argenx reports half year 2020 financial results and provides second quarter business update
July 30, 2020 at 01:00 AM EDT
July 30, 2020
“We are proud of the progress we have made during the first half of 2020 to advance our immunology pipeline and validate our first-in-class FcRn antagonist, efgartigimod. We announced positive topline results from the Phase 3 ADAPT trial, furthering our conviction that efgartigimod has the potential to significantly improve the standard of care for people with gMG as well as several other autoantibody-driven diseases. We are focused on our planned 2021 U.S. commercial launch of efgartigimod to bring this therapy to patients as quickly as possible and to advance on our ‘argenx 2021’ vision,” said Tim Van Hauwermeiren, CEO of argenx.
"We also remain committed to advancing our robust pipeline, including our late-stage efgartigimod trials in additional autoimmune indications and our early-stage candidates from our Immunology Innovation Program. Regarding cusatuzumab, which we are currently developing in a global collaboration with Janssen, as clinical trial sites re-open, we are taking the opportunity to evaluate the most appropriate development strategy given the rapidly evolving treatment landscape, ” continued Mr. Van Hauwermeiren.
argenx continues to execute on its “argenx 2021” vision to become a fully integrated, global immunology company. The company continues to implement measures across the organization and in the operations of globally run clinical trials to minimize the impact of COVID-19 on employees, patients and their communities, physicians and ongoing business priorities.
Total operating income decreased by €20.2 million for the six months ended June 30, 2020 to €31.1 million, compared to €51.3 million for the six months ended June 30, 2019. This decrease is primarily related to the milestone payments following the first-in-human clinical trial with ABBV-151 under the AbbVie collaboration which was achieved in the first six months of 2019, partly offset by the revenue recognition of the transaction price related to the Janssen collaboration and the increase in other income mainly driven by higher payroll tax rebates for employing certain research and development personnel.
Research and development expenses in the first six months of 2020 amounted to €171.7 million, compared to €78.3 million for the first six months of 2019. The increase resulted primarily from higher external research and development expenses primarily related to the efgartigimod program in various indications, the cusatuzumab program and other clinical and preclinical programs. Furthermore, the personnel expenses increased due to the planned increase in headcount.
Selling, general and administrative expenses totaled €61.6 million in the first six months of 2020, compared to €27.5 million for the first six months of 2019. This increase primarily resulted from higher personnel expenses and consulting fees related to the preparation of a possible future commercialization of argenx’s lead product candidate, efgartigimod.
For the six months ended June 30, 2020, financial expenses, which primarily relate to interest received and changes in fair value of current financial assets, amounted to €2.2 million compared to a financial income of €7.2 million for the six months ended June 30, 2019. Financial expenses corresponded mainly to a decrease in net asset value on its current financial assets following the impact of the COVID-19 outbreak on the financial markets.
Exchange gains totaled €0.2 million for the six months ended June 30, 2020, compared to €2.5 million for the six months ended June 30, 2019 and were mainly attributable to unrealized exchange rate gains on cash, cash equivalents and current financial assets.
A net loss of €205.6 million and an operating loss of €201.4 million were realized for the six months ended June 30, 2020, compared to a net loss of €45.1 and operating loss of €54.5 million for the six months ended June 30, 2019.
EXPECTED 2020 FINANCIAL CALENDAR:
·October 22, 2020: Q3 financial results & business update
Confirmation Code: 7470386
For further information, please contact:
Beth DelGiacco, Vice President, Investor Relations (US)
Joke Comijn, Director Corporate Communications & Investor Relations (EU)
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,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements argenx makes concerning its 2020 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and argenx’s, and its collaboration partners’, advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing of regulatory filings and regulatory approvals. 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 argenx’s expectations regarding its 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.