- Topline
data from Phase 3 ADAPT trial of efgartigimod in gMG expected in
mid-2020
-
Continued progress across broadest FcRn antagonist pipeline with up
to five Phase 3 trials to be ongoing in 2020
- Ended
2019 well-capitalized to advance late-stage pipeline with €1.3
billion in cash, cash equivalents and current financial assets
February 27, 2020
Breda, the Netherlands / Ghent, Belgium – argenx
(Euronext & Nasdaq: ARGX), a clinical-stage biotechnology
company developing a deep pipeline of differentiated antibody-based
therapies for the treatment of severe autoimmune diseases and
cancer, today announced its financial results for the full year
2019 and provided a fourth quarter business update and outlook for
2020.
“The significant achievements we made throughout
2019 have provided the foundation for us to execute yet another
exciting year ahead as we advance our ‘argenx 2021’ vision to
become a global, integrated immunology company,” commented Tim Van
Hauwermeiren, CEO of argenx. “We are progressing our entire
FcRn pipeline across four indications with a fifth to be
announced this year and are planning for a 2021 launch of
efgartigimod in gMG, which could be the first approved FcRn
antagonist.”
“We continue to build innovation into every step
of our development, highlighted by our collaborative Innovative
Access Program translating immunology breakthroughs into medicines,
our unique trial designs incorporating input from our patients, and
our integrated commercial thinking with the launch of the first
real-world evidence study in MG. We have demonstrated our ability
to perform across our late-stage pipeline and will prioritize
maintaining this reputation for execution in 2020 with up to five
registrational trials to be ongoing.”
FOURTH QUARTER 2019 AND RECENT
HIGHLIGHTSargenx continues to execute on its “argenx 2021”
vision to become a fully integrated, global immunology company,
which includes the building of two initial commercial franchises in
neuromuscular disorders and hematology/oncology and the expanding
of its global presence to support its anticipated first commercial
launch of efgartigimod in 2021.
Efgartigimod: First-in-class opportunity
across range of high-value autoimmune
indicationsEfgartigimod is a human IgG1 Fc fragment
engineered for optimal blocking of FcRn and targeted reduction of
IgG autoantibodies. argenx expects to have up to five
registrational trials ongoing in 2020. Efgartigimod is currently
being evaluated in four targeted indications where IgG
autoantibodies are directly pathogenic, including:
- Generalized Myasthenia Gravis (gMG)
- Completed enrollment of 167
patients in global, multi-center Phase 3 ADAPT trial with 10mg/kg
intravenous (IV) efgartigimod. Topline results from ADAPT expected
in mid-2020
- Received Fast Track designation for
efgartigimod in MG from U.S. Food and Drug Administration
(FDA)
- Biologics License Agreement (BLA)
expected to be filed in fourth quarter of 2020 with launch planned
for 2021
- Plans to engage with FDA in 2020 on
potential bridging strategy for 1000mg subcutaneous (SC)
ENHANZE®-efgartigimod
- Primary Immune Thrombocytopenia
(ITP)
- Global Phase 3 registrational
program includes:
- Ongoing Phase 3 ADVANCE trial
evaluating approximately 150 primary ITP patients dosed with
10mg/kg IV efgartigimod for both induction and maintenance of
platelet response
- ADVANCE SC trial expected to
initiate in second half of 2020 evaluating 10mg/kg IV efgartigimod
for induction of platelet response and fixed dose of SC
efgartigimod for maintenance
- Small confirmatory IV trial
expected to initiate in first half of 2020
- Presented previously announced data
from completed Phase 2 proof-of-concept trial in December 2019 at
61st American Society of Hematology (ASH) Annual Meeting
demonstrating that efgartigimod was well-tolerated and showed
correlation of reduced IgG levels, increased platelet counts and
reduced bleeding in ITP patients
- Published Phase 2 data in American
Journal of Hematology in article titled, “Phase 2 study of
efgartigimod, a novel FcRn antagonist, in adult patients with
primary immune thrombocytopenia”
- Pemphigus Vulgaris (PV)
- Announced positive proof-of-concept
data in 23 patients from Phase 2 trial evaluating 10mg/kg and
25mg/kg IV efgartigimod, which support advancement to
registrational trial anticipated to start in second half of 2020
- 78% (18/23) of patients achieved
rapid disease control (DC); median time to DC for both monotherapy
and combination therapy is 14-15 days
- Fast complete clinical remission
(CR) observed within 2-10 weeks of treatment in 70% (5/7) of
patients receiving optimized dosing regimen
- Established optimized dosing
regimen to be weekly or bi-weekly dosing of efgartigimod in
combination with oral prednisone (0.25-0.5mg/kg)
- Patients still in trial in extended
dosing cohort; detailed results of Phase 2 data to be presented
during Society for Investigative Dermatology Annual Meeting in May
2020
- Chronic Inflammatory Demyelinating
Polyneuropathy (CIDP)
- Launched Phase 2 ADHERE trial with
SC ENHANZE®-efgartigimod
- Fifth efgartigimod indication
expected to be announced in 2020
argenx has established proof-of-concept in all
three beachhead indications in neuromuscular disorders, hematology
and dermatology therapeutic areas for efgartigimod.
Cusatuzumab: First-in-class opportunity
with potential in hematological malignancies
Cusatuzumab is an anti-CD70 monoclonal antibody
being developed under an exclusive global collaboration and license
agreement with Janssen for the treatment of acute myeloid leukemia
(AML), high-risk myelodysplastic syndromes (MDS) and other
hematological malignancies.
- Enrollment ongoing in dose-confirming Phase 2 pivotal CULMINATE
trial of cusatuzumab in combination with azacitidine for newly
diagnosed, elderly AML patients who are unfit for intensive
chemotherapy
- Phase 1b platform trial underway in various AML subpopulations
and settings with initial trial evaluating combinations of
cusatuzumab, venetoclax and azacitidine; additional trials expected
to launch under platform trial in first half of 2020
- Randomized Phase 2 trial of cusatuzumab in combination with
azacitidine in higher-risk MDS patients expected to launch in first
half of 2020
- Phase 1 trial of cusatuzumab in combination with azacitidine to
launch in first half 2020 in Japanese patients with AML and
MDS
- Data update from cusatuzumab development expected in 2020
ARGX-117: First-in-class anti-C2
antibody expected to enter clinic in first quarter
2020ARGX-117 is a complement-targeting antibody against C2
with potential therapeutic applications in multiple autoimmune
diseases.
- Phase 1 trial in healthy volunteers expected to begin in first
quarter of 2020
- Multiple doses and formulations (IV and SC
ENHANZE®-efgartigimod) to be evaluated as part of dose-finding
work
- Following analysis of Phase 1 data in fourth quarter of 2020,
argenx plans to launch Phase 2 proof-of-concept trial in multifocal
motor neuropathy (MMN) within its neuromuscular franchise and to
develop in additional indications
Early-stage
Pipelineargenx continues to expand its early-stage
pipeline with first-in-class antibodies against immunologic
targets:
- Lead optimization work ongoing of ARGX-118 for airway
inflammation
- New product candidate ARGX-119 expected to be announced in
2020
Collaborations
- Received first development milestone payment under Janssen
collaboration for achievement of enrollment milestone in Phase 2
pivotal CULMINATE trial
- Awarded first clinical milestone payment under AbbVie
collaboration for initiating first-in-human clinical trial with
antibody product ABBV-151 (formerly named ARGX-115), which was
created as part of argenx’s Innovative Access Program and
exclusively licensed to AbbVie in 2016
YEAR 2019 FINANCIAL RESULTS (CONSOLIDATED)
|
|
Year Ended December 31, |
|
|
|
|
|
|
|
|
in thousands of € |
|
2019 |
|
2018 |
|
Variance |
Revenue |
|
€ |
69,783 |
|
€ |
21,482 |
|
€ |
48,301 |
Other operating income |
|
€ |
12,801 |
|
€ |
7,749 |
|
€ |
5,052 |
Total operating income |
|
€ |
82,584 |
|
€ |
29,231 |
|
€ |
53,353 |
Research and development expenses |
|
€ |
(197,665) |
|
€ |
(83,609) |
|
€ |
(114,056) |
Selling, general and administrative expenses |
|
€ |
(64,569) |
|
€ |
(27,471) |
|
€ |
(37,098) |
Changes in fair value on financial assets |
|
|
1,096 |
|
|
— |
|
|
1,096 |
Operating loss |
|
€ |
(178,554) |
|
€ |
(81,849) |
|
€ |
(96,705) |
Financial income |
|
€ |
14,399 |
|
€ |
3,694 |
|
€ |
10,705 |
Financial expense |
|
€ |
(124) |
|
€ |
— |
|
€ |
(124) |
Exchange gain/(losses) |
|
€ |
6,066 |
|
€ |
12,308 |
|
€ |
(6,242) |
Loss before taxes |
|
€ |
(158,213) |
|
€ |
(65,847) |
|
€ |
(92,366) |
Income tax expense |
|
€ |
(4,752) |
|
€ |
(794) |
|
€ |
(3,958) |
Loss for the year and total comprehensive
loss |
|
€ |
(162,965) |
|
€ |
(66,641) |
|
€ |
(96,324) |
|
|
|
|
|
|
|
|
|
|
Net increase in cash, cash equivalents and current financial assets
compared to year-end 2018 and 2017 |
|
€ |
771,252 |
|
€ |
204,795 |
|
|
|
Cash, cash equivalents and current financial assets at the end of
the period |
|
€ |
1,335,821 |
|
€ |
564,569 |
|
|
|
DETAILS OF THE FINANCIAL
RESULTS
Cash, cash equivalents and current financial assets totaled
€1,335.8 million for the year ended December 31, 2019, compared to
€564.6 million for the year ended December 31, 2018. The increase
in the year-end cash balance on December 31, 2019 resulted
primarily from (i) the closing of the collaboration and license
agreement for cusatuzumab with Janssen which resulted in a $300
million upfront payment and a $200 million equity investment in
January 2019, and (ii) €479.0 million of net proceeds received from
the global offering in November 2019.
Operating income increased by €53.4 million for
the year ended December 31, 2019 to €82.6 million, compared to
€29.2 million for the year ended December 31, 2018. The increase
primarily related to (i) the partial recognition of the upfront
payment and the recognition of research and development service
fees under the collaboration and license agreement for cusatuzumab
with Janssen and (ii) the recognition of the milestone payment
following the initiation of a first-in-human clinical trial with
ABBV-151 under the AbbVie collaboration.
Research and development expenses totaled €197.7
million and €83.6 million for the years ended December 31, 2019 and
2018, respectively. The increase is mainly the result of (i)
increased external research and development expenses reflecting
higher clinical trial costs and manufacturing expenses related to
the development of argenx’s product candidate portfolio and (ii)
higher personnel expenses as a result of increased costs of the
share-based payment compensation plans related to the grant of
stock options to its research and development employees and
increased costs associated with additional research and development
employees.
Selling, general and administrative expenses totaled €64.6
million and €27.5 million for the years ended December 31, 2019 and
2018, respectively. The increase of €37.1 million was principally
due to an increase of personnel expense, resulting from (i) higher
costs of the share-based payment compensation plans related to the
grant of stock options to argenx’s selling, general and
administrative employees and (ii) increased costs associated with
additional employees recruited to strengthen its selling, general
and administrative activities, notably in preparation of the
potential commercial launch of efgartigimod in the U.S.
For the year ended December 31, 2019, financial income amounted
to €14.4 million compared to €3.7 million for the year ended
December 31, 2018. The increase of €10.7 million primarily related
to an increase in the interest received on argenx’s cash, cash
equivalents and current financial assets.
Exchange gains totaled €6.1 million for the year
ended December 31, 2019 compared to €12.3 million for the year
ended December 31, 2018 and were mainly attributable to unrealized
exchange rate gains on argenx’s cash, cash equivalents and current
financial assets position in U.S. dollars due to the favorable
fluctuation of the EUR/USD exchange rate.
The total comprehensive loss for the year ended
December 31, 2019 was €163.0 million compared to €66.6 million for
the year ended December 31, 2018.
US SEC and statutory Financial Reporting
argenx’s primary accounting standard for
quarterly earnings releases and annual reports is International
Financial Reporting Standards (IFRS) as issued by the International
Accounting Standards Board (IASB). Quarterly summarized statements
of profit and loss based on IFRS as issued by the IASB are
available on www.argenx.com.
In addition to reporting financial figures in
accordance with IFRS as issued by the IASB, argenx also reports
financial figures in accordance with IFRS as adopted by the EU for
statutory purposes. The consolidated statement of financial
position, the consolidated statements of profit and loss, the
consolidated statements of cashflow, and the consolidated statement
of changes in equity are not affected by any differences between
IFRS as issued by the IASB and IFRS as adopted by the EU.
The consolidated statement of profit and loss
data of argenx SE as of December 31, 2019, as presented in this
press release is unaudited.
Annual Report 2019 argenx will publish its 2019
Annual Report based on IFRS as issued by the IASB and its 2019
Annual Report for statutory purposes based on IFRS as adopted by
the EU on March 24, 2020. These Annual Reports will be
available on www.argenx.com.
EXPECTED 2020 FINANCIAL
CALENDAR:
- May 14 2020: Q1 financial results & business update
- July 30 2020: HY 2020 financial results & business
update
- October 22 2020: Q3 financial results & business
update
CONFERENCE CALL DETAILSThe full
year results will be discussed during a conference call and webcast
presentation today at 3 pm CET/9 am ET. To participate in the
conference call, please select your phone number below and use the
confirmation code 2484158. The webcast may be accessed on the
homepage of the argenx website at www.argenx.com or by clicking
here.
Dial-in numbers:Please dial in
5–10 minutes prior to 3 pm CET/ 9 am ET using the number and
conference ID below.
Confirmation Code:
2484158Belgium
+32 (0)2 400 9874Belgium
0800 48740France
+33 (0)1 767
00794France
0805 103028 Netherlands
+31 (0)20 714
3545Netherlands
0800 0249557United Kingdom
+44 (0)844 571 8892United Kingdom
0800 376 7922United
States
+1 (631) 510 7495United
States
+1 (866) 966 1396
About argenxargenx is a global
immunology company developing antibody-based medicines for patients
suffering from severe autoimmune diseases and cancer. By
translating immunology breakthroughs into innovative drug
candidates, argenx is building a world-class portfolio of
first-in-class antibodies in both early and late clinical-stages of
development. argenx is evaluating efgartigimod in multiple serious
autoimmune indications and cusatuzumab in hematological
malignancies in collaboration with Janssen, along with advancing
earlier stage assets within its therapeutic franchises.
www.argenx.com
For further information, please contact:
Beth DelGiacco, Vice President, Investor Relations +1 518 424
4980bdelgiacco@argenx.com
Joke Comijn, Director Corporate Communications & Investor
Relations (EU)+32 (0)477 77 29 44+32 (0)9 310 34
19info@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 2020 business and financial calendar and related
plans; the clinical data 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. 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 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.
- Y2019 Consolidated Financial Statements argenx SE
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