- 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
"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.
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
| 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 revenue | 18,281 | - | 138,404 | 35,160 | |||||||
| Collaboration revenue | 168,017 | 79,435 | 482,580 | 249,804 | |||||||
| Other revenue | 224 | 29 | 6,257 | 179 | |||||||
| Total revenue | 186,522 | 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 gains | 125,056 | 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 TAX | 40,511 | (146,812 | ) | (158,133 | ) | (520,118 | ) | ||||
| Income tax (expense)/benefit | (14,227 | ) | 1,994 | (18,893 | ) | 1,864 | |||||
| NET INCOME (LOSS) FOR THE PERIOD | 26,284 | (144,818 | ) | (177,026 | ) | (518,254 | ) | ||||
| Attributable to: | |||||||||||
| Ordinary equity holders of the parent | 26,284 | (144,818 | ) | (177,026 | ) | (518,254 | ) | ||||
| NET INCOME (LOSS) PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE PARENT | |||||||||||
| Basic | 0.07 | (0.40 | ) | (0.48 | ) | (1.47 | ) | ||||
| Diluted | 0.07 | (0.40 | ) | (0.48 | ) | (1.47 | ) | ||||
| ORDINARY SHARES USED IN NET INCOME (LOSS) PER SHARE COMPUTATION | |||||||||||
| Basic | 366,648,551 | 363,655,317 | 365,702,143 | 352,165,418 | |||||||
| Diluted | 402,806,991 | 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 equipment | 99,288 | 108,725 | |||
| Advance payments for property, plant and equipment | 374 | 451 | |||
| Right-of-use assets | 101,932 | 80,502 | |||
| Time deposits | 4,362 | 4,362 | |||
| Intangible assets | 2,160 | 4,061 | |||
| Collaboration prepaid leases | 172,064 | 151,216 | |||
| Other non-current assets | 6,056 | 1,493 | |||
| Total non-current assets | 386,236 | 350,810 | |||
| CURRENT ASSETS | |||||
| Collaboration inventories, net | 23,903 | 19,433 | |||
| Trade receivables | 6,287 | 100,041 | |||
| Prepayments, other receivables and other assets | 130,975 | 69,251 | |||
| Financial assets at fair value through profit or loss | - | 663 | |||
| Pledged deposits | 70 | 357 | |||
| Time deposits | 835,934 | 30,341 | |||
| Cash and cash equivalents | 286,749 | 1,277,713 | |||
| Total current assets | 1,283,918 | 1,497,799 | |||
| Total assets | 1,670,154 | 1,848,609 | |||
| CURRENT LIABILITIES | |||||
| Trade payables | 38,594 | 30,655 | |||
| Other payables and accruals | 166,180 | 122,307 | |||
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