Legend Biotech Reports First Quarter 2021 Financial Results and Recent Highlights
- Rolling submission of BLA to the FDA completed for ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed or refractory multiple myeloma (RRMM)
- European Marketing Authorisation Application (MAA) submitted for cilta-cel for the treatment of RRMM
-
New and updated cilta-cel data to be presented at the upcoming 2021
American Society of Clinical Oncology (ASCO) Annual Meeting andEuropean Hematology Association (EHA) Virtual Congress
“We built on the momentum of 2020 during the first quarter of this year for our BCMA CAR-T therapy cilta-cel with our collaboration partner,
*In
First Quarter 2021 & Recent Highlights
-
In the first quarter of 2021, the rolling submission of a Biologics License Application (BLA) to the
U.S. Food and Drug Administration (FDA) was completed by Legend Biotech’s collaborator, Janssen, for cilta-cel, for the treatment of adults with RRMM. -
On
April 30, 2021 the Marketing Authorisation Application (MAA) to theEuropean Medicines Agency (EMA) was made by Legend Biotech’s collaborator, Janssen, for cilta-cel for the treatment of adults with RRMM. This follows the granting of an accelerated assessment for this MAA by the EMA’s Committee for Medicinal Products for Human Use (CHMP) inFebruary 2021 . -
On
May 13, 2021 ,Legend Biotech entered into a subscription agreement with an institutional investor for the offer and sale of 20,809,805 ordinary shares in a private placement at a purchase price of$14.41625 per ordinary share (equivalent to$28.8325 per American Depositary Share, or ADS) and the issuance of a warrant exercisable for up to an aggregate of 10,000,000 ordinary shares, exercisable for a two-year period at an exercise price of$20.00 per ordinary share (equivalent to$40.00 per ADS).
Key Upcoming Milestones
-
Updated clinical data, including longer term follow up results from the CARTITUDE-1 trial, will be presented at the virtual 2021 ASCO Annual Meeting taking place on
June 4-8 , 2021 (oral presentation, abstract #8005) along with initial data from the CARTITUDE-2 trial (abstracts #8013, #8028). In addition, there will be three poster presentations featuring real-world data (abstracts #8045, #8030 and #8041). -
Nine abstracts will be presented at the
European Hematology Association Virtual Congress taking place virtually onJune 9-17, 2021 . (abstracts #S190, #EP964, #EP1003, #EP987, #EP990, #EP1049, #EP978, #EP977 and #EP972). -
Legend Biotech intends to use the data from the CARTIFAN-1 study in support of a regulatory submission to theChina Center for Drug Evaluation (CDE) in the second half of 2021 seeking approval of cilta-cel for the treatment of adults with RRMM. -
Legend Biotech’s collaboration partner, Janssen, anticipates submitting a New Drug Application (NDA) to the
Japan Ministry of Health, Labor and Welfare (JMHLW) in the second half of 2021 seeking approval of cilta-cel for the treatment of adults with RRMM. -
Legend Biotech expects to initiate its Phase 1 clinical trial of LB1901 in RR T-cell lymphoma (TCL) inthe United States in 2021. -
Legend Biotech anticipates supporting investigators with publishing a clinical data update from LEGEND-2 study in 2021.
Financial Results for First Quarter Ended
Cash and Cash Equivalents and Time Deposits
As of
Revenue
Revenue for the three months ended
Research and Development Expenses
Research and development expenses for the three months ended
Administrative Expenses
Administrative expenses for the three months ended
Selling and Distribution Expenses
Selling and distribution expenses for the three months ended
Other Income and Gains
Other income and gains for the three months ended
Other Expenses
Other expenses for the three months ended
Finance Costs
Finance costs for the three months ended
Loss for the Period
For the three months ended
About
We are engaged in a strategic collaboration to develop and commercialize our lead product candidate, cilta-cel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.
About Ciltacabtagene autoleucel (cilta-cel)
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 outside of
About Clinical Development Program
CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory multiple myeloma who have received at least three prior lines of therapy or are double refractory to an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI), received an IMiD, a PI and an anti-CD38 antibody, and documented disease progression within 12 months of starting the most recent therapy.1 The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint.
CARTITUDE-2 (NCT04133636) is a global, multi-cohort Phase 2 study evaluating cilta-cel in patients with multiple myeloma in various clinical settings.2 This study is being conducted to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive cilta-cel.
CARTITUDE-4 (NCT04181827) is a global, randomized Phase 3 study, evaluating cilta-celin patients with multiple myeloma who have received 1-3 prior lines of therapy including a PI and IMiD and are refractory to lenalidomide.3 The study is being conducted to evaluate the efficacy of cilta-cel compared to standard therapies including daratumumab, pomalidomide and low-dose dexamethasone (DPd) or pomalidomide, bortezomib and low-dose dexamethasone (PVd).
CARTIFAN-1 (NCT03758417) is a Phase 2 confirmatory trial registered with the
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; the anticipated timing of, and ability to progress, clinical trials, including the initiation of the phase 1 clinical trial of LB1901 in RRTCL; the ability to make, the timing of, and the ultimate success of, regulatory submissions globally, including the BLA for cilta-cel submitted to the
CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
Three months ended |
|||||
(in thousands, US$, except share and per share data) |
2021 (Unaudited) |
2020 (Unaudited) |
|||
REVENUE |
13,682 |
|
11,546 |
|
|
Other income and gains |
722 |
|
2,531 |
|
|
Research and development expenses |
(71,072 |
) |
(48,003 |
) |
|
Administrative expenses |
(8,742 |
) |
(3,430 |
) |
|
Selling and distribution expenses |
(13,417 |
) |
(6,545 |
) |
|
Other expenses |
(2,034 |
) |
(45 |
) |
|
Finance costs |
(38 |
) |
(3,991 |
) |
|
|
|
||||
LOSS BEFORE TAX |
(80,899 |
) |
(47,937 |
) |
|
|
|
||||
Income tax credit |
- |
|
3,709 |
|
|
|
|
||||
LOSS FOR THE PERIOD |
(80,899 |
) |
(44,228 |
) |
|
Attributable to: |
|
|
|||
Equity holders of the parent |
(80,899 |
) |
(44,228 |
) |
|
|
|
||||
Loss per share attributable to ordinary equity holders of the parent: |
|
|
|||
Ordinary shares – basic |
(0.30 |
) |
(0.22 |
) |
|
Ordinary shares – diluted |
(0.30 |
) |
(0.22 |
) |
|
|
|
||||
Shares used in loss per share computation: |
|
|
|||
Ordinary shares – basic |
266,293,913 |
|
200,000,000 |
|
|
Ordinary shares – diluted |
266,293,913 |
|
200,000,000 |
|
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(Unaudited) |
|
||
(in thousands, US$) |
|||
|
|
|
|
NON-CURRENT ASSETS |
|||
Property, plant and equipment |
122,905 |
|
113,091 |
Other non-current assets |
3,983 |
|
3,973 |
Advance payments for property, plant and equipment |
1,663 |
|
224 |
Right-of-use assets |
7,547 |
|
8,009 |
Intangible assets |
4,081 |
|
2,852 |
|
|
|
|
Total non-current assets |
140,179 |
|
128,149 |
|
|
|
|
CURRENT ASSETS |
|
|
|
Inventories |
2,097 |
|
1,800 |
Trade receivables |
- |
|
74,978 |
Prepayments, other receivables and other assets |
10,425 |
|
10,007 |
Pledged short-term deposits |
256 |
|
384 |
Time deposits |
50,000 |
|
50,000 |
Cash and cash equivalents |
412,296 |
|
455,689 |
|
|
|
|
Total current assets |
475,074 |
|
592,858 |
|
|
|
|
Total assets |
615,253 |
|
721,007 |
|
|
|
|
CURRENT LIABILITIES |
|
|
|
Trade and notes payables |
9,649 |
|
5,238 |
Other payables and accruals |
80,096 |
|
99,168 |
Government grants |
281 |
|
283 |
Lease liabilities |
1,460 |
|
1,464 |
Contract liabilities |
54,456 |
|
55,014 |
|
|
|
|
Total current liabilities |
145,942 |
|
161,167 |
|
|
|
|
NON-CURRENT LIABILITIES |
|
|
|
Contract liabilities |
258,666 |
|
275,071 |
Lease liabilities |
1,673 |
|
1,909 |
Other non-current liabilities |
554 |
|
554 |
Government grants |
1,967 |
|
2,051 |
|
|
|
|
Total non-current liabilities |
262,860 |
|
279,585 |
|
|
|
|
Total liabilities |
408,802 |
|
440,752 |
|
|
|
|
EQUITY |
|
|
|
Share capital |
27 |
|
27 |
Reserves |
206,424 |
|
280,228 |
|
|
|
|
Total ordinary shareholders’ equity |
206,451 |
|
280,255 |
|
|
|
|
Total equity |
206,451 |
|
280,255 |
|
|
|
|
Total liabilities and equity |
615,253 |
|
721,007 |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
|
Three months ended |
||||
(in thousands, US$) |
2021
|
2020
|
|||
|
|
|
|||
LOSS BEFORE TAX |
(80,899 |
) |
(47,937 |
) |
|
|
|
|
|||
CASH FLOWS USED IN OPERATING ACTIVITIES |
(26,787 |
) |
(45,796 |
) |
|
|
|
|
|||
CASH FLOWS USED IN INVESTING ACTIVITIES |
(17,150 |
) |
(17,499 |
) |
|
|
|
|
|||
CASH FLOWS FROM FINANCING ACTIVITIES |
207 |
|
148,755 |
|
|
|
|
|
|||
|
(43,730 |
) |
85,460 |
|
|
|
|
|
|||
Effect of foreign exchange rate changes, net |
337 |
|
(27 |
) |
|
Cash and cash equivalents at beginning of the period |
455,689 |
|
83,364 |
|
|
|
|
|
|||
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD |
412,296 |
|
168,797 |
|
|
|
|
|
|||
ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS |
|
|
|||
Cash and bank balances |
462,552 |
|
244,612 |
|
|
Less: Pledged short-term deposits |
256 |
|
256 |
|
|
Time deposits |
50,000 |
|
75,559 |
|
|
Cash and cash equivalents as stated in the statement of financial position |
412,296 |
|
168,797 |
|
|
Cash and cash equivalents as stated in the statement of cash flows |
412,296 |
|
168,797 |
|
______________________________
1 ClinicalTrials.gov. A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma (CARTITUDE-1). Available at: https://clinicaltrials.gov/ct2/show/NCT03548207. Last accessed
2 ClinicalTrials.gov. A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma (CARTITUDE-2). Available at: https://clinicaltrials.gov/ct2/show/NCT04133636. Last accessed
3 ClinicalTrials.gov. A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). https://clinicaltrials.gov/ct2/show/NCT04181827. Last accessed
4 ClinicalTrials.gov. A Study of LCAR-B38M CAR-T Cells, a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Chinese Participants With Relapsed or Refractory Multiple Myeloma (CARTIFAN-1). https://clinicaltrials.gov/ct2/show/NCT03758417. Last accessed
View source version on businesswire.com: https://www.businesswire.com/news/home/20210518005178/en/
Media and Investor Relations:
jessie.yeung@legendbiotech.com or investor@legendbiotech.com
crystal.chen@legendbiotech.com or media@legendbiotech.com
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