Legend Biotech Reports Second Quarter 2024 Results and Recent Highlights
09 Agosto 2024 - 1:00PM
Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a
global leader in cell therapy, today reported its second quarter
2024 unaudited financial results and key corporate highlights.
“In the second quarter, approval of CARVYKTI in the second line
increased demand and interest from patients and the healthcare
community. Momentum for CARVYTKI is growing and we are excited to
see it helping not only later line patients, but an increasing
number of earlier line patients. I am encouraged by the progress we
have been making in both the inpatient and outpatient settings,
enabling more patients to receive our transformative one-time
treatment,” said Ying Huang, Ph.D., Chief Executive Officer of
Legend Biotech. “We look forward to starting commercial production
at our Obelisc facility in Belgium later this year in order to meet
the growing demand, and we remain laser-focused on increasing our
manufacturing capacity.”
Regulatory Updates
- The United Kingdom’s Medicines and Healthcare products
Regulatory Agency (MHRA) approved CARVYKTI® for the treatment of
adult patients with relapsed and refractory multiple myeloma, who
have received at least one prior therapy, including an
immunomodulatory agent (IMiD) and a proteasome inhibitor (PI), have
demonstrated disease progression on the last therapy and are
refractory to lenalidomide.
- Health Canada approved CARVYKTI® for the treatment of adult
patients with multiple myeloma, who have received one to three
prior lines of therapy including a PI and an IMiD, and who are
refractory to lenalidomide.
Key Business Developments
- Novartis Pharmaceuticals Corporation initiated clinical
production in July 2024.
- Completed CARTITUDE 5 enrollment in July 2024.
- Announced positive results from a second interim analysis of
the Phase 3 CARTITUDE-4 study demonstrating a statistically
significant and clinically meaningful improvement in overall
survival for multiple myeloma patients treated with CARVYKTI®
versus standard-of-care treatment regimens. These new results will
be presented at an upcoming medical meeting and shared with
regulatory agencies for label updates worldwide.
- New data from the Phase 2 CARTITUDE-2 Cohort D study and new
and updated data from the Phase 3 CARTITUDE-4 study of cilta-cel
were featured at the 2024 American Society of Clinical Oncology
(ASCO) Annual Meeting (Abstracts #7504 and 7505) and European
Hematology Association (EHA) 2024 Hybrid Congress (Abstract
#S205).
- On June 28, 2024, Legend Biotech received a milestone payment
of $30 million in connection with the Janssen Agreement.
- On August 8, 2024, Peter Salovey, Ph.D., was appointed to the
Company's Board of Directors, effective August 9, 2024.
* In December 2017, Legend Biotech entered into an exclusive
worldwide collaboration and license agreement with Janssen Biotech,
Inc., a Johnson & Johnson company, to develop and commercialize
cilta-cel (the Janssen Agreement).
Second Quarter 2024 Financial Results
- License Revenue: License revenue was $90.8
million for the three months ended June 30, 2024, compared to $15.1
million for the three months ended June 30, 2023. The increase was
primarily driven by a $60.0 million increase in revenue that was
recognized due to the nature of, and timing of milestones achieved
as outlined in the Global Development Plan under the Janssen
Agreement for cilta-cel. Additionally, the increase in license
revenue is driven by the recognition of $15.7 million of revenue
due to the timing of underlying activities performed in connection
with the global license agreement with Novartis Pharma AG (the
"Novartis License Agreement") to develop, manufacture, and
commercialize LB2102 and other potential CAR-T therapies
selectively targeting DLL3. Legend Biotech did not recognize any
license revenue from the Novartis License Agreement for the three
months ended June 30, 2023.
- Collaboration Revenue: Collaboration revenue
was $93.3 million for the three months ended June 30, 2024,
compared to $58.2 million for the three months ended June 30, 2023.
The increase was primarily due to an increase in revenue generated
from sales of CARVYKTI® in connection with the Janssen
Agreement.
- Collaboration Cost of Revenue: Collaboration
cost of revenue was $45.4 million for the three months ended June
30, 2024, compared to $32.7 million for the three months ended June
30, 2023. The increase was primarily due to Legend Biotech’s share
of the cost of sales in connection with CARVYKTI® sales under the
Janssen Agreement.
- Cost of License and Other Revenue: Cost of
license and other revenue for the three months ended June 30,
2024, was $5.1 million and consisted of costs in connection with
the Novartis License Agreement. The Company did not incur any cost
of license and other revenue for the three months ended June 30,
2023.
- Research and Development Expenses: Research
and development expenses were $112.6 million for the three months
ended June 30, 2024, compared to $95.8 million for the three months
ended June 30, 2023. The increase was primarily driven by
continuous research and development activities in cilta-cel,
including start up costs for clinical production in Belgium and
continued investment in Legend Biotech’s solid tumor programs.
- Administrative Expenses: Administrative
expenses were $35.4 million for the three months ended June 30,
2024, compared to $27.8 million for the three months ended June 30,
2023. The increase was primarily due to the expansion of
administrative functions and infrastructure to increase
manufacturing capacity.
- Selling and Distribution Expenses: Selling and
distribution expenses were $30.1 million for the three months ended
June 30, 2024, compared to $21.4 million for the three months ended
June 30, 2023.The increase was primarily driven by costs associated
with commercial activities for cilta-cel, including the expansion
of the sales force and second line indication launch
preparation.
- Net Loss: Net loss was $18.2 million for the
three months ended June 30, 2024, compared to a net loss of $199.1
million for the three months ended June 30, 2023.
- Cash Position: Cash and cash equivalents, time
deposits, and short-term investments were $1.3 billion as of
June 30, 2024.
Webcast/Conference Call Details:Legend Biotech
will host its quarterly earnings call and webcast today at 8:00
a.m. 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 BiotechLegend 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 www.legendbiotech.com and follow us on X
(formerly Twitter) and LinkedIn.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING
STATEMENTSStatements 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 its
therapeutic potential; statements relating to the potential
approval of CARVYKTI® for earlier lines of therapy; statements
related to Legend Biotech manufacturing expectations for CARVYKTI®;
statements related to Legend Biotech’s ability to achieve operating
profit; 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; government,
industry, and general product pricing and other political
pressures; 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 19,
2024. 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.
INVESTOR CONTACT:
Jessie YeungTel: (732) 956-8271
jessie.yeung@legendbiotech.com
PRESS CONTACT:
Mary Ann OndishTel: (914) 552-4625media@legendbiotech.com
|
LEGEND BIOTECH CORPORATIONCONDENSED
CONSOLIDATED STATEMENTS OF PROFIT OR LOSS |
| |
| |
|
Three Months EndedJune 30,
2024 |
Six Months EndedJune 30,
2024 |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
| US$’000, except share
and per share data |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
| REVENUE |
|
|
|
|
|
|
|
|
|
License revenue |
|
90,846 |
|
|
|
15,115 |
|
|
|
103,027 |
|
|
|
15,115 |
|
|
Collaboration revenue |
|
93,254 |
|
|
|
58,152 |
|
|
|
171,735 |
|
|
|
94,432 |
|
|
Other revenue |
|
2,423 |
|
|
|
63 |
|
|
|
5,752 |
|
|
|
119 |
|
|
Total revenue |
|
186,523 |
|
|
|
73,330 |
|
|
|
280,514 |
|
|
|
109,666 |
|
| Collaboration cost of
revenue |
|
(45,355 |
) |
|
|
(32,672 |
) |
|
|
(94,456 |
) |
|
|
(68,285 |
) |
| Cost of license and other
revenue |
|
(5,096 |
) |
|
|
— |
|
|
|
(10,734 |
) |
|
|
— |
|
| Other income and gains |
|
29,484 |
|
|
|
16,433 |
|
|
|
93,037 |
|
|
|
20,994 |
|
| Research and development
expenses |
|
(112,626 |
) |
|
|
(95,791 |
) |
|
|
(213,590 |
) |
|
|
(180,680 |
) |
| Administrative expenses |
|
(35,353 |
) |
|
|
(27,753 |
) |
|
|
(67,282 |
) |
|
|
(49,958 |
) |
| Selling and distribution
expenses |
|
(30,063 |
) |
|
|
(21,429 |
) |
|
|
(54,286 |
) |
|
|
(39,383 |
) |
| Other expenses |
|
— |
|
|
|
(21 |
) |
|
|
(2 |
) |
|
|
(7,117 |
) |
| Fair value loss of warrant
liability |
|
— |
|
|
|
(105,750 |
) |
|
|
— |
|
|
|
(85,750 |
) |
| Finance costs |
|
(5,484 |
) |
|
|
(5,185 |
) |
|
|
(10,959 |
) |
|
|
(10,298 |
) |
| LOSS BEFORE TAX |
|
(17,970 |
) |
|
|
(198,838 |
) |
|
|
(77,758 |
) |
|
|
(310,811 |
) |
| Income tax expense |
|
(226 |
) |
|
|
(290 |
) |
|
|
(231 |
) |
|
|
(418 |
) |
| LOSS FOR THE PERIOD |
|
(18,196 |
) |
|
|
(199,128 |
) |
|
|
(77,989 |
) |
|
|
(311,229 |
) |
| Attributable to: |
|
|
|
|
|
|
|
|
|
Ordinary equity holders of the parent |
|
(18,196 |
) |
|
|
(199,128 |
) |
|
|
(77,989 |
) |
|
|
(311,229 |
) |
| LOSS PER SHARE ATTRIBUTABLE TO
ORDINARY EQUITY HOLDERS OF THE PARENT |
|
|
|
|
|
|
|
|
| Basic |
|
(0.05 |
) |
|
|
(0.57 |
) |
|
|
(0.21 |
) |
|
|
(0.91 |
) |
| Diluted |
|
(0.05 |
) |
|
|
(0.57 |
) |
|
|
(0.21 |
) |
|
|
(0.91 |
) |
|
ORDINARY SHARES USED IN LOSS PER SHARE COMPUTATION |
|
|
|
|
|
|
|
|
| Basic |
|
365,204,154 |
|
|
|
350,517,429 |
|
|
|
364,610,589 |
|
|
|
340,779,779 |
|
| Diluted |
|
365,204,154 |
|
|
|
350,517,429 |
|
|
|
364,610,589 |
|
|
|
340,779,779 |
|
|
LEGEND BIOTECH CORPORATIONCONDENSED
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION |
| |
|
|
|
June 30, 2024 |
|
|
|
December 31, 2023 |
|
| |
|
US$’000 |
|
|
|
US$’000 |
|
| |
|
(Unaudited) |
|
|
|
|
|
| NON-CURRENT ASSETS |
|
|
|
|
|
|
|
| Property, plant and
equipment |
|
105,018 |
|
|
|
108,725 |
|
| Advance payments for property,
plant and equipment |
|
295 |
|
|
|
451 |
|
| Right-of-use assets |
|
114,718 |
|
|
|
80,502 |
|
| Time deposits |
|
4,400 |
|
|
|
4,362 |
|
| Intangible assets |
|
2,772 |
|
|
|
4,061 |
|
| Collaboration prepaid
leases |
|
144,552 |
|
|
|
151,216 |
|
| Other non-current assets |
|
1,596 |
|
|
|
1,493 |
|
| Total non-current assets |
|
373,351 |
|
|
|
350,810 |
|
| CURRENT ASSETS |
|
|
|
|
|
|
|
| Collaboration inventories |
|
18,870 |
|
|
|
19,433 |
|
| Trade receivables |
|
13,064 |
|
|
|
100,041 |
|
| Prepayments, other receivables
and other assets |
|
100,628 |
|
|
|
69,251 |
|
| Financial assets at fair value
through profit or loss |
|
42,201 |
|
|
|
663 |
|
| Pledged deposits |
|
431 |
|
|
|
357 |
|
| Time deposits |
|
1,048,385 |
|
|
|
30,341 |
|
| Cash and cash equivalents |
|
201,253 |
|
|
|
1,277,713 |
|
| Total current assets |
|
1,424,832 |
|
|
|
1,497,799 |
|
| Total assets |
|
1,798,183 |
|
|
|
1,848,609 |
|
| CURRENT LIABILITIES |
|
|
|
|
|
|
|
| Trade payables |
|
39,490 |
|
|
|
20,160 |
|
| Other payables and
accruals |
|
169,531 |
|
|
|
132,802 |
|
| Government grants |
|
545 |
|
|
|
68 |
|
| Lease liabilities |
|
3,325 |
|
|
|
3,175 |
|
| Tax payable |
|
6,566 |
|
|
|
7,203 |
|
| Contract liabilities |
|
74,845 |
|
|
|
53,010 |
|
| Total current liabilities |
|
294,302 |
|
|
|
216,418 |
|
| NON-CURRENT LIABILITIES |
|
|
|
|
|
|
|
| Collaboration interest-bearing
advanced funding |
|
291,559 |
|
|
|
281,328 |
|
| Lease liabilities long
term |
|
44,042 |
|
|
|
44,169 |
|
| Government grants |
|
6,574 |
|
|
|
7,305 |
|
| Contract liabilities |
|
2,704 |
|
|
|
47,962 |
|
| Other non-current
liabilities |
|
— |
|
|
|
56 |
|
| Total non-current
liabilities |
|
344,879 |
|
|
|
380,820 |
|
| Total liabilities |
|
639,181 |
|
|
|
597,238 |
|
| EQUITY |
|
|
|
|
|
|
|
| Share capital |
|
37 |
|
|
|
36 |
|
| Reserves |
|
1,158,965 |
|
|
|
1,251,335 |
|
| Total ordinary shareholders’
equity |
|
1,159,002 |
|
|
|
1,251,371 |
|
| Total equity |
|
1,159,002 |
|
|
|
1,251,371 |
|
| Total liabilities and
equity |
|
1,798,183 |
|
|
|
1,848,609 |
|
|
LEGEND BIOTECH CORPORATIONCONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOW |
| |
|
|
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|
US$’000 |
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
| |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
| |
|
|
|
|
|
|
|
|
| LOSS BEFORE TAX |
|
(17,970 |
) |
|
|
(198,838 |
) |
|
|
(77,758 |
) |
|
|
(310,811 |
) |
| CASH FLOWS (USED IN)/PROVIDED
BY OPERATING ACTIVITIES |
|
(1,651 |
) |
|
|
(95,730 |
) |
|
|
13,867 |
|
|
|
(236,783 |
) |
| CASH FLOWS USED IN INVESTING
ACTIVITIES |
|
(695,631 |
) |
|
|
(123,581 |
) |
|
|
(1,091,779 |
) |
|
|
(105,651 |
) |
| CASH FLOWS PROVIDED BY
FINANCING ACTIVITIES |
|
955 |
|
|
|
789,890 |
|
|
|
1,786 |
|
|
|
789,604 |
|
| NET (DECREASE)/INCREASE IN
CASH AND CASH EQUIVALENTS |
|
(696,327 |
) |
|
|
570,579 |
|
|
|
(1,076,126 |
) |
|
|
447,170 |
|
| Effect of foreign exchange
rate changes, net |
|
9 |
|
|
|
2,584 |
|
|
|
(334 |
) |
|
|
12 |
|
| Cash and cash equivalents at
beginning of the period |
|
897,571 |
|
|
|
660,050 |
|
|
|
1,277,713 |
|
|
|
786,031 |
|
| |
|
|
|
|
|
|
|
|
| CASH AND CASH EQUIVALENTS AT
END OF THE PERIOD |
|
201,253 |
|
|
|
1,233,213 |
|
|
|
201,253 |
|
|
|
1,233,213 |
|
| ANALYSIS OF BALANCES OF CASH
AND CASH EQUIVALENTS |
|
|
|
|
|
|
|
|
| Cash and bank balances |
|
1,254,469 |
|
|
|
1,334,482 |
|
|
|
1,254,469 |
|
|
|
1,334,482 |
|
| Less: Pledged deposits |
|
431 |
|
|
|
1,246 |
|
|
|
431 |
|
|
|
1,246 |
|
| Time deposits |
|
1,052,785 |
|
|
|
100,023 |
|
|
|
1,052,785 |
|
|
|
100,023 |
|
| Cash and cash equivalents as
stated in the statement of financial position |
|
201,253 |
|
|
|
1,233,213 |
|
|
|
201,253 |
|
|
|
1,233,213 |
|
| Cash and cash equivalents as
stated in the statement of cash flows |
|
201,253 |
|
|
|
1,233,213 |
|
|
|
201,253 |
|
|
|
1,233,213 |
|
Grafico Azioni Legend Biotech (NASDAQ:LEGN)
Storico
Da Ott 2024 a Nov 2024
Grafico Azioni Legend Biotech (NASDAQ:LEGN)
Storico
Da Nov 2023 a Nov 2024
