Clarify if the In Vivo CAR-T is not gamma delta, provide the program name, and detail the trial design and expected scope of efficacy data.

Ying Huang confirmed the program is an In Vivo CAR-T targeting CD19 and CD20 using a lentiviral vector (not gamma delta), with internal codename LB2501, and is listed on clinicaltrials.gov. Guowei Fang added that the trial, initiated last year, is expected to release both safety and efficacy data, aiming for manageable safety and promising efficacy, including deep response. “Our current thinking is that we are expecting or we are looking for deep and durable response, and therefore, the benchmark would be expected to align with that type of efficacy response.”

What will the CARVYKTI line of therapy mix look like in 1-2 years, and can the one-time COGS impact in Q1 be quantified?

Alan Bash expects the proportion of CARVYKTI use in second and third-line settings to grow from 41% to about 75% of the business over the next year or so. Carlos Santos explained the Q1 gross margin decline was due to one-time expenses for manufacturing ramp-up, expecting recovery to over 50% in Q2, but declined to quantify the specific one-time impact. “Probably to about 3/4 of our business is where we would anticipate that emerging over the next year or so.”

What is the impact of TECVAYLI approval on CARVYKTI, and how should investors benchmark the upcoming In Vivo CAR-T data?

Alan Bash stated that the multiple myeloma market is large and underserved, allowing for growth of multiple options, and CARVYKTI continues healthy growth despite competition. Guowei Fang explained that for the LB2501 In Vivo CAR-T, the benchmark is for deep and durable responses in NHL, and the platform's potential for 'better cell thinness' could translate to improved clinical responses across diseases. “Our current thinking is that we are expecting or we are looking for deep and durable response, and therefore, the benchmark would be expected to align with that type of efficacy response.”

LEGN

Legend Biotech (LEGN) Q1 FY26 earnings call: guidance and Q&A

Earnings call· Mar 2026 (Q1 FY26)· Health Care· May 12, 2026

Source: earnings call transcript

Executive summary

Legend Biotech Q1 FY26 — Strong CARVYKTI Sales and Pipeline Progress

Legend Biotech began FY26 with robust commercial execution for CARVYKTI, driven by strong demand in earlier lines and global expansion, alongside efficient manufacturing. The company is advancing its pipeline, including In Vivo CAR-T programs, and remains on track for company-wide adjusted profitability in 2026, despite a temporary dip in gross margin due to manufacturing ramp-up.

Highlights

CARVYKTI net trade sales reached $597 million, representing 52% growth compared to Q1 2025.
U.S. CARVYKTI sales grew 36% year-over-year, while ex-U.S. sales surged over 200% year-over-year.
41% of CARVYKTI apheresis volume in the U.S. originated from second and third-line settings in Q1 2026, up from 29% a year ago.
Achieved a 99% manufacturing success rate and a median turnaround time of approximately 29 days for CARVYKTI.
Adjusted net loss narrowed to $11 million in Q1 2026, compared to $27 million in the same period last year.

Concerns

Gross margin on net product sales declined to 41% in Q1 2026, down from 57% in Q4 2025, primarily due to one-time expenses for manufacturing ramp-up.
U.S. CARVYKTI sequential growth was 3% from Q4 2025 to Q1 2026, partially impacted by holiday seasonality.

Guidance & targets

Category	Target	Timeline	Confidence
Company-wide profitability	Achieve profitability on an adjusted basis high materiality	FY26	High
Gross margin on net product sales	Back over 50% medium materiality	Q2 · FY26	High
U.S. IND filings	One to two medium materiality	FY26	High
CARVYKTI sales growth	Sequential growth quarter-on-quarter high materiality	Remainder of FY26	High
CARTITUDE-5 data	Data at some point in '26 or '27 high materiality	CY26-CY27	Medium

Segment performance

Segment	Revenue	YoY	QoQ	Margin
CARVYKTI Strong demand in early line settings, continued global expansion, and consistently best-in-class manufacturing execution drove growth. Sequential growth from Q4 2025 was 8%. U.S. sales growth YoY: 36%Ex-U.S. sales growth YoY: >200%	$597M	52%	8%	—
Collaboration Revenue Primarily driven by CARVYKTI net trade sales under collaboration with Johnson & Johnson.	$298M	—	—	—
License and Other Revenue Contribution from other licensing activities.	$7M	—	—	—

LEGN operating KPIs by quarter

LEGN operating KPIs stated on its earnings calls, by fiscal quarter
KPI	Dec 2025 Q4 FY25	This call Mar 2026 Q1 FY26	Jun 2026 Q2 FY26	Change vs prior quarter
Global treatment sites	294 Our global growth was driven by continued share gains, site expansion and growing geographic footprint, now reaching 294 global treatment sites across 14 markets worldwide. Source: earnings call transcript	300+ Outside the US 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. Source: earnings call transcript	348 We recently launched CARVYKTI in Ireland, further expanding availability to 348 global treatment sites, reflecting continued geographic expansion with our partner, J&J Across geographies, we continue to see encouraging trends in both market penetration and earlier line utilization. Source: earnings call transcript	—

Operating figures the company stated on at least two of the calls shown, checked against each call's transcript. Click a figure to read the sentence. A dash means it was not stated that quarter.

Deals & partnerships

Johnson & Johnson Collaboration for CARVYKTI net trade sales and BCMA-directed cell therapy in multiple myeloma.

Partnership covers all and any BCMA-directed cell therapy in multiple myeloma that both companies are working on.

Renier Brentjens, Spencer Fisk, Carl June, Maximilian Konig, Tony Polverino, Georg Schett Engagement of six distinguished scientific advisers.

Advisers bring expertise across oncology, immunology, cell therapy, and translational research to guide critical scientific and clinical decisions and strengthen long-term R&D strategy.

Risks & headwinds

Manufacturing ramp-up expenses Q1 FY26

Gross margin on net product sales declined to 41% in Q1 FY26 from 57% in Q4 2025.

Mitigation:Expected gross margin recovery to over 50% in Q2 FY26 as economies of scale are realized with increasing utilization.

Seasonality impacting CARVYKTI sales Q1 FY26

U.S. CARVYKTI sequential growth was 3% from Q4 2025 to Q1 2026.

Mitigation:Strong order flow and patient bookings observed through the quarter and into April/May; sequential growth expected for the remainder of FY26.

What to watch in Q2 FY26

Gross Margin on Net Product Sales

Q2 FY26

Current 41%

Target Back over 50%

Why it matters

Verifying the recovery of gross margin is crucial for the company's profitability trajectory, especially after the Q1 dip due to manufacturing ramp-up.

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.

Find out whether LEGN delivers this. Inve re-checks your case every morning.

Q&A highlights

When can we expect data from the lymphoma In Vivo program, and what can we learn about durability from the first data set?

Ying Huang confirmed plans to present initial data for the non-Hodgkin lymphoma In Vivo CAR-T program (LB2501, CD19/CD20 targeting) at a major medical meeting around mid-year. She noted that while a reasonable number of patients would be included, very long follow-up for durability is not expected in this first disclosure.

“The only thing I can confirm is that we are planning to potentially present the data set for the first time in patients with non-Hodgkin lymphoma at a major medical meeting around midyear.”

asked by Terence Flynn · answered by Ying Huang

3 min read 5 chapters

Detailed narrative

CARVYKTI Commercial Performance and Market Penetration

CARVYKTI demonstrated strong commercial performance in Q1 FY26, with net trade sales of $597 million, driven by significant year-over-year growth in both U.S. (36%) and ex-U.S. (over 200%) markets. The therapy is seeing increasing penetration in earlier lines of treatment, with 41% of U.S. apheresis volume coming from second and third-line settings, up from 29% a year ago.

This trend is supported by growing physician confidence and the ability to reliably support the shift at scale. The company expects this earlier-line penetration to continue, potentially reaching 75% of its business over the next year or so. The overall multiple myeloma market in second to fourth line is estimated at 100,000 patients, with only about 5% having seen a BCMA therapy, indicating significant growth potential.

Approximately 80% of patients in the U.S. are treated in the community setting, highlighting the importance of community adoption for CARVYKTI.

Pipeline Advancement and In Vivo CAR-T Programs

Legend Biotech is actively advancing its pipeline beyond CARVYKTI, with several In Vivo CAR-T programs showing progress. The BCMA In Vivo program for autoimmune diseases and the GPRC5D In Vivo program for multiple myeloma have both entered Phase I clinical trials.

The company's In Vivo CAR-T program targeting CD19 and CD20 for Non-Hodgkin's Lymphoma (LB2501) is expected to report initial clinical data at a major medical meeting around mid-year 2026, focusing on both safety and efficacy. Management anticipates filing one to two U.S.

INDs in 2026, underscoring its commitment to expanding its innovative cell therapy platforms. The In Vivo CAR-T platform is believed to have transformative potential by moving cell engineering and expansion into the patient's body, aiming for better cell thinness and improved clinical responses across different disease areas.

Financial Performance and Profitability Trajectory

The company reported total revenue of $305 million for Q1 FY26, with collaboration revenue of $298 million primarily from CARVYKTI sales. Adjusted net loss significantly narrowed to $11 million, compared to $27 million in Q1 FY25, and the company remains confident in achieving company-wide adjusted profitability in 2026.

Gross margin on net product sales was 41% in Q1, a decline from 57% in Q4 2025, attributed to one-time expenses for ramping up new manufacturing capacity at the Raritan and Tech Lane facilities. However, gross margin is expected to recover to over 50% in Q2 as utilization increases.

The company ended the quarter with a strong balance sheet, holding $835 million in cash, cash equivalents, and time deposits, with no long-term debt, providing flexibility for strategic investments.

Manufacturing Optimization and Global Expansion

Legend Biotech continues to optimize its manufacturing capabilities, achieving a 99% manufacturing success rate and a median turnaround time of approximately 29 days for CARVYKTI in Q1 2026. Over 95% of final product deliveries were released on time. This operational efficiency is crucial for broadening adoption and supporting the shift towards earlier CAR-T treatment.

Globally, CARVYKTI is now available in 18 markets and over 300 treatment sites, with international growth scaling as site experience, manufacturing slots, and referral patterns mature. In the U.S., the company has 148 authorized treatment centers, with about one-third being community and regional hospitals, bringing CARVYKTI closer to patients.

Strategic R&D and Scientific Advisory Board

To strengthen its long-term R&D strategy and guide critical scientific and clinical decisions, Legend Biotech recently engaged six distinguished scientific advisers with deep expertise in oncology, immunology, cell therapy, and translational research. This initiative aims to leverage external expertise as the company broadens its pipeline and matures its next-generation cell therapy platforms.

The R&D budget is increasingly being reinvested into promising In Vivo programs, utilizing the profitability generated by CARVYKTI to fund future growth and innovation.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.