• Legend Biotech Reports Fourth Quarter and Full Year 2024 Results and Recent Highlights

    Источник: Nasdaq GlobeNewswire / 11 мар 2025 07:00:00   America/New_York

    • CARVYKTI® net trade sales of approximately $334 million and $963 million for the fourth quarter and full year 2024, respectively
    • Over 5,000 patients treated to date
    • Initiated commercial production of CARVYKTI® at a Novartis production facility
    • Spain's national health system approved reimbursement for CARVYKTI® in second-line plus settings for multiple myeloma patients
    • Cash and cash equivalents, and time deposits of $1.1 billion, as of December 31, 2024, which Legend Biotech believes will provide financial runway into the second quarter of fiscal year 2026

    SOMERSET, N.J., March 11, 2025 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported financial results for the fourth quarter and year ended December 31, 2024, and key corporate highlights.

    “We are coming off a tremendously successful year. Our 2024 total revenue nearly achieved blockbuster status, and we are just now building out our many opportunities with CARVYKTI. There are more milestones ahead that will potentially make CARVYKTI available to even more patients,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “CARVYKTI has already helped thousands of multiple myeloma patients. Even though CARVYKTI is the market leader for CAR-T in multiple myeloma, we are still working relentlessly to elevate our commercial, manufacturing, regulatory and clinical efforts. While we are focused on executing with excellence for CARVYKTI this year, we continue to prioritize the right investments to enhance our opportunities as a stand-alone cell therapy company for the long term.”

    Key Business Developments

    • Treated over 5,000 clinical and commercial patients to date.
    • Announced positive three-year follow-up data from the Phase 3 CARTITUDE-4 study showing that CARVYKTI® increased the minimal residual disease (MRD) negativity rates when compared to the standard of care for patients with relapsed or refractory multiple myeloma. In the study, 89 percent of evaluable patients achieved MRD negativity at the 10-5 threshold, with the majority of patients achieving MRD negativity in less than two months.
    • In the first quarter of 2025, initiated commercial production of CARVYKTI® at a Novartis production facility pursuant to the master manufacturing and supply agreement among Legend, Janssen, and Novartis.
    • Spain's national health system, Sistema Nacional de Salud (“SNS”), approved reimbursement for CARVYKTI® for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of treatment, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression after the last treatment and are refractory to lenalidomide.
    • Cash and cash equivalents, and time deposits of $1.1 billion, as of December 31, 2024, which Legend Biotech believes will provide financial runway into the second quarter of fiscal year 2026, when Legend Biotech anticipates potentially achieving an operating profit excluding unrealized foreign exchange gains or losses.

    Financial Results for Quarter and Year Ended December 31, 2024

    Cash and Cash Equivalents, and Time Deposits

    As of December 31, 2024, Legend Biotech had approximately $1.1 billion of cash and cash equivalents and time deposits.

    Revenue

    License Revenue
    There was $18.3 million license revenue for the three months ended December 31, 2024, and no license revenue for December 31, 2023. This increase of $18.3 million was primarily driven by the license revenue recognized in 2024 pursuant to Legend Biotech’s license agreement with Novartis for the development, manufacture, and commercialization of LB2102 and other potential CAR-T therapies selectively targeting DLL-3 (the “Novartis License Agreement”), and since the license agreement was effective as of December 28, 2023, no license revenue was recognized in 2023. License revenue for the year ended December 31, 2024, was $138.4 million, compared to $35.2 million for the year ended December 31, 2023. This increase of $103.2 million was primarily driven by the license revenue recognized in 2024 pursuant to the Novartis License Agreement, as well as the nature and timing of milestones achieved as outlined under the Janssen Agreement for cilta-cel.

    Collaboration Revenue
    Collaboration revenue for the three months and year ended December 31, 2024, was $168.0 million and $482.6 million, respectively, compared to $79.4 million and $249.8 million for the three months and year ended December 31, 2023, respectively. The increase of $88.6 million and $232.8 million for the three months and year ended, respectively, was due to an increase in revenue generated from sales of CARVYKTI® in connection with the Janssen Agreement.

    Other Revenue
    Other revenue for the three months and year ended December 31, 2024, was $0.2 million and $6.3 million, respectively, compared to $0.0 million and $0.2 million for the three months and year ended December 31, 2023, respectively. Other revenue primarily includes payments made in connection with the supply of materials by us to Novartis under the terms of the Novartis License Agreement.

    Operating Expenses

    Cost of Collaboration Revenue
    Cost of collaboration revenue for the three months and year ended December 31, 2024, was $69.4 million and $216.4 million, respectively, compared to $32.5 million and $144.2 million for the three months and year ended December 31, 2023, respectively. The increase of $36.9 million and $72.2 million for the three months and year ended, respectively, were due to a combination of Legend Biotech’s share of the cost of sales in connection with CARVYKTI® sales under the Janssen Agreement and expenditures to support expansion in manufacturing capacity.

    Cost of License and Other Revenue
    Cost of license and other revenue for the three months and year ended December 31, 2024, was $4.5 million and $18.2 million, respectively, and consisted of costs in connection with the Novartis License Agreement. The Company did not incur any costs of license and other revenue for the three months and year ended December 31, 2023.

    Research and Development Expenses
    Research and development expenses for the three months and year ended December 31, 2024, were $104.4 million and $413.5 million, respectively, compared to $105.7 million and $382.2 million for the three months and year ended December 31, 2023, respectively. The increase of $31.3 million for the year ended was 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 for the three months and year ended December 31, 2024, were $34.2 million and $136.8 million, respectively, compared to $28.7 million and $106.8 million for the three months and year ended December 31, 2023, respectively. The increase of $5.5 million and $30.0 million for the three months and year ended, respectively, was primarily due to the expansion of administrative functions and the additional headcount needed to provide administrative support as a result of the company's expanded infrastructure, driven by increased manufacturing capacity.

    Selling and Distribution Expenses
    Selling and distribution expenses for the three months and year ended December 31, 2024, were $48.9 million and $147.5 million, respectively, compared to $33.7 million and $94.2 million for the three months and year ended December 31, 2023, respectively. The increase of $15.2 million and $53.3 million for the three months and year ended, respectively was primarily driven by an increase in costs associated with commercial activities for cilta-cel, including the expansion of the sales force and second line indication launch.

    Other Income and Gains
    Other income and gains for the three months and year ended December 31, 2024, were $125.1 million and $173.1 million, respectively, compared to $18.5 million and $58.1 million for the three months and year ended December 31, 2023, respectively. The increase of $106.6 million and $115.0 million for the three months and year ended, respectively, were primarily attributable to an increase in unrealized foreign exchange gains related to the changes in the intercompany loan balances and cash balances as a result of exchange rate changes between USD and Euro.

    Other Expenses
    For the three months and year ended December 31, 2024, there were no expenses, compared to $38.4 million and $28.5 million for the three months and year ended December 31, 2023. The decrease of $38.4 million and $28.5 million for the three months and year ended, respectively, were primarily due to unrealized foreign currency exchange loss related to the changes in the intercompany loan balances and cash balances as a result of exchange rate changes between USD and Euro.

    Net income or loss for the Period
    For the three months ended December 31, 2024, net income was $26.3 million, or $0.07 per share, compared to a net loss of $144.8 million, or $0.40 per share, for the three months ended December 31, 2023. The increase of $171.1 million for the three months ended was primarily attributable to unrealized foreign currency exchange gains due to changes in the intercompany loan balances and cash balances as a result of exchange rate changes between USD and Euro. For the year ended December 31, 2024, net loss was $177.0 million, or $0.48 per share, compared to a net loss of $518.3 million, or $1.47 per share, for the year ended December 31, 2023.

    Adjusted Net Loss for the Period
    Adjusted net loss for the three months ended December 31, 2024 was $59.1 million, or an adjusted net loss of $0.16 per share, compared to an adjusted net loss of $88.5 million, or an adjusted net loss of $0.24 per share, for the three months ended December 31, 2023. For the year ended December 31, 2024, adjusted net loss was $188.8 million, or an adjusted net loss of $0.52 per share, compared to an adjusted net loss $335.7 million, or an adjusted net loss of $0.95 per share, for the year ended December 31, 2023.

    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
    With over 2,500 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. The company is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the US, Legend is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI’s patient access and therapeutic potential. From this platform, the company plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.

    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 related to Legend Biotech manufacturing expectations for CARVYKTI®, statements related to Legend Biotech’s ability to fund its operations into 2026 and Legend Biotech’s anticipated achievement of operating profit excluding unrealized foreign exchange gains or losses in 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 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 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
    (UNAUDITED)
       
     Three Months Ended
    December 31,
    		 Year Ended
    December 31,
     2024 2023 2024 2023
    US$’000, except share and per share data       
    REVENUE       
    License revenue18,281  —  138,404  35,160 
    Collaboration revenue168,017  79,435  482,580  249,804 
    Other revenue224  29  6,257  179 
    Total revenue186,522  79,464  627,241  285,143 
    Cost of collaboration revenue(69,399) (32,450) (216,365) (144,214)
    Cost of license and other revenue(4,523) —  (18,216) — 
    Research and development expenses(104,432) (105,683) (413,544) (382,218)
    Administrative expenses(34,201) (28,707) (136,783) (106,769)
    Selling and distribution expenses(48,925) (33,677) (147,481) (94,158)
    Other income and gains125,056  18,450  173,093  58,126 
    Other expenses(12) (38,389) (40) (28,484)
    Fair value loss of warrant liability—  —  —  (85,750)
    Loss on Asset Impairment(4,423) —  (4,423) — 
    Finance costs(5,152) (5,820) (21,615) (21,794)
    INCOME (LOSS) BEFORE TAX40,511  (146,812) (158,133) (520,118)
    Income tax (expense)/benefit(14,227) 1,994  (18,893) 1,864 
    NET INCOME (LOSS) FOR THE PERIOD26,284  (144,818) (177,026) (518,254)
    Attributable to:       
    Ordinary equity holders of the parent26,284  (144,818) (177,026) (518,254)
    NET INCOME (LOSS) PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE PARENT       
    Basic0.07  (0.40) (0.48) (1.47)
    Diluted0.07  (0.40) (0.48) (1.47)
    ORDINARY SHARES USED IN NET INCOME (LOSS) PER SHARE COMPUTATION       
    Basic366,648,551  363,655,317  365,702,143  352,165,418 
    Diluted402,806,991  363,655,317  365,702,143  352,165,418 
                


    LEGEND BIOTECH CORPORATION
    CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
    (UNAUDITED)
          
     December 31,
    2024
    		 December 31,
    2023
     US$’000
    		 US$’000
    NON-CURRENT ASSETS     
    Property, plant and equipment99,288  108,725 
    Advance payments for property, plant and equipment374  451 
    Right-of-use assets101,932  80,502 
    Time deposits4,362  4,362 
    Intangible assets2,160  4,061 
    Collaboration prepaid leases172,064  151,216 
    Other non-current assets6,056  1,493 
    Total non-current assets386,236  350,810 
    CURRENT ASSETS     
    Collaboration inventories, net23,903  19,433 
    Trade receivables6,287  100,041 
    Prepayments, other receivables and other assets130,975  69,251 
    Financial assets at fair value through profit or loss—  663 
    Pledged deposits70  357 
    Time deposits835,934  30,341 
    Cash and cash equivalents286,749  1,277,713 
    Total current assets1,283,918  1,497,799 
    Total assets1,670,154  1,848,609 
    CURRENT LIABILITIES     
    Trade payables38,594  30,655 
    Other payables and accruals166,180  122,307 
    Government grants532  68 
    Lease liabilities4,794  3,175 
    Tax payable20,671  7,203 
    Contract liabilities46,874  53,010 
    Total current liabilities277,645  216,418 
    NON-CURRENT LIABILITIES     
    Collaboration interest-bearing advanced funding301,196  281,328 
    Lease liabilities long term44,613  44,169 
    Government grants6,154  7,305 
    Contract liabilities—  47,962 
    Other non-current liabilities—  56 
    Total non-current liabilities351,963  380,820 
    Total liabilities629,608  597,238 
    EQUITY     
    Share capital37  36 
    Reserves1,040,509  1,251,335 
    Total ordinary shareholders’ equity1,040,546  1,251,371 
    Total equity1,040,546  1,251,371 
    Total liabilities and equity1,670,154  1,848,609 
          


    LEGEND BIOTECH CORPORATION
    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
    (UNAUDITED)
                
     Three Months Ended December 31,
    		 Year Ended December 31,
    US$’0002024 2023 2024 2023
                
    INCOME (LOSS) BEFORE TAX40,511  (146,812) (158,133) (520,118)
    CASH FLOWS (USED IN) OPERATING ACTIVITIES(82,078) (95,645) (144,033) (393,276)
    CASH FLOWS (USED IN)/PROVIDED BY INVESTING ACTIVITIES(87,842) 407,509  (850,544) 92,786 
    CASH FLOWS (USED IN)/PROVIDED BY FINANCING ACTIVITIES(333) 925  5,698  791,490 
    NET (DECREASE)/INCREASE IN CASH AND CASH EQUIVALENTS(170,253) 312,789  (988,879) 491,000 
    Effect of foreign exchange rate changes, net(2,275) 1,454  (2,085) 682 
    Cash and cash equivalents at beginning of the period459,277  963,470  1,277,713  786,031 
            
    CASH AND CASH EQUIVALENTS AT END OF THE YEAR286,749  1,277,713  286,749  1,277,713 
    ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS       
    Cash and bank balances1,127,115  1,312,773  1,127,115  1,312,773 
    Less: Pledged deposits70  357  70  357 
    Time deposits840,296  34,703  840,296  34,703 
    Cash and cash equivalents as stated in the statement of financial position286,749  1,277,713  286,749  1,277,713 
    Cash and cash equivalents as stated in the statement of cash flows286,749  1,277,713  286,749  1,277,713 
                

    RECONCILIATION OF IFRS TO NON-IFRS MEASURES

    We use Adjusted Net Loss and Adjusted Net Loss per Share (which we sometimes refer to as “ANI per Share”) as performance metrics. Adjusted Net Loss and ANI 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:

    • 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.
    • Adjusted Net Income (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.
    • Adjusted Net Loss does not reflect changes in, or cash requirements for, our working capital needs.
    • In addition, Adjusted Net Loss excludes such as share based compensation expense, which has been, and will continue to be for 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 operation of and planning for the future of the business. We believe that Adjusted Net Loss provides a useful measure of our operating performance from 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, impairment loss and fair value loss of warrant liability 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.

        
    LEGEND BIOTECH CORPORATION
    RECONCILIATION OF IFRS TO NON-IFRS
    (UNAUDITED)
        
      Three Months Ended December 31,Year Ended December 31,
    US$’000 2024 2023 2024 2023
             
    Net Income (Loss) 26,284  (144,818) (177,026) (518,254)
    Depreciation and amortization 6,796  5,351  23,359  20,451 
    Share based compensation 13,388  12,589  68,941  47,680 
    Impairment loss 4,423  —  4,423  — 
    Unrealized foreign exchange (gain)/loss (included in Other Expenses, other income and gains) (109,975) 38,332  (108,509) 28,645 
    Fair value loss of warrant liability —  —  —  85,750 
    Adjusted net loss (59,084) (88,546) (188,812) (335,728)
             
    ANI per share:        
    ANI per share - basic (0.16) (0.24) (0.52) (0.95)
    ANI per share - diluted (0.15) (0.24) (0.52) (0.95)
             

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