- $329
million in third quarter global net product sales
- On track
to submit VYVGART® Hytrulo sBLA for CIDP by year-end 2023
- Results
from the ADVANCE-IV study published in The Lancet
-
Management to host conference call today at 1:30 pm CET (8:30 am
ET)
October 31, 2023
Amsterdam, the Netherlands –
argenx SE (Euronext & Nasdaq: ARGX), a global immunology
company committed to improving the lives of people suffering from
severe autoimmune diseases, today announced its third quarter 2023
financial results and provided a business update and outlook for
the remainder of the year.
“We continue to prioritize patient impact with
VYVGART and VYVGART Hytrulo, broadening our two gMG products into
earlier treatment lines and new geographies. VYVGART has now been
used in thousands of patients over multiple treatment years, and
its unique clinical profile has built patient trust and physician
confidence in the brand,” said Tim Van Hauwermeiren, Chief
Executive Officer of argenx. “There is a significant opportunity
before us to transform autoimmunity across multiple indications
with VYVGART. Based on the successful ADHERE trial, we are ready to
file the sBLA by the end of 2023 to bring our first-in-class FcRn
blocker to CIDP patients as quickly as possible. We are also on
track with two near-term pivotal readouts and an ambitious plan
forward over the coming years as we continue to execute and drive
innovation within our FcRn portfolio and across immunology more
broadly.”
THIRD QUARTER 2023 AND RECENT BUSINESS
UPDATE
VYVGART Expansion
VYVGART® is a first-in-class antibody fragment
targeting the neonatal Fc receptor (FcRn) and is now approved
globally in seven countries or regions (U.S., Japan, EU, UK,
Israel, China, Canada) for generalized myasthenia gravis (gMG).
VYVGART Hytrulo (subcutaneous (SC) injection) was approved in the
U.S. in June 2023. argenx is planning for multi-dimensional
expansion to reach more patients with gMG and other severe
autoimmune diseases through additional global regulatory
approvals.
- Generated global net product
revenues (inclusive of both VYVGART and VYVGART Hytrulo) of $329
million in the third quarter of 2023
- Health Canada approved VYVGART on
September 21, 2023, marking the seventh global approval for
gMG
- European Commission (EC) approval
of SC efgartigimod for gMG expected in fourth quarter of 2023
following positive recommendation from Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA)
- Japan approval decision regarding
SC efgartigimod for gMG expected by first quarter of 2024
- Japan marketing authorization
application (MAA) filed for VYVGART for primary immune
thrombocytopenia (ITP); approval decision expected in first quarter
of 2024
- U.S. supplemental Biologics License
Application (sBLA) for VYVGART Hytrulo in chronic inflammatory
demyelinating polyneuropathy (CIDP) on track to be filed by end of
2023
- China approval decision regarding
SC efgartigimod for gMG expected by end of 2024 through partnership
with Zai Lab
Efgartigimod Research and
Development
argenx is solidifying its leadership in FcRn
blockade and demonstrating the broad potential of efgartigimod by
advancing its clinical development programs of IgG-mediated
autoimmune diseases. By 2025, efgartigimod is expected to be
approved, in regulatory review or in development in 15 severe
autoimmune diseases
- Topline data from ADVANCE-SC (ITP)
expected in fourth quarter of 2023; results from ADVANCE-IV study
were published in The Lancet in September 2023
- Topline data from ADDRESS
(pemphigus) and GO/NO GO decision from BALLAD (bullous pemphigoid)
both expected around year-end 2023
- GO/NO GO decision expected from
ALKIVIA (myositis) in second half of 2024
- Topline data from ALPHA (post-COVID
postural orthostatic tachycardia syndrome (PC-POTS)) expected in
first quarter of 2024 and RHO (Sjogren’s syndrome) in first half of
2024
Pipeline Progress
argenx is advancing a robust portfolio of
innovative clinical programs, including empasiprubart (C2
inhibitor) and ARGX-119 (muscle-specific kinase (MuSK) agonist).
Both programs have the potential to be first-in-class opportunities
for multiple severe indications.
- Topline data from Phase 2 ARDA
study of empasiprubart (ARGX-117) in multifocal motor neuropathy
(MMN) expected in 2024
- Phase 1 study of ARGX-119 ongoing
in healthy volunteers; subsequent Phase 1b trial planned to assess
early signal detection in patients with congenital myasthenic
syndrome (CMS) and amyotrophic lateral sclerosis (ALS)
Immunology Innovation
Program
argenx continues to invest in its discovery
engine, the Immunology Innovation Program, to foster a robust
innovation ecosystem and drive early-stage pipeline growth. argenx
expects to nominate one new pipeline candidate in 2023.
THIRD QUARTER 2023 FINANCIAL
RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM
STATEMENTS OF PROFIT OR LOSS
|
|
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
(in thousands of $ except for shares and EPS) |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Product net sales |
|
$ |
329,097 |
|
$ |
131,329 |
|
$ |
816,432 |
|
$ |
227,325 |
Collaboration revenue |
|
|
692 |
|
|
6,652 |
|
|
3,047 |
|
|
9,262 |
Other operating income |
|
|
10,050 |
|
|
8,508 |
|
|
31,275 |
|
|
26,565 |
Total operating
income |
|
$ |
339,839 |
|
$ |
146,489 |
|
$ |
850,754 |
|
$ |
263,152 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
$ |
(35,999) |
|
$ |
(10,264) |
|
$ |
(78,358) |
|
$ |
(16,646) |
Research and development
expenses |
|
|
(191,755) |
|
|
(236,681) |
|
|
(553,119) |
|
|
(515,568) |
Selling, general and
administrative expenses |
|
|
(191,930) |
|
|
(108,181) |
|
|
(503,079) |
|
|
(336,845) |
Loss from investment in joint
venture |
|
|
(743) |
|
|
- |
|
|
(2,623) |
|
|
- |
Total operating
expenses |
|
|
(420,427) |
|
|
(355,126) |
|
|
(1,137,179) |
|
|
(869,059) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss |
|
$ |
(80,588) |
|
$ |
(208,637) |
|
$ |
(286,425) |
|
$ |
(605,907) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income |
|
$ |
30,049 |
|
$ |
8,007 |
|
$ |
67,078 |
|
$ |
13,740 |
Financial expense |
|
|
(231) |
|
|
(785) |
|
|
(626) |
|
|
(2,916) |
Exchange gains/(losses) |
|
|
(32,509) |
|
|
(39,609) |
|
|
(23,345) |
|
|
(92,991) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the period
before taxes |
|
$ |
(83,279) |
|
$ |
(241,024) |
|
$ |
(243,318) |
|
$ |
(688,074) |
Income tax
(expense)/benefit |
|
$ |
10,637 |
|
$ |
5,982 |
|
$ |
47,437 |
|
$ |
17,096 |
Loss for the
period |
|
$ |
(72,642) |
|
$ |
(235,042) |
|
$ |
(195,881) |
|
$ |
(670,978) |
Loss for the year
attributable to: |
|
|
- |
|
|
|
|
|
|
|
|
|
Owners of the parent |
|
$ |
(72,642) |
|
$ |
(235,042) |
|
$ |
(195,881) |
|
$ |
(670,978) |
Weighted average number of
shares outstanding |
|
|
58,128,233 |
|
|
55,203,655 |
|
|
56,512,254 |
|
|
54,049,119 |
Basis and diluted loss per
share (in $) |
|
|
(1.25) |
|
|
(4.26) |
|
|
(3.47) |
|
|
(12.41) |
Net increase/(decrease) in
cash, cash equivalents and current financial assets compared to
year-end 2022 and 2021 |
|
|
|
|
|
|
|
$ |
993,035 |
|
$ |
48,813 |
Cash and cash equivalents and
current financial assets at the end of the period |
|
|
|
|
|
|
|
$ |
3,185,583 |
|
$ |
2,385,541 |
DETAILS OF THE FINANCIAL
RESULTS
Total operating income for the
third quarter and year-to-date in 2023 was $339.8 million and
$850.8 million, respectively, compared to $146.5 million and $263.2
million for the same periods in 2022, and mainly consists of:
- Product net sales
of VYVGART for the three months ended and nine months ended
September 30, 2023, were $329.1 million and $816.4 million,
compared to $131.3 million and $227.3 million for the same periods
in 2022.
- Other operating
income for the third quarter and year-to-date in 2023 was
$10.1 million and $31.3 million, respectively, compared to $8.5
million, and $26.6 million for the same periods in 2022. The other
operating income for the three and nine months ended September 30,
2023, primarily relates to research and development tax incentives
and payroll tax rebates. Other income also includes $0.7 million in
royalty revenue from VYVGART sales in China.
Total operating expenses for
the third quarter and year-to-date in 2023 were $420.4 million and
$1,137.2 million, respectively, compared to $335.1 million and
$869.1 million for the same periods in 2022, and mainly consists
of:
- Cost of sales for
the third quarter and year-to-date in 2023 was $36.0 million and
$78.4 million, respectively, compared to $10.3 million and $16.6
million for the same periods in 2022. The cost of sales was
recognized with respect to the sale of VYVGART and VYVGART
Hytrulo.
- Research and development
expenses for the third quarter and year-to-date in 2023
were $191.8 million and $553.1 million, respectively, compared to
$236.7 million and $515.6 million for the same periods in 2022. The
research and development expenses mainly relate to external
research and development expenses and personnel expenses incurred
in the clinical development of efgartigimod in various indications
and the expansion of other clinical and preclinical pipeline
candidates.
- Selling, general and
administrative expenses for the third quarter and
year-to-date in 2023 were $191.9 million and $503.1 million,
respectively, compared to $108.2 million and $336.8 million for the
same periods in 2022. The selling, general and administrative
expenses mainly relate to professional and marketing fees linked to
the commercialization of VYVGART and VYVGART Hytrulo in the U.S.,
EU and Japan, and personnel expenses.
Financial income for the third
quarter and year-to-date in 2023 was $30.0 million and $67.1
million, respectively, compared to $8.0 million and $13.7 million
for the same periods in 2022. The increase in financial income is
mainly due to an increase in interest income on current financial
assets and cash and cash equivalents attributable to higher
interest rates.
Exchange losses for the third
quarter and year-to-date in 2023 were $32.5 million and $23.3
million respectively, compared to $39.6 million and $93.0 million
of exchange losses for the same periods in 2022. Exchange
gains/losses are mainly attributable to unrealized exchange rate
gains or losses on the cash, cash equivalents and current financial
assets position in Euro.
Income tax for the third
quarter and year-to-date in 2023 was $10.6 million and $47.4
million of tax benefit, respectively, compared to $6.0 million and
$17.1 million of tax benefit for the same periods in 2022. Tax
benefit for the nine months ended September 30, 2023, consists of
$23.8 million of income tax expense and $71.3 million of deferred
tax income, compared to $15.0 million of income tax expense and
$32.1 million of deferred tax income for the comparable prior
period.
Net loss for the three and
nine-month periods ended September 30, 2023, was $72.6 million and
$195.9 million, respectively, compared to $235.0 million and $671.0
million over the prior year periods. On a per weighted average
share basis, the net loss was $3.47 and $12.41 for the nine months
ended September 30, 2023 and 2022, respectively.
Cash, cash equivalents and current
financial assets totalled $3.2 billion as of September 30,
2023, compared to $2.2 billion as of December 31, 2022. The
increase in cash and cash equivalents and current financial assets
resulted primarily from the closing of a global offering of shares,
including a U.S. offering, which resulted in the receipt of $1.2
billion in net proceeds in July 2023, partially offset by net cash
flows used in operating activities.
EXPECTED 2024 FINANCIAL
CALENDAR
- February 29, 2024: FY 2023
financial results and business update
- May 9, 2024: Q1 2024 financial
results and business update
- July 25, 2024: Q2 2024 financial
results and business update
- October 24, 2024: Q3 2024 financial
results and business update
CONFERENCE CALL DETAILS The
third quarter 2023 financial results and business update will be
discussed during a conference call and webcast presentation today
at 1:30 pm CET/8:30 am ET. A webcast of the live call may be
accessed on the Investors section of the argenx website at
argenx.com/investors. A replay of the webcast will be available on
the argenx website.
Dial-in numbers: Please dial in
15 minutes prior to the live call.
Belgium 32
800 50
201France 33
800
943355Netherlands 31
20 795 1090United
Kingdom 44 800 358
0970United States
1
888 415
4250Japan 81
3 4578
9081Switzerland 41
43 210 11 32
About argenx
argenx is a global immunology company committed
to improving the lives of people suffering from severe autoimmune
diseases. Partnering with leading academic researchers through its
Immunology Innovation Program (IIP), argenx aims to translate
immunology breakthroughs into a world-class portfolio of novel
antibody-based medicines. argenx developed and is commercializing
the first approved neonatal Fc receptor (FcRn) blocker in the U.S.,
Japan, Israel, the EU, the UK, China and Canada. The Company is
evaluating efgartigimod in multiple serious autoimmune diseases and
advancing several earlier stage experimental medicines within its
therapeutic franchises. For more information,
visit www.argenx.com and follow us
on LinkedIn, Twitter, and Instagram.
For further information, please
contact:
Media:Erin
Murphyemurphy@argenx.com
Investors:Alexandra Roy
(US)aroy@argenx.com
Lynn Elton (EU)lelton@argenx.com
Forward-looking Statements
The contents of this announcement include
statements that are, or may be deemed to be, “forward-looking
statements.” These forward-looking statements can be identified by
the use of forward-looking terminology, including the terms
“believes,” “hope,” “estimates,” “anticipates,” “expects,”
“intends,” “may,” “will,” or “should” and include statements argenx
makes regarding its plans to execute and drive innovation within
its FcRn portfolio and across immunology; its plans for
multi-dimensional expansion to reach more patients with gMG and
other autoimmune diseases through additional global regulatory
approvals; advancement of, and anticipated clinical development,
data readouts and regulatory milestones and plans, including the
(1) expected EC approval of SC efgartigimod for gMG in the fourth
quarter of 2023, (2) expected approval decision regarding SC
efgartigimod for gMG in Japan by the first quarter of 2024, (3)
expected MAA for VYVGART for primary ITP approval decision in Japan
in the first quarter of 2024, (4) expected filing of the sBLA for
VYVGART Hytrulo in CIDP by the end of 2023, (5) expected approval
decision regarding SC efgartigimod for gMG in China by end of 2024
through its partnership with Zai Lab; (6) expected topline data
from ITP in the fourth quarter of 2023, (7) expected topline data
from ADDRESS and the GO/NO GO decision from BALLAD around year-end
2023, (8) expected GO/NO GO decision from ALKIVIA in the second
half of 2024, (9) expected topline dtaa from ALPHA in the first
quarter of 2024 and RHO in the first half of 2024, (10) expected
topline data from Phase 2 ARDA study of ARGX-117 in MMN in 2024,
(11) planned Phase 1b trial to assess early signal detection in
patients with CMS and ALS and (12) planned nomination of a new
pipeline candidate in 2023; continued investment in its Immunology
Innovation Program to foster a robust innovation ecosystem and
drive early-stage pipeline growth; and 2023 business and financial
outlook and related plans, the timeline of future releases of
financial results and business updates. By their nature,
forward-looking statements involve risks and uncertainties and
readers are cautioned that any such forward-looking statements are
not guarantees of future performance. argenx’s actual results may
differ materially from those predicted by the forward-looking
statements as a result of various important factors, including
inflation and deflation and the corresponding fluctuations in
interest rate; regional instability and conflicts, such as the
conflict between Russia and Ukraine, argenx’s expectations
regarding the inherent uncertainties associated with competitive
developments, preclinical and clinical trial and product
development activities and regulatory approval requirements;
argenx’s reliance on collaborations with third parties; estimating
the commercial potential of argenx’s product candidates; argenx’s
ability to obtain and maintain protection of intellectual property
for its technologies and drugs; argenx’s limited operating history;
and argenx’s ability to obtain additional funding for operations
and to complete the development and commercialization of its
product candidates. A further list and description of these risks,
uncertainties and other risks can be found in argenx’s U.S.
Securities and Exchange Commission (SEC) filings and reports,
including in argenx’s most recent annual report on Form 20-F filed
with the SEC as well as subsequent filings and reports filed by
argenx with the SEC. Given these uncertainties, the reader is
advised not to place any undue reliance on such forward-looking
statements. These forward-looking statements speak only as of the
date of publication of this document. argenx undertakes no
obligation to publicly update or revise the information in this
press release, including any forward-looking statements, except as
may be required by law.
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