Japanese Marketing Authorization Application
(J-MAA) for efgartigimod accepted for review by Japan’s
Pharmaceuticals and Medical Device Agency (PMDA) for generalized
myasthenia gravis (gMG)
Management to host conference call today at 2:30
pm CEST (8:30 am ET)
May
14,
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
reported financial results for the first quarter 2021 and provided
a business update.
“We’ve had a strong start to 2021 with the
acceptance for review of the BLA and J-MAA for efgartigimod in gMG
by the regulatory agencies in the U.S. and Japan. The submissions
in China and the EU are on track and we are well-positioned for a
global launch of our first-in-class FcRn antagonist. We are
building an exceptional team with significant launch experience in
neurology and rare disease and hope to reach patients this year,”
said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
“Efgartigimod has the potential to help people
living with gMG as well as several other severe autoimmune diseases
mediated by IgG autoantibodies. Our team is advancing
registrational trials across four indications with plans to start
enrollment in two additional efgartigimod indications this year. We
are also broadening our reach within autoimmunity with our
first-in-class C2 inhibitor, ARGX-117, from which we will have
Phase 1 data mid-year. To complement our clinical pipeline, we
continue to invest in our discovery capabilities through our
Immunology Innovation Program and strategic technology partnerships
that position us well to generate long-term value for shareholders.
We are closer each day to building an integrated, innovative,
global immunology organization with the goal of impacting the lives
of patients,” concluded Mr. Van Hauwermeiren.
FIRST QUARTER 2021 AND RECENT BUSINESS
UPDATE
Commercial
preparations
on-track
for global launch of IV
efgartigimod for
gMG, including regulatory submissions, initial
salesforce hires and key
stakeholder engagement efforts
- Biologics License Application (BLA)
for IV efgartigimod for treatment of gMG accepted for review by
U.S. Food and Drug Administration (FDA) 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
- Zai Lab Limited to discuss
potential accelerated regulatory pathway for approval in China with
National Medical Products Administration (NMPA)
- Commercial readiness activities
on-track, including:
- Continued build-out of global
commercial organization, including hiring of U.S. regional business
directors during first quarter
- Launched pre-approval access (PAA)
program in March 2021 in U.S., Canada and Europe to open
availability of efgartigimod to people living with gMG who meet the
pre-approval access program criteria
Immunology pipeline advancing
with five ongoing registrational
trials of efgartigimod
and initial upcoming data from
second potential
pipeline-in a product
candidate,
ARGX-117
- Enrollment ongoing in five
registrational trials across four indications, including ADAPT-SC
(gMG), ADHERE (chronic inflammatory demyelinating polyneuropathy or
CIDP), ADVANCE and ADVANCE-SC (primary immune thrombocytopenia or
ITP), and ADDRESS (pemphigus)
- Go-forward decision confirmed in
February 2021 in ADHERE trial evaluating subcutaneous (SC)
efgartigimod in CIDP based on evaluation of interim safety and
efficacy assessments that surpassed pre-defined threshold
- Enrollment in trials for fifth and
sixth indications to begin in 2021
- Additional efgartigimod indications
to be evaluated as part of collaboration with Zai Lab Limited
- Data expected mid-year from Phase 1
trial of C2 inhibitor, ARGX-117; Phase 2 dosing plan to be
identified for indications, including multifocal motor neuropathy
(MMN)
- Phase 2 trial of MMN on track to
start by end of 2021
- Combination trials of cusatuzumab
remain ongoing for treatment of acute myeloid leukemia (AML) as
part of global collaboration and licensing agreement with Cilag
GmbH International, an affiliate of Janssen
- Decision to initiate additional
cusatuzumab studies under collaboration will be determined
following review of all available data
Immunology Innovation Program
(IIP) continues to
grow pipeline through
wholly-owned development, partnered
opportunities, asset-centric
spinoff companies and the
addition of strategic technology capabilities
- Preclinical work ongoing in
early-stage pipeline, including ARGX-118, ARGX-119 and
ARGX-120
- 15-20 discovery programs under
evaluation at any point in time that have emerged from IIP
- Initiated collaboration and license
agreement with Elektrofi to explore new subcutaneous formulations
for current and future pipeline candidates, including efgartigimod
- Secured exclusivity for FcRn and
one additional target
- Ongoing development of ARGX-112
(LEO Pharma), ARGX-114 (AgomAb), ARGX-115 (ABBV-151, AbbVie) and
ARGX-116 (Staten Biotech) by IIP collaboration partners
Strong balance sheet
and expanded
Board of
Directors
support transition into integrated, global
immunology organization
- Completed public offering of
3,593,750 ordinary shares in February 2021 with gross proceeds of
$1.15 billion
- Implemented transition agreement
for Chief Financial Officer Eric Castaldi as part of evolution to
commercial-stage company; recruitment efforts ongoing for
U.S.-based successor
- Proposed resolutions presented
during Annual General Meeting of Shareholders were approved,
including:
- Appointment to Board of Directors
of Yvonne Greenstreet, President and Chief Operating Officer of
Alnylam
- Re-appointment of Anthony Rosenberg
to Board of Directors
- Approval of new remuneration
policy
argenx to host virtual R&D Day on
July 20, 2021 to share long-term corporate
vision, disclose additional
potential efgartigimod
indications and provide updates
across immunology
pipeline.
FIRST QUARTER 2021 FINANCIAL
RESULTS (CONSOLIDATED)
|
|
Three Months Ended |
|
|
|
|
|
March 31, |
|
|
|
(in thousands of $ except for shares and EPS) |
|
2021 |
|
2020 |
|
Variance |
Revenue |
|
$ |
158,155 |
|
$ |
21,139 |
|
$ |
137,017 |
Other operating income |
|
|
9,260 |
|
|
4,672 |
|
|
4,588 |
Total operating
income |
|
|
167,415 |
|
|
25,811 |
|
|
141,604 |
Research and development
expenses |
|
|
(122,328) |
|
|
(104,661) |
|
|
(17,666) |
Selling, general and
administrative expenses |
|
|
(56,253) |
|
|
(27,609) |
|
|
(28,644) |
Total operating
expenses |
|
|
(178,580) |
|
|
(132,270) |
|
|
(46,310) |
Change in fair value on
non-current financial assets |
|
|
11,152 |
|
|
0 |
|
|
11,152 |
Operating
loss |
|
$ |
(13) |
|
$ |
(106,459) |
|
$ |
106,446 |
Financial
income/(expenses) |
|
|
(420) |
|
|
(3,591) |
|
|
3,171 |
Exchange gain/(losses) |
|
|
(28,817) |
|
|
22,985 |
|
|
(51,802) |
Loss before
taxes |
|
$ |
(29,249) |
|
$ |
(87,064) |
|
$ |
57,815 |
Income taxes |
|
|
(11,184) |
|
|
(1,200) |
|
|
(9,984) |
Loss for the period
and total comprehensive loss |
|
$ |
(40,433) |
|
$ |
(88,264) |
|
$ |
47,831 |
Weighted average number of
shares outstanding |
|
|
49,946,515 |
|
|
42,786,194 |
|
|
|
Basic and diluted
profit/(loss) per share (in $) |
|
|
(0.81) |
|
|
(2.06) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase/(decrease) in
cash, cash equivalents and current financial assets compared to
year-end 2020 and 2019 |
|
|
910,903 |
|
|
(70,318) |
|
|
|
Cash, cash equivalents and
current financial assets at the end of the period |
|
|
2,907,355 |
|
|
1,430,343 |
|
|
|
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 its 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 $2,907.4 million on March 31, 2021, compared to
$1,996.5 million on December 31, 2020. The increase in cash, 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 in the form of newly issued Zai
Lab shares received as part of the strategic collaboration for
efgartigimod in Greater China, partially offset by (iii) the
payment of $98.0 million related to the purchase of a priority
review voucher from Bayer HealthCare Pharmaceuticals and other net
cash flows used in operating activities.
Total operating income increased by $141.6
million for the three months ended March 31, 2021 to $167.4
million, compared to $25.8 million for the three months ended March
31, 2020. The increase was primarily due to 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
$17.7 million for the three months ended March 31, 2021 to $122.3
million, compared to $104.7 million for the three months ended
March 31, 2020. The increase in the first three months of 2021
resulted primarily from higher external research and development
expenses, mainly related to the efgartigimod program in multiple
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 $56.3 million for the three months ended March 31, 2021,
compared to $27.6 million for the three months ended March 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 of a possible future
commercialization of efgartigimod.
The increase in fair value on non-current
financial assets amounted to $11.2 million for the three months
ended March 31, 2021, which is the result of the closing of a
Series B financing round of AgomAb Therapeutics, for which the
Company maintains a profit share in exchange for granting the
license for the use of HGF-mimetic antibodies from the SIMPLE
Antibody™ platform.
Exchange losses totaled $28.8 million for the
three months ended March 31, 2021, compared to an exchange gain of
$23.0 million for the three months ended March 31, 2020. As a
result of the change in the Company’s functional and presentation
currency, the exchange losses for the three months ended March 31,
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 seven expected global
trials of efgartigimod, and the continued investment in its
Immunology Innovation Program.
EXPECTED
2021 FINANCIAL
CALENDAR
- July 29, 2021: HY 2021 financial
results and business update
- October 28, 2021: Q3 2021 financial
results and business update
CONFERENCE CALL DETAILSThe
first quarter 2021 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
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, 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, 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,” “estimates,” “anticipates,” “expects,” “intends,”
“may,” “will,” or “should” and include statements argenx makes
concerning 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 fifth and
sixth indications to begin in 2021; its statement that data
expected mid-year from Phase 1 trial of C2 inhibitor, ARGX-117;
Phase 2 dosing plan to be identified for indications including
multifocal motor neuropathy (MMN), and 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 as well as several
other severe autoimmune diseases mediated by IgG autoantibodies;
its plans to start enrollment in two additional efgartigimod
indications this year, its expectation to have Phase 1 data
mid-year for its C2 inhibitor, ARGX-117, 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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