Recent Updates
Recently added Catalysts
ARGX

argenx Reports Third Quarter 2020 Financial Results and Provides Business Update - Biologics License Application (BLA) for efgartigimod in generalized myasthenia gravis (gMG) on track to be submitted to U.S. Food and Dru

Key Takeaway: argenx Reports Third Quarter 2020 Financial Results and Provides Business Update - Biologics License Application (BLA) for efgartigimod in generalized myasthenia gravis (gMG) on track to be submitted to U.S. Food and Drug Administration (FDA) - Global Phase 3 ADDRESS trial ev

Full Press Release Details

argenx Reports Third Quarter 2020 Financial
Results and Provides Business Update
- Biologics License Application (BLA) for
efgartigimod in generalized myasthenia gravis (gMG) on track to be submitted to U.S. Food and Drug Administration (FDA)
- Global Phase 3 ADDRESS trial evaluating
subcutaneous (SC) efgartigimod in pemphigus patients on track to initiate by end of 2020 -
- Decision to continue ADHERE trial beyond
first 30 patients in chronic inflammatory demyelinating polyneuropathy (CIDP) now expected in first half of 2021 -
- Management to host conference call today
at 2:30 pm CEST (8:30 am ET) -
Breda, the Netherlands / Ghent, Belgium
- argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people
suffering from severe autoimmune diseases and cancer, today announced its financial results for the third quarter ended September 30,
2020 and provided a business update.
"It has been an important year for
argenx, marked by a number of significant achievements that position us to file our first BLA for efgartigimod as a new treatment
for gMG by year-end. We remain focused on both the BLA filing and commercial preparations as we work to bring efgartigimod to patients
as soon as possible," said Tim Van Hauwermeiren, CEO of argenx. "We have built an exceptional team, established our
global supply chain and connected with physicians, payors and patient advocacy groups - all critical elements for a successful
"We are building a broad FcRn antagonist
program by leveraging the potential of efgartigimod across a number of important indications where there is a high unmet need for
innovation. Our global Phase 3 ADDRESS trial in pemphigus is on track to start soon and, as we did with the ADAPT trial in MG,
we have carefully designed the trial alongside patients and physicians to best address the complex challenges presented by this
serious disease. We continue to ground our pipeline expansion strategy in biology, working from the science to address severe autoimmune
diseases and advance our argenx 2021' vision across our emerging franchises," continued Mr. Van Hauwermeiren.
THIRD QUARTER 2020 AND RECENT BUSINESS
Preparations underway to support potential
approval and launch of FcRn antagonist, efgartigimod, in gMG in U.S., Japan and EU
Presented supportive data from global
Phase 3 ADAPT trial of efgartigimod in gMG at recent medical meetings, showing rapid and clinically meaningful responses to efgartigimod
and a safety profile comparable to placebo
Broad efgartigimod development plan
progressing with Phase 2 trial of fifth indication expected to start in mid-2021
Development of cusatuzumab ongoing as
potential treatment for acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes (MDS) as part of global collaboration
and licensing agreement with Cilag GmbH International, an affiliate of Janssen
Initiated Phase 1 healthy volunteer
study of IV and SC ARGX-117 targeting complement C2
Continued investment in Immunology Innovation
Program to build pipeline of first-in-class antibodies against immunologic targets
Q3 2020 FINANCIAL RESULTS
Nine Months Ended
September 30,
(in thousands of except for shares and EPS) 2020 2019 Variance
Revenue 30,062 52,264 (22,202 )
Other operating income 12,524 8,914 3,610
Total operating income 42,586 61,178 (18,592 )
Research and development expenses (246,284 ) (122,800 ) (123,484 )
Selling, general and administrative expenses (100,380 ) (41,734 ) (58,646 )
Total operating expenses (346,664 ) (164,534 ) (182,130 )
Change in fair value on non-current financial assets 1,076 - 1,076
Operating loss (303,002 ) (103,356 ) (199,646 )
Financial income/(expenses) (1,683 ) 10,789 (12,472 )
Exchange gain/(losses) (55,896 ) 26,943 (82,838 )
Loss before taxes (360,581 ) (65,624 ) (294,956 )
Income taxes (2,715 ) (4,433 ) 1,718
Loss for the period and total comprehensive loss (363,296 ) (70,057 ) (293,238 )
Weighted average number of shares outstanding 44,717,568 37,882,282
Basic and diluted profit/(loss) per share (in ) (8.12 ) (1.85 )
Net increase in cash, cash equivalents and current financial assets compared to year-end 2019 468,223 358,679
Cash, cash equivalents and current financial assets at the end of the period 1,804,043 923,248
DETAILS OF THE FINANCIAL RESULTS
Cash, cash equivalents and current financial
assets totaled 1,804.0 million on September 30, 2020, compared to 1,335.8 million on December 31, 2019. The
increase in cash and cash equivalents and current financial assets resulted primarily from the closing of a global offering, including
a U.S. offering and a European private placement, which resulted in the receipt of 730.7 million in net proceeds in June 2020,
and net cash flows used in operating activities.
Total operating income decreased by 18.6
million for the nine months ended September 30, 2020 to 42.6 million, compared to 61.2 million for the nine months
ended September 30, 2019. The decrease was due to the milestone payments following the first-in-human clinical trial with
ABBV-115 under the AbbVie collaboration which was achieved in the nine months ended September 30, 2019. This was partly offset
by higher revenue recognition of the transaction price related to the Janssen collaboration and the increase in other income driven
by higher payroll tax rebates for employing certain research and development personnel.
Research and development expenses increased
by 123.5 million for the nine months ended September 30, 2020 to 246.3 million, compared to 122.8 million
for the nine months ended September 30, 2019. The increase in the first nine months of 2020 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 a planned increase in
Selling, general and administrative expenses
totaled 100.4 million for the nine months ended September 30, 2020, compared to 41.7 million for the nine months
ended September 30, 2019. The increase resulted primarily 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 nine months ended September 30,
2020, financial expenses, which primarily relate to interest received and changes in fair value of current financial assets, amounted
to 1.7 million, compared to a financial income of 10.8 million for the nine months ended September 30, 2019. Financial
expenses corresponded mainly to a decrease in net asset value of current financial assets following the impact of the COVID-19
outbreak on the financial markets.
Exchange losses totaled 55.9 million
for the nine months ended September 30, 2020, compared to an exchange gain of 26.9 million for the nine months ended
September 30, 2019. The change is mainly attributable to unrealized exchange rate losses on the cash, cash equivalents and
current financial asset position in U.S. dollars.
EXPECTED 2021 FINANCIAL CALENDAR:
CONFERENCE CALL DETAILS
The third quarter 2020 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.
Please dial in 15 minutes prior to the
argenx is a global immunology company
committed to improving the lives of people suffering from severe autoimmune diseases and cancer. 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 is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab
in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines
within its therapeutic franchises. argenx has offices in Belgium, the United States, and Japan. For more information, visit www.argenx.com
For further information, please contact:
Beth DelGiacco, Vice President, Corporate Communications &
Joke Comijn, Director Corporate Communications & Investor
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," "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 and outcome 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
Last updated: Oct 22, 2020