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Legend Biotech (NASDAQ: LEGN) projects 2026 profit on CARVYKTI growth

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(Neutral)
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Form Type
6-K

Rhea-AI Filing Summary

Legend Biotech presents an updated corporate overview focused on its CAR-T therapy CARVYKTI and a path to profitability. The company reports approximately $1B in cash, cash equivalents and time deposits as of September 30, 2025, and about $1.7B in last-twelve-month CARVYKTI net trade sales through Q3 2025. Operating margin has improved from -142% in Q2 2023 to -16% in Q3 2025, and Legend Biotech expects to achieve company-wide operating profit, excluding unrealized foreign exchange losses, in 2026.

CARVYKTI is described as the top-selling CAR-T therapy in a single quarter, with an estimated peak annual sales potential of over $5B, more than 10,000 patients treated worldwide and 10,000 annualized dose capacity expected in 2026. Legend Biotech highlights a 2,900+ person global team, multiple global manufacturing sites, and a 50/50 cost-sharing and profit-split collaboration with Johnson & Johnson (30/70 in Greater China). The presentation also outlines a diversified cell therapy pipeline, an in vivo CAR-T platform entering clinical proof-of-concept, and 2026 priorities to maximize CARVYKTI market leadership, advance innovation, and drive profitability.

Positive

  • Path to profitability: Operating margin improved from -142% in Q2 2023 to -16% in Q3 2025, and the company expects to achieve operating profit excluding unrealized FX losses in 2026.
  • Strong CARVYKTI performance: About $1.7B in LTM CARVYKTI net trade sales through Q3 2025, estimated >$5B peak annual sales potential, and more than 10,000 patients treated worldwide.
  • Solid liquidity: Approximately $1B in cash, cash equivalents and time deposits as of September 30, 2025, alongside positive operating cash flow supported by CARVYKTI growth.

Negative

  • None.

Insights

Legend Biotech ties CARVYKTI growth to a 2026 profitability goal.

Legend Biotech centers its story on CAR-T therapy CARVYKTI, showing rapid revenue scaling and improving margins. CARVYKTI last-twelve-month net trade sales reached about $1.7B based on Q4 2024 through Q3 2025, while operating margin improved from -142% in Q2 2023 to -16% in Q3 2025 as revenue nearly quadrupled since Q2 2023 with roughly 60%+ gross margins.

The company reports roughly $1B in cash, cash equivalents and time deposits as of September 30, 2025, and states that CARVYKTI is already profitable on a contribution basis (net trade sales minus cost of goods sold and operating expenses). It highlights more than 10,000 patients treated with CARVYKTI and 10,000 annualized dose capacity expected in 2026, supported by four manufacturing sites under a global collaboration with Johnson & Johnson that includes a 50/50 cost and profit split outside Greater China.

Management indicates an expectation to achieve company-wide operating profit excluding unrealized foreign exchange losses in 2026, and outlines 2026 priorities: maximizing CARVYKTI market leadership, advancing the broader cell therapy pipeline (including in vivo candidates already in investigator-initiated trials), and maintaining disciplined operating expense management. The actual trajectory will depend on CARVYKTI uptake in earlier lines of multiple myeloma, execution on global expansion, and progress of late-stage trials such as CARTITUDE-4, -5, and -6.

 
 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 6-K

 

 

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

of the Securities Exchange Act of 1934

 

Date of Report: January 14, 2026

 

Commission File Number: 001-39307

 

 

 

Legend Biotech Corporation

(Exact Name of Registrant as Specified in its Charter)

 

 

 

2101 Cottontail Lane

Somerset, New Jersey 08873

(Address of principal executive office)

 

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

 

Form 20-F  ☒            Form 40-F  ☐

 

 

 

 

 

Legend Biotech Updates Corporate Presentation at the 44th Annual J.P. Morgan Healthcare Conference

 

On January 14, 2026, Legend Biotech Corporation (the “Company”) will make its updated corporate presentation available on its website. The presentation is attached to this Form 6-K as Exhibit 99.1 and may be viewed on the Company’s website at https://investors.legendbiotech.com/events-and-presentations.

 

This Form 6-K shall be deemed to be incorporated by reference in the registration statements of the Company on Form F-3 (Nos. 333-278050, 333-257625, and 333-272222) and Form S-8 (No. 333-239478 and 333-283217), to the extent not superseded by documents or reports subsequently filed.

 

EXHIBIT INDEX

 

Exhibit Title
   
99.1 Corporate Presentation – January 2026

 

 

 

 

 

 

  

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

    LEGEND BIOTECH CORPORATION
       
Date: January 14, 2026   By: /s/ Ying Huang
    Name: Ying Huang, Ph.D.
    Title: Chief Executive Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

Exhibit 99.1

 

Legend Biotech Corporate Presentation J.P. Morgan Healthcare Conference January 2026 © 2025 Legend Biotech. All rights reserved.

 

 

Disclaimer 2 This presentation has been prepared by Legend Biotech Corporation (“Legend Biotech” or the “Company”) solely for information purpose and does not contain all relevant information relating to the Company. The safety and efficacy of the agents and/or uses under investigation discussed in this presentation have not been established, except to the extent specifically provided by marketing authorizations previously received from relevant health authorities. Further, for investigational agents and/or uses, the Company cannot guarantee health authority approval or that such agents and/or uses will become commercially available in any country. Certain information contained in this presentation and statements made orally during this presentation relate to or are based on studies, publications, surveys and other data obtained from third - party sources and Legend Biotech's own internal estimates and research. While Legend Biotech believes these third - party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third - party sources. While Legend Biotech believes its internal research is reliable, such research has not been verified by any independent source. Statements in this presentation about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward - looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives; statements relating to CARVYKTI® (ciltacabtagene autoleucel; cilta - cel) , including patient population of CARVYKTI®, Legend Biotech’s expectations for CARVYKTI®, including manufacturing expectations for CARVYKTI®; statements about regulatory submissions for CARVYKTI®, statements related to Legend Biotech's ability to achieve operating profit; statements related to Legend Biotech’s anticipated achievement of operating profit excluding unrealized foreign exchange losses in 2026; the progress of such submissions with the FDA, the EMA and other regulatory authorities; expected results and timing of clinical trials; Legend Biotech’s expectations on advancing their pipeline and product portfolio; statements regarding the estimated market siz e for Legend Biotech’s products and the potential benefits of Legend Biotech’s product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward - looking statements, although not all forward - looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward - looking statements a s a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected ne w clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays a s a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; competition in general; government, industry, and general product pricing and other political pressures; a s well a s the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20 - F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (SEC) on March 11, 2025 and Legend Biotech’s other filings with the SEC. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this presentation as anticipated, believed, estimated or expected. Any forward - looking statements contained in this presentation speak only as of the date of this presentation. Legend Biotech specifically disclaims any obligation to update any forward - looking statement, whether as a result of new information, future events or otherwise.

 

 

Unlocking the Potential of Immune Cells to Treat the Toughest Diseases 3 • • State - of - the - art R&D facility opened in Philadelphia, Pennsylvania • Patients dosed for IIT In Vivo CAR - T studies in 2025 • Novel clinical proof of concept approach emphasizes speed to entry • $1B in Cash, Cash Equivalents and Time Deposits 6 • Expected to achieve company - wide operating profit in 2026 • 2,900+ person global team, with largest presence in United States Operating Cash Flow 2 LTM CARVYKTI Net Trade Sales 3 Pipeline Programs 1) Net Trade Sales - Cost of Good Sold - Operating Expenses = CARVYKTI Profit; 2) As of September 30, 2025; 3) Last Twelve Months Net Trade Sales based on Q4 2024 through Q3 2025; 4) MM = Multiple Myeloma; 5) Based on companies’ public filings; 6) As of September 30, 2025; 7) Legend Biotech and Johson & Johnson Estimate; 8) As of January 6, 2026 CAR - T Leadership in MM 4 Cell Therapy Innovation Durable Global Business • CARVYKTI ® is the top - selling CAR - T in a single quarter 5 • >$5B peak annual sales potential 7 • Partnered with Johnson & Johnson on CARVYKTI ® >10,000 patients treated with CARVYKTI ® 8

 

 

4 Reaching a Profitability Inflection Point Operating margin improvement from - 142% in 2Q 2023 to - 16% in 3Q 2025 Revenue ($MM) 0 300 250 200 150 100 50 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 2023 2023 2023 2024 2024 2024 2024 2025 2025 2025 Revenue Revenue has scaled nearly 4 ð since 2Q23 while sustaining ~60%+ gross margins 2026 will be an inflection point for adjusted non - GAAP operating income Non - GAAP Operating Loss/Income (USD $M) - 336 - 189 - 89 2H 2026 2025 YTD 1 2024 2023 1) As of the nine months period ended September 30, 2025

 

 

5 Our 2026 Priorities Shaping the Next Era of Growth Through Leadership and Innovation 01 Maximize CARVYKTI ® Market Leadership 02 Advancing Our Cell Therapy Innovation 03 Drive Profitability

 

 

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10,000+ Patients Have Been Treated with CARVYKTI ® 1) as of December 21, 2025 7 • All Manufacturing Sites Now Online: ⁻ Raritan, NJ ⁻ Obelisc and Tech Lane in Ghent, Belgium ⁻ Morris Plains, NJ (Novartis CMO Site) • 97% Manufacturing Success Rate • <30 - day median turnaround time (TAT) • 10,000 annualized dose capacity in 2026 • • 141 Activated Treatment Sites in the US • 279 global treatment sites • Global Expansion: • 2022 - 2024: 5 markets • 2025: 9 additional markets “The long - term PFS and OS data with cilta - cel in CARTITUDE 1 and CARTITUDE 4 are unprecedented in relapsed myeloma. When you see patients achieving durable disease control for years after a single infusion, it fundamentally changes how we think about the treatment journey. At first relapse, we as treaters should be considering CAR - T with every eligible patient” - Dr. Binod Dhakal, Medical College of Wisconsin, Division of Hematology

 

 

Legend and Johnson & Johnson Global Collaboration License Agreement to Develop and Commercialize Cilta - cel with J&J 8 PARTNERSHIP ACCOMPLISHMENTS Enrolled the largest multiple myeloma CAR - T program to date Operationalized 4 manufacturing sites worldwide WORLDWIDE COLLABORATION J&J is the global multiple myeloma market leader 50/50% cost - sharing/profit - split arrangement except in Greater China 1 1) J&J and Legend have a 30/70% cost - sharing/profit - split arrangement in Greater China

 

 

9 From Chronic Disease to Potential Cure: CARVYKTI ® Long - Term Survival CARTITUDE - 1: ≥5 - Year Remission and Survival After A Single Infusion How a Single Infusion is Changing Multiple Myeloma 4 “A single infusion of immunotherapy has kept patients healthy for more than five years. This is an unprecedented milestone for this tough - to - treat blood cancer.” - Forbes Effective Immunotherapy for a Blood Cancer 3 “one - third of the treated individuals had no evidence of detectable myeloma after five years without further therapy, an outcome widely thought of as a prerequisite to consider using the term cure...” - Nature JCO = Journal of Clinical Oncology ; *attention score a weighted number showing how much online attention a research paper gets from sources like news, blogs, social media ,etc. 1) Jagannath, Sundar, et al. “Long - Term (≥5 - Year) Remission and Survival After Treatment With Ciltacabtagene Autoleucel in CARTITUDE - 1 Patients With Relapsed/Refractory Multiple Myeloma.” Journal of Clinical Oncology; https://doi.org/10.1200/JCO - 25 - 00760; 2) https://asco.altmetric.com/details/17771164 1 Accessed on 12.21.25; 3) Bird, S., & Pawlyn, C. “Immunotherapy using CAR T cells shows promising long - term outcomes for people with myeloma.” Nature News & Views, Aug 19, 2025 4. Haseltine, W. A. “How a Single Infusion Is Changing Multiple Myeloma Treatment.” Forbes, Oct 1, 2025. Median overall survival at 61.3 - month median follow - up (N=97; 95% CI, 41.9 – NE) 1 ; were treatment - and progression - free for ≥5 years after a single infusion , providing the first evidence that cilta - cel is potentially curative in RRMM 1 Overall Survival *Median prior lines of therapy was 6 (range, 3 - 18) 1 JCO article by attention* (last 6 months) 2

 

 

10 a As - treated population. b mFU from randomization. BCMA, B - cell maturation antigen; CAR, chimeric antigen receptor; cilta - cel, ciltacabtagene autoleucel; FU, follow - up; MRD, minimal residual disease; pLOT, prior line of therapy; RRMM, relapsed/refractory multiple myeloma; TCE, triple - class exposed. 1) Berdeja JG, et al. Lancet 2021;398:314 - 24; 2) Martin T, et al. J Clin Oncol 2023;41:1265 - 74. 3)Parekh, et al. Presentation at 7th American Society of Hematology (ASH) Annual Meeting. “Earlier use of ciltacabtagene autoleucel (cilta - cel) is associated with better immune fitness and stronger immune effects as shown by correlative analysis of peripheral blood and the bone marrow tumor microenvironment (TME) from the CARTITUDE - 4 study” Raising the Bar for Progression - Free Survival (PFS) CARVYKTI ® has demonstrated profound efficacy in patients with RRMM 1,2 PRESENTED AT ASH 2025 (DEC) 3 CARTITUDE - 4 a RRMM 1 - 3 pLOT CARTITUDE - 1 + CARTITUDE - 4 a TCE RRMM 3pLOT CARTITUDE - 1 TCE RRMM ≥ 3 pLOT 176 34 97 N NR (mFU b : 34.0 months) 50.4 months 34.9 months Median PFS

 

 

Earlier Use of CARYKTI ® is Associated With Better Outcomes 11 OS by pLOT in CARTITUDE - 1 and CARTITUDE - 4 1 0 25 50 75 100 0 6 12 30 36 42 48 18 24 OS, months CARTITUDE - 4, 1 pLOT CARTITUDE - 4, 2 pLOT CARTITUDE - 4 and CARTITUDE - 1, 3 pLOT CARTITUDE - 1, ≥4 pLOT Patients alive, % Overall, 99 % of products manufactured using cells from patients with 1 - 3 pLOT compared with 97 % for ≥ 4 pLOT MANUFACTURING RELIABILITY 4 OS = Overall Survival; pLOT= prior line of therapy. 1) Parekh S, et al. Blood . 2025;146(suppl 2) Abstract 92. Presented at: 67th ASH Annual Meeting; Dec 6 - 9, 2025; Orlando, FL. 2) CARVYKTI Prescribing Information. Janssen Biotech, Inc. Revised April 2024; 3) Dhakal B, et al. Blood . 2025;146(suppl 1):Abstract 2215. Presented at: 67th ASH Annual Meeting; Dec 6 - 9, 2025; Orlando, FL; 4) Bowden R, et al. Blood . 2025;146(suppl 1):Abstract 2411. Presented at: 67th ASH Annual Meeting; Dec 6 - 9, 2025; Orlando, FL • In CARTITUDE - 4, no cases of parkinsonism in patients who achieved ≥PR with bridging therapy 3 SAFETY • Following implementation of patient management strategies, parkinsonism rates were reduced from 6% in CARTITUDE - 1 to 1% in CARTITUDE - 4 2 Median follow - up for CARTITUDE - 1: 33.4 months. Median follow - up for CARTITUDE - 4: 30.5 months from cilta - cel infusion.

 

 

12 2026 CARVYKTI ® MARKET POTENTIAL (US) 1 : Significant Market Potential in Earlier Line Multiple Myeloma Growth potential is clear, supported by scalable manufacturing capacity 0 20,000 40,000 60,000 2L - 4L Patients Treated (2025) 5L+Patients Treated (2025) CAR - T Therapy Doublet/Triplet Tx In 2025 1 , • ≤5% of patients were treated with a BCMA targeting agent (CAR - T, Bi - Specific, or ADC) in 2L - 4L • ≤10% of patients were treated with a CAR - T in 5L+ 1) Komodo/SHS Claims Data

 

 

Treatment of Myeloma At First Relapse 13 1) Vincent Rajkumar is a Professor of Medicine at the Mayo Clinic in Rochester and Editor - in - Chief at Blood Cancer Journal. Available at: oncoldaily.com . “Vincent Rajkumar: First - Relapse Myeloma Algorithm for ASH25”. Accessed Dec 10, 2025. ASCT; autologous stem cell transplant; Auto; autologous; CAR - T, chimeric antigen receptor T - cell; Dara, daratumumab; Dara - KPd, daratumumab, carfilzomib, pomalidomide, and dexamethasone; DPd, daratumumab, pomalidomide, dexamethasone; DRd, daratumumab, lenalidomide, dexamethasone; KRd, carfilzomib, lenalidomide, dexamethasone; Len, lenalidomide; SCT, stem cell transplant; Tec, teclistamab. Not Refractory to Anti - CD38 Refractory to Anti - CD38 Have access and able to give cell therapy and bispecifics per recommends guidelines Unable to give cell therapy and bispecifics per guidelines Have access and able to give cell therapy per recommends guidelines Unable to give cell therapy per guidelines Standard Triplet** Standard Triplet** *Cilta - cel should be considered in eligible patients , and patients should have a discussion on pros and cons of a one - time CAR - T approach vs. prolonged therapy **Choice of standard triplet is based on refractoriness to Len and other drugs. Key options are DRd, KRd, KPd, DPd, Dara - KPd Consider salvage ACST as alternative in patients eligible for ACST who have not had transplant before; Consider 2 nd auto SCT if eligible and had >36 months response duration with maintenance to first ACST Cilta - cel* or Tec - Dara Cilta - cel* or Standard Triplet** Vincent Rajkumar, Professor of Medicine at the Mayo Clinic ASH25 algorithm for Relapsed Myeloma: First Relapse 1

 

 

Driving CARVYKTI ® Expansion Into the Frontline Advancing into earlier lines to broaden use and fuel long - term growth. 14 CARTITUDE - 2 1 CARTITUDE - 5 2 CARTITUDE - 6 3 • Global, multi - cohort study (NCT04133636) • Phase II open - label study of Cilta - cel in various clinical settings • Global, randomized, registrational study ( NCT04923893 ) • Phase III open - label study of VRd followed by cilta - cel vs. VRd followed by Rd maintenance, in patients with NDMM for whom ASCT is not planned as initial therapy • Global, randomized, registrational study ( NCT05257083 ) • Phase III open - label study comparing DVRd followed by cilta - cel vs. DVRd followed by ASCT in NDMM patients who are transplant eligible ASCT, autologous stem cell transplant; DVRd, daratumumab, bortezomib, lenalidomide, dexamethasone; NDMM, newly diagnosed multiple myeloma; VRd, bortezomib, lenalidomide, dexamethasone. 1) Clinicaltrials.gov: NCT04133636; 2) Clinicaltrials.gov: NCT04923893; 3) Clinicaltrials.gov: NCT05257083. CARTITUDE - 6 is a collaborative study sponsored by the European Myeloma Network.

 

 

Accelerating Growth in the United States Through Community & Outpatient Adoption *combined Legend Biotech and Johnson & Johnson 1) Based on CARVYKTI authorized treatment centers in the United States 15 1/3 Regional/ Community Hospitals 2/3 Academic Hospitals of the MM market is now within 50 miles of a CARVYKTI site (US) of RRMM patients are in the community CARVYKTI ® in the Community 1 Continued Growing Presence in Community Community Network Activation

 

 

16 CARVYKTI ® : Unmatched Real World Results in BCMA CAR - T Unrivaled Evidence. Unmatched Experience. 1) Berdeja et al. [Supplement] Lancet. 2021;398(10297):314 - 324; 2) clinicaltrials.gov. https://www.clinicaltrials.gov/study/NCT03548207 ; 3) Kaur et al, European Hematology Association 2025, Abstract S201; 4) clinicaltrials.gov https://clinicaltrials.gov/study/NCT05396885 ; 5) Based on CARTITUDE 1 exclusion criteria “Have known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma” and iMMagine - 1 exclusion criteria, “Any sign of active or prior CNS pathology including but not limited to history of epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or CNS bleed, severe brain injury, dementia, cerebellar disease, Parkinson's disease”; 6) Arcellx. Investor Relations Event at the 67th ASH Annual Meeting . December 6, 2025. Company presentation; 7) ClinicalTrials.gov. U.S. National Library of Medicine, National Institutes of Health. Available at: https://clinicaltrials.gov . Accessed December 21, 2025; 8) Patel KK, et al. [Abstract title] . Presented at the 67th American Society of Hematology (ASH) Annual Meeting; December 2025. Abstract #256; 9) Patel et al, American Society of Hematology 2025, Abstract 256; 10) National Comprehensive Cancer Network®. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Multiple Myeloma . Version 2.2026. © 2025 National Comprehensive Cancer Network, Inc. All rights reserved. Accessed July 16, 2025. CARVYKTI ® : THE FIRST AND ONLY CAR - T CELL THERAPY TO BE DESIGNATED AS NCCN CATEGORY 1 FOR MULTIPLE MYELOMA AFTER 1 PRIOR THERAPY 10 Anito - Cel 19 clinical sites 7 0 commercial sites ~150 patients (clinical trials only) 6 Not reported 15.9 months Median follow - up (iMMagine - 1) 8 Not approved in any indication No Anito - cel reported two delayed ICANS events (Grade 1 and Grade 2) during ASH 2025 presentation 9 • 3 pLOT • Stricter CNS exclusion criteria 5 • 73% steroid use Late Line mPFS Study Key Patient Data vs. Active triple class exposed (TCE) Data US Site Real - world Indicated Characteristics 1 - 4 Control with 3 pLOT Maturity Experience experience Patients 6 pLOT Less strict CNS exclusion criteria 5 22% steroid use • • • Yes, Superior OS (CART - 4 in label) 50.4 months (CART - 1 & CART - 4) 61.3 months Median follow - up (CART - 1) 141 Sites 10,000+ patients treated (worldwide) 2L+

 

 

17 Optimizing Bridging Therapy Is Associated With Improved CARVYKTI ® Safety Outcomes • 134 patients across 18 US academic medical centers and 2 German centers • 98 RRMM patients received talquetamab bridging therapy and CARVYKTI KEY FINDING There were no cases of IEC colitis or parkinsonism • 761 CARVYKTI treated patients • Risk of parkinsonism was higher in patients who did not respond to bridging therapy • Parkinsonism occurred in 2.9% of patients (n=22) KEY FINDING 95% (21/22) of all Parkinsonism cases occurred in those who did not respond to bridging therapy. 1. Dhakal B, et al. Blood. 2025;146(Suppl 1) 2. Sidana S, et al. Blood. 2025;146(Suppl 1):1034 Dhakal B, et al 1 : USE OF GPRC5D BI - SPECIFIC Sidana S, et al 2 : RESPONSE TO BRIDGING THERAPY IS KEY

 

 

Updated NCCN Guidelines Recommend Bridging Therapy 18 National Comprehensive Cancer Network Guidelines Update 1 “The panel recommends that talquetamab may be considered as a bridge to BCMA CAR - T Therapy in RRMM…” 1. National Comprehensive Cancer Network®. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Multiple Myeloma . Version 5.2026. © 2025 National Comprehensive Cancer Network, Inc. All rights reserved. Accessed January 9, 2026.

 

 

19 The Proven Leader Forging the Path to Cure 1) Based on company public filings and FDA Adverse Event Reporting System (FAERS) Public Dashboard; 2) L.J. Costa et al. “International myeloma working group immunotherapy committee recommendation on sequencing immunotherapy for treatment of multiple myeloma.” Leukemia; https://doi.org/10.1038/s41375 - 024 - 02482 - • First and only CAR - T with demonstrated Overall Survival benefit • First and only CAR - T therapy with meaningful progression free outcomes of ≥5 years in late line MM Highly Effective • Parkinsonism has decreased in earlier lines with patient management strategies • Leveraging large patient data set to assist further risk mitigation efforts Well Tolerated • Efficacy, safety, and manufacturing outcomes all improved with earlier use • IMWG recommends CAR - T therapy before Bispecific T - Cell Engagers in patients eligible for both 2 • mPFS for CARTITUDE 4 is NR with median follow - up of 34 months Earlier Treatment is Better • One - time infusion provides freedom to patients • Can be administered on inpatient or outpatient basis due CARVYKTI’s unique CRS profile • Earlier CAR - T may lower overall treatment costs by reducing future therapies and healthcare utilization One - Time Treatment

 

 

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Pipeline of Transformative Cell Therapy Advancements Provides Continued Value Creation 21 • *In collaboration with Janssen, Pharmaceutical Companies of Johnson & Johnson. †Phase 1 investigator - initiated trial. ‡IND applications have been cleared by the U.S. FDA. #Subject to an exclusive license agreement with Novartis Pharma AG. The safety and efficacy of the agents and/or uses under investigation have not been established. There is no assurance that the agents will receive health authority approval or become commercially available in any country for the uses being investigated. Additionally, as some programs are still confidential, certain candidates may not be included in this list. INDICATIONS: LCNEC: large cell neuroendocrine carcinoma; MM: multiple myeloma; NDMM: newly diagnosed multiple myeloma; NHL: non - Hodgkin lymphoma; RRMM: relapsed or refractory multiple myeloma; SCLC: small cell lung cancer TARGETS: BCMA: B - cell maturation antigen; DLL3: delta - like ligand 3; GCC: guanylyl cyclase C; GPRC5D: G - protein coupled receptor, family C, group 5, member D BCMA - directed Autologous Therapy CARTIFAN - 1* RRMM NCT03758417 CARTITUDE - 1* RRMM NCT03548207 CARTITUDE - 2* MM NCT04133636 CARTITUDE - 4* RRMM 1 - 3 Prior Lines NCT04181827 CARTITUDE - 6* NDMM Transplant Eligible NCT05257083 Ciltacabtagene Autoleucel Clinical Studies P H A S E 2 P H A S E 3 P H A S E 1 LEGEND - 2 † RRMM NCT03090659 P H A S E 1 SCLC & LCNEC ‡# (DLL3) MM † (CD19 X GPRC5D), (GPRC5D) GASTRIC & PANCREATIC ‡ (CLAUDIN 18.2) Additional Pipeline Programs NHL † (CD20) CAR - αβ T MM † (BCMA) CAR - NK NHL † (CD19 X CD20) CAR - γδ T COLORECTAL † (GCC) AUTOIMMUNE † (CD19 X CD20 X CD22) AUTOIMMUNE † (CD19 X BCMA) (CD19 X CD70) NHL † (CD19 X CD20) CARTITUDE - 10* NDMM Transplant Not Intended NCT07149857 CARTITUDE - 5 NDMM Transplant Not Intended NCT04923893 Autologous Therapies Allogeneic Therapies In Vivo Therapies

 

 

22 Advancing R&D Innovation to Drive Long - Term Growth Lean Approach to Clinical Proof of Concept Utilizes R&D Investments Efficiently 1 2 3 Disciplined IIT - to - Global Transition Drives Speed and Capital Efficiency • Advances only assets with validated clinical activity into global trials • Avoids broad early - stage spend across unproven programs • Aligns development investment with demonstrated probability of success Platform - Enabled Execution Delivers Rapid Time - to - First - Patient • Demonstrates repeatable development velocity across emerging platforms • In vivo platform advanced from candidate selection to first patient dosed in approximately six months Unique Proof - of - Concept Model Accelerates Global Entry • Leverages investigator - initiated trials (IITs) in China to rapidly establish early clinical proof - of - concept • De - risks programs prior to initiating larger, more resource - intensive US and EU clinical trials

 

 

Leveraging Stand - Alone Cell Therapy Leadership In Vivo TaVec (T - Cell Activation Vector) Design and Mechanism of Action TARGET • Oncology and autoimmune indications • TaVec platform • Provide T cell specificity, activation and safety • Mutations in glycoprotein and CD3 single - chain variable fragment to block transduction of non - T cells MECHANISM Clinical Development Progress • First few patients dosed for IIT studies in 2025 • Multiple US - IND enabling studies planned for oncology indications State - of - the - art R&D facility opened in Philadelphia, Pennsylvania 23

 

 

CAR - T Expansion & B - Cell Depletion Post In Vivo CAR - T in Monkeys 24 Achieved a dose - dependent CAR - T expansion along with B cell elimination post in vivo CAR - T administration in pigtailed monkeys. 1. BM = Bone Marrow; PBMC= Peripheral Blood Mononuclear Cells 1 1 Low Dose High Dose High Dose:

 

 

2026 Commitment to Business Development 25 Continue Innovation Through Generate Non - Dilutive Funding Through Strategic Partnerships Enabling Technologies Generate Other Revenue Beyond CARVYKTI ® Build on Core Cell & Gene Therapies & Expand Beyond Maintain Hematology Leadership

 

 

26

 

 

Strong Balance Sheet Fueled by CARVYKTI Growth Net Sales (Q3) CARVYKTI ® Net Trade Sales ($MM) 24 55 55 70 114 146 167 258 358 396 2 3 12 140 13 16 140 20 27 31 304 51 318 81 128 0 100 200 300 400 500 600 YoY Growth (Q3 2024) Commercial Momentum • $1.7B LTM CARVYKTI ® Net Trade Sales 1 • CARVYKTI ® Profitable 2 • Positive Cash Flow * $524M in Q3’25 vs. $286M in Q3’24 Cash, cash equivalents, & time deposits as of September 2025 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2022 2022 2022 2023 2023 2023 2023 2024 2024 2024 2024 2025 2025 2025 U.S. OUS ***Certain prior year amounts have been reclassified to combine pledged deposits into prepayments, other receivables, and other assets for comparative purposes. 1) Last Twelve Months Net Trade Sales based on Q4 2024 through Q3 2025 2) Net Trade Sales - Cost of Good Sold - Operating Expenses = CARVYKTI Profit; Compound Annual Growth Rate (CAGR) since launch in 2022 27

 

 

2026 Priorities to Unlock Next Stage of Growth 28 • Deliver sequential CARVYKTI growth • 3/4 of CARVYKTI ® orders from 2 - 4L • Present additional long - term data • Continued globalization ONGOING ONGOING ONGOING ONGOING Advancing Our Cell Therapy Innovation Drive Profitability Maximize CARVYKTI ® Market Leadership TIMING • Present in vivo data • File 1 - 2 US INDs 2H 2026 2H 2026 • Achieve company - wide operating profit • Disciplined operating expense management 2026 ONGOING PRIORITIES GOALS

 

 

 

FAQ

What is the main focus of Legend Biotech (LEGN) in this presentation?

The presentation focuses on CARVYKTI, Legend Biotech’s BCMA-directed CAR-T therapy for multiple myeloma, its commercial growth, clinical data, manufacturing scale-up, and the company’s broader cell therapy pipeline and profitability goals for 2026.

How much revenue is CARVYKTI generating for Legend Biotech (LEGN)?

Legend Biotech reports about $1.7B in last-twelve-month CARVYKTI net trade sales based on Q4 2024 through Q3 2025, and notes that CARVYKTI is profitable on a contribution basis after cost of goods sold and operating expenses.

What is Legend Biotech’s profitability outlook for 2026?

The company states that it expects to achieve company-wide operating profit in 2026, excluding unrealized foreign exchange losses, supported by revenue growth, approximately 60%+ gross margins, and disciplined operating expense management.

How strong is Legend Biotech’s balance sheet according to this update?

Legend Biotech reports about $1B in cash, cash equivalents and time deposits as of September 30, 2025, positive operating cash flow, and a 2,900+ person global team backing its CAR-T and cell therapy programs.

What are Legend Biotech’s 2026 strategic priorities?

For 2026, Legend Biotech highlights three priorities: maximizing CARVYKTI market leadership, advancing its cell therapy innovation (including in vivo platforms and new INDs), and driving company-wide profitability through disciplined spending.

How is Legend Biotech collaborating with Johnson & Johnson on CARVYKTI?

Legend Biotech and Johnson & Johnson have a global collaboration for ciltacabtagene autoleucel with 50/50 cost-sharing and profit-split outside Greater China, and a 30/70 arrangement in Greater China, supporting manufacturing and commercialization.

What clinical results for CARVYKTI are highlighted in this presentation?

The presentation notes that in CARTITUDE-1, some relapsed/refractory multiple myeloma patients remained treatment- and progression-free for ≥5 years after a single CARVYKTI infusion, and that CARTITUDE-4 shows a median progression-free survival not reached at a 34-month median follow-up.
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