- $269
million in second quarter VYVGART® (efgartigimod alfa-fcab) global
net product sales
- VYVGART®
Hytrulo now available in the U.S. with first vials shipped in
July
- Global
VYVGART expansion continued with commercial launch in Italy and
distribution agreement with Handok in South Korea
- Topline
results from ADVANCE-SC and ADDRESS expected in fourth quarter of
2023
-
Management to host conference call today at 2:30 pm CET (8:30 am
ET)
July 27,
2023
Amsterdam, the
Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a
global immunology company committed to improving the lives of
people suffering from severe autoimmune diseases, today announced
its half year 2023 financial results and provided a second quarter
business update.
“We are thrilled to see the momentum continue
across all aspects of our business, with a catalyst-rich first half
of the year. For another quarter we saw consistent revenue growth
with VYVGART, delivering on our promise to bring transformative
change to the treatment of gMG and reaching more patients through
global approvals and the launch of our SC offering. Now with the
positive ADHERE data, we have strengthened our conviction in the
potential of VYVGART for CIDP patients but also more broadly across
IgG-mediated autoimmune diseases, motivating us to explore the full
extent of the opportunity. Our ambition level is high and we are
positioning argenx for long-term growth with VYVGART,
empasiprubart, and our pipeline of immunology solutions. It is time
to raise the bar for patients on what a treatment can offer and we
are more inspired than ever in our pursuit to do so,” said Tim Van
Hauwermeiren, Chief Executive Officer of argenx.
SECOND QUARTER
2023 AND RECENT BUSINESS
UPDATE
VYVGART
Expansion
VYVGART is a first-in-class antibody fragment
targeting the neonatal Fc receptor (FcRn) and is now approved
globally in six countries or regions (U.S., Japan, EU, UK, Israel,
China) for generalized myasthenia gravis (gMG). VYVGART Hytrulo was
approved by the U.S. Food and Drug Administration (FDA) on June 20,
2023, and is the first subcutaneous (SC) injectable for gMG. argenx
is planning for multi-dimensional expansion to reach more patients
with VYVGART through additional global regulatory approvals.
- Generated global net VYVGART
revenues of $269 million in second quarter of 2023
- Launched VYVGART Hytrulo in U.S.
and shipped first vials in July
- Launched VYGART in Italy in July
following successful completion of reimbursement negotiations
- VYVGART approval decision in Canada
expected in third quarter of 2023
- Approval decisions of SC
efgartigimod expected in Europe in fourth quarter of 2023, Japan by
first quarter of 2024, and China by end of 2024
- Marketing authorization application
(MAA) filed in Japan for VYVGART for primary immune
thrombocytopenia (ITP); approval decision expected in first half of
2024
- Entered into VYVGART commercial and
distribution agreement with Handok in South Korea
Efgartigimod Research and
Development
argenx is solidifying its leadership in
immunology innovation by expanding the scope of IgG-mediated
autoimmune diseases in development and further demonstrating the
potential of FcRn blockade in ongoing clinical trials. By the end
of 2023, efgartigimod is expected to be approved, in regulatory
review or in development in 13 severe autoimmune diseases.
- Announced positive topline results
from ADHERE of VYVGART Hytrulo for chronic inflammatory
demyelinating polyneuropathy (CIDP)
- Primary endpoint met (p=0.000039);
VYVGART Hytrulo demonstrated 61% reduction (HR: 0.39 95% CI: 0.25;
0.61) in risk of relapse versus placebo
- 67% of patients in open-label Stage
A demonstrated evidence of clinical improvement (ECI), indicating
IgG autoantibodies play significant role in underlying biology of
CIDP
- Safety and tolerability profile
consistent with confirmed safety profile of VYVGART
- 91% (226/249) of eligible patients
continued to ADHERE+ open-label extension study
- Topline data from ADDRESS
(pemphigus) and ADVANCE-SC (primary immune thrombocytopenia)
studies expected in fourth quarter of 2023
- GO/NO GO decisions expected from
BALLAD (bullous pemphigoid) in first quarter of 2024 and ALKIVIA
(myositis) in second half of 2024
- Topline data from ALPHA (post-COVID
postural orthostatic tachycardia syndrome (PC-POTS)) expected in
first quarter of 2024 and RHO (Sjogren’s syndrome) in second half
of 2024
- Studies ongoing in membranous
nephropathy (MN) and lupus nephritis (LN) through Zai Lab
collaboration
- Registrational study in thyroid eye
disease (TED) and proof-of-concept studies in ANCA-associated
vasculitis (ANCA) and antibody mediated rejection (AMR) in kidney
transplant to start in fourth quarter of 2023
Pipeline
Progress
argenx is advancing a robust portfolio of
innovative clinical programs, including empasiprubart (C2
inhibitor) and ARGX-119 (muscle-specific kinase (MuSK) agonist).
Both programs have the potential to be first-in-class opportunities
for multiple severe indications.
- Initiated second dose cohort in
Phase 2 ARDA study of empasiprubart in multifocal motor neuropathy
(MMN)
- Independent Data Monitoring
Committee recommended study continuation based on favorable safety
profile observed in first dose cohort
- Early efficacy signals support
proof-of-concept in MMN
- Second cohort to evaluate next dose
of empasiprubart based on efficacy signals observed in first
cohort
- Topline results from both first and
second cohorts expected in 2024
- Phase 2 studies of empasiprubart in
delayed graft function (DGF) on track to start by end of year and
dermatomyositis in first quarter of 2024
- Phase 1 study of ARGX-119 ongoing
in healthy volunteers; subsequent Phase 1b trial to assess early
signal detection in patients with congenital myasthenic syndrome
and amyotrophic lateral sclerosis (ALS)
Immunology Innovation
Program
argenx continues to invest in its discovery
engine, the Immunology Innovation Program, to foster a robust
innovation ecosystem and drive early-stage pipeline growth. argenx
expects to nominate one new pipeline candidate in 2023.
SECOND QUARTER
2023 FINANCIAL
RESULTS
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
(in thousands of $ except for shares and EPS) |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Product net sales |
|
$ |
269,313 |
|
$ |
74,833 |
|
$ |
487,335 |
|
$ |
95,996 |
Collaboration revenue |
|
|
1,237 |
|
|
361 |
|
|
2,355 |
|
|
2,610 |
Other operating income |
|
|
10,485 |
|
|
9,989 |
|
|
21,225 |
|
|
18,057 |
Total operating income |
|
|
281,035 |
|
|
85,183 |
|
|
510,915 |
|
|
116,663 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
(24,024) |
|
|
(5,010) |
|
|
(42,359) |
|
|
(6,382) |
Research and development expenses |
|
|
(195,509) |
|
|
(126,919) |
|
|
(361,364) |
|
|
(278,887) |
Selling, general and administrative expenses |
|
|
(161,977) |
|
|
(127,798) |
|
|
(311,149) |
|
|
(228,664) |
Loss from investment in joint venture |
|
|
(1,619) |
|
|
- |
|
|
(1,880) |
|
|
- |
Total operating expenses |
|
|
(383,129) |
|
|
(259,727) |
|
|
(716,752) |
|
|
(513,933) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
$ |
(102,094) |
|
$ |
(174,544) |
|
$ |
(205,837) |
|
$ |
(397,270) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income |
|
|
20,441 |
|
|
4,912 |
|
|
37,029 |
|
|
5,733 |
Financial expense |
|
|
(207) |
|
|
(1,178) |
|
|
(395) |
|
|
(2,131) |
Exchange gains/(losses) |
|
|
(2,001) |
|
|
(46,169) |
|
|
9,164 |
|
|
(53,382) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the period before taxes |
|
$ |
(83,861) |
|
$ |
(216,979) |
|
$ |
(160,039) |
|
$ |
(447,050) |
Income tax (expense)/benefit |
|
$ |
(10,507) |
|
$ |
8,229 |
|
$ |
36,800 |
|
$ |
11,114 |
Loss for the period |
|
$ |
(94,368) |
|
$ |
(208,750) |
|
$ |
(123,239) |
|
$ |
(435,936) |
Loss for the period
attributable to: |
|
|
|
|
|
|
|
|
|
|
|
|
Owners of the parent |
|
$ |
(94,368) |
|
$ |
(208,750) |
|
$ |
(123,239) |
|
$ |
(435,936) |
Weighted average number of shares outstanding |
|
|
55,828,239 |
|
|
54,802,339 |
|
|
55,690,873 |
|
|
53,449,915 |
Basis and diluted loss per share (in $) |
|
|
(1.69) |
|
|
(3.81) |
|
|
(2.21) |
|
|
(8.16) |
Net increase/(decrease) in cash, cash equivalents and current
financial assets compared to year-end 2021 and 2022 |
|
|
|
|
|
|
|
|
(195,580) |
|
|
260,665 |
Cash and cash equivalents and current financial assets at the end
of the period |
|
|
|
|
|
|
|
|
1,996,968 |
|
|
2,597,393 |
DETAILS OF THE FINANCIAL
RESULTS
Total operating income for the
second quarter and year-to-date in 2023 was $281.0 million and
$510.9 million, respectively, compared to $85.2 million and $116.7
million for the same periods in 2022, and mainly consists of:
- Product net sales
of VYVGART for the three months ended and six months ended June 30,
2023, were $269.3 million and $487.3 million, compared to $74.8
million and $96.0 million for the same periods in 2022.
- Other operating
income for the second quarter and year-to-date in 2023 was
$10.5 million and $21.2 million, respectively, compared to $10.0
million, and $18.1 million for the same periods in 2022. The other
operating income for the three and six months ended June 30, 2023
primarily relates to research and development tax incentives and
payroll tax rebates.
Total operating expenses for
the second quarter and year-to-date in 2023 were $383.1 million and
$716.8 million, respectively, compared to $259.7 million and $513.9
million for the same periods in 2022, and mainly consists of:
- Cost of sales for
the second quarter and year-to-date in 2023 was $24.0 million and
$42.4 million, respectively, compared to $5.0 million and $6.4
million for the same periods in 2022. The cost of sales was
recognized with respect to the sale of VYVGART.
- Research and
development expenses increased by $68.6
million and $82.5 million for the three months and six months ended
June 30, 2023, to $195.5 million and $361.4 million, respectively,
compared to $126.9 million and $278.9 million for the same periods
in 2022. The research and development expenses mainly relate to
external research and development expenses and personnel expenses
incurred in the clinical development of efgartigimod in various
indications and the expansion of other clinical and preclinical
pipeline candidates.
- Selling, general and
administrative expenses for the second
quarter and year-to-date in 2023 were $162.0 million and $311.1
million, respectively, compared to $127.8 million and $228.7
million for the same periods in 2022. The selling, general and
administrative expenses mainly relate to professional and marketing
fees linked to commercialization of VYVGART in the U.S., EU and
Japan, and personnel expenses.
Financial income for the second
quarter and year-to-date in 2023 was $20.4 million and $37.0
million, respectively, compared to $4.9 million and $5.7 million
for the same periods in 2022. The increase in financial income is
mainly due to an increase in interest income on current financial
assets and cash and cash equivalents attributable to higher
interest rates.
Exchange gains/losses for the
second quarter and year-to-date in 2023 were $2.0 million of
exchange losses and $9.2 million of exchange gains, respectively,
compared to $46.2 million and $53.4 million of exchange losses for
the same periods in 2022. Exchange gains/losses are mainly
attributable to unrealized exchange rate gains or losses on the
cash, cash equivalents and current financial assets position in
Euro.
Income tax for the second
quarter and year-to-date in 2023 was $10.5 million of tax expense
and $36.8 million of tax benefit, respectively, compared to $8.2
million and $11.1 million of tax benefit for the same periods in
2022.
Net loss for the three and six
month periods ended June 30, 2023, was $94.4 million and $123.2
million, respectively, compared to $208.8 million and $435.9
million over the prior year periods. On a per weighted average
share basis, the net loss was $2.21 and $8.16 for the six months
ended June 30, 2023 and 2022, respectively.
Cash, cash equivalents and current
financial assets totalled $2.0 billion as of June 30,
2023, compared to $2.2 billion as of December 31, 2022. Cash and
cash equivalents and current financial assets decreased primarily
as a result of net cash flows used in operating activities. The
cash position as of June 30, 2023, excludes the $1.3 billion in
estimated gross proceeds from the global equity offering, which
closed on July 24, 2023.
With the closing of this transaction, argenx
will review its cash burn expectations and provide an update
accordingly.
UPCOMING FINANCIAL
CALENDAR
- October 31, 2023: Q3 2023 financial
results and business update
- February 29, 2024: FY 2023
financial results and business update
CONFERENCE CALL DETAILS The
second quarter 2023 financial results and 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.
Dial-in numbers: Please dial in
15 minutes prior to the live call.
Belgium 32
800 50
201France 33
800
943355Netherlands 31
20 795 1090United
Kingdom 44 800 358
0970United States
1
888 415
4250Japan 81
3 4578
9081Switzerland 41
43 210 11 32
About argenx
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 approved neonatal Fc receptor (FcRn) blocker in the U.S.,
Japan, Israel, the EU, the UK and China. The Company is evaluating
efgartigimod in multiple serious autoimmune diseases and advancing
several earlier stage experimental medicines within its therapeutic
franchises. For more information,
visit www.argenx.com and follow us
on LinkedIn, Twitter, and Instagram.
For further information, please
contact:
Media:Erin Murphyemurphy@argenx.com
Investors:Alexandra Roy
(US)aroy@argenx.com
Lynn Elton (EU)lelton@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 regarding its plans for its global commercial expansion of
VYVGART to reach more patients; continued investment in its
Immunology Innovation Program to foster a robust innovation
ecosystem and drive early-stage pipeline growth; the therapeutic
potential of its product candidates; the intended results of its
strategy and its collaboration partners’, including ongoing studies
through its collaboration with Zai Lab; advancement of, and
anticipated clinical development, data readouts and regulatory
milestones and plans, including the (1) expected topline data from
registrational ADDRESS and ADVANCE-SC studies in 2023, (2) expected
GO/NO GO decisions from its BALLAD and ALKIVIA trials in 2024, (3)
expected topline data from its ALPHA and RHO trials in 2024, (4)
timeline of registrational and proof-of-concept studies in
ANCA-associated vasculitis and antibody mediated rejection in
kidney transplant, (5) potential of empasiprubart and ARGX-119 to
be first-in-class opportunities for multiple serious indications
and timeline of studies and results thereof and (6) planned
nomination of a new product development candidate in 2023; the
timing and outcome of regulatory filings and regulatory approvals,
including the anticipated regulatory approvals of VYVGART in Canada
and Japan and approvals of SC efgartigimod in Europe, Japan and
China, and the number of autoimmune diseases for which efgartigimod
is expected to be approved, in regulatory review or in development
by end of 2023; and 2023 business and financial outlook and related
plans, including the anticipated release of updated cash burn
expectations and the timeline of future releases of financial
results and business updates. 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
inflation and deflation and the corresponding fluctuations in
interest rate; regional instability and conflicts, such as the
conflict between Russia and Ukraine, argenx’s expectations
regarding 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.
Argen X (EU:ARGX)
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