October 26, 2017
Breda, the Netherlands / Ghent, Belgium argenx (Euronext Brussels & 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 financial results and provided a business update for the third quarter ended September 30,
2017.
"We made strong progress during the third quarter launching the Phase 2 study of ARGX-113 in pemphigus vulgaris
(PV) and delivering on our promise to expand the ARGX-113 program into new, carefully selected indications. With data readouts
expected in 2018 from the Phase 2 studies in myasthenia gravis (MG), immune thrombocytopenia (ITP) and now PV, we will evaluate
ARGX-113 in indications where disease progression is driven by pathogenic autoantibodies of the Immunoglobulin G (IgG) type,"
commented Tim Van Hauwermeiren, CEO of argenx. "We are also progressing well with our lead oncology candidate, ARGX-110, and expect
interim data from both our Phase 1/2 trial in acute myeloid leukemia (AML) and Phase 2 trial in cutaneous T-cell lymphoma (CTCL) by
the 2017 American Society of Hematology (ASH) Annual Meeting (December, 2017). Between our wholly-owned pipeline and our programs
partnered with AbbVie, Leo Pharma and through our Innovative Access Program, we believe we are very well-positioned for a
catalyst-rich 2018."
THIRD QUARTER 2017 AND RECENT HIGHLIGHTS
Products in clinical development:
ARGX-113
- Completed enrollment for Phase 2 clinical trial of MG.
- Announced orphan drug designation by U.S. Food and Drug Administration for ARGX-113 for the treatment of MG.
- Reached 50% enrollment in Phase 2 proof-of-concept clinical trial of ARGX-113 in ITP.
- Launched Phase 2 proof-of-concept clinical trial of ARGX-113 for the treatment of PV.
ARGX-111
- Met safety endpoints in the Phase 1 clinical trial in treatment-refractory patients with advanced cancers whose tumors
overexpress the MET protein. Complete data set from ARGX-111 Phase 1b clinical trial presented at Best of ASCO Asia 2017
(Singapore).
Collaborations:
ARGX-116
- Announced publication of new preclinical data in 'Nature Medicine' on ARGX-116 inhibiting ApoC3, a metabolic target
correlated with blood lipid levels that provide further rationale for the development of ARGX-116 for the treatment of
dyslipidemia.
Corporate:
- Established argenx US, Inc., a U.S. subsidiary located in Boston.
UPCOMING CLINICAL MILESTONES
ARGX-113
- Topline data from Phase 2 clinical trials in MG expected in 1Q 2018 at the latest and ITP expected in 2H 2018. Interim data
from Phase 2 clinical trial in PV expected in 2H 2018.
- Initiation of Phase 1 clinical trial of subcutaneous dosing in healthy volunteers expected in Q4 2017.
ARGX-110
- Interim data from Phase 1/2 clinical trial in AML and Phase 2 clinical trial in CTCL each expected by ASH (December 11,
2017).
FINANCIAL HIGHLIGHTS (as of September 30, 2017) (compared to financial highlights as of September 30, 2016)
- Operating income of €30.5 million (September 30, 2016: €12.5 million).
- Total comprehensive loss of €16.5 million (September 30, 2016: €12.6 million).
- Cash position of €161.7 million (cash, cash-equivalents and current financial assets) allowing argenx to pursue development
of its pipeline as planned.
KEY FIGURES (CONSOLIDATED AND UNAUDITED)
| |
Nine months ended September 30, 2016 |
Nine months ended September 30, 2017 |
Variance |
| (in thousands of €) |
|
|
|
| |
|
|
|
| Revenue |
10,515 |
28,422 |
17,907 |
| Other operating income |
2,010 |
2,090 |
80 |
| Total operating income |
12,525 |
30,512 |
17,987 |
| Research and development expenses |
(20,170) |
(36,655) |
(16,485) |
| General and administrative expenses |
(4,927) |
(7,339) |
(2,412) |
| Operating
loss |
(12,572) |
(13,482) |
(910) |
| Financial income |
55 |
88 |
(33 |
| Exchange gains/(losses) |
(51) |
(2,476) |
(2,425) |
| Loss before
taxes |
(12,568) |
(15,870) |
(3,302) |
| Income tax income/(expense) |
0 |
(597) |
(597) |
| TOTAL
COMPREHENSIVE PROFIT / (LOSS) |
(12,568) |
(16,467) |
(3,899) |
| Net increase / (decrease) in cash, cash-equivalents and
current financial assets compared to year-end 2015 and 2016 |
60,740 |
64,989 |
|
| Cash, cash-equivalents and current
financial assets at the end of the period |
103,067 |
161,717 |
|
DETAILS OF THE FINANCIAL RESULTS
Operating income reached €30.5 million for the nine months ended September 30, 2017, compared to €12.5 million
for the nine months ended September 30, 2016. The increase in operating income in 2017 results primarily from (i) the deferred
revenue recognized from the collaboration agreement signed with AbbVie in April 2016 and (ii) the milestone payment received from
AbbVie in the first half of 2017.
For the nine months ended September 30, 2017, research and development expenses totaled €36.7 million, compared to €20.2 million
the nine months ended September 30, 2016. This increase in research and development expenses in 2017 was principally related to the
advancement of (i) the manufacturing and clinical development activities of ARGX-113 and ARGX-110 and (ii) other preclinical and
discovery-stage product candidates including external research and development expenses incurred under the collaboration agreements
with LEO Pharma and AbbVie.
General and administrative expenses amounted to €7.3 million for the nine months ended September 30, 2017, compared to €4.9 million
for the nine months ended September 30, 2016. The increase of general and administrative expenses in 2017 primarily resulted from
higher personnel expenses, office costs and consulting fees incurred to support the growth of argenx and for argenx to prepare to
become, and continue operating as, a Nasdaq-listed company.
Exchange losses totaled €2.5 million on September 30, 2017, compared to €0.1 million on September 30, 2016. This increase is mainly
attributable to unrealized exchange rate losses on argenx's cash and current financial assets position in U.S. dollars due to the
unfavorable fluctuation of the EUR/USD exchange rate during the nine months ended September 30, 2017.
For the nine months ended September 30, 2017, argenx generated a total comprehensive loss of €16.5 million, compared to a total
comprehensive loss of €12.6 million for the nine months ended September 30, 2016.
On September 30, 2017, argenx's cash, cash-equivalents and current financial assets amounted to €161.7 million, compared to €96.7
million on December 31, 2016 and €103.1 million on September 30, 2016. The increase in argenx's cash, cash-equivalents and current
financial assets in 2017 is explained by the proceeds received from argenx's U.S. initial public offering on Nasdaq in May
2017.
About argenx
argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the
treatment of severe autoimmune diseases and cancer. We are focused on developing product candidates with the potential to be either
first-in-class against novel targets or best-in-class against known, but complex, targets in order to treat diseases with a
significant unmet medical need. Our ability to execute on this focus is enabled by our suite of differentiated technologies. Our
SIMPLE Antibody(TM) Platform, based on the powerful llama immune system, allows us to exploit novel and complex targets, and our
three antibody engineering technologies are designed to enable us to expand the therapeutic index of our product candidates.
www.argenx.com
For further information, please contact:
Joke Comijn, Corporate Communications Manager
+32 (0)477 77 29 44
+32 (0)9 310 34 19
info@argenx.com
Beth DelGiacco (US IR)
Stern Investor Relations
+1 212 362 1200
beth@sternir.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 the
intended results of its strategy; its financial condition, results of operation and business outlook; the sufficiency of its cash,
cash equivalents and current financial assets; and the momentum of its product candidate pipeline as well as the advancement of,
and anticipated clinical development and regulatory milestones and plans related to, and data readouts for, argenx's product
candidates and preclinical and clinical trials. 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 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 the final prospectus related to argenx's initial U.S. public offering filed with the SEC pursuant
to Rule 424(b) of the Securities Act of 1933, as amended, 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.
