- CARTITUDE-4, a Phase 3 study of CARVYKTI®
(ciltacabtagene autoleucel) meets primary endpoint at the study’s
first pre-specified interim analysis
- FDA clearance of IND application for LB2102 in Extensive Stage
Small Cell Lung Cancer (SCLC)
- CARVYKTI® (ciltacabtagene autoleucel) receives approval
from Japan’s Ministry of Health, Labour and Welfare (MHLW) for the
treatment of patients with relapsed or refractory multiple
myeloma
- China’s National Medical Products Administration (NMPA) has
formally accepted the New Drug Application (NDA) for ciltacabtagene
autoleucel (cilta-cel)
Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a
global biotechnology company developing, manufacturing and
commercializing novel therapies to treat life-threatening diseases,
today reported its full year 2022 audited financial results.
"2022 was a year of significant milestones for Legend Biotech,
marked by the regulatory approvals of CARVYKTI® in the U.S.,
Europe, and Japan. In addition to launching our first commercial
product, we advanced our clinical development program for
cilta-cel, obtained FDA clearances on two investigational new drug
applications targeting solid tumors, and critically, expanded our
commercial infrastructure and manufacturing capabilities to support
future growth" said Ying Huang, Chief Executive Officer of Legend
Biotech.
"Our teams across the entire business delivered exceptionally
during an incredibly busy year. Looking forward, we remain focused
on the continued expansion of our manufacturing footprint and
advancing our clinical program in order to bring CARVYKTI®
to more eligible patients."
Second Half 2022 Highlights and Recent Events
- On January 27, 2023, Legend Biotech announced that CARTITUDE-4,
the Phase 3 study evaluating CARVYKTI® (ciltacabtagene
autoleucel) for the treatment of adult patients with relapsed and
lenalidomide-refractory multiple myeloma, met its primary endpoint
of showing a statistically significant improvement in
progression-free survival (PFS) compared to standard therapy at the
study’s first pre-specified interim analysis
- On January 2, 2023, Legend Biotech announced that China’s
National Medical Products Administration (NMPA) has formally
accepted the New Drug Application (NDA) for ciltacabtagene
autoleucel (cilta-cel)
- On November 21, 2022, Legend Biotech announced that the U.S.
Food and Drug Administration (FDA) cleared Legend Biotech’s
Investigational New Drug (IND) application to proceed with the
clinical development of LB2102, an investigational, autologous
chimeric antigen receptor T-cell (CAR-T) therapy for the treatment
of adult patients with extensive stage small cell lung cancer
(SCLC)
- On September 27, 2022, Legend Biotech announced that Japan’s
Ministry of Health, Labour and Welfare (MHLW) approved
CARVYKTI® (ciltacabtagene autoleucel) for the treatment of
adults with relapsed or refractory multiple myeloma, limited to
cases meeting both of the following conditions: patients have no
history of CAR-positive T cell infusion therapy targeting BCMA; and
patients have received three or more lines of therapies, including
an immunomodulatory agent, a proteasome inhibitor and an anti-CD38
monoclonal antibody, and in whom multiple myeloma has not responded
to or has relapsed following the most recent therapy
Financial Results for Year Ended December 31, 2022
Cash and Cash Equivalents, Time Deposits, and Short-Term
Investments
As of December 31, 2022, Legend Biotech had approximately $1.0
billion of cash and cash equivalents, time deposits, and short-term
investments.
Revenue
Revenue for the year ended December 31, 2022 was $117.0 million
compared to $68.8 million for the year ended December 31, 2021. The
increase of $48.2 million was due to product sales for the
commercial launch of CARVYKTI® in the U.S. in connection
with Legend Biotech’s collaboration agreement with Janssen Biotech,
Inc. (the “Janssen Agreement”).
Research and Development Expenses
Research and development expenses for the year ended December
31, 2022 were $335.6 million compared to $313.3 million for the
year ended December 31, 2021. This increase of $22.3 million was
primarily due to continued investment in cilta-cel for earlier
lines of therapies and increase in Legend Biotech’s pipeline
expenditures as it filed two Investigational New Drug applications
and began preparation for Phase 1 clinical development in the U.S.
in the year ended December 31, 2022.
Administrative Expenses
Administrative expenses for the year ended December 31, 2022
were $80.6 million compared to $47.0 million for the year ended
December 31, 2021. The increase of $33.7 million was primarily due
to the final phase of separation of certain information technology
services from GenScript Biotech Corporation, required enhancements
for cybersecurity and privacy, along with the required information
technology infrastructure build to support manufacturing
facilities.
Selling and Distribution Expenses
Selling and distribution expenses for the year ended December
31, 2022 were $93.4 million compared to $102.5 million for the year
ended December 31, 2021. This increase of $9.1 million was
primarily due to costs associated with the commercialization of
CARVYKTI®.
Other Income and Gains
Other income and gains for the year ended December 31, 2022 were
$12.0 million compared to $3.1 million for the year ended December
31, 2021. The increase of $8.9 million was primarily due to
increase in interest income, government grants and fair value gain
from financial assets.
Other Expenses
Other expenses for the year ended December 31, 2022 were $9.8
million compared to $9.1 million for the year ended December 31,
2021. The increase was primarily due to foreign currency exchange
loss in the year.
Finance Costs
Finance costs for the year ended December 31, 2022 were $10.8
million compared to $0.9 million for the year ended December 31,
2021. The increase was primarily due to interest on advance
funding, which is interest-bearing borrowings funded by Janssen
under the Janssen Agreement and constituted by principal and
applicable interests upon such principal. Legend Biotech elected to
borrow an incremental $130.3 million as of December 31, 2022 in
accordance with the terms of the Janssen Agreement.
Fair Value Gain of Warrant Liability
Fair value gain of warrant liability for the year ended December
31, 2022 was $20.9 million caused by changes in the fair value of a
warrant that Legend Biotech issued to an institutional investor
through a private placement transaction in May 2021 with an initial
fair value of $81.7 million at the issuance date. The warrant was
assessed as a financial liability with a fair value of $67.0
million as of December 31, 2022.
Loss for the Period
For the year ended December 31, 2022, net loss was $446.3
million, or $1.40 per share, compared to a net loss of $403.6
million, or $1.43 per share, for the year ended December 31,
2021.
About Legend Biotech
Legend Biotech is a global biotechnology company dedicated to
treating, and one day curing, life-threatening diseases.
Headquartered in Somerset, New Jersey, we are developing advanced
cell therapies across a diverse array of technology platforms,
including autologous and allogeneic chimeric antigen receptor
T-cell and natural killer (NK) cell-based immunotherapy. From our
three R&D sites around the world, we apply these innovative
technologies to pursue the discovery of cutting-edge therapeutics
for patients worldwide.
Learn more at www.legendbiotech.com and follow us on 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® and other product
candidates, including Legend Biotech’s expectations for CARVYKTI®
and other product candidates, such as Legend Biotech’s
manufacturing and commercialization expectations for CARVYKTI® and
the potential effect of treatment with CARVYKTI® and other product
candidates; statements about submissions for CARVYKTI® and other
product candidates to, and the progress of such submissions with,
the U.S. Food and Drug Administration (FDA) and other regulatory
authorities; the anticipated timing of, and ability to progress,
clinical trials; and the ability to generate, analyze and present
data from clinical trials. 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; competition in general; government, industry,
and general product 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 Legend Biotech’s Annual Report on Form 20-F
filed with the Securities and Exchange Commission on March 30,
2023. 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.
LEGEND BIOTECH CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
Twelve months ended December 31 (in thousands, US$,
except share and per share data)
2022
2021
2020
REVENUE License revenue
50,000
65,402
75,000
Collaboration revenue
66,677
-
-
Other revenue
328
3,424
0
Total revenue
117,005
68,826
75,000
Collaboration cost of revenue
(65,363
)
-
-
Other income and gains
12,049
3,059
6,119
Research and development expenses
(335,648
)
(313,346
)
(232,160
)
Administrative expenses
(80,631
)
(46,961
)
(23,134
)
Selling and distribution expenses
(93,417
)
(102,542
)
(49,571
)
Other expenses
(9,823
)
(9,132
)
(346
)
Fair value gain/(loss) of warrant liability
20,900
(6,200
)
-
Fair value loss of convertible redeemable preferred shares
-
-
(79,984
)
Finance costs
(10,796
)
(900
)
(4,209
)
LOSS BEFORE TAX
(445,724
)
(407,196
)
(308,285
)
Income tax (expense)/credit
(625
)
3,614
41,912
LOSS FOR THE YEAR
(446,349
)
(403,582
)
(266,373
)
Attributable to:
Ordinary equity holders of the parent
(446,349
)
(403,582
)
(266,373
)
Loss per share attributable to ordinary equity holders of
the parent: Ordinary shares - basic
(1.40
)
(1.43
)
(1.13
)
Ordinary shares - diluted
(1.40
)
(1.43
)
(1.13
)
Shares used in loss per share computation: Weighted average
number of ordinary shares
318,083,913
281,703,291
236,305,234
LEGEND BIOTECH CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(in thousands, US$)
December 31, 2022
December 31, 2021
NON-CURRENT ASSETS Property, plant and equipment
105,168
102,506
Advance payments for property, plant and equipment
914
2,168
Right-of-use assets
55,590
38,283
Time deposits
-
4,705
Intangible assets
3,409
4,684
Collaboration prepaid leases
65,276
12,121
Other non-current assets
1,487
5,148
Total non-current assets
231,844
169,615
CURRENT ASSETS Collaboration inventories
10,354
1,749
Trade receivables
90
50,410
Prepayments, other receivables and other assets
61,755
13,852
Financial assets at fair value through profit or loss
185,603
-
Financial assets measured at amortized cost
-
29,937
Pledged deposits
1,270
1,444
Time deposits
54,016
163,520
Cash and cash equivalents
786,031
688,938
Total current assets
1,099,119
949,850
Total assets
1,330,963
1,119,465
CURRENT LIABILITIES Trade payables
32,893
7,043
Other payables and accruals
184,109
123,558
Government grants
451
304
Lease liabilities
3,563
911
Tax payable
9,772
9,488
Warrant liability
67,000
87,900
Total current liabilities
297,788
229,204
NON-CURRENT LIABILITIES Collaboration
interest-bearing advanced funding
260,932
120,462
Lease liabilities long term
20,039
1,593
Government grants
7,659
1,866
Other non-current liabilities
233
396
Total non-current liabilities
288,863
124,317
Total liabilities
586,651
353,521
EQUITY Share capital
33
31
Reserves
744,279
765,913
Total ordinary shareholders’ equity
744,312
765,944
Total equity
744,312
765,944
Total liabilities and equity
1,330,963
1,119,465
LEGEND BIOTECH CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands, US$)
2022
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES Loss before tax
(445,724
)
(407,196
)
(308,285
)
Adjustments for: Finance income
(8,182
)
(971
)
(2,930
)
Finance costs
10,796
900
4,209
Depreciation of property, plant and equipment
10,173
8,139
6,234
Loss on disposal of property, plant and equipment
481
974
55
Amortization of intangible assets
2,476
1,379
192
Depreciation of right-of-use assets
5,743
4,399
3,507
Fair value (gain)/ loss of warrant liability
(20,900
)
6,200
-
Fair value loss of convertible redeemable preferred shares
-
-
79,984
Fair value gains on financial assets measured at fair value change
through profit or loss
(593
)
-
(47
)
Foreign currency exchange loss/(gain), net
9,159
4,867
(66
)
Equity-settled share-based compensation expense
34,338
20,158
4,760
Deferred government grant
(307
)
(295
)
(114
)
(402,540
)
(361,446
)
(212,501
)
Decrease/(increase) in trade receivables
50,320
24,590
(45,000
)
(Increase)/decrease in prepayments, other receivables and other
assets
(50,614
)
(2,966
)
3,366
Decrease/(increase) in other non-current assets
3,661
(1,175
)
(3,973
)
(Increase)/decrease in collaboration inventories
(8,605
)
51
(643
)
Government grant received
6,180
80
2,452
Increase/(decrease) in trade payables
25,850
1,805
(4,348
)
Increase in other payables and accruals
165,883
140,747
26,932
Increase/(decrease) in other non-current liabilities
(163
)
(158
)
554
Increase in pledged deposits, net
(15
)
(1,060
)
(128
)
Cash used in operations
(210,043
)
(199,532
)
(233,289
)
Income tax paid
-
-
(278
)
Finance income received
6,832
652
3,366
Income tax received
3,709
557
7,391
Interest on lease payments
(527
)
(142
)
(195
)
Net cash used in operating activities
(200,029
)
(198,465
)
(223,005
)
2022
2021
2020
CASH FLOWS FROM INVESTING ACTIVITIES Purchase of property,
plant and equipment
(20,927
)
(42,197
)
(26,254
)
Purchase of intangible assets
(1,348
)
(3,207
)
(4,029
)
Prepayment to collaborator for collaboration assets
(14,810
)
(1,708
)
(19,493
)
Purchase of financial assets measured at fair value through profit
or loss
(285,000
)
(50,000
)
(22,682
)
Cash received from withdrawal of financial assets measured at fair
value through profit or loss
99,990
50,081
22,682
Cash received from withdrawal of financial assets measured at
amortized cost
30,000
-
-
Cash receipts of investment income
-
-
47
Proceeds from disposal of property, plant and equipment
-
4
1
Addition in time deposits
(369,971
)
(298,107
)
(50,000
)
Decrease in time deposits
483,617
180,000
75,559
Decrease in pledged deposits
105
-
-
Purchase of financial assets measured at amortized cost
-
(29,849
)
-
Net cash used in investing activities
(78,344
)
(194,983
)
(24,169
)
CASH FLOWS FROM FINANCING ACTIVITIES Repayment of
cash advances from related parties
-
-
(4
)
Proceeds from convertible redeemable preferred shares
-
-
160,450
Proceeds from issuance of ordinary shares for initial public
offering, net of issuance costs
-
-
450,085
Proceeds from issuance of ordinary shares relating to private
placement by GenScript
-
-
12,000
Proceeds from issuance of ordinary shares for follow on public
offering, net of issuance costs
377,643
323,440
-
Proceeds from issuance of ordinary shares and warrant relating to
private placement for an institutional investor
-
300,000
-
Proceeds from exercise of share options
2,929
4,642
1,464
Payments of expenses for issuance of convertible redeemable
preferred shares
-
-
(2,514
)
Principal portion of lease payments
(2,596
)
(1,419
)
(2,602
)
Net cash provided by financing activities
377,976
626,663
618,879
2022
2021
2020
NET INCREASE IN CASH AND CASH EQUIVALENTS
99,603
233,215
371,705
Effect of foreign exchange rate changes, net
(2,510
)
34
620
Cash and cash equivalents at beginning of year
688,938
455,689
83,364
CASH AND CASH EQUIVALENTS AT END OF YEAR
786,031
688,938
455,689
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230330005616/en/
Investor Contacts: Joanne Choi, Senior Manager, Investor
Relations, Legend Biotech Joanne.choi@legendbiotech.com
Crystal Chen, Manager, Investor Relations, Legend Biotech
crystal.chen@legendbiotech.com
Press Contact: Tina Carter, Corporate Communications
Lead, Legend Biotech tina.carter@legendbiotech.com (908)
331-5025
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