Annual Report 2023

Annual Report 2023

Overview

Since our inception in 2008, we have focused most of our financial resources and efforts towards developing our SIMPLE Antibody™ Platform and antibody engineering technologies, identifying potential product candidates, establishing process, development and manufacturing capabilities for our product candidates and advancing multiple discovery programs into the clinic. In 2022, we executed on our global launch of VYVGART our first-in-class neonatal FcRn blocker for intravenous use, which is now approved in the U.S., Japan, Europe, Israel, Canada and China for gMG. In 2023, we executed on our global launch of VYVGART SC, the first-and-only neonatal FcRn blocker administered by subcutaneous injection, which is now approved in the U.S. and Europe. In 2023, the successful commercialization of VYVGART and VYVGART SC generated a global product net sales of $1.2 billion.

On our research and development, we continue towards advancing a deep pipeline of both clinical- and preclinical-stage product candidates for the treatment of severe autoimmune diseases. Leveraging our technology suite and clinical expertise, we have advanced several candidates into late-stage clinical development and we currently have multiple programs in the discovery stage.

As of December 31, 2023 and December 31, 2022, we had cash, cash equivalents and current financial assets of $3,180 million and $2,193 million, respectively.

Our Statement of financial position shows our total assets of $4,542 million for the year ended December 31, 2023, compared to $3,134 million for the year ended December 31, 2022. The main reason for the material change in balance sheet total are the various equity financing rounds, completed over the periods covered by the financial statements.

Since our inception, we have incurred significant operating losses. For the years ended December 31, 2023 and 2022, we incurred total comprehensive losses of $295 million and $730 million, respectively. As of December 31, 2023, we had accumulated losses of $2,405 million.

Although we have generated revenue of $1.2 billion from global product net sales of VYVGART and VYVGART SC for gMG in the fiscal year ended December 31, 2023, we can provide no assurances that we will be able to achieve or sustain profitability based on product net sales in that indication alone or that we will be able to receive regulatory approval of and commercialize VYVGART or VYVGART SC in other indications or in other countries.

On December 17, 2021, the FDA approved efgartigimod, which is marketed as VYVGART, for the intravenous treatment of gMG in adult patients who are AChR-AB+, followed by Japanese PMDA approval (including seronegative patients) and approval the EU Commission in 2022 and China’s NMPA approval on July 30, 2023. On June 20, 2023, the FDA approved VYVGART SC for the subcutaneous treatment of gMG in adult patients who are AChR-AB+, followed by approval of the EU Commission on November 16, 2023. These are the only approved products we currently have.

We expect our expenses to continue to increase as we expand our global commercial infrastructure and drug product inventory for VYVGART and VYVGART SC for the treatment of gMG, the commercial launch of VYVGART SC for the treatment of CIDP if and when approval obtained, the advancement of our clinical-stage pipeline, including ongoing registrational clinical trials across five indications of efgartigimod, and continued investment in our IIP. We anticipate that our expenses will increase if and as we:

Research and development activities:

  • execute the phase 2 clinical trials of efgartigimod in SjD, POTS post-COVID-19 and AMR
  • execute the phase 2 clinical trials with our partner Zai Lab in MN and LN
  • execute the seamless phase 2/3 clinical trials of efgartigimod in Myositis and BP
  • execute the phase 3 clinical trials of efgartigimod in MG seronegatives and Pediatric and TED
  • launch phase 2 and/or phase 3 in other indications with efgartigimod
  • execute the phase 2 clinical trials of empasiprubart in MMN, DGF and DM
  • execute the phase 1 clinical trial of ARGX-119 in healthy volunteers and the phase 1b / phase 2a clinical trials in CMS and ALS, respectively
  • continue the research and development of our other clinical- and preclinical-stage product candidates and discovery stage programs; and
  • seek regulatory approvals for any product candidates, including new indications, that successfully complete clinical trials.

Pre-commercial and commercial activities:

  • further build our sales, marketing and distribution infrastructure and scale-up of manufacturing capabilities for the commercialization expansion of VYVGART and VYVGART SC and any product candidate, including new indications, for which we may obtain approval; and
  • expand our global reach enabling us to commercialize any product candidates, including new indications, for which we may obtain regulatory approval.

Other activities:

  • seek to enhance our technology platform and discover and develop additional product candidates;
  • maintain, expand and protect our intellectual property portfolio, including litigation costs associated with defending against alleged patent infringement claims;
  • add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support our product development and potential future commercialization efforts; and
  • experience any delays or encounter any issues, including failed studies, ambiguous clinical trial results, safety issues or other regulatory challenges.

We expect that the costs of development and commercialization might also increase due to current and future collaborations with research and development partners as well as commercial partners.

Information pertaining to the year ended December 31, 2022 was included in our annual report on Form 20-F for the year ended December 31, 2022 under Item 5, “Operating and Financial Review and Prospects,” which was filed with the SEC on March 16, 2023.