Legend Biotech - Earnings Call - Q3 2025

Transcript

Speaker 1

Ladies and gentlemen, thank you for standing by. Welcome to Legend Biotech's third quarter 2025 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you would need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Jessie Yeung, Vice President of Investor Relations and Finance. Please go ahead.

Speaker 4

Good morning. This is Jessie Yeung, Vice President of Investor Relations and Finance at Legend Biotech. Thank you for joining our conference call today to review our third quarter of 2025 performance. 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. Joining me on today's call are Ying Huang, the company's Chief Executive Officer; Alan Bash, the company's President of CARVYKTI; and Carlos Santos, the company's Chief Financial Officer. Following the prepared remarks, we will open up the call for Q&A. We have our President of R&D, Guowei Fang, joining the Q&A session. During today's call, we will be making forward-looking statements, which are subject to risks and uncertainties that may cause our actual results to differ materially from those expressed or implied 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 investor section of our company website. In addition, adjusted net income or loss is a non-IFRS metric. 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. There are a number of limitations related to the use of these non-IFRS financial measures versus their closest IFRS equivalents. However, we believe that providing information concerning adjusted net income or loss and adjusted net income or loss per share enhances an investor's understanding of our financial performance. We use adjusted net income or loss as a performance metric that guides management in its operation of and planning for the future of the business.

We believe that adjusted net income or loss provides a useful measure of our operating performance from period to period. Our press release includes IFRS to non-IFRS for consideration for these measures. With that, I will now turn the call over to Ying.

Speaker 0

Hello everyone. Thank you for joining us today. The third quarter was marked by significant milestones that I will elaborate on momentarily, and we are looking forward to presenting new data at the annual American Society of Hematology meeting in December. During the third quarter, CARVYKTI net trade sales were approximately $524 million, which is an 84% increase year over year. We have now treated over 9,000 patients with CARVYKTI, and our launch remains the strongest CAR-T launch to date. In the U.S., the majority of our utilization is in the earlier line setting. Additionally, we continue to see a lot of excitement about our long-term survival data presented at ASCO on CARTITUDE-1. As a reminder, one-third of patients with heavily pretreated relapsed/refractory myeloma remain alive and progression-free for five years or more after being treated with CARVYKTI.

This is especially impressive considering that today's bridging protocol did not exist at the time of the CARTITUDE-1 trial, and patients in the trial had received a median of 6.5 prior lines of therapy. Ever since our CARTITUDE-1 results were first presented in 2020, we have been setting new standards for efficacy in CAR-T for multiple myeloma. We're now changing that standard to curative potential. In fact, a recent article from Nature stated that one-third of the treated individuals had no evidence of detectable myeloma after five years without further therapy, an outcome widely thought of as a prerequisite to consider using the term cure. This kind of efficacy for heavily pretreated patients is unprecedented in the field of multiple myeloma. On a regulatory front, the FDA recently approved an update to include CARVYKTI's overall survival benefit in this label.

This was based on an analysis from the phase three CARTITUDE-4 study showing a statistically significant improvement in overall survival for CARVYKTI compared to the standard of care therapy in patients with relapsed/refractory multiple myeloma after one to three prior lines of therapy. Importantly, CARVYKTI is the only approved CAR-T in multiple myeloma with a demonstrated overall survival benefit in this label, which represents another step forward towards educating the physician community on CARVYKTI's unique profile as we work to bring CARVYKTI to more second-line patients in need across the United States. We expect label updates such as these and previous REMS updates will continue to improve the patient experience and enhance access in both community and academic settings.

In fact, I want to share findings from a recent survey that was presented at the International Myeloma Society meeting, where 237 patients and 267 physicians were represented across the U.S., U.K., Spain, France, Germany, Italy, Japan, and Brazil. In terms of what patients value when selecting a new line of treatment, overall survival was clearly the most important attribute for patients. Also, on the topic of survival, we are pleased that there will be two oral presentations on CARVYKTI at this year's upcoming ASH meeting. Before we dive deeper into this, I want to highlight that there will be an oral presentation at ASH on LUCAR-G35D, our first-in-class allogeneic gamma delta T CAR-T cell therapy targeting both CD19 and CD20 in adults with relapsed refractory B cell non-Hodgkin's lymphoma.

As you may have seen in the abstract, we are pleased that preliminary efficacy showed an encouraging response rate and sustained durability in patients. Turning to the CARVYKTI oral presentations, based on the CARTITUDE-4 subgroup analysis, 80% of patients with standard risk cytogenetics were progression-free and off treatment at 2.5 years. In patients with standard risk disease who achieved MRD negative CR at one year, this rate increased to 100%. The low rate of progression events in CARVYKTI treated patients with standard risk cytogenetics shows the profound benefit of a single infusion in this population. In the second oral presentation on CARVYKTI, based on correlated biomarker data, longer PFS is associated with better immune fitness at baseline and stronger immune responses post-CARVYKTI infusion, as observed in peripheral blood and within the tumor microenvironment of patients with relapsed/refractory multiple myeloma in CARTITUDE-1 and CARTITUDE-4 studies.

The peripheral immune fitness was more pronounced in patients with one and prior lines of therapy versus three prior lines of therapy and beyond, where deterioration plateaued. Similarly, on this topic, on the next slide featuring data we presented at ASCO, you can see that while CARVYKTI has a favorable benefit risk profile across all different subgroups and lines of therapy, its PFS improvement diminishes with each line of therapy, which is why it's important to follow the latest International Myeloma Working Group guidelines on obtaining CAR-T therapy as early as first relapse. This slide also contextualizes the significance of our efficacy data from CARTITUDE-1, where there were 6.5 prior lines of therapy, and CARVYKTI still demonstrates a median PFS of 35 months.

As we approach 10,000 annualized dose manufacturing capacity, we continue to extend our leadership in cell therapy through further advancing the field of CAR-T in multiple myeloma. We recently initiated another study called CARTITUDE-10, which is a phase 2 multicohort trial to further characterize the efficacy and safety of CARVYKTI, which speaks to our commitment to investigating new protocols. Furthermore, a recent Blood paper on effective bridging strategies across 20 centers found that among the 119 patients who proceeded to CAR-T therapy after receiving Tecvayli, including 98 patients receiving CARVYKTI, not only were these deep responses, sustained soluble B cell maturation antigen decline, and consistent CAR-T expansion, there were also no cases of peripheral neuropathy, Parkinsonism, or colitis reported.

As we focus on educating the physician community on our overall survival benefit based on the extensive CARVYKTI data that's been generated, we're also taking the opportunity to remind physicians about the latest research on bridging therapy and ALC monitoring, as well as the most recent IMWG guidelines on CAR-T. In a few moments, you'll hear from Alan on how we and our partner, Johnson & Johnson, are bringing CARVYKTI to more multiple myeloma patients in need. In light of the demand we continue to see across the U.S. and overseas, we are moving full steam ahead on our capacity expansion plans. On a final note on CARVYKTI, before we turn to our pipeline, we continue to expect to complete enrollment for CARTITUDE-5 and CARTITUDE-6 this year. We believe the CARTITUDE-5 and CARTITUDE-6 trials are key to moving CARVYKTI into the frontline setting.

Looking ahead at our long-term growth, in addition to looking forward, moving CARVYKTI into the frontline, we remain focused on solidifying our leadership in cell therapy more broadly. We are making progress in new indications such as solid tumor and NHL programs, as you have seen with the data at recent medical conferences. Additionally, we are looking forward to the ribbon-cutting ceremony tomorrow for our new research facility in Philadelphia, where in vivo delivery will be one of its key focuses, positioning us well to pursue this area of innovation. We remain excited about this new frontier of cell therapy. To sum up, Legend is the largest standalone cell therapy company with over 9,000 CARVYKTI patients treated as we forge the path to a cure.

With a cash position of nearly $1 billion, we are investing in our core differentiators in cell therapy and remain focused on delivering operational efficiency in order to ensure durable long-term growth. We continue to anticipate achieving profitability for CARVYKTI by the end of 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses. With that, I'll pass it over to Alan to provide an update on CARVYKTI.

Speaker 3

Thank you, Ying. CARVYKTI remains the undisputed leader of CAR-T sales in a single quarter, with net trade sales of $524 million during the third quarter. In addition to being the highest-selling CAR-T ever, CARVYKTI has also achieved a CAGR of 111% since launch, which is unmatched in this class. Despite these record-setting numbers, we continue to believe there is significant opportunity for further market penetration for CARVYKTI, given the magnitude of the addressable multiple myeloma market opportunity for CAR-T. While we are continuing to expand our footprint of authorized treatment centers in the US, the next frontiers of growth are also expected to come from expanding our presence in the community setting in the US and expanding our market leadership outside the US. Diving deeper into our performance this quarter, CARVYKTI net trade sales grew 84% year over year and 19% from the second quarter.

Our global growth was driven by continued share gains and site expansion. US net trade sales of $396 million grew 53% year over year and 11% quarter over quarter. Quarter over quarter growth in the US was primarily driven by continued strong demand, with 60% utilization in earlier line settings. Regarding our performance outside the US, we had sales of $128 million, which is nearly five times the amount over the same period a year ago and represents a 58% increase quarter over quarter. Our performance outside the US was driven not only by continued growth in Germany, but by strong launches in Spain and Belgium. In terms of supply tailwinds to further build upon our CAR-T market leadership in multiple myeloma, I would like to provide some incremental updates since the second quarter.

We are proud to announce that our manufacturing network growth and continued efficiencies mean that we are now able to fully supply the demand, and there is no longer a wait for patients. We expect both supply and demand will continue to expand together to help ensure a seamless customer experience. In the U.S., we are currently in the final stages of the expansion of the Raritan facility that will significantly expand capacity to support continued U.S. market growth. As it relates to supporting growth outside the U.S., I am pleased to announce that our TechLane facility recently initiated commercial production. This is an important milestone for serving patients in Europe to meet the increasing demand. Turning to demand drivers, first, of course, is the recent unprecedented long-term survival data that we presented at ASCO on CARTITUDE-1.

Second is our demonstrated overall survival benefit, which has now been added to the US label. We are focused on educating both treating and referring physicians in the academic and community settings on how CARVYKTI is the first and only multiple myeloma cell therapy via a single infusion to significantly extend overall survival versus standard therapies and on our long-term survival data. In the community setting, we continue to raise awareness, drive referrals, and educate oncologists and nursing staff on managing patients once they transition back to their offices. As Ying mentioned, we are also educating them on the IMWG guidelines and the importance of treating eligible patients as early as possible to take advantage of T cell fitness and potentially improve survival outcomes.

Lastly, in the U.S., the number of authorized treatment centers now stands at 132 sites across the U.S., with about one-third of our sites being community and regional hospitals, which serve an important need in the community setting. We are also pleased with the discussions we have had with many stakeholders about the need to bring CAR-T even closer to the community and with adoption by community networks or practices. Our early experience with Virginia Oncology Associates indicates that this is an area of large need and opportunity. Currently, we estimate that 80% of myeloma patients live within 50 mi of a CARVYKTI authorized treatment center. While that is strong coverage, we think we can do even better over the next one to two years. Outside the U.S., we will continue to benefit from the new launches.

With reference to new markets, we are proud to say that we have currently launched in 14 markets around the world. With the help of our partner, Johnson & Johnson, we have activated 246 treatment sites. We continue to be excited about bringing CARVYKTI to more eligible patients in Denmark, Sweden, Belgium, Luxembourg, Spain, Portugal, Saudi Arabia, and the private markets of Israel and the U.K. With the approval of commercial production at our TechLane facility, we are well on our way to being able to treat over 10,000 patients on an annualized basis around the world. Now it's time to take a closer look at the financials, so I'll turn the call over to Ying as we provide a warm welcome to Carlos.

Speaker 0

Thank you, Alan. As many of you already know, in August, we announced that Carlos Santos was joining Legend as our new Chief Financial Officer. I would like to extend my gratitude to Jessie Yeung for her outstanding leadership and significant contributions in guiding our finance organization prior to Carlos's arrival. Carlos joined Legend from AstraZeneca, where he held various positions over the last 10 years, including CFO for US Oncology, CFO of Latin America Business, and Acting Area VP of the Latin America Commercial Unit. His extensive experience in the biotech sector and wealth of financial leadership expertise will be invaluable as we continue to execute on our commercial and clinical plans and seek to attain company-wide profitability in 2026. We are pleased to welcome Carlos to our executive team.

Speaker 3

Thank you, Ying. Good morning, everyone. I am very excited to join Legend at this pivotal moment in its global development and growth. After my first three months here and visiting our TechLane facility, I can confidently say that there is a clear vision and path for Legend to be the global leader in cell therapy. I also see a strong path to profitability through our revenue growth and operational efficiency. First of all, CARVYKTI continues to grow at a strong rate, with net sales up 84% year over year in the third quarter. As Alan mentioned, we have a number of tailwinds that should continue to generate demand in the vast multiple myeloma market. I believe there is a significant opportunity for growth in the community setting, especially with our unique outpatient administration advantage, which provides physicians with flexibility.

As Ying has mentioned previously, both CARTITUDE-5 and CARTITUDE-6 approvals have the potential to significantly expand the opportunity for our already proven commercial therapy, CARVYKTI. In terms of Legend's operational efficiency, our operating expenses as a percentage of revenue have significantly improved over the last 12 months due to our focus on disciplined expense management and increasing automation throughout our organization. We continue to look at ways to further unlock efficiencies. Drilling deeper into our third quarter, we delivered solid financial results with CARVYKTI net sales up 84% year over year. Total revenues were $272 million, driven by collaboration revenue growth of 84% year over year. In Q3, we delivered a $40 million net loss, with $19 million on an adjusted net loss basis after excluding items that are not representative of the company's core business, such as $15 million in stock-based compensation.

Importantly, our operating loss of $17 million in the same period one year ago was reduced by 38% to a $43 million operating loss during the third quarter. This meaningful improvement in operating results was driven by our operational efficiency and disciplined expense management, even though we continue to invest in our robust pipeline and supporting the second line indication launch and our manufacturing capacity. Our third quarter gross margin on net product sales remained consistent at 57%. As expected, R&D expense on an IFRS basis grew slightly to $113 million, or 42% of revenue, while SG&A on an IFRS basis grew 10% from the prior year to $87 million in the third quarter, or 32% of revenue. Overall, we have made significant progress on operating cash flow generation, as evidenced by our $29 million in cash flow from operations this quarter.

We are continuing to make strides towards profitability. Our adjusted diluted earnings per share was a negative $0.05 compared to a negative $0.11 for the same period last year. Now, turning to capital allocation, we have maintained a strong balance sheet with approximately $1 billion in cash and equivalents and time deposits. We will continue to prioritize disciplined expense management as we fund our operating and capital expenditures, including future innovation, until we achieve company-wide profitability, excluding foreign exchange gains and losses, which we anticipate in 2026. In summary, our third quarter results demonstrate continued commercial execution supported by CARVYKTI's unique clinical outcomes, along with increased operational efficiency. We are also pleased with our progress towards pioneering next-generation cell therapy treatments as we leverage our unique innovation model to maximize our cell therapy platform. It is now time to take your questions.

Operator, we're ready for the first question, please.

Speaker 1

Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. The first question comes from Gena Wang with Barclays. Your line is now open.

Speaker 6

Thank you for taking my questions. Also, Carlos, congratulations on the new position. Since you closed the remarks, maybe I will ask you, I know 2026, we should start to see positive cash flow. And if, given the robust revenue that CARVYKTI could generate, you actually, in 2026, there could be very decent inflow cash. Maybe I wanted to ask you, with this increased cash in hand, what will be the best way to prioritize the cash in terms of pipeline assets? I have a very quick question regarding the ASH abstract. I do know both J&J and Legend actually withdrew a presentation of a comparison between Imaging One and CARVYKTI One. Maybe, Ying, if you can, or Alan, if you can give a little bit more insight regarding the rationale behind it.

Lastly, very quickly, regarding the Raritan site, I know you did say like a second half, there should be complete completion of expansion. Given we only have less than two months left, should we expect everything is on track? I know the last step would need to be signed off by the FDA. Should we expect that should happen before year end 2025?

Speaker 3

Okay. Thank you, Gena. This is Carlos. In terms of your inquiry about how we're going to allocate cash, given our profitability expected in 2026, I would say that first and foremost, we want to maximize our CARVYKTI franchise. This is our priority in terms of capital allocation. As you know, we've been making significant capital investments in manufacturing and expanding our network. At the same time, we will also continue to significantly invest in our CAR-T platform. We're going to be looking into every opportunity to accelerate our existing programs that would strengthen our market leadership in CAR-T, including business development.

Speaker 1

The next question.

Speaker 3

How should Gena? Yeah, let me answer the other two questions. In terms of Raritan, the plan is very much on track to be able to have the facility expansion completed. We have already started the submission process for that. Everything is on track for us to head into 2026 with the annualized doses for 10,000 doses. That is complemented by, of course, as you know, the news we announced around the commercial production in TechLane. Now we have all four nodes operating on a commercial basis. I did want to just address your question on the abstract. There was a poster from ASH that was withdrawn. Due to the limited data available for Anita Cell in the public domain at this point, the abstract was withdrawn in alignment with the authors. We are looking forward to future opportunities to share the data.

Speaker 1

Thank you. Our next question will come from Terrence Flynn with Morgan Stanley. Your line is open.

Speaker 5

Hi. Thanks for taking the questions. I just wondered, I know you provided us with the ATC numbers both in the U.S. and rest of the world now, but as you look into 2026, where do you think those can go realistically? On the manufacturing capacity, again, great to hear all the progress there. You mentioned the 10,000 unit number now. When you kind of complete all of these ongoing efforts, where should that number end up approximately? Thank you.

Speaker 3

Regarding the ATC that you mentioned, we're at 131. Actually, we have an update. We have 132 sites in the U.S. Combine that with the U.S., we're past the 250 mark for total number of sites. That's our recent update. We continue to update this every single day as we watch it. To your question about where it could go in 2026, we have our sights on continuing to expand, for example, making sure that we have full coverage in the 160-plus sites that some of the competition has. As you hear from competitors around their network, we're very confident that in 2026, by the time they are launched, we'll be able to have coverage in the same vein.

I will also add that as we look even ahead, the total number of sites in the U.S. that have either started to do CAR-T or have seriously expressed interest and have started the process is something in the 180 number of sites mark. We believe that we are well on track to be able to get there over time and then continue to expand further into the community setting. I will also address your question about the plans beyond 10,000. With all four nodes in the network, that being in the U.S., obviously Raritan, the expansion there, Novartis, which continues to ramp for us and deliver. Of course, in Europe, with the increasing demand in Europe, we have the TechLane facility now coming online with full commercial production and Oval-leth continuing to drive production as well and gaining efficiencies.

This is the network that we believe will enable us to get eventually to 20,000 doses annualized. That's through not only continued ramp in all four of the nodes, but also continued efficiencies, lowering the added stack, improving the manufacturing success rates.

Speaker 1

Thank you. Our next question will come from Eric Schmidt with Canner. Your line is now open.

Speaker 0

Thanks for the question. As you move from a supply-constrained environment to a demand-constrained environment, what do you think the most important things are that you need to do to mobilize demand to fulfill your new supply? How quickly do you think you can get to essentially near full utilization of the 10,000 doses? Thank you.

Speaker 3

Hi, this is Alan again. In terms of accelerating demand, we have a number of plans in place to be able to do that. First of all, it's all about making sure that physicians around the U.S. and around the world really fully appreciate the benefits of treating earlier. That's something that we have certainly gotten traction on, whether that's data that's coming out in the real world or some of the ASH posters that you see in presentations. There's a broader and greater appreciation for the fact that efficacy is better when you treat in the earlier lines. The safety, the incidence of neurologic events and other adverse events is lower when you have patients treated in the earlier lines. You have improved T-cell fitness, which is another aspect of the poster that's going to be at ASH.

As you see from the ASH posters, we also have data that clearly suggests that the abspect rates are lower. In a word, everything is better earlier. That is a key message that we will continue to drive not only with the current authorized treatment centers, but also the referrers in the community. Just to add one more point, we have a network, as we talked about, and a footprint today. Our community strategy is really based on not only continuing to leverage the one-third of sites that are in the community, the one-third of sites in our current network that are community and regional hospitals, but also driving referrals from the physician practices that are not in the network.

We're having conversations with some of the large practices, such as the one you saw from our announcement earlier in the year in VOA, to enable the community to actually start to administer CAR-T themselves.

Speaker 0

Any sense on when you get to full capacity?

Speaker 3

I think as we said today, our capacity is now meeting the demand in the marketplace. As we're going to be increasing capacity, we'll also be increasing the demand as well.

Speaker 0

I meant in terms of having almost 10,000 doses to dose in the near future. Do you think there's a timeline to utilize that capacity?

Speaker 3

I think we'll be able to achieve those goals in 2026. That translates into the consensus revenues that we see in 2026 that have been issued for 2026. We are very much on track for that.

Speaker 0

Thank you very much.

Speaker 1

Hey, Eric. This is Dean. Maybe I'll just tell you that from where I sit, the latest data suggests that we're really running at nearly 100% capacity utilization at all four nodes right now. We continue to expect that all four nodes will be utilized at very high capacity next year as well. Thank you.

Thank you. Our next question will come from Jessica Fye with JP Morgan. Your line is open.

Speaker 0

Hey, guys. Good morning. This is Tanmay on for Jess. I really have just one question here where I wanted to ask you if you guys could throw some color on anything that you'd be watching out for at ASH from a competitive standpoint.

Speaker 3

It might be the absence of information, sorry, it's Alan here. It might be the absence of information that is most relevant. We're fully ready and prepared to compete with a potential BCMA CAR-T that's coming out potentially next year. I will say that we haven't seen a Kaplan-Meier curve from Anita Cell yet. It's quite hard to know what that data is going to look like. I will say that we're going to continue to be raising the bar on efficacy. We have a significant advantage in terms of the efficacy that we've seen in the CARTITUDE-4 population, in the subgroups, in the earlier lines in CARTITUDE-4. Over the next year, we're going to be also demonstrating the fact that just as we did in CARTITUDE-1, that CARTITUDE-4 has the long-term durability that physicians and patients are asking for.

We're very comfortable with the data that we're going to be presenting in terms of efficacy. It's really just a question of when we might see that data from competition.

Speaker 1

Yeah. This is what we on the pipeline side, we are also going to release early clinical data for our internal Gamma Delta platform. This is a product with unique design and unique CMC process. We see a highly manageable safety profile and good expansion in oncology patients. The preliminary efficacy should encourage new response rate and also, importantly, sustain the durability.

Speaker 0

Thank you.

Speaker 1

Thank you. Our next question will come from Jonathan Miller with Evercore. Your line is open.

Speaker 0

Thanks for taking my question, guys. Congrats on all the progress. I'd love to dial in more on the community progress that you've made. Specifically, in the VOA network, have you been treating patients there already? How has that update been going in that patient network? Do you have plans to expand beyond the Virginia network near term? When you say that one-third of your sites are regional or community centers, I mean, I assume most of that is regional centers. Can you talk a little bit more about adoption expectations in the community specifically as we head into 2026?

Speaker 3

Sure. Yeah. Let me unpack that a little bit. We think about the community strategy on a number of paradigms. The first is the fact that we have in our current network, as you mentioned, sites that are already community and regional hospitals. It is a mix because sometimes a large regional hospital will be servicing a community. That is what we mean by that group. It is about a third of the 130 or so sites that we currently have. We see that that segment of our network is already contributing about half the growth that we see. It is a very healthy, robust part of our network. It is going to continue to grow. It is going to continue to serve the community at large. The second part of the strategy is around engaging community physicians who are referrers.

We have been doing that over the last many months with our partner, Johnson & Johnson. We have sales teams and medical teams who are engaging fully with the referring network. We are building a lot of good information there for them. We are communicating on the profile. We are communicating on the fact that referring earlier is better. We are gaining traction there as well. The third leg of the journey, if you will, is then going to the community networks. You mentioned VOA. Just to answer your question, yes, we have started to treat patients at VOA. The feedback has been positive so far. We are also learning a number of things about just how these community networks will need to be supported throughout their experience of coming online.

There is definitely a plan to engage not only with VOA and continue to grow that network, but also to engage with other practices throughout the next several months and into 2026.

Speaker 0

When you think about the community-specific practices here, I mean, I guess I'm asking about your ability to dose in settings where your potential competitors absolutely would not be able to dose, at least not first, not just referring to academic centers, but folks getting treated in the community where competitors don't have reach. Can you talk about how that'll evolve in 2026?

Speaker 3

I think we're laying the groundwork for having all of that presence in the community. Also, to your point, we have about half of our current patients are treated in the outpatient setting. By virtue of the fact that we have a median onset of the CRS in the clinical studies at seven days, that means that increasingly practices are comfortable with making sure that physicians can dose patients in the outpatient setting. They can be monitored. If they need to be readmitted for one reason or the other, they're able to do that afterwards. In addition, as we've discussed before, the removal of the REMS is also an important tailwind because it's enabling patients to have only two weeks of local modeling before they're able to go back home.

It also removes the driving restriction of eight weeks, and that's now down to two weeks. That's another important factor for patients being able to get dosed, get infused, and then be able to be monitored more close to home and get back with their lives.

Speaker 1

Thank you. The next question will come from Yaron Werber with TD Cowen. Your line is open.

Speaker 6

Hi. This is Jana on for Yaron. Congrats on an amazing quarter. I have a question on the ASH abstracts. I think there were two abstracts from Mayo and Moffitt suggesting that prophylactic DEX doesn't seem to reduce the risk of delayed neurotox with CARVYKTI. Given those results, how are you thinking about adjusting your strategy for mitigating delayed neurotox? Are you considering any alternative regimens or thinking about amending any phase three protocols? Thanks so much.

Speaker 1

Hi. Good morning, Jana. This is Dean. Alan answered this question. Obviously, if you look at both presentations, you see that ALC remains a very predictive marker. However, the dexamethasone prophylaxis may not be sufficient. In fact, recently, you have seen publications from real-world studies, including the Blood paper that was published in August, right? We think that the most important factor is you need to treat those patients with high tumor burden with effective bridging regimen. You will see actually quite a few abstracts coming out in the ASH next month that various centers are using different recipes or different regimens. Again, all the commonality suggests that you have to use an effective bridging therapy. In fact, one of the PIs from Mayo, right, Dr.

Lim, recently said at IMS that you have to switch to a different effective regimen if the first one does not work. The critical factor here is we have to bring the tumor burden down. Once you do that, you will not see adverse events such as neurotox, colitis, or CRS. That is actually a trend we're seeing. Like I said, you will see more real-world data and also more presentations at ASH about this.

Speaker 6

Thanks so much.

Speaker 1

The next question will come from James Shin with DB. Your line is open.

Speaker 5

Hey, good morning, guys. Thank you for the question. Got a couple on the CAR-T2/10. I see fludarabine is being removed, but is there any change to cyclophosphamide dosing? I guess, assuming this looks, I guess, to Legend standards, will this be somehow added to the label or formally, I guess, approved by the FDA and can be adopted broadly? Thank you.

Speaker 1

Hey, good morning, James. This is Ying. You're right. We and our partner, Johnson & Johnson, recently initiated a phase two study called CAR-T2/10. The first cohort would evaluate the fludarabine-free regimen for lymphodepletion. The reason being that we know fludarabine has been established as a neurotox factor here. We'd like to see whether we can actually achieve a similar level of lymphodepletion without using fludarabine. That is already up and running. We're enrolling and dosing patients now. On your second question, we have to generate the data first. Of course, if the data is positive, we would potentially take that to the FDA to see if that could be included in the label. Right now, it's premature to say anything about the label inclusion.

Speaker 5

Can I ask one more on the primary being MRD? Was that any insight from the FDA? Do you have any insight on MRD becoming formally a surrogate? Thank you.

Speaker 1

Yeah. James, regarding MRD as a potential registration endpoint, we're continuing our discussion with the FDA. Also, we'd like to see under which setting, in which line, potentially can MRD inactivity be an endpoint. You have to stay tuned. When we have more to say, we'll disclose about that. Thank you.

Speaker 5

Thank you.

Speaker 1

Thank you. The next question is going to come from Justin Zeland with BTIG. Your line is open.

Speaker 0

Thanks for taking our questions. I was curious if you could give us an update on outpatient administration. What percentage of the patients are you seeing dose in the outpatient setting? Any update on the contribution of revenue from earlier lines versus later lines?

Speaker 3

Yeah. I think I mentioned this earlier. Outpatient, based on claims data, is about 50% of the patients currently. We continue to expect that will be growing over time. Although, as we onboard new sites, sometimes they tend to start with patients in the inpatient. The growth of the site network is also a little bit of a drag on the outpatient overall mix. Those sites that have converted into outpatient are doing so with good success. It is enabling additional capacity at each site and efficiency. To answer your second question, we see about 60% of our overall scripts coming from the second through fourth line population. That does continue to grow, albeit a little bit more slowly than we had anticipated. We see that evolution continue. In fact, the fastest growing part of that mix is in the third line.

What that tells us is that increasingly, there is adoption, there is acceptance, and there is enthusiasm for bringing CAR-T and CARVYKTI specifically into the earlier line setting based on the CARTITUDE-4 data.

Speaker 0

Thanks for taking our questions.

Speaker 1

Thank you. The next question will come from Mitchell Kapoor with HC Wainwright. Your line is open.

Speaker 6

Good morning. This is Katie on for Mitchell. Regarding your guidance for profitability by 2026, what milestones and roadblocks are kind of underpinning that? What should we be keeping an eye on to understand if you're on track to hit that goal?

Speaker 4

Yeah. Thank you, Katie. Our view on profitability has not changed. We actually expect to have profitability for CARVYKTI this year in 2025 and enterprise-wide or for Legend as a company in 2026. This is underpinned by our significant growth trajectory for CARVYKTI and our management of operating expenses resulting in positive free cash flow in the year of 2026. Again, as we've mentioned, we have significant tailwinds in our revenue growth. This should serve us well for profitability next year.

Speaker 1

Thank you. The next question will come from Ashwani Verma with UBS. Your line is open.

Speaker 2

Hi. Thanks for taking our questions as well. Just maybe I'm trying to understand the dynamic between the second to fourth line that you commented on. Third line, you said is the most prominent. Can you give us a sense of how much is that? Just secondly, on the logistic three data, the top line is available now, but just curious how that can start to impact the second line opportunity for you in any way. Thanks.

Speaker 3

Yeah. We would not break down, we are not going to break down the split between how much is coming from each line. I think it is important that all of the lines of therapy on an absolute basis are growing. We are getting more and more patients in the second line, more and more patients in third, etc., etc. We also happen to be getting more patients in the later lines. That is just by virtue of the demand for CARVYKTI across all lines. That is why the mix continues to be about a 60/40 split between the earlier lines of CAR-T2/4 and the CAR-T2/1 populations. Again, where the growth we are seeing most pronounced is in the third line. That is because, again, physicians are recognizing that they want to try to get patients into CARVYKTI treatment as quickly as possible post first relapse or perhaps second relapse.

Speaker 1

Thank you.

Speaker 0

Ash, I do want to answer your question about Majesty III. First of all, we're really pleased that there could be potentially another regimen for patients in second line with multiple myeloma. Secondly, I want to point out that the commercial opportunity for this addressable market is very large. You're looking at about 80,000-100,000 patients in that segment. Thirdly, I think we're targeting potentially different segments here, right? Because if you look at CARVYKTI, we want to emphasize that CARVYKTI has unmatched, unprecedented survival data and also with durability. It's also a one-time treatment. There are certain patient populations who really prefer that kind of a convenience, brought by a one-time infusion without further need for any other medication for myeloma. That is how I view this market.

We do not really expect the MAJESTY-3 data will really impact the uptake for CARVYKTI in second line.

Speaker 1

Thank you. Our next question comes from Clara Dong with Jefferies. Your line is open.

Speaker 6

Hi. Good morning. Thanks for taking our questions. This is Jana on for Clara. Could you give us some comments on your strong international growth? Maybe elaborate on where are you seeing the strongest demand and uptake now versus where do you see higher growth potential after TechLane comes on? Going into 2026 and beyond, how do you foresee the TechLane capacity impact EU market share? Thank you so much.

Speaker 3

Yeah. Outside of the U.S., which is obviously led by our partner, J&J, there's been strong uptake in Germany, Spain, and Belgium in particular, as well as the other markets that have launched. Many of the European markets really see the value here of a one-time infusion. The durability that you get with the PFS and OS benefits is truly providing a strong value not only to patients but also to the health system. There is a lot of support for using CARVYKTI earlier in the treatment paradigm. That is encouraging. We continue to advance the launches that we've already had in the 14 markets around the world, which we listed in the presentation.

We're very excited to have TechLane now online from a commercial standpoint to enable the supply. Both between TechLane and Ovalt together will be able to meet the capacity demands for the growing European launches.

Speaker 6

Thank you.

Speaker 1

Thank you. Our next question will come from Sean McCutcheon with Raymond James. Your line is open.

Speaker 0

Hi, guys. A couple of quick ones from us. Thanks for the question. You noted improving out-of-spec rates. Can you speak to the trend as you see more real-world patients in the earlier line setting and ongoing efforts to push that out-of-spec rate lower? Any commentary on what you think is a feasible kind of minimum steady state there? Secondarily, can you speak to any early impact of loosening of the REMS requirements for auto CAR-T and whether you're seeing an uptake in referrals for earlier line patients? Thanks.

Speaker 3

Yeah. There is an abstract at ASH that's reviewing about 3,000 patient records for out-of-spec. The out-of-spec rate is somewhere in the 6-9% according to that abstract. In fact, it's lower in the earlier line. It is very consistent with what we're hearing around earlier is better. It is very consistent with the fact that the T cell fitness is stronger in the earlier patients. That is enabling better dose and better viability and lower out-of-spec. We will continue to drive that down over time across all the nodes in the network. We believe that is going to be very competitive with other products on the market. In terms of the REMS, it's a little bit early. We're hearing sort of a mix of reactions from sites.

One is that this is great news for patients and that it is enabling patients to get back home more quickly. Other sites are taking a little bit more of a wait-and-see approach and saying they're going to decide on a patient-by-patient basis which patients are able to go back and which patients they want to keep more close to home. It's going to be a consultation. The bottom line is it's a burden lifted. It's one that is enabling a more robust conversation about the fact that we can extend the benefit and the efficacy we see with CARVYKTI to more and more patients.

Speaker 1

Thank you. I show no further questions at this time. I would now like to turn the call back over to Ying for closing remarks.

Thanks, everyone, for joining today's call. As you can see, we had a really strong quarter. We continue to expect another strong quarter in the fourth quarter, as well as a very strong year in the next year in 2026. I just want to say that we look forward to seeing everyone here at ASH because we and J&J are very confident about the efficacy of CARVYKTI. In fact, we will publish data in our presentation of some data that's not included in the ASH abstract. We strongly believe that the data at ASH will raise the bar even further for efficacy. We look forward to seeing everyone in Orlando. Thank you.

Thank you. That does conclude today's conference call. Thank you for participating. You may now disconnect.