Earnings release
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Legend Biotech Reports Third Quarter 2025 Results and Recent Highlights November 12, 2025 CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) net trade sales of approximately $524 million EC and U.S. FDA label updates for CARVYKTI ® to include overall survival benefit versus standard of care Over 9,000 patients treated to date Initiated CARVYKTI® commercial production at Tech Lane facility in Belgium Cash and cash equivalents, and time deposits of approximately $1.0 billion, as of September 30, 2025 SOMERSET, N.J., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its third quarter 2025 unaudited financial results and key corporate highlights. “CARVYKTI continues to deliver strong sequential revenue growth, driven by sustained demand and recognition of its unprecedented survival benefit, now supported by five-year progression free data from the CARTITUDE-1 study,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “CARVYKTI remains the market leader in multiple myeloma CAR-T as the only approved therapy for second-line treatment, now with a survival benefit label. With commercial supply from our Tech Lane facility in Belgium now supporting the European market, and our Raritan physical expansion on track for approval by year end, we believe we are poised to achieve CARVYKTI profitability by year-end and company-wide profitability in 2026.” Regulatory Updates The U.S. Food and Drug Administration (FDA) and the European Commission (EC) approved label updates for CARVYKTI® to include the overall survival (OS) data from the landmark Phase 3 CARTITUDE-4 study, which demonstrated a statistically significant OS benefit for CARVYKTI ® versus standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in patients with relapsed or lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor (PI), and an immunomodulatory agent (IMiD). Based on clinical trial data and post-marketing reports, the US and European CARVYKTI® labels were also updated to include risk of immune effector cell-associated enterocolitis. Key Business Developments Treated over 9,000 clinical and commercial patients to date. Received European Union approval for and initiated commercial production of CARVYKTI ® at the Tech Lane facility in Ghent, Belgium, which will begin to support additional global demand in the first half of 2026. Continued to expand global commercial footprint, with CARVYKTI ® available in 14 markets worldwide. Initiated CARTITUDE-10, a Phase 2 multicohort clinical trial to further evaluate efficacy and safety of CARVYKTI ® in patients with newly diagnosed multiple myeloma. Appointed Carlos Santos as Chief Financial Officer (CFO). Mr. Santos is a seasoned finance executive who has led financial operations in the pharmaceutical and technology sectors across the United States , Latin America , Europe, the Middle East, and Africa. Cash and cash equivalents, and time deposits of approximately $1.0 billion as of September 30, 2025, which Legend Biotech believes will provide financial runway beyond 2026, when Legend Biotech believes it will achieve a company-wide operating profit. Third Quarter 2025 Financial Results Cash Position: Cash and cash equivalents, and time deposits were approximately $1.0 billion as of September 30, 2025. License Revenue : License revenue was $10.5 million for the three months ended September 30, 2025 , compared to $17.1 million for the three months ended September 30, 2024. License revenue relates to the Novartis License Agreement, for which revenue is recognized over time as Legend conducts a Phase 1 clinical trial for LB2102. The decrease resulted from the timing of activities performed in connection with the trial. Collaboration Revenue : Collaboration revenue was $261.8 million for the three months ended September 30, 2025, compared to $142.8 million for the three months ended September 30, 2024. The increase was due to an increase in revenue generated from sales of CARVYKTI ® in connection with the Janssen collaboration and license agreement (the “Janssen Agreement”). Cost of Collaboration Revenue : Cost of collaboration revenue was $113.3 million for the three months ended
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September 30, 2025, compared to $52.5 million for the three months ended September 30, 2024. The increase was primarily due to Legend's share of the cost of sales in connection with CARVYKTI ® sales under the Janssen Agreement and expenditures to support expansion in manufacturing capacity. Research and Development Expenses : Research and development expenses were $113.1 million for the three months ended September 30, 2025 compared to $95.5 million for the three months ended September 30, 2024.The increase was due to higher pipeline related research and development activities, as well as expenditures in BCMA front line clinical studies. Administrative Expenses: Administrative expenses were $34.7 million for the three months ended September 30, 2025 , compared to $35.3 million for the three months ended September 30, 2024, remaining relatively flat. Selling and Distribution Expenses : Selling and distribution expenses were $52.6 million for the three months ended September 30, 2025, compared to $44.3 million for the three months ended September 30, 2024. The increase was due to higher commercial costs, including sales force expansion and Janssen-related marketing and market access activities, which rose with collaboration revenue. Net Loss: Net loss was $39.7 million for the three months ended September 30, 2025 , compared to a net loss of $125.3 million for the three months ended September 30, 2024. Adjusted Net Loss: Adjusted net loss was $18.8 million for the three months ended September 30, 2025, compared to an adjusted net loss of $42.0 million for the three months ended 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 With over 2,900 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 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® and the ability of the commercial production in Belgium to begin supporting global demand in the first half of 2026; statements related to Legend Biotech’s ability to fund its operations into 2026 and to achieve company-wide profitability in 2026 and Carvykti-profitability by end of 2025; and statements related to 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: Alexandra Ventura Tel: (732) 850-5598 media@legendbiotech.com
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LEGEND BIOTECH CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS (UNAUDITED; DOLLARS IN THOUSANDS, EXCEPT PER SHARE AND SHARES DATA) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 REVENUE License revenue $ 10,481 $ 17,096 $ 55,249 $ 120,123 Collaboration revenue 261,831 142,828 667,163 314,563 Other revenue 18 281 111 6,033 Total revenue 272,330 160,205 722,523 440,719 Cost of collaboration revenue (113,264) (52,510) (277,633) (146,966) Cost of license and other revenue (2,042) (2,959) (7,008) (13,693) Research and development expenses (113,148) (95,522) (313,374) (309,112) Administrative expenses (34,721) (35,300) (98,778) (102,582) Selling and distribution expenses (52,607) (44,270) (141,628) (98,556) Loss on asset impairment — — (970) — Operating loss (43,452) (70,356) (116,868) (230,190) Finance costs (5,636) (5,504) (15,919) (16,463) Finance income* 9,661 16,630 32,150 47,550 Other income/(expense), net* 354 (61,656) (162,364) 459 Loss before tax (39,073) (120,886) (263,001) (198,644) Income tax expense (616) (4,435) (2,984) (4,666) Net loss $ (39,689) $ (125,321) $ (265,985) $ (203,310) LOSS PER SHARE Basic $ (0.11) $ (0.34) $ (0.72) $ (0.56) Diluted $ (0.11) $ (0.34) $ (0.72) $ (0.56) Weighted average shares outstanding Basic 369,273,247 366,562,487 368,363,143 365,268,372 Diluted 369,273,427 366,562,487 368,363,143 365,268,372 *Certain prior year amounts have been reclassified to present finance income as a separate line item and to combine other income/(expense), net for comparative purposes. LEGEND BIOTECH CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (DOLLARS IN THOUSANDS) September 30, 2025 December 31, 2024 NON-CURRENT ASSETS (Unaudited) Property, plant and equipment $ 111,403 $ 99,288 Right-of-use assets 142,338 101,932 Collaboration prepaid leases 206,213 172,064 Other non-current assets* 10,990 12,952 Total non-current assets 470,944 386,236 CURRENT ASSETS Collaboration inventories, net 29,184 23,903 Trade receivables 1,236 6,287 Prepayments, other receivables and other assets*** 218,993 131,045 Time deposits 713,698 835,934 Cash and cash equivalents 278,893 286,749 Total current assets 1,242,004 1,283,918 TOTAL ASSETS $ 1,712,948 $ 1,670,154 CURRENT LIABILITIES Trade payables $ 102,455 $ 38,594 Other payables and accruals 147,183 166,180
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Lease liabilities 7,374 4,794 Tax payable 10,108 20,671 Contract liabilities 22,576 46,874 Other current liabilities** 1,003 532 Collaboration interest-bearing advanced funding 142,873 — Total current liabilities 433,572 277,645 NON-CURRENT LIABILITIES Collaboration interest-bearing advanced funding long term 171,930 301,196 Lease liabilities long term 88,061 44,613 Other non-current liabilities** 8,125 6,154 Total non-current liabilities 268,116 351,963 TOTAL LIABILITIES 701,688 629,608 EQUITY Share capital 37 37 Reserves 1,011,223 1,040,509 Total equity 1,011,260 1,040,546 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 1,712,948 $ 1,670,154 *Certain prior year amounts have been reclassified to combine advance payments for property, plant, and equipment, non-current time deposits, and intangible assets into other non-current assets for comparative purposes. **Prior year current and non-current government grants have been renamed to other current and non-current liabilities, respectively. ***Certain prior year amounts have been reclassified to combine pledged deposits into prepayments, other receivables, and other assets for comparative purposes. LEGEND BIOTECH CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW (UNAUDITED; DOLLARS IN THOUSANDS) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Loss before tax $ (39,073) $ (120,886) $ (263,001) $ (198,644) Cash flows provided by/(used in) operating activities 28,801 (75,822) (87,995) (61,955) Cash flows (used in)/provided by investing activities (20,001) 329,077 71,114 (762,702) Cash flows provided by financing activities 670 4,245 347 6,031 Effect of foreign exchange rate changes, net 2,837 524 8,678 190 Net increase/(decrease) in cash and cash equivalents 12,307 258,024 (7,856) (818,436) Cash and cash equivalents at beginning of the period 266,586 201,253 286,749 1,277,713 CASH AND CASH EQUIVALENTS AT END OF THE PERIOD $ 278,893 $ 459,277 $ 278,893 $ 459,277 Analysis of balances of cash and cash equivalents Cash and bank balances $ 992,661 $ 1,217,492 $ 992,661 $ 1,217,492 Less: Pledged deposits 70 583 70 583 Time deposits 713,698 757,632 713,698 757,632 Cash and cash equivalents as stated in the statement of financial position $ 278,893 $ 459,277 $ 278,893 $ 459,277 Cash and cash equivalents as stated in the statement of cash flows$ 278,893 $ 459,277 $ 278,893 $ 459,277 RECONCILIATION OF IFRS TO NON-IFRS MEASURES We use Adjusted Net Loss and Adjusted Net Loss per Share (which we sometimes refer to as “Adjusted EPS” or “ANL per Share”, respectively) 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: 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 Loss excludes unrealized foreign exchange gain or loss which resulted primarily from changes in the
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intercompany loan balances and cash balances as a result of exchange rate changes between USD and EUR. 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 ANL 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 ANL 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 (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. ANL per Share is computed by dividing Adjusted Net Loss by the weighted average shares outstanding. A reconciliation between Adjusted Net Loss and Net Loss, the most directly comparable measure under IFRS, has been provided in the table below. LEGEND BIOTECH CORPORATION RECONCILIATION OF IFRS TO NON-IFRS (UNAUDITED; DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Net loss $ (39,689) $ (125,321) $ (265,985) $ (203,310) Depreciation and amortization 6,014 5,472 17,067 16,563 Share-based compensation expense 15,015 15,111 49,658 55,553 Impairment loss — — 970 — Unrealized foreign exchange (gain)/loss (included in Other (expense)/income, net) (120) 62,774 162,602 1,466 Adjusted net loss (ANL) $ (18,780) $ (41,964) $ (35,688) $ (129,728) ANL per share: ANL per share - basic $ (0.05) $ (0.11) $ (0.10) $ (0.36) ANL per share - diluted $ (0.05) $ (0.11) $ (0.10) $ (0.36) Source: Legend Biotech USA Inc.