Reported $402 million in preliminary* full-year
2022 global net VYVGART sales
ADHERE topline results now expected in second
quarter of 2023; Stage B enrollment has surpassed projected target
of 130 patients
Registrational trial of efgartigimod in thyroid
eye disease (TED) to start in 2023; additional proof-of-concept
trials to start in ANCA-associated vasculitis and antibody mediated
rejection (AMR)
Submission for marketing approval in Japan of
VYVGART for immune thrombocytopenia (ITP) expected in mid-2023
Amsterdam, the
Netherlands – January 9, 2022 – argenx SE
(Euronext & Nasdaq: ARGX), a global immunology company
committed to improving the lives of people suffering from severe
autoimmune diseases, today announced its strategic priorities for
2023 and provided preliminary financial results for the full year
2022, including global net product sales of VYVGART® (efgartigimod
alfa-fcab).
“We had a landmark year in 2022, marking our
first as a fully integrated immunology company transforming the
treatment paradigm of generalized myasthenia gravis, and one which
will stand as only the very beginning of what we expect to achieve
as an organization,” said Tim Van Hauwermeiren, Chief Executive
Officer, argenx. “Looking forward, we will be expanding our
patient reach both geographically and through the anticipated U.S.
approval and launch of subcutaneous efgartigimod in March. By the
end of 2023, we will be active in 15 IgG- and complement-mediated
autoimmune diseases as we work to uncover the full breadth of our
differentiated pipeline with key data readouts from additional
indications of efgartigimod, as well as ARGX-117 and
ARGX-119.”
2023 Strategic
Priorities
argenx will focus on four strategic priorities in 2023 to drive
sustained growth and value creation as part of its ‘argenx 2025’
vision and a path to profitability.
Reach
More
Patients with
VYVGART argenx is planning for multi-dimensional
expansion to reach more patients with VYVGART, its first-in-class
neonatal Fc receptor blocker. This includes generalized myasthenia
gravis (gMG) patients through regulatory approvals in new regions
and the launch of its subcutaneous (SC) product offering, as well
as a new autoimmune indication with the VYVGART regulatory
submission for ITP in Japan.
- Prescription Drug User Fee Act
(PDUFA) target action date of March 20, 2023, for U.S. Food
and Drug Administration approval decision on SC efgartigimod for
gMG
- Regulatory approval decision on SC
efgartigimod for gMG expected in EU in fourth quarter of 2023
- Submission for marketing approval
of SC efgartigimod for gMG expected in Japan in first quarter of
2023
- Regulatory approval decisions of
VYVGART for gMG expected in Canada in third quarter of 2023 and in
China and Israel by end of 2023
- gMG launch in France, United
Kingdom and Italy expected by year-end 2023 following review of
respective reimbursement dossiers
- Submission for Japan marketing
approval of VYVGART for ITP expected in mid-2023
Pioneer
Development of FcRn
Class with
New
Clinical and
Translational
Dataargenx aims to solidify its
FcRn leadership by expanding the scope of IgG-mediated autoimmune
diseases in development and further demonstrating the potential of
FcRn blockade with three Phase 3 trial readouts, one
proof-of-concept trial readout, and a commitment to a
‘bedside-to-bench’ translational biology effort. By the end of
2023, efgartigimod is expected to be approved, in regulatory review
or in development in 13 severe autoimmune diseases.
- ADHERE: Topline data in chronic
inflammatory demyelinating polyneuropathy (CIDP) now expected in
second quarter of 2023; Stage B enrollment has surpassed the
initial projected target of 130 patients
- ADDRESS: Topline data in pemphigus
expected in second half of 2023
- ADVANCE-SC: Topline data from SC
trial in ITP expected in second half of 2023
- Proof-of-concept data in
post-COVID-19 postural orthostatic tachycardia syndrome (PC-POTS)
expected in fourth quarter of 2023
- Registrational trial to start in
TED in fourth quarter of 2023
- Proof-of-concept trials to start in
ANCA-associated vasculitis and AMR in kidney transplant in fourth
quarter of 2023; AAV trial to be run through IQVIA
collaboration
- Externally sponsored research
studies to launch in IgG-mediated neuromuscular autoimmune diseases
in 2023
- Translational work ongoing to
understand potential disease-modifying effect of FcRn
mechanism
Drive
Earlier-Stage
Immunology
Opportunities
Towards
Clinical
Proof-of-ConceptBeyond
efgartigimod, argenx is advancing a robust portfolio of innovative
clinical programs, including ARGX-117 (C2 inhibitor) and ARGX-119
(muscle-specific kinase (MuSK) agonist). Both programs have the
potential to be first-in-class opportunities for multiple severe
autoimmune indications.
- ARDA: Interim data from
proof-of-concept trial of ARGX-117 in multifocal motor neuropathy
expected mid-2023
- Proof-of-concept trial of ARGX-117
expected to start following regulatory discussions for prevention
of delayed graft function after kidney transplantation
- Dermatomyositis selected as third
autoimmune indication for development of ARGX-117
- Phase 1 dose-escalation trial of
ARGX-119 in healthy volunteers to start in first quarter of 2023
with subsequent Phase 1b trial to assess early signal detection in
patients
Build
Immunology
Innovation
Ecosystem to
Drive
Long-Term
Pipeline
Growthargenx 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 development candidate in
2023.
Preliminary*
Fourth Quarter and Full Year 2022
Financial Resultsargenx also announced today
preliminary* global net VYVGART revenues for the fourth quarter and
full-year 2022 of approximately $175 million and $402 million,
respectively.
As of December 31, 2022, argenx had
approximately $2.2 billion in cash, cash equivalents and current
financial assets*. Based on its current operating plans and a
projected 2023 cash burn of approximately $500 million, argenx
expects its existing cash, cash equivalents and current financial
assets, together with anticipated future product revenues, to fund
the company to profitability.
* - The preliminary selected financial results
are unaudited, subject to adjustment, and provided as an
approximation in advance of the Company’s announcement of complete
financial results in March 2023.
41st
Annual J.P. Morgan Healthcare Conference Presentation and
WebcastMr. Van Hauwermeiren will highlight these updates
in a corporate presentation at the 41st Annual J.P. Morgan
Healthcare Conference today, Monday, January 9, 2023, at 9:00 a.m.
PT. The live webcast of the presentation may be accessed under
Investors on the argenx website. A replay will be available for 30
days following the presentation.
About argenxargenx 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., Japan and the EU.
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.
Media:
Kelsey Kirkkkirk@argenx.com
Investors:
Beth DelGiaccobdelgiacco@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 its preliminary financial results for the full
year 2022; its expectations of future profitability; its plans for
geographic expansion; the anticipated launch of its subcutaneous
(SC) product in the U.S.; the initiation, timing, progress and
results of its anticipated clinical development, data readouts and
regulatory milestones and plans; its strategic priorities,
including the timing and outcome of regulatory filings and
regulatory approvals, and anticipated expansions in generalized
myasthenia gravis (gMG) and IgG-mediated autoimmune diseases; the
potential of its innovative clinical programs; and the nomination
of new development candidates. 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. 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 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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