Shareholder Letter
Dear Shareholder,
2023 was a remarkable year for argenx as we carry forward our work to develop and deliver transformative therapies for autoimmune patients. We are strengthening and growing our ongoing collaborations with the world’s leading scientists to pioneer FcRn biology, while also developing novel molecules in the lab and clinic. And, as we execute on our ambitious business plan and step into our potential as a global organization, we hear more and more stories about the transformative impact VYVGART is having for patients, inspiring us to continue the work of rewriting the book on autoimmunity.
We have now reached and improved the lives of over 6,000 gMG patients with VYVGART and this past year launched VYVGART HYTRULO, introducing optionality for patients and health care providers. VYVGART is setting new expectations in gMG with almost half of patients reaching minimal symptom expression. VYVGART has also shown meaningful steroid tapering, fast access to treatment and a very robust safety database. We were proud to earn more than $1.2 billion in revenue in 2023 and look forward to continued commercial excellence as we expand globally.
Last summer, we shared groundbreaking results from our Phase 3 ADHERE clinical trial of VYVGART in chronic inflammatory demyelinating polyneuropathy (CIDP). In addition to providing a clinically meaningful benefit for patients and, importantly, a favorable safety profile, this clinical trial was of high quality and showed consistency across geographies. We have submitted our application for FDA approval, and if approved, look forward to launching mid-year. We know CIDP patients are waiting and we are eager to reach them with this life-changing treatment option which would represent the first real innovation for CIDP patients in many years.
We are also advancing our second asset, empasiprubart, for which we achieved proof-of-concept (POC) in multifocal motor neuropathy (MMN). MMN patients often experience a lengthy, frustrating, and emotional diagnosis and lack effective treatment options. MMN patients are ready for a targeted and effective treatment option and we are committed to rapidly advancing this program.
Looking ahead, we expect to file four new investigational new drug (IND) candidates by the end of 2025 delivered by our IIP. This program is a process innovation unique to argenx, and has been the driving force behind our work to pioneer first-in-class targets and is the engine that produced VYVGART, empasiprubart and ARGX-119 as well as partnered molecules such as ARGX-115 (AbbVie) and ARGX-112 (LEO Pharma). Our business model creates optionality within a molecule and within our pipeline bringing more first-in-class assets into clinical development. There will be attrition but the way you protect against it is by creating this type of optionality.
We are driven by a relentless commitment to innovate for patients, but our ambition to innovate does not end in the lab. We are building argenx as a fully integrated and sustainable company – one where our people are inspired to grow our company, our partnerships, our science, and ourselves, because when we do, we deliver more for patients.
We remain grateful for the continued support, encouragement, and advice from our investor community and collaborators, as together we forge ahead to pioneer novel biology that will bring new medicines to patients living with autoimmune disease. We will continue to execute on our strategy, with confidence in our products, pipeline, the people and the passion to achieve our bold ambition to transform autoimmunity.