Legend Biotech Reports Third Quarter 2024 Results and Recent Highlights
12 Novembre 2024 - 1:00PM
Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a
global leader in cell therapy, today reported its third quarter
2024 unaudited financial results and key corporate highlights.
“We are delighted with the robust sales growth in the third
quarter, during which we have continued to increase commercial
capacity and deliver CARVYKTI to more multiple myeloma patients
around the world. The positive data from our CARTITUDE-4 study
further strengthened our competitive position as CARVYKTI is now
the first and only cell therapy shown to significantly extend
overall survival compared to standard therapies for multiple
myeloma patients as early as second line. This underscores the
transformational benefits of this therapy and the importance of our
efforts to expand patient access,” said Ying Huang, Ph.D., Chief
Executive Officer of Legend Biotech. “To this end, we recently
initiated commercial production at our Obelisc facility in Ghent,
Belgium, which is anticipated to help fulfill demand for CARVYKTI
around the world. We look forward to expanding our capacity further
while advancing our R&D programs as part of our long-term
strategy to strengthen Legend Biotech’s position as a leader in
cell therapy innovation.”
Regulatory Updates
- China’s National Medical Products Administration (NMPA)
approved cilta-cel for the treatment of adult patients with
relapsed or refractory multiple myeloma who have received at least
three prior lines of therapy, including a proteasome inhibitor and
immunomodulatory agent.
- Swissmedic approved label expansion of CARVYKTI® for the
treatment of adult patients with relapsed and refractory multiple
myeloma who have received at least two prior lines of therapy,
including an immunomodulatory agent, a proteasome inhibitor and an
anti-CD38 antibody and are refractory to lenalidomide.
Key Business Developments
- Announced positive three-year follow-up data from the Phase 3
CARTITUDE-4 study showing that CARVYKTI® significantly extended
overall survival in patients with relapsed or refractory multiple
myeloma who have received at least one prior line of therapy,
reducing the risk of death by 45 percent versus standard therapies.
These findings were presented in a late-breaking oral session at
the 2024 International Myeloma Society (IMS) Annual Meeting. Legend
Biotech and Janssen Biotech, Inc.* plan to share these results with
US and EU regulatory agencies to support potential label
updates.
- Received approval for and initiated commercial production of
CARVYKTI® at the new Obelisc site in Ghent, Belgium, which is
expected to help fulfill additional patient demand.
- Launched CARVYKTI® in Switzerland in the third quarter, marking
the expansion into the fifth country where CARVYKTI® is
commercially available.
- Announced the establishment of a new, state-of-the-art research
and development (R&D) facility in Philadelphia, Pennsylvania,
expected to be completed in the third quarter of 2025, to expand
Legend Biotech’s existing U.S. R&D footprint and advance its
portfolio of next-generation cell therapies.
* 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”).
Third Quarter 2024 Financial
Results
- License Revenue: License revenue was $17.1
million for the three months ended September 30, 2024, which was
entirely contributed by the Novartis License Agreement; compared to
$20.1 million for the three months ended September 30, 2023, which
was entirely contributed by the achievement of milestones under the
Janssen Agreement.
- Collaboration Revenue: Collaboration revenue
was $142.8 million for the three months ended September 30, 2024
compared to $75.9 million for the three months ended September 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 $52.5 million for the three months ended
September 30, 2024 compared to $43.5 million for the three months
ended September 30, 2023. The increase was primarily due to higher
net trade sales of CARVYKTI®. Collaboration Cost of Revenue is
determined based on 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
September 30, 2024 was $3.0 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 September 30, 2023.
- Other Income and Gains: Other income and gains
were $16.8 million for the three months ended September 30, 2024
compared to $35.8 million for the three months ended September 30,
2023.The decrease of $19.0 million was primarily driven by the lack
of unrealized foreign exchange gains in the three months ended
September 30, 2024, compared to $16.1 million of unrealized foreign
exchange gains for the three months ended September 30, 2023.
- Research and Development Expenses: Research
and development expenses were $95.5 million for the three months
ended September 30, 2024, compared to $95.9 million for the three
months ended September 30, 2023. These expenses are primarily due
to research and development activities in cilta-cel, including
start-up costs for clinical production in Belgium, as well as
continued investment in our solid tumor programs.
- Administrative Expenses: Administrative
expenses were $35.3 million for the three months ended September
30, 2024, compared to $28.1 million for the three months ended
September 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 $44.3 million for the three months ended
September 30, 2024, compared to $21.1 million for the three months
ended September 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.
- Other Expenses: Other expenses were $61.8
million for the three months ended September 30, 2024, compared to
$0.1 million for the three months ended September 30, 2023. This
increase was almost entirely driven by approximately $62.8 million
of unrealized foreign exchange loss for the three months ended
September 30, 2024. The unrealized foreign exchange losses were
primarily driven by intercompany transactions and balances between
the US and non-US legal entities related to the research and
development activities. For the three months ended September 30,
2023, there was no unrealized foreign exchange loss.
- Net Loss: Net loss was $125.3 million for the
three months ended September 30, 2024, compared to a net loss of
$62.2 million for the three months ended September 30, 2023.
- Cash Position: Cash and cash equivalents, and
time deposits were $1.2 billion as of September 30, 2024.
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 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 https://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®
and the completion of a new R&D facility in the third quarter
of 2024, statements related to Legend Biotech’s ability to fund its
operations into 2026; 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)
956-8271jessie.yeung@legendbiotech.com
PRESS CONTACT:Mary Ann OndishTel: (914)
552-4625media@legendbiotech.com
|
LEGEND BIOTECH CORPORATIONCONDENSED
CONSOLIDATED STATEMENTS OF PROFIT OR LOSS |
| |
| |
Three Months EndedSeptember 30,
2024 |
Nine Months EndedSeptember 30,
2024 |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
| US$’000, except share
and per share data |
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
| REVENUE |
|
|
|
|
|
|
|
|
License revenue |
|
17,096 |
|
|
|
20,057 |
|
|
|
120,123 |
|
|
|
35,172 |
|
|
Collaboration revenue |
|
142,828 |
|
|
|
75,937 |
|
|
|
314,563 |
|
|
|
170,369 |
|
|
Other revenue |
|
281 |
|
|
|
19 |
|
|
|
6,033 |
|
|
|
138 |
|
|
Total revenue |
|
160,205 |
|
|
|
96,013 |
|
|
|
440,719 |
|
|
|
205,679 |
|
| Collaboration cost of
revenue |
|
(52,510 |
) |
|
|
(43,479 |
) |
|
|
(146,966 |
) |
|
|
(111,764 |
) |
| Cost of license and other
revenue |
|
(2,959 |
) |
|
|
— |
|
|
|
(13,693 |
) |
|
|
— |
|
| Other income and gains |
|
16,815 |
|
|
|
35,838 |
|
|
|
49,148 |
|
|
|
49,812 |
|
| Research and development
expenses |
|
(95,522 |
) |
|
|
(95,855 |
) |
|
|
(309,112 |
) |
|
|
(276,535 |
) |
| Administrative expenses |
|
(35,300 |
) |
|
|
(28,104 |
) |
|
|
(102,582 |
) |
|
|
(78,062 |
) |
| Selling and distribution
expenses |
|
(44,270 |
) |
|
|
(21,098 |
) |
|
|
(98,556 |
) |
|
|
(60,481 |
) |
| Other expenses |
|
(61,841 |
) |
|
|
(134 |
) |
|
|
(1,139 |
) |
|
|
(231 |
) |
| Fair value loss of warrant
liability |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(85,750 |
) |
| Finance costs |
|
(5,504 |
) |
|
|
(5,676 |
) |
|
|
(16,463 |
) |
|
|
(15,974 |
) |
| LOSS BEFORE TAX |
|
(120,886 |
) |
|
|
(62,495 |
) |
|
|
(198,644 |
) |
|
|
(373,306 |
) |
| Income tax expense |
|
(4,435 |
) |
|
|
288 |
|
|
|
(4,666 |
) |
|
|
(130 |
) |
| LOSS FOR THE PERIOD |
|
(125,321 |
) |
|
|
(62,207 |
) |
|
|
(203,310 |
) |
|
|
(373,436 |
) |
| Attributable to: |
|
|
|
|
|
|
|
|
Ordinary equity holders of the parent |
|
(125,321 |
) |
|
|
(62,207 |
) |
|
|
(203,310 |
) |
|
|
(373,436 |
) |
| LOSS PER SHARE ATTRIBUTABLE TO
ORDINARY EQUITY HOLDERS OF THE PARENT |
|
|
|
|
|
|
|
| Basic |
|
(0.34 |
) |
|
|
(0.17 |
) |
|
|
(0.56 |
) |
|
|
(1.07 |
) |
| Diluted |
|
(0.34 |
) |
|
|
(0.17 |
) |
|
|
(0.56 |
) |
|
|
(1.07 |
) |
| ORDINARY SHARES USED IN LOSS
PER SHARE COMPUTATION |
|
|
|
|
|
|
|
| Basic |
|
366,562,487 |
|
|
|
363,075,209 |
|
|
|
365,268,372 |
|
|
|
348,293,363 |
|
| Diluted |
|
366,562,487 |
|
|
|
363,075,209 |
|
|
|
365,268,372 |
|
|
|
348,293,363 |
|
|
LEGEND BIOTECH CORPORATIONCONDENSED
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION |
| |
|
|
|
September 30, 2024 |
|
|
|
December 31, 2023 |
|
| |
|
US$’000 |
|
|
|
US$’000 |
|
| |
|
(Unaudited) |
|
|
|
|
|
| NON-CURRENT ASSETS |
|
|
|
|
|
|
|
| Property, plant and
equipment |
|
104,031 |
|
|
|
108,725 |
|
| Advance payments for property,
plant and equipment |
|
376 |
|
|
|
451 |
|
| Right-of-use assets |
|
99,452 |
|
|
|
80,502 |
|
| Time deposits |
|
4,509 |
|
|
|
4,362 |
|
| Intangible assets |
|
2,507 |
|
|
|
4,061 |
|
| Collaboration prepaid
leases |
|
172,981 |
|
|
|
151,216 |
|
| Other non-current assets |
|
1,932 |
|
|
|
1,493 |
|
| Total non-current assets |
|
385,788 |
|
|
|
350,810 |
|
| CURRENT ASSETS |
|
|
|
|
|
|
|
| Collaboration inventories,
net |
|
23,548 |
|
|
|
19,433 |
|
| Trade receivables |
|
705 |
|
|
|
100,041 |
|
| Prepayments, other receivables
and other assets |
|
112,801 |
|
|
|
69,251 |
|
| Financial assets at fair value
through profit or loss |
|
— |
|
|
|
663 |
|
| Pledged deposits |
|
583 |
|
|
|
357 |
|
| Time deposits |
|
753,123 |
|
|
|
30,341 |
|
| Cash and cash equivalents |
|
459,277 |
|
|
|
1,277,713 |
|
| Total current assets |
|
1,350,037 |
|
|
|
1,497,799 |
|
| Total assets |
|
1,735,825 |
|
|
|
1,848,609 |
|
| CURRENT LIABILITIES |
|
|
|
|
|
|
|
| Trade payables |
|
26,906 |
|
|
|
20,160 |
|
| Other payables and
accruals |
|
164,864 |
|
|
|
132,802 |
|
| Government grants |
|
554 |
|
|
|
68 |
|
| Lease liabilities |
|
4,342 |
|
|
|
3,175 |
|
| Tax payable |
|
11,067 |
|
|
|
7,203 |
|
| Contract liabilities |
|
63,161 |
|
|
|
53,010 |
|
| Total current liabilities |
|
270,894 |
|
|
|
216,418 |
|
| NON-CURRENT LIABILITIES |
|
|
|
|
|
|
|
| Collaboration interest-bearing
advanced funding |
|
296,623 |
|
|
|
281,328 |
|
| Lease liabilities long
term |
|
45,626 |
|
|
|
44,169 |
|
| Government grants |
|
6,548 |
|
|
|
7,305 |
|
| Contract liabilities |
|
— |
|
|
|
47,962 |
|
| Other non-current
liabilities |
|
27 |
|
|
|
56 |
|
| Total non-current
liabilities |
|
348,824 |
|
|
|
380,820 |
|
| Total liabilities |
|
619,718 |
|
|
|
597,238 |
|
| EQUITY |
|
|
|
|
|
|
|
| Share capital |
|
37 |
|
|
|
36 |
|
| Reserves |
|
1,116,070 |
|
|
|
1,251,335 |
|
| Total ordinary shareholders’
equity |
|
1,116,107 |
|
|
|
1,251,371 |
|
| Total equity |
|
1,116,107 |
|
|
|
1,251,371 |
|
| Total liabilities and
equity |
|
1,735,825 |
|
|
|
1,848,609 |
|
|
LEGEND BIOTECH CORPORATIONCONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOW |
| |
|
|
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|
US$’000 |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
| |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
| |
|
|
|
|
|
|
|
|
| LOSS BEFORE TAX |
|
|
(120,886 |
) |
|
|
(62,495 |
) |
|
|
(198,644 |
) |
|
|
(373,306 |
) |
| CASH FLOWS USED IN OPERATING
ACTIVITIES |
|
|
(75,822 |
) |
|
|
(60,848 |
) |
|
|
(61,955 |
) |
|
|
(297,631 |
) |
| CASH FLOWS PROVIDED BY/(USED
IN) INVESTING ACTIVITIES |
|
|
329,077 |
|
|
|
(209,072 |
) |
|
|
(762,702 |
) |
|
|
(314,723 |
) |
| CASH FLOWS PROVIDED BY
FINANCING ACTIVITIES |
|
|
4,245 |
|
|
|
961 |
|
|
|
6,031 |
|
|
|
790,565 |
|
| NET INCREASE/(DECREASE) IN
CASH AND CASH EQUIVALENTS |
|
|
257,500 |
|
|
|
(268,959 |
) |
|
|
(818,626 |
) |
|
|
178,211 |
|
| Effect of foreign exchange
rate changes, net |
|
|
524 |
|
|
|
(784 |
) |
|
|
190 |
|
|
|
(772 |
) |
| Cash and cash equivalents at
beginning of the period |
|
|
201,253 |
|
|
|
1,233,213 |
|
|
|
1,277,713 |
|
|
|
786,031 |
|
| |
|
|
|
|
|
|
|
|
| CASH AND CASH EQUIVALENTS AT
END OF THE PERIOD |
|
|
459,277 |
|
|
|
963,470 |
|
|
|
459,277 |
|
|
|
963,470 |
|
| ANALYSIS OF BALANCES OF CASH
AND CASH EQUIVALENTS |
|
|
|
|
|
|
|
|
| Cash and bank balances |
|
|
1,217,492 |
|
|
|
1,242,669 |
|
|
|
1,217,492 |
|
|
|
1,242,669 |
|
| Less: Pledged deposits |
|
|
583 |
|
|
|
356 |
|
|
|
583 |
|
|
|
356 |
|
| Time deposits |
|
|
757,632 |
|
|
|
278,843 |
|
|
|
757,632 |
|
|
|
278,843 |
|
| Cash and cash equivalents as
stated in the statement of financial position |
|
|
459,277 |
|
|
|
963,470 |
|
|
|
459,277 |
|
|
|
963,470 |
|
| Cash and cash equivalents as
stated in the statement of cash flows |
|
|
459,277 |
|
|
|
963,470 |
|
|
|
459,277 |
|
|
|
963,470 |
|
Legend Biotech (NASDAQ:LEGN)
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