• Legend Biotech Reports Third Quarter 2024 Results and Recent Highlights

    Источник: Nasdaq GlobeNewswire / 12 ноя 2024 07:00:01   America/New_York

    • 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 the International Myeloma Society Annual Meeting
      • Initiated commercial production at Obelisc facility in Ghent, Belgium
      • Launched in Switzerland during 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 appointed Alan Bash as President of CARVYKTI®
    • Announced plans for new, state-of-the-art cell therapy R&D facility in Philadelphia
    • Cash and cash equivalents, and time deposits of $1.2 billion, as of September 30, 2024, which Legend Biotech believes will provide financial runway into 2026, when Legend Biotech anticipates 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,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “To this end, we recently initiated commercial production at our Obelisc facility in Ghent, 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’s National 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.
    • Swissmedic approved 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 2024 International Myeloma Society (IMS) Annual Meeting. Legend Biotech and Janssen 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 in Ghent, Belgium, which is expected to help fulfill additional patient demand.
    • Launched CARVYKTI® in Switzerland in 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 in Philadelphia, Pennsylvania, expected to be completed in the third quarter of 2025, to expand Legend Biotech’s existing U.S. R&D footprint and advance its portfolio of next-generation cell therapies.

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

    Third Quarter 2024 Financial Results

    • License Revenue: License revenue was $17.1 million for the three months ended September 30, 2024, which was entirely contributed by the Novartis License Agreement; compared to $20.1 million for the three months ended September 30, 2023, which was entirely contributed by the achievement of milestones under the Janssen Agreement.
    • Collaboration Revenue: Collaboration revenue was $142.8 million for the three months ended September 30, 2024 compared to $75.9 million for the three months ended September 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 million for the three months ended September 30, 2024 compared to $43.5 million for the three months ended September 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 ended September 30, 2024 was $3.0 million and 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 ended September 30, 2023.
    • Other Income and Gains: Other income and gains were $16.8 million for the three months ended September 30, 2024 compared to $35.8 million for the three months ended September 30, 2023.The decrease of $19.0 million was primarily driven by the lack of unrealized foreign exchange gains in the three months ended September 30, 2024, compared to $16.1 million of unrealized foreign exchange gains for the three months ended September 30, 2023.
    • Research and Development Expenses: Research and development expenses were $95.5 million for the three months ended September 30, 2024, compared to $95.9 million for the three months ended September 30, 2023. These expenses are primarily due to research and development activities in cilta-cel, including start-up costs for clinical production in Belgium, as well as continued investment in our solid tumor programs.
    • Administrative Expenses: Administrative expenses were $35.3 million for the three months ended September 30, 2024, compared to $28.1 million for the three months ended September 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 million for the three months ended September 30, 2024, compared to $21.1 million for the three months ended September 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 million for the three months ended September 30, 2024, compared to $0.1 million for the three months ended September 30, 2023. This increase was almost entirely driven by approximately $62.8 million of unrealized foreign exchange loss for the three months ended September 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 ended September 30, 2023, there was no unrealized foreign exchange loss.
    • Net Loss: Net loss was $125.3 million for the three months ended September 30, 2024, compared to a net loss of $62.2 million for the three months ended September 30, 2023.
    • Cash Position: Cash and cash equivalents, and time deposits were $1.2 billion as of September 30, 2024.

    Webcast/Conference Call Details:
    Legend Biotech will host its quarterly earnings call and webcast today at 8:00am ET. To access the webcast, please visit this weblink.

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

    About Legend Biotech
    Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, 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 at https://legendbiotech.com and follow us on X (formerly Twitter) and LinkedIn.

    CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
    Statements 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 to Legend Biotech manufacturing 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 the U.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 the Securities and Exchange Commission on March 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 Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

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

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


    LEGEND BIOTECH CORPORATION
    CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
     
     Three Months Ended
    September 30, 2024    		Nine Months Ended
    September 30, 2024
      2024   2023   2024   2023 
    US$’000, except share and per share data(Unaudited) (Unaudited) (Unaudited) (Unaudited)
    REVENUE       
    License revenue 17,096   20,057   120,123   35,172 
    Collaboration revenue 142,828   75,937   314,563   170,369 
    Other revenue 281   19   6,033   138 
    Total revenue 160,205   96,013   440,719   205,679 
    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 gains 16,815   35,838   49,148   49,812 
    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       
    Basic 366,562,487   363,075,209   365,268,372   348,293,363 
    Diluted 366,562,487   363,075,209   365,268,372   348,293,363 



    LEGEND BIOTECH CORPORATION
    CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
     
      September 30, 2024   December 31, 2023 
      US$’000   US$’000 
      (Unaudited)     
    NON-CURRENT ASSETS       
    Property, plant and equipment 104,031   108,725 
    Advance payments for property, plant and equipment 376   451 
    Right-of-use assets 99,452   80,502 
    Time deposits 4,509   4,362 
    Intangible assets 2,507   4,061 
    Collaboration prepaid leases 172,981   151,216 
    Other non-current assets 1,932   1,493 
    Total non-current assets 385,788   350,810 
    CURRENT ASSETS       
    Collaboration inventories, net 23,548   19,433 
    Trade receivables 705   100,041 
    Prepayments, other receivables and other assets 112,801   69,251 
    Financial assets at fair value through profit or loss —   663 
    Pledged deposits 583   357 
    Time deposits 753,123   30,341 
    Cash and cash equivalents 459,277   1,277,713 
    Total current assets 1,350,037   1,497,799 
    Total assets 1,735,825   1,848,609 
    CURRENT LIABILITIES       
    Trade payables 26,906   20,160 
    Other payables and accruals 164,864   132,802 
    Government grants 554   68 
    Lease liabilities 4,342   3,175 
    Tax payable 11,067   7,203 
    Contract liabilities 63,161   53,010 
    Total current liabilities 270,894   216,418 
    NON-CURRENT LIABILITIES       
    Collaboration interest-bearing advanced funding 296,623   281,328 
    Lease liabilities long term 45,626   44,169 
    Government grants 6,548   7,305 
    Contract liabilities —   47,962 
    Other non-current liabilities 27   56 
    Total non-current liabilities 348,824   380,820 
    Total liabilities 619,718   597,238 
    EQUITY       
    Share capital 37   36 
    Reserves 1,116,070   1,251,335 
    Total ordinary shareholders’ equity 1,116,107   1,251,371 
    Total equity 1,116,107   1,251,371 
    Total liabilities and equity 1,735,825   1,848,609 



    LEGEND BIOTECH CORPORATION
    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
     
      Three Months Ended September 30,Nine Months Ended September 30,
    US$’000  2024   2023   2024   2023 
      

    (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 ACTIVITIES  329,077   (209,072)  (762,702)  (314,723)
    CASH FLOWS PROVIDED BY FINANCING ACTIVITIES  4,245   961   6,031   790,565 
    NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS  257,500   (268,959)  (818,626)  178,211 
    Effect of foreign exchange rate changes, net  524   (784)  190   (772)
    Cash and cash equivalents at beginning of the period  201,253   1,233,213   1,277,713   786,031 
             
    CASH AND CASH EQUIVALENTS AT END OF THE PERIOD  459,277   963,470   459,277   963,470 
    ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS        
    Cash and bank balances  1,217,492   1,242,669   1,217,492   1,242,669 
    Less: Pledged deposits  583   356   583   356 
    Time deposits  757,632   278,843   757,632   278,843 
    Cash and cash equivalents as stated in the statement of financial position  459,277   963,470   459,277   963,470 
    Cash and cash equivalents as stated in the statement of cash flows  459,277   963,470   459,277   963,470 

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