– U.S. and Japan commercial teams fully staffed
ahead of potential launches of efgartigimod in generalized
myasthenia gravis (gMG) –
– Signed partnership agreement with Medison for
distribution of efgartigimod in Israel –
–
Wim Parys, M.D. to retire as Chief Medical Officer in March 2022
–
– Management to host conference call today at
2:30 pm CEST (8:30 am ET) –
October
28,
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 third quarter 2021 financial results and provided a
business update and outlook for the remainder of the year.
“With three parallel regulatory reviews in our
key priority territories of the U.S., Japan and the EU and the
simultaneous build-out of our respective commercial organizations,
we are well-positioned for the planned global launch of
efgartigimod for the treatment of generalized myasthenia gravis. In
order to optimize our strategy to make efgartigimod available to
patients in need across the world, we are pursuing innovative
partnerships, such as the strategic partnership with Zai Lab in
China and the agreement with Medison in Israel which we are excited
to announce today,” said Tim Van Hauwermeiren, Chief Executive
Officer of argenx.
“As part of our commitment to becoming a
fully-integrated, global immunology company, we are expanding our
efgartigimod development plan to be in at least 15 indications by
2025 while also advancing a series of additional high-potential
programs emerging from our Immunology Innovation Program. This
includes a first-in-class C2 inhibitor, ARGX-117, which is on track
to begin the first Phase 2 trial in multifocal motor neuropathy
patients by the end of this year. Our growing commercial
infrastructure along with our expanding pipeline ambitions provide
considerable opportunity for argenx to deliver long-term,
sustainable growth,” concluded Mr. Van Hauwermeiren.
THIRD
QUARTER 2021 AND RECENT BUSINESS UPDATE
Three global
regulatory reviews ongoing for FcRn
antagonist efgartigimod for the
treatment of 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 quarter of
2022
- MAA under review with European
Medicines Agency (EMA) with anticipated approval in second half of
2022
- Zai Lab on track with expected
regulatory discussions with National Medical Products
Administration (NMPA) for approval in China
- Signed exclusive partnership
agreement with Medison to commercialize efgartigimod for gMG in
Israel; under agreement, Medison will also be responsible for
seeking requisite regulatory approvals
- Field teams onboard in U.S. and
Japan, including 70 U.S. and 24 Japan sales representatives
New
data from Phase 3 ADAPT trial of efgartigimod for the
treatment of gMG presented during American
Association of Neuromuscular and Electrodiagnostic Medicine (AANEM)
Annual Meeting. Additional data to
be presented at upcoming
Myasthenia Gravis Foundation of America (MGFA) Scientific
Session. Highlights
of the new data points
include:
- Among acetylcholine
receptor-antibody positive (AChR-Ab+) patients, minimal symptom
expression or MSE (MG-ADL of 0 or 1) was achieved by 59.1% (26/44)
of MG-ADL responders following efgartigimod treatment during first
cycle and 44.4% (16/36) during second cycle, compared to 36.8%
(7/19) and 0% (0/11), respectively, for placebo patients
- Among acetylcholine
receptor-antibody negative (AChR-Ab-) patients, MSE was achieved in
31.6% (6/19) of MG-ADL responders following efgartigimod treatment
during first cycle compared to 15.8% (3/19) for placebo
patients
- gMG and pemphigus patients who were
vaccinated for influenza and pneumococcus during and prior to
efgartigimod treatment in recent clinical trials showed that the
ability to mount an immune antibody response was not impacted
- Consistent and statistically
significant disease score improvements were demonstrated following
efgartigimod treatment across ADAPT patient subtypes, regardless of
concomitant medication or affected muscle domain (bulbar, ocular,
respiratory, limb/gross motor)
- Initial patient-reported data from
MyRealWorld® MG real-world evidence study (N = 144) showed that
despite taking an average of 2.3 treatments to control symptoms,
people living with gMG experience substantial negative physical,
mental, social, and emotional impacts of the disease
- 92% of responders agreed there is a
significant need for new gMG treatments and are hopeful for ones
with fewer side effects (96%)
- In a separate argenx-sponsored
patient burden survey (N = 150), 51% of gMG patients stopped
working entirely as a consequence of their disease
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)
- Enrollment complete in ADAPT-SC and
ADVANCE (IV); topline data for both trials expected in first half
of 2022
- Full Phase 2 trial results of
efgartigimod for treatment of pemphigus published in British
Journal of Dermatology
- Protocol finalized for
registrational trial of efgartigimod for treatment of idiopathic
inflammatory myopathy (myositis), following FDA consultation; trial
on track to start in first quarter of 2022
- Registrational trial of
efgartigimod for treatment of bullous pemphigoid on track to start
by end of 2021
ARGX-117, a
first-in-class
C2-inhibitor, has
potential to be the next pipeline-in-a-product opportunity
across multiple severe autoimmune indications
- Phase 1 data showed favorable
safety profile and potential for infrequent dosing schedules
- Phase 2 trial for treatment of
multifocal motor neuropathy (MMN) on track to start by end of
2021
Wim Parys, M.D. to retire as Chief
Medical Officer (CMO) on March
31, 2022 and transition to member of Research and
Development Committee of argenx
Board of Directors
- Succession plans underway for Luc
Truyen, M.D., Ph.D., Vice President, Research & Development
Operations at argenx, to assume CMO role in April 2022
THIRD QUARTER FINANCIAL
RESULTS (CONSOLIDATED)
|
|
Nine Months Ended |
|
|
|
|
|
September 30, |
|
|
|
(in thousands of $ except for shares and EPS) |
|
2021 |
|
2020 |
|
Variance |
Revenue |
|
$ |
471,255 |
|
$ |
33,652 |
|
$ |
437,603 |
Other operating income |
|
|
23,327 |
|
|
14,056 |
|
|
9,271 |
Total operating
income |
|
|
494,582 |
|
|
47,708 |
|
|
446,874 |
Research and development
expenses |
|
|
-413,346 |
|
|
-276,412 |
|
|
-136,935 |
Selling, general and
administrative expenses |
|
|
-210,221 |
|
|
-113,206 |
|
|
-97,015 |
Total operating
expenses |
|
|
-623,568 |
|
|
-389,618 |
|
|
-233,950 |
Change in fair value on
non-current financial assets |
|
|
11,152 |
|
|
1,201 |
|
|
9,951 |
Operating income /
(loss) |
|
$ |
-117,834 |
|
$ |
-340,709 |
|
$ |
222,875 |
Financial
income/(expenses) |
|
|
-1,040 |
|
|
-1,824 |
|
|
785 |
Exchange gain/(losses) |
|
|
-35,990 |
|
|
-65,324 |
|
|
29,335 |
Profit / (Loss) for
the period |
|
$ |
-154,864 |
|
$ |
-407,857 |
|
$ |
252,993 |
Income taxes |
|
|
-15,584 |
|
|
-3,023 |
|
|
-12,561 |
Profit / (Loss) for
the period |
|
$ |
-170,447 |
|
$ |
-410,880 |
|
$ |
240,433 |
Weighted average number of
shares outstanding |
|
|
52,774,661 |
|
|
44,717,568 |
|
|
|
Basic profit / (loss) per
share (in $) |
|
|
-3.23 |
|
|
-9.19 |
|
|
|
Diluted profit / (loss) per
share (in $) |
|
|
-3.23 |
|
|
-9.19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase/(decrease) in
cash, cash equivalents and current financial assets compared to
year-end 2020 and 2019 |
|
|
537,518 |
|
|
611,512 |
|
|
|
Cash, cash equivalents and
current financial assets at the end of the period |
|
|
2,533,969 |
|
|
2,112,174 |
|
|
|
DETAILS OF THE FINANCIAL
RESULTS
As of January 1, 2021, the Company changed its
functional and presentation currency from euro to U.S. dollar,
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 $2,534.0 million as of September 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 $446.9
million for the nine months ended September 30, 2021 to $494.6
million, compared to $47.7 million for the nine months ended
September 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
$136.9 million for the nine months ended September 30, 2021 to
$413.3 million, compared to $276.4 million for the nine months
ended September 30, 2020. The increase in the first nine 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 $210.2 million for the nine months ended September 30,
2021, compared to $113.2 million for the nine months ended
September 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 nine months
ended September 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 $36.0 million for the
nine months ended September 30, 2021, compared to $65.3 million for
the nine months ended September 30, 2020. As a result of the change
in the Company’s functional and presentation currency, the exchange
losses for the nine months ended September 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 full-year 2021 cash burn to approximately double from
2020. The increased spend has supported 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 registrational
trials of efgartigimod in six indications, and the continued
investment in its Immunology Innovation Program. As argenx further
expands its commercial infrastructure and differentiated pipeline
of assets, it is expected that the spend associated with these
activities will continue to increase.
EXPECTED 2022
FINANCIAL CALENDAR
- March 3, 2022: FY 2021 financial results and business
update
- May 12, 2022: Q1 2022 financial results and business
update
- July 28, 2022: HY 2022 financial results and business
update
- October 27, 2022: Q3 2022 financial
results and business update
CONFERENCE CALL DETAILSThe
third 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. 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 and Twitter.
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 regulatory reviews in priority territories and
commercial build out; that it is well-positioned for a global
launch of efgartigimod; its statement that it is expanding its
efgartigimod development plan to be in at least 15 indications by
2025 while also advancing a series of additional high-potential
programs emerging from our Immunology Innovation Program including
a first-in-class C2 inhibitor, ARGX-117, which is on track to begin
the first Phase 2 trial in multifocal motor neuropathy patients by
the end of this year 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 approval in
2022; MAA expected approval by European Medicines Agency (EMA) in
2022; and Zai Lab Limited support for mid-2022 submission in China
with National Medical Products Administration (NMPA); statements
regarding its commercial readiness; its statement that topline data
expected in first half of 2022 in trials for ADAPT-SC and
ADVANCE(IV) ; its statement that a trial of efgartigimod for
treatment of myositis to start in first half of 2022, pending
interactions with FDA and Phase 3 registrational trial of
efgartigimod for treatment of bullous pemphigoid on track to start
by end of 2021; 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 statements regarding the therapeutic
potential of Efgartigimod in patients with gMG; the 2021 business
and financial outlook and related plans, including its opportunity
to deliver long-term, sustainable growth; the therapeutic potential
of its product candidates; the intended results of its strategy and
argenx’s, and its collaboration partners’, advancement of,
anticipated clinical development, data readouts and regulatory
milestones and plans, including the timing of planned clinical
trials and expected data readouts; and 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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