Full Press Release Details
Galapagos reports on historic first quarter 2019
Key Q1 2019 results:
Webcast presentation tomorrow, 26 April 2019, at 14.00 CET/8 AM ET,
+32 2 404 0659, code 1452466, www.glpg.com
Mechelen, Belgium; 25 April 2019, 22.01 CET; regulated information 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 burn1 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
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 Sj gren s syndrome and cutaneous lupus, and launch a Phase 3 trial in psoriatic arthritis.
This alternative performance
measure is in our view an important metric for a biotech company in the development stage.
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
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.
| 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) |
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.
the drug candidates mentioned in this press release are investigational; their efficacy and safety have not yet been established.
Senior Director Communications & Public Affairs
Director Communications
Forward-looking statements
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 2019), 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 2019 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.