传奇生物 (LEGN.US) 2026年第一季度业绩电话会
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会议摘要
Legend Biotech reports a 62% increase in Carvotti net trade sales to $597 million, expanding presence in earlier therapies and international markets. The company progresses in Car-T therapies, particularly multiple myeloma, and initiates in-vivo CAR-T programs. Financially stable, Legend Biotech anticipates profitability and pipeline innovation, with plans to present initial data for in-vivo CD19/CD20 CAR-T at a major medical meeting mid-year.
会议速览
Legend Biotech reported strong Q1 2026 sales growth, particularly for its CAR T therapy in multiple myeloma, with a 62% increase to $597 million. The company emphasized global expansion, pipeline innovation including new CAR T trials, and financial discipline, positioning itself for long-term value creation.
Karvikkko achieved 8% sequential growth in Q1, driven by share gains, global market penetration, and increasing early-line therapy utilization. Manufacturing success rates reached 99%, with 95% on-time order releases. The company anticipates continued growth, especially with potential label expansion into first-line settings.
Revenue scaled due to carvi performance, collaboration, and Johnson & Johnson licensing, totaling $305M. Anticipate company-wide profitability in Q2, with gross margins expected to improve. Continued R&D investment in vivo Car T platform and next-generation technologies. Manufacturing ramp-up expenses affected Q1 gross margin, which is projected to recover in Q2.
The dialogue discusses how declining RD expenses, particularly in the later phases of studies, will enable reinvestment into the company's pipeline. This strategy aims to fund future growth through promising in vivo programs, leveraging the benefits of increased profitability.
The company reported narrowed operating losses, maintained profitability projections, and ended the quarter with a robust balance sheet, supporting pipeline advancement and growth investments.
The speaker provides an update on the timing of data presentation for the lymphoma program, emphasizing the necessity of abstract acceptance before disclosure. Durability of the first data set is discussed in terms of patient numbers and the initial nature of the disclosure, with no specific patient outcomes mentioned.
The dialogue discusses an in vivo CAR T program targeting CD19 and CD20, clarifying it's not a gamma delta program, identified as Lb 2501. The program is live on clinicaltrials.gov, with expectations of manageable safety and promising efficacy, including deep response, pending data presentation for specific disclosures.
Discussion on future trends of Covid drug utilization across therapies and questioning the allocation of IT budget within a financial institution.
Discussed the increasing penetration in second and third line businesses, aiming for three quarters of business in these segments within a year. Also, addressed the temporary decline in gross margins due to new capacity, expecting recovery to over 50% in Q2.
Discussion centers on the anticipated recovery of growth margins to previous levels by the second quarter, with confidence expressed in reaching these financial targets as forecasted.
A congratulatory note is followed by inquiries about the effects of data approval on particular patient segments and geographies, along with a request for clarification on the advancements concerning Vivo Car T treatment.
The dialogue highlights the significant growth potential for CAR T therapies in the treatment of hematologic malignancies, particularly in earlier lines of therapy. It discusses the competitive landscape, noting that despite the presence of other therapies and bispecifics, the market remains underserved and offers substantial opportunities for new treatments. The speaker emphasizes the healthy growth of their product, Perfect, amidst potential competition, suggesting a promising future for CAR T therapies in this field.
The discussion revolves around the effectiveness of an individual Car T program for non-hydrogen ecoma patients, aiming for deep and durable responses. It explores the potential translation of such responses from NHL to multiple myeloma, emphasizing the transformative impact of autologous cell engineering and expansion in patients' bodies, expecting enhanced clinical outcomes across various diseases.
The dialogue covers progress on CAR T-cell trials for CAR 5 and CAR 6, updates on the Nvivo CarSyn platform targeting BCMA in melanoma, and an upcoming trial for autoimmune diseases using LV 2505, emphasizing collaborative efforts and future disclosures.
A quick follow-up discusses the expectation of having data on the car to 2.5 event rate by the end of the year, reflecting an update on a previously anticipated timeline.
Discussed the rationale behind using adjusted net income as a more accurate profitability metric, excluding noncash items, and its alignment with industry practices for better peer and year-over-year comparison. The $44 million differential is expected to persist, reflecting ongoing adjustments to noncash items.
The discussion clarified that all GPRC5D programs use the same binder, aiming to validate and understand patient responses. It was also confirmed that excluding a one-time charge would have resulted in profitability on an adjusted income basis.
The dialogue explores the adoption rates of CAR T therapy at specific community centers, focusing on actual usage rather than referrals, and discusses strategies for expanding access to additional centers capable of administering the treatment.
The dialogue highlights the positive community adoption of Perfectly, emphasizing its ease of administration in outpatient settings and growing clinician comfort with patient management. It also mentions the referral fee system's success and expanding hospital integration, bringing care closer to patients. Additional sites are expected to come online this year, showcasing a longer setup cycle but promising infrastructure readiness.
The dialogue focuses on the strategy to drive utilization of Carticruzumab in transplant-eligible and non-intended multiple myeloma patients. It compares the drug's efficacy against Rvd, referencing historical trials and confidence in achieving superiority. The conversation also touches on the potential unlocked by Carticruzumab in these populations, highlighting its cross-trial comparison and the scale of opportunity.
The dialogue discusses safety differentiation in CD19/CD20 CAR-T programs, emphasizing unique design mechanisms for enhanced safety profiles. It also covers Q1 performance analysis and potential sequential growth in the US market, including considerations for Majestic Tree's impact on COVID sales.
Despite initial lag post-holidays, patient appointment trends show strong growth, with expectations of continued sequential improvement both in the U.S. and overseas. Weekly tracking of scripts and sales reveals robust performance, indicating a positive trajectory for the remainder of the year.
Discussion covers the effect of delayed product infusion due to seasonal inventory, projecting continued growth in orders. Highlights advancements in BCMA targeting through glyco mutations and optimized CD3 binders for improved therapeutic outcomes, aiming to reduce liver uptake and inflammatory side effects.
A discussion on the competitive landscape for LD 251, emphasizing the evolving benefits of dual-targeting cell therapies and anticipation for clinical program updates, amidst recent discontinuations in related programs.
The CEO expresses confidence in future growth, highlights successful community involvement, and looks forward to upcoming events, concluding the call with gratitude.
要点回答
Q:How is adjusted net loss useful in evaluating the company's financial performance?
A:Adjusted net loss is a non-IFRS financial measure that excludes realized gains or losses from foreign exchange rate changes. The company believes that providing information concerning adjusted loss and adjusted net loss per share enhances investors' understanding of its financial performance.
Q:What are the key performance indicators for the company's first quarter of script mentioned in the transcript?
A:The key performance indicators for the company's first quarter include strong momentum in commercial execution, a robust pipeline, approximately $597 million in carve net trade sales representing 62% growth compared to the first quarter of 2025, and a 99% manufacturing success rate with a median turnaround time of approximately 29 days.
Q:What is the significance of the results presented in the company's first quarter financial report?
A:The significance of the results in the company's first quarter financial report lies in the sequential growth of Kaviti, continuing share gains, strong site productivity, increasing penetration in earlier lines of therapy, and a robust pipeline of potentially transformative cell therapies across therapeutic areas.
Q:What are the company's future plans to advance its pipeline and clinical trials?
A:The company has engaged six distinguished scientific advisors to broaden its pipeline and is conducting pivotal clinical trials such as Car 5 and Car 6 in multiple myeloma, as well as phase 1 trials for its next-generation cell therapy platforms in BCMA immuno and GPRC 5D programs in multiple myeloma.
Q:How does the company plan to optimize its manufacturing processes and what are the current results?
A:The company is focusing on optimizing manufacturing processes which has resulted in a 99% manufacturing success rate and a median turnaround time of approximately 29 days, with more than 95% on-time order releases.
Q:What is the potential impact of earlier line treatment adoption on the company's future growth?
A:The potential impact of earlier line treatment adoption is significant, with nearly 80% of patients in the US treated in the community setting. This trend reflects growing physician confidence in Kaviti's benefit-risk profile and is expected to drive future growth, especially as the company advances towards a potential label expansion into the first line setting.
Q:What is the company's outlook for gross margin in the second quarter?
A:The company expects gross margin to be back over 50% in the second quarter as the economies of scale from manufacturing investments are realized with increasing utilization.
Q:How is the investment in research and development (R&D) expected to affect future expenses?
A:R&D expenses were $86 million, reflecting continued investment in the in vivo T platform and next-generation programs. The company expects a substantial decline in associated R&D expenses for phase 3 studies, allowing an increasing proportion of the R&D budget to be reinvested into the pipeline.
Q:What is the projected adjusted net loss for the current period?
A:The projected adjusted net loss is $19 million, which is an improvement compared to an adjusted net loss of $27 million in the same period last year.
Q:How is the company positioned financially?
A:The company ended the quarter with approximately $85 million in cash, cash equivalents, and time deposits, and no long-term debt, providing a strong balance sheet for advancing the in vivo T pipeline, supporting continued profitability, expansion, business opportunities, and funding modest capital expenditures.
Q:What can be expected from the lymphoma program in terms of data and timing?
A:The company plans to potentially present data for the first-in-patients with lymphoma at a major medical meeting around mid-year. While specific timing and data details are not disclosed until the abstract is officially accepted and published, the company expects a reasonable number of patients in the first disclosure and is planning for durable results.
Q:What does the company anticipate for its in vivo program in terms of trial design and data disclosure?
A:The in vivo program targets CD 19 and CD 20 using a lentivirus vector and has an internal code name of Lb 2501, already listed on clinicaltrials.gov. The company anticipates manageable safety and promising efficacy, including deep response, but specific information will be disclosed during the data presentation.
Q:How is the business mix expected to evolve over the next year or so?
A:The company expects that the business mix will continue to evolve with growth in second through fourth-line treatment, increasing from two-thirds to three-quarters of the business over the next year or so. This is based on the adoption of patients in earlier lines and better safety and manufacturing data.
Q:What is the projected impact of new capacity on gross margins?
A:Gross margins are expected to return to over 50% in the second quarter after a sequential decline in the first quarter due to one-time expenses related to the expansion of new capacity, particularly in Raritan.
Q:What is the expected growth margin recovery for the second and e.m. quarter according to Carlos?
A:The growth margin is expected to recover to prior levels in the second and e.m. quarter for the year ago, as stated by Carlos.
Q:What impact has the set data approval had on any particular segment of patients or geographies?
A:The impact of set data approval on particular segments of patients or geographies was not clearly specified in the transcript, but it was mentioned as a topic for inquiry.
Q:What is the benchmarking comparison investors are making with your upcoming data and other in-vivo car T therapies?
A:Investors are trying to compare the upcoming data to other in-vivo car T therapies in NHL and in multiple myeloma, specifically looking at competition from TACAO and the presence of iPEC's.
Q:How is the business growing and what is the potential for multiple options in the earlier lines of treatment?
A:The business is growing, particularly in the earlier lines. There is potential for multiple options in the earlier lines due to the large market size—about 100,000 patients with only 5% having seen BCMA, indicating significant growth potential.
Q:What is the benchmarking for the individual car T program targeting CD19 CD20 in non-HL patients?
A:The benchmark for the individual car T program targeting CD19 CD20 in non-HL patients is a deep and durable response, with expectations set for in-line efficacy responses as the program is still early and data is being accumulated.
Q:Can the deep responses seen in NHL translate to multiple myeloma for the in-vivo car T program?
A:The deep responses seen in NHL are thought to translate to multiple myeloma to some extent for the in-vivo car T program.
Q:Can you discuss the scope and design of the BCNA trial with the Nvivo car T cell therapy Lb 2505?
A:The scope and design of the BCNA trial with the Nvivo car T cell therapy Lb 2505 involve collaboration with Johann Johnson, focusing on BCMA-directed cell therapy in melanoma, but the details were not provided in the transcript.
Q:What is the timing update for the CART 5 and CART 6 trials?
A:The timing for CART 5 and CART 6 trials is event-driven and cannot be determined as these trials are fully enrolled, pending the occurrence of certain events.
Q:Is the expectation still to have data by the end of the year for the 25 event rate?
A:The expectation is to have data for the CART 5 event rate at some point in either 2026 or 2027, pending the accrual of events.
Q:What is the adjusted net income guidance for profitability in 2026 and is the $44 million adjustment ongoing?
A:The adjusted net income guidance indicates a non-GAAP adjustment of approximately $44 million to net income. This adjustment is expected to be ongoing as it excludes certain noncash items not representative of core business operations.
Q:Are the GPRC 5D binders consistent across all in-vivo car T therapies?
A:All GPRC 5D programs use the same binder, and efforts are being made to validate the binder and understand patient response.
Q:If the one-time charge is excluded, would the company have been profitable on an adjusted income basis?
A:Yes, if the one-time charge is excluded, the company would have been profitable on an adjusted income basis.
Q:What is the uptake and plan for additional community centers to administer Car T?
A:Uptake in community centers is positive, with feedback from clinicians in the mentioned community networks. Plans for additional community centers to administer Car T are in progress, with some sites already online and more expected to come online throughout the year.
Q:What factors are driving the growth of the company's online business and patient management in the outpatient setting?
A:The growth of the company's online business and patient management in the outpatient setting is driven by the ability to administer treatments effectively in an outpatient setting, increased comfort among clinicians with patient management, and the addition of referral fees which has led to additional referrals.
Q:How is the company framing the utilization of frontline transplant and eligible or transplant non-intended patients in cross-trial basis relative to CPD?
A:The company is framing the utilization of frontline transplant and eligible or transplant non-intended patients in a cross-trial basis relative to CPD by demonstrating confidence in achieving superiority against Rd in specified patient populations based on historical data and trial results.
Q:What safety concerns are associated with the CD 19 CD 20 car T program and how does it compare to other programs?
A:The safety concerns associated with the CD 19 CD 20 car T program include the potential for minimal cases of grade 3 above CRS and ICANS. The program is confident in its ability to maintain safety, with a unique design mechanism and manufacturing process intended to provide differentiated safety profiles. Comparative data with other programs will be disclosed once the clinical data is presented.
Q:What are the expectations for quarterly growth in the US and international markets?
A:The expectations for quarterly growth in the US and international markets are positive, with a trend of sequential growth quarter on quarter, as seen through patient bookings and performance trends through the quarter and into the following months.
Q:What are the considerations and design features of the BCMA compound's binder?
A:The BCMA compound's binder design incorporates glyco mutations on the virus itself, making it recognizable to the LDL receptor, and an internally discovered and optimized CD3 binder for T cell targeting. This design differs from other players in the space who use existing CD3 binders. There is also an intention to avoid certain side effects by detargeting the LDL receptor to reduce inflammation and liver uptake.
Q:What is the competitive landscape for the Lb 25 oh 1, the NVO zv 1920 program and how does it compare to other targeting mechanisms?
A:The competitive landscape for the Lb 25 oh 1, the NVO zv 1920 program is competitive with other targeting mechanisms, with a focus on the potential of deep and durable response driving the program. A recent announcement indicates that this compound is the company's lead program for the new targeting mechanism, although specific comments on competitors are not provided. The company looks forward to disclosing their clinical program in due course.

Legend Biotech Corp.
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