Legend Biotech Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Highlights
Legend Biotech announced the FDA approval of CARVYKTI™ (ciltacabtagene autoleucel) for treating adults with relapsed/refractory multiple myeloma after four prior therapies. The company reported unaudited Q4 2021 financial results, showing a revenue decrease to $39 million from $40.8 million in Q4 2020, while annual revenue rose to $89.8 million from $75.7 million. R&D expenses increased by 29% in Q4 and 35% for 2021, totaling $313.3 million. Net losses for Q4 and the full year were $88.3 million and $386.2 million, respectively, reflecting ongoing commercialization efforts.
- FDA approval of CARVYKTI positions Legend Biotech for strong market entry in 2022.
- Annual revenue increased by $14.1 million, driven by milestone achievements.
- Strong cash position with approximately $887.1 million available for R&D and commercialization.
- Quarterly revenue declined by $1.8 million compared to Q4 2020.
- Net losses increased to $386.2 million for the year, up from $303.5 million in 2020.
- R&D expenses surged to $313.3 million for the year, indicating high operational costs.
-
U.S. Food Drug Administration approved CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel), a BCMA-directed CAR T-cell therapy for the treatment of adults with relapsed or refractory multiple myeloma (MM) who have received four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody - The CARTITUDE clinical development program is progressing to evaluate cilta-cel in patients with newly diagnosed MM across two randomized Phase 3 studies (CARTITUDE-5 and CARTITUDE-6)
-
Longer-term follow-up data for CARTITUDE-1 presented at 63rd
American Society of Hematology Annual Meeting continued to show deep and durable responses -
Legend Biotech appointsMarc L. Harrison as Vice President and General Counsel
“Legend Biotech ended the fourth quarter with strong data on our lead product candidate and nearly
Recent Highlights
-
The
U.S. Food and Drug Administration (U.S. FDA) approved CARVYKTI™ (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple myeloma (MM) who have received four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. -
Legend Biotech and its collaboration partnerJanssen Biotech, Inc. (Janssen) is progressing the CARTITUDE clinical development program in earlier lines across Phase 3 studies, including a collaborative study.- CARTITUDE-4 completed enrollment. The Phase 3, open-label study evaluates cilta-cel in patients with multiple myeloma who have received 1-3 prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent and are refractory to lenalidomide. The purpose of this study is to compare the efficacy of cilta-cel with standard therapy – either pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).
- CARTITUDE-5 initiated enrollment. The Phase 3, randomized, open-label study compares bortezomib, lenalidomide and dexamethasone (VRd) induction followed by cilta-cel vs. VRd induction followed by lenalidomide and dexamethasone (Rd) maintenance in patients with newly diagnosed MM for whom autologous stem cell transplant (ASCT) is not planned as initial therapy (NCT04923893)
- CARTITUDE-6 (not yet recruiting; sponsored by the European Myeloma Network). The Phase 3, randomized, open-label study compares daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) followed by cilta-cel vs. DVRd followed by autologous stem cell transplant (ASCT) in newly diagnosed patients with MM who are transplant eligible (NCT05257083)
-
New and updated results from the CARTITUDE clinical development program studying cilta-cel in various clinical settings were presented at the 63rd
American Society of Hematology (ASH) Annual Meeting and Exposition in 2021. Two-year follow-up data for CARTITUDE-1 were presented showing continued deep and durable responses of cilta-cel in patients with heavily pretreated MM. -
A New Drug Application for cilta-cel was submitted to the
Ministry of Health, Labour and Welfare (MHLW) inJapan by Janssen inDecember 2021 . - New, preclinical in vivo data on Legend Biotech’s novel tri-specific, single-domain antibody (VHH) CAR-T (LCAR-AIO) were presented at ASH 2021 as a poster (Abstract #1700). LCAR-AIO targets three antigens—CD19, CD20 and CD22.
-
Legend Biotech raised approximately in gross proceeds in a follow-on public offering of its American depositary shares (ADSs).$345 million -
Marc L. Harrison was appointed Vice President and General Counsel ofLegend Biotech inJanuary 2022 .Mr. Harrison brings more than 20 years of experience in healthcare and life sciences to the role. He previously served as Vice President, General Counsel and Head of Compliance atBreckenridge Pharmaceutical, Inc. and has held senior legal and leadership positions atIpsen Biopharmaceuticals ,Medco Health Solutions and WebMD. -
A clinical hold was placed by the
U.S. FDA inFebruary 2022 on the Phase 1, open-label, multicenter clinical trial to evaluate LB1901, an investigational autologous CD4-targeted CAR-T therapy for the treatment of adults with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL) (NCT04712864).Legend Biotech subsequently received an official clinical hold letter from the FDA datedMarch 1, 2022 . In the letter, FDA stated that the reason for the hold is because the related IND does not contain sufficient information required by 21 CFR 312.23 to assess the risks to subjects. -
Legend Biotech achieved two milestone payments amounting to , under the terms of its collaboration and license agreement with Janssen for the joint development and commercialization of cilta-cel.$50 million
Financial Results for the Quarter and Year Ended
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Fair Value Loss of Convertible Redeemable Preferred Shares
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Loss for the Period
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About
Learn more at www.legendbiotech.com and follow us on Twitter and LinkedIn.
About CARVYKTI™ (Ciltacabtagene autoleucel; cilta-cel)
CARVYKTI™ is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells. The CARVYKTI™ CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.1
In
In
About the CARTITUDE-1 Study
CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, single arm, multi-center trial evaluating cilta-cel for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received at least three prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 monoclonal antibody. Of the 97 patients enrolled in the trial, 99 percent were refractory to the last line of treatment and 88 percent were triple-class refractory, meaning their cancer did not respond, or no longer responds, to an IMiD, a PI and an anti-CD38 monoclonal antibody.1
The longer-term efficacy and safety profile of cilta-cel is being assessed in the ongoing CARTITUDE-1 study, with two-year follow-up results recently presented at ASH 2021.2
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.3 In 2022, it is estimated that more than 34,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the
Cautionary Statement:
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™, such as Legend Biotech’s manufacturing and commercialization expectations for CARVYKTI™ and the potential effect of treatment with CARVYKTI™; statements about submissions for cilta-cel to, and the progress of such submissions with, the
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||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS |
||||||||||||
Three months ended
|
Year ended
|
|||||||||||
(in thousands, US$, except share and per share data) |
2021 |
2020 |
2021 |
2020 |
||||||||
(Unaudited) |
(Unaudited) |
(Unaudited) |
||||||||||
REVENUE |
38,995 |
|
40,783 |
|
89,792 |
|
75,676 |
|
||||
Other income and gains |
743 |
|
2,079 |
|
3,059 |
|
6,119 |
|
||||
Research and development expenses |
(86,503 |
) |
(66,934 |
) |
(313,346 |
) |
(232,160 |
) |
||||
Administrative expenses |
(17,142 |
) |
(9,171 |
) |
(46,939 |
) |
(23,147 |
) |
||||
Selling and distribution expenses |
(52,811 |
) |
(24,182 |
) |
(102,542 |
) |
(49,571 |
) |
||||
Other expenses |
(2,214 |
) |
(290 |
) |
(9,132 |
) |
(346 |
) |
||||
Fair value gain/(loss) of warrant liability.. |
31,200 |
|
- |
|
(6,200 |
) |
- |
|
||||
Fair value loss of convertible redeemable preferred
|
- |
|
- |
|
- |
|
(79,984 |
) |
||||
Finance costs |
(602 |
) |
(40 |
) |
(900 |
) |
(4,209 |
) |
||||
LOSS BEFORE TAX |
(88,334 |
) |
(57,755 |
) |
(386,208 |
) |
(307,622 |
) |
||||
|
|
|
|
|||||||||
Income tax (expense)/credit |
- |
|
(72 |
) |
(1 |
) |
4,145 |
|
||||
|
|
|
|
|||||||||
LOSS FOR THE PERIOD |
(88,334 |
) |
(57,827 |
) |
(386,209 |
) |
(303,477 |
) |
||||
Attributable to: |
|
|
|
|
||||||||
Equity holders of the parent |
(88,334 |
) |
(57,827 |
) |
(386,209 |
) |
(303,477 |
) |
||||
|
|
|
|
|||||||||
Loss per share attributable to ordinary equity holders
|
|
|
|
|
||||||||
Ordinary shares – basic |
(0.30 |
) |
(0.22 |
) |
(1.37 |
) |
(1.28 |
) |
||||
Ordinary shares – diluted |
(0.30 |
) |
(0.22 |
) |
(1.37 |
) |
(1.28 |
) |
||||
|
|
|
|
|||||||||
Shares used in loss per share computation: |
|
|
|
|
||||||||
Ordinary shares – basic |
293,199,033 |
|
264,720,588 |
|
281,703,291 |
|
236,305,234 |
|
||||
Ordinary shares – diluted |
293,199,033 |
|
264,720,588 |
|
281,703,291 |
|
236,305,234 |
|
|
|||
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION |
|||
|
|
||
(in thousands, US$) |
(Unaudited) |
||
|
|
|
|
NON-CURRENT ASSETS |
|||
Property, plant and equipment |
145,724 |
113,091 |
|
Advance payments for property, plant and equipment |
2,168 |
224 |
|
Right-of-use assets |
7,186 |
8,009 |
|
Other non-current assets |
5,148 |
3,973 |
|
Intangible assets |
4,684 |
2,852 |
|
Time deposits |
4,705 |
- |
|
|
|
|
|
Total non-current assets |
169,615 |
128,149 |
|
|
|
|
|
CURRENT ASSETS |
|
||
Inventories |
1,749 |
1,800 |
|
Trade receivables |
50,410 |
74,978 |
|
Prepayments, other receivables and other assets |
12,754 |
10,007 |
|
Financial assets measured at amortized cost |
29,937 |
- |
|
Pledged deposits |
1,444 |
384 |
|
Time deposits |
163,520 |
50,000 |
|
Cash and cash equivalents |
688,938 |
455,689 |
|
|
|
|
|
Total current assets |
948,752 |
592,858 |
|
|
|
|
|
Total assets |
1,118,367 |
721,007 |
|
|
|
|
|
CURRENT LIABILITIES |
|
||
Trade and notes payables |
7,043 |
5,238 |
|
Other payables and accruals |
123,464 |
99,168 |
|
Government grants |
304 |
283 |
|
Warrant liability |
87,900 |
- |
|
Lease liabilities |
911 |
1,464 |
|
Contract liabilities |
60,644 |
55,014 |
|
|
|
|
|
Total current liabilities |
280,266 |
161,167 |
|
|
|
|
|
NON-CURRENT LIABILITIES |
|
||
Contract liabilities |
242,578 |
275,071 |
|
Lease liabilities |
1,593 |
1,909 |
|
Interest-bearing loans and borrowings |
120,462 |
- |
|
(in thousands, US$) |
|
|
|
(Unaudited) |
|||
|
|
|
|
Government grants |
1,866 |
2,051 |
|
Other non-current liabilities |
396 |
554 |
|
|
|
|
|
Total non-current liabilities |
366,895 |
279,585 |
|
|
|
|
|
Total liabilities |
647,161 |
440,752 |
|
|
|
|
|
EQUITY |
|
||
Share capital |
31 |
27 |
|
Reserves |
471,175 |
280,228 |
|
|
|
|
|
Total equity |
471,206 |
280,255 |
|
|
|
|
|
Total liabilities and equity |
1,118,367 |
721,007 |
|
|||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
|||||||||||
|
Three months ended
|
Year ended
|
|||||||||
(in thousands, US$) |
2021
|
2020
|
2021
|
2020 |
|||||||
|
|
|
|
|
|||||||
LOSS BEFORE TAX |
(88,334 |
) |
(57,755 |
) |
(386,208 |
) |
(307,622 |
) |
|||
|
|
|
|
|
|||||||
CASH FLOWS USED IN OPERATING ACTIVITIES |
(69,547 |
) |
(55,952 |
) |
(198,465 |
) |
(223,005 |
) |
|||
|
|
|
|
|
|||||||
CASH FLOWS FROM/(USED IN) INVESTING
|
96,512 |
|
61,165 |
|
(194,983 |
) |
(24,169 |
) |
|||
|
|
|
|
|
|||||||
CASH FLOWS FROM FINANCING
|
323,561 |
|
661 |
|
626,663 |
|
618,879 |
|
|||
|
|
|
|
|
|||||||
NET INCREASE IN CASH AND CASH
|
350,526 |
|
5,874 |
|
233,215 |
|
371,705 |
|
|||
|
|
|
|
|
|||||||
Effect of foreign exchange rate changes, net |
78 |
|
434 |
|
34 |
|
620 |
|
|||
Cash and cash equivalents at beginning of the
|
338,334 |
|
449,381 |
|
455,689 |
|
83,364 |
|
|||
|
|
|
|
|
|||||||
CASH AND CASH EQUIVALENTS AT END OF THE
|
688,938 |
|
455,689 |
|
688,938 |
|
455,689 |
|
|||
|
|
|
|
|
|||||||
ANALYSIS OF BALANCES OF CASH AND CASH
|
|
|
|
|
|||||||
Cash and bank balances |
858,607 |
|
506,073 |
|
858,607 |
|
506,073 |
|
|||
Less: Pledged deposits |
1,444 |
|
384 |
|
1,444 |
|
384 |
|
|||
Time deposits |
168,225 |
|
50,000 |
|
168,225 |
|
50,000 |
|
|||
Cash and cash equivalents as stated in the
|
688,938 |
|
455,689 |
|
688,938 |
|
455,689 |
|
|||
Cash and cash equivalents as stated in the
|
688,938 |
|
455,689 |
|
688,938 |
|
455,689 |
|
1 CARVYKTI™ Prescribing Information.
2 Martin, T. Updated Results From CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Patients with Relapsed/Refractory Multiple Myeloma. Abstract #549 [Oral]. Presented at the 2021
3
4
5
6 Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol. 2020;95(5),548-567. doi:10.1002/ajh.25791.
7 Kumar SK, Dimopoulos MA, Kastritis E, et al. Natural history of relapsed myeloma, refractory to immunomodulatory drugs and proteasome inhibitors: a multicenter IMWG study. Leukemia. 2017;31(11):2443-2448.
8 Gandhi UH, Cornell RF, Lakshman A, et al. Outcomes of patients with multiple myeloma refractory to CD38-targeted monoclonal antibody therapy. Leukemia. 2019;33(9):2266-2275.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220318005087/en/
Investors:
joanne.choi@legendbiotech.com
crystal.chen@legendbiotech.com
Press:
tina.carter@legendbiotech.com
(908) 331-5025
Source:
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