- Completion of enrollment expected by year-end
for ADAPT-SC and ADVANCE (IV) trials of efgartigimod; topline data
for both trials expected in first half of 2022
- Introduced “argenx 2025” vision during R&D
Day to highlight commitment to patients and science and outline
path to becoming global, integrated immunology leader
- Management to host conference call today at
2:30 pm CEST (8:30 am ET) -
July
29,
2021Breda, the
Netherlands – 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 half year 2021 financial results and provided a
second quarter business update and outlook for the remainder of the
year.
“The first half of 2021 has been marked by
clinical, financial and regulatory achievements for argenx. As we
look toward 2022, we believe we are well-positioned to build on the
impressive progress we have made with our first-in-class FcRn
antagonist, efgartigimod. We are expanding our commercial
organization to reach patients living with generalized myasthenia
gravis this year and expect that these investments will benefit us
in the future and support our growing, differentiated pipeline,”
said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
“Beyond myasthenia gravis, we are expanding the
breadth of efgartigimod into our fifth and sixth indications,
myositis and bullous pemphigoid, and simultaneously investing in
potential scientific breakthroughs through our Immunology
Innovation Program (IIP). Our first-in-class C2 inhibitor,
ARGX-117, emerged from the IIP and has the potential to be our next
pipeline-in-a-product opportunity. Collectively, the demonstrated
execution this year supports our ‘argenx 2025’ vision and brings us
closer than ever to becoming a global, integrated, immunology
company,” concluded Mr. Van Hauwermeiren.
SECOND QUARTER 2021 AND
RECENT BUSINESS UPDATE
During its July
20th R&D Day, argenx
introduced its long-term
vision to
becoming a global, integrated
immunology organization. The ‘argenx 2025’ vision
includes the following goals:
- Efgartigimod being globally
available to patients across its three expanding commercial
franchises in neuromuscular diseases, hematology and
dermatology
- Efgartigimod either being
commercially available or in clinical development in 15 active
indications
- Progress across broader immunology
pipeline with ARGX-117 in multiple late-stage trials and ARGX-119
demonstrating proof-of-concept
- Investment in continued expansion
of differentiated pipeline through its Immunology Innovation
Program (IIP), generating one new asset into pipeline each
year
On track with
buildout of global commercial
organization in anticipation of potential approval of efgartigimod
for treatment of generalized myasthenia gravis
(gMG)
- Biologics License Application (BLA)
under review with U.S. Food and Drug Administration (FDA) with
target action date of December 17, 2021 under Prescription Drug
User Fee Act (PDUFA)
- Marketing Authorization Application
(J-MAA) under review with Japan’s Pharmaceuticals and Medical
Devices Agency (PMDA) with anticipated approval in first half of
2022
- MAA on track and expected to be
filed with European Medicines Agency (EMA) in second half of
2021
- Zai Lab on track with expected
regulatory discussions with National Medical Products
Administration (NMPA) for approval in China
- ADAPT Phase 3 trial results of
efgartigimod for treatment of gMG published in The Lancet
Neurology
- Hiring of salesforce expected to be
completed in U.S. in third quarter of 2021 and in Japan in fourth
quarter of 2021
- Ongoing engagement with gMG patient
community through awareness and advocacy efforts, including
award-winning docuseries “A Mystery to Me”, and continued
enrollment into real-world evidence study, MyRealWorld®MG
Efgartigimod is currently being
evaluated in five
ongoing registrational trials across four
indications, including ADAPT-SC (gMG), ADHERE (chronic inflammatory
demyelinating polyneuropathy or CIDP), ADVANCE
(IV) and ADVANCE-SC (primary immune
thrombocytopenia or ITP), and ADDRESS (pemphigus)
- Completion of enrollment expected
by end of 2021 in ADAPT-SC and ADVANCE (IV); topline data for both
trials expected in first half of 2022
- Broadened efgartigimod opportunity
with announcement of new indications, idiopathic inflammatory
myopathies (myositis) within neuromuscular franchise and bullous
pemphigoid within dermatology franchise
- Phase 2/3 trial of efgartigimod for
treatment of myositis to start by end of 2021, pending interactions
with FDA
- Phase 3 registrational trial of
efgartigimod for treatment of bullous pemphigoid to start by end of
2021
- Phase 2 proof-of-concept trials of efgartigimod in additional
indications to be evaluated as part of collaboration with Zai
Lab
Phase 1 healthy
volunteer data of C2-inhibitor,
ARGX-117, support path forward into multifocal
motor neuropathy (MMN)
- Favorable safety profile
demonstrated across single and multiple ascending doses and both IV
and SC formulations
- Pharmacokinetic/pharmacodynamic
profiles demonstrate potential for infrequent dosing schedules
- Phase 2 trial of MMN patients on
track to start by end of 2021
Immunology Innovation Program
(IIP) continues
to bring value to argenx through
internal pipeline programs,
partnerships and licensing agreements
- ARGX-119, a SIMPLE Antibody aimed
at boosting the neuromuscular junction in disease, emerging from
IIP to be next pipeline candidate within neuromuscular
franchise
- Regained worldwide rights to
anti-CD70 antibody cusatuzumab from Janssen; argenx to evaluate
potential alternatives to advance cusatuzumab through
partnership
- 15-20 discovery programs under
evaluation at any point in time that have emerged from IIP
HALF YEAR 2021
FINANCIAL RESULTS
(CONSOLIDATED)
|
|
Six Months Ended |
|
|
|
|
|
June 30, |
|
|
|
(in thousands of $ except for shares and EPS) |
|
2021 |
|
2020 |
|
Variance |
Revenue |
|
$ |
470.398 |
|
$ |
24.683 |
|
$ |
445.715 |
Other operating income |
|
|
17.079 |
|
|
9.619 |
|
|
7.460 |
Total operating
income |
|
|
487.477 |
|
|
34.302 |
|
|
453.175 |
Research and development
expenses |
|
|
-273.907 |
|
|
-189.251 |
|
|
-84.656 |
Selling, general and
administrative expenses |
|
|
-129.599 |
|
|
-67.926 |
|
|
-61.673 |
Total operating
expenses |
|
|
-403.506 |
|
|
-257.177 |
|
|
-146.329 |
Change in fair value on
non-current financial assets |
|
|
11.152 |
|
|
934 |
|
|
10.218 |
Operating
income /
(loss) |
|
$ |
95.123 |
|
$ |
-221.941 |
|
$ |
317.064 |
Financial
income/(expenses) |
|
|
-745 |
|
|
-2.403 |
|
|
1.658 |
Exchange gain/(losses) |
|
|
-18.375 |
|
|
245 |
|
|
-18.620 |
Profit
/ (Loss)
before taxes |
|
$ |
76.003 |
|
$ |
-224.099 |
|
$ |
300.102 |
Income taxes |
|
|
-12.835 |
|
|
-2.491 |
|
|
-10.345 |
Profit /
(Loss) for the
period |
|
$ |
63.167 |
|
$ |
-226.590 |
|
$ |
289.757 |
Weighted average number of
shares outstanding |
|
|
50.638.702 |
|
|
43.476.103 |
|
|
|
Basic profit / (loss) per
share (in $) |
|
|
1,25 |
|
|
-5,21 |
|
|
|
Diluted profit / (loss) per
share (in $) |
|
|
1,17 |
|
|
-5,21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase/(decrease) in
cash, cash equivalents and current financial assets compared to
year-end 2020 and 2019 |
|
|
734.545 |
|
|
663.686 |
|
|
|
Cash, cash equivalents and
current financial assets at the end of the period |
|
|
2.730.997 |
|
|
2.164.347 |
|
|
|
DETAILS OF THE FINANCIAL
RESULTS
As of January 1, 2021, the Company changed its
functional and presentation currency from euro to U.S. dollars,
which results in reporting financial highlights in U.S. dollar as
compared to euro in prior periods. Historical financials have been
converted at the average exchange rate of the related period.
Cash, cash equivalents and current financial
assets totaled $2,731.0 million as of June 30, 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 (i) the closing of a global offering, which resulted in the
receipt of $1,092.1 million in net proceeds in February 2021, (ii)
the net receipt of a $73.1 million non-creditable, non-refundable
development cost-sharing payment received from Zai Lab as part of
the strategic collaboration for efgartigimod in Greater China,
(iii) 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.
Total operating income increased by $453.2
million for the six months ended June 30, 2021 to $487.5 million,
compared to $34.3 million for the six months ended June 30, 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 recognition
of $315.1 million and the closing of the strategic collaboration
for efgartigimod with Zai Lab, resulting in the recognition of
$151.9 million in collaboration revenue.
Research and development expenses increased by
$84.7 million for the six months ended June 30, 2021 to $273.9
million, compared to $189.3 million for the six months ended June
30, 2020. The increase in the first six months of 2021 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 $129.6 million for the six months ended June 30, 2021,
compared to $67.9 million for the six months ended June 30, 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 of a possible future commercialization of
argenx’s lead product candidate efgartigimod.
The change in fair value on non-current
financial assets amounted to $11.2 million for the six months ended
June 30, 2021, which is the result of the closing of a Series B
financing round of AgomAb Therapeutics, for which argenx maintains
a profit share in exchange for granting the license for the use of
HGF-mimetic antibodies from the SIMPLE AntibodyTM platform.
Exchange losses totaled $18.4 million for the
six months ended June 30, 2021, compared to an exchange gain of
$0.2 million for the six months ended June 30, 2020. As a result of
the change in the Company’s functional and presentation currency,
the exchange losses for the six months ended June 30, 2021 are
reflecting the unfavorable change in euro/U.S. dollar exchange
rate, mainly attributable to unrealized exchange rate losses on
cash, cash equivalents and current financial asset position in
euro.
FINANCIAL GUIDANCE
Based on current plans to fund anticipated
operating expenses and capital expenditures, argenx continues to
expect its 2021 cash burn to approximately double from 2020. The
increased spend will support the Company’s transition to an
integrated immunology company, including the build-out of global
commercial infrastructure and drug product inventory ahead of the
expected launch of efgartigimod in gMG in the U.S, the advancement
of its clinical-stage pipeline, including expected global trials of
efgartigimod in six indications, and the continued investment in
its Immunology Innovation Program.
EXPECTED 2021
FINANCIAL CALENDAR
- October 28, 2021: Q3 2021 financial
results and business update
CONFERENCE CALL DETAILSThe half
year 2021 financial results and second quarter 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
0800
389 13 France
0805
102 319 Netherlands
0800
949 4506 United Kingdom
0800 279 9489
United States 1 844 808 7140International 1 412 902 0128
About argenxargenx 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. argenx is also advancing several earlier stage
experimental medicines within its therapeutic franchises. argenx
has offices in Belgium, the United States, Japan, and Switzerland.
For more information, visit www.argenx.com and follow us on
LinkedIn at https://www.linkedin.com/company/argenx/ and Twitter at
https://twitter.com/argenxglobal.
For further information, please contact:
Media:Kelsey KirkKKirk@argenx.com
Joke Comijn (EU)jcomijn@argenx.com
Investors:Beth
DelGiaccobdelgiacco@argenx.com
Michelle Greenblattmgreenblatt@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 concerning the argenx 2025 vision; its statement that the
submissions in China and the EU are on track and that it is
well-positioned for a global launch of its first-in-class FcRn
antagonist, including that BLA for IV efgartigimod for treatment of
gMG accepted for review by the U.S. Food and Drug Administration
(FDA) in March 2021 with target action date of December 17, 2021
under Prescription Drug User Fee Act (PDUFA); J-MAA submitted to
Japan’s PMDA and accepted for review with anticipated Japan
commercial launch in 2022; MAA expected to be filed with European
Medicines Agency (EMA) in second half of 2021 and Zai Lab Limited
to discuss potential accelerated regulatory pathway for approval in
China with National Medical Products Administration (NMPA);
statements regarding its commercial readiness; its statement that
enrollment in trials for ADAPT-SC and ADVANCE(IV) to complete by
end of 2021 and topline data expected in first half of 2022; its
statementthat a Phase 2/3 trial of efgartigimod for treatment of
myositis to start by end of 2021, pending interactions with FDA,
Phase 3 registrational trial of efgartigimod for treatment of
bullous pemphigoid to start by end of 2021, and Phase 2
proof-of-concept trials to be evaluated with Zai Lab Limited; its
plan to evaluate alternatives; its expectation of a U.S. launch of
efgartigimod; that Phase 2 trial of MMN on track to start by end of
2021; its expectation that its 2021 cash burn will approximately
double from 2020; its hope to reach patients this year; its
statements regarding the therapeutic potential of Efgartigimod in
patients with gMG; its plans to start enrollment in two additional
efgartigimod indications this year ;;, the 2021 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 the forward-looking
statements as a result of various important factors, including the
effects of the COVID-19 pandemic, 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.
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