Full Press Release Details
argenx Highlights 2023 Strategic Priorities
Across Immunology Pipeline
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
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.
Pioneer Development of FcRn Class with
New Clinical and Translational Data
argenx 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
Drive Earlier-Stage Immunology Opportunities
Towards Clinical Proof-of-Concept
Beyond 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.
Build Immunology Innovation Ecosystem to Drive
Long-Term Pipeline Growth
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 development candidate in 2023.
Preliminary* Fourth Quarter and Full Year
2022 Financial Results
argenx 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 Webcast
Mr. 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.
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., Japan
and the EU. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental
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.