- A supplemental Biologics License Application (sBLA) was
submitted to the U.S. Food and Drug Administration (FDA) and a Type
II Variation Application was submitted to the European Medicines
Agency (EMA) by Janssen, seeking approval of CARVYKTI®
(ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of
patients with relapsed or refractory multiple myeloma
- The FDA set the Prescription Drug User Fee Act target date for
the CARVYKTI® sBLA to April 5, 2024
- The FDA granted Orphan Drug Designation for LB2102 (DLL-3)
(NCT05680922), which is being evaluated for the treatment of small
cell lung cancer. The US clinical trial is actively recruiting at
two sites1
- On August 3, 2023, Legend Biotech received a payment in the
amount of $15 million for the EMA’s acceptance of the Type II
Variation Application for CARVYKTI®, in accordance with Legend
Biotech’s license and collaboration agreement with Janssen (Janssen
Agreement)
- On August 4, 2023, Legend Biotech earned a milestone payment of
$20 million in connection with the FDA’s acceptance of the sBLA, in
accordance with the Janssen Agreement
- New data from the CARTITUDE-4 study (NCT04181827) of cilta-cel
were featured at the 2023 American Society of Clinical Oncology
(ASCO) Annual Meeting (Abstract #LBA106) and European Hematology
Association (EHA) 2023 Hybrid Congress (Abstract #S100); these data
were also published in The New England Journal of Medicine2
- Long-term data from the cilta-cel CARTITUDE-1 (NCT03548207) and
LEGEND-2 (NCT03090659) studies were also presented at ASCO
(Abstract #8009, Abstract #8010) and EHA (Abstract #S202, Abstract
#P874)
- Cash and cash equivalents, deposits and investments of $1.5
billion, as of June 30, 2023, extends Legend Biotech’s cash runway
through 2025, strengthened by recently completed financings
- In April and May 2023, Legend Biotech entered into subscription
agreements with certain institutional investors pursuant to which
Legend Biotech sold an aggregate of 8,834,742 ordinary shares for
aggregate gross proceeds of approximately $235 million
- In May 2023, Legend Biotech sold 5,468,750 American Depositary
Shares (the “ADSs”), each representing two ordinary shares, to
certain investors in a registered direct offering at a price of
$64.00 per ADS for aggregate gross proceeds of $350 million
- In May 2023, an institutional investor exercised in full a
warrant to purchase 10,000,000 ordinary shares of Legend Biotech at
an exercise price of $20.00 per ordinary share for an aggregate
exercise price of $200 million
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 unaudited financial results for the three and
six months ended June 30, 2023.
In addition to financial performance, Legend Biotech reported on
the success of its portfolio and pipeline, including the CARTITUDE
clinical development program for CARVYKTI®, in collaboration with
the Janssen Biotech, Inc. (Janssen).
Initial data from the CARTITUDE-4 study presented at ASCO and
EHA supported recent submissions to U.S. and E.U. regulatory
agencies by Janssen to expand the indication of CARVYKTI® into
earlier treatment of patients (1-3 prior lines of therapy) with
relapsed or refractory multiple myeloma.
"We remain committed to exploring the full potential of
CARVYKTI® and are pleased with the continued growth of our
development program, including two regulatory submissions made
during the second quarter," said Ying Huang, Chief Executive
Officer of Legend Biotech. “Following our most recent fundraising,
we are well positioned to advance our pipeline and portfolio. We
remain grateful to the investors who support our endeavors.”
Financial Results for Quarter Ended June 30, 2023
Cash and Cash Equivalents, Time Deposits, and Short-Term
Investments
As of June 30, 2023, after giving effect to the registered
direct offering, private placements or warrant exercise noted
above, Legend Biotech had approximately $1.5 billion of cash and
cash equivalents, time deposits, and short-term investments.
Revenue
License Revenue
License revenue for the three months ended
June 30, 2023 was $15.1 million due to the achievement of a
milestone during the quarter, compared to no milestones achieved
during the three months ended June 30, 2022. License revenue for
the six months ended June 30, 2023 was $15.1 million, compared to
$50 million for the six months ended June 30, 2022. This decrease
of $34.9 million was primarily driven by the nature and timing of
milestones achieved as outlined in the Global Development Plan
under the Janssen Agreement for cilta-cel six months ended June 30,
2023.
Collaboration Revenue
Collaboration revenue for the three and six
months ended June 30, 2023 was $58.2 million and $94.4 million,
respectively, compared to $11.9 million for the three and six
months ended June 30, 2022. The increases of $46.3 million and
$82.5 million for the three and six-month periods, respectively,
were due to an increase in revenue generated from sales of
CARVYKTI® in connection with the Janssen Agreement.
Operating Expenses
Collaboration cost of revenue
Collaboration cost of revenue for the three
and six months ended June 30, 2023 was $32.7 million and $68.3
million, respectively, compared to $16.9 million for the three and
six months ended June 30, 2022. The increases of $15.7 million and
$51.3 million for the three and six months ended, respectively were
a combination of Legend’s portion of collaboration cost of sales in
connection with collaboration revenue under the Janssen Agreement
along with expenditures to support the manufacturing capacity
expansion which cannot be capitalized.
Research and Development Expenses
Research and development expenses for the
three and six months ended June 30, 2023 were $95.8 million and
$180.7 million, respectively, compared to $68.8 million and $150.4
million for the three and six months ended June 30, 2022,
respectively. The increases of $27.0 million and $30.3 million for
the three and six-month periods, respectively, were primarily due
to continuous research and development activities in cilta-cel,
including higher patient enrollment for Phase 3 clinical trials for
cilta-cel, and an increase in research and development activities
for other pipeline items. The other pipeline expenses include
continued investment in our solid tumor programs, which include two
IND approvals that advanced into phase 1 development.
Administrative Expenses
Administrative expenses for the three and six months ended June
30, 2023 were $27.8 million and $50 million, respectively, compared
to $18.1 million and $30.7 million for the three and six months
ended June 30, 2022, respectively. The increases of $9.7 million
and $19.3 million for the three and six-month periods,
respectively, were primarily due to the expansion of supporting
administrative functions to facilitate continuous business growth
and continued investment in building global information technology
infrastructure.
Selling and Distribution Expenses
Selling and distribution expenses for the three and six months
ended June 30, 2023 were $21.4 million and $39.4 million,
respectively, compared to $27.4 million and $48.7 million for the
three and six months ended June 30, 2022. The decrease of $6
million and $9.4 million were primarily due to non-recurring launch
expenses incurred in the first half of 2022 to support the
commercialization in the U.S market.
Other Income and Gains
Other income and gains for the three and six months ended June
30, 2023 were $16.4 million and $21 million, respectively, compared
to $1.9 million and $2.9 million for the three and six months ended
June 30, 2022, respectively. The increase of $14.5 million in the
three months ended June 30, 2023 compared to the three months ended
June 30, 2022 was primarily attributable to approximately a $10.9
million increase in interest income and gain on investment, as well
an increase of approximately $3.6 million in foreign currency
exchange gain. The increase of $18.1 million for the six month
period ended June 30, 2023 compared to the six months ended June
30, 2022 was primarily due to an increase in interest income and
gain on investments.
Other Expenses
Other expenses for the three and six months ended June 30, 2023
were $0.02 million and $7.1 million, respectively, compared to $8.1
million and $9.6 million for the three and six months ended June
30, 2022. The decrease in both comparative periods was primarily
due to a decrease in foreign currency exchange loss.
Finance Costs
Finance costs for the three and six months ended June 30, 2023
were $5.2 million and $10.3 million, respectively, compared to $1.6
million and $2.7 million for the three and six months ended June
30, 2022. The increase in both comparative periods was primarily
due to interest on advance funding, which is interest-bearing
borrowings funded by Janssen under the Janssen Agreement and
constituted of principal and applicable interests upon such
principal.
Fair Value Loss of Warrant Liability
Fair value loss of warrant liability for the six months ended
June 30, 2023 was $85.8 million, compared to a fair value loss of
$31 million for the six months ended June 30, 2022. The increase
was due to the fair value loss recorded on the full exercise of the
warrant, which took place on May 11, 2023.
Loss for the Period
For the three months ended June 30, 2023, net loss was $199.1
million, or $0.57 per share, compared to net loss of $193.2
million, or $0.62 per share, for the three months ended June 30,
2022. For the six months ended June 30, 2023, net loss was $311.2
million, or $0.91 per share, compared to a net loss of $225.5
million, or $0.73 per share, for the six months ended June 30,
2022.
Webcast/Conference Call Details:
Legend Biotech will host its quarterly earnings call and webcast
today at 8:00am ET. To access the webcast, please visit this
weblink.
A replay of the webcast will be available on Legend Biotech’s
website at
https://investors.legendbiotech.com/events-and-presentations.
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, gamma-delta 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 https://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®, including Legend
Biotech’s expectations for CARVYKTI®; and statements about
regulatory submissions for CARVYKTI®, and the progress of such
submissions with the FDA, the EMA and other regulatory authorities;
and expected results of clinical trials; Legend Biotech’s
expectations on advancing their pipeline and product portfolio; and
the potential benefits of Legend Biotech’s 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 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 (SEC) on March 30, 2023 and Legend Biotech’s other
filings with the SEC. 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
Three Months Ended June
30,
Six months ended June
30,
2023
2022
2023
2022
US$’000, except per share data
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
REVENUE
License revenue
15,115
—
15,115
50,000
Collaboration revenue
58,152
11,937
94,432
11,937
Other revenue
63
34
119
74
Total revenue
73,330
11,971
109,666
62,011
Collaboration cost of revenue
(32,672
)
(16,939
)
(68,285
)
(16,939
)
Other income and gains
16,433
1,856
20,994
2,868
Research and development expenses
(95,791
)
(68,827
)
(180,680
)
(150,375
)
Administrative expenses
(27,753
)
(18,050
)
(49,958
)
(30,707
)
Selling and distribution expenses
(21,429
)
(27,440
)
(39,383
)
(48,742
)
Other expenses
(21
)
(8,099
)
(7,117
)
(9,626
)
Fair value loss of warrant liability
(105,750
)
(65,900
)
(85,750
)
(31,000
)
Finance costs
(5,185
)
(1,643
)
(10,298
)
(2,687
)
LOSS BEFORE TAX
(198,838
)
(193,071
)
(310,811
)
(225,197
)
Income tax expense
(290
)
(157
)
(418
)
(320
)
LOSS FOR THE PERIOD
(199,128
)
(193,228
)
(311,229
)
(225,517
)
Attributable to:
Ordinary equity holders of the parent
(199,128
)
(193,228
)
(311,229
)
(225,517
)
LOSS PER SHARE ATTRIBUTABLE TO ORDINARY
EQUITY HOLDERS OF THE PARENT
Basic
(0.57
)
(0.62
)
(0.91
)
(0.73
)
Diluted
(0.57
)
(0.62
)
(0.91
)
(0.73
)
ORDINARY SHARES USED IN LOSS PER SHARE
COMPUTATION
Basic
350,517,429
309,777,816
340,779,779
309,241,404
Diluted
350,517,429
309,777,816
340,779,779
309,241,404
LEGEND BIOTECH
CORPORATION
CONDENSED CONSOLIDATED
STATEMENTS OF FINANCIAL POSITION
June 30, 2023
December 31, 2022
US$’000
US$’000
(Unaudited)
(Audited)
NON-CURRENT ASSETS
Property, plant and equipment
110,978
105,168
Advance payments for property, plant and
equipment
1,061
914
Right-of-use assets
78,497
55,590
Time deposits
4,209
—
Intangible assets
2,465
3,409
Collaboration prepaid leases
119,173
65,276
Other non-current assets
1,414
1,487
Total non-current assets
317,797
231,844
CURRENT ASSETS
Collaboration inventories
15,196
10,354
Trade receivables
15,064
90
Prepayments, other receivables and other
assets
66,573
61,755
Financial assets at fair value through
profit or loss
185,756
185,603
Pledged deposits
1,246
1,270
Time deposits
95,814
54,016
Cash and cash equivalents
1,233,213
786,031
Total current assets
1,612,862
1,099,119
Total assets
1,930,659
1,330,963
CURRENT LIABILITIES
Trade payables
21,544
32,893
Other payables and accruals
165,519
184,109
Government grants
435
451
Lease liabilities
3,558
3,563
Tax payable
10,326
9,772
Warrant liability
—
67,000
Total current liabilities
201,382
297,788
NON-CURRENT LIABILITIES
Collaboration interest-bearing advanced
funding
270,614
260,932
Lease liabilities long term
44,444
20,039
Government grants
7,036
7,659
Other non-current liabilities
152
233
Total non-current liabilities
322,246
288,863
Total liabilities
523,628
586,651
EQUITY
Share capital
36
33
Reserves
1,406,995
744,279
Total ordinary shareholders’ equity
1,407,031
744,312
Total equity
1,407,031
744,312
Total liabilities and equity
1,930,659
1,330,963
LEGEND BIOTECH
CORPORATION
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOW
Three Months Ended June
30,
Six months ended June
30,
US$’000
2023
2022
2023
2022
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
LOSS BEFORE TAX
(198,838)
(193,071)
(310,811)
(225,197)
CASH FLOWS USED IN OPERATING
ACTIVITIES
(95,730)
(740)
(236,783)
(79,427)
CASH FLOWS USED IN INVESTING
ACTIVITIES
(123,581)
2,585
(105,651)
(229,915)
CASH FLOWS FROM FINANCING ACTIVITIES
789,890
1,009
789,604
1,034
NET INCREASE/(DECREASE) IN CASH AND CASH
EQUIVALENTS
570,579
2,854
447,170
(308,308)
Effect of foreign exchange rate changes,
net
2,584
(864)
12
(854)
Cash and cash equivalents at beginning of
the period
660,050
377,786
786,031
688,938
CASH AND CASH EQUIVALENTS AT END OF THE
PERIOD
1,233,213
379,776
1,233,213
379,776
ANALYSIS OF BALANCES OF CASH AND CASH
EQUIVALENTS
Cash and bank balances
1,334,482
788,982
1,334,482
788,982
Less: Pledged deposits
1,246
1,402
1,246
1,402
Time deposits
100,023
407,804
100,023
407,804
Cash and cash equivalents as stated in the
statement of financial position
1,233,213
379,776
1,233,213
379,776
Cash and cash equivalents as stated in the
statement of cash flows
1,233,213
379,776
1,233,213
379,776
____________________________
1 ClinicalTrials.gov. DLL3-Directed
Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage
Small Cell Lung Cancer. Available at:
https://classic.clinicaltrials.gov/ct2/show/NCT05680922. Last
accessed Aug 2023.
2 San-Miguel, J, Dhakal B, Yong K, et al.
Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple
Myeloma. N Engl J Med. 2023;389:335-347
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230815252970/en/
Press: Tina Carter, Corporate Communications Lead, Legend
Biotech tina.carter@legendbiotech.com (908) 331-5025
Investor: Jessie Yeung, Head of Investor Relations and
Public Relations, Legend Biotech jessie.yeung@legendbiotech.com
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