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Galapagos half year revenues up 21%

09 August 2013 at 07:30 CET

·         Group revenues €77.4 M compared to €64.5 M in H1 2012
·         Group net loss reduced to €5.4 M, from €11.3 M last year
·         Cash position of €136.7 M on 30 June 2013
·         Strong clinical pipeline with five Phase 2 and one Phase 1 program
·         Service division external revenues for the running business €28.0 M (H1 '12: €29.4 M)
·         Services EBITDA €3.0 M compared to €5.7 M last year
·         Full year guidance: €160 M in Group revenues reiterated, year end cash position €100 M

Click here to access the live audio webcast presentation at 10.00 CET today,
call numbers: Belgium +32-2290-1608, Toll-free 0800-50747; Netherlands +31-20-794-8504, Toll-free 0800 265 8526

Mechelen, Belgium; 9 August 2013 - Galapagos NV (Euronext: GLPG) announces its unaudited half year results and retains guidance for the full year 2013.

"Galapagos delivered again in the first half of 2013, with strong progress in our pipeline.  Galapagos now has five Phase 2 clinical studies in patients.  The Phase 2B program in RA with JAK1-inhibitor GLPG0634 progressed as planned, and we expanded the '634 franchise with AbbVie twice, with the expansion of the Phase 2B program in RA and the initiation of a Phase 2 study in Crohn's disease.  GSK announced the start of two Phase 2 studies with GSK2586184 (formerly GLPG0778) in lupus and psoriasis.  Galapagos initiated a Phase 2 Proof-Of-Concept study with GLPG0974 in ulcerative colitis.  We achieved substantial milestones in our alliances, declared a new pre-clinical candidate in our internal program on triple-negative breast cancer, and reported promising results with a potentiator series in cystic fibrosis.  Our service division had a disappointing performance during the first half, but with a strong pipeline we are confident that the result will improve over the second half of the year.  Galapagos is well on track to achieve its operational goals for the year and we reiterate our full year guidance of €160 million in Group revenues and provide guidance for year end cash of €100 million," said Galapagos CEO Onno van de Stolpe.

Key figures half year 2013
(€ millions, except net loss per share)

30 June 2013 30 June 2012 Change
Revenues 77.4 64.5 12.9
Services cost of sales -20.1 -25.0 4.9
Gross profit 57.3 39.5 17.8
R&D expenditure -48.0 -35.9 -12.1
General & administrative -12.9 -11.9 -1.0
Sales & marketing -1.1 -1.1 -
Restructuring & integration costs -0.6 -0.4 -0.2
Result on liquidation -2.9 2.9
Operating loss -5.2 -12.6 7.4
Net loss for the period -5.4 -11.3 5.9
Basic loss per share (€) -0.19 -0.43 0.24
Cash and cash equivalents 136.7 122.6 14.1

Details of the financial results

Revenues
Galapagos' revenues for the first half of 2013 amount to €77.4 million compared to €64.5 million in the same period of 2012.  The R&D division reported external revenues of €49.1 million, compared to €31.5 million in the same period last year.  The R&D division revenue increase was driven by revenue recognition on the upfront payment from AbbVie in the global collaboration on GLPG0634, the amendment announced in April 2013 for extended scope of the Phase 2B program, and the achievement of significant milestone payments from the other alliances.  Services external revenues amounted to €28.4 million in the first half of 2013, compared to €32.9 million in the same period last year.  Normalizing for the closure and relocation of the Basel site activities last year and the Cangenix acquisition this year, external service revenues for the running business were €28.0 million, compared to €29.4 million in the same period last year.

Results
The group net loss for the first half of 2013 was €5.4 million, an improvement of 52% compared to a loss of €11.3 million for the first six months of 2012.

The EBITDA before intersegment and IFRS adjustments for the service operations over the first six months of the year was €3.0 million, compared to €5.7 million last year.  Gross margins of the service operations were 31%, compared to 34% in the first half last year.  Profitability of the Services unit is traditionally lower in the first half of the year.

The R&D division reported an EBITDA loss before intersegment and IFRS adjustments of €1.3 million, compared to a loss of €8.3 million in the first six months of 2012.  R&D expenses for the Group in the first half-year of 2013 were €48.0 million compared to €35.9 M in 2012.  This increase is mainly due to outsourcing costs related to the GLPG0634 franchise, which was as expected with the larger Ph2B program.

General and administrative (G&A) expenses of the Group were €12.9 million in the first half of 2013 (17% of Group revenues), compared to €11.9 million (18% of Group revenues) in the first half of 2012.

Liquid assets position
Galapagos' cash and cash equivalents amounted to €136.7 million on 30 June 2013.  The Company's liquid asset position of €150.3 million on 30 June 2013 (€115.4 million at year end 2012) included €13.6 million in alliance related receivables for which revenues were recorded in H1 2013, and payment was received in Q3 2013.  A net increase of €42.1 million in cash and cash equivalents was recorded during the first half of 2013, compared to an increase of €90.1 million in the same period last year.  The increase this year is due to the €52.8 million net proceeds from a private placement in April 2013.  The increase last year was due to the collection of the $150 million (€112 million) cash upfront payment made by AbbVie in the collaboration on GLPG0634.  Furthermore, Galapagos' balance sheet holds an unconditional and unrestricted receivable from the French government (Crιdit d'Impτt Recherche)[1] now amounting to €28 million, payable in four yearly tranches starting in early 2014.

Operational overview

R&D division

·         Other
o    Announced the termination of the Roche and Lilly alliances
o    Announced three grant awards from IWT: €2.7 million to discover new antibiotic treatments, €2.5 million for inflammatory bowel disease research and development, and €2.4 million for psoriasis research

Service division
·         Extended the collaboration between BioFocus and The Michael J. Fox Foundation for optimization of agents for disease specific biomarkers
·         Signed a new collaboration between Argenta and Antabio for the identification of novel anti-bacterial agents and discovery of a development candidate
· Signed an integrated drug discovery collaboration between Argenta en Boehringer Ingelheim in which Argenta will apply its extensive respiratory drug discovery services
·         Acquired Cangenix, a structure-based drug discovery company, to augment Argenta's ability to design new drugs and fill a growing client need

Corporate
·         The AGM appointed Katrine Bosley to the Board of Directors to replace Ferdinand Verdonck
·         Raised €1,181,926 in equity through warrant exercises, resulting in the issuance of 197,581 new shares
·         Completed a private placement of 2,696,831 new ordinary shares, raising €54 million (€52.8 million net proceeds) with primarily US institutional investors, bringing the total number of shares outstanding as of 30 June 2013 to 29,665,159
·         NYSE Liffe, the Europe-based derivatives business of NYSE Euronext (NYX), added options on the shares of Galapagos (GLS)

Outlook 2013
The Phase 2B clinical study in RA with GLPG0634 started in the second quarter of 2013, on track to delivering the 12-week data to AbbVie in late 2014 and 24-week data in early 2015.  The Company expects to make significant progress in both partnered and non-partnered R&D programs as the clinical pipeline continues to mature across a broad range of therapeutic areas, resulting in five Phase 2 and multiple Phase 1 programs by end 2013.

Galapagos management reiterates full-year 2013 financial guidance for Group revenues of €160 million and provides guidance of €100 million in cash at year end.

Interim Report 2013
The electronic version of Galapagos' Interim Report for half year 2013 is now available online at www.glpg.com/index.php/companyoverview/financialskey-financials/financial-reports/.  Printed versions of the report can be requested by e-mailing ir@glpg.com.

Conference call and webcast presentation
Galapagos will conduct a conference call open to the public today at 10.00 Central European Time (CET), which will also be webcast.  To participate in the conference call, please call Belgium +32-2290-1608, Toll-free 0800-50747; Netherlands +31-20-794-8504, Toll-free 0800 265 8526, ten minutes prior to commencement of the call.  A question and answer session will follow the presentation of the results.  Click here to access the live audio webcast.  The archived webcast will also be available for replay shortly after the close of the call.

Financial calendar 2013
3Q13 interim update                   15 November 2013
Full year results 2013                 7 March 2014
Annual shareholders meeting      29 April 2014

About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a large pipeline of five clinical, six pre-clinical, and more than 20 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications.
GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, currently in Phase 2B studies in RA and about to enter Phase 2 studies in Crohn's disease.  AbbVie and Galapagos signed a worldwide license agreement whereby AbbVie will be responsible for further development and commercialization after Phase 2B.  Galapagos has another selective JAK1 inhibitor in Phase 2 in lupus and psoriasis, GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012).  GLPG0187 is a novel integrin receptor antagonist currently in a Phase 1B patient study in metastasis.  GLPG0974 is the first inhibitor of FFA2 to be evaluated clinically for the treatment of IBD; this program is currently in a Proof of Concept Phase 2 study.  GLPG1205 is a first-in-class molecule that targets inflammatory disorders and is currently in a First-in-Human Phase 1 study.
The Galapagos Group, including fee-for-service companies BioFocus, Argenta and Fidelta, has 800 employees and operates facilities in five countries, with global headquarters in Mechelen, Belgium.  Further information at: www.glpg.com

CONTACT

Galapagos NV
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
ir@glpg.com

Galapagos forward-looking statements
This release may contain forward-looking statements, including, without limitation, statements containing the words "believes," "anticipates," "expects," "intends," "plans," "seeks," "estimates," "may," "will," "could," "stands to," and "continues," as well as similar expressions. Such forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. 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, unless required by law or regulation.


[1] Crιdit d'Impτt Recherche refers to an innovation incentive system underwritten by the French government

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