Full Press Release Details
argenx Reports Full Year 2021 Financial Results
and Provides Fourth Quarter Business Update
(efgartigimod alfa-fcab) approved in the U.S. and Japan as the first-and-only neonatal Fc receptor (FcRn) blocker; U.S. commercial
results from Phase 3 bridging study of subcutaneous (SC) efgartigimod in generalized myasthenia gravis (gMG) on track for first quarter
Moorthy appointed as General Counsel
to host conference call today at 2:30 pm CET (8:30 am ET)
Breda, the Netherlands - argenx (Euronext &
Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today
reported financial results for the full year 2021 and provided a fourth quarter business update.
"2021 was a transformational year for argenx,
culminating with the FDA approval of VYVGART, our first-in-class FcRn blocker, in December. We carried this momentum into 2022 with the
official U.S. launch of VYVGART and the Japan approval. We were well-prepared to launch VYVGART at the time of approval and are encouraged
by the early response of the medical community, the engagement from patients, and the coverage decisions that have been made by payers.
We continue to expect steady launch progress in 2022 as we aim to deliver this new therapy to patients living with generalized myasthenia
gravis," said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
"In addition to executing the global commercial
launch of VYVGART, we are primed to deliver several upcoming catalysts through our development pipeline in high-value autoimmune indications.
We expect multiple registrational trial readouts for efgartigimod in the next four quarters, the first of which is the SC bridging study
in gMG this month. We are expanding the scope of development for efgartigimod to 10 indications and ARGX-117 to two indications by the
end of this year, and will also advance ARGX-119 into first-in-human studies. We remain focused on all components of our integrated business
so that we can continue to redefine immunology on behalf of patients and deliver shareholder value," continued Mr. Van Hauwermeiren.
FOURTH QUARTER 2021 AND RECENT BUSINESS UPDATE
U.S. commercial launch ongoing for VYVGART,
the first FDA-approved FcRn blocker for adult gMG patients who are anti-acetylcholine receptor (AChR) antibody positive
On track with global launch strategy to make
VYVGART available in Japan, Europe, China and Canada, as well as additional regions through license and distribution agreements
Topline data expected from five ongoing efgartigimod
registrational trials by end of first quarter of 2023
polyneuropathy expected in first quarter
argenx's leadership position in FcRn
blockade to be solidified through expansion of efgartigimod development portfolio into ten total autoimmune conditions by end of 2022
ARGX-117, a novel C2 inhibitor, has potential
to be second pipeline-in-a-product for multiple autoimmune indications
Continued investment in Immunology Innovation
Program (IIP) to broaden autoimmune pipeline for sustained value creation opportunities
Strengthened leadership team with appointment
of Malini Moorthy as General Counsel
Yvonne Greenstreet to step down from argenx
Board of Directors in order to focus on her transition to Chief Executive Officer at Alnylam
FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL
| Year Ended | ||||||||||||
| December 31, | ||||||||||||
| (in thousands of $ except for shares and EPS) | 2021 | 2020 | Variance | |||||||||
| Revenue | $ | 497,277 | $ | 41,243 | $ | 456,034 | ||||||
| Other operating income | 42,141 | 23,668 | 18,473 | |||||||||
| Total operating income | 539,418 | 64,911 | 474,507 | |||||||||
| Research and development expenses | (580,520 | ) | (370,885 | ) | (209,635 | ) | ||||||
| Selling, general and administrative expenses | (307,644 | ) | (171,643 | ) | (136,001 | ) | ||||||
| Total operating expenses | (888,164 | ) | (542,528 | ) | (345,636 | ) | ||||||
| Operating loss | $ | (348,746 | ) | $ | (477,617 | ) | $ | 128,871 | ||||
| Financial income/(expenses) | (944 | ) | (1,501 | ) | 557 | |||||||
| Exchange gains/(losses) | (50,053 | ) | (126,234 | ) | 76,181 | |||||||
| Loss before taxes | $ | (399,743 | ) | $ | (605,352 | ) | $ | 205,609 | ||||
| Income tax expense | $ | (8,522 | ) | $ | (3,103 | ) | $ | (5,419 | ) | |||
| Loss for the year | $ | (408,265 | ) | $ | (608,455 | ) | $ | 200,190 | ||||
| Loss for the year attributable to: | ||||||||||||
| Owners of the parent | $ | (408,265 | ) | $ | (608,455 | ) | $ | 200,190 | ||||
| Weighted average number of shares outstanding | 51,075,827 | 45,410,442 | 5,665,385 | |||||||||
| Basic and diluted loss per share (in $) | (7.99 | ) | (13.40 | ) | ||||||||
| Net increase in cash and cash equivalents and current financial assets compared to year-end 2020 and 2019 | $ | 340,276 | $ | 495,791 | ||||||||
| Cash and cash equivalents and current financial assets at the end of the period | $ | 2,336,728 | $ | 1,996,452 |
DETAILS OF THE FINANCIAL RESULTS
Cash, cash equivalents and current financial assets
totaled $2,336.7 million as of December 31, 2021, compared to $1,996.5 million on December 31, 2020. The increase in cash and
cash equivalents and current financial assets resulted primarily from the closing of a global offering of shares, which resulted in the
receipt of $1,092.1 million in net proceeds in February 2021 and the net receipt of a $73.1 million non-creditable, non-refundable
development cost-sharing payment from Zai Lab as part of the strategic collaboration for efgartigimod in Greater China in part offset
by the payment of $98.0 million related to the purchase of the priority review voucher from Bayer HealthCare Pharmaceuticals, and other
net cash flows used in operating activities.
Revenue increased by $456.0 million for the twelve
months ended December 31, 2021 to $497.3 million, compared to $41.2 million for the twelve months ended December 31, 2020. The
increase was primarily due to the recognition of the transaction price as a consequence of the termination of the collaboration agreement
with Janssen resulting in the one-time recognition of $315.1 million, and the recognition of $177.5 million in collaboration revenue related
to the strategic collaboration with Zai Lab, including the cost-sharing payment and the development milestone, triggered by the FDA approval
Other operating income increased by $18.5 million
to $42.1 million for the year ended December 31, 2021, compared to $23.7 million for the year ended December 31, 2020. The increase
was primarily driven by (i) the increase in research and development incentives, as a result of the increased research and development
costs incurred, (ii) the increase in payroll tax rebates, as a direct result of the increase in the employment of highly qualified
research and development personnel eligible for specific payroll tax rebates, and (iii) the increase in fair value of argenx's
profit share in AgomAb Therapeutics NV.
Research and development expenses increased by
$209.6 million for the twelve months ended December 31, 2021 to $580.5 million, compared to $370.9 million for the twelve months
ended December 31, 2020. The increase resulted primarily from higher external research and development expenses, mainly related to
the efgartigimod program in various indications and other clinical and preclinical programs. Furthermore, the research and development
personnel expenses increased due to a planned increase in headcount and the increased costs of the share-based payment compensation plans
related to the grant of stock options.
Selling, general and administrative expenses totaled
$307.6 million for the twelve months ended December 31, 2021, compared to $171.6 million for the twelve months ended December 31,
2020. The increase resulted primarily from higher personnel expenses, including the costs of the share-based payment compensation plans
related to the grant of stock options, and consulting fees linked to the preparation for a commercialization of VYVGART.
Exchange losses totaled $50.1 million for the
twelve months ended December 31, 2021, compared to $126.2 million for the twelve months ended December 31, 2020 and are mainly
attributable to unrealized exchange rate losses on the cash, cash equivalents and current financial assets position in Euro.
Based on current plans to fund anticipated operating
expenses and capital expenditures, argenx expects to utilize up to half of its available cash, cash equivalents and current financial
assets in 2022. The increased spend 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
US SEC AND STATUTORY FINANCIAL REPORTING
argenx's primary accounting standard for
quarterly earnings releases and annual reports is International Financial Reporting Standards (IFRS) as issued by the International Accounting
Standards Board (IASB). Quarterly summarized statements of profit or loss based on IFRS as issued by the IASB are available on www.argenx.com.
In addition to reporting financial figures in
accordance with IFRS as issued by the IASB, argenx also reports financial figures in accordance with IFRS as adopted by the EU for statutory
purposes. The consolidated statements of financial position, the consolidated statements of profit or loss, the consolidated statements
of comprehensive income / loss, the consolidated statements of cash flows, and the consolidated statements of changes in equity are not
affected by any differences between IFRS as issued by the IASB and IFRS as adopted by the EU.
The consolidated statements of profit or loss
of argenx SE for the year ended December 31, 2021, as presented in this press release are unaudited.
EXPECTED 2022 FINANCIAL CALENDAR:
CONFERENCE CALL DETAILS
The full year 2021 results and fourth quarter
business update will be discussed during a conference call and webcast presentation today at 2:30 pm CET/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.
Please dial in 15 minutes prior to the live
| Belgium | 32 800 50 201 |
| France | 33 800 943355 |
| Netherlands | 31 20 795 1090 |
| United Kingdom | 44 800 358 0970 |
| United States | 1 888 415 4250 |
| Japan | 81 3 4578 9752 |
| Switzerland | 41 43 210 11 32 |
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. and Japan.