Exhibit 99.1
Legend Biotech Corporate Presentation This presentation is for investor relations purposes only – Not for product promotional purposes JANUARY 2024
Disclaimer 3 This presentation is for investor relations purposes only – Not for product promotional purposes 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®, including Legend Biotech’s expectations for CARVYKTI®, including manufacturing expectations for CARVYKTI®; and statements about regulatory submissions for CARVYKTI®, and the progress of such submissions with the FDA, the EMA and other regulatory authorities; and expected results and timing of clinical trials; Legend Biotech’s expectations for LB2102 and its potential benefits; Legend Biotech’s ability to close the licensing transaction with Novartis and potential benefits of the transaction; Legend Biotech’s expectations on advancing their pipeline and product portfolio; 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 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 U.S. litigation process; competition in general; government, industry, and general product 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 Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission (SEC) on March 30, 2023 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.
Legend Biotech Highlights Core Technologies: CAR-T, including universal CAR CAR-NK – T3 Global Manufacturing Sites for CARVYKTI®: 3 This presentation is for investor relations purposes only – Not for product promotional purposes 1 site in US 2 sites in EU (Ghent)4 2 sites in China4 1 Novartis site (CMO) Pipeline Programs Covering: Hematologic malignancies Solid tumors in Cash and Cash Equivalents, Deposits, and Short-Term Investments5 1. In collaboration with J&J; 2. Please read Prescribing Information for full safety information: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/CARVYKTI-pi.pdf; 3. gamma delta T cells; 4. EU and China manufacturing site construction is in progress; 5. As of September 30, 2023 Marketed Product: CARVYKTI® (ciltacabtagene autoleucel; cilta-cel)1,2 Years Since Inception One of the earliest companies to engineer CAR-T cells for the BCMA protein Employees Dedicated to R&D
CARVYKTI® Uptake Continues → U.S. QoQ growth of 23% primarily driven by: Successful launch execution Deepening market share Capacity improvements Increased number of activated U.S. treatment sites to 64 → EU QoQ growth of 300% due to launch in Germany Continued market penetration, geographic expansion, and population in earlier lines of treatment represent significant growth drivers and opportunity CARVYKTI® Net Product Sales ($MM) +176% growth vs Q3’22 U.S. EU 24 55 55 70 114 140 0 0 0 2 3 12 0 20 40 60 80 100 120 140 160 Q2 2022 Q3 2022 Q4 2022 Q1 2023 Q2 2023 Q3 2023 YOY GROWTH Q3 ’23 OVER Q2 ’23 GROWTH U.S. 155% 23% EU N/A 300% GLOBAL 176% 30% 3 This presentation is for investor relations purposes only – Not for product promotional purposes
A New Standard for CAR-T Launches C A RV YK T I ® - I N D U S T RY L E A D I N G E A R LY L A U N C H P E RFORM A NCE F I R S T S I X QU A RT E R S OU T P E R F OR M I N G H I S TOR I C A L CA R - T L A UNCHES 93 96 92 50 0 100 Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 Q13 Q14 Q15 Q16 Q17 Q18 Q19 Q20 Q21 Q22 Q23 Q24 W O R L D W I D E S A L E S O F C A R - T T H E R A P I E S , B Y Q U A R T E R O F L A U N C H ( I N $ M M ) 400 391 Kymriah Yescarta Tecartus Breyanzi Abecma Carvykti 350 300 250 200 152 150 124 Quarters since launch Quarterly sales ($MM) Data Source: Companies' public filings. 3 This presentation is for investor relations purposes only – Not for product promotional purposes
Pioneer and Leader in Cell Therapy 3 This presentation is for investor relations purposes only – Not for product promotional purposes
7 A Fully Integrated Global Leader in Cell Therapy MANUFACTURING EXPERTISE DEVELOPED THROUGH GLOBAL COLLABORATION WITH J&J* Cilta-cel development collaboration combines Legend’s leadership in cell therapy with J&J’s* expertise in global drug development Expanding manufacturing capacity in the US and China and building large-scale manufacturing facilities in the EU INTEGRATED CELL THERAPY PLATFORM In-house antibody generation and CAR-T specific functional screening technologies Early clinical proof-of-concept, working with KOLs in China, the US and globally Autologous and allogeneic platforms enable sustainable growth and scalability to address future commercial demand Strong intellectual property position KOL, key opinion leaders *Legal entity to the agreement is Janssen Biotech, Inc.; collaboration established in December 2017 MARKET-LEADING MULTIPLE MYELOMA (MM) CAR-T THERAPY sBLA and Type II variation to support label expansion accepted by U.S. FDA (PDUFA target action date of April 5, 2024) and EMA, respectively Application supported by first randomized Phase 3 study for cilta-cel use as early as 2L COMPELLING MM PROGRAM AND AN INNOVATIVE PIPELINE Cilta-cel demonstrates consistently deep and durable responses across clinical trials with a manageable safety profile De-risked Phase 3 Programs present opportunities to unlock value in earlier line MM indications Additional pre- / early clinical stage programs targeting both hematologic and solid tumor indications This presentation is for investor relations purposes only – Not for product promotional purposes
8 Our Differentiated R&D Approach Diverse platform for allogeneic treatments Diverse allogeneic platforms, including non- gene editing universal CAR-T and NK Antibody screening & engineering In-house antibody generation and CAR-T- specific functional screening technologies Armoring strategy for solid tumors Multiple armored CAR-T strategies to overcome challenges in treatment of solid tumors Antibody Screening Platforms This presentation is for investor relations purposes only – Not for product promotional purposes High-throughput antibody screening and engineering capability, including single- domain antibodies generated from llama and conventional antibodies Binding Domain Selection and Construct Design Proprietary methodology to optimize the selection of binding domains and design CAR-T constructs with two or more antigen-binding domains Pre-clinical Validation Robust in vitro and in vivo screening platforms to prioritize pipeline assets Clinical Proof of Concept Efficient clinical translation with IND and IIT studies, working with KOLs in US and China Potential best-in-class proprietary technology platforms and end-to-end capability
9 This presentation is for investor relations purposes only – Not for product promotional purposes Legend and J&J Global Collaboration Worldwide collaboration and license agreement to develop and commercialize cilta-cel 2023 2018 2019 2020 2021 Eligible for Potential Additional Milestone Payments First Milestone $25 million Dec 2018 Fourth Milestone $30 million Jan 2020 Third Milestone $30 million Jul 2019 Second Milestone $25 million Jul 2019 Upfront Payment $350 million Q1 2018 Fifth Milestone $75 million December 2020 Sixth Milestone $15 million May 2021 50/50 United States Europe Japan 50/50 50/50 70/30 Greater China 7th/8th Milestones $50 million January 2022 9th Milestone $50 million April 2022 2022 10th/11th Milestones $35 million* August 2023 *On August 3, 2023, Legend Biotech received a payment in the amount of $15 million for the EMA’s acceptance of the Type II Variation Application for CARVYKTI®, in accordance with Legend Biotech’s license and collaboration agreement with Janssen (Janssen Agreement). In September 2023, Legend Biotech received a milestone payment of $20 million in connection with the FDA’s acceptance of the sBLA, in accordance with the Janssen Agreement.
Global Manufacturing Footprint EU Facilities US Facilities China Facilities Raritan, NJ Nanjing 75-acre Somerset, NJ Nanjing Legend China Clinical Supply Site for Pipeline Programs & Potential China Launch Site for CARVYKTI® GMP Operational Potential Future Commercial Site for CARVYKTI® Construction ongoing US / EU / JP / ROW Launch/ Commercial Site for CARVYKTI® GMP Operational US / EU / JP Legend Clinical Supply Site for Pipeline Programs Building E Ghent, Belgium 13 This presentation is for investor relations purposes only – Not for product promotional purposes Ghent, Belgium Future Commercial Site for CARVYKTI® Clinical production scheduled in January 2024 and commercial production expected in 2H 2024 Future Commercial Site for CARVYKTI® Construction ongoing
Expanding Our Manufacturing Capabilities Novartis as CMO for Clinical Supply J&J In-House Lentivirus Facilities* Bringing cell therapies to market given unique challenges to improve overall supply State-Of-The-Art CARVYKTI® Manufacturing Facilities Obelisc Facility in Ghent, Belgium received license from the Federal Agency for Medicines and Health Products in Belgium for clinical supply manufacturing Awaiting Investigational Medicinal Product Dossier approvals from local authorities Anticipate manufacturing cilta-cel at Ghent for clinical use in January 2024 and commercial use in 2H 2024 13 This presentation is for investor relations purposes only – Not for product promotional purposes J&J facility in Switzerland now producing Lentivirus in- house All commercial Lentivirus now produced in-house and we are self-sufficient Additional Lentivirus supply is expected to be available from J&J facilities in US and Netherlands in 2024 and 2025, respectively Signed CMO agreement with Novartis during Q2 2023 On track to produce clinical materials in 1H 2024 *All the Lentivirus facilities are owned by J&J.
Out-licensing Deal with Novartis on CAR-T Therapies Targeting DLL3 Legend announced on Nov 13, 2023 an exclusive, global license agreement with Novartis to advance certain DLL3-targeted CAR-T therapies, including LB2102, an investigational therapy for small cell lung cancer. Legend announced on Jan 3, 2024 closing of the license transaction. AN UPFRONT PAYMENT ELIGIBLE MILESTONE PAYMENTS up to $1.01B POTENTIAL APPLICATION OF T-Charge™ Platform of Novartis FOR MANUFACTURING DLL3 DEVELOPMEMT AND COSTS → Legend to conduct Ph1 for LB2102 in the US → Novartis to conduct all other development for the licensed products Plus Tiered Royalties on Net Sales 13 This presentation is for investor relations purposes only – Not for product promotional purposes $100M
Our Pipeline Global US China P R E C L I N I C A L P H A S E 2 P H A S E 3 P H A S E 1 NSCLC (GPC3) Autologous *In collaboration with Janssen, Pharmaceutical Companies of Johnson & Johnson. †Phase 1 IIT in China. ‡IND applications have been cleared by the U.S. FDA. §Subject to an exclusive license agreement with Novartis Pharma AG. Under the License Agreement, Legend Biotech will conduct a Phase 1 clinical trial for LB2102 in the U.S. and Novartis will conduct all other development for the licensed products. 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. ALL, acute lymphoblastic leukemia; BCMA, B-cell maturation antigen; DLL3, delta-like ligand 3; GPC3, glypican-3; GCC, guanylyl cyclase C; HCC, hepatocellular carcinoma; IIT, investigator-initiated trial; MM, multiple myeloma; ND, newly diagnosed; NHL, non-Hodgkin lymphoma; NSCLC, non small cell lung cancer; RRMM, relapsed or refractory multiple myeloma; SCLC, small cell lung cancer. COLORECTAL (GCC) Autologous NHL† /ALL† (CD19 X CD20 X CD22)† Autologous NCT05318963 NCT05292898 MM† (BCMA) Allogeneic – CAR- T NCT05376345 RRMM (BCMA) LEGEND-2† Autologous NCT03090659 MM† (BCMA) Allogeneic CAR-NK NCT05498545 GASTRIC & ESOPHAGEAL & PANCREATIC‡ (CLAUDIN 18.2) Autologous NCT05539430 HCC† (GPC3) Autologous NCT05352542 RRMM (BCMA)* CARTIFAN-1 Autologous NCT03758417 RRMM (BCMA)* CARTITUDE-1 Autologous NCT03548207 MM (BCMA)* CARTITUDE-2 Autologous NCT04133636 RRMM (BCMA)* 1-3 Prior Lines CARTITUDE-4 Autologous NCT04181827 NDMM (BCMA)* Transplant Not Intended 1L CARTITUDE-5 Autologous NCT04923893 NDMM (BCMA)* Transplant Eligible 1L CARTITUDE-6 Autologous NCT05257083 SCLC‡§ (DLL3) Autologous NCT05680922 13 This presentation is for investor relations purposes only – Not for product promotional purposes
NEAR-TERM GOALS Outlook: 2024 and Beyond → Continue to increase manufacturing capacity and efficiency → Begin manufacturing from Ghent facilities → Complete enrollment of CARTITUDE-5 in 1H24 → Ongoing enrollment of CARTITUDE-6 → Advance early-stage pipeline programs → Launch lenalidomide refractory 1-3 prior lines indication based on CARTITUDE-4, if approved by regulatory authorities. The PDUFA target action date is April 5, 2024. CHMP opinion, anticipated in 1Q 2024 → Move CARVYKTI® to earlier lines of therapy; increase penetration in the US and expand into global markets → Focus on unmet medical needs in hematology/oncology → Develop therapies with transforming potential → Increase accessibility through lower cost and scalable manufacturing → Build a global powerhouse by leveraging external collaborations LONG-TERM GROWTH STRATEGY 13 This presentation is for investor relations purposes only – Not for product promotional purposes