This is Jeet on for Justin. So you said you expect the majority of patients to ultimately be treated outpatients, but can you share any color on what percent you think can ultimately be treated there? Is there a plateau here on outpatient versus inpatient and a second question more on the financial side? How should we be thinking about CapEx going forward from a modeling perspective? Thanks.
Unknown Speaker
Speaker Change: Yeah, we're seeing continue growth in the outpatient setting. I don't think there's really a cap that we've modeled in terms of how far that can go.
Speaker Change: As I said before, centers tend to start with inpatient utilization and then they very quickly develop the protocol and it's beneficial for patients and the center so that continues to grow. There's no really ceiling on that.
Speaker Change: And move on, we continue to invest in our CAP-X Worldwide, but the bulk of it will be completed in 2025.
Ash Burma: Thank you. Our next question comes from Ash Verma with UBS. Your line is open.
Ash Burma: Thanks for taking my questions. So, can you remind us when do you start to see meaningful benefit from the what is commercial? So, I'm going to show, um,
Speaker Change: Manufacturing, and then what percentage of her atrocity, let's say by the end of this year would be driven off, no artist.
Ash Burma: And then secondly, it's an encouraging to see this kind of data, but how would this play out in the community setting? And as you're starting to look to have more of a focus on the outpatient setting, would the physicians manage the blood work, etc., in that setting without any resistance or do you think that might potentially become a hurdle? [inaudible]
Thanks. Bye.
Speaker Change: With the Novartis Commercial Approval, this quarter we expect that that will start to meaningfully contribute in the second quarter of this year. And I don't really break down the percentage contribution of our overall capacity, but again, it's an important part of us doubling capacity this year.
Yaron. [inaudible]
Speaker Change: Results that is checked very frequently and commonly at all centers, including academic centers as well as a community setting.
Speaker Change: that can be done very easily as well. The steroids are inexpensive and readily available at all of these centers. Again, in the academic results in these settings. Therefore, we think that if this proves to be a very successful risk mitigation strategy that would be easily adoptable.
Speaker Change: Hi, thanks for taking my questions. Two from me. One, can you talk about meeting demand in the ARP a little bit more?
Speaker Change: We got some feedback from European docs that they've been having a bit trouble getting.
Speaker Change: getting demand-filled for their patients. That's number one, and number two, you know, now that you have CAR-25 wrapped up in CAR-26 closing enrollments shortly, how should we think about R&D going forward? Thanks.
Unknown Speaker 0 5. Okay.
So, the demand in Europe is being satisfied by our...
Speaker Change: Two facilities, again, and in part by Raritan, but more and more, we're exclusively going to be supplying it from our, from our against facilities. So, that's Fulbelaskin, and that was approved for commercial use in September of 2024. So it really is now at this point, coming through a holiday is just now delivering a full capacity. And then as we mentioned, our tech length facility, which we're continuing to invest in, well, we anticipate having commercial approval by the end of 2025. So between now, we're going to move on to the next one.
Speaker Change: On end of 2025, to your point, demand is, we're still in a supply exchange environment in Europe , and demand is, as demand grows, we're going to work to keep up, but there is a queue in the, in the get, in the get facilities to support the European markets. Yes.
Speaker Change: We are working very closely with each center to make sure that we deliver the product when we can.
Speaker Change: and overall across our network, we're increasing reliability, particularly in our rarerant facility where when we have a projected delivery date, 95% of the time we're able to deliver products on it before that delivery date.
Speaker Change: Now regarding your R&D span questions, so we remain financially disciplined, and that's why you see a flatish spending in R&D, despite celebrity growth in revenue from Q424, Q423. And I want to say that, make sure you may still see similar spending in R&D for BCMA, but then in 2027, you may see declining the BCMA R&D fund.
Speaker Change: Unknown Speaker 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Speaker Change: Thank you. Our next question comes from Sean McCutcheon with Raymond James. Your line is open.
Sean McCutcheon: Hi guys, thanks for taking the questions. Can you speak a bit more to how broadly the ALC monitoring mitigation protocols are?
Speaker Change: are being implemented now and how that process of communicating these findings is going across the spectrum of...
Treatment Facilities, versus how much. [inaudible]
Speaker Change: of a gating factor for their clinical data will be for that process. And then maybe separately for that 2028 tech lane expansion, is that part of the current CAPEX initiative, and if not, can you get some more color there? Thanks.
Implementation of the ALC, I think what is...
Speaker Change: Both internally and externally to provide more information on this mediation strategy moving forward this year and next year. As we talked about earlier, we have an investigator initiated trial that we're having conversations with multiple centers on participating. In addition, we've incorporated the strategy into our internal programs that are have ongoing enrollment in the cartoon studies. [inaudible]
Speaker Change: In addition, there's other real world evidence data that will be coming out, both at conferences as well as manuscripts throughout this year. So we look forward to interrogating this further and spreading this to more and more centers.
that we will be talking to you further.
regarding your question on Tatlin.
Speaker Change: Extension Plan, so the phase one will be completed this year that we will have clinical production in first half commercial production in the second half and for phase two we will see you in the next video.
Speaker Change: In fact, incremental of $150 million, and that will start in second half of 2025, and we expect to complete in 2008, an early engineering and design work has already been initiated.
Rick Biankowski: Thank you. Our next question comes from Rick Bienkowski with Cancer Fitzgerald. Your line is open.
Rick Biankowski: Good morning everyone, congrats on the progress and thanks for taking the question.
Rick Biankowski: So given, there is a lot of uncertainty regarding US tariff policy, I wanted to ask about the potential impact on Carvicte, if broad tariffs are maintained on Canada, Mexico and China, is there any impact to the manufacturing costs of Carvicte moving forward, or any potential impact to the supply chain?
Jessica Fye: Rick, this is Jessie, so under our current assessment, we have immaterial exposure to tariffs in Canada, Mexico, and China. We will continue to monitor the situation closely and just a reminder regarding your supply chain question. All our potential product comes from the U.S. and Europe and we plan to supply Europe from our Belgium facilities going forward. We will continue to monitor your supply chain question. We will continue to monitor your supply chain question.
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Great, thank you.
Speaker Change: Thank you. Our next question comes from from Prem Lockman with Maximus Capital. Your line is open.
Speaker Change: Hai, Ying, I'd like to ask you two or three questions first.
Speaker Change: Can you clarify that the outlook for this year is modest sequential growth in the first quarter following a strong Q4, stronger sequential growth in Q2, as Alan said, and then the second half of the year also will be stronger and just-
Speaker Change: Are you comfortable with the consensus 1.9 billion dollar estimate for this year? And secondly,
Speaker Change: The question regarding 26 outlook that was asked earlier, well, 10,000 patients run rate, increased penetration in the outpatient setting, as you said
It's over 400,000 per patient, the math is pretty straightforward. Forward.
for the analyst estimates are lower.
Speaker Change: The reason is, they're expecting a new competitor in the second half of the year.
Speaker Change: So, can you clarify the market dynamics you intend to see versus a new competitor in the second half of the year and how you're going to maintain your strong 90% market share or how you're going to maintain your market share strength and the. [inaudible]
Multiple Miloma Market, thanks.
Speaker Change: Thank you for the questions. So, I'll address the first one. Yes.
Speaker Change: We feel highly confident about achieving the doubling of commercial supply. I'm not in common exactly consensus number but as you heard from my colleague Alan, we feel confident that we can deliver that to the market.
Speaker Change: And I can also confirm that we do expect sequential growth in Q1 and also the following three quarters as you are correctly mentioned.
Speaker Change: We do expect significant growth in the second quarter, thanks to the Novartis CMO facility coming online, and also the continued expansion in Riharton and also our Belgium facilities.
Speaker Change: We do expect also stronger second half of this year, again at this point we anticipate sequential growth in third quarter and in fourth quarter as well.
Speaker Change: Regarding our second question, we do see potential competition coming in in 2026, probably in the second half of 2026
Speaker Change: However, you also heard from my colleague Alan saying that at this point, we already have over half of our revenue coming from the second.
Unknown Executive, Jessie Yeung
Jessie Yeung: and we do expect that trend to continue for the rest of 2025. So by end of this year, we fully expect that two-thirds or maybe three-quarters of our revenue will come in from second to fourth line. Therefore, we think we're very well positioned to enter into 2026 because by then the large overwhelming majority of our revenue mix will come in from the second to fourth line.
Cartoon for Indication. And as you know, we feel really good about Carvictious Profile because
Speaker Change: It's safety and efficacy have been consistently demonstrated from late-line to early-line trial across different settings in the clinic. And we also have the unmatched PFS.
Speaker Change: CR-rate, and now overall survival, which we do expect to be ridden in the label in the first half in Europe and then second half in the US approved by FDA. So we think that Carvicti is the best in class therapy. That is prompted by data and facts. Thank you.
Thank you. That's all the time we have for questions.
Yaron Werber
Unknown Executive, Jessie Yeung
Speaker Change: Nethework, coaches, U Anywhere. We don't Universe. Universities all throughout the U S and around the world, right?
Lori Macomber, Unknown Executive, Jessie Yeung