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 11, 2021

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 ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

Legend Biotech Presentation at J.P. Morgan 39th Annual Healthcare Conference 2021 DIGITAL

On January 13, 2021, Legend Biotech Corporation will make its company presentation for J.P.Morgan 39th Annual Healthcare Conference 2021 Digital available on its website. The presentation is attached hereto as Exhibit 99.1 and may be viewed at the Company’s website at https://www.legendbiotech.com/index.php.

EXHIBIT INDEX

Exhibit Title
 
 
99.1 Presentation dated January 13, 2021

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
 
(Registrant)
 
 
 
January 11, 2021
By:
/s/ Ying Huang
 
 
Ying Huang, Ph.D.
 
 
Chief Executive Officer and Chief Financial Officer

Exhibit 99.1

 

 Disclaimer  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. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated.Certain information contained in this presentation and statements made orally during this presentation relates to or is 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. Forward-Looking Statements This presentation contains “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. 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. These forward-looking statements include, but are not limited to, statements relating to the Company’s strategies and objectives; the anticipated timing of, and ability to progress, clinical trials; the ability to make, and the timing of, regulatory submissions in the United States, Europe and Asia, including the ongoing BLA filings for cilta-cel to the U.S. FDA, the submission of a marketing authorization application for cilta-cel to the EMA, and the submission of an IND LB1901 in relapsed or refractory TCL; the ability to generate, analyze and present data from clinical trials; patient enrollment; anticipated timing regarding regulatory approvals by the FDA, EMA or CDE; and the potential benefits of Legend Biotech’s product candidates. Actual results may differ materially from those indicated by such forward-looking statements as 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 new 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 as 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 US litigation process; competition in general; government, industry, and general public pricing and other political pressures; the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation; as well as the other factors discussed in the “Risk Factors” section of the Company’s prospectus filed with the Securities and Exchange Commission on June 8, 2020. 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. None of the Company nor any of its affiliates, advisers, or representatives has any obligation and does not undertake to update any forward-looking statements to reflect future events or circumstances.   2 
 

 Cell Therapy Platform Overview 
 

 FUTURE PIPELINE  Global collaboration with Janssen for the development of cilta-cel established December 2017Received an upfront payment of $350 million and a total of $110 million in milestone payments to dateUp to an additional $1,165 million in potential future milestone payments  We Are A Fully Integrated Global Cellular Therapy Company  4  RRMM: Relapsed and/or Refractory Multiple Myeloma; AML: acute myeloid leukemia; KOL: key opinion leaders*Legal entity to the agreement is Janssen Biotech, Inc.          COMPELLING DATA WITHINNOVATIVE PIPELINE  GLOBAL COLLABORATION WITH JANSSEN*  INTEGRATED CELL THERAPY PLATFORM  In-house antibody generation and CAR-T specific functional screening technologiesEarly clinical proof-of-concept, leveraging KOL relationships in China, the US and globallyBuilding large-scale manufacturing facilities in the United States, Europe and China>800 employees worldwide in US, China and Europe  Lead product candidate ciltacabtagene autoleucel (cilta-cel) may have the potential to deliver deep and durable anti-tumor responses in RRMMBroad portfolio of earlier-stage autologous product candidates targeting both hematologic and solid cancers, as well as allogeneic CAR-T approaches  AML  LYMPHOMA  GASTRIC CANCER  OVARIAN CANCER  INFECTIOUS DISEASE 
 

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Legend Biotech’s Global R&D Strategy  5  With a Presence in Major Geographies, our Mission is to Improve the Lives of Patients Worldwide  CAR, Chimeric Antigen Receptor; TCR, T-Cell Receptor        CoreTechnologies  Disease Areas  Product Platforms  Hematologic Malignancies  CAR  Autologous  Allogeneic  TCR  Solid Tumors  Infectious Diseases  
 

 End-to-End R&D Capability  6  Proprietary methodology to optimize the selection of binding domains and design CAR-T constructs with two or more antigen-binding domains  Robust in vitro and in vivo screening platforms to prioritize pipeline assets   High-throughput antibody screening and engineering capability including single-domain antibodies generated from Llama and conventional antibodies      Binding Domain Selection and Construct Design  Pre-clinical Validation  Antibody Screening Platforms      Clinical Proof of Concept  Efficient clinical translation, leveraging deep relationships with KOLs in US and China                  
 

   Robust Pipeline of Next-Generation Cell Therapies  7  InfectiousDiseases  SolidTumors  Preclinical  Phase 1  Phase 2  Phase 3  Autologous  TCL(CD4)  NHL-DLBCL(CD19 x CD22)  AML(CD33 x CLL-1)  MM*(BCMA)  Allogeneic  NHL-DLBCL, FL, MCL, SLL (CD20)  HIV (Undisclosed)  LEGEND-2  CARTITUDE-4    Pancreatic Cancer(Claudin 18.2)  Gastric Cancer(Claudin 18.2)      Ovarian Cancer (MSLN)    Hematologic Malignancies  CARTITUDE-1  CARTIFAN-1  CARTITUDE-2                    US / RoW    China  AML=acute myeloid leukemia, BCMA=B-cell maturation antigen, DLBCL=diffuse large B-cell lymphoma, FL=follicular lymphoma, HIV= human immunodeficiency virus, MCL=mantle cell lymphoma, NHL=non-Hodgkin lymphomas, MM= multiple myeloma, MSLN=mesothelin, RoW=Rest of World, SLL=small lymphocytic lymphoma, TCL=T-cell lymphoma*In collaboration with Janssen, Pharmaceutical Companies of Johnson & Johnson  MM (BCMA)    US / China             
 

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Legend and Janssen Global Collaboration  8    Worldwide collaboration and license agreement to develop and commercialize cilta-cel  US 50 / 50  Europe 50 / 50   Greater China 70 / 30 Legend / Janssen  Japan50 / 50  Potential Additional Milestone Paymentsup to $1,040 million  Potential Additional Manufacturing Milestone Paymentsup to $125 million  First Milestone$25 millionDec 2018  Fourth Milestone$30 millionJan 2020  Third Milestone$30 millionJul 2019  Second Milestone$25 millionJul 2019  Upfront Payment$350 millionQ1 2018                    Fifth Milestone$75 millionDecember 2020   
 

 Highly Experienced Management Team  9    CHINA    US      TRACY LUOClinical Development  CHONG YANGCommercial Development  FRANK FANResearch & Development  SIMON WUResearch & Development      YUHONG QIUGlobal Regulatory  STEVE GAVELCommercial Development   ALAN KICKGlobal Quality  ELIZABETH GOSENGlobal Manufacturing  MEETA CHATTERJEEGlobal Business Development  QIONG WANGResearch & Development  YING HUANG Chief Executive Officer/ Chief Financial Officer 
 

 Cilta-celClinical Development  
 

   Multiple Myeloma: Blood Cancer with a High Unmet Need  11  CI, confidence interval; PI, Protease Inhibitor; IMiD, immunomodulatory drug; MM, multiple myeloma; OS, overall survival 1 Cancer Stat Facts: Myeloma. https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed March 2020. 2 Palumbo A, et al. N Engl J Med. 2011;364(11):1046–60. 3 Globocan 2018 World Fact Sheet: World. https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed March 2020. 4 Globocan 2018 World Fact Sheet: United States of America. http://gco.iarc.fr/today/data/factsheets/populations/840-united-states-of-america-fact-sheets.pdf. Accessed March 2020. 5 Globocan 2018 World Fact Sheet: Europe. https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf. Accessed March 2020. 6 Globocan 2018 World Fact Sheet: China. https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Accessed March 2020. 7 Gandhi UH, et al. Leukemia. 2019;33:2266-75.      US: Incidence is 25,962, with mortality of 13,6484  EUROPE: Incidence is 48,297, with mortality of 30,8605  CHINA: Incidence is 20,066, with mortality of 14,6556  160,000 NEW CASES WORLDWIDE IN 2018,accounting for 1% of worldwidenew cancer cases3                                                                                                                                                                                                                                                                                                    1.0  0.8  0.6  0.4  0.2  0.0  0  10  20  30  40  50  Months  Proportion Surviving  Non-triple-refractory (N=57)  Triple-and quad-refractory (N=148)  Penta-refractory (N=70)  P=0.002                            POOR SURVIVAL OUTCOMES IN MULTIPLE REFRACTORY MMMedian OS < 12 months                                                                                                                                                                                                              3RD MOST COMMON BLOOD CANCER1,   accounting for >10% of all hematologic cancer2  in patients refractory to anti-CD38, ≥ 1 PI(s) and / or ≥ 1 IMiD(s)7  Median OS for each group        Median OS(months)  95% Cl        Non-triple-refractory  11.2  (5.4–17.1)        Triple-and quad-refractory  9.2  (7.1–11.2)        Penta-refractory  5.6  (3.5–7.8)                                                                     
 

 First-in-Human, Phase 1, Dose Finding Study in RRMM LEGEND-2: LCAR-B38M CAR-T cells  12                                                                Shanghai  Jiangsu Province Hospital2 Chen, ASH 2019 Poster  Nanjing  Second Affiliated Hospital of Xi’an Jiaotong University1 Wang et al, ASH 2019 Oral Presentation  Xi’an  Data cut-off: 31 July 2019 (N=57) and 31 October 2019 (N=17);1 Wang B-Y et al. Abstract presented at: 61st ASH Annual Meeting 2019; December 7-10, 2019; Orlando, FL2 Chen, et al. ASH 2019. Abstract #1858; Orlando, FL    Shanghai Ruijin Hospital2Chen, ASH 2019 Poster  Shanghai Changzheng Hospital2Chen, ASH 2019 Poster    Xi’an        Nanjing      Shanghai      Enrollment  Total: 74 patients (4 sites in China) Xi’an: N=57, Wang, et al. ASH 2019JS/RJ/CZ sites: N=17, Chen, et al. ASH 2019  Active MM defined by IMWG criteria with documented disease progression during or within 12 months of most recent anti-MM drugs or auto-HSCTRelapsed on prior regimens  Key Inclusion Criteria1,2  Administered dose (CAR+ viable T cells/kg)  Xi'an1 (median)=0.5x106 (0.07-2.1x106)RJ/CZ/JS2 (mean)=0.70x106 (0.2–1.5x106)   Preconditioning  Cyclophosphamide only (Xi’an, Jiangsu)1,2Cyclophosphamide + fludarabine (Changzheng, Ruijin)2   Safety & Tolerability  Cilta-cel CAR-T cells displayed a safety profile consistent with other safety reports of BCMA-targeting CAR-T cell therapy1,2 
 

 LEGEND-2: Long-Term Deep Responses and High Response Rate  13  ORRa = 88%  74%(n=42)  4%(n=2)  11%(n=6)  9%(n=5)  2%(n=1)  2%(n=1)  82%(n=14)  6%(n=1)  12%(n=2)  Xi'an: Best overall response (N=57)1  ORRa = 88%  Median time to initial response= 1 month2mPFS = 18 months; mOS= not reached2   mDOR= 27.0 months (mDOR for CR= 29.1 months)1Median time to initial response= 1 month1mPFS= 19.9 months (mPFS for CR= 28.2 months)1 mOS = 36.1 months (mOS for CR not reached)1   Ruijin (RJ), Jiangsu (JS), Changzheng (CZ): Best overall response (N=17)2  Median follow-up 25 months   Median follow-up 26 months   Data cut-off: 31 July 2019 (N=57) and 31 October 2019 (N=17); Xi'an: NE patient died of PE/ACS prior to first evaluation. RJ,JS, CZ: For NE patients, 1 patient died on Day 13 due to CRS and tumor lysis syndrome; 1 patient received chemotherapy prior to first assessment and was censored. a ORR=PR or better; response assessed per International Myeloma Working Group criteriaCR, complete response; VGPR, very good partial response; PR, partial response; SD, stable disease; PD, progressive disease; NE, not evaluable; mDOR, median duration of response; MRD, minimal residual disease; ORR, overall response rate; mPFS, median progression free survival; mOS, median overall survival.1 Wang B-Y et al. Abstract presented at: 61st ASH Annual Meeting 2019; December 7-10, 2019; Orlando, FL; 2 Chen, et al. ASH 2019. Abstract #1858 
 

 Post-infusion AssessmentsSafety, Efficacy, PK, PD, Biomarker  Screening (28 Days)  Apheresis  Bridging Therapya (as needed)  Cy (300 mg/m2) + Flu (30 mg/m2)  Cilta-cel InfusionTarget: 0.75x106 (0.5 – 1.0x106) CAR+ viable T cells/kg  Follow-up  CARTITUDE-1: Phase 1b/2 Study Design  14  14                                Day -5 to -3  Day 1      Primary Objectives  Key Inclusion Criteria  Administered dose  Median administered dose was 0.71x106(0.51 – 0.95x106) CAR+ viable T cells/kg  Progressive MM per IMWG criteriaECOG PS ≤1 Measurable diseaseReceived ≥3 prior therapies or double refractoryPrior PI, IMiD, anti-CD38 therapy  Phase 1b: Characterize the safety of cilta-cel and confirm the recommended phase 2 dosePhase 2: Evaluate the efficacy of cilta-cel by ORR            NCT03548207; Data cut-off: 01 Sept 2020; a Treatment that was received previously and resulted in at least stable disease. Cy=cyclophosphamide; ECOG PS=Eastern Cooperative Oncology Group performance status; Flu=fludarabine; IMiD=immunomodulatory drug; IMWG=International Myeloma Working Group; PI=proteasome inhibitor; PD=pharmacodynamic; PK=pharmacokinetic ; MM=multiple myelomaMadduri et al. ASH Annual Meeting Virtual Experience; December 2-11, 2020; Abstract 177..  
 

 15  CARTITUDE-1: Baseline Characteristics   Characteristic  N=97  Age, median (range) years  61.0 (43–78)  Male, n (%)  57 (58.8)  Extramedullary plasmacytomas ≥1, n (%)  13 (13.4)a  Bone-marrow plasma cells ≥60%, n (%)  21 (21.9)  Years since diagnosis, median (range)  5.9 (1.6–18.2)  High-risk cytogenetic profile, n (%)  23 (23.7)  del17p  19 (19.6)  t(14;16)  2 (2.1)  t(4;14)  3 (3.1)  Tumor BCMA expression ≥50%, n (%)  57 (91.9)b  Characteristic  N=97  Prior lines of therapy, median (range)  6.0 (3–18)  Previous stem-cell transplantation, n (%)    Autologous  87 (89.7)  Allogenic  8 (8.2)  Triple-class exposed,c n (%)  97 (100)  Penta-exposed,d n (%)   81 (83.5)  Triple-class refractoryc  85 (87.6)  Penta-refractoryd  41 (42.3)  Refractory status, n (%)     Carfilzomib  63 (64.9)   Pomalidomide  81 (83.5)  Anti-CD38 antibody  96 (99.0)  Refractory to last line of therapy, n (%)  96 (99.0)  Data cut-off: 01 Sept 2020; aAdditional 6 patients had a soft-tissue component of a bone-based plasmacytoma (total plasmacytomas, 19.6%). bDenominator n=62, the number of evaluable samples; BCMA expression detected in all evaluable samples. cAt least 1 PI, at least 1 IMiD, and 1 anti-CD38 antibody. dAt least 2 PIs, at least 2 IMiDs, and 1 anti-CD38 antibody.BCMA, B-cell maturation antigen; IMiD, immunomodulatory drug; PI, proteasome inhibitor.        Madduri et al. ASH Annual Meeting Virtual Experience; December 2-11, 2020; Abstract 177 
 

 16  Madduri et al. ASH Annual Meeting Virtual Experience; December 2-11, 2020; Abstract 177.     N = 97      Any Grade  Grade 3/4   Hematologic AEs, (≥30%), n (%)  97 (100)  96 (99.0)   Neutropenia  93 (95.9)  92 (94.8)   Anemia  79 (81.4)  66 (68.0)   Thrombocytopenia  77 (79.4)  58 (59.8)   Leukopenia  60 (61.9)  59 (60.8)   Lymphopenia  51 (52.6)  48 (49.5)  Non-hematologic AEs (≥30%), n (%)       Hypocalcemia  31 (32.0)  3 (3.1)   Hypophosphatemia  30 (30.9)  7 (7.2)   Fatigue   36 (37.1)  5 (5.2)   Cough   34 (35.1)  0  CAR-T-associated AEs, n (%)       CRS  92 (94.8)  4 (4.1)   Neurotoxicity   20 (20.6)  9 (9.3)  Data cut-off: 01 Sept 2020; aEvents not reported as ICANS [ie, onset after a period of recovery from CRS and/or ICANS]). bAmong 12 patients with other NTX, 5 had AEs including movement and/or neurocognitive changes, and 7 had AEs including nerve palsy and peripheral motor neuropathy. AE, adverse event; CAR-T, chimeric antigen receptor T cell; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome.   CARTITUDE-1: Safety  CRS94.6% of patients experienced low-grade CRS (n=92)Median time to onset of 7 days (range, 1-12)Median duration of 4 days (range, 1-97) and managed with supportive care measures Neurotoxicity20.6% of patients experienced neurotoxicity in total with overlap between ICANS and Other Neurotoxicities (Grade ≥3: 10.3%)ICANS observed in 16.5% (Grade ≥3: 2.1%)Other Neurotoxicities observed in 12.4% (Grade ≥3: 9.3%)Deaths14 total deaths observedDeaths due to progressive disease (n=5)Deaths due to adverse events unrelated to treatment (n=3)Deaths due to adverse events related to treatment (n=6) 
 

 17  CARTITUDE-1: Early, Deep Responses and High Response Rate  Data cut-off: 01 Sept 2020; aPR or better, Independent Review Committee assessed. bNo patient had CR or stable disease as best response. cMRD was assessed in evaluable samples at 10-5 threshold by next-generation sequencing (clonoSEQ, Adaptive Biotechnologies) in all treated patients at Day 28, and at 6, 12, 18, and 24 months regardless of the status of disease measured in blood or urine; patients were not evaluable primarily due to lack of an identifiable clone in the baseline bone marrow sample. dAll treated patients. CAR, chimeric antigen receptor; CR, complete response; MRD, minimal residual disease; ORR, overall response rate; PR, partial response; sCR, stringent complete response; VGPR, very good partial response. Madduri et al. ASH Annual Meeting Virtual Experience; December 2-11, 2020; Abstract 177  Median time to first response: 1 month (0.9–8.5)Responses ongoing in 70 (72.2%) patientsOf evaluable patients, 93.0% achieved MRD 10-5 negativityMedian time to MRD 10-5 negativity: 1 month (0.8–7.7)  ≥VGPR: 92.8%  sCR: 67.0%    sCR  VGPR  PR   Best responseb =       
 

 18  CARTITUDE-1: PFS  Overall PFS   Overall 12-month PFS: 76.6% (95% CI, 66.0–84.3)Median PFS not reached  Data cut-off: 01 Sept 2020; OS, overall survival; PFS, progression-free survival; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.Madduri et al. ASH Annual Meeting Virtual Experience; December 2-11, 2020; Abstract 177  PFS by sCR and VGPR  At median duration of follow-up of 12.4 months (range, 1.5–24.9), median PFS has not been reached12-month PFS rate: 76.6% (95% CI, 66.0–84.3)12-month OS rate: 88.5% (95% CI, 80.2–93.5)  No. at risk  sCR  VGPR  25  24  19  15  3  2  0  0  0  0  65  65  62  53  27  12  2  1  1  0      12-month PFSsCR: 84.5% (95% CI, 72.0–91.8)VGPR: 68.0% (95% CI, 46.1–82.5) Median PFS not reached in either group                                                                                   
 

 Clinical Program: Cilta-cel Studies in Multiple Myeloma  19  DPd=daratumumab, pomalidomide, dexamethasone; EU=European Union; JP=Japan; PVd=pomalidomide, bortezomib, dexamethasone; RRMM=relapsed and/or refractory multiple myeloma; SoC=standard of care; US=United States. 1 NCT03090659. Clinicaltrials.gov website. https://clinicaltrials.gov/ct2/show/NCT03090659. Accessed Jan 2021; 2 NCT03548207. Clinicaltrials.gov website. https://clinicaltrials.gov/ct2/show/NCT03548207. Accessed Jan 2021;3 NCT03758417. Clinicaltrials.gov website. https://clinicaltrials.gov/ct2/show/NCT03758417. Accessed Jan 2021; 4 NCT04133636. Clinicaltrials.gov website. https://clinicaltrials.gov/ct2/show/NCT04133636. Accessed Jan 2021; 5 NCT04181827. Clinicaltrials.gov website: https://clinicaltrials.gov/ct2/show/NCT04181827. Accessed Jan 2021    FIH Study in ChinaLong-term Follow-up     Registrational Studies    Earlier Lines of Therapy  LEGEND-21  NCT03090659  NCT03548207  NCT03758417  NCT04133636  NCT04181827  Phase 1, multi-centerstudy of LCAR-B38M CAR-T cells in RRMMFully enrolled and ongoing in China  Phase 2, multi-center confirmatory study ofcilta-cel in RRMMOngoing in China  Phase 1b/2, multi-center registration study of cilta-cel in RRMMFully enrolled and ongoing in US and Japan  Global, multi-cohort studyPhase 2 open-label study of cilta-cel in various clinical settings to evaluate MRD negativityEnrolling in US / EU/ Israel  Global, randomized studyPhase 3 open-label study of cilta-cel vs DPd or PVd in patients with RRMM, 1–3 lines of prior therapy and refractory to lenalidomideEnrolling in US/EU/JP/AUS/ Israel  CARTITUDE-1MMY20012  CARTIFAN-1MMY20023  CARTITUDE-2MMY20034  CARTITUDE-4MMY30025 
 

   Global Manufacturing Network  20                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                EU Facility In Planning    US Facilities   China Facilities    Raritan, NJ  Nanjing  Zhenjiang  Somerset, NJ  BCMA US / EU / JP / ROW Launch/ Commercial SiteGMP Operational  BCMA China Launch Site & Legend Clinical Supply SiteGMP Operational  Additional Commercial Site Construction in progress  US / EU / JP Legend Clinical Supply SiteInitiating construction phase  State-of-the Art Manufacturing  Robust and Scalable Global Supply of Cell Therapies  EU launch from Raritan, NJ, USEU Site in planning phase   
 

   Future Potential Milestone Payments  21    Clinical Milestones: $105M  $105 million for the achievement of specified future development milestones  $725 million for the achievement of specified regulatory milestones  Regulatory Milestones: $725M  Further milestone payments of up to $125 million for the achievement of specified manufacturing milestones  Manufacturing Milestones: $125M  $210 million for the achievement of specified net trade sales milestones.  Commercial Milestones: $210M   Future Milestones 
 

 Near-Term Targets for Legend Biotech  22    File BLA in China for cilta-cel    Targeted FDA approval for cilta-cel in US    1H21  2H21  US: United States; BLA: Biologics License Application; FDA: Federal Drug Administration; MAA: Marketing Authorization Application; EMA: European Medicines Agency  Targeted CDE approval for cilta-cel in China    2022  Targeted EMA approval for cilta-cel in EU    2022  Initiate phase 1 study for LB1901 for T-cell Lymphoma in US    2021  File MAA with EMA for cilta-cel    2H21 
 

 Investment Highlights  23    Global Collaboration  Global collaboration with Janssen for the development of cilta-cel with ongoing clinical trials  Deep and durable anti-tumor responses observed in heavily pretreated patients; initiation of BLA submission with the FDA took place in December 2020  Promising Clinical Data  End-to-end R&D and manufacturing capabilities with two core technologies (CAR and TCR) and two platforms (Autologous and Allogeneic)  Experienced team with broad involvement in biopharmaceutical drug discovery, development and commercialization  Fully Integrated Platform  Strong Management         
 

 

 Thank You !