Q3 2025 Legend Biotech Corp Earnings Call

November 12, 2025

Speaker #1: Ladies gentlemen , by . thank you Welcome to and standing Call . only time , all participants are in listen . After the a there will be At this and quarter a ask a question presentation , question press session , you would session .

Speaker #1: one on your one need to telephone . You will speaker's an mode automated message then hear advising your star raised . To one one Please again .

Speaker #1: Being Jessie Yeung now to conference over to withdraw your Young, Vice President of Finance. Turn the investor, please. Go ahead.

Speaker #2: morning . . . Thank you for Jessie Good conference call finance at joining our review of and president of this call , we Prior to issued a release investor Legend Biotech press our our third results for

Speaker #2: is Young

Speaker #2: . You can find release the press on website at quarter quarter financial are Relations and IR Joining me company's the Carlos Officer company's chief of .

Speaker #2: we will ahead financial today's call call for have our chief on . Alan Bash . The joining the R&D Executive remarks , Legend Biotech .

Speaker #2: we will ahead financial today's call call for have our chief on . Alan Bash . The joining the R&D Executive remarks , Legend Biotech . .

Speaker #2: subject to actual of our addition , statements or investor results to in a metric addition month , Financial read and are to IFRS and detail financial to to the .

Speaker #3: year momentarily . of which in 9000 patients net that I Carvykti and sales over

Speaker #3: changing efficacy in is that We're to Cartitude of the time we . nature fact , from now recent individuals had one third of the of myeloma detectable .

Speaker #3: potential widely thought of and a using outcome no cure article for efficacy heavily unprecedented in the pretreated . multiple field of . On a after treated This regulatory is the the myeloma prerequisite to term patients an consider update to .

Speaker #3: In this further update, the FDA has indicated that, as of the recent survival benefit label on Carvykti, there is a significant improvement in survival for patients with myeloma compared to standard therapy, based on a four-study comparison.

Speaker #3: After 1 to 3 prior phase three trials, Importantly, lines of multiple myeloma multiple. Carvykti is statistically standard in patients with its benefit in overall survival. Car-T demonstrated therapy, the educating of profile Carvykti more second line care need physician across the United States. We work to demonstrate the benefit of Carvykti towards improving patient outcomes.

Speaker #3: After 1 to 3 prior phase three Importantly , lines of multiple myeloma multiple . Carvykti is statistically standard in patients with its benefit in overall with a Car-T demonstrated therapy the the educating of profile Carvykti more second line care need physician across the United survival as we patients label Carvykti is towards work to . runs these and We experience to States updates such as Updates and access in academic bring and fact , I will .

Speaker #3: survival was clearly important for attribute patients selecting a and are pleased that survival , we presentations on . at value Also the this Ash upcoming two oral .

Speaker #3: relapsed pleased that may have preliminary seen in the response rate and As you sustained durability in efficacy patients Turning to the oral encouraging presentations .

Speaker #3: analysis standard 80% of patients with risk cytogenetics free , at were 2.5 years in treatment patients with standard disease achieved at one year .

Speaker #3: CR This and off rate MRD increased The to 100% . low rate who in events Carvykti patients progression with standard treated negative of risk risk profound the a .

Speaker #3: infusion of population In . Cytogenetics presentation on Carvykti , on the based data , longer PFS biomarker associated with is better at fitness immune baseline and stronger immune responses .

Speaker #3: Post As infusion . observed in tumor with relapsed microenvironment of peripheral refractory patients myeloma multiple cartoon won and cartoon for studies , the was more immune patients fitness pronounced in peripheral one and prior , versus therapy three prior lines of therapy and lines of beyond , deterioration plateaued where .

Speaker #3: Similarly , on this topic , on the next slide featuring data , we at can see that presented while Carvykti has a favorable benefit Asco , you risk all across different subgroups and lines therapy , its PFS of diminishes with improvement each line of which is why it's important to follow the latest international Myeloma Working Group on guidelines obtaining Car-T therapy .

Speaker #3: early As as first relapse . This slide also contextualizes the of our data from efficacy where there significance were and 6.5 million prior lines of carvykti Car-T one , still demonstrated a median PFS of 35 months .

Speaker #3: approach dose manufacturing we capacity , continue to our in cell therapy through leadership extend further multiple field of advancing the 10,000 annualized myeloma .

Speaker #3: initiated called study another is a Kaatsu which phase two multi-cohort trial ten , further characterize the efficacy and safety of which We our speaks to new investigating protocols Carvykti , .

Speaker #3: a paper on recent bridging strategies across effective 20 centers among found the 119 patients who Car-T therapy proceeded to that receiving Talvey , after receiving Carvykti only were these 98 patients , not deep responses soluble B-cell maturation sustained antigen and decline , Car-T expansion , they were no also cases of peripheral , parkinsonism , or including neuropathy colitis reported .

Speaker #3: focus educating the physician on community our As we overall survival benefit based on the Carvykti on data been generated , extensive we're also taking the opportunity to remind physicians latest research on that's therapy monitoring , as and well as the bridging recent ALK Car-T on guidelines .

Speaker #3: In a few moments, you will hear from Allen on how we and our Johnson partner are bringing Carvykti to more patients in need of multiple myeloma treatment.

Speaker #3: light of the In demand , continue we to see across the US and are moving full overseas . our We capacity expansion . On note , a final Carvykti , before we on our turn to continue to pipeline , we expect to complete enrollment for Cardiff five year plans .

Speaker #3: six this We believe the Cardiff five six trials key to are moving and Carvykti into frontline , setting . at our long ahead term growth , in addition to looking Looking forward moving carvykti into the frontline , we remain focused on solidifying our therapy .

Speaker #3: We are progress in making indications such new tumor as NHL programs . have seen with the As you at recent medical data . Additionally , we are looking solid forward to the cutting ceremony ribbon for our new research tomorrow in facility , where in vivo delivery will Philadelphia conferences focuses be one of its key well us , positioning pursue this to area of .

Speaker #3: We innovation excited remain this new about frontier of cell therapy . To up sum , legend is the largest standalone cell therapy company with 9000 carvykti over patients as we forged treated path to the cure cash position of with the nearly $1 billion .

Speaker #3: We are investing in our core in cell differentiators therapy and remain focused on operational efficiency in order to delivering ensure durable , long term growth .

Speaker #3: We continue to anticipate achieving profitability for Carvykti by the end 2025 , and of wide company profitability in 2026 . Excluding foreign unrealized exchange losses gains or that , I'll pass it over to Alan to provide an update on Carvykti . .

Speaker #4: Thank you . Ying . Carvykti remains the undisputed leader of Car-T cells single in a with net trade sales $524 million of third quarter .

Speaker #4: to being the addition highest In Car-T ever , Carvykti also achieved has a kegger selling of 111% since launch , which unmatched in this is class .

Speaker #4: Despite these setting numbers , we record to believe there is quarter significant opportunity for further market penetration for Carvykti , given the magnitude of the addressable myeloma multiple market , for Car-T opportunity .

Speaker #4: While we are to expand our footprint of continuing authorized treatment centers in the US , the next frontiers of growth are also expected to from expanding our presence in in the community US setting the and expanding our market outside US .

Speaker #4: Deeper diving this quarter, the company leadership into our sales performance: Carvykti netted 84% year over year, 19% from the second quarter.

Speaker #4: Our global driven by continued share expansion . US net gains and site sales of growth was grew $396 million and 11% quarter over over 53% year quarter quarter .

Speaker #4: Over quarter growth in the US was driven primarily by continued strong demand , with in 60% utilization line settings earlier . Regarding our performance outside the US , had sales we $128 million , of which is five nearly the same period a year times the ago .

Speaker #4: And represents 58% increase quarter over quarter a . Our performance outside the was driven US by not only growth in Germany , but by strong launches Spain in and continued Belgium .

Speaker #4: In supply terms of tailwinds to further upon our build market leadership in multiple would like to provide incremental myeloma , I updates . Since the second quarter .

Speaker #4: 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.

Speaker #4: We expect both supply and demand will continue to expand to help ensure a customer seamless experience US . are final We stages of the expansion of the in the Raritan will currently in the facility that significantly expand capacity to support continued US market growth .

Speaker #4: As to it relates supporting growth outside the US , am I pleased to announce that our tech lane facility recently initiated commercial production .

Speaker #4: This is an important for serving patients in milestone 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 Cartitude one .

Speaker #4: Second is our demonstrated overall survival which has now benefit , added to the US label . We are focused on educating both treating and referring physicians in the academic and settings on how been is the first and only myeloma multiple cell therapy a single infusion significantly extend overall survival versus standard via therapies on .

Speaker #4: our long term And data survival in the community setting , we continue to raise awareness , drive referrals educate oncologists and , and patients transition back to once they staff on offices .

Speaker #4: And as mentioned , we also are educating them Imwg on the guidelines and the importance of treating patients eligible as managing possible to take advantage of T cell fitness and potentially improved survival outcomes .

Speaker #4: Lastly , in the US , authorized centers now number of treatment the at 131 sites across the US , with about one third of our sites community and regional hospitals , which serve an important need in the community setting .

Speaker #4: also We are pleased with the we have discussions had with many stakeholders about the need to Car-T closer to the bring even community , and networks community or adoption practices .

Speaker #4: Our early experience with Oncology with Virginia Associates indicates that by this is an area of large need and opportunity . Currently , we estimate that 80% of myeloma patients live within 50 miles of a carvykti treatment authorized center .

Speaker #4: While that is strong coverage , we can do even better over the next 1 to 2 years . And US , we will continue to from the benefit launches outside .

Speaker #4: And with new markets, we are proud to say that we have currently launched 14 markets around the world with the help of our partner, Johnson & Johnson.

Speaker #4: We have world activated 246 treatment sites . We continue to be excited about Carvykti to more bringing eligible patients in Denmark , Sweden , Luxembourg , Spain , Portugal , Belgium , Saudi Arabia and the private markets of Israel and the .

Speaker #4: With the approval of commercial production at our tech lane facility . are We well on our way to being able to treat over 10,000 patients on an annualized basis around the world .

Speaker #4: Now it's take a time to at the financials closer look turn the call over to Ying UK provide a warm welcome to Carlos .

Speaker #3: Thank you . Alan . you As many of know , in already August we announced that Carlos Santos was joining legend as our new chief financial officer .

Speaker #3: I would like to extend my gratitude to Jessie Yeung for her outstanding leadership and significant contributions in guiding our Prior to organization . Carlos arrival finance , Carlos joins legend from AstraZeneca , he held various positions over the last where ten years , including CFO for us oncology , CFO of Latin America and Acting Area Business VP of the Latin America Commercial .

Speaker #3: Unit His extensive experience in the biotech sector and wealth financial leadership of expertise will be invaluable as continue to we execute on our commercial and clinical plans and seek to attain wide profitability in 2026 .

Speaker #3: We are pleased to welcome Carlos to company our executive team .

Speaker #5: Thank you . Ying , and good morning , everyone . I am very excited to join legend at this pivotal moment in its global development and growth .

Speaker #5: After my first three months here visiting our tech and Lane facility , I can confidently say that there is a clear vision and for path legend to be the global leader in cell therapy I .

Speaker #5: also see a strong path to profitability through our revenue growth and operational . First of all , Carvykti continues to grow at a efficiency with net rate up sales 84% year over year .

Speaker #5: third quarter . And as In the Alan mentioned , strong we have a number of tailwinds that should continue to generate demand in the vast multiple myeloma market .

Speaker #5: I believe there is a significant for growth in the community setting , especially opportunity with our outpatient unique administration advantage , which provides physicians with flexibility .

Speaker #5: has mentioned As Ying previously , both five and Q2 Cartitude two six approvals potential to significantly expand the have the opportunity for our already proven commercial therapy Carvykti .

Speaker #5: In terms of operational efficiency, our operating expenses as a percentage of revenue have significantly decreased over the last 12 months due to our focus on disciplined expense management and increasing automation throughout our organization.

Speaker #5: And continue to look for improved ways to unlock efficiencies over the coming months. Drilling deeper into our third quarter, we delivered solid financial results with Carvykti net sales at year-end.

Speaker #5: And continue to look improved ways to further months we unlock efficiencies , drilling deeper into our third quarter , delivered we solid financial with Carvykti net sales results at 84% year over Total revenues were $272 million , driven by collaboration revenue growth of 84% year over year in We Q3 .

Speaker #5: a $40 million net loss , but was delivered $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 .

Speaker #5: Importantly , our operating loss of $70 million in the same period one year ago was reduced by 38% to a $43 million operating loss during the third quarter .

Speaker #5: This meaningful improvement in operating results was driven by our operational efficiency and disciplined expense management . Even though we invest in our robust pipeline and supporting the second line indication .

Now behind it. And lastly very quickly regarding the Remington site. Uh, I know uh, you did see like a second half you know, that should be complete completion of the expansion and uh giving we only have a less than 2 months left, uh should we expect, you know, everything is on track. You know, is the, I know the last step will need to be signed off by the FDA and should we expect that should happen? Uh, before year end 25?

Okay. Thank you, Gina. This is Carlos. In terms of your inquiry about...

How we are going to allocate cash. Given our, uh, profitability expected in 2026? I would say that first and foremost, we want to maximize our corrective franchise. So this is our priority in terms of capital allocation. Um, and as you know, we've been making significant Capital investments in manufacturing and expanding our Network.

Um at the same time we will also continue to significantly invest in our cartt platform. We're going to be looking into every opportunity to accelerate our existing programs that will strengthen our Market leadership and carti including Business Development.

and the next,

Yeah, let me answer, uh, the other 2 questions. Um, in terms of Raritan, uh, the plan is very much on track to be able to have the uh uh facility expansion completed, and we've already started the submission process for that. So everything is on track for us to head into 2026 with the annualized, uh, doses for 10,00 doses. Um, and that uh, is complemented by, of course, as you know, the news we announced around the commercial production in Tech Lane. So now we have all 4 nodes operating on a commercial basis.

Um, I did want to just address your question on the, on the abstract. Um, so, uh, there was a poster, um, from Ash that was withdrawn, uh, and 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 and we are looking forward to Future opportunities, to share the data.

Thank you. And our next question will come from Karen's Flynn with Morgan Stanley. Your line is open

Hi, thanks for taking the questions. Um, I just wondered I know you provided us with the, the ATC numbers, um, both in the US and, and rest of world now. But as you look into 2026, um, where do you think those can go, um, realistically and then, um, on the manufacturing capacity, again, great to hear all the progress there you mentioned that the 10,000 um, uh unit number. Now, again, when you kind of complete all these ongoing efforts where, where should that number end up approximately, thank you.

A recent update, we continue to update this every single day as we watch it. And to your question about where it could go in, 26 we have our sights on continue to expand, for example, making sure that we have full coverage in the 160 plus sites that some of the competition has. So as you hear from competitors around their Network, we're very confident that in 2026. By the time they are launched. That will 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 US that have either started to do carti, or have seriously, expressed interest and have started. The process is something in the 180, uh, number of sites Mark, and we believe that we are well on track to be able to get there over time, um, and then continue to expand further into the community setting. Um, I will also address your question about the, uh, the the plans Beyond 10,000. So with all 4 notes,

In the network, uh, that being in the US, obviously, Raritan the expansion there, a Novartis which continues to ramp for us and deliver, uh, in and, of course, in Europe with the increasing demand in Europe, we have the tech Lane facility. Now, coming online, uh, with full commercial production and overall less continuing to drive production as well. And and getting efficiencies, this is the network that we believe will enable us to get eventually to 20,000 doses uh annualized. And that's

Through not only continuing continued ramp in all 4 of the nodes, but also continue to efficiencies lowering the out of Step. Improving the manufacturing success rates.

Thank you. And our next question will come from Eric Schmidt with caner. Your line is now open.

Thanks for the question. Um, if you move from a supply constraint environment to a demand constraint environment, what do you think the most important things are that you need to do to, to mobilize demand to fulfill, uh, your, your new Supply and how quickly do you think you can get to, you know, essentially um, your full utilization of the 10,000 doses. Thank you.

Oh, hi. This is Alan again. So, in terms of accelerating demand, uh, we have a number of plans in place to be able to do that. First of all, it's all about making sure that, uh, Physicians around, uh, the US and around the world really fully appreciate the benefits of treating earlier. And that's something that we have, uh, certainly gotten traction on, uh, whether that's data that's coming out in the real world, or some of the apps posters that you see in presentations, uh, there's a broader and greater appreciation for the fact that efficacy is better when you treat ear. An earlier lines, the safety, the the the incidence of neurologic events and other Adverse Events is lower, when you have patience, um, treated in the earlier lines, you have improved T Cell Fitness, which is another aspect of a poster,

That's going to be at ask. And as as you see, from the as posture as we also have data. That clearly suggests that the ad spec rates are lower. So in a word, everything is better earlier, and that's a key message that we'll continue to drive, not only with, uh, the, the current, uh, authorized treatment centers but also the refers in the community, uh, just to add 1 more Point. Um, we have a network as we talked about and a footprint today, but, uh, our community strategy is really based on not only continuing to Leverage The 1-3 of sites that are in the community. The 1, the 1 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. Uh and then ultimately we're having conversations with some of the large practices uh such as the 1 you saw from our announcement earlier in the year in VA to enable the community to actually start to administer a carti themselves.

and any sense on when you can get to full capacity,

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

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

Well, I think we'll be able to achieve those goals in 2026, and you know, that translates into the consensus revenues that we see for 2026 or that have been issued for 2026. So, we're very much on track for that.

Thank you very much.

At all 4 notes right now so we continue to expect that. The offer notes will be utilized at very high capacity next year as well. Thank you.

Thank you. And our next question will come from Jessica fee with JP Morgan. Your line is open.

Hey guys, uh good morning. This is uh thumbnail for jazz. Uh I really have just 1 question here. Uh I wanted to I wanted to ask you if you guys could throw some color on anything that would be um watching out for apps from a competitive standpoint.

Well, I think the app is of information. Uh, sorry it's Alan. Here, it might be the absence of information that is most relevant, you know? Um, we're we're fully ready and prepared to, um, to compete with a potential, uh, bcefa carte that's coming out, uh, potentially next year. But I will say that we haven't seen a Kaplan Meier curve um, from Anita cell yet. So it it's quite hard to know, um, what that data is going to look like. But I will say that we're going to continue to be raising the bar on efficacy. Uh, we have a significant advantage in terms of the efficacy that we've seen, uh, in the cartoon for population in the subgroups, uh, in the earlier lines in Cart 4, uh, and over the next year, we're going to be also demonstrating the fact that just as we did in cartee, uh, Karthik 1

That um carter food 4 has the long-term durability that Physicians and patients are asking for. So um we're very comfortable with the data that we're going to be presenting in terms of uh efficacy. And it's really just a question of when we might see that data from competition,

yeah, and

well, we, um

I release uh, early clinical data for our internal gamma data platform. And this is um, uh, product with unique design and unique CMC process. We see, uh, uh, how the manageable safety profile and the good expansion, um, in oncology patients. So the preliminary efficacy issue in currently response rate. And also importantly, uh, sustained, uh durability.

Thank you.

Thank you. And our next question will come from John Miller with ever core. Your line is open.

Uh, thanks for taking my question, guys. Congrats on all the progress. I, I, I'd love to dial in more on the community progress that you've made, um, specifically in the VA Network. Have you been treating patients there already? How is it update been going in that in that patient Network, do you have plans to expand beyond the Virginia network, uh, near-term? Uh, and when you say that 1/3 of your sites are Regional or community centers. I mean, I assume most of that is regional

Sanders, can you talk a little bit more about adoption expectations in the community, specifically as we head into 2026?

Sure, yeah, so so let me unpack that a little bit. Um, we think about the community strategy on a number of uh Paradigm. The first is the fact that we have in our current Network. As you mentioned, uh, sites that are already community and Regional hospitals and and it's a, it's a mix because sometimes a large, Regional Hospital will be servicing a community. And and that's that's what we mean by that group. It's about a third of the 130 or so space that we currently have. And we see that that segment of our network is already contributing about half the growth that we see. So it's a very healthy robust part of our Network. It's going to continue to grow and it's going to continue to serve the community at large. The second uh part of the strategy is around engaging community physicians who are referred and we've been doing that over the last many months with our partner J&J. We have a sales teams and medical teams who are engaging fully with uh the referring network. Uh we're building

this is, uh, throughout the the, the next several months and into 2026,

And, and 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. 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 will evolve in 26?

Well, you know, I I think we're laying the groundwork for, you know, having that having all that presence in the community, but also, um, to your point, uh, we have about half of our current, uh, patients are treated in the outpatient setting and by virtue of the fact that we have uh, a meeting onset of the CRS. Um, in the clinical studies as 7 days. That means that increasingly, uh, practices are are comfortable with making sure that position, uh, Physicians can do those patients in the outpatient setting? They can be monitored. Uh, and then if they need to be readmitted for for 1 reason, or the other, they're able to do that afterwards. Um, and in addition, uh, as as we've discussed before, the removal of the Rams, is also an important Tailwind because it's an enabling patients to have only 2 weeks of local modeling before they're able to go back home. Uh, and then also, um, you know, it removes the, the driving restriction of uh, of 8.

Weeks. And that's now down to 2 weeks. So, that's another important factor for patients, being able to get a dose, um, get infused and then be able to, um, be monitored more close to home and get back with their lives.

Thank you. And the next question will come from your on wherever with tdo and your line is open.

Hi. This is Dana on for your road, congrats on an amazing quarter. Um, I have a question on the ash abstract, I think there were 2 abstracts from mayo and mockup, suggesting that prophylactic text doesn't seem to reduce the risk of delayed neurotox, with curvy and get those results. How are you thinking about adjusting your strategy for mitigating delayed neurotox. You consider any alternative regimens or thinking about amending? Any phase 3 protocols? Thanks so much.

Hi, good morning Jana. Uh, this is in our answer is, uh, this question. So, obviously, if you look at both, uh, presentations, the apps that you see that alsc remains are very predictive marker. However, the text message Zone, prophylaxis may not be sufficient. And in fact, recently, you have seen Publications from Real World studies including the blood paper that was published in uh, August. Right? So we think that the most important factor is you need to treat those patients with high tumor burden with effect.

Active bridging regimen and you will see actually quite a few assets coming out in the ash next month that um, very center of the using different, um, recipes or different regimens. But again, all the commonality suggests that you have to use the effective bridging therapy. In fact, uh, 1 of the pi is from uh uh Mayo Wright, Dr. Lin uh, recently said that IMS, that you have to switch to a different uh effective regimen. If the first 1 does not work. So the critical, um, Factor here is we have to bring the tumor burden down, and once you do that, you will not see Adverse Events such as neurotoxicity or CRS. So, that is actually, um, a trend. We're seeing, like I said, you will see more real world data, and also more presentations, and Ash about this,

I'm from James Shin with DB. Your line is open.

Hey, good morning guys. Thank you for the question. Got a couple of the part 210.

Include the airline is being removed, but is there any chance to cycle? Fox smart dosing. And assuming this looks I guess to Legend standards will this be somehow added to the label or formerly? Um,

I guess approved by the FDA and it can be adopted. Broadly, thank you.

Question. Um, we have to generate the data first and of course if the data is positive we would that potentially take that 2D FDA to see if that could be included in the label. But right now it's premature to uh say anything about the label inclusion.

Can I ask 1 more on the primary being mrd? Was that

Any insight from the FDA and do you have any insight on mrd becoming formerly? Uh, a surrogate. Thank you.

Yeah, so James. Um, regarding mrd as a potential registration, no endpoint. We're continuing our discussion with the FDA. And also, uh, we like to see under which setting in which line potentially can, uh, mrd in activity, be an endpoint. But, uh, you have to, uh, stay tuned. And when we have more to say, We'll disclose about that. Thank you.

Thank you.

Thank you. And the next question is going to come from Justin Zealand with btig? Your line is open.

Thanks for taking our questions. I was curious. If you could give us an update on outpatient Administration, um, what percentage of the patients are you seeing those in the outpatient setting and any um, any update on the contribution of revenue from earlier lines versus later lines?

Yeah, so I I think I mentioned this earlier outpacing. Uh, based on claims data is about 50% of the patients currently, uh, and we continue to expect that. We'll, we'll be growing over time. Although, as we onboard new sites, um, sometimes they tend to start with patients in the inpatient. So, you know, the growth of the site network is also a little bit of a drag on the outpatient overall mix, but those sites that have converted into outpatient, um, are doing so with good success. And it's it's enabling additional capacity at each site and, and efficiency to answer your second question. We see about 60% of our overall, uh, scripts, uh, coming from the, uh, second through fourth line population, uh, that does continue to grow. Albeit a little bit more slowly than we had anticipated, but we see that Evolution continued. And in fact, the fastest growing part of that, uh, mix is in the third line. So what that tells us is that, uh, increasingly there there is

An adoption. There's there's acceptance and there's enthusiasm for bringing curtsy uh and card um and and carvykti specifically into the earlier line setting based on the Karthik data.

Thanks for taking my question.

Thank you. And then next question will come from Mitchell Kapoor with HC Wayne Wright? Your line is open

Good morning. This is Katie on for Mitchell. Um,

Um what milestones and roadblocks are kind of underpinning that um and what should we be? Keeping an eye on to understand if you're on track to hit that goal?

You Katie.

Our view on profitability has not changed. We actually, um, expect to have profitability for CVT this year in 2025 and Enterprise wide, or for a legend as a company in 2026. Um, this is underpinned by our significant growth trajectory for carvi and our

Management of operating expenses resulting in. Um,

Positive free cash flow in the year of 2026. Um, again as we've mentioned we have significant Tailwinds in our Revenue growth and this should uh, serve us well for profitability next year.

Thank you. And the next question will come from Ash Verma with UBS. Your line is open.

Uh hi. Uh, thanks for taking your questions as well. So just very like, uh, I'm trying to send it and make the between the 2nd to 4th Line, uh, that you commented on, uh, third line. Uh, you said there's a post prominent, can you give us a sense of how much is that? And just secondly, on the Majestic uh 3 data uh like the top top line, uh is available now. But this curious, how that can start to impact the second line opportunity for you in any way. Thanks.

Uh we also happen to be getting more patients in the later lines. That's just by virtue of the the the demand for carvykti, across all lines. And that's why the mix continues to be about a 6040 split between the earlier lines of Carter 24 and the cartisian 1 populations. Uh, but again, uh, the, the the we're the growth we're we're seeing most pronounced is in the, the third line. And that's because again, uh, Physicians are recognizing that they want to try to get patients in with interpret the treatment, as quickly as possible, uh, post first relapse or, or perhaps second relapse

Thank you. And then

Ash. Um, I do want to answer your question about Majesty 3. First of all, we're really pleased that uh, there could be potentially another regimen for patients in second line with about Myoma. And secondly I want to point out that the commercial opportunity for this address for Market is very large, you're looking at about 80 to 100,000 patients in that segment. Um and thirdly I think uh you know we're talking potentially different segments here right? Because uh if you look at carvykti we want to emphasize that carvykti has unmatched unprecedented survival data and also with durability. It's also a 1-time treatment. So there's certain patient population who really prefer that kind of a convenience, right? Brought by a 1-time infusion. Without further need for any other medication for my law. So that is how I uh, view this Market.

And we don't really expect subjective 3 data will really impact the uptake for uh, carving second line.

Thank you.

And our next question comes from Clara dong with Jeffrey, your line is open.

Hi, good morning, thanks for taking our questions. This is Jenna over for Clara. Um, could you give us some comments on your strong International growth? Maybe elaborate on. Um, where are you seeing the strongest? Um, demand and uptake Now versus where do you see higher growth potential, after tackling comes on? Um, and going into 26 and Beyond, how do you foresee the TechLink capacity impact in your market? Share, thank you so much.

Yeah. Um, after the US which is obviously led by our partner J&J, um there's been strong, uptake in Germany, Spain and Belgium in particular as well as the other markets that have launched. Uh many of the European markets uh really see the value here of a 1 time. Infusion the durability that you get with the PFS and Os benefits as as truly providing a strong value, not only to patients but also to the health system. So there's a lot of support for using curvic, the earlier in the treatment Paradigm, and that's encouraging. Uh, we continue to, uh, Advanced the launches that we've already had in the 14s around the world, uh, which we listed in the presentation and, uh, we're very excited to have Tech Lane, now, online from a commercial,

Standpoint to uh enable the supply both between Tech Lane and other oh OS together. We'll be able to meet the capacity demands for the growing European launches.

Thank you.

Thank you. And our next question will come from Sean McCutchen with Raymond James. Your line is open.

All right guys, a couple quick ones from us, thanks for the questions. Uh, you noted improving uh, out of spec grades, can you speak to the the trend as you see more real world patients in the early lines setting and ongoing efforts to push that out of spec rate lower and any commentary on what you think is a feasible, kind of a minimum steady state there and then secondarily. Um, can you speak to any early impacts of loosening up the rims requirements for autoart and whether you're seeing an uptick in referrals for earlier? Line patience, thanks.

Yeah, there, there, there is an abstract at Ash, um, that's reviewing about 3,000, patient records for out of spec, and the uh, out of separate. Um, is, is somewhere in the 6 to 9%, according to that abstract. And in fact, it lower in the earlier line. So it's very consistent with what we're hearing around. Um, earlier is better. Uh, it's very consistent with the fact that um the the T Cell Fitness is stronger in the earlier patients and that enable enabling um better dose and better viability and lower out of spec.

Side on a patient-by-patient basis, which patients are able to go back and which patients they want to keep more close to home, but it's going to be a consultation. The bottom line is, it's a burden lifted and 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 Curvy to more and more patients.

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

Thanks everyone for joining today. Call, as you can see, we have a really strong quarter and we continue to expect another strong quarter in the fourth quarter as well as a very strong year, in the next year in 2026. Um, so I just want to uh, say that uh, we look forward to seeing everyone here at Ash because uh, we and James are very confident about the efficacy of carvykti. And in fact, we will publish your data in oral presentation of uh some data That's not including the Ash abstracts and we strongly believe that the data that will raise the bar even further for efficacy. So we look forward to seeing everyone in Orlando. Thank you.

Thank you that does conclude today's conference call. Thank you for participating and you may now disconnect

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