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Firmly on our way to becoming a fully integrated biopharma companyRevenues doubled in 2018 Key 2018 clinical results:
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Webcast presentation tomorrow, 22 February 2019 at 14.00 CET/8 AM ET, +32 (0)2 404 0659, www.glpg.com Mechelen, Belgium; 21 February 2019, 22.01 CET, regulated information - Galapagos NV (Euronext & NASDAQ: GLPG) presents financial results and highlights the key events for the full year 2018. "The year 2018 was truly pivotal in the history of our company, with the publication of our first ever Phase 3 results, from the FINCH 2 trial in rheumatoid arthritis patients. We also saw promising Phase 2 results with filgotinib in TORTUGA and EQUATOR. Once again, we are encouraged by the results observed, and we are looking forward to the FINCH 1 & 3 Phase 3 results expected in Q1 2019. We significantly expanded our fully proprietary fibrosis portfolio, most notably with the start of the ISABELA and PINTA trials in IPF, while our programs in OA and AtD are also advancing in late stage development," CEO Onno van de Stolpe commented. "The coming year will be data-rich for filgotinib. Following the outcome of the FINCH trials, we expect our collaboration partner Gilead to submit an application for approval for filgotinib in RA - another true milestone for our company. Filgotinib will also advance in the other inflammatory indications, with the readout of the Phase 2 trials in Sjögren's and cutaneous lupus anticipated this year. For MOR106 in AtD, together with our collaboration partners MorphoSys and Novartis, we expect top-line results of the Phase 2 IGUANA study and the subcutaneous Phase 1 bridging study. Meanwhile, recruitment for our other clinical trials is ongoing, and we hope to complete recruitment of the ROCCELLA and PINTA trials, in OA and IPF respectively, before year-end. We are also excited by the progress in our preclinical pipeline, and more particularly with our Toledo family: in H2 2019, the first compound, GLPG3312, should read out Phase 1 results, with a second compound expected to enter the clinic before year-end. 'Thinking big' has brought us where we are today, and this remains our motto as we build towards becoming a fully-integrated biopharma company." Bart Filius, COO and CFO of Galapagos, added: "Thanks to a successful capital transaction for gross proceeds of €296.2 million, as well as the important business development deals signed with Novartis and AbbVie, we ended 2018 with an extraordinarily strong balance sheet, while still delivering substantial research & development (R&D) spend and progress. We remain focused on investing in our maturing clinical pipeline of novel mechanism of action candidates, and expect to run over 40 clinical trials this year. We will also expand our commercial organization further as we gear up for a potential market launch of filgotinib in 2020. All this will contribute to our financial guidance for operational cash burn[1] between €320 and €340 million for full year 2019." Key figures (consolidated)
Revenues and other income Operating result R&D expenses for the Group in 2018 were €322.8 million compared to €218.5 million in 2017. This planned increase was due mainly to increased efforts on our clinical and preclinical programs, primarily filgotinib, our IPF program and the proprietary preclinical programs in inflammation and fibrosis. G&A and S&M expenses of the Group were €39.8 million in 2018, compared to €27.2 million in 2017. This increase was due primarily to a planned headcount increase and higher costs for warrant plans (non-cash), mainly as a result of the increase of the Galapagos share price. Net result Cash position A net increase of €139.6 million in cash and cash equivalents was recorded in 2018. Net cash flows from financing activities generated €280.2 million through a public offering in the United States, as well as €7.7 million from warrant exercises. Total operational cash burn in 2018 amounted to €158.4 million, within the guided range, and consisted of a net cash outflow from operating activities of €142.5 million and an investing cash outflow of €15.9 million. Finally €10.1 million unrealized positive exchange rate differences were generated on cash and cash equivalents. Furthermore, Galapagos' balance sheet holds a receivable from the French government (Crédit d'Impôt Recherche[4]), payable in four yearly tranches and a receivable from the Belgian Government for R&D incentives, for a total of both receivables of €84.6 million. Outlook 2019 We also plan to fully recruit our Phase 2 PINTA study for our fully proprietary IPF compound GLPG1205 as well as our ROCCELLA study in OA, together with collaboration partner Servier. For GLPG1690, we plan to continue our ISABELA trials as well as the NOVESA Phase 2 trial in systemic sclerosis (SSc), for which a first patient was dosed in early 2019. For MOR106, together with our collaboration partners MorphoSys and Novartis, we plan to start a Phase 2 trial in AtD with MOR106 in combination with topical corticosteroids (the GECKO Phase 2 trial) as well as a Japanese ethno-bridging study. In the second half of the year, we expect the primary analysis of the IGUANA Phase 2 trial in AtD and topline results of the subcutaneous Phase 1 bridging study. Pending positive results, these four studies combined should offer a solid data package for our collaboration partner Novartis to move into Phase 3. With regard to our earlier and fully proprietary programs, we expect Phase 1 readouts of a number of earlier stage studies, including for GLPG3312, the first Toledo compound that entered the clinic in early 2019. This molecule is scheduled to be dosed in patients in a first proof-of-concept study before the end of the year. We also plan to initiate a Phase 1 trial with our second generation Toledo compound, GLPG3970, in the second half of the year. Given the large number of maturing proprietary clinical programs and the expansion of our R&D and commercial team, we expect an operational cash burn between €320 and €340 million in 2019. Annual report 2018 Conference call and webcast presentation Galapagos will conduct a conference call open to the public tomorrow, 22 February 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: 5739601 Belgium: +32 2 404 0659 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 About Galapagos All of the drug candidates mentioned in this press release are investigational; their efficacy and safety are yet to be established. Contacts Investors: Elizabeth Goodwin Sofie Van Gijsel Media: Carmen Vroonen Evelyn Fox Forward-looking statements [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 full year of 2017, the operational cash burn represented €154.1 million. [2] General & Administrative [3] Sales & Marketing [4] Crédit d'Impôt Recherche refers to an innovation incentive system underwritten by the French government. Attachment |