LEGN
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Earnings documents stored for LEGN.
Investor releaseQuarter not tagged2026-06-03Legend Biotech (LEGN) Soars 42% on Promising Cancer Therapy Results
Insider Monkey
Legend Biotech (LEGN) Soars 42% on Promising Cancer Therapy Results
Legend Biotech Corp. (NASDAQ:LEGN) is one of the 10 Stocks Delivering Massive Returns. Legend Biotech snapped a four-day losing streak on Tuesday, jumping 42.22 percent to close at $36.28 apiece following the strong first phase results of its cancer treatment candidate, which saw as much as a 100 percent response rate in enrolled patients. In an updated report, Legend Biotech Corp. (NASDAQ:LEGN) said that all six patients enrolled in the study to test the efficacy of LB2501 in patients with relapsed/refractory B-cell non-Hodgkin lymphoma fully responded to the higher dose level of the treatment, while five achieved a complete response, which means that no detectable signs of cancer remained. For illustration purposes only. Photo by Pavel Danilyuk on Pexels LB2501 is designed to infuse CAR-T cells directly into the patient’s body via a single IV. It is expected to treat faster and be less expensive than the traditional CAR-T therapies, which require a patient’s cells to be collected first and engineered in laboratories and infused back weeks later. Legend Biotech Corp. (NASDAQ:LEGN) also said that the therapy candidate showed no serious adverse effects or deaths. The company is scheduled to present additional data at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden, on June 11 to 14. “The upcoming presentation of Phase 1 LB2501 data in patients with B-cell malignancies represents an important step in advancing in vivo CAR-T approaches,” Legend Biotech Corp. (NASDAQ:LEGN) CEO Ying Huang said. “By generating CAR-T cells directly within the patient, this approach has the potential to simplify treatment delivery and expand access for patients who may not be able to receive traditional CAR-T cell therapies. LB2501 is built on the TaVec platform, which is a proprietary lentiviral vector engineered to enhance T-cell specificity, transduction efficiency, and safety, while restricting transduction of non-T cells.” While we acknowledge the potential of LEGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and Cathie Wood 2026 Portfolio: 1...
Investor releaseQuarter not tagged2026-06-01Legend Biotech Presents First-in-Human LB2102 Results in Solid Tumors and New CARVYKTI® Data in Multiple Myeloma at ASCO 2026
GlobeNewswire
Legend Biotech Presents First-in-Human LB2102 Results in Solid Tumors and New CARVYKTI® Data in Multiple Myeloma at ASCO 2026
LB2102 demonstrated a manageable safety profile and encouraging clinical activity in solid tumors among heavily pretreated patients Responses observed at higher dose levels of LB2102 with an ORR of 28.6% and a DCR of 78.6%, with durable responses seen in some patients New CARVYKTI® data continue to support durable efficacy and a consistent safety profile in multiple myeloma BRIDGEWATER, N.J., June 01, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech or the Company), a global leader in cell therapy, today announced first-in-human clinical data for LB2102, its investigational DLL3-targeted CAR-T cell therapy for patients with relapsed or refractory small cell lung cancer (SCLC) or large-cell neuroendocrine carcinoma (LCNEC). The data demonstrate early evidence of clinical activity and a manageable safety profile. At higher dose levels, an objective response rate (ORR) of 28.6% and disease control rate (DCR) of 78.6% were observed, including durable responses in some heavily pretreated patients. The data, presented in a rapid oral presentation (Abstract #8012) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, support the clinical potential of CAR-T cell therapy in solid tumors. Additionally, new analyses from the CARTITUDE program were presented, further highlighting sustained clinical benefit and a consistent safety profile for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) in multiple myeloma. “The data presented at ASCO underscores the progress of our next-generation pipeline and the meaningful impact that CARVYKTI continues to deliver to patients,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “LB2102 marks an early step in expanding CAR-T cell therapy into solid tumors, addressing the unique challenges where current treatment options are limited and early data show promising clinical activity in difficult-to-treat cancers. At the same time, CARVYKTI continues to demonstrate durable efficacy and a consistent safety profile, reinforcing its role as a transformative therapy for multiple myeloma and supporting our leadership in cell therapy.” LB2102: Early Evidence of Clinical Activity Observed in Solid Tumors Early Phase 1 results from the ongoing study of LB2102 demonstrate encouraging anti-tumor activity and a manageable safety profile in patients with relapsed or refractory (R/...
Investor releaseQuarter not tagged2026-05-14These Analysts Revise Their Forecasts On Legend Biotech After Q1 Results
Benzinga
These Analysts Revise Their Forecasts On Legend Biotech After Q1 Results
Legend Biotech Corp (NASDAQ:LEGN) reported downbeat results for the first quarter on Tuesday. The company posted quarterly losses of 3 cents per share which missed the analyst consensus estimate of losses of 2 cents per share. The company reported quarterly sales of $305.100 million which missed the analyst consensus estimate of $307.035 million. View more earnings on LEGN “We believe CARVYKTI’s continued adoption and strong year‑over‑year growth reinforce our leadership in BCMA CAR‑T and the strength of our underlying operating model,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “As scale continues to build, we are seeing operating leverage translate into improving margins, supporting our path toward sustainable profitability. This continued progress is enabling us to advance our broad pipeline of cell therapy programs and extend the impact of our platform to address unmet needs for patients across multiple indications.” Legend Biotech shares rose 1.3% to trade at $28.63 on Wednesday. These analysts made changes to their price targets on Legend Biotech following earnings announcement. RBC Capital analyst Leonid Timashev maintained Legend Biotech with an Outperform rating and raised the price target from $62 to $64. Morgan Stanley analyst Matthew Harrison maintained the stock with an Overweight rating and lowered the price target from $49 to $48. TD Cowen analyst Yaron Werber maintained the stock with a Hold and raised the price target from $21 to $29. Considering buying LEGN stock? Here’s what analysts think: Photo via Shutterstock View more ratings on LEGN UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga: LEGEND BIOTECH (LEGN): Free Stock Analysis Report This article These Analysts Revise Their Forecasts On Legend Biotech After Q1 Results originally appeared on Benzinga.com © 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Investor releaseQuarter not tagged2026-05-13Legend Biotech (LEGN) Q1 2026 Earnings Transcript
Motley Fool
Legend Biotech (LEGN) Q1 2026 Earnings Transcript
Image source: The Motley Fool. Tuesday, May 12, 2026 at 8 a.m. ET Chief Executive Officer — Ying Huang President, CARVYKTI — Alan Bash Chief Financial Officer — Carlos Santos Vice President, Investor Relations and Finance — Jessie Yeung President of R&D — Guowei Fang Jessie Yeung: 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 first quarter of 2026 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 also 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 Investors section of our company website. In addition, adjusted net 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 loss and adjusted net loss per share enhances an investor understanding of our financial performance. We use adjusted net loss as a performance metric that guides management in its operation of and planning for the future of the business. In particular, we exclude unrealized gain or loss from foreign exchange rate changes. We believe that adjusted net income or loss provide a useful measure of our operating performance from period to period. Our press release includes IFRS to non-IFRS reconciliations for these measures. With that, I will now turn the call over to Ying. Ying Huang: Hello, everyone. Thank you for joining us...
Investor releaseQuarter not tagged2026-05-13Legend Biotech Corp (LEGN) Q1 2026 Earnings Call Highlights: Strong CARVYKTI Sales and ...
GuruFocus.com
Legend Biotech Corp (LEGN) Q1 2026 Earnings Call Highlights: Strong CARVYKTI Sales and ...
This article first appeared on GuruFocus. CARVYKTI Net Trade Sales: Approximately USD597 million, representing 62% growth year-over-year and 8% sequential growth from Q4 2025. Revenue: Total revenue of USD305 million for the quarter, including collaboration revenue of USD298 million and license and other revenue of USD7 million. Gross Margin: 41% on net product sales, with an expectation to exceed 50% in the next quarter. Research and Development Expense: USD86 million, focused on in vivo CAR-T platform and next-generation programs. SG&A Expense: USD90 million, driven by commercial investments for CARVYKTI growth. Adjusted Net Loss: USD11 million, or USD0.03 per diluted share, compared to USD27 million or USD0.07 per diluted share in the same period last year. Cash and Cash Equivalents: Approximately USD835 million, with no long-term debt. Warning! GuruFocus has detected 4 Warning Signs with LEGN. Is LEGN fairly valued? Test your thesis with our free DCF calculator. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Legend Biotech Corp (NASDAQ:LEGN) reported strong financial performance with CARVYKTI net trade sales reaching approximately USD597 million, representing a 62% growth compared to the first quarter of 2025. The company achieved a 99% manufacturing success rate and a median turnaround time of approximately 29 days, with more than 95% on-time order releases for final product delivery. Legend Biotech Corp (NASDAQ:LEGN) is expanding its global footprint, with CARVYKTI now available across 18 global markets and more than 300 global treatment sites. The company has a strong balance sheet with approximately USD835 million in cash, cash equivalents, and time deposits, and no long-term debt. Legend Biotech Corp (NASDAQ:LEGN) is advancing its pipeline with pivotal Phase III studies, CARTITUDE-5 and CARTITUDE-6, and is on track to report initial data from its in vivo CAR-T programs this year. Gross margin on net product sales declined to 41% from 57% in the previous quarter due to one-time expenses associated with ramping up manufacturing. Research and development expenses were USD86 million, reflecting continued investment in the in vivo CAR-T platform and next-generation programs. The company reported an adjusted net loss of USD11 million in Q1, although it anticipates company-wid...
Investor releaseQuarter not tagged2026-05-12Legend Biotech Q1 Earnings Call Highlights
MarketBeat
Legend Biotech Q1 Earnings Call Highlights
Interested in Legend Biotech Corporation Sponsored ADR? Here are five stocks we like better. CARVYKTI sales surged in Q1 2026, with net trade sales of about $597 million, up 62% year over year. Growth was driven by earlier-line use in the U.S. and strong international expansion, with ex-U.S. sales rising more than 200%. Manufacturing execution improved but margins dipped due to one-time ramp costs at expanded facilities. Legend said gross margin was 41% in the quarter and expects it to rebound above 50% in Q2 as utilization improves. Legend’s pipeline is advancing beyond CARVYKTI, especially its in vivo CAR T programs. The company said its BCMA and GPRC5D programs have entered Phase I, initial non-Hodgkin’s lymphoma data is expected this year, and it remains on track for 2026 profitability on an adjusted basis. CPI Data Sparks Rally in Biotech Stocks Legend Biotech (NASDAQ:LEGN) reported sharply higher first-quarter 2026 sales for CARVYKTI, its CAR T therapy for multiple myeloma, as management said demand continued to move into earlier lines of treatment and international markets expanded. Chief Executive Officer Ying Huang said the company began 2026 with “strong momentum” commercially and in its pipeline. He described Legend as “the largest standalone cell therapy company” and said CARVYKTI remains the company’s anchor product while it works to advance the therapy into the first-line treatment setting. → Beyond NVIDIA: Picks-and-Shovels AI Plays with Strong Momentum Why Legend Biotech Stock Is Having Its Best Month Yet CARVYKTI net trade sales were approximately $597 million in the first quarter, up 62% from the first quarter of 2025. Huang said U.S. sales grew 36% year over year, while ex-U.S. sales rose more than 200%. Alan Bash, Legend’s President of CARVYKTI, said the therapy delivered 8% sequential growth from the fourth quarter of 2025. In the U.S., growth was driven primarily by increased use in earlier-line settings, activation of new authorized treatment centers and throughput at existing sites. Outside the U.S., Bash said demand was supported by established European markets and recent launches. → MercadoLibre Boldly Invests in Growth: Discount Deepens CARVYKTI is now available in 18 global markets and at more than 300 treatment sites worldwide, according to the company. Bash said international growth should continue scaling as site experience, ma...
TranscriptFY2026 Q12026-05-12FY2026 Q1 earnings call transcript
Earnings source - 88 paragraphs
FY2026 Q1 earnings call transcript
Good day, and thank you for standing by. Welcome to the Legend Biotech first quarter 2026 earnings conference call. At this time, all participants on 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 will need to press star one one on your telephone. You will then hear an automated message advising that your hand is raised. Today's conference is being recorded. I will now hand the conference over to your speaker host for today, Jessie Yeung, Vice President of Investor Relations and Finance. Please go ahead.
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 first quarter of 2026 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 also 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 herein.
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 session of our company website. In addition, adjusted net loss is a non-IFRS metrics. 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 this non-IFRS financial measures versus that closes IFRS equivalents. However, we believe that providing information concerning adjusted net loss and adjusted net loss per share enhances an investor understanding of our financial performance. We use adjusted net loss as a performance metric that guides management in its operation of and planning for the future of the business. In particularly, we exclude unrealized gain or loss from foreign exchange rate changes.
We believe that adjusted net income or loss provide a useful measure of our operating performance from period to period. Our press release includes IFRS to non-IFRS reconciliations for these measures. With that, I will now turn the call over to Ying.
Hello, everyone. Thank you for joining us today. We began 2026 with strong momentum as we executed commercially and continued to advance our pipeline. Legend is the largest standalone cell therapy company anchored by CARVYKTI, our market-leading and profitable CAR T therapy for multiple myeloma. In parallel, we're working to advance CARVYKTI into the first-line treatment setting to help reach more patients and further broaden its long-term opportunity. Beyond CARVYKTI, we also have a strong pipeline of potentially transformative cell therapies across additional therapeutic areas where curative options remain limited. As this pipeline matures and it generates more meaningful clinical data, we're looking forward to presenting some of this data at upcoming medical conferences this year. During the first quarter of 2026, CARVYKTI net trade sales were approximately $597 million, representing 62% growth compared to the first quarter of 2025.
This was comprised of 36% growth in the U.S. year-over-year and more than 200% growth from ex-U.S. sales. This performance reflects strong demand in early line settings, continued global expansion, and consistently best-in-class manufacturing execution. Importantly, the myeloma treatment paradigm continues to shift toward earlier use of CAR T. In a recent social media poll for KOLs conducted by Dr. Ben Derman from University of Chicago, 66% of respondents indicated they would recommend CAR T at first relapse for contemporary myeloma patient followed by DVRd induction and maintenance, assuming daratumumab resistance. We view this sentiment as further validation that CARVYKTI is increasingly considered a foundational therapy earlier in the disease course. Before transitioning to the pipeline, I want to highlight an important step we announced earlier this month.
We recently engaged 6 distinguished scientific advisors, Renier Brentjens, Spencer Fisk, Carl June, Maximilian F. Konig, Anthony Polverino, and Georg Schett, who bring deep expertise across oncology, immunology, and in particular, cell therapy, as well as translational research. As we broaden our pipeline, we believe their input and advice will help guide critical scientific and clinical decisions and strengthen the rigor behind our long-term R&D strategy. At the top of pipeline, we have some of the larger active CARVYKTI trials. Most importantly, CARTITUDE-5 and CARTITUDE-6 are pivotal phase III studies designed to assess CARVYKTI in frontline multiple myeloma following its label expansion in earlier lines. Turning to our earlier stage pipeline, you're going to start to hear more about these programs as the clinical data starts to mature from our next-generation cell therapy platforms. Our BCMA in vivo program in autoimmune diseases has entered phase I.
Beyond BCMA, our GPRC5D in vivo program in multiple myeloma has also entered phase I. In parallel, our other in vivo CAR T programs continue to progress, and we remain on track to report initial data this year in non-Hodgkin's lymphoma. We continue to expect to file 1 to 2 U.S. INDs in 2026 and are excited by the differentiated potential of our approach. Financially, our strong balance sheet provides us with flexibility to invest in our priorities while maintaining a clear focus on profitability. We believe this combination of commercial leadership, pipeline innovation, and financial discipline positions Legend well to deliver durable value for patients and shareholders over the long term. With that, I will turn the call over to Alan.
Thank you, Ying. I'll start with a high-level view of CARVYKTI's commercial performance and then spend time on what's driving growth beneath the surface. In Q1, CARVYKTI delivered another quarter of sequential growth, reflecting continued share gains, strong site productivity, and increasing penetration in earlier lines of therapy. Demand remained healthy across all major geographies, supported by our expanding global footprint and consistently reliable manufacturing execution. CARVYKTI net trade sales in the first quarter were approximately $597 million, representing 8% sequential growth from Q4 2025. In the U.S., growth was driven primarily by increased utilization in earlier line settings, continued activation of new authorized treatment centers, and steady throughput at existing sites.
Outside the U.S., demand was supported by continued uptake in established European markets and contributions from recent launches, with CARVYKTI now available across 18 global markets and more than 300 global treatment sites. As expected, international growth continues to scale as site experience, manufacturing slots, and referral patterns mature. Turning to the next slide, we want to highlight how we are accelerating growth through our manufacturing optimization and earlier line momentum. From a manufacturing standpoint, we continue to optimize. This past quarter, we achieved a 99% manufacturing success rate and a median turnaround time of approximately 29 days with delivering more than 95% on-time order releases for final product delivery. We believe these metrics are a testament to our commitment to broadening adoption, particularly as physicians move CAR T earlier in the treatment paradigm.
Importantly, although we do not intend to break this out every quarter since we think about our business on a longer-term basis, we wanted to provide a glimpse of the traction made in earlier line settings in the U.S., where nearly 80% of patients are treated in the community setting. As you can see on the far right-hand part of the slide in the color teal, patients in second line and third line represented 41% of CARVYKTI apheresis volume in the U.S. in the first quarter of 2026, compared to 29% in the same period a year ago. This trend reflects growing physician confidence in CARVYKTI's benefit risk profile earlier in the disease course and our ability to reliably support that shift at scale.
We expect this trend to continue and be a major driver of future growth, especially as we advance towards a potential label expansion into the first line setting. With that, I will turn the call over to Carlos to walk through our financial performance.
Thank you, Alan, and good morning, everyone. I'm pleased to walk you through our financial performance, which reflects an important quarter of commercial growth and disciplined investment. Turning to the next slide, this chart highlights our progress towards profitability. As you can see, revenue has continued to scale, driven by CARVYKTI performance, and profitability metrics have improved steadily over time. We anticipate company-wide profitability on an adjusted basis in 2026 and expect continued margin improvements from our ongoing expense discipline. Regarding Q1, the next slide illustrates how revenue growth is translating into operating leverage. Collaboration revenue was approximately $298 million in the first quarter, primarily driven by CARVYKTI net trade sales under our collaboration with Johnson & Johnson. License and other revenue was approximately $7 million, resulting in total revenue of $305 million for the quarter.
Gross margin on net product sales was 41%. The decline from the fourth quarter at 57% was primarily due to one-time expenses associated with ramping up manufacturing in the newly expanded section of our Raritan site and the ongoing Tech Lane facility ramp. Looking ahead to the second quarter, we expect gross margin to be back over 50% as the economies of scale from our manufacturing investment are realized with increasing utilization. Research and development expense was $86 million, reflecting continued investment in our in vivo CAR T platform and next generation programs. As the Phase III CARTITUDE-5 and 6 studies for CARVYKTI mature, we expect a substantial decline in the associated R&D expenses.
This allows an increasing proportion of the R&D budget to be reinvested into the pipeline as we leverage the benefit of CARVYKTI profitability to fund the future growth of Legend that will come from the promising in vivo programs and extensive earlier stage pipeline that Ying showed earlier. SG&A expense was $90 million, driven by targeted commercial investments supporting CARVYKTI growth. Operating loss narrowed compared to the prior year, with an adjusted net loss of $11 million in Q1. We feel very comfortable in maintaining our projection for achieving company-wide profitability on an adjusted basis in 2026. On a non-IFRS basis, this represents $0.03 per diluted share, compared with an adjusted net loss of $27 million or $0.07 per diluted share in the same period last year.
Turning to the next slide, we ended the quarter with approximately $835 million in cash equivalents, and time deposits, and no long-term debt. We believe this strong balance sheet provides us with flexibility to advance our in vivo CAR-T pipeline, support continued CARVYKTI profitability expansion, pursue focused business development opportunities, and fund modest capital expenditures tied to manufacturing capacity. Based on our recent progress, we remain confident in our company-wide profitability trajectory as we continue to invest prudently in long-term growth. In summary, the first quarter reflects a business that is scaling efficiently, generating increasing operating leverage, and approaching sustained profitability. With that, we're happy to take your questions.
First question coming from the line of Terence Flynn with Morgan Stanley. Your line is now open.
Great. Thanks so much for taking the question. Obviously, there's a growing focus on in vivo programs, platforms. Maybe, Ying, you could give us a little bit of update in terms of how much data we should expect from your lymphoma program and any more specifics on timing. Is EHA a possibility, or is it more likely ASH? How are you thinking about durability, and what will we learn from this first data set with respect to that question? Thank you.
Morning, Terence. Thank you for that question. As typical with our disclosure practice, we cannot really comment on the data without the abstract being officially accepted and also published by the major medical meeting. The only thing I can confirm is that we are planning to potentially present this data set for the first time in patient with non-Hodgkin's lymphoma at a major medical meeting around mid-year. That's the only thing I can confirm right now. In terms of, you know, durability, I guess it's really depending on how many patients and how much follow-up we have. In general, because this is the first disclosure for our clinical data here, I wouldn't expect a very, very long follow-up. We do expect a reasonable number of patients in this first disclosure.
I hope that answers your question, Terence.
Thank you. Our next question coming from the line of Umer Raffat with Evercore ISI. Your line is now open.
Hi, guys. Thanks for taking my question. I wanted to touch up on this in vivo CAR T theme in a little more detail, perhaps. Maybe for everyone listening in, Ying, because this is a new theme popping up beyond CARVYKTI, beyond our cell x, could you just remind everyone, first of all, that the CD19, CD20 CAR T you have is not the gamma delta, which is allo. We're talking about in vivo, A, if you could just clarify that. B, the name of the program, like the number. Number 3, I acknowledge you can't say if it'll be at EHA or not and the scope of the data, but could you just give us a sense for what the trial design is that's being run?
Should we expect efficacy data as well, or should the data disclosure only be limited to whether you dosed it and they developed CAR T, and then what the safety looked like? Should there be some early efficacy as well? Thank you.
Umer, thanks for your question. I will answer the first two parts, then I'll ask my colleague, Guowei, President of R&D, to answer the third question regarding the design and everything else. First of all, yes, we can confirm that this is not the gamma delta T program. This is actually in vivo CAR-T targeting CD19 and CD20, using a lentiviral vector delivery. That's first. Secondly, I can confirm that the internal codename we use for this program is LB2501. This program is already up on ClinicalTrials.gov. If you want to search for the details on the protocol and the enrollment. On the third question, I'll ask Wei to answer.
Yes. In terms of clinical data to be released, the trial was initiated last year. We do expect to release both safety and efficacy data. We have to wait and share the data presentation to really disclose specific information. In terms of our internal expectation, our expectation for in vivo program is to have manageable safety and promising efficacy, including deep response. That's our expectation.
Thank you very much.
Thank you. Our next question coming from the line of Jessica Fye with JPMorgan. Your line is now open.
Hey, guys. Good morning. Thanks for taking my questions. A couple on kind of the existing business. First, you know, appreciate the additional detail on the breakdown of CARVYKTI used across lines of therapy. If we look out another year or two, what do you think that pie chart mix will look like? Second, just on the higher COGS this quarter, how much of that about $100 million year-over-year increase was one-time versus sort of ongoing? Thank you.
Hi, it's Alan. Thanks for the question. In terms of our business mix, we're very pleased to show the data that reflects the fact that in earlier lines, specifically in second and third line, we have about 41% of our patients coming through those lines. I think that's important for a couple of reasons. One is it does speak to the fact that we're getting community adoption because those earlier patients start in the community and are getting referred into the authorized treatment centers. It also speaks to the fact that our clinical data is resonating with the earlier is better data both for efficacy, safety, and manufacturing, all, you know, based on the data that we shared at ASH and previous conferences that earlier is better.
I think it also sets us up well from a competitive standpoint to make sure we are penetrating the 2nd and 3rd line businesses in the face of whether it's bispecifics or potential future BCMA CAR-T competition. To answer your question, we've also shown progression in the overall 2nd through 4th line at about 2/3 of our business, and we do expect that that will continue to grow, probably to about 3/4 of our business is where we would anticipate that emerging over the next year or so. All segments continue to grow, and we're very excited by the penetration in the earlier lines.
Related to the gross margin question, we did see a sequential decline in the first quarter since we brought new capacity into our network, specifically to our Raritan site. This, together with one-time expenses associated with the expansion, resulted in this one-time impact to gross margin. However, we do expect that gross margins will return to over 50% in Q2.
Can you quantify the one-time impact a little more?
We do not disclose those particulars.
Thank you.
Jess, this is Ying. I just want to add that you heard from Carlos that we fully expect the gross margin to recover to prior level in the second and also the ensuing quarters for the year.
Thanks.
Thank you. Our next question coming from the line of Kostas Biliouris with Oppenheimer.
Thanks for taking our question. Congrats on the progress. Maybe a couple of quick questions from us. One on the commercial side, do you see any meaningful impact after TECVAYLI approval in the second line now, perhaps on any particular segments of patients or any particular geographies? The second one on the in vivo CAR-T, can you help us understand what the benchmarking is there? Some investors are trying to compare your upcoming data to other ex vivo CAR-T therapies in NHL. Some other investors are looking to benchmark it to in vivo CAR-T from multiple myeloma. Any thoughts on where the benchmarking is in your view would be helpful. Thank you.
Our business continues to grow, as you saw from our report today, it continues to grow, particularly in the earlier lines. In terms of competition from TECVAYLI or the presence of bispecifics, I'll remind you that this is a large market in 2nd through 4th line, about 100,000 patients. Only about 5% have seen a BCMA, there's significant growth potential for multiple options in the earlier lines. I think that's also reflected by the IQVIA data that you see. While other products are growing, CARVYKTI has also shown healthy growth as well. Through potential competition with bispecifics, I think this is a large market that's severely underserved and under-penetrated, that portends well for the opportunity for CARVYKTI.
For the second question, in term of a benchmark for in vivo CAR T program, our lead program is CD19, CD20 dual targeting in vivo CAR T program targeted for non-Hodgkin's lymphoma patient. Our current thinking is that we are expecting or we are looking for deep and durable response, and therefore, the benchmark would expected to align with that type of efficacy response. Currently that's still early, and we are accumulating more data.
If I can add a follow-up here. If you see these type of responses in NHL, deep responses as you call it, would that translate to multiple myeloma to some extent as well for the in vivo CAR-T platform? Thank you.
Excellent question. We do think that in vivo CAR T platform has the transformative potential by moving all the cell engineering and the cell expansion into the body of patients, therefore generate a better cell fitness. Therefore, that could translate into even better clinical response. That's our expectation across different disease areas. Thank you.
Thank you. Our next question coming from the line of Ed Sauder with Barclays. Your line is now open.
Great. Thanks for taking the question. Congrats on the quarter. A couple of questions, maybe on the CARVYKTI side, if you could maybe provide any updates, new updates on the timing for CARVYKTI 5 or 6. On the pipeline, just wondered if you could maybe talk about the scope of the BCMA trial that you're initiating with the in vivo CAR-T, I think LB2505. Maybe if you can comment on the scope and the trial design there. Thank you.
Yeah. CARTITUDE-5 and CARTITUDE-6 are fully enrolled, but these are event driven, so we don't have an update here on the timing, and we'll continue to monitor in terms of how the events accrue.
For the in vivo CAR-T program, we are excited about our platform and product. We are exploring this product platform across different diseases. Multiple myeloma is important disease area. BCMA certainly is a top target within the multiple myeloma disease space. Our partnership with Johnson & Johnson cover all and any BCMA-directed cell therapy in multiple myeloma that both company are working on. Therefore, at this point, there's nothing more we can share.
Ed, this is Ying. I also want to add that we are initiating another trial for the same construct, LB2505, targeting BCMA, and this will be in autoimmune diseases. You will learn in the near future about that program once we include that in clinicaltrials.gov.
Great. Thank you.
Thank you. Our next question coming from the line of Eric Schmidt with Cantor Fitzgerald. Your line is now open.
Thanks for taking my question. Maybe just a quick follow-up on the CARTITUDE-5 event rate. I think at one point we had expected it would be possible to have data toward the end of this year. Is that still the case, Alan? Then a financial question on the adjusted net income guidance for profitability in 2026. The adjustments in Q1 are about $40 million, $44 million to net income. Is that sort of a non-GAAP adjustment that we'll see on an ongoing basis? I guess I'm looking for some help on the differential between adjusted and GAAP financials. Thank you.
On CARTITUDE-5, Eric, we would plan to see data at some point in either 2026 or 2027. Again, this is event-driven, so it's really reflective of how the events accrue.
Yes. On the adjusted net income, as we approach profitability, we wanted to be more specific with our definition. As we mentioned when we introduced the non-IFRS reconciliation last year, we view adjusted net income as a more accurate reflection of profitability and our financial performance since it excludes certain non-cash items that are not representative of our core business operations. This is aligned with the way most of the industry reports, and it will also allow better comparison both with peers and consistently year-over-year.
Okay, I understand why you're doing it. Is the $44 million differential between the two metrics something that might exist on an ongoing basis?
Yeah. As I mentioned, we do exclude the certain non-cash items, so this would be primarily share-based compensation, depreciation, amortization, and impairments, and foreign exchange.
Thank you.
Thank you. Our next question coming from the line of James Shin with Deutsche Bank. Your line is now open.
Good morning. Thank you for the questions. Circling back to the pipeline, there's three autologous and one in vivo variant for the GPRC5Ds. Are these GPRC5D binders consistent across all the variants, or are the FasT CAR variants using a different manufacturing process and therefore have different binders? Then just following up on the one-time cost of collaboration question, if you exclude this one-time charge, would 1Q 2026 been profitable on an adjusted basis? Thank you.
On the GPRC 5D front, all autologous program use the same binder. We are testing the, have tried to validate the binder as well as try to understand how the patient respond using different, design of the CAR T molecule.
Yes. On the one-time charge, question, the answer is yes. If we wouldn't have had that one-time charge, we would have been profitable on an adjusted income basis.
Thank you. Our next question coming from the line of Leonid Timashev with RBC Capital. Your line is now open.
Hey, guys. Thanks for taking my question. Wanted to ask on community adoption. I think before you've talked about how you've onboarded Virginia Oncology, Tennessee Oncology. I guess, how's uptake looking in those centers? I guess I'm specifically curious about the actual use of CAR T in those centers, not necessarily referrals, and sort of what the plan and cadence is of adding additional community centers that can actually administer the CAR T. Thanks.
Hey, it's Alan. As we've said before, the community adoption has 2 components to it, one of which is the one you're speaking to, which is administration in the community among the community networks. We're seeing positive responses from the clinicians in both those sites. You mentioned 2 of them, we also have the West Cancer Center in Tennessee as well. There are additional sites that are coming online this year. I would say that it's a bit of a longer cycle to make sure that those sites are set up well and have the infrastructure, but we do expect additional sites this year. The experience has been quite positive.
Again, speaking to the fact that CAR T can be administered in the outpatient setting relatively easily, and clinicians are getting more and more comfortable with patient management dynamics. The other part of the community adoption is the referral piece, which you alluded to as well. Again, there we're seeing strong indications that we are getting additional referrals, again, speaking to the fact that our earlier line business is growing significantly. Then finally, just as a point, we're up to 148 authorized treatment centers in the U.S. About a third of those are community and regional hospitals, and that's an important component to our mix because that means that we're bringing CARVYKTI closer to patients in those settings as well.
Thank you. Our next question coming from the line of Sean McCutcheon with Raymond James. Your line is now open.
Hey, guys. Thanks for the question. One on CARTITUDE-5 for me. Can you speak to how you're framing, and you know, what you need to show to drive utilization in the frontline transplant-eligible or transplant not intended population on a cross-trial basis relative to CEPHEUS, and how you think about the scale and opportunity that could be unlocked by CARTITUDE-5? Thanks.
Morning, Sean. This is Ying. If you look at the design for CARTITUDE-5, we are enrolling patients who are not eligible for stem cell transplant or who are eligible but who choose to defer transplant for various reasons. If you look at comparison arm, it is RVd, it's a three-drug cocktail composing of REVLIMID, Velcade and dexamethasone. Historically, if you look at RVd in the frontline setting in this transplant ineligible population, you have two trials. One is the IFM trials, run by Celgene. The other one is the SWOG S0777 trial. If you look at the median PFS for RVd in this setting in those two phase II trials, it's in the range of 35-40 months. That is our assumption when we at JNJ designed this trial for CARTITUDE-5.
Again, we're looking at cross-trial comparison, as you rightfully mentioned, 35-40. If you recall, Sean, in CARTITUDE-1, where we enrolled 97 patients with heavily pretreated regimen, the median line of therapy, prior therapy was 6.5, yet we still achieved 35 month PFS for CARVYKTI treated patients. This is why we and JNJ are highly confident that we will be able to achieve the superiority against RVd in this specific patient population. If you compare that to CEPHEUS and other trials, of course, you do see certain numbers shifting because of better standard of care.
On the other hand, still, given what we know about CARTITUDE-1 and also CARTITUDE-4, where, with a median follow-up of nearly 3 years, we have not reached median PFS yet in that, second to fourth line patient population. We remain highly confident that CARVYKTI will demonstrate superiority in PFS compared to RVd. That is our assumption here.
Thank you. Our next question coming from the line of Ashwani Verma with UBS. Your line is now open.
Hi. Thanks for taking our question. Maybe just on the CD19, CD20 CAR T. Can you talk about the safety differentiation with some of the other programs out there? Some of these programs have seen CRS or ICANS or neutropenia. Are you confident that your program can have minimal to no cases of grade 3 and above CRS and ICANS? Then, just like secondly, on CARVYKTI, I mean, the 4Q to 1Q sequential growth in U.S. is at 3%. Any seasonality dynamic going on there? Just like trying to understand what is the growth trajectory from here. Can you continue to see sequential growth for the rest of 2026 and any impact of MajesTEC-3 on CARVYKTI sales?
Thanks.
Thanks, Ash. Yeah. I can answer the first question on the safety side. Certainly, safety is paramount for a novel platform in oncology patients. I cannot disclose specific clinical safety profile at this point. We have to wait until the clinical data is presented. What I can say is that safety is a key parameter we focus on from the get-go in the design phase. Our unique design mechanism as well as the CMC manufacturing process, I think that will provide differentiate the safety profile in clinic. In term of how the research data correlates with the clinical data, let's wait, stay tuned until we are ready to disclose clinical data. Thank you.
On the CARVYKTI performance in Q1, yes, you know, coming out of the holidays there is a little bit of a lag in patient appointments as patients get re-upped in their insurance and they get rescheduled. We're very encouraged with the trends that we've seen in the patient bookings through the progress of the quarter and even beyond that. I would say that we would expect to see sequential growth, quarter-on-quarter both in the U.S. and OUS for the remainder of this year.
Ash, maybe, this is Ying. I want to add that you guys all follow IQVIA weekly scripts and weekly sales. As you can see, we had a very strong March followed by a very strong April. Now we're early in May, but again, ordering looks quite strong. You guys can track that every week. As we have mentioned before, it's not a zero-sum game. You see both TECVAYLI and daratumumab and you see CARVYKTI steadily growing in second-line.
Thank you.
Thank you. Our next question in the queue coming from the line of Yaron Werber with TD Cowen. Yaron, it's now open.
Great. Thanks so much for taking my question. Maybe just the first question, Alan, for you, the those seasonality that you mentioned in Q4 with some of the bags sort of remaining over and ultimately being infused in early Q1, and it seems like as you're moving upstream in Q1, J&J talked about having the same effect. Can you give us a little bit of a sense, kind of net-net, how that worked out on a quarter-over-quarter basis? Is that sort of phenomenon of just a little bit of a delay to infusion will continue as you're moving to second line? A question for in vivo for BCMA, can you maybe share a little bit about the construct itself? Are you using sort of the same camelid antibody targeting BCMA with the same dual epitope targeting?
Is it sort of the same stem? Are you doing any de-targeting through the LDL receptor, and CD3 to try to avoid the sort of liver uptake and the sink and reduce some of the ICANS and inflammation? Thank you.
Yaron, it's Alan. I'll just go back to what I said previously, which is that we do continue to see a strong order flow both as the quarter progresses as well as Yin mentioned, going into April and beyond. We do expect to continue to see the growth and in particular in that earlier line setting, where we are, you know, gaining more and more patients, more and more referrals, setting us up well from a competitive standpoint as well.
With regard to the BCMA compound, in term of the binder design, we are not ready to disclose special information at this point. On the platform side, I do want to add that we generate glycoprotein mutations on the virus itself, and therefore the engineered virus does not recognize the receptor. We use internally discovered and optimize the CD3 binder for T-cell targeting, which is differentiated from many other players in the space where they use existing CD3 binder borrowed from other purpose.
Thank you so much.
Thank you. Our next question coming from the line of Mitchell Kapoor with H.C. Wainwright. Your line is now open.
Hi, thank you for taking my question. This is Mitchell Kapoor sitting in for Mitchell Kapoor. I have a question on the LB2501, the in vivo CD1920 program. You list the studies enrolling, and you have pointed to this in vivo data coming later in the year. Separately, you know, you have Johnson & Johnson recently announcing it discontinued its ex vivo CD20 mono and CD19, 20 bi-CAR-T programs in LBCL. Without asking you to comment on their program specifically, I just wanna get a sense of how you're thinking about the competitive bar for LB2501.
This is a dual targeting mechanism and cumulative data across all targets cells clinical data on the targets front comparing CD19 versus CD19, CD20 dual targeting mechanism do point to the promise of dual targeting in term of driving deeper and the more durable response. J&J recently announced that they discontinued their development program for the dual targeting mechanism, and I will not be able to comment on their specific rationale. But we do believe that the dual targeting mechanism provide benefit over the mono targeting. The in vivo data is evolving and we are very much looking forward to disclose our clinical program.
Thank you.
Thank you. I'm showing no further questions in the queue at this time. I will now turn the call back over to the CEO, Ying Huang, for any closing remarks.
Well, it's great hearing from everyone this morning. We are really pleased with the momentum of CARVYKTI. As you heard from Alan, we look forward to stronger quarters in the rest of the year, and we do expect sequential growth in both U.S. and ex-U.S. We continue to see deepening penetration in the community and also in second line. We're actually all full speed on with our in vivo programs. We look forward to seeing you all at the upcoming major medical meetings. Thank you.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation, and you may now disconnect.
Investor releaseQuarter not tagged2026-04-28Legend Biotech to Host Investor Conference Call on First Quarter 2026 Results
GlobeNewswire
Legend Biotech to Host Investor Conference Call on First Quarter 2026 Results
SOMERSET, N.J., April 28, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, will host a conference call for investors at 8:00 am ET on Tuesday, May 12, 2026, to review first quarter 2026 financial results. During the conference call and accompanying webcast, senior management will provide an overview of quarterly financial performance. Investors and other interested parties may access the live audio webcast via this weblink. A replay of the webcast, along with the earnings press release, will be available in the Investor Relations section of the Legend Biotech website under Events and Presentation approximately two hours after the conclusion of the call. ABOUT LEGEND BIOTECH With over 2,900 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. The company is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the US, Legend is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI’s patient access and therapeutic potential. From this platform, the company plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities. Learn more at www.legendbiotech.com and follow us on X (formerly Twitter) and LinkedIn. INVESTOR CONTACT: Jessie Yeung Tel: (732) 956-8271 [email protected] PRESS CONTACT: Kim Fox Tel: (848) 388-8445 [email protected]
Investor releaseQuarter not tagged2026-03-16Genscript Biotech Corp (GNNSF) Full Year 2025 Earnings Call Highlights: Record Revenue Growth ...
GuruFocus.com
Genscript Biotech Corp (GNNSF) Full Year 2025 Earnings Call Highlights: Record Revenue Growth ...
This article first appeared on GuruFocus. Group Revenue: Increased by 61.4% year over year to $959.5 million. Adjusted Net Profit: Reached nearly $230 million. Life Science Group Revenue: Grew 14.8% year over year to $522.1 million. ProBio Revenue: Achieved 309.1% growth to $388.7 million, including nearly $280 million from a Lenovo license deal. Bestzyme Revenue: Grew by 7.9% year over year to $58 million. Adjusted Gross Profit Margin: 51.2%. Adjusted Operating Profit: $95.4 million. Legend Biotech Adjusted Net Loss: Narrowed to $33.1 million. Impairment Loss: $398.1 million due to investment in Legend Biotech. Share of Loss from Legend Biotech: $310.4 million. R&D Expenses: Approximately 9% of total revenue. SG&A Expenses: Increased due to investments in Europe and North America. Warning! GuruFocus has detected 9 Warning Signs with GNNSF. Is GNNSF fairly valued? Test your thesis with our free DCF calculator. Release Date: March 15, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Genscript Biotech Corp (GNNSF) achieved a 61.4% year-over-year revenue growth, reaching $959.5 million. The company's gene to protein platform contributed significantly, accounting for 65% of total revenue growth. Genscript's global expansion strategy is effective, with North American and European markets contributing 38% of total revenue. The company made significant progress in sustainability, receiving an upgraded ESG rating and inclusion in the FTSE for Good Index Series. Legend Biotech, an associate company, achieved profitability in 2025, positively impacting Genscript's financial outlook. Genscript Biotech Corp (GNNSF) recorded a loss of $532.4 million due to a shock loss and impairment from its investment in Legend Biotech. The gross profit margin for both the Life Science Group and Bestzyme declined compared to 2024. Increased SG&A expenses due to global expansion and marketing efforts impacted profitability. The company faces intensified market competition and price pressure in the enzyme industry. Regulatory scrutiny and geopolitical uncertainties pose potential challenges for the company's operations and customer relations. Q: How much revenue was recognized from the Lenovo deal in the second half of 2025, and what were the key growth drivers? A: We received a portion of the Lenovo second milestone payment in the...
Investor releaseQuarter not tagged2026-03-11Legend Biotech Corp (LEGN) Q4 2025 Earnings Call Highlights: Record Growth and Profitability ...
GuruFocus.com
Legend Biotech Corp (LEGN) Q4 2025 Earnings Call Highlights: Record Growth and Profitability ...
This article first appeared on GuruFocus. Revenue: $306 million, representing 64% year-over-year growth. Gross Margin: 61%, with a gross margin on Carvicti net product sales of 57%. Operating Margin: Improved from 142% in Q2 2023 to 6% in Q4 2025. Carvicti Net Trade Sales: $555 million in Q4 2025, a 66% increase year-over-year. US Net Trade Sales: $420 million, a 38% increase year-over-year. International Sales: $135 million, over a threefold increase year-over-year. Adjusted Net Income: $2.5 million, compared to a $59 million adjusted net loss a year ago. Adjusted Diluted Income Per Share: $0.01, compared to $0.15 for the same period last year. Cash Position: $949 million in cash equivalents and time deposits. Operating Cash Flow: $12 million in outlays, compared to $82 million in outlays for the same period last year. Carvicti Manufacturing Success Rate: 97% overall, with 99% success for patients with 1 to 3 prior lines of therapy. Carvicti Treatment Sites: 294 global treatment sites across 14 markets. Warning! GuruFocus has detected 3 Warning Signs with LEGN. Is LEGN fairly valued? Test your thesis with our free DCF calculator. Release Date: March 10, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Legend Biotech Corp (NASDAQ:LEGN) achieved profitability in 2025 and anticipates company-wide profitability in 2026. Carvicti net trade sales grew by 66% year over year, reaching approximately $555 million in the fourth quarter of 2025. The company has expanded its manufacturing capacity to support annual production of 10,000 doses, with plans to increase to 20,000 doses. Carvicti has demonstrated a 97% overall manufacturing success rate and is available in 14 global markets. Clinical data shows that earlier treatment with Carvicti leads to better outcomes, with a median progression-free survival (PFS) of 50.4 months for certain patient groups. The CAR T therapy market remains underpenetrated, with less than 5% of patients in the second to fourth line setting treated with a BCMA targeting agent in 2025. Despite growth, the company faces challenges in expanding community adoption and educating physicians on the benefits of Carvicti. The competitive landscape is intensifying, with recent M&A activity in the space, such as Gilead's acquisition of a competitor. There are ongoing concerns about neurotoxicity...
Investor releaseQuarter not tagged2026-03-10Legend Biotech Adjusted Q4 Earnings, Revenue Increase
MT Newswires
Legend Biotech Adjusted Q4 Earnings, Revenue Increase
Legend Biotech (LEGN) reported Q4 adjusted earnings Tuesday of $0.01 per diluted share, swinging fro
Investor releaseQuarter not tagged2026-03-10Legend Biotech Reports Fourth Quarter and Full Year 2025 Results and Recent Highlights
GlobeNewswire
Legend Biotech Reports Fourth Quarter and Full Year 2025 Results and Recent Highlights
CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) net trade sales of approximately $555 million and $1.9 billion for the fourth quarter and full year 2025, respectively Surpassed milestone of more than 10,000 patients treated with CARVYKTI® CARVYKTI now available across 294 sites worldwide; continued expansion in U.S. community settings Advanced early-stage cell therapy portfolio, including first-patient dosing of in vivo candidates and presentation of first-in-human results for LUCAR-G39D, an allogeneic CAR-T therapy Cash and cash equivalents, and time deposits of $949 million, as of December 31, 2025 SOMERSET, N.J., March 10, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported financial results for the fourth quarter and year ended December 31, 2025, and key corporate highlights. “CARVYKTI® continued to build on its leadership in multiple myeloma CAR‑T in 2025, as we reached more than 10,000 patients treated and achieved franchise profitability,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “With expanding capacity and ongoing efforts to broaden adoption, including in the community setting, we are focused on executing against the opportunities ahead while extending our innovation leadership across in vivo and allogeneic programs.” Key Business Developments Achieved CARVYKTI® franchise profitability for the full year 2025. Treated more than 10,000 clinical and commercial patients to date with CARVYKTI®. Strengthened manufacturing and supply capabilities, completing the newly expanded portion of the Raritan facility, making it the largest cell therapy manufacturing site in the United States supporting treatment of up to 10,000 patients annually. Expanded global commercial footprint, with CARVYKTI® now available in 14 markets across 294 sites worldwide alongside continued growth in United States community and outpatient settings. Presented new clinical and translational data from CARTITUDE-1 and CARTITUDE-4 at the 67th American Society of Hematology (ASH) Annual Meeting and presented data at the 2026 Tandem Meetings of ASTCT® and CIBMTR®, reinforcing durable outcomes associated with earlier use of CARVYKTI®. Advanced pipeline and development platform, opening a 31,000-square-foot R&D facility in Philadelphia, Pennsylvania and presenting encouraging first-in-h...

