- VYVGART®
(efgartigimod alfa-fcab) approved in the U.S. and Japan as the
first-and-only neonatal Fc receptor (FcRn) blocker; U.S. commercial
launch underway
- Topline
results from Phase 3 bridging study of subcutaneous (SC)
efgartigimod in generalized myasthenia gravis (gMG) on track for
first quarter 2022
- Malini
Moorthy appointed as General Counsel
-
Management to host conference call today at 2:30 pm CET (8:30 am
ET)
March 3, 2022
Breda, the Netherlands – argenx
(Euronext & Nasdaq: ARGX), a global immunology company
committed to improving the lives of people suffering from severe
autoimmune diseases, today reported financial results for the full
year 2021 and provided a fourth quarter business update.
“2021 was a transformational year for argenx,
culminating with the FDA approval of VYVGART, our first-in-class
FcRn blocker, in December. We carried this momentum into 2022 with
the official U.S. launch of VYVGART and the Japan approval. We were
well-prepared to launch VYVGART at the time of approval and are
encouraged by the early response of the medical community, the
engagement from patients, and the coverage decisions that have been
made by payers. We continue to expect steady launch progress in
2022 as we aim to deliver this new therapy to patients living with
generalized myasthenia gravis,” said Tim Van Hauwermeiren, Chief
Executive Officer of argenx.
“In addition to executing the global commercial
launch of VYVGART, we are primed to deliver several upcoming
catalysts through our development pipeline in high-value autoimmune
indications. We expect multiple registrational trial readouts for
efgartigimod in the next four quarters, the first of which is the
SC bridging study in gMG this month. We are expanding the scope of
development for efgartigimod to 10 indications and ARGX-117 to two
indications by the end of this year, and will also advance ARGX-119
into first-in-human studies. We remain focused on all components of
our integrated business so that we can continue to redefine
immunology on behalf of patients and deliver shareholder value,”
continued Mr. Van Hauwermeiren.
FOURTH QUARTER 2021 AND RECENT BUSINESS
UPDATE
U.S. commercial launch ongoing
for VYVGART, the first
FDA-approved FcRn
blocker for adult gMG patients who are
anti-acetylcholine receptor
(AChR) antibody
positive
- VYVGART U.S. salesforce launched in
early January; team interacted with over 60% of the 1,000 top
priority neurologist targets as of end of February
- VYVGART-specific payer policies
have been published in plans covering approximately 25% of U.S.
commercial lives; expected to have broad coverage in place by end
of second quarter 2022
- Commercial launch preparedness
enabled immediate activation of key launch activities
- My VYVGART Path, a personalized
patient support system, was active at time of approval;
approximately 90% of enrollment forms have come in through this
program
- Distribution channels stocked
within one week following FDA approval
On track with global launch strategy to
make VYVGART available in Japan, Europe, China
and Canada, as well as
additional regions through license and
distribution agreements
- VYVGART approved for adult patients
with gMG on January 20, 2022 by Japan’s Ministry of Health, Labour
and Welfare with expected launch to occur in second quarter
2022
- Decision from European Medicines
Agency on Marketing Authorization Application expected in second
half of 2022
- argenx Canada established in
preparation for potential Health Canada approval and commercial
launch
- Medison to file for approval in
Israel in second quarter of 2022
- Zai Lab to file for approval in
China in mid-2022
- Entered into commercial and
distribution agreement with GenPharm for VYVGART commercialization
in the Middle East
- Additional license and distribution
agreements expected in 2022 to expand global patient reach
Topline data
expected from five
ongoing efgartigimod
registrational trials by end of
first quarter of 2023
- Neuromuscular
franchise
- ADAPT-SC: Topline data from
bridging study of SC efgartigimod for gMG expected in first quarter
of 2022
- ADHERE: Topline data of SC
efgartigimod for chronic inflammatory demyelinating
polyneuropathy
expected in first quarter of 2023
- Hematology
franchise
- ADVANCE: Topline data of
intravenous efgartigimod for primary immune thrombocytopenia (ITP)
expected in second quarter of 2022
- ADVANCE-SC: Topline data of SC
efgartigimod for primary ITP expected in first quarter of 2023
- Dermatology
franchise
- ADDRESS: Timing of topline data of
SC efgartigimod for pemphigus foliaceous and vulgaris is currently
under review given geopolitical events in Ukraine
argenx’s leadership
position in FcRn blockade to be solidified through
expansion of efgartigimod
development portfolio
into ten
total autoimmune conditions by end of
2022
- BALLAD:
Registrational trial ongoing of SC efgartigimod for bullous
pemphigoid with interim analysis planned of first 40 patients
- ALKIVIA:
Registrational trial on track to start in first quarter of 2022 for
idiopathic inflammatory myopathy (myositis); interim analysis
planned of first 30 patients of each subtype (immune-mediated
necrotizing myopathy, anti-synthetase syndrome and
dermatomyositis)
- Zai Lab to launch proof-of-concept
trials in lupus nephritis and membranous nephropathy in 2022 with
argenx to lead global registrational programs for each potential
indication
- Entered strategic collaboration
with IQVIA to leverage its global clinical development capabilities
and accelerate expansion of efgartigimod into additional potential
indications
- Proof-of-concept trials in primary
Sjogren’s syndrome expected to initiate in second half of 2022 and
COVID-19-mediated postural orthostatic tachycardia syndrome (POTS)
in mid-2022
ARGX-117, a novel C2 inhibitor, has
potential to be second pipeline-in-a-product for multiple
autoimmune indications
- Ongoing proof-of-concept trial to
evaluate safety, tolerability, and potential dosing regimen in
multifocal motor neuropathy (MMN)
- Phase 2 proof-of-concept trial
expected to start in 2022 for prevention of delayed graft function
and/or allograft failure after kidney transplantation
Continued investment in Immunology
Innovation Program (IIP) to
broaden autoimmune pipeline for sustained value creation
opportunities
- Phase 1 dose-escalation trial of
ARGX-119, an agonist SIMPLE Antibody™ to muscle-specific kinase
(MuSK), expected to start after Clinical Trial Application filing
in fourth quarter of 2022
- Trial will evaluate safety,
tolerability, pharmacokinetics and pharmacodynamics in healthy
volunteers, and also early signal detection in patients
Strengthened leadership team with
appointment of
Malini Moorthy as General Counsel
- Ms. Moorthy brings to argenx over
20 years of global legal and compliance experience in the
pharmaceutical and medical device industries
Yvonne Greenstreet to step down from
argenx Board of Directors in order to focus on her
transition to Chief Executive Officer at
Alnylam
FOURTH QUARTER AND FULL YEAR
2021 FINANCIAL RESULTS
|
|
Year Ended |
|
|
|
December 31, |
|
(in thousands of $ except for shares and EPS) |
2021 |
|
2020 |
|
Variance |
|
Revenue |
$ |
497,277 |
|
$ |
41,243 |
|
$ |
456,034 |
Other operating income |
|
42,141 |
|
|
23,668 |
|
|
18,473 |
Total operating
income |
|
539,418 |
|
|
64,911 |
|
|
474,507 |
|
|
|
|
|
|
|
|
|
Research and development
expenses |
|
(580,520) |
|
|
(370,885) |
|
|
(209,635) |
Selling, general and
administrative expenses |
|
(307,644) |
|
|
(171,643) |
|
|
(136,001) |
Total operating
expenses |
|
(888,164) |
|
|
(542,528) |
|
|
(345,636) |
|
|
|
|
|
|
|
|
|
Operating
loss |
$ |
(348,746) |
|
$ |
(477,617) |
|
$ |
128,871 |
|
|
|
|
|
|
|
|
|
Financial
income/(expenses) |
|
(944) |
|
|
(1,501) |
|
|
557 |
Exchange gains/(losses) |
|
(50,053) |
|
|
(126,234) |
|
|
76,181 |
|
|
|
|
|
|
|
|
|
Loss
before taxes |
$ |
(399,743) |
|
$ |
(605,352) |
|
$ |
205,609 |
|
|
|
|
|
|
|
|
|
Income tax expense |
$ |
(8,522) |
|
$ |
(3,103) |
|
$ |
(5,419) |
|
|
|
|
|
|
|
|
|
Loss
for the year |
$ |
(408,265) |
|
$ |
(608,455) |
|
$ |
200,190 |
|
|
|
|
|
|
|
|
|
Loss for the year
attributable to: |
|
|
|
|
|
|
|
|
Owners of the
parent |
$ |
(408,265) |
|
$ |
(608,455) |
|
$ |
200,190 |
Weighted average number of
shares outstanding |
|
51,075,827 |
|
|
45,410,442 |
|
|
5,665,385 |
Basic and diluted loss per
share (in $) |
|
(7.99) |
|
|
(13.40) |
|
|
|
Net increase in cash and cash
equivalents and current financial assets compared to year-end 2020
and 2019 |
$ |
340,276 |
|
$ |
495,791 |
|
|
|
Cash and cash equivalents and
current financial assets at the end of the period |
$ |
2,336,728 |
|
$ |
1,996,452 |
|
|
|
DETAILS OF THE FINANCIAL
RESULTS
Cash, cash equivalents and current financial
assets totaled $2,336.7 million as of December 31, 2021, compared
to $1,996.5 million on December 31, 2020. The increase in cash and
cash equivalents and current financial assets resulted primarily
from the closing of a global offering of shares, which resulted in
the receipt of $1,092.1 million in net proceeds in February 2021
and the net receipt of a $73.1 million non-creditable,
non-refundable development cost-sharing payment from Zai Lab as
part of the strategic collaboration for efgartigimod in Greater
China in part offset by the payment of $98.0 million related to the
purchase of the priority review voucher from Bayer HealthCare
Pharmaceuticals, and other net cash flows used in operating
activities.
Revenue increased by $456.0 million for the
twelve months ended December 31, 2021 to $497.3 million, compared
to $41.2 million for the twelve months ended December 31, 2020. The
increase was primarily due to the recognition of the transaction
price as a consequence of the termination of the collaboration
agreement with Janssen resulting in the one-time recognition of
$315.1 million, and the recognition of $177.5 million in
collaboration revenue related to the strategic collaboration with
Zai Lab, including the cost-sharing payment and the development
milestone, triggered by the FDA approval of VYVGART.
Other operating income increased by $18.5
million to $42.1 million for the year ended December 31, 2021,
compared to $23.7 million for the year ended December 31, 2020. The
increase was primarily driven by (i) the increase in research and
development incentives, as a result of the increased research and
development costs incurred, (ii) the increase in payroll tax
rebates, as a direct result of the increase in the employment of
highly qualified research and development personnel eligible for
specific payroll tax rebates, and (iii) the increase in fair value
of argenx’s profit share in AgomAb Therapeutics
NV. Research and development expenses increased by
$209.6 million for the twelve months ended December 31, 2021 to
$580.5 million, compared to $370.9 million for the twelve months
ended December 31, 2020. The increase resulted primarily from
higher external research and development expenses, mainly related
to the efgartigimod program in various indications and other
clinical and preclinical programs. Furthermore, the research and
development personnel expenses increased due to a planned increase
in headcount and the increased costs of the share-based payment
compensation plans related to the grant of stock
options.
Selling, general and administrative expenses
totaled $307.6 million for the twelve months ended December 31,
2021, compared to $171.6 million for the twelve months ended
December 31, 2020. The increase resulted primarily from higher
personnel expenses, including the costs of the share-based payment
compensation plans related to the grant of stock options, and
consulting fees linked to the preparation for a commercialization
of VYVGART.
Exchange losses totaled $50.1 million for the
twelve months ended December 31, 2021, compared to $126.2 million
for the twelve months ended December 31, 2020 and are mainly
attributable to unrealized exchange rate losses on the cash, cash
equivalents and current financial assets position in Euro.
FINANCIAL GUIDANCEBased on
current plans to fund anticipated operating expenses and capital
expenditures, argenx expects to utilize up to half of its available
cash, cash equivalents and current financial assets in 2022. The
increased spend will support the global VYVGART launches, clinical
development of efgartigimod in 10 indications and ARGX-117 in two
indications, investment in the global supply chain, and continued
focus on pipeline expansion through the Immunology Innovation
Program.
US SEC AND STATUTORY
FINANCIAL REPORTINGargenx’s primary accounting standard
for quarterly earnings releases and annual reports is International
Financial Reporting Standards (IFRS) as issued by the International
Accounting Standards Board (IASB). Quarterly summarized statements
of profit or loss based on IFRS as issued by the IASB are available
on www.argenx.com.
In addition to reporting financial figures in
accordance with IFRS as issued by the IASB, argenx also reports
financial figures in accordance with IFRS as adopted by the EU for
statutory purposes. The consolidated statements of financial
position, the consolidated statements of profit or loss, the
consolidated statements of comprehensive income / loss, the
consolidated statements of cash flows, and the consolidated
statements of changes in equity are not affected by any differences
between IFRS as issued by the IASB and IFRS as adopted by the
EU.
The consolidated statements of profit or loss of
argenx SE for the year ended December 31, 2021, as presented in
this press release are unaudited.
EXPECTED 2022 FINANCIAL
CALENDAR:
- May 5, 2022: Q1 2022 financial
results and business update
- July 28, 2022: HY 2022 financial
results and business update
- October 27, 2022: Q3 2022 financial
results and business update
CONFERENCE CALL DETAILSThe full
year 2021 results and fourth quarter business update will be
discussed during a conference call and webcast presentation today
at 2:30 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
9752Switzerland 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-and-only approved neonatal Fc receptor (FcRn) blocker in
the U.S. and Japan. 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:Kelsey Kirkkkirk@argenx.com
Joke Comijn (EU)jcomijn@argenx.com
Investors:Beth
DelGiaccobdelgiacco@argenx.com
Michelle Greenblattmgreenblatt@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 concerning execution of its global launch strategy and
expected therapy delivery to patients in Japan, Europe, China and
Canada; its expectation concerning its development pipeline and
ability to deliver shareholder value as a result thereof; expected
registrational trial readouts in 2022; development of efgartigimod
in up to ten indications and ARGX-117 in up to two indications by
end of 2022; expected advancement of ARGX-119 into first-in-human
studies; expected broad U.S. policy coverage of VYVGART by the end
of second quarter 2022; the estimated number of covered patients in
the U.S.; anticipated pathway for approval in Japan and launch in
the second quarter of 2022; expected approval by European Medicines
Agency of MAA in the second half of 2022; establishment of argenx
Canada in the first quarter of 2022 and preparation for potential
Health Canada approval and commercial launch; plans for Medison to
file for approval in Israel in second quarter of 2022; expected
partnership with GenPharm for commercialization in the Middle East;
partnership agreements expected to be announced in 2022; the timing
and its expectations with respect to reporting data from
registrational trials; expectations with respect to leadership
potential through expansion of efgartigimod portfolio into ten
indications by end of 2022; expected launch and timing of proof of
concept trials, including by Zai Labs and IQVIA, and dose
escalation trials in 2022; and its expectations with respect to its
use of available cash and liquidity needs for 2022. 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.
- ARGX FY21 Primary Financials - Press Release FINAL 3.3.22
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