Key 2015 financials:
- Cash burn of €122 million, in line with guidance
- Cash balance on 31 December 2015 of €348
million
- Cash in January 2016, post-closing of Gilead
transaction, of €1.02 billion
Management guidance for 2016:
- Week 20 results from filgotinib in FITZROY Phase 2
study in Crohn's disease in April
- Start of Phase 3 studies with filgotinib in rheumatoid
arthritis and Crohn's disease
- Phase 2 topline results from SAPHIRA study with
potentiator GLPG1837 in cystic fibrosis and patient recruitment
completion with GLPG1690 in idiopathic pulmonary
fibrosis
- Phase 1 topline results with multiple cystic fibrosis
compounds and with osteoarthritis program GLPG1972
- Reduced cash burn of between €100 - 120
million
Webcast presentation tomorrow, 4 March, at 14.00 CET/8 AM
ET, +32 2 6200138 www.glpg.com
MECHELEN, Belgium, March 3, 2016 (GLOBE NEWSWIRE)
-- Galapagos NV (Euronext & NASDAQ: GLPG)
presents financial results and highlights the key events for the
full year 2015.
"The year 2015 has been a stellar one for
Galapagos, as we have truly stepped up to the next level in our
development towards a commercially based biotech company. We
achieved a number of remarkable milestones in 2015: delivery of
potentially best-in-class efficacy and safety Phase 2 data with our
selective JAK1 inhibitor filgotinib in rheumatoid arthritis and
Crohn's disease, a NASDAQ listing, and a licensing deal with Gilead
that will help transform our company. In our cystic fibrosis
(CF) program, we completed the discovery phase for a triple
combination therapy that is expected to address 90% of patients
with CF, and we advanced several of our novel mechanism of action
programs to later stages. All of these were important
stepping stones in our ongoing efforts to deliver novel medications
to patients.
I wish to thank our shareholders for their
support. We ended 2015 strong, both financially and
operationally," CEO Onno van de Stolpe commented. "Now we
want to use our strong position to get the most effective
combination therapy in CF ready for Phase 2 studies and to advance
the rest of our promising pipeline, while assisting Gilead with the
start and preparation of two Phase 3 programs with filgotinib."
Bart Filius, CFO, added: "Last year Galapagos
took major steps toward financial independence as a company: the
NASDAQ listing and financing round grossed $317 million and
increased our trading liquidity, and later came the Gilead deal on
filgotinib which brought in $725 million cash upon closing in
January 2016. Riding on the success of filgotinib, a compound
developed against the JAK1 target discovered by Galapagos, we aim
to advance more programs using proprietary targets out of our
discovery platform toward the clinic. In addition, we will
ramp up our clinical activities in cystic fibrosis, with six
studies in progress in 2016, on track to have a potential triple
combination therapy in patient studies in 2017. All this will
contribute to our financial guidance for operational cash burn of
between €100 and 120 million."
Key figures (consolidated) (€ millions, except basic
income/loss per share)
|
31 Dec
2015 Group Total |
31 Dec
2014 Group Total |
Revenues |
60.6 |
90.0 |
R&D expenditure |
-129.7 |
-111.1 |
G&A and S&M
expenses |
-20.3 |
-14.9 |
Operating result before
exceptional items |
-89.4 |
-36.0 |
Restructuring &
integration costs |
|
-0.7 |
Operating loss |
-89.4 |
-36.6 |
Non-cash adjustment on
short term financial asset1 |
-30.61 |
|
Other financial
result |
0.4 |
1.4 |
Income taxes |
1.2 |
-2.1 |
Net loss from
continuing operations |
-118.4 |
-37.3 |
Net income from
discontinued operations |
|
70.52 |
Net result for the
period |
-118.4 |
33.2 |
Basic income / Loss (-)
per share for continuing operations (€) |
-3.32 |
-1.24 |
Cash, Cash
equivalents and Restricted cash at year-end |
348.2 |
198.4 |
Notes:
- Reflects non-cash financial asset adjustment resulting from the
Gilead subscription agreement, to be offset by positive €57.5
million non-cash adjustment in Q1 2016.
- Galapagos sold its service operations to Charles River
Laboratories Inc. on 1 April 2014. As a result of this sale,
the service operations are reported as discontinued
operations. Group results include both continuing and
discontinued operations.
Details of the financial results
Revenues Galapagos' revenues and other income
for 2015 amounted to €60.6 million, compared to €90.0 million in
2014. Revenues were lower due to a decrease in revenue recognition
of upfront payments and reduced milestone payments from partners,
reflecting the increasingly proprietary nature of our pipeline
programs.
Operating result The Group realized a net
operating loss in 2015 of €89.4 million, compared to a net
operating loss of €36.6 million in 2014 for continuing
operations.
R&D expenses for the Group in 2015 were
€129.7 million compared to €111.1 million in 2014. This
planned increase is due mainly to increased efforts on our clinical
and pre-clinical programs, primarily the cystic fibrosis
programs.
G&A and S&M expenses of the Group were
€20.3 million in 2015, compared to €14.9 million in 2014.
This increase is due primarily to non-cash items such as a higher
provision for short term and long term management bonus and higher
costs for warrant plans, mainly as a result of the evolution of the
Galapagos share price.
Non-cash adjustment on short term financial
asset Galapagos recognized a short term financial asset worth €39
million upon signing of the share subscription agreement with
Gilead, as required under IAS 39. This financial asset
initially reflected the share premium that Gilead committed to pay
above the closing stock price of Galapagos on the day of signing of
the subscription agreement. Under IAS 39, the fair value of
the financial asset needed to be re-measured at year end and again
upon entering into force of the subscription agreement on 19
January 2016, when the financial asset expired. Variations in
fair value of the financial asset were recorded in the income
statement.
The decrease in the fair value of the financial
asset resulting from the increase in the Galapagos share price
between signing of the subscription agreement and 31 December 2015,
resulted in a negative, non-cash adjustment of €30.6 million in the
2015 financial results. The subsequent increase in the fair
value of the financial asset resulting from the decrease in the
Galapagos share price between 1 January 2016 and 19 January 2016
will result in a positive non-cash adjustment of €57.5 million in
the financial result of the first quarter 2016 financial
reporting.
Cash position Cash, cash equivalents, and
restricted cash totalled €348.2 million on 31 December 2015.
A net increase of €149.8 million in cash, cash
equivalents and restricted cash was recorded in 2015. Net
cash flows from financing activities generated €259.4 million
through a global offering and concurrent listing on NASDAQ, as well
as €12.0 million from warrant exercises. Furthermore, the
Company continued to intensify its R&D investments, resulting
in a cash burn of €121.6 million in 2015.
Furthermore, Galapagos' balance sheet holds an
unconditional and unrestricted receivable from the French
government (Crédit d'Impôt Recherche[1])now amounting to €33.4
million, payable in 4 yearly tranches. Galapagos' balance
sheet also holds a receivable from the Belgian Government for
R&D incentives now amounting to €25.1 million.
Galapagos received $725 million in cash from
Gilead upon closing of their global collaboration agreement on 19
January 2016. Galapagos had €1.02 billion in cash, cash
equivalents, and restricted cash after the closing of the
transaction.
Outlook 2016 The 20-week results from
filgotinib in Crohn's disease (FITZROY) are expected in
April. Galapagos and Gilead are preparing to initiate Phase 3
programs in two indications with filgotinib in 2016.
In cystic fibrosis, Galapagos expects to report
topline results with GLPG1837 in the Phase 2 SAPHIRA study in Class
III mutation patients before year end and report Phase 1 topline
results with other CF compounds. All components of a future
triple combination are anticipated to be in clinical evaluation by
year end.
Galapagos expects to complete recruitment in its
Phase 2 study with GLPG1690 in idiopathic pulmonary fibrosis before
year end for topline results in 1H 2017, and to report topline
results from its Phase 1 study with osteoarthritis program GLPG1972
around mid-year.
The Company expects an operational use of cash
of €100-120 million during 2016, excluding payments received from
our partner Gilead for filgotinib.
Annual Report 2015 Galapagos is currently
finalizing its financial statements for the year ended 31 December
2015. The Auditor has confirmed that his audit procedures,
which are substantially completed, have not revealed any material
corrections required to be made to the financial information
included in this press release. Should any material changes
arise during the audit finalization, an additional press release
will be issued. Galapagos expects to be able to publish its
fully audited Annual Report for the full year 2015 on or around 25
March 2016.
Conference call and webcast
presentation
Galapagos will conduct a conference call open to
the public tomorrow, 4 March 2016, at 14:00 Central European Time
(CET)/8 AM Eastern Time, 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:
4962190
United Kingdom:
+44 20 3427 1918 Toll free United Kingdom:
0800 279 4841 France:
+33 1 76 77 22 22 Toll free France:
0805 631 579 Belgium:
+32 2 6200138 Toll free Belgium:
0800 58033 USA:
+1646 254 3366 Toll free USA:
+1646 254 3366 Netherlands:
+31 20 721 9158 Toll free Netherlands:
0800 020 2577
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 calendar 26 April
2016
Annual General Meeting of Shareholders in Mechelen 29 April
2016
First Quarter 2016 Results 29 July 2016
First Half 2016 Results 28 October
2016
Third Quarter 2016 Results 3 March
2017
Full Year 2016 Results
About Galapagos Galapagos(Euronext & NASDAQ: GLPG) is
a clinical-stage biotechnology company specialized in the discovery
and development of small molecule medicines with novel modes of
action. Our pipeline comprises three Phase 2, three Phase 1,
five pre-clinical, and 20 discovery studies in cystic fibrosis,
inflammation, fibrosis, osteoarthritis and other indications.
We have discovered and developed filgotinib: in collaboration with
Gilead we aim to bring this JAK1-selective inhibitor for
inflammatory indications to patients all over the world.
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 440 employees, operating from its Mechelen, Belgium
headquarters and facilities in The Netherlands, France, and
Croatia. More information at www.glpg.com.
CONTACT
Investors:
Media: Elizabeth
Goodwin
Evelyn Fox VP IR & Corporate
Communications
Director Communications Tel: +1 781 460
1784
Tel: +31 6 53 591 999 E-mail:
ir@glpg.com
E-mail:
communications@glpg.com
Forward-Looking Statements This release may contain
forward-looking statements, including statements regarding any
guidance given by Galapagos' management, the anticipated timing of
clinical studies with filgotinib, GLPG1690, GLPG1972, or in the
field of cystic fibrosis, the progression and results of such
studies, the anticipated cash burn for Galapagos' contemplated
operations, and the possible activity and clinical utility of a
potential triple combination therapy for cystic fibrosis.
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 2016 revenues and financial results and its 2016 operating
expenses may be incorrect (including because one or more of its
assumptions underlying its revenue or expense expectations may not
be realized), the inherent uncertainties associated with
competitive developments, clinical trial and product development
activities and regulatory approval requirements (including that
data from Galapagos' ongoing clinical research programs in
rheumatoid arthritis, Crohn's disease, idiopathic pulmonary
fibrosis, osteoarthritis and cystic fibrosis may not support
registration or further development of its drug candidates due to
safety, efficacy or other reasons), Galapagos' reliance on
collaborations with third parties (including its collaboration
partner for filgotinib, Gilead, and its collaboration partner for
cystic fibrosis, AbbVie), and estimating the commercial potential
of Galapagos' product candidates. 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' prospectus filed with
the SEC on 14 May 2015 and subsequent 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] Crédit d'Impôt Recherche refers to an
innovation incentive system underwritten by the French
government.
Financial tables
http://hugin.info/133350/R/1991766/732921.pdf
HUG#1991766
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