Slides
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1 First Quarter 2025 Financial Results & Corporate Update May 13, 2025 This presentation is for investor relations purposes only - Not for product promotional purposes
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Opening Remarks Q1 2025 Performance Overview Our Pipeline Upcoming Milestones CARVYKTI® Performance Overview Financial Performance Q&A Agenda 1 2 3 4 5 6 7 2 This presentation is for investor relations purposes only - Not for product promotional purposes
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Ying Huang, PhD Chief Executive Officer Jessie Yeung Interim Chief Financial Officer 3 This presentation is for investor relations purposes only - not for product promotional purposes Alan Bash President of CARVYKTI®
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Forward-looking Statements 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®; and statements about regulatory submissions for CARVYKTI®, statements related to Legend Biotech's ability to achieve operating profit; statements related to Legend Biotech’s ability to fund its operations into the second quarter of 2026 and 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 its pipeline and product portfolio, including TaVec; 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; as well as 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. 4 This presentation is for investor relations purposes only - Not for product promotional purposes
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5 Non-IFRS financial metrics This presentation refers to certain non-IFRS financial metrics. We use Adjusted Net Loss and Adjusted Net Loss per Share (which we sometimes refer to as “ANL per Share”) as performance metrics. Adjusted Net Loss and ANL per Share are not defined under IFRS, are not a measure of operating income, operating performance, or liquidity presented in accordance with IFRS, and are subject to important limitations. Our use of Adjusted Net Loss has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under IFRS. For example: (i) although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and Adjusted Net Loss does not reflect cash capital expenditure requirements for such replacements or for new capital expenditure requirements; (ii) Adjusted Net Loss excludes unrealized foreign exchange gain (loss) which was primarily resulted from changes in the intercompany loan balances and cash balances as a result of exchange rate changes between USD and EURO; (iii) Adjusted Net Loss does not reflect changes in, or cash requirements for, our working capital needs; and (iv) Adjusted Net Loss excludes such as share based compensation expense, which has been, and will continue to be fore the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy. Also, our definition of Adjusted Net Loss and Adjusted Net Loss per share may not be the same as similarly titled measures used by other companies. However, we believe that providing information concerning Adjusted Net Loss and Adjusted Net Loss per Share enhances an investor’s understanding of our financial performance. We use Adjusted Net Loss as a performance metric that guides management in its operations of planning for the future of the business. We believe that Adjusted Net Loss provides a useful measure of our operation performance from a period to period by excluding certain items that we believe are not representative of our core business. We define Adjusted Net Loss as net loss adjusted for (1) non-cash items such as depreciation and amortization, share-based compensation, and impairment loss and (2) unrealized foreign exchange gain or loss mainly related to intercompany loan balances and cash deposit balances as a result of exchange rate changes between USD and EUR. Adjusted Net Loss per Share is computed by dividing Adjusted Net Loss by the weighted average shares outstanding. Reconciliations of Adjusted Net Loss and Adjusted Net Loss per Share to the most directly comparable IFRS measures are included on the slide 19 of this presentation. 5 This presentation is for investor relations purposes only - Not for product promotional purposes
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6 6 1. 79% Net Trade Sales CAGR for CARVKYTI compared to <50% CAGR since launch for other CAR-T launches. 2. Committee for Medicinal Products for Human Use of the European Medicines Agency 3. 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/s41375-024-02482-6 First and only CAR-T cell therapy demonstrating superior OS vs SoC in Multiple Myeloma >6,000 patients treated worldwide Strongest CAR-T launch to date with industry leading 79% NTS CAGR since launch1 Positive opinion from CHMP2 for inclusion of CARTITUDE-4 Overall Survival benefit in CARVYKTI® label International Myeloma Working Group recommended using CAR-T therapy ahead of bi-specifics3 – Proven Leader Forging the Path to Cure This presentation is for investor relations purposes only - Not for product promotional purposes
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7 This presentation is for investor relations purposes only - Not for product promotional purposes - Proven CAR-T Market Leader in Multiple Myeloma 2022 2023 2024 Approval and Indication Expansion Deepening Community Penetration Preparing for 1L Approval Ongoing Data Redefining Treatment Expectations in MM 4L+ Approval 2L+ Approval Continued Market Leadership 2025 2026 CARVYKTI® Transformed the Multiple Myeloma Treatment Paradigm Extensive Real World Data New data anticipated at upcoming major medical meetings First and Only Approved BCMA Targeting Therapy in 2L+ MM Global Market Launches • United States (2L+) • Canada (2L+) • Europe (2L+) • Brazil (2L+) • Anticipated additional global submissions Significant Market Opportunity >150,000 MM patients worldwide IMWG Recommendation International Myeloma Working Group recommended BCMA CAR-T therapy before Bispecific T-Cell Engagers in patients who are reasonable candidates for both1 1. 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- 024-02482-6
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8 *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: ALL: acute lymphoblastic leukemia; 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 Autologous Therapies BCMA-directed Autologous Therapy P H A S E 2 P H A S E 3 LEGEND-2† RRMM NCT03090659 CARTIFAN-1* RRMM NCT03758417 CARTITUDE-1* RRMM NCT03548207 CARTITUDE-2* MM NCT04133636 CARTITUDE-4* RRMM 1-3 Prior Lines NCT04181827 CARTITUDE-5* NDMM Transplant Not Intended NCT04923893 CARTITUDE-6* NDMM Transplant Eligible NCT05257083 Ciltacabtagene Autoleucel Clinical Studies P H A S E 1 P R E C L I N I C A L P H A S E 1 NHL † /ALL† (CD19 X CD20 X CD22) GASTRIC & PANCREATIC‡ (CLAUDIN 18.2) SCLC & LCNEC‡# (DLL3) COLORECTAL† (GCC) Additional Pipeline Assets Allogeneic Therapies MM† (BCMA) CAR-γδ T NHL† (CD19 X CD20) CAR-γδ T NHL† (CD20) CAR-αβ T MM† (BCMA) CAR-NK MM † (CD19 X GPRC5D), (GPRC5D) AUTOIMMUNE † (CD19 X CD20 X CD22) AUTOIMMUNE (CD19 X BCMA) Our Pipeline
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9 In Vivo Delivery 9 This presentation is for investor relations purposes only - Not for product promotional purposes A next generation approach to off-the shelf CAR-T In Vivo CAR-T Therapy Reprogramming immune cells directly in the body through direct infusion, eliminating the need for ex vivo cell engineering and manufacturing • Better CAR-T cell fitness • Off-the-shelf therapy • No lymphodepletion necessary • Scalable manufacturing T cell binder
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10 R E C E N T M I L E S T O N E S A N T I C I P A T E D M I L E S T O N E S Establishing a strong foundation for CARVYKTI® market penetration Obtained FDA1 and EMA2 approval for CARVYKTI® in 2L+ relapsed and lenalidomide-refractory MM OS label update in Europe • Continue executing global launches for CARVYKTI® in 2L+ therapy • Outpatient program expansion • OS label update in U.S. Strengthening our manufacturing capabilities Initiated commercial production of CARVYKTI® at Novartis* production facility in Q1 2025 Initiated clinical production at the Tech Lane facility in Belgium in Q1 2025 • Approval of new Raritan section in 2H25 • Belgium - Tech Lane to initiate commercial production Unlocking value across our broader pipeline Completed enrollment in CARTITUDE-5 in July 2024 Made investments in a new, state-of-the-art R&D facility in Philadelphia • Complete enrollment in CARTITUDE-6 • Advance in vivo pipeline programs targeting oncology and autoimmune targets • Philadelphia R&D site expected to open during 2H 2025 *Novartis Pharmaceuticals Corporation Recent and Upcoming Anticipated Milestones 10 This presentation is for investor relations purposes only - Not for product promotional purposes 1. U.S. Food and Drug Administration 2. The European Union Medicines Agency
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+135% growth to $369M in Q1 ’25 vs. $157M in Q1’24 CARVYKTI® Net Trade Sales ($MM) U.S. OUS 24 55 55 70 114 140 146 140 167 258 304 318 0 0 0 2 3 12 13 16 20 27 31 51 0 50 100 150 200 250 300 350 400 Q2 2022 Q3 2022 Q4 2022 Q1 2023 Q2 2023 Q3 2023 Q4 2023 Q1 2024 Q2 2024 Q3 2024 Q4 2024 Q1 2025 → U.S. QoQ growth of 5% primarily driven by manufacturing performance and capacity expansion • Number of activated U.S. treatment sites increased to 114 • Continued strong demand with >50% utilization in earlier line settings → OUS QoQ growth of 65% primarily driven by: • Capacity expansion • Ongoing launch strength, with recent launches in the UK, Denmark, Israel, Spain and Belgium Continued market penetration, population in earlier lines of treatment represents significant opportunity for continued growth 11 CARVYKTI® Uptake Continues YoY Growth1 QoQ Growth2 U.S. 127% 5% OUS 219% 65% Global 135% 10% 1. Q1 2025 vs Q1 2024; 2. Q1 2025 vs Q4 2024 This presentation is for investor relations purposes only - Not for product promotional purposes
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12 1H22 2H22 1H23 2H23 1H24 2H24 1H25 2H25 1H26 2H26 1H27 2H27 2028 2029 2030 Doses Launch Facilities Expansion/ Process Optimization Raritan Slot Ramp Up Obelisc Clinical + Commercial Online Tech Lane Online CMO Clinical + Commercial Online Raritan Physical Expansion Facilities Driving To Full Capacity • Aim to double commercial supply in 2025 to achieve: • 10,000 annualized doses exiting 2025 • 20,000 annualized doses exiting 2027 • Initial commercial production at Tech Lane Facility targeted for 2H 2025 • New section approval expected in Raritan facility in 2H 2025 UPCOMING ANTICIPATED MILESTONES 12 US and EU CARVYKTI® Supply Overview This presentation is for investor relations purposes only - Not for product promotional purposes
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13 13 Reliable Manufacturing for Physicians and their MM1 Patients This presentation is for investor relations purposes only - Not for product promotional purposes • The International Myeloma Working Group recommends bridging therapy (BT) after apheresis for CAR-T manufacturing in certain MM patients3 • In CARTITUDE 4, all 208 patients randomized to the CARVYKTI arm received BT with DPd or PVd • DPd, DKd, PVd5, and Talvey cycles range 7 to 28 days, with washout periods ranging 14 to 28 days CARVYKTI TAT Accommodates Bridging Therapy 1. Multiple Myeloma 2. Defined as (CARVYKTI Deliveries + exceptional-release cilta-cel deliveries) / (Patients who underwent leukapheresis for CARVYKTI – orders cancelled for non-manufacturing-related reasons) = % of Patients infused with CAR-T Cell Therapy 3. Costa, L.J., Banerjee, R., Mian, H. et al. International myeloma working group immunotherapy committee recommendation on sequencing immunotherapy for treatment of multiple myeloma. Leukemia 39, 543–554 (2025). https://doi.org/10.1038/s41375-024-02482-6 4. Over the last six months 5. Daratumumab + pomalidomide, + dexamethasone, Daratumumab (Darzalex) + carfilzomib (Kyprolis) + dexamethasone, pomalidomide + bortezomib + dexamethasone 6. Turn Around Time from apheresis to release 97% Success in CAR-T Cell Manufacturing2 CARVYKTI delivered on-time (or before) 95% of the time4 Declining median Turn Around Time (TAT) of 30 Days6
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14 14 This presentation is for investor relations purposes only - Not for product promotional purposes Q1 2025 Financial Highlights 94 195 0 50 100 150 200 -60 -101 -120 -100 -80 -60 -40 -20 0 -0.23 -0.07 -0.25 -0.20 -0.15 -0.10 -0.05 0.00 0.05 0.10 IFRS Total Revenue (in $MM) IFRS Net Income/(Loss) (in $MM) Adjusted Net Loss Per Share 1 Q1 2024 Q1 2025 Q1 2024 Q1 2025 Q1 2024 Q1 2025 -0.16 -0.27 -0.30 -0.25 -0.20 -0.15 -0.10 -0.05 0.00 IFRS Net Loss Per Share Q1 2024 Q1 2025 -85 -27 -90 -80 -70 -60 -50 -40 -30 -20 -10 0 Adjusted Net Loss 1 (in $MM) Q1 2024 Q1 2025 1. Adjusted Net Loss and Adjusted Net Loss per Share (on basic shares basis) are non-IFRS measures. Reconciliations of Adjusted Net Loss and Adjusted Net Loss Per Share to the most directly comparable IFRS measures are included on slide 18 of this presentation. The definitions of these non-GAAP measures are at the beginning of this presentation.
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15 15 This presentation is for investor relations purposes only - Not for product promotional purposes Focused Investments in Commercialization and Pipeline Q1 2025 OpEx increased 11% versus Q1 2024 o Research and development (R&D) spend increased by $1 million due to R&D activities in cilta-cel with two ongoing frontline studies, offset by a decrease in other cilta-cel research and development activities. o Selling and distribution (S&D) spend increased by $17 million due to commercial activities including expansion of the sales force due to growing sales of CARVYKTI. o Administrative expenses remained flat, due to increased staffing related expenses offset by lower infrastructure expenses. Cash position of approximately $1.0 billion expected to fund operating and capital expenditures into Q2 2026 157 16 174 1 2024 Q1 R&D Delta SG&A Delta 2025 Q1 0 20 40 60 80 100 120 140 160 180 200 Operating Expenses ($MM)
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16 Executing Toward Anticipated Company Wide Profitability in 2026 16 KEY DRIVERS COMMERCIAL Further expand market leadership in Multiple Myeloma CAR-T therapies Add overall survival to label MANUFACTURING Increasing manufacturing efficiency Expanding capacity for 10,000 annualized doses exiting 2025 FINANCIAL Scaling business with ~$1B cash position Continued margin expansion This presentation is for investor relations purposes only - Not for product promotional purposes
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17 Ying Huang, Ph.D. Chief Executive Officer Jessie Yeung Interim Chief Financial Officer Mythili Koneru, M.D., Ph.D. Chief Medical Officer Alan Bash President of CARVYKTI® 17 Q&A Guowei Fang, Ph.D. President of Research and Development This presentation is for investor relations purposes only - Not for product promotional purposes
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18 Thank you! This presentation is for investor relations purposes only - Not for product promotional purposes
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19 19 Reconciliation of IFRS to Non-IFRS Metrics Three months ended March 31, ($ in thousands, except per share data) 2025 2024 Net loss (100,916) (59,793) Depreciation and amortization 5,199 5,722 Share-based compensation 15,946 18,703 Impairment loss 970 — Unrealized foreign exchange loss/(gain) (included in Other income/(expense), net) 51,802 (49,889) Adjusted net loss (ANL) (26,999) (85,257) ANL per share: ANL per share – basic (0.07) (0.23) ANL per share - diluted (0.07) (0.23) Financials under IFRS Earnings per share – basic (0.27) (0.16) Earnings per share – diluted (0.27) (0.16) Shares – basic 367,525,855 364,010,429 Shares - diluted 367,525,855 364,010,429 This presentation is for investor relations purposes only - Not for product promotional purposes