Key Q1 2018 results:
- Group revenues of €44.8 million
- Operating loss €32.0 million
- Net loss of €37.3 million
- End of first quarter cash and cash equivalents €1.1
billion
- Clinical progress reported in CF and OA, preparations
for multiple late stage studies
Webcast presentation tomorrow, 26 April 2018,
at 14.00 CET/8 AM ET, +32 2 404 0659, code 5747918,
www.glpg.com
Mechelen, Belgium; 25 April 2018, 22.01 CET;
regulated information - Galapagos NV (Euronext & NASDAQ:
GLPG) presents financial results and highlights the key events for
the first quarter of 2018.
"Galapagos is delivering on a very productive
biotech pipeline. The first quarter of 2018 brought us closer to
the expected start in the second quarter of the next patient
studies in our osteoarthritis, atopic dermatitis, and cystic
fibrosis programs. Importantly, we received feedback from
regulatory authorities for our ISABELA global pivotal studies with
GLPG1690 in idiopathic pulmonary fibrosis, expected to start in the
second half of 2018. We await the next round of filgotinib clinical
study results starting with the EQUATOR study in psoriatic
arthritis in the second quarter as well. First quarter 2018 was
about preparation for a significant expected future newsflow," said
Onno van de Stolpe, CEO of Galapagos.
Bart Filius, COO & CFO, added: "While
delivering on our earlier stage programs and preparing several
important later stage studies, we incurred an operational cash burn
of €41.3[1] million in the first quarter. Given the expected growth
in late stage development activity this year, we retain our full
year 2018 cash burn guidance of €220-240 million. Our current total
cash and cash equivalents position is approximately €1.1 billion,
maintaining a strong position to finance the studies and earlier
R&D research we expect to run in 2018. Overall, we remain very
well positioned for the execution of our strategy in the coming
years." Key figures Q1 2018 (unaudited)(€ millions, except
basic & diluted loss per share)
|
31 Mar
2018 Group total |
31 Mar
2017 Group total |
Revenues and other
income |
44.8 |
39.9 |
R&D expenditure |
-69.8 |
-44.9 |
G&A and S&M
expenses |
-7.1 |
-6.2 |
Operating loss |
-32.0 |
-11.2 |
|
|
|
Financial result |
-5.2 |
-2.4 |
Taxes |
-0.1 |
|
Net result for the
period |
-37.3 |
-13.6 |
Basic and diluted loss
per share (€) |
-0.73 |
-0.29 |
Cash and cash
equivalents |
1,108.2 |
953.4 |
Outlook 2018Galapagos aims to report
topline results with the FINCH 2 (rheumatoid arthritis), EQUATOR
(psoriatic arthritis), TORTUGA (ankylosing spondilitis) filgotinib
studies as well as a decision to continue to Phase 3 in SELECTION
(ulcerative colitis). Our collaboration partner Gilead expects to
complete recruitment of FINCH 1 and FINCH 3, the remaining RA Phase
3 studies with filgotinib. In cystic fibrosis we anticipate the
readout of the PELICAN patient study with GLPG2737 and an interim
readout with our first triple combination therapy in FALCON.
Galapagos recently announced the design for the ISABELA pivotal
studies with GLPG1690 in IPF. We expect to start dosing ISABELA and
initiate Phase 2 studies with GLPG1205 (IPF), an additional CF
triple combination, GLPG1972 (osteoarthritis), and MOR106 (atopic
dermatitis) later in 2018.
Galapagos expects an operational cash burn between €220 and €240
million in 2018.
First quarter report 2018 Galapagos has
published its online financial report for the first quarter ended
31 March 2018, which can be accessed via
http://reports.glpg.com/2018/q1/en/
Conference call and webcast
presentation
Galapagos will conduct a conference call open to
the public tomorrow, 26 April 2018, at 14:00 CET/8 AM ET, which
will also be webcast. To participate in the conference call, please
call one of the following numbers ten minutes prior to
commencement:
Confirmation Code:
5747918
United Kingdom:
+44 330 336 9105France:
+33 1 76 772 274Belgium:
+32 2 404 0659USA:
+1 323 794 2093Netherlands:
+31 20 721 9251
A question and answer session will follow the
presentation of the results. Go to www.glpg.com to access the live
audio webcast. The archived webcast will also be available for
replay shortly after the close of the call.
Financial calendar2 August
2018
Half year 2018 results (webcast 3 August 2018)25 October
2018
Third quarter 2018 results (webcast 26 October 2018)21 February
2019
Full year 2018 results (webcast 22 February 2019)
About GalapagosGalapagos (Euronext & NASDAQ: GLPG) is
a clinical-stage biotechnology company specialized in the discovery
and development of small molecule medicines with novel modes of
action. Galapagos' pipeline comprises Phase 3 through to discovery
programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis
and other indications. Our target discovery platform has delivered
three novel mechanisms showing promising patient results in,
respectively, inflammatory diseases, idiopathic pulmonary fibrosis
and atopic dermatitis. Galapagos is focused on the development and
commercialization of novel medicines that will improve people's
lives. The Galapagos group, including fee-for-service subsidiary
Fidelta, has approximately 634 employees, operating from its
Mechelen, Belgium headquarters and facilities in the Netherlands,
France, Switzerland, the US and Croatia. More information at
www.glpg.com.
All the drug candidates mentioned in this press
release are investigational; their efficacy and safety have not yet
been established.
ContactsInvestors:Elizabeth
GoodwinVP IR & Corporate Communications +1 781 460 1784
Paul van der HorstDirector IR & Business
Development +31 71 750 6707ir@glpg.com
Media:Evelyn FoxDirector Communications
+31 6 53 591 999 communications@glpg.com
Forward-looking statementsThis release may contain
forward-looking statements, including, among other things,
statements regarding the guidance from management (including
guidance regarding the expected operational cash burn during
financial year 2018), financial results, the timing of audited
financial results, timing and/or results of clinical studies, and
interaction with regulators. Galapagos cautions the reader that
forward-looking statements are not guarantees of future
performance. Forward-looking statements involve known and unknown
risks, uncertainties and other factors which might cause the actual
results, financial condition and liquidity, performance or
achievements of Galapagos, or industry results, to be materially
different from any historic or future results, financial conditions
and liquidity, performance or achievements expressed or implied by
such forward-looking statements. In addition, even if Galapagos'
results, performance, financial condition and liquidity, and the
development of the industry in which it operates are consistent
with such forward-looking statements, they may not be predictive of
results or developments in future periods. Among the factors that
may result in differences are that Galapagos' expectations
regarding its 2018 operating expenses may be incorrect (including
because one or more of its assumptions underlying its expense
expectations may not be realized), Galapagos' expectations
regarding its development programs may be incorrect, the inherent
uncertainties associated with competitive developments, clinical
study and product development activities and regulatory approval
requirements (including that data from Galapagos' ongoing clinical
research programs may not support registration or further
development of its product candidates due to safety, efficacy or
other reasons), Galapagos' reliance on collaborations with third
parties, and estimating the commercial potential of its development
programs. A further list and description of these risks,
uncertainties and other risks can be found in Galapagos' Securities
and Exchange Commission (SEC) filings and reports, including in
Galapagos' most recent annual report on form 20-F filed with the
SEC and other filings and reports filed by Galapagos 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. Galapagos expressly disclaims any obligation to
update any such forward-looking statements in this document to
reflect any change in its expectations with regard thereto or any
change in events, conditions or circumstances on which any such
statement is based or that may affect the likelihood that actual
results will differ from those set forth in the forward-looking
statements, unless specifically required by law or regulation.
[1] The operational cash burn (or operational
cash flow if this performance measure is positive) is equal to the
sum of the net cash flows generated / used (-) in operating
activities and the net cash flows generated / used (-) in investing
activities minus (i) the proceeds or cash used, if any, in
acquisitions or disposals of businesses; and (ii) the movement in
restricted cash, if any. This alternative performance measure is in
our view an important metric for a biotech company in the
development stage. For the first quarter of 2017, the operational
cash burn represented €23.9 million.
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