- New and updated data from the CARTITUDE Clinical Development
Program and LEGEND-2 study evaluating ciltacabtagene autoleucel
(cilta-cel) will be presented at the 2023 American Society of
Clinical Oncology (ASCO) Annual Meeting and the European Hematology
Association’s (EHA) 2023 Hybrid Congress
- $350 million in gross proceeds raised in a registered direct
offering
- $212 million in gross proceeds raised from private
placements
- Gross proceeds of $200 million received from the exercise of
warrant issued in May 2021
- Strategic advisory board established with the appointments of
John Maraganore, Ph.D., former CEO of Alnylam Pharmaceuticals and
Michel Vounatsos, former CEO of Biogen Inc. as advisors
- Mythili Koneru, M.D., Ph.D. appointed as Company’s Chief
Medical Officer
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 first quarter 2023 unaudited financial
results.
"We are extremely pleased to announce that we have recently
raised $762 million in funding. With this substantial capital
infusion, we are poised to embark on a critical chapter in our
company’s growth to advance CARVYKTI® toward its full potential,
and we look forward to presenting the latest data from our
CARTITUDE clinical development programs at ASCO and EHA this June,"
said Ying Huang, Chief Executive Officer of Legend Biotech. Dr.
Huang continued, “We would like to extend our deepest gratitude to
our investors for their overwhelming support and confidence in our
company’s mission and remain committed to creating long-term value
for all of our stakeholders.”
Financial Results for Quarter Ended March 31, 2023
Cash and Cash Equivalents, Time Deposits, and Short-Term
Investments As of March 31, 2023, prior to giving effect to the
registered direct offering, private placements or warrant exercise
noted above, Legend Biotech had approximately $854 million of cash
and cash equivalents, time deposits, and short-term
investments.
Revenue Total revenue for the three months ended March 31, 2023
was $36.3 million compared to $50.0 million for the three months
ended March 31, 2022. Collaboration revenue recognized in the first
quarter of 2023 was from CARVYKTI® sales primarily in the U.S.
License revenue recognized in first quarter of 2022 was due to the
achievement of commercial milestone for FDA approval in the U.S. in
connection with the license and collaboration agreement (the
“Janssen Agreement”) with Janssen Biotech, Inc. (“Janssen”).
Collaboration Cost of Revenue Collaboration cost of revenue for
the three months ended March 31, 2023 was $35.6 million. Legend
Biotech did not have any collaboration cost of revenue in the three
months ended March 31, 2022. The $35.6 million is 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 months ended March 31, 2023 were $84.9
million compared to $81.5 million for the three months ended March
31, 2022. This increase of $3.4 million was primarily due to higher
patient enrollment for Phase 3 clinical trials for cilta-cel in the
first quarter of 2023.
Administrative Expenses Administrative expenses for the three
months ended March 31, 2023 were $22.2 million compared to $12.7
million for the three months ended March 31, 2022. The increase of
$9.5 million was primarily due to continued investment in building
global information technology infrastructure along with
non-recurring financial and legal fees related to Legend Biotech’s
restatement of its historical financial statements as reported by
Legend Biotech in February 2023.
Selling and Distribution Expenses Selling and distribution
expenses for the three months ended March 31, 2023 were $18.0
million compared to $21.3 million for the year three months ended
March 31, 2022. This decrease of $3.3 million was primarily due to
non-recurring launch expenses incurred in the first quarter of 2022
to support the commercialization in the U.S market.
Other Income and Gains Other income and gains for the three
months ended March 31, 2023 were $8.2 million compared to $1.0
million for the three months ended March 31, 2022. The increase of
$7.2 million was primarily due to increase in interest income and
gain on investments.
Other Expenses Other expenses for the three months ended March
31, 2023 were $10.7 million compared to $1.5 million for the three
months ended March 31, 2022. The increase was primarily due to
unrealized foreign currency exchange loss in the quarter.
Finance Costs Finance costs for the three months ended March 31,
2023 were $5.1 million compared to $1.0 million for the three
months ended March 31, 2022. 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.
Fair Value Gain of Warrant Liability Fair value gain of warrant
liability for the three months ended March 31, 2023 was $20.0
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 $47.0
million as of March 31, 2023. On May 12, 2023, Legend Biotech
announced that the warrant had been exercised in full.
Loss for the Period For the three months ended March 31, 2023,
net loss was $112.1 million, or $0.34 per share, compared to a net
loss of $32.3 million, or $0.10 per share, for the three months
ended March 31, 2022.
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®, including Legend
Biotech’s expectations for CARVYKTI®, such as Legend Biotech’s
manufacturing and commercialization expectations for CARVYKTI® and
the potential effect of treatment with CARVYKTI®; 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;
the ability to generate, analyze and present data from clinical
trials; expected results of clinical trials; 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 on March 29, 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
Three months ended March 31,
2023
Three months ended March 31,
2022
US$’000, except per share
data
US$’000, except per share
data
(Unaudited)
(Unaudited)
REVENUE
License revenue
—
50,000
Collaboration revenue
36,280
—
Other revenue
56
40
Total revenue
36,336
50,040
Collaboration cost of revenue
(35,613)
—
Other income and gains
8,199
1,012
Research and development expenses
(84,889)
(81,548)
Administrative expenses
(22,205)
(12,657)
Selling and distribution expenses
(17,954)
(21,302)
Other expenses
(10,734)
(1,527)
Fair value gain/(loss) of warrant
liability
20,000
34,900
Finance costs
(5,113)
(1,044)
LOSS BEFORE TAX
(111,973)
(32,126)
Income tax (expense)/credit
(128)
(163)
LOSS FOR THE PERIOD
(112,101)
(32,289)
Attributable to:
Ordinary equity holders of the parent
(112,101)
(32,289)
LOSS PER SHARE ATTRIBUTABLE TO ORDINARY
EQUITY HOLDERS OF THE PARENT
Basic
(0.34)
(0.10)
Diluted
(0.34)
(0.10)
ORDINARY SHARES USED IN LOSS PER SHARE
COMPUTATION
Basic
330,497,072
308,699,034
Diluted
330,497,072
308,699,034
LEGEND BIOTECH
CORPORATION
CONDENSED CONSOLIDATED
STATEMENTS OF FINANCIAL POSITION
March 31, 2023
December 31, 2022
US$’000
US$’000
(Unaudited)
Audited
NON-CURRENT ASSETS
Property, plant and equipment
110,045
105,168
Advance payments for property, plant and
equipment
2,193
914
Right-of-use assets
80,459
55,590
Time deposits
4,366
—
Intangible assets
2,289
3,409
Collaboration prepaid leases
93,548
65,276
Other non-current assets
1,062
1,487
Total non-current assets
293,962
231,844
CURRENT ASSETS
Collaboration inventories
12,176
10,354
Trade receivables
56
90
Prepayments, other receivables and other
assets
51,761
61,755
Financial assets at fair value through
profit or loss
185,705
185,603
Pledged deposits
1,283
1,270
Time deposits
4,366
54,016
Cash and cash equivalents
660,050
786,031
Total current assets
915,397
1,099,119
Total assets
1,209,359
1,330,963
CURRENT LIABILITIES
Trade payables
29,811
32,893
Other payables and accruals
146,378
184,109
Government grants
457
451
Lease liabilities
4,595
3,563
Tax payable
9,940
9,772
Warrant liability
47,000
67,000
Total current liabilities
238,181
297,788
NON-CURRENT LIABILITIES
Collaboration interest-bearing advanced
funding
265,864
260,932
Lease liabilities long term
44,302
20,039
Government grants
7,631
7,659
Other non-current liabilities
224
233
Total non-current liabilities
318,021
288,863
Total liabilities
556,202
586,651
EQUITY
Share capital
33
33
Reserves
653,124
744,279
Total ordinary shareholders’ equity
653,157
744,312
Total equity
653,157
744,312
Total liabilities and equity
1,209,359
1,330,963
LEGEND BIOTECH
CORPORATION
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOW
Three months ended March 31,
2023
Three months ended March 31,
2022
US$’000
US$’000
(Unaudited)
(Unaudited)
LOSS BEFORE TAX
(111,973)
(32,126)
CASH FLOWS USED IN OPERATING
ACTIVITIES
(141,053)
(78,687)
CASH FLOWS USED IN INVESTING
ACTIVITIES
17,930
(232,500)
CASH FLOWS FROM FINANCING
ACTIVITIES
(286)
25
NET DECREASE IN CASH AND CASH
EQUIVALENTS
(123,409)
(311,162)
Effect of foreign exchange rate changes,
net
(2,572)
10
Cash and cash equivalents at beginning of
the period
786,031
688,938
CASH AND CASH EQUIVALENTS AT END OF THE
PERIOD
660,050
377,786
ANALYSIS OF BALANCES OF CASH AND CASH
EQUIVALENTS
Cash and bank balances
670,065
667,465
Less: Pledged deposits
1,283
1,448
Time deposits
8,732
288,231
Cash and cash equivalents as stated in the
statement of financial position
660,050
378
Cash and cash equivalents as stated in the
statement of cash flows
660,050
377,786
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230518005185/en/
PRESS CONTACT: Tina Carter, Corporate Communications
Lead, Legend Biotech tina.carter@legendbiotech.com (908)
331-5025
INVESTOR CONTACTS: Joanne Choi, Senior Manager, Investor
Relations, Legend Biotech joanne.choi@legendbiotech.com
Crystal Chen, Manager, Investor Relations, Legend Biotech
crystal.chen@legendbiotech.cn
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