Annual Report 2022

Annual Report 2022

Overview

Since our inception in 2008, we have focused most of our financial resources and efforts towards developing our SIMPLE AntibodyTM 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, which is now approved in the U.S., Japan and Europe, the successful commercialization of which generated a global product net sales of $400.7 million. 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, hematological disorders and cancer. 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. Through December 31, 2022, we have raised aggregate gross proceeds of $4,318.5 million, including total net cash proceeds of $761.0 million from our U.S. public offering on Nasdaq in March 2022.

As of December 31, 2022 and December 31, 2021, we had cash, cash equivalents and current financial assets of $2,192.5 million and $2,336.7 million, respectively.

Our balance sheet shows our total assets accumulate to $3,134.3 million for the year ended December 31, 2022, compared to $2,850.3 million for the year ended December 31, 2021 and $2,279.4 million for the year ended December 31, 2020. The main reason for the material change in balance sheet total are the various equity financing rounds, completed over the period covered by the financial statements.

Since our inception, we have incurred significant operating losses. For the years ended December 31, 2022 and 2021, we incurred total comprehensive losses of $730.3 million and $450.6 million, respectively. As of December 31, 2022, we had accumulated losses of $2,109.8 million.

Although we have generated revenue of $400.7 million from global product net sales of VYVGART in fiscal year 2022, we can provide no assurances that we will be able to achieve or remain profitable based on sales in that indication alone or that we will be able to receive regulatory approval of and commercialize VYVGART in other indications or in other countries. On December 17, 2021, the FDA approved efgartigimod, which is marketed as VYVGART™ (efgartigimod alfa-fcab), for the treatment of gMG in adult patients who are AChR-AB+. On January 20, 2022, the PMDA approved VYVGART™ (efgartigimod alfa) for the treatment of adult patients with gMG who do not have sufficient response to steroids or non-steroidal ISTs. On August 11, 2022, the EU Commission granted marketing authorization for VYVGART™ (efgartigimod alfa-fcab) as an add-on to standard therapy for the treatment of adult patients with gMG who are AChR-AB+. 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™ for the treatment of gMG, 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 substantially if and as we:

Research and Development Activities:

  • execute the Phase 2/3 clinical trials of efgartigimod in ITP, CIDP, PF and in PV;
  • execute the Phase 2/3 clinical trials of efgartigimod in BP and Myositis and launch Phase 2/3 clinical trials in other indications;
  • 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-out our sales, marketing and distribution infrastructure and scale-up manufacturing capabilities for the continued commercialization of VYVGART™ for which we obtained regulatory approval from the FDA, PMDA and EU Commission 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 significantly 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, 2021 was included in our annual report on Form 20-F for the year ended December 31, 2021 under “Operating and Financial Review and Prospects”, which was filed with the SEC on March 21, 2022.