Full Press Release Details
argenx Highlights 2025 Strategic Priorities
Reported $2.2 billion in preliminary* full-year
2024 global product net sales, inclusive of $737 million in fourth quarter sales
Pre-filled syringe FDA PDUFA on track for April 2025
to support reaching patients earlier in treatment paradigm
10 ongoing registrational studies in 2025 across
efgartigimod and empasiprubart enable next wave of indications
Empasiprubart to be evaluated in two head-to-head
registrational studies against IVIg to position C2 inhibitor for broad, early-line use in MMN and CIDP
Transition to sustainable profitability in 2025
enables continued investment in innovation
January 13, 2025, 7:00 AM CET
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 reported preliminary financial results for the full-year 2024, including global product net sales, and announced its strategic
priorities for 2025.
"2024 was a transformative year as we significantly
expanded our global patient reach with VYVGART and advanced a world-class pipeline of precision therapies," said Tim Van Hauwermeiren,
Chief Executive Officer of argenx. "The team's strong execution has positioned argenx to be a profitable company in 2025,
providing us flexibility to invest in the next wave of innovation across the company. Today, we are all in on our innovation mission,
applying our successful innovation playbook to bring transformational outcomes to even more patients by unleashing the next wave of autoimmune
indications and therapies, and securing our future by advancing multiple programs against first-in-class targets. We are positioned for
significant expansion in 2025 with the FDA decision on approval of our pre-filled syringe, global CIDP rollout, and label-expansion studies
underway for MG. To further support our growth, we are thrilled to have 10 ongoing registrational and 10 proof-of-concept studies in 2025,
teeing us up for several data readouts across our pipeline in the next 12-24 months.
"Innovation is the cornerstone of everything
we do, from the foundational science all the way to payor negotiations; it is our goal to deliver innovative and disruptive science for
the benefit of patients who need better access to transformational safe, effective, and convenient precision therapies. Innovation has
no meaning unless it reaches the marketplace, and we will continue to prioritize patient outcomes in all that we do."
2025 Strategic Priorities
argenx established its Vision 2030'
to outline the next phase of growth as part of its long-term commitment to transform the treatment of autoimmune diseases. Through this
vision, argenx aims to treat 50,000 patients globally with its medicines, secure 10 labeled indications across all approved medicines,
and advance five pipeline candidates into Phase 3 development by 2030.
To achieve the goals set out in its Vision
2030', argenx has set the following priorities for 2025:
Expand the global VYVGART opportunity and launch
VYVGART SC as a pre-filled syringe
(IV: efgartigimod alfa-fcab and SC: efgartigimod alfa and hyaluronidase-qvfc)
is a first-in-class FcRn blocker approved in three indications, including generalized myasthenia gravis (gMG) globally, primary immune
thrombocytopenia (ITP) in Japan, and chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S., Japan, and China.
Execute 10 registrational and 10 proof-of-concept
studies across efgartigimod, empasiprubart and ARGX-119
argenx continues to demonstrate breadth and depth
within its immunology pipeline, advancing multiple first-in-class product candidates with potential across multiple high-need indications.
argenx is solidifying its leadership in FcRn biology with efgartigimod, complement inhibition with empasiprubart and in the role of MuSK
at the neuromuscular junction with ARGX-119. In 2025, argenx plans to execute 10 registrational and 10 proof-of-concept studies across
efgartigimod, empasiprubart and ARGX-119 to advance its next wave of launches.
Efgartigimod Development
Efgartigimod is being evaluated in more than 15
severe autoimmune diseases (including MG, CIDP and ITP), exploring the significance of FcRn biology across neurology and rheumatology
indications, as well as new therapeutic areas. To prioritize those indications that can drive transformative benefit, argenx has made
the decision to discontinue development of efgartigimod in bullous pemphigoid (BP).
Empasiprubart Development
argenx is evaluating empasiprubart in registrational
studies in multifocal motor neuropathy (MMN) and CIDP, and proof-of-concept studies in delayed graft function (DGF) and DM.
ARGX-119 Development
argenx is evaluating ARGX-119 in congenital myasthenic
syndromes (CMS), amyotrophic lateral sclerosis (ALS), and spinal muscular atrophy (SMA).
Advance four new pipeline molecules and generate
sustainable value through continued investment in Immunology Innovation Program
argenx continues to invest in its Immunology Innovation
Program (IIP) to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates have been nominated, including:
ARGX- 213, targeting FcRn and further solidifying argenx's leadership in this new class of medicine; ARGX- 121, a first-in-class
molecule targeting IgA; ARGX-109, targeting IL-6, which plays an important role in inflammation, and ARGX-220, a first-in-class sweeping
antibody for which the target has not yet been disclosed.
Preliminary* Fourth Quarter and Full-Year 2024
Today, argenx also announced preliminary* global
product net sales for the fourth quarter and full-year 2024 of approximately $737 million and $2.2 billion, respectively.
As of December 31, 2024, argenx had approximately
$3.4 billion in cash, cash equivalents and current financial assets*.
* - The preliminary selected financial information
is unaudited, subject to adjustment, and provided as an approximation in advance of the company's announcement of complete financial
results in February 2025. Refer to the Preliminary Financial Results note in this document.
2025 Financial Guidance
Based on its current operating plans, argenx expects
its combined R&D and SG&A expenses in 2025 to be approximately $2.5 billion.
43rd Annual J.P. Morgan Healthcare
Conference Presentation and Webcast
Tim Van Hauwermeiren will highlight these updates
in a corporate presentation at the 43rd Annual J.P. Morgan Healthcare Conference today, Monday, January 13, 2025, at 9:45
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 VYVGART and VYVGART SC
is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn),
resulting in the reduction of circulating IgG autoantibodies. It is the first approved FcRn blocker for the treatment of generalized myasthenia
gravis (gMG), chronic inflammatory demyelinating polyneuropathy (CIDP), and primary immune thrombocytopenia (ITP). VYVGART SC is a subcutaneous
combination of efgartigimod alfa and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology
to facilitate subcutaneous injection delivery of biologics. It is marketed as VYVGART Hytrulo
in the U.S., VYVGART SC in Europe, VYVDURA in Japan, and
may be marketed under different proprietary names following approval in other regions.
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, globally 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
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Preliminary Financial Results
The financial information presented in this press
release is preliminary, estimated, and unaudited. They are subject to the completion and finalization of argenx's financial and