Legend Biotech Reports Fourth Quarter and Full Year 2023 Results and Recent Highlights
- None.
- Net loss increased from $446.3 million in 2022 to $518.3 million in 2023.
- License revenue decreased from $50 million in 2022 to $35.2 million in 2023.
- Increase in operating expenses across collaboration, research and development, administrative, selling and distribution.
- Significant fair value loss of $85.8 million in 2023 due to the full exercise of a warrant by an institutional investor.
Insights
The reported net sales of CARVYKTI® indicate a robust market uptake, with $159 million in Q4 and $500 million for the full year 2023. This performance is significant as it reflects the product's strong commercial viability and the company's effective market penetration strategies. The financial runway, bolstered by $1.3 billion in cash reserves, positions Legend Biotech to sustain operations and investment in R&D through the end of 2025. This is a positive signal to investors, suggesting financial stability and the potential for continued growth without the immediate need for additional capital raising.
The CHMP's recommendation for CARVYKTI® label expansion could lead to increased market share and revenue streams, as it would allow the treatment to be used in earlier lines of therapy. It is important to note the potential for stock volatility around the FDA ODAC meeting date, as investor sentiment can be influenced by anticipated regulatory outcomes. The upfront payment from Novartis is a strong endorsement of Legend Biotech's pipeline, adding non-dilutive capital that can accelerate R&D efforts.
The CHMP's positive opinion for label expansion and the upcoming FDA ODAC review are critical milestones that could potentially broaden the treatment landscape for multiple myeloma patients. CARVYKTI®'s performance in clinical trials, such as CARTITUDE-4 and its ability to improve health-related quality of life are key factors in its adoption. The strategic partnership with Johnson & Johnson and the licensing agreement with Novartis Pharma AG underscore Legend Biotech's strong position in the CAR-T therapy market. This could lead to further clinical advancements and expansion of therapeutic options, which is not only beneficial for patients but also for Legend Biotech's long-term growth prospects.
Legend Biotech's expansion of manufacturing capacity by 100% and plans to deliver 10,000 annual doses by year-end 2025 demonstrate the company's commitment to meeting commercial demand. This operational scalability is crucial for maintaining the supply chain and supporting global distribution. The availability of CARVYKTI® in Germany and Austria, along with the treatment of over 2,500 patients across more than 80 authorized centers, signifies a growing footprint in the international market. This expansion, coupled with regulatory advancements, suggests a favorable outlook for market share acquisition and competitive positioning.
-
CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) net trade sales of approximately
$159 million $500 million - CHMP recommended CARVYKTI® label expansion in earlier lines of treatment for adult patients with relapsed and lenalidomide-refractory multiple myeloma. FDA ODAC to meet on March 15 to review data from the CARTITUDE-4 study supporting the use of cilta-cel in earlier lines of treatment for adult patients with relapsed and lenalidomide-refractory multiple myeloma
-
On January 3, 2024, Legend received a
$100 million -
Cash and cash equivalents, deposits, and short-term investments of
$1.3 billion
“With worldwide sales of half a billion dollars in its first full year of commercialization, our rapid, successful launch of CARVYKTI® reinforces its position as a leading CAR-T therapy for patients with relapsed and refractory multiple myeloma,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “Our accomplishments in 2023, through our strategic partnership with Johnson & Johnson*, created the foundation for strong growth and uptake of CARVYKTI®, positioning us to bring CARVYKTI® to more patients in need of treatment going forward.”
Regulatory Updates
-
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending label expansion for CARVYKTI® to include the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide. The
U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) intends to meet on March 15 to review data from the CARTITU-cel in earlier lines of treatment for adult patients with relapsed and lenalidomide-refractory multiple myeloma.DE-4 study supporting the use of cilta
Key Business Developments
-
On January 3, 2024, Legend received a
$100 million -
Promoted Birk Vanderweeën to Senior Vice President of Global Manufacturing & Supply responsible for overseeing the production and delivery of CARVYKTI® for patients across the globe. Previously he was General Manager,
Europe . Mr. Vanderweeën brings over 25 years of experience in Operations, Quality, Supply Chain, and Manufacturing at industry leading companies -
Expanded manufacturing capacity by
100% since the beginning of 2023, including starting clinical production at the new Obelisc site in Ghent - Plans to deliver production capacity of 10,000 annual doses by year-end 2025
-
CARVYKTI® is now available in
Germany andAustria , as commercial demand continues with over 2,500 patients treated across 80+ authorized treatment centers globally - Presented patient-reported outcome data at the 2023 American Society of Hematology Annual Meeting from the Phase 3 CARTITUDE-4 study demonstrating clinically meaningful improvements in health-related quality of life and reductions in multiple myeloma symptoms following treatment with CARVYKTI® compared to standard of care1
* In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc., a Johnson & Johnson company, to develop and commercialize cilta-cel (the Janssen Agreement).
Financial Results for Quarter and Year Ended December 31, 2023
Cash and Cash Equivalents, Time Deposits, and Short-Term Investments
As of December 31, 2023, Legend Biotech had approximately
Revenue
License Revenue
There was no license revenue for the three months ended December 31, 2023, and December 31, 2022. License revenue for the year ended December 31, 2023, was
Collaboration Revenue
Collaboration revenue for the three months and year ended December 31, 2023, was
Other Revenue
Other revenue for the three months and year ended December 31, 2023, was
Operating Expenses
Collaboration Cost of Revenue
Collaboration cost of revenue for the three months and year ended December 31, 2023, was
Research and Development Expenses
Research and development expenses for the three months and year ended December 31, 2023, were
Administrative Expenses
Administrative expenses for the three months and year ended December 31, 2023, were
Selling and Distribution Expenses
Selling and distribution expenses for the three months and year ended December 31, 2023, were
Other Income and Gains
Other income and gains for the three months and year ended December 31, 2023, were
Other Expenses
Other expenses for the three months and year ended December 31, 2023, were
Finance Costs
Finance costs for the three months and year ended December 31, 2023, were
Fair Value (Loss)/Gain of Warrant Liability
There was no fair value (loss)/gain of warrant liability for the three months ended December 31, 2023, compared to a loss of
Loss for the Period
For the three months ended December 31, 2023, net loss was
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
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 patient population for CARVYKTI®, Legend Biotech’s expectations for CARVYKTI®, including manufacturing expectations for CARVYKTI®; expected results and timing of clinical trials; Legend Biotech’s expectations for LB2102 and its potential benefits; the potential benefits of licensing transactions; Legend Biotech’s expectations on advancing their pipeline and product portfolio; 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
LEGEND BIOTECH CORPORATION
|
||||||||
|
|
Three Months Ended
|
Year Ended
|
|||||
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
US$’000, except share and per share data |
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
(audited) |
REVENUE |
|
|
|
|
|
|
|
|
License revenue |
|
— |
|
— |
|
35,160 |
|
50,000 |
Collaboration revenue |
|
79,435 |
|
27,441 |
|
249,804 |
|
66,677 |
Other revenue |
|
29 |
|
192 |
|
179 |
|
328 |
Total revenue |
|
79,464 |
|
27,633 |
|
285,143 |
|
117,005 |
Collaboration cost of revenue |
|
(32,450) |
|
(22,964) |
|
(144,214) |
|
(65,363) |
Other income and gains |
|
18,450 |
|
7,356 |
|
58,126 |
|
12,049 |
Research and development expenses |
|
(105,683) |
|
(80,756) |
|
(382,218) |
|
(335,648) |
Administrative expenses |
|
(28,707) |
|
(26,681) |
|
(106,769) |
|
(80,631) |
Selling and distribution expenses |
|
(33,677) |
|
(25,823) |
|
(94,158) |
|
(93,417) |
Other expenses |
|
(38,389) |
|
(327) |
|
(28,484) |
|
(9,823) |
Fair value (loss)/gain of warrant liability |
|
— |
|
(9,300) |
|
(85,750) |
|
20,900 |
Finance costs |
|
(5,820) |
|
(4,861) |
|
(21,794) |
|
(10,796) |
LOSS BEFORE TAX |
|
(146,812) |
|
(135,723) |
|
(520,118) |
|
(445,724) |
Income tax benefit/(expense) |
|
1,994 |
|
(153) |
|
1,864 |
|
(625) |
LOSS FOR THE PERIOD |
|
(144,818) |
|
(135,876) |
|
(518,254) |
|
(446,349) |
Attributable to: |
|
|
|
|
|
|
|
|
Ordinary equity holders of the parent |
|
(144,818) |
|
(135,876) |
|
(518,254) |
|
(446,349) |
LOSS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE PARENT |
|
|
|
|
|
|
|
|
Basic |
|
(0.40) |
|
(0.41) |
|
(1.47) |
|
(1.40) |
Diluted |
|
(0.40) |
|
(0.41) |
|
(1.47) |
|
(1.40) |
ORDINARY SHARES USED IN LOSS PER SHARE COMPUTATION |
|
|
|
|
|
|
|
|
Basic |
|
363,655,317 |
|
329,923,489 |
|
352,165,418 |
|
318,083,913 |
Diluted |
|
363,655,317 |
|
329,923,489 |
|
352,165,418 |
|
318,083,913 |
LEGEND BIOTECH CORPORATION
|
||||
|
|
December 31,
|
|
December 31,
|
|
|
US$’000 |
|
US$’000 |
|
|
(unaudited) |
|
(audited) |
NON-CURRENT ASSETS |
|
|
|
|
Property, plant and equipment |
|
108,725 |
|
105,168 |
Advance payments for property, plant and equipment |
|
451 |
|
914 |
Right-of-use assets |
|
80,502 |
|
55,590 |
Time deposits |
|
4,362 |
|
— |
Intangible assets |
|
4,061 |
|
3,409 |
Collaboration prepaid leases |
|
151,216 |
|
65,276 |
Other non-current assets |
|
1,493 |
|
1,487 |
Total non-current assets |
|
350,810 |
|
231,844 |
CURRENT ASSETS |
|
|
|
|
Collaboration inventories |
|
19,433 |
|
10,354 |
Trade receivables |
|
100,041 |
|
90 |
Prepayments, other receivables and other assets |
|
69,251 |
|
61,755 |
Financial assets at fair value through profit or loss |
|
663 |
|
185,603 |
Pledged deposits |
|
357 |
|
1,270 |
Time deposits |
|
30,341 |
|
54,016 |
Cash and cash equivalents |
|
1,277,713 |
|
786,031 |
Total current assets |
|
1,497,799 |
|
1,099,119 |
Total assets |
|
1,848,609 |
|
1,330,963 |
CURRENT LIABILITIES |
|
|
|
|
Trade payables |
|
20,160 |
|
32,893 |
Other payables and accruals |
|
132,802 |
|
184,109 |
Government grants |
|
68 |
|
451 |
Lease liabilities |
|
3,175 |
|
3,563 |
Tax payable |
|
7,203 |
|
9,772 |
Contract liabilities |
|
53,010 |
|
— |
Warrant liability |
|
— |
|
67,000 |
Total current liabilities |
|
216,418 |
|
297,788 |
NON-CURRENT LIABILITIES |
|
|
|
|
Collaboration interest-bearing advanced funding |
|
281,328 |
|
260,932 |
Lease liabilities long term |
|
44,169 |
|
20,039 |
Government grants |
|
7,305 |
|
7,659 |
Contract liabilities |
|
47,962 |
|
— |
Other non-current liabilities |
|
56 |
|
233 |
Total non-current liabilities |
|
380,820 |
|
288,863 |
Total liabilities |
|
597,238 |
|
586,651 |
EQUITY |
|
|
|
|
Share capital |
|
36 |
|
33 |
Reserves |
|
1,251,335 |
|
744,279 |
Total ordinary shareholders’ equity |
|
1,251,371 |
|
744,312 |
Total equity |
|
1,251,371 |
|
744,312 |
Total liabilities and equity |
|
1,848,609 |
|
1,330,963 |
LEGEND BIOTECH CORPORATION
|
||||||||
|
|
Three Months Ended December 31, |
Year Ended December 31, |
|||||
US$’000 |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
(audited) |
|
|
|
|
|
|
|
|
|
LOSS BEFORE TAX |
|
(146,812) |
|
(135,723) |
|
(520,118) |
|
(445,724) |
CASH FLOWS USED IN OPERATING ACTIVITIES |
|
(95,645) |
|
(49,742) |
|
(393,276) |
|
(201,281) |
CASH FLOWS FROM/(USED IN) INVESTING ACTIVITIES |
|
407,509 |
|
24,932 |
|
92,786 |
|
(77,092) |
CASH FLOWS FROM/(USED IN) FINANCING ACTIVITIES |
|
925 |
|
(783) |
|
791,490 |
|
377,976 |
NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS |
|
312,789 |
|
(25,593) |
|
491,000 |
|
99,603 |
Effect of foreign exchange rate changes, net |
|
1,454 |
|
(1,109) |
|
682 |
|
(2,510) |
Cash and cash equivalents at beginning of the period |
|
963,470 |
|
812,733 |
|
786,031 |
|
688,938 |
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS AT END OF THE YEAR |
|
1,277,713 |
|
786,031 |
|
1,277,713 |
|
786,031 |
ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS |
|
|
|
|
|
|
|
|
Cash and bank balances |
|
1,312,773 |
|
841,317 |
|
1,312,773 |
|
841,317 |
Less: Pledged deposits |
|
357 |
|
1,270 |
|
357 |
|
1,270 |
Time deposits |
|
34,703 |
|
54,016 |
|
34,703 |
|
54,016 |
Cash and cash equivalents as stated in the statement of financial position |
|
1,277,713 |
|
786,031 |
|
1,277,713 |
|
786,031 |
Cash and cash equivalents as stated in the statement of cash flows |
|
1,277,713 |
|
786,031 |
|
1,277,713 |
|
786,031 |
1 Mina, R. Patient-Reported Outcomes in the Phase 3 CARTITUDE-4 Study of Ciltacabtagene Autoleucel Vs Standard of Care in Patients with Lenalidomide-Refractory Multiple Myeloma after 1-3 Lines of Therapy. Abstract #1063 [Oral Presentation]. Presented at the 2023 American Society of Hematology Annual Meeting.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240311811905/en/
INVESTOR CONTACT:
Jessie Yeung
Tel: (732) 956-8271
jessie.yeung@legendbiotech.com
PRESS CONTACT:
Alexandra Ventura
Tel: (732) 850-5598
media@legendbiotech.com
Source: Legend Biotech Corporation
FAQ
What were Legend Biotech's net trade sales for the fourth quarter of 2023?
What was the total net trade sales for Legend Biotech in 2023?
What is the FDA reviewing regarding CARVYKTI®?
How much did Legend Biotech receive from Novartis?
What is the financial status of Legend Biotech as of December 31, 2023?
