- Biologics License Application (BLA) for IV
efgartigimod accepted for review by U.S. Food and Drug
Administration (FDA) for generalized myasthenia gravis (gMG)
- Pre-approval access program opened in U.S. and
Europe for eligible gMG patients
-
Management to host conference call today at 2:30 pm CEST (8:30 am
ET) -
March 4, 2021 Breda,
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 full year 2020 and provided a
fourth quarter business update.
“2020 was an exceptional year for argenx, marked
by execution across the organization and highlighted by the
positive results of our pivotal Phase 3 ADAPT trial. We have
started 2021 on strong footing with the FDA’s acceptance for review
of the BLA for efgartigimod, bringing us one step closer to
offering a new therapy option to people living with gMG. In
preparation for our first commercial launch, we remain committed to
a series of educational and engagement efforts with patients,
physicians and payors on FcRn as a target and the unmet disease
burden that gMG patients face,” said Tim Van Hauwermeiren, Chief
Executive Officer of argenx.
“With proof-of-concept established for
efgartigimod in four indications and enrollment on track to begin
in the fifth and sixth indications this year, we are building out a
broad development plan with our FcRn antagonist. In addition, we
expect Phase 1 healthy volunteer data mid-year from our C2
antagonist ARGX-117, our second program in severe autoimmunity,
solidifying our commitment to continued pipeline expansion with
antibody-based medicines that have potential in multiple autoimmune
indications,” concluded Mr. Van Hauwermeiren.
FOURTH QUARTER 2020 AND RECENT BUSINESS
UPDATE
BLA for efgartigimod accepted for review
by FDA; on track with commercial and regulatory preparations in the
U.S., Japan, the EU and China.
- BLA for IV efgartigimod for treatment of gMG accepted for
review by FDA with action date set for December 17, 2021 under
Prescription Drug User Fee Act (PDUFA)
- Japanese Marketing Authorization Application (J-MAA) expected
to be filed with Pharmaceuticals and Medical Devices Agency (PMDA)
in first half of 2021 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:
- Build-out of supply chain to ensure ample commercial product
available at launch to meet early demand
- Hiring of experienced, neurology-focused sales team with aim to
have approximately 70 sales representatives in place for
launch
- Ongoing education efforts with key stakeholder groups,
including patients, physicians and payors
- Launched pre-approval access program (PAA) in the U.S. and
Europe to open availability of efgartigimod to people living with
gMG who have a high degree of unmet clinical need and are not able
to participate in a clinical trial
Seven global trials to be ongoing in
2021 of efgartigimod across IV and subcutaneous (SC) formulations;
proof-of-concept now demonstrated in four indications, which
strategically fit within growing commercial
franchises.
- ADAPT-SC: Enrollment ongoing in registrational
trial evaluating non-inferiority based on pharmacodynamic effect of
SC efgartigimod compared to IV efgartigimod for treatment of gMG;
trial expected to enroll approximately 50 patients
- ADHERE: Enrollment ongoing in registrational
trial evaluating SC efgartigimod for treatment of chronic
inflammatory demyelinating polyneuropathy (CIDP) following interim
analysis of safety data as well as efficacy assessments that
surpassed pre-defined “GO” threshold; trial expected to enroll
approximately 130 patients
- ADVANCE and ADVANCE-SC: Registrational trials
ongoing of IV and SC efgartigimod for treatment of primary immune
thrombocytopenia (ITP); trials expected to each enroll
approximately 156 patients
- ADDRESS: Registrational trial ongoing of SC
efgartigimod for treatment of pemphigus (vulgaris and foliaceus);
trial expected to enroll approximately 150 patients
- Enrollment in fifth and sixth indications to begin in 2021
- Agreement with Zai Lab Limited expected to expand and
accelerate global development of efgartigimod, including into
additional autoimmune indications
Data
expected mid-2021 from Phase 1 healthy volunteer trial of ARGX-117,
a potential first-in-class C2 antagonist and second program with
broad applicability in severe autoimmunity.
-Trial to evaluate safety and
tolerability of single and multiple ascending doses of IV and SC
ARGX-117, and to identify dose to take forward into potential Phase
2 proof-of-concept trials, including for multifocal motor
neuropathy (MMN)
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.
- Data update from Phase 2 CULMINATE trial evaluating cusatuzumab
in combination with azacitidine for treatment of newly diagnosed
AML to be presented in peer-reviewed forum
- Decision to initiate additional cusatuzumab studies under
collaboration will be determined following review of all available
data including ongoing Phase 1b ELEVATE trial (NCT04150887), which
is evaluating cusatuzumab in combination with venetoclax and
azacitidine for treatment of newly diagnosed AML
Immunology Innovation Program (IIP)
continues to drive pipeline expansion by identifying potential
value-creation opportunities through collaboration with leading
disease biologists.
- Preclinical work ongoing in early-stage pipeline, including
ARGX-118, ARGX-119 and ARGX-120
- 17 discovery programs under evaluation that emerged from
IIP
argenx continues its transition to a
global, integrated, immunology organization.
- Geneva office opened to support commercial infrastructure ahead
of expected EU launch of efgartigimod
- Planned transition agreement in place for Chief Financial
Officer Eric Castaldi as part of evolution to commercial-stage
company; recruitment efforts ongoing for U.S.-based successor
- Yvonne Greenstreet, President and Chief Operating Officer of
Alnylam, has been nominated to Board of Directors to fill position
of Dr. David Lacey, who intends to transition to an advisory role
for the Company
- Completed public offering of 3,593,750 ordinary shares in
February 2021 with gross proceeds of $1.15 billion
Q4 AND FY2020 FINANCIAL RESULTS
|
|
|
Year
Ended |
|
|
|
December
31, |
(in thousands of € except for shares and EPS) |
|
2020 |
|
2019 |
|
Variance |
Revenue |
|
€ |
36,425 |
|
€ |
69,783 |
|
€ |
(33,358) |
Other operating income |
|
|
18,109 |
|
|
12,801 |
|
|
5,308 |
Total operating income |
|
|
54,534 |
|
|
82,584 |
|
|
(28,050) |
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
(325,479) |
|
|
(197,665) |
|
|
(127,814) |
Selling, general and administrative expenses |
|
|
(149,367) |
|
|
(64,569) |
|
|
(84,798) |
Total operating expenses |
|
|
(474,846) |
|
|
(262,234) |
|
|
(212,612) |
|
|
|
|
|
|
|
|
|
|
Change in fair value on non-current financial
assets |
|
|
2,544 |
|
|
1,096 |
|
|
1,448 |
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
€ |
(417,769) |
|
€ |
(178,554) |
|
€ |
(239,215) |
|
|
|
|
|
|
|
|
|
|
Financial income/(expense) |
|
|
(1,414) |
|
|
14,275 |
|
|
(15,689) |
Exchange gains/(losses) |
|
|
(106,956) |
|
|
6,066 |
|
|
(113,022) |
|
|
|
|
|
|
|
|
|
|
Loss before taxes |
|
€ |
(526,139) |
|
€ |
(158,213) |
|
€ |
(367,926) |
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
€ |
(2,784) |
|
€ |
(4,752) |
|
€ |
1,968 |
|
|
|
|
|
|
|
|
|
|
Loss for the year and total comprehensive
loss |
|
€ |
(528,923) |
|
€ |
(162,965) |
|
€ |
(365,958) |
|
|
|
|
|
|
|
|
|
|
Loss for the year and total comprehensive
loss attributable to: |
|
|
|
|
|
|
|
|
|
Owners of the parent |
|
€ |
(528,923) |
|
€ |
(162,965) |
|
€ |
(365,958) |
Weighted average number of shares outstanding |
|
|
45,410,442 |
|
|
38,619,121 |
|
|
|
Basic and diluted loss per share (in €) |
|
|
(11.65) |
|
|
(4.22) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents and
current financial assets compared to year-end 2019 and 2018 |
|
|
291,147 |
|
|
771,252 |
|
|
|
Cash and cash equivalents and current financial
assets at the end of the period |
|
|
1,626,968 |
|
|
1,335,821 |
|
|
|
DETAILS OF FINANCIAL
RESULTS
Cash and cash equivalents and current financial
assets totaled €1,627.0 million on December 31, 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 in May 2020, including a U.S.
offering and a European private placement, which resulted in the
receipt of €778.1 million in gross proceeds, decreased by €47.4
million of underwriter discounts and commissions, and offering
expenses, partially offset by net cash flows used in operating
activities.
Revenue decreased by €33.4 million for the year
ended December 31, 2020 to €36.4 million, compared to €69.8 million
for the year ended December 31, 2019. The decrease was due to the
milestone payments following the first-in-human clinical trial with
ABBV-151 under the AbbVie collaboration which was achieved in the
year ended December 31, 2019, partly offset by revenue recognition
of the transaction price related to the Janssen collaboration. The
increase in other income is primarily driven by increased research
and development incentives and higher payroll tax rebates for
employing certain highly qualified research and development
personnel.
Research and development expenses increased by
€127.8 million for the year ended December 31, 2020 to €325.5
million, compared to €197.7 million for the year ended December 31,
2019. The increase resulted primarily from higher external research
and development expenses, primarily related to the efgartigimod
program in various indications, cusatuzumab program and other
clinical and preclinical programs. Furthermore, the personnel
expenses increased due to a planned increase in headcount.
Selling, general and administrative expenses
totaled €149.4 million for the year ended December 31, 2020,
compared to €64.6 million for the year ended December 31, 2019. The
increase primarily resulted 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 year ended December 31, 2020, financial
expenses, which is the net of primarily interest received and
changes in fair value of invested funds, amounted to €1.4 million,
compared to a financial income of €14.3 million for the year ended
December 31, 2020. Financial expenses correspond mainly to the
decrease in net asset value of money invested funds following the
impact of the COVID-19 outbreak on the financial markets.
Exchange losses totaled €107.0 million for the
year ended December 31, 2020, compared to an exchange gain of €6.1
million for the year ended December 31, 2019. The unfavorable
change is mainly attributable to unrealized exchange rate losses on
cash and cash equivalents and current financial asset position in
U.S. dollars.
FINANCIAL GUIDANCE
Based on current plans to fund anticipated
operating expenses and capital expenditures, argenx expects its
cash burn to increase significantly in 2021, approximately doubling
compared to 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
- May 14, 2021: Q1 2021 financial results and business
update
- July 29, 2021: HY 2021 financial results and business
update
- October 28, 2021: Q3 2021 financial results and business
update
CONFERENCE CALL DETAILSThe full
year 2020 results and fourth 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, 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 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
Investors:Beth
DelGiaccobdelgiacco@argenx.com
Joke Comijn (EU)jcomijn@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 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.
- Q4FY20 Press Release - Financial Tables_FINAL
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