Strategy and Objectives

Company’s Strategies

Our goal is to transform the lives of at least 50,000 patients and their communities before 2030 by providing them with life-changing medicines built on scientific breakthroughs in immunology. To reach this goal, we plan to deliver a set of different strategies:

• Maximize the VYVGART^® opportunity: redefine treatment expectations for MG and CIDP, and deliver 6 additional labelled indications We plan to do this through our differentiated scientific and clinical activities and our commercial execution to drive VYVGART preference. Our PFS with PDUFA Date in April 2025 as a perfect example of our continued innovation for the patient experience. Beyond neurology, we plan to establish argenx and VYVGART in rheumatology as we prepare for data in Myositis and SjD, while also maximizing the therapeutic potential of VYVGART in other indications through the execution of multiple Phase 2 and Phase 3 studies.
• Maximize the empasiprubart opportunity: establish its potential as a pipeline-in-a-product We plan to develop argenx as scientific leader in complement inhibitions and elevate the differentiation story. In particular, we have advanced the clinical development of empasiprubart in MMN, currently in Phase 3, DGF in the context of kidney transplants and DM, currently in Phase 2, and expect to start a registrational clinical trial for our fourth selected indication, CIDP in 2025. For both MMN and CIDP we will prepare for launches, building on key elements of the VYVGART playbook.
• Build a sustainable, diversified portfolio of breakthrough and differentiated antibody-based products We plan to further advance ARGX-119 to a differentiated first-in-class MuSK agonist in multiple indications (CMS, ALS, SMA, 1 new indication), maximize our leadership position in the FcRn space through multiple generations of projects (e.g. ARGX-213), substantially grow our clinical portfolio of differentiated pipeline-in-a-product opportunities (ARGX-109, ARGX-121, ARGX-220, ARGX-213, other), create an exciting portfolio of promising new assets (through our IIP) and advance our clinical trial designs and speed.
• Grow a unique, global biotech company by scaling the argenx Way: one company, one plan, on a mission to achieve the unthinkable We plan to embed the argenx Way throughout the organization, who we are through our cultural pillars and how we work through our operating principles. We want to demystify innovation and make it everyone’s business, strengthen the ‘winning’ competencies to share the future of argenx and advance our partnership approach to access. To be able to continue in this way, we plan to remain a magnet for talent and create unlimited opportunities for growth and development of our people, an important driver of developing the business.
• Ensure long-term sustainability We plan to continue to seek out, listen to and prioritize on behalf of the patient in all what we do, accelerate the science of immunology by being an active and trusted partner in the global immunology ecosystem through high-quality publications and patent applications, elevate and expand our relationships with regulatory, payors and policy stakeholders and create long-term shareholder value.
• In our 2030 vision, we aim to build on our strong strategic pillars to have a continuous pipeline of innovation, strengthen our FcRn leadership and scale in a disciplined way. Our goal is to have 5 new molecules in Phase 3 development, 10 labelled indications and reaching 50,000 patients who are on treatment by 2030.

Competitive position

We participate in a highly innovative industry characterized by a rapidly growing understanding of disease biology, quickly changing technologies, strong intellectual property barriers to entry, and a multitude of companies involved in the creation, development and commercialization of novel therapeutics. Many of these companies are highly sophisticated and often strategically collaborate with each other.

Competition in the autoimmune field is intense and involves multiple monoclonal antibodies (mAbs), other biologics and small molecules either already marketed or in development by many different companies, including large pharmaceutical companies. We compete with a wide range of biopharmaceutical companies, who are developing products for the treatment of gMG, CIDP, ITP and other autoimmune diseases, including products that are in the same class as VYVGART, as well as products that are similar to some of our product candidates. We are aware of several FcRn inhibitors that are in clinical development or marketed. Competitive product launches may erode future sales of our products, including our existing products and those currently under development, or result in unanticipated product obsolescence. Such launches continue to occur, and potentially competitive products are in various stages of development. We could also face competition for use of limited international infusion sites, particularly in new markets as competitors launch new products. We cannot predict with accuracy the timing or impact of the introduction of competitive products that treat diseases and conditions like those treated by our products or product candidates. In addition, our competitors compete with us to recruit and retain qualified scientific and management personnel, establish clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, the development of our products. Please see the risk factor titled “We face significant competition for our drug discovery and development efforts.“ for further details on the competition we face.