Galapagos reports on historic first quarter 2019

 

Galapagos NV (Euronext & NASDAQ: GLPG) presents financial results and highlights the key events for the first quarter of 2019.

"The first quarter of 2019 was one of the most historic ones in our nearly 20 year existence: our Phase 3 FINCH 1 and 3 results with our lead program, selective JAK1 inhibitor filgotinib, show competitive efficacy and safety potential in rheumatoid arthritis. With over 40 trials running in 2019, including our fully-owned ISABELA and PINTA programs in IPF and Toledo in inflammation, we are looking forward to a particulary busy and interesting rest of the year," said Onno van de Stolpe, CEO of Galapagos.

Bart Filius, COO & CFO, added: "While expanding our early stage clinical portfolio and executing clinical trials on the later stage assets, we incurred an operational cash burn[1] of €76.3 million in the first quarter. Given the expected growth in development activity this year, we retain our full year 2019 cash burn guidance of €320-340 million. Our current total cash and cash equivalents position is approximately €1.2 billion, maintaining an excellent financial position to deliver the trials and earlier R&D research planned."

Outlook 2019
Following on the positive Phase 3 FINCH trial results, Gilead plans to discuss submissions for approval of filgotinib in RA with regulatory authorities in 2019. They also plan to report topline results for the proof-of-concept trials in Sjögren's syndrome and cutaneous lupus, and launch a Phase 3 trial in psoriatic arthritis.
We will continue recruitment in our proprietary ISABELA and NOVESA trials, and plan to fully recruit our PINTA trial. With collaboration partner Servier, we also aim to finalize recruitment in the ROCCELLA trial. For MOR106, together with our collaboration partners MorphoSys and Novartis, we plan to continue executing the Phase 1 and 2 trials running.

With regard to our earlier and fully proprietary programs, we expect Phase 1 readouts of a number of trials, including for GLPG3312, our first Toledo compound, with a Phase 1 for a second Toledo compound (GLPG3970), scheduled for the second half of the year.
We retain our guidance for an operational cash burn between €320 - 340 million in 2019.

Key figures Q1 2019 (unaudited)
(€ millions, except basic & diluted loss per share)

 

31 Mar 2019 Group total

31 Mar 2018 Group total

Revenues and other income

40.9

44.8

R&D expenditure

-83.2

-69.8

G&A and S&M expenses

-11.0

-7.1

Operating loss

-53.2

-32.0

 

 

 

Financial result

4.7

-5.2

Taxes

-0.1

-0.1

Net result for the period

-48.7

-37.3

Basic and diluted loss per share (€)

-0.89

-0.73

 

 

Cash and cash equivalents  

1,222.9

1,108.2

First quarter report 2019
Galapagos has published its online financial report for the first quarter ended 31 March 2019, which can be accessed via http://reports.glpg.com/2019/q1/en/

Conference call and webcast presentation
Galapagos will conduct a conference call open to the public tomorrow, 26 April 2019, 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:   1452466

United Kingdom:                                               +44 330 336 9105

France:                                                             +33 1 76 772 274

Belgium:                                                           +32 2 404 0659

USA:                                                                 +1 323 794 2551

Netherlands:                                                     +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 calendar

25 July 2019                 Half year 2019 results (webcast 26 July 2019)

24 October 2019           Third quarter 2019 results (webcast 25 October 2019)

20 February 2020          Full year 2019 results (webcast 21 February 2020)

 

Note

Galapagos (Euronext & NASDAQ: GLPG) discovers and develops small molecule medicines with novel modes of action, three of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, osteoarthritis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. 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.

 

 

Interested in a regular update of the Life Sciences and biotech sector in Flanders?