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 announced its third quarter 2022 financial results and provided a business update and outlook for the remainder of the year.
“We had a strong third quarter of our global VYVGART launch now underway in our priority territories of the U.S., Japan and the EU. I am proud of what our teams have achieved, working cross-functionally to set a new treatment standard in gMG and serve as many patients as possible. Looking ahead, we are ready to support a SC efgartigimod launch in the first half of 2023 so that gMG patients can have multiple ways to individualize their treatment,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “gMG is also just the beginning and we are committed to advancing our immunology pipeline of efgartigimod, ARGX-117 and ARGX-119 with eight ongoing clinical trials in severe autoimmune diseases and more to start by the end of the year. We believe we are well on our way to realizing our goal of becoming a leading, multi-product immunology company and that we have the right team, a differentiated pipeline, and a sustainable discovery engine to continue innovating on behalf of patients.”
THIRD QUARTER 2022 AND RECENT BUSINESS UPDATE
VYVGART Launch
VYVGART is the first-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan and the European Union (EU). VYVGART is approved in the United States (U.S.) and the EU for the treatment of adult gMG patients who are anti-acetylcholine receptor (AChR) antibody positive and in Japan for adult gMG patients who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs).
Efgartigimod Research and Development
argenx is positioned to expand its leadership position in FcRn blockade to include ten total autoimmune indications in the pipeline by the end of 2022
Pipeline Progress
argenx is developing ARGX-117 and ARGX-119, which both have pipeline-in-a-product potential for multiple autoimmune indications. Additional candidates that emerged from the Immunology Innovation Program are in development by partners or spin-off companies.
Hans de Haard, Ph.D. to retire as CSO on January 1, 2023 and transition to consultant within Immunology Innovation Program and strategic advisor to Research and Development Committee of argenx Board of Directors
Nomination of Ana Cespedes as non-executive director to Board of Directors
Ana Cespedes’s appointment is pending approval, which is expected to occur at an extraordinary general meeting of shareholders to be held in December 2022. She is Chief Operating Officer of IAVI, a global organization dedicated to developing accessible vaccines and antibodies for infectious diseases. She brings robust experience across a broad range of critical areas for commercialization and access, as well as for organizational effectiveness.
THIRD QUARTER 2022 FINANCIAL RESULTS
ARGENX SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENT OF PROFIT OR LOSS
DETAILS OF THE FINANCIAL RESULTS
Total operating income for the third quarter and year-to-date in 2022 was $146.5 million and $263.2 million, respectively, compared to $7.1 million and $505.7 million for the same periods in 2021, and consists of:
Total operating expenses for the third quarter and year-to-date in 2022 were $355.1 million and $869.1 million, respectively, compared to $220.1 million and $623.6 million for the same periods in 2021, and consists of:
Exchange losses for the third quarter and year-to-date in 2022 were $39.6 million and $93.0 million, respectively, compared to $17.6 million and $36.0 million for the same periods in 2021. Exchange losses are mainly attributable to unrealized exchange rate losses on cash, cash equivalents and current financial assets position in Euro.
Income tax for the third quarter and year-to-date in 2022 was $6.0 million and $17.1 of tax income, respectively, compared to $2.7 million and $15.6 million of tax expense for the same periods in 2021. Tax income for the three months ended September 30, 2022 consists of $7.3 million of income tax expense and $13.3 million of deferred tax income, compared to $4.3 million of income tax expense and $1.6 million of deferred tax income for the same period in 2021.
Net loss for the third quarter and year-to-date in 2022 was $235.0 million and $671.0 million, respectively, compared to net loss of $233.6 million and $170.4 million for the same periods in 2021.
Cash, cash equivalents and current financial assets totaled $2,385.5 million as of September 30, 2022, compared to $2,336.7 million as of December 31, 2021. Cash and cash equivalents and current financial assets increased primarily as a result of the closing of a global offering of shares, which resulted in the receipt of $761.0 million in net proceeds in March 2022, offset by net cash flows used in operating activities.
FINANCIAL GUIDANCE
Based on current plans to fund anticipated operating expenses and capital expenditures, argenx continues to expect its 2022 cash burn to be up to $1 billion. This will support the global VYVGART launches, clinical development of efgartigimod in 10 indications and ARGX-117 in two indications, investment in the global supply chain, and continued focus on pipeline expansion through the Immunology Innovation Program.
EXPECTED 2023 FINANCIAL CALENDAR
CONFERENCE CALL DETAILS
The third quarter 2022 financial results and business update will be discussed during a conference call and webcast presentation today at 2:30 pm CEST/8:30 am ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website.
Dial-in numbers:
Please dial in 15 minutes prior to the live call.
Belgium | 32 800 50 201 |
United Kingdom | 44 800 358 0970 |
United States | 1 888 415 4250 |
All other locations | 1 646 960 0294 |
About argenx
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-and- only approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan and the EU. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Twitter, and Instagram.
For further information, please contact:
Media:
Kelsey Kirk kkirk@argenx.com
Investors:
Beth DelGiacco bdelgiacco@argenx.com
Forward-looking Statements
The contents of this announcement include statements that are, or may be deemed to be, “forward- looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “hope,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements argenx makes regarding the VYVGART launch strategy to make VYVGART available in the EU, China, Canada and select other regions, the approval and commercial launch following the submission of the Biologics License Application to the U.S. Food and Drug Administration for Subcutaneous (SC) Efgartigimod for Treatment of Generalized Myasthenia Gravis and the long-term safety and tolerability of SC Efgartigimod; Zai Lab and Medison’s respective pending approvals in China and Israel; its position to expand its leadership position in FcRn blockade to include ten autoimmune indications by the end of 2022; the therapeutic potential of its product candidates; the intended results of its strategy and its collaboration partners’, advancement of, and anticipated clinical development and regulatory milestones and plans, including the timing of planned clinical trials; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals; its expectation that its 2022 cash burn will be up to $1 billion and the 2022 business and financial outlook and related plans. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the effects of the COVID-19 pandemic, inflation and deflation and the corresponding fluctuations in interest rates; regional instability and conflicts, such as the conflict between Russia and Ukraine, argenx’s expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.
