Legend Biotech Corporation (NASDAQ: LEGN) (“Legend Biotech” or
the “Company”), a global clinical-stage biopharmaceutical company
engaged in the discovery and development of novel cell therapies
for oncology and other indications, today reported financial
results for the quarter ended September 30, 2020.
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the full release here:
https://www.businesswire.com/news/home/20201116005237/en/
Legend Biotech’s Development Pipeline
(Graphic: Business Wire)
“Legend Biotech continues to execute on our corporate strategy,
advancing the development of our lead product candidate,
ciltacabtagene autoleucel (cilta-cel), in collaboration with
Janssen Biotech, Inc. as well as our other pipeline programs,” said
Dr. Ying Huang, Chief Executive Officer (“CEO”) and Chief Financial
Officer (“CFO”) of Legend Biotech. “We look forward to initiation
of the Biologics License Application (“BLA”) filing for cilta-cel
by Janssen Biotech, Inc.”
Third Quarter 2020 & Recent Highlights
- On November 9, 2020, Legend Biotech announced that Ms. Ye
(Sally) Wang was appointed, effective November 6, 2020, as
Chairwoman of the Board of Directors of Legend Biotech. The Board
of Directors also named Dr. Ying Huang as CEO of Legend Biotech,
effective November 6, 2020. Dr. Huang had been serving as interim
CEO since September 21, 2020. Dr. Huang will continue to hold his
position as CFO until such time as a successor CFO is
identified.
- On November 5, 2020, Legend Biotech announced that the Company
will present new and updated data from its CARTITUDE-1 and LEGEND-2
studies at the 62nd American Society of Hematology (ASH) Annual
Meeting and Exposition taking place virtually December 5-8,
2020.
- On September 21, 2020, Legend Biotech announced that the
Customs Anti-Smuggling Department of the People’s Republic of China
(“PRC”) had inspected places of business in China of Legend Biotech
and GenScript Biotech Corporation, Legend Biotech’s majority
shareholder, in connection with what Legend Biotech understands to
be an investigation relating to suspected violations of import and
export regulations under the laws of the PRC (the “Investigation”)
and that Dr. Fangliang Zhang, the Chairman of the Board of
Directors and CEO of Legend at that time, had been placed under
“residential surveillance” in the PRC. No charges have been filed
against Legend Biotech, Dr. Zhang, or any of its other officers or
directors, and the Company does not believe that Legend Biotech is
a subject of the investigation.
- On August 5, 2020, Legend Biotech announced that the China
Center for Drug Evaluation (“CDE”) of National Medical Products
Administration (“NMPA”) recommended Breakthrough Therapy
Designation (“BTD”) for cilta-cel for the treatment of adults with
relapsed/refractory multiple myeloma. The designation was granted
on August 13, 2020, making cilta-cel the first investigational
product to obtain BTD in China.
Key Upcoming Milestones
- On Saturday, December 5, 2020, during the Myeloma session at
ASH entitled: Myeloma/Amyloidosis: Therapy, excluding
Transplantation: Novel Therapies Targeting B Cell Maturation
Antigen in Relapsed/Refractory Multiple Myeloma, the Phase 1b/2
clinical efficacy and safety data from the CARTITUDE-1 study will
be presented.
- During the ASH Annual Meeting and Exposition, LEGEND-2 data in
patients with relapsed or refractory multiple myeloma and
extramedullary disease will be presented as a poster.
- Legend Biotech’s collaboration partner Janssen Biotech, Inc.
anticipates initiating the BLA submission for cilta-cel to the U.S.
Food and Drug Administration (“FDA”) by the end of 2020 and
submitting a marketing authorization application to the European
Medicines Agency (“EMA”) in early 2021.
- Legend Biotech expects to use data from CARTIFAN-1 study to
file a regulatory submission in China in 2021.
- Please see Legend Biotech’s comprehensive development pipeline
as shown below.
Development Pipeline
The extent to which the COVID-19 pandemic may impact our
business and clinical trials is highly uncertain and cannot be
predicted with confidence, such as the ultimate geographic spread
of the disease, the duration of the outbreak and social distancing
regulations, travel restrictions, business closures or business
disruptions and the effectiveness of actions taken in the United
States and other countries to contain and treat the disease.
Financial Results for the Three-month and Nine-month Periods
Ended September 30, 2020
Cash and Cash Equivalents:
As of September 30, 2020, Legend Biotech had approximately
$449.4 million of cash and cash equivalents and approximately
$125.6 million in time deposits.
Revenue
Revenue for the three months ended September 30, 2020 was $11.7
million compared to $17.7 million for the three months ended
September 30, 2019. The decrease of $6.0 million was primarily due
to milestone achieved in July 2019 under the agreement with Janssen
Biotech, Inc., which resulted in additional consideration being
allocated to the licensing of intellectual property and the
steering committee service for the three months ended September 30,
2019, net-off by additional milestone that was achieved in December
2019, which resulted in additional consideration being allocated to
the steering committee service for the three months ended September
30, 2020. Revenue for the nine months ended September 30, 2020 was
$34.9 million compared to $37.8 million for the nine months ended
September 30, 2019. Similarly, the decrease of the nine months
period in 2020 was primarily driven by additional milestone payment
received from Janssen Biotech, Inc. that was achieved in July 2019,
net-off by additional milestone that was achieved in December 2019,
which resulted in additional consideration being allocated to the
steering committee service for the nine month ended September 30,
2020. Legend Biotech has not generated any revenue from product
sales to date.
Research and Development Expenses
Research and development expenses for the three months ended
September 30, 2020 were $63.7 million compared to $41.9 million for
the three months ended September 30, 2019. This increase of $21.8
million was primarily due to a higher number of clinical trials, a
higher number of patients enrolled in those trials and a higher
number of research and development product candidates in the three
months ended September 30, 2020. Consistently, research and
development expenses for the nine months ended September 30, 2020
was $165.2 million compared to $95.8 million for the nine months
ended September 30, 2019 with a $69.4 million increase.
Administrative Expenses
Administrative expenses for the three months ended September 30,
2020 were $6.0 million compared to $2.0 million for the three
months ended September 30, 2019. The increase of $4.0 million was
primarily due to Legend Biotech’s expansion of supporting
administrative functions to aid continued research and development
activities. Due to the consistent business expansion,
administrative expenses for the nine months ended September 30,
2020 increased by $9.3 million, which was $14.0 million compared to
$4.7 million for the nine months ended September 30, 2019.
Selling and Distribution Expenses
Selling and distribution expenses for the three months ended
September 30, 2020 were $9.3 million compared to $4.5 million for
the three months ended September 30, 2019. This increase of $4.8
million was primarily due to increased costs associated with
commercial preparation activities for cilta-cel. Driven by the same
commercial preparation activities, selling and distribution
expenses for the nine months ended September 30, 2020 was $25.4
million compared to $12.2 million for the nine months ended
September 30, 2019.
Other Income and Gains
Other income and gains for the three months ended September 30,
2020 was $1.5 million compared to $3.0 million for the three months
ended September 30, 2019. The decrease was primarily driven by net
foreign exchange loss incurred, net of an increase in government
grant received. Other income and gains for the nine months ended
September 30, 2020 was $5.3 million compared to $6.6 million for
the nine months ended September 30, 2019. The decrease of the nine
months period was primarily driven by reduced average interest rate
for holding of time deposits that generate interest income.
Other Expenses
Other expenses for the three months ended September 30, 2020 was
$1.2 million compared to $0.002 million for the three months ended
September 30, 2019. Other expenses for the nine months ended
September 30, 2020 was $1.3 million compared to $0.2 million for
the nine months ended September 30, 2019. The increase was
primarily due to foreign exchange loss.
Loss for the Period
For the three months ended September 30, 2020, net loss was
$66.5 million, or $0.25 per share, compared to a net loss of $27.8
million, or $0.14 per share, for the three months ended September
30, 2019. Net loss was $245.7 million for the nine months ended
September 30, 2020 compared to $69.0 million for the nine months
ended September 30, 2019.
Grant of restricted share units and share options
On September 1, 2020, we granted a total number of 777,382
restricted share units (each representing the right to receive one
ordinary share) to grantees with a grant date fair market value of
$16.335 per share. On September 1, 2020, we granted share options,
representing the right to acquire a total number of 569,000 shares
to grantees with an exercise price of $16.335 per share.
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 cutting edge cell
therapies for patients in need.
We are engaged in a strategic collaboration with Janssen
Biotech, Inc. to develop and commercialize our lead product
candidate, ciltacabtagene autoleucel, an investigational
BCMA-targeted CAR-T cell therapy for patients living with multiple
myeloma. This candidate is currently being studied in
registrational clinical trials.
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; the ability to make, and the timing of, regulatory
submissions globally, including the BLA for cilta-cel to the U.S.
FDA, the marketing authorization application (MAA) for cilta-cel to
the EMA, regulatory submission filing for CARTIFAN-1 in China and
the Investigational New Drug Application (IND) of LB1901, a CAR T
product under development for the treatment of relapsed or
refractory T-cell lymphoma (TCL), to the U.S. FDA; the ability to
generate, analyze and present data from clinical trials; patient
enrollment; the potential benefits of our product candidates, the
status and outcome of the Investigation and its impact on the
Company’s operations. 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, including the
factors discussed in the “Risk Factors” section of the prospectus
filed with the Securities and Exchange Commission on June 8, 2020.
Any forward-looking statements contained in this press release
speak only as of the date hereof, and Legend Biotech specifically
disclaims any obligation to update any forward-looking statement,
whether as a result of new information, future events or otherwise.
Readers should not rely upon the information on this page as
current or accurate after its publication date.
LEGEND BIOTECH
CORPORATION
UNAUDITED INTERIM
CONDENSED
CONSOLIDATED STATEMENTS OF
PROFIT OR LOSS
FOR THE THREE AND NINE MONTHS
ENDED SEPTEMBER 30, 2020 AND 2019
Three months ended September
30
Nine months ended September
30
(in thousands, US$, except per share
data)
2020 (unaudited)
2019 (unaudited)
2020 (unaudited)
2019 (unaudited)
REVENUE
11,747
17,674
34,893
37,814
Other income and gains
1,519
2,987
5,315
6,649
Research and development expenses
(63,656
)
(41,917
)
(165,226
)
(95,846
)
Administrative expenses
(6,038
)
(1,992
)
(13,976
)
(4,704
)
Selling and distribution expenses
(9,287
)
(4,460
)
(25,389
)
(12,246
)
Other expenses
(1,249
)
(2
)
(1,331
)
(216
)
Fair value loss of convertible redeemable
preferred shares
—
—
(79,984
)
—
Finance costs
(90
)
(82
)
(4,169
)
(139
)
LOSS BEFORE TAX
(67,054
)
(27,792
)
(249,867
)
(68,688
)
Income taxes credits / (expenses)
508
(5
)
4,217
(341
)
LOSS FOR THE PERIOD
(66,546
)
(27,797
)
(245,650
)
(69,029
)
Attributable to:
Equity holders of the parent
(66,546
)
(27,797
)
(245,650
)
(69,029
)
LOSS PER SHARE ATTRIBUTABLE TO ORDINARY
EQUITY HOLDERS OF THE PARENT
Ordinary shares—basic
(0.25
)
(0.14
)
(1.08
)
(0.35
)
Ordinary shares—diluted
(0.25
)
(0.14
)
(1.08
)
(0.35
)
ORDINARY SHARES USED IN LOSS PER SHARE
COMPUTATION
Ordinary shares—basic
264,328,630
200,000,000
226,764,437
200,000,000
Ordinary shares—diluted
264,328,630
200,000,000
226,764,437
200,000,000
LEGEND BIOTECH
CORPORATION
UNAUDITED INTERIM CONDENSED
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
AS AT SEPTEMBER 30, 2020 AND
DECEMBER 31, 2019
September 30, 2020
(Unaudited)
December 31, 2019
(in thousands, US$)
NON-CURRENT ASSETS
Property, plant and equipment
96,125
70,079
Advance payments for property, plant and
equipment
675
665
Right-of-use assets
8,077
9,348
Intangible assets
1,042
519
Total non-current assets
105,919
80,611
CURRENT ASSETS
Inventories
1,513
1,157
Trade receivables
—
29,991
Prepayments, other receivables and other
assets
24,662
16,777
Financial assets at fair value through
profit or loss
1,175
—
Pledged short-term deposits
430
256
Time deposits
125,559
75,559
Cash and cash equivalents
449,381
83,364
Total current assets
602,720
207,104
Total assets
708,639
287,715
CURRENT LIABILITIES
Trade and notes payables
7,399
9,586
Other payables and accruals
67,889
70,854
Lease liabilities
1,445
1,027
Contract liabilities
46,789
46,294
Total current liabilities
123,522
127,761
NON-CURRENT LIABILITIES
Contract liabilities
245,641
277,765
Lease liabilities
2,543
5,058
Government grants
2,033
—
Total non-current liabilities
250,217
282,823
Total liabilities
373,739
410,584
EQUITY
Share capital
26
20
Reserves / (deficits)
334,874
(122,889
)
Total ordinary shareholders’ equity /
(deficit)
334,900
(122,869
)
Total equity / (deficit)
334,900
(122,869
)
Total liabilities and equity
708,639
287,715
LEGEND BIOTECH
CORPORATION
UNAUDITED INTERIM CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE THREE AND NINE MONTHS
ENDED SEPTEMBER 30, 2020 AND 2019
Three months ended September
30
Nine months ended September
30
(in thousands, US$)
2020 (Unaudited)
2019 (Unaudited)
2020 (Unaudited)
2019 (Unaudited)
LOSS BEFORE TAX
(67,054
)
(27,792
)
(249,867
)
(68,688
)
CASH FLOWS (USED IN)/GENERATED FROM
OPERATING ACTIVITIES
(64,375
)
19,947
(167,056
)
(23,078
)
CASH FLOWS USED IN INVESTING
ACTIVITIES
(58,623
)
(21,194
)
(85,334
)
(172,103
)
CASH FLOWS FROM/(USED IN) FINANCING
ACTIVITIES
9,663
(154
)
618,221
21,346
NET (DECREASE)/INCREASE IN CASH AND CASH
EQUIVALENTS
(113,335
)
(1,401
)
365,831
(173,835
)
Effect of foreign exchange rate changes,
net
325
(44
)
186
(55
)
Cash and cash equivalents at beginning of
the period
562,391
37,721
83,364
210,166
CASH AND CASH EQUIVALENTS AT END OF THE
PERIOD
449,381
36,276
449,381
36,276
ANALYSIS OF BALANCES OF CASH AND CASH
EQUIVALENTS
Cash and bank balances
575,370
147,592
575,370
147,592
Less: Pledged short-term deposits
430
255
430
255
Time deposits
125,559
111,061
125,559
111,061
Cash and cash equivalents as stated in the
statement of financial position
449,381
36,276
449,381
36,276
Cash and cash equivalents as stated in the
statement of cash flows
449,381
36,276
449,381
36,276
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201116005237/en/
Media and Investor Relations: Jessie Yeung, Head of
Corporate Finance and Investor Relations, Legend Biotech
jessie.yeung@legendbiotech.com or investor@legendbiotech.com
Surabhi Verma, Manager of Investor Relations and Corporate
Communications, Legend Biotech surabhi.verma@legendbiotech.com or
media@legendbiotech.com
For Medical Affairs inquiries, please contact: Tonia
Nesheiwat, Executive Director, Medical Affairs, Legend Biotech USA
Inc. tonia.nesheiwat@legendbiotech.com or
medicalinformation@legendbiotech.com
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