Full Press Release Details
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 and European Hematology Association (EHA) Virtual Congress
SOMERSET, N.J. (BUSINESS WIRE) May
18, 2021 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today reported its
unaudited financial results for the first quarter of 2021.
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, Janssen Biotech, Inc.*(Janssen), completing the Biologics License Application to the U.S. FDA and the Marketing
Authorisation Application to the EMA, said Ying Huang, PhD, CEO and CFO of Legend Biotech. We look forward to an exciting year with new and updated data from the CARTITUDE clinical development program and reaching our goal of bringing a
new CAR-T treatment option to patients living with multiple myeloma worldwide pending regulatory approvals.
First Quarter 2021 & Recent Highlights
Key Upcoming Milestones
Financial Results for First Quarter Ended March 31, 2021
Cash and Cash Equivalents and Time Deposits
March 31, 2021, Legend Biotech had approximately $412.3 million of cash and cash equivalents and approximately $50.0 million in time deposits.
Revenue for the three months ended
March 31, 2021 was $13.7 million compared to $11.5 million for the three months ended March 31, 2020. The increase of $2.2 million was primarily due to revenue recognition of additional milestone payment achieved pursuant to
Legend Biotech s agreement with Janssen. Milestone payments are constrained as a result of the uncertainty of whether the milestone will be achieved, but recognized when the associated milestone is achieved and the uncertainty relieved. In the
first quarter of 2021, this resulted in a larger amount of revenue recognized from the contract liabilities. Legend Biotech has not generated any revenue from product sales to date.
Research and Development Expenses
development expenses for the three months ended March 31, 2021 were $71.1 million compared to $48.0 million for the three months ended March 31, 2020. This increase of $23.1 million was primarily due to a higher number of
clinical trials with more patients enrolled and a higher number of research and development product candidates.
Administrative Expenses
Administrative expenses for the three months ended March 31, 2021 were $8.7 million compared to $3.4 million for the three months ended
March 31, 2020. The increase of $5.3 million was primarily due to Legend Biotech s expansion of supporting administrative functions to aid continued research and development activities.
Selling and Distribution Expenses
Selling and distribution expenses for the three months ended March 31, 2021 were $13.4 million compared to $6.5 million for the three months
ended March 31, 2020. This increase of $6.9 million was primarily due to increased costs associated with commercial preparation activities for cilta-cel.
Other Income and Gains
Other income and gains for the
three months ended March 31, 2021 was $0.7 million compared to $2.5 million for the three months ended March 31, 2020. The decrease of $1.8 million was primarily due to lower government grant and interest income received in
first quarter of 2021.
the three months ended March 31, 2021 was $2.0 million compared to $0.05 million for the three months ended March 31, 2020. The increase was primarily due to higher foreign currency exchange loss in first quarter of 2021.
Finance costs for the three months ended
March 31, 2021 was $0.04 million compared to $4.0 million for the three months ended March 31, 2020. The decrease was primarily due to finance costs related to the issuance of convertible redeemable preferred shares in 2020,
which were fully converted into ordinary shares upon the completion of Legend Biotech s initial public offering in June 2020.
For the three months ended March 31, 2021, net loss was $80.9 million, or $0.30 per share, compared to a net loss of $44.2 million, or
$0.22 per share, for the three months ended March 31, 2020.
About Legend Biotech
Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other
indications. Our team of over 800 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover,
develop, and manufacture best-in-class cell therapies for patients in need.
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 China and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for
the treatment of patients with relapsed and/or refractory multiple myeloma and in earlier lines of treatment. Cilta-cel is a differentiated CAR-T therapy with two
BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement to develop and commercialize cilta-cel. In addition to a
Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020. A Biologics License Application seeking approval of cilta-cel was submitted to the
U.S. FDA and a Marketing Authorization Application was submitted to the European Medicines Agency.
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
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.
(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 China Center for Drug Evaluation
(CTR20181007) to further evaluate LCAR-B38M CAR-T cells in patients with advanced RRMM.4
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 U.S. FDA, the MAA for cilta-cel submitted to the EMA, and the submissions for cilta-cell to the CDE and the
JMHLW; the ability to generate, analyze and present data from clinical trials; patient enrollment; and the potential benefits of our 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
US litigation process; competition in general; government, industry, and general public pricing and other political pressures; the duration and severity of the COVID-19 pandemic and governmental and regulatory
measures implemented in response to the evolving situation; as well as the other factors discussed in the Risk Factors section of the Company s Annual Report on Form 20-F filed with the
Securities and Exchange Commission on April 2, 2021. 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 presentation
as anticipated, believed, estimated or expected. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
LEGEND BIOTECH CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
| Three months ended March 31 | ||||||||
| (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 |
LEGEND BIOTECH CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
| March 31, 2021 (Unaudited) | December 31, 2020 | |||||||
| (in thousands, US$) | ||||||||
| NON-CURRENT ASSETS | ||||||||
| Property, plant and equipment | 122,905 | 113,091 | ||||||
| Other non-current assets | 3,983 | 3,973 | ||||||
| Advance payments for property, plant and equipment | 1,663 | 224 | ||||||
| Right-of-use assets | 7,547 | 8,009 | ||||||
| Intangible assets | 4,081 | 2,852 | ||||||
| Total non-current assets | 140,179 | 128,149 | ||||||
| CURRENT ASSETS | ||||||||
| Inventories | 2,097 | 1,800 | ||||||
| Trade receivables | 74,978 | |||||||
| Prepayments, other receivables and other assets | 10,425 | 10,007 | ||||||
| Pledged short-term deposits | 256 | 384 | ||||||
| Time deposits | 50,000 | 50,000 | ||||||
| Cash and cash equivalents | 412,296 | 455,689 | ||||||
| Total current assets | 475,074 | 592,858 | ||||||
| Total assets | 615,253 | 721,007 | ||||||
| CURRENT LIABILITIES | ||||||||
| Trade and notes payables | 9,649 | 5,238 | ||||||
| Other payables and accruals | 80,096 | 99,168 | ||||||
| Government grants | 281 | 283 | ||||||
| Lease liabilities | 1,460 | 1,464 | ||||||
| Contract liabilities | 54,456 | 55,014 | ||||||
| Total current liabilities | 145,942 | 161,167 | ||||||
| NON-CURRENT LIABILITIES | ||||||||
| Contract liabilities | 258,666 | 275,071 | ||||||
| Lease liabilities | 1,673 | 1,909 | ||||||
| Other non-current liabilities | 554 | 554 | ||||||
| Government grants | 1,967 | 2,051 | ||||||
| Total non-current liabilities | 262,860 | 279,585 | ||||||
| Total liabilities | 408,802 | 440,752 | ||||||
| EQUITY | ||||||||
| Share capital | 27 | 27 | ||||||
| Reserves | 206,424 | 280,228 | ||||||
| Total ordinary shareholders equity | 206,451 | 280,255 | ||||||
| Total equity | 206,451 | 280,255 | ||||||
| Total liabilities and equity | 615,253 | 721,007 |
LEGEND BIOTECH CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| Three months ended March 31 | ||||||||
| (in thousands, US$) | 2021 (Unaudited) | 2020 (Unaudited) | ||||||
| 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 | ||||||
| NET (DECREASE)/INCREASE IN CASH AND CASH EQUIVALENTS | (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 |
Media and Investor Relations:
Jessie Yeung, Head of Corporate Finance and Investor Relations, Legend Biotech
Crystal Chen, Manager of Investor Relations and Corporate Communications, Legend Biotech
Source: Legend Biotech