Legend Biotech Reports Third Quarter 2024 Results and Recent Highlights

LEGN 11.12.2024

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Drug:ciltacabtagene-autoleucel CARVYKTI
Diseases:multiple myeloma
Date of Upcoming Event:2024-11-12
Name of Upcoming Event:International Myeloma Society Annual Meeting
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Recent News

  • 01.14.2025 - 43rd Annual JP Morgan Healthcare Conference
  • 12.19.2024 - Legend Biotech to Present at the 43rd Annual J.P. Morgan Healthcare Conference
  • 12.10.2024 - CARVYKTI® Significantly Improved Minimal Residual Disease Negativity Compared to Standard of Care for Patients with Relapsed or Refractory Multiple Myeloma

Recent Filings

  • 01.22.2025 - 6-K Report of foreign issuer [Rules 13a-16 and 15d-16]
  • 01.14.2025 - EX-99.1 EX-99.1
  • 01.10.2025 - 144 Report of proposed sale of securities
  • CARVYKTI®(ciltacabtagene autoleucel; cilta-cel) updates:
    • Net trade sales of approximately$286 million, representing operational growth of 87.6% year-over-year and 53.2% quarter-over-quarter
    • First and only cell therapy clinically shown to significantly extend overall survival versus standard therapies in multiple myeloma patients as early as second line; presented CARTITUDE-4 three-year follow-up data at theInternational Myeloma SocietyAnnual Meeting
    • Initiated commercial productionat Obelisc facility inGhent,Belgium
    • Launched inSwitzerlandduring the third quarter and recently received label expansion into third-line plus settings for multiple myeloma patients
    • Received China’s NMPA approval for the treatment of fourth-line plus multiple myeloma
    • Recently appointedAlan Bashas President of CARVYKTI®
  • Announced plans for new, state-of-the-art cell therapy R&D facility inPhiladelphia
  • Cash and cash equivalents, and time depositsof$1.2 billion, as ofSeptember 30, 2024, whichLegend Biotechbelieves will provide financial runway into 2026, whenLegend Biotechanticipates achieving an operating profit

SOMERSET, N.J.,Nov. 12, 2024(GLOBE NEWSWIRE) --Legend Biotech Corporation(NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its third quarter 2024 unaudited financial results and key corporate highlights.

“We are delighted with the robust sales growth in the third quarter, during which we have continued to increase commercial capacity and deliver CARVYKTI to more multiple myeloma patients around the world. The positive data from our CARTITUDE-4 study further strengthened our competitive position as CARVYKTI is now the first and only cell therapy shown to significantly extend overall survival compared to standard therapies for multiple myeloma patients as early as second line. This underscores the transformational benefits of this therapy and the importance of our efforts to expand patient access,” saidYing Huang, Ph.D., Chief Executive Officer ofLegend Biotech. “To this end, we recently initiated commercial production at our Obelisc facility inGhent,Belgium, which is anticipated to help fulfill demand for CARVYKTI around the world. We look forward to expanding our capacity further while advancing our R&D programs as part of our long-term strategy to strengthen Legend Biotech’s position as a leader in cell therapy innovation.”

Regulatory Updates

  • China’sNational Medical Products Administration(NMPA) approved cilta-cel for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent.
  • Swissmedicapproved label expansion of CARVYKTI®for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and are refractory to lenalidomide.

Key Business Developments

  • Announced positive three-year follow-up data from the Phase 3 CARTITUDE-4 study showing that CARVYKTI®significantly extended overall survival in patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, reducing the risk of death by 45 percent versus standard therapies. These findings were presented in a late-breaking oral session at the 2024International Myeloma Society(IMS) Annual Meeting.Legend BiotechandJanssen Biotech, Inc.* plan to share these results with US and EU regulatory agencies to support potential label updates.
  • Received approval for and initiated commercial production of CARVYKTI®at the new Obelisc site inGhent,Belgium, which is expected to help fulfill additional patient demand.
  • Launched CARVYKTI®inSwitzerlandin the third quarter, marking the expansion into the fifth country where CARVYKTI®is commercially available.
  • Announced the establishment of a new, state-of-the-art research and development (R&D) facility inPhiladelphia, Pennsylvania, expected to be completed in the third quarter of 2025, to expand Legend Biotech’s existingU.S.R&D footprint and advance its portfolio of next-generation cell therapies.

* InDecember 2017,Legend Biotechentered into an exclusive worldwide collaboration and license agreement withJanssen Biotech, Inc., a Johnson & Johnson company, to develop and commercialize cilta-cel (the “Janssen Agreement”).

ThirdQuarter 2024 Financial Results

  • License Revenue: License revenue was$17.1 millionfor the three months endedSeptember 30, 2024, which was entirely contributed by the Novartis License Agreement; compared to$20.1 millionfor the three months endedSeptember 30, 2023, which was entirely contributed by the achievement of milestones under the Janssen Agreement.
  • Collaboration Revenue: Collaboration revenue was$142.8 millionfor the three months endedSeptember 30, 2024compared to$75.9 millionfor the three months endedSeptember 30, 2023. The increase was primarily due to an increase in revenue generated from sales of CARVYKTI®in connection with the Janssen Agreement.
  • Collaboration Cost of Revenue: Collaboration cost of revenue was$52.5 millionfor the three months endedSeptember 30, 2024compared to$43.5 millionfor the three months endedSeptember 30, 2023. The increase was primarily due to higher net trade sales of CARVYKTI®. Collaboration Cost of Revenue is determined based on Legend Biotech’s share of the cost of sales in connection with CARVYKTI®sales under the Janssen Agreement.
  • Cost of License and Other Revenue: Cost of license and other revenue for the three months endedSeptember 30, 2024was$3.0 millionand consisted of costs in connection with the Novartis License Agreement. The Company did not incur any cost of license and other revenue for the three months endedSeptember 30, 2023.
  • Other Income and Gains:Other income and gains were$16.8 millionfor the three months endedSeptember 30, 2024compared to$35.8 millionfor the three months endedSeptember 30, 2023.The decrease of$19.0 millionwas primarily driven by the lack of unrealized foreign exchange gains in the three months endedSeptember 30, 2024, compared to$16.1 millionof unrealized foreign exchange gains for the three months endedSeptember 30, 2023.
  • Research and Development Expenses: Research and development expenses were$95.5 millionfor the three months endedSeptember 30, 2024, compared to$95.9 millionfor the three months endedSeptember 30, 2023. These expenses are primarily due to research and development activities in cilta-cel, including start-up costs for clinical production inBelgium, as well as continued investment in our solid tumor programs.
  • Administrative Expenses:Administrative expenses were$35.3 millionfor the three months endedSeptember 30, 2024, compared to$28.1 millionfor the three months endedSeptember 30, 2023. The increase was primarily due to the expansion of administrative functions and infrastructure to increase manufacturing capacity.
  • Selling and Distribution Expenses: Selling and distribution expenses were$44.3 millionfor the three months endedSeptember 30, 2024, compared to$21.1 millionfor the three months endedSeptember 30, 2023.The increase was primarily driven by costs associated with commercial activities for cilta-cel, including the expansion of the sales force and second line indication launch.
  • Other Expenses:Other expenses were$61.8 millionfor the three months endedSeptember 30, 2024, compared to$0.1 millionfor the three months endedSeptember 30, 2023. This increase was almost entirely driven by approximately$62.8 millionof unrealized foreign exchange loss for the three months endedSeptember 30, 2024. The unrealized foreign exchange losses were primarily driven by intercompany transactions and balances between the US and non-US legal entities related to the research and development activities. For the three months endedSeptember 30, 2023, there was no unrealized foreign exchange loss.
  • Net Loss: Net loss was$125.3 millionfor the three months endedSeptember 30, 2024, compared to a net loss of$62.2 millionfor the three months endedSeptember 30, 2023.
  • Cash Position: Cash and cash equivalents, and time deposits were$1.2 billionas ofSeptember 30, 2024.

Webcast/Conference Call Details:Legend Biotechwill host its quarterly earnings call and webcast today at8:00am ET. To access the webcast, please visit thisweblink.

A replay of the webcast will be available on Legend Biotech’s website athttps://investors.legendbiotech.com/events-and-presentations.

AboutLegend BiotechLegend Biotechis a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered inSomerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogeneic chimeric antigen receptor T-cell, gamma-delta T cell and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of cutting-edge therapeutics for patients worldwide.

Learn more athttps://legendbiotech.comand follow us onX (formerly Twitter)andLinkedIn.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSStatements in this press release 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®and its therapeutic potential; statements relating to the potential approval of CARVYKTI®for earlier lines of therapy; statements related toLegend Biotechmanufacturing expectations for CARVYKTI®and the completion of a new R&D facility in the third quarter of 2024, statements related to Legend Biotech’s ability to fund its operations into 2026; statements related to Legend Biotech’s ability to achieve operating profit; 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 theU.S.litigation process; 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 filed with theSecurities and Exchange CommissiononMarch 19, 2024. 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 press release as anticipated, believed, estimated or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release.Legend Biotechspecifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

INVESTOR CONTACT:Jessie YeungTel: (732) 956-8271jessie.yeung@legendbiotech.com

PRESS CONTACT:Mary Ann OndishTel: (914) 552-4625media@legendbiotech.com

LEGEND BIOTECH CORPORATIONCONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
Three Months EndedSeptember 30, 2024Nine Months EndedSeptember 30, 2024
2024202320242023
US$’000, except share and per share data(Unaudited)(Unaudited)(Unaudited)(Unaudited)
REVENUE
License revenue17,09620,057120,12335,172
Collaboration revenue142,82875,937314,563170,369
Other revenue281196,033138
Total revenue160,20596,013440,719205,679
Collaboration cost of revenue(52,510)(43,479)(146,966)(111,764)
Cost of license and other revenue(2,959)—(13,693)—
Other income and gains16,81535,83849,14849,812
Research and development expenses(95,522)(95,855)(309,112)(276,535)
Administrative expenses(35,300)(28,104)(102,582)(78,062)
Selling and distribution expenses(44,270)(21,098)(98,556)(60,481)
Other expenses(61,841)(134)(1,139)(231)
Fair value loss of warrant liability———(85,750)
Finance costs(5,504)(5,676)(16,463)(15,974)
LOSS BEFORE TAX(120,886)(62,495)(198,644)(373,306)
Income tax expense(4,435)288(4,666)(130)
LOSS FOR THE PERIOD(125,321)(62,207)(203,310)(373,436)
Attributable to:
Ordinary equity holders of the parent(125,321)(62,207)(203,310)(373,436)
LOSS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE PARENT
Basic(0.34)(0.17)(0.56)(1.07)
Diluted(0.34)(0.17)(0.56)(1.07)
ORDINARY SHARES USED IN LOSS PER SHARE COMPUTATION
Basic366,562,487363,075,209365,268,372348,293,363
Diluted366,562,487363,075,209365,268,372348,293,363

LEGEND BIOTECH CORPORATIONCONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
September 30, 2024December 31, 2023
US$’000US$’000
(Unaudited)
NON-CURRENT ASSETS
Property, plant and equipment104,031108,725
Advance payments for property, plant and equipment376451
Right-of-use assets99,45280,502
Time deposits4,5094,362
Intangible assets2,5074,061
Collaboration prepaid leases172,981151,216
Other non-current assets1,9321,493
Total non-current assets385,788350,810
CURRENT ASSETS
Collaboration inventories, net23,54819,433
Trade receivables705100,041
Prepayments, other receivables and other assets112,80169,251
Financial assets at fair value through profit or loss—663
Pledged deposits583357
Time deposits753,12330,341
Cash and cash equivalents459,2771,277,713
Total current assets1,350,0371,497,799
Total assets1,735,8251,848,609
CURRENT LIABILITIES
Trade payables26,90620,160
Other payables and accruals164,864132,802
Government grants55468
Lease liabilities4,3423,175
Tax payable11,0677,203
Contract liabilities63,16153,010
Total current liabilities270,894216,418
NON-CURRENT LIABILITIES
Collaboration interest-bearing advanced funding296,623281,328
Lease liabilities long term45,62644,169
Government grants6,5487,305
Contract liabilities—47,962
Other non-current liabilities2756
Total non-current liabilities348,824380,820
Total liabilities619,718597,238
EQUITY
Share capital3736
Reserves1,116,0701,251,335
Total ordinary shareholders’ equity1,116,1071,251,371
Total equity1,116,1071,251,371
Total liabilities and equity1,735,8251,848,609

LEGEND BIOTECH CORPORATIONCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
Three Months EndedSeptember 30,Nine Months EndedSeptember 30,
US$’0002024202320242023
(Unaudited)(Unaudited)(Unaudited)(Unaudited)
LOSS BEFORE TAX(120,886)(62,495)(198,644)(373,306)
CASH FLOWS USED IN OPERATING ACTIVITIES(75,822)(60,848)(61,955)(297,631)
CASH FLOWS PROVIDED BY/(USED IN) INVESTING ACTIVITIES329,077(209,072)(762,702)(314,723)
CASH FLOWS PROVIDED BY FINANCING ACTIVITIES4,2459616,031790,565
NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS257,500(268,959)(818,626)178,211
Effect of foreign exchange rate changes, net524(784)190(772)
Cash and cash equivalents at beginning of the period201,2531,233,2131,277,713786,031
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD459,277963,470459,277963,470
ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS
Cash and bank balances1,217,4921,242,6691,217,4921,242,669
Less: Pledged deposits583356583356
Time deposits757,632278,843757,632278,843
Cash and cash equivalents as stated in the statement of financial position459,277963,470459,277963,470
Cash and cash equivalents as stated in the statement of cash flows459,277963,470459,277963,470

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Source: Legend Biotech USA Inc.

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