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 financial results for the quarter
ended June 30, 2020.
“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
Frank Zhang, Ph.D., Chief Executive Officer and Chairman of the
Board of Legend Biotech. “We look forward to presenting data from
the CARTITUDE-1 study at a major medical conference in the second
half of 2020.”
Second Quarter 2020 & Recent Highlights
- Collaborative Research and License Agreement with Noile-Immune
Biotech. On April 27, 2020, Legend Biotech entered into a
collaborative research and license agreement with Noile-Immune
Biotech Inc. pursuant to which Legend Biotech obtained a license to
develop and commercialize next-generation CAR-T and/or TCR-T cell
therapies incorporating Noile-Immune’s PRIME
(proliferation-inducing and migration-enhancing) technology for up
to two targets for all indications.
- Updated Results from Janssen sponsored Phase 1b/2 CARTITUDE-1
study. On May 13, 2020, Legend Biotech announced positive follow up
data (median of 11.5 months) from the Phase 1b portion of the
CARTITUDE-1 study evaluating cilta-cel1 (JNJ-4528) in heavily
pretreated patients with relapsed or refractory multiple myeloma
(RRMM).
- Appointment of Three New Directors. In May 2020, Dr. Corazon
(Corsee) Dating Sanders, Dr. Darren Ji, and Mr. Philip Yau joined
Legend Biotech’s Board of Directors.
- Successful Initial Public Offering. On June 9, 2020, Legend
Biotech successfully completed its initial public offering for
total gross proceeds of approximately $487.3 million.
- Appointment of Dr. Frank Zhang as CEO. On August 1, 2020, the
Board of Directors of Legend Biotech appointed Dr. Frank Zhang to
serve as Chief Executive Officer, succeeding Dr. Yuan Xu upon her
resignation.
- First Breakthrough Therapy Designation from China CDE. On
August 5, 2020, Legend Biotech announced that the China Center for
Drug Evaluation (“CDE”), National Medical Products Administration
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
- Legend Biotech, in collaboration with Janssen Biotech, Inc.,
anticipates the presentation of data from the CARTITUDE-1 study at
a major medical conference in the second half of 2020.
- Janssen Biotech, Inc., Legend Biotech’s collaboration partner,
expects to initiate the BLA filing for cilta-cel to the U.S. FDA by
the end of 2020 and also expects that a marketing authorization
application will be submitted to the European Medicines Agency
(“EMA”) in early 2021.
- Legend Biotech expects to use the data from CARTIFAN-1 in
support of a regulatory submission for approval in China in
2021.
- Legend Biotech intends to submit an IND application for LB1901
in relapsed or refractory T cell Lymphoma (“TCL”) in the second
half of 2020.
The extent to which the COVID-19 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 Quarter Ended June 30, 2020
Cash and Cash Equivalents:
As of June 30, 2020, Legend Biotech had approximately $562.4
million of cash and cash equivalents and approximately $75.6
million in time deposits.
Revenue
Revenue for the three months ended June 30, 2020 was $11.6
million compared to $10.1 million for the three months ended June
30, 2019. This increase of $1.5 million was primarily due to
additional milestone payments from Janssen Biotech, Inc. that were
achieved in late 2019, which resulted in additional consideration
being allocated to steering committee service for the three month
ended June 30, 2020. Revenue for the three months ended June 30,
2020 and June 30, 2019 consisted of recognition of upfront and
milestone payments allocated to steering committee service pursuant
to the license and collaboration agreement with Janssen Biotech,
Inc. 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
June 30, 2020 were $53.6 million compared to $32.6 million for the
three months ended June 30, 2019. This increase of $21.0 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 June 30, 2020.
Administrative Expenses
Administrative expenses for the three months ended June 30, 2020
were $4.5 million compared to $1.6 million for the three months
ended June 30, 2019. This increase of $2.9 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
June 30, 2020 were $9.6 million compared to $5.0 million for the
three months ended June 30, 2019. This increase of $4.6 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 June 30, 2020
was $1.3 million compared to $1.2 million for the three months
ended June 30, 2019.
Fair Value Loss of Convertible Redeemable Preferred Shares
For the three months ended June 30, 2020, Legend Biotech
reported a one-time non-cash charge of $80.0 million caused by
changes of fair value of Series A convertible redeemable preferred
shares (Series A Preferred Shares). Upon listing on the Nasdaq
Global Market, all outstanding Series A Preferred Shares were
converted into ordinary shares of Legend Biotech and all accrued
but unpaid dividends were settled in the form of ordinary shares of
Legend Biotech.
Loss for the Period
For the three months ended June 30, 2020, net loss was $134.9
million, or $0.63 per share, compared to a net loss of $28.8
million, or $0.14 per share, for the three months ended June 30,
2019.
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 700
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 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 in the United States, Europe and Asia, including the
BLA filing for cilta-cel to the U.S. FDA, the submission of a
marketing authorization application for cilta-cel to the EMA, and
the submission of an IND LB1901 in relapsed or refractory TCL; 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, 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 SIX MONTHS ENDED JUNE 30, 2020 AND 2019
Three months ended June
30
Six months ended June
30
(in thousands, US$, except share and
per share data)
2020 (unaudited)
2019 (unaudited)
2020 (unaudited)
2019 (unaudited)
REVENUE
11,600
10,087
23,146
20,140
Other income and gains
1,265
1,221
3,796
4,073
Research and development expenses
(53,567)
(32,640)
(101,570)
(53,929)
Administrative expenses
(4,508)
(1,607)
(7,938)
(2,712)
Selling and distribution expenses
(9,557)
(5,030)
(16,102)
(7,786)
Other expenses
(37)
(478)
(82)
(625)
Fair value loss of convertible redeemable
preferred shares
(79,984)
—
(79,984)
—
Finance costs
(88)
(19)
(4,079)
(57)
LOSS BEFORE TAX
(134,876)
(28,466)
(182,813)
(40,896)
Income tax (expense)/credit
—
(336)
3,709
(336)
LOSS FOR THE PERIOD
(134,876)
(28,802)
(179,104)
(41,232)
Attributable to:
Equity holders of the parent
(134,876)
(28,802)
(179,104)
(41,232)
LOSS PER SHARE ATTRIBUTABLE TO ORDINARY
EQUITY HOLDERS OF THE PARENT
Ordinary shares—basic
(0.63)
(0.14)
(0.86)
(0.21)
Ordinary shares—diluted
(0.63)
(0.14)
(0.86)
(0.21)
Ordinary shares used in loss per share
computation:
Ordinary shares—basic
215,551,887
200,000,000
207,775,944
200,000,000
Ordinary shares—diluted
215,551,887
200,000,000
207,775,944
200,000,000
LEGEND BIOTECH CORPORATION UNAUDITED INTERIM
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION AS AT JUNE
30, 2020 AND DECEMBER 31, 2019
June 30, 2020
(Unaudited)
December 31, 2019
(in thousands, US$)
NON-CURRENT ASSETS
Property, plant and equipment
88,589
70,079
Advance payments for property, plant and
equipment
2,121
665
Right-of-use assets
7,786
9,348
Intangible assets
978
519
Total non-current assets
99,474
80,611
CURRENT ASSETS
Inventories
1,668
1,157
Trade receivables
—
29,991
Prepayments, other receivables and other
assets
33,517
16,777
Pledged short-term deposits
256
256
Time deposits
75,559
75,559
Cash and cash equivalents
562,391
83,364
Total current assets
673,391
207,104
Total assets
772,865
287,715
CURRENT LIABILITIES
Trade and notes payables
6,976
9,586
Other payables and accruals
60,429
70,854
Lease liabilities
1,314
1,027
Contract liabilities
46,312
46,294
Total current liabilities
115,031
127,761
NON-CURRENT LIABILITIES
Contract liabilities
254,714
277,765
Lease liabilities
2,119
5,058
Total non-current liabilities
256,833
282,823
Total liabilities
371,864
410,584
EQUITY
Share capital
26
20
Reserves/(deficits)
400,975
(122,889)
Total ordinary shareholders’
equity/(deficit)
401,001
(122,869)
Total equity/(deficit)
401,001
(122,869)
Total liabilities and equity
772,865
287,715
LEGEND BIOTECH CORPORATION UNAUDITED INTERIM
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE THREE AND
SIX MONTHS ENDED JUNE 30, 2020 AND 2019
Three months ended June
30
Six months ended
June 30
(in thousands, US$)
2020 (Unaudited)
2019 (Unaudited)
2020 (Unaudited)
2019 (Unaudited)
LOSS BEFORE TAX
(134,876)
(28,466)
(182,813)
(40,896)
CASH FLOWS USED IN OPERATING
ACTIVITIES
(56,885)
(38,766)
(102,681)
(43,025)
CASH FLOWS USED IN INVESTING
ACTIVITIES
(9,212)
(36,031)
(26,711)
(150,909)
CASH FLOWS FROM/(USED IN) FINANCING
ACTIVITIES
459,803
(7,177)
608,558
21,500
NET INCREASE/(DECREASE) IN CASH AND CASH
EQUIVALENTS
393,706
(81,974)
479,166
(172,434)
Effect of foreign exchange rate changes,
net
(112)
(16)
(139)
(11)
Cash and cash equivalents at beginning of
the period
168,797
119,711
83,364
210,166
CASH AND CASH EQUIVALENTS AT END OF THE
PERIOD.
562,391
37,721
562,391
37,721
ANALYSIS OF BALANCES OF CASH AND CASH
EQUIVALENTS
Cash and bank balances
638,206
149,032
638,206
149,032
Less: Pledged short-term deposits
256
250
256
250
Time deposits
75,559
111,061
75,559
111,061
Cash and cash equivalents as stated in the
statement of financial position
562,391
37,721
562,391
37,721
Cash and cash equivalents as stated in the
statement of cash flows
562,391
37,721
562,391
37,721
1tacabtagene autoleucel (cilta-cel) refers to both JNJ-4528 (the
identifier for the investigational product being studied outside of
China) and LCAR-B38M CAR-T cell (the identifier for the
investigational product being studied in China), both of which
identify the same CAR-T cell therapy.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200828005366/en/
Media and Investor Relations: Jessie Yeung, Head of Corporate
Finance and Investor Relations, Legend Biotech
jessie.yeung@legendbiotech.com or investor@legendbiotech.com
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