Full Press Release Details
Galapagos demonstrates regulatory and commercial
Webcast presentation tomorrow, 6 May 2022, at
14.00 CET / 8 AM ET,
www.glpg.com, + 32 (0)2 793 38 47, code 9523309
Mechelen, Belgium; 5 May 2022, 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) today announced its first
quarter 2022 financial results, a year-to-date business update and its outlook for the remainder of 2022. The results are further detailed in the Q1 2022 financial
report available on the financial reports section of the website.
It is an honor to address you for the first time as CEO of Galapagos.
I want to express my respect and appreciation to previous CEO and founder Onno van de Stolpe, who successfully built Galapagos from a start-up to an independent, established publicly listed company. Since
I joined a few weeks ago, I have been working closely with the board and the teams across the entire organization to thoroughly review our R&D product portfolio, shape our business strategy and lay the foundations for accelerated growth,
said Dr. Paul Stoffels, CEO of Galapagos. Our mission is to bring novel medicines to patients around the world and to help them live longer, better lives by adding years of life and improving quality of life. We have the people, the
science, the R&D capabilities, the commercial infrastructure, and financial resources to realize that ambition. There are exciting opportunities ahead of us and I look forward to sharing my vision and strategy for the future later this
In the first quarter of this year, the launch of our Jyseleca franchise continued to gain momentum with robust sales growth,
added Bart Filius, President, COO and CFO of Galapagos. Following the recent approval of filgotinib in UC in Great Britain and Japan, we are very excited to also bring Jyseleca to patients in this indication, while further progressing our roll-out in RA and UC throughout the European Union. We continue to focus on operational excellence and reiterate our cash burnii guidance of 450- 490 million, including anticipated net sales for Jyseleca of 65- 75 million, compared to the cash burn of 564.8 million over
the same period in 2021.
First quarter 2022 and recent business update
Commercial & regulatory progress with filgotinib in RA and UC:
Pipeline and corporate update:
First quarter 2022 financial highlights (unaudited)
( millions, except basic & diluted income/loss per share)
| 31 March 2022 group total | 31 March 2021 group total | Variance | ||||||||||
| Product net sales | 14.4 | 0.1 | 14.3 | |||||||||
| Collaboration revenues | 121.9 | 113.8 | 8.1 | |||||||||
| Total net revenues | 136.3 | 113.9 | 22.4 | |||||||||
| Cost of sales | (2.9 | ) | (2.9 | ) | ||||||||
| R&D expenditure | (99.9 | ) | (130.0 | ) | 30.1 | |||||||
| G&A iii and S&M iv expenses | (62.3 | ) | (45.0 | ) | (17.3 | ) | ||||||
| Other operating income | 7.7 | 10.3 | (2.6 | ) | ||||||||
| Operating loss | (21.1 | ) | (50.8 | ) | 29.7 | |||||||
| Fair value re-measurement of financial instruments | (0.2 | ) | 2.0 | (2.2 | ) | |||||||
| Net other financial result | 9.7 | 36.2 | (26.5 | ) | ||||||||
| Income taxes | (1.7 | ) | (0.2 | ) | (1.5 | ) | ||||||
| Net loss from continuing operations | (13.3 | ) | (12.8 | ) | (0.5 | ) | ||||||
| Net profit from discontinued operations | 22.2 | (22.2 | ) | |||||||||
| Net profit/loss (-) of the period | (13.3 | ) | 9.4 | (22.7 | ) | |||||||
| Basic and diluted income/loss (-) per share ( ) | (0.2 | ) | 0.14 | |||||||||
| Basic and diluted loss per share from continuing operations ( ) | (0.2 | ) | (0.2 | ) | ||||||||
| Current financial investments and cash and cash equivalents | 4,643.4 | 5,114.7 |
Q1 2022 financial results
We reported product net sales of Jyseleca in Europe for the first three months of 2022 amounting to 14.4 million ( 0.1 million in the
first quarter of 2021). Our counterparties for the sales of Jyseleca were mainly hospitals and wholesalers located in Belgium, the Netherlands, France, Italy, Spain, Germany, the United Kingdom, Ireland, Austria, Norway, Sweden and Finland.
Cost of sales related to Jyseleca net sales in the first three months of 2022 amounted to 2.9 million.
Collaboration revenues amounted to 121.9 million for the first three months of 2022, compared to 113.8 million for the first three
Revenues recognized related to the collaboration agreement with Gilead for the filgotinib development were 59.0 million in the
first three months of 2022 compared to 55.3 million for the same period last year. This slight increase was mainly due to higher revenue recognition of milestone payments, strongly influenced by the milestone achieved related to the
regulatory approval in Japan for UC in the first quarter of 2022. The revenue recognition related to the exclusive access rights for Gilead to our drug discovery platform amounted to 57.3 million for the first three months of 2022
( 57.8 million for the same period last year).
We have recognized royalty income from Gilead for Jyseleca for 4.6 million in the first three
months of 2022 (compared to 0.7 million in the same period last year) of which 3.6 million royalties on milestone income for UC approval in Japan.
Additionally, we recorded a milestone of 1.0 million triggered by the first sale of Jyseleca in the Czech Republic by our distribution and
commercialization partner Sobi, in the first quarter of 2022.
Our deferred income balance on 31 March 2022 includes 1.7 billion allocated
to our drug discovery platform that is recognized linearly over the remaining period of our 10 year collaboration, and 0.6 billion allocated to the filgotinib development that is recognized over time until the end of the development
Our R&D expenditure in the first three months of 2022 amounted to 99.9 million, compared to 130.0 million for the first
three months of 2021. This decrease was primarily explained by a decrease in subcontracting costs from 73.0 million in the first quarter of 2021 to 41.7 million in the first quarter of 2022, primarily due to the winding down of
the ziritaxestat (IPF) program and reduced spend on our Toledo (SIKi) and other programs. This was partly offset by cost increases for our filgotinib program, on a three months basis compared to the same period in 2021.
Our S&M and G&A expenses were respectively 29.0 million and 33.4 million in the first three months of
2022, compared to respectively 14.5 million and 30.4 million in the first three months of 2021. This increase was primarily due to an increase in personnel costs mainly driven by higher average FTEs on a three months
comparison basis following the commercial launch of filgotinib in Europe, as well as higher costs for RSU plans. The increase was also explained by the termination of our 50/50 co-commercialization cost
sharing agreement with Gilead for filgotinib in 2022, while in the first quarter of 2021 such costs were still shared with Gilead.
Other operating income
( 7.7 million vs 10.3 million for the same period last year) decreased, mainly driven by lower grant and R&D incentives income.
Net other financial income in the first three months of 2022 amounted to 9.7 million, compared to net other financial income of
36.2 million for the first three months of 2021. Net other financial income in the first three months of 2022 was primarily attributable to 13.8 million of unrealized currency exchange gains on our cash and cash equivalents and
current financial investments at amortized cost in U.S. dollars, to 0.2 million of negative changes in (fair) value of current financial investments and to 2.1 million of interest expenses. The other financial expenses also
contained the effect of discounting our long term deferred income of 1.9 million.
We realized a net loss from continuing operations of
13.3 million for the first three months of 2022, compared to a net loss of 12.8 million for the first three months of 2021.
profit from discontinued operations for the three months ended 31 March 2021 consisted of the gain on the sale of Fidelta, our fee-for-services business, for
We reported a group net loss for the first three months of 2022 of 13.3 million, compared to a group net profit of
9.4 million for the first three months of 2021.
Current financial investments and cash and cash equivalents totaled 4,643.4 million on 31 March 2022, as compared to 4,703.2 million
on 31 December 2021.
Total net decrease in cash and cash equivalents and current financial investments amounted to
59.8 million during the first three months of 2022, compared to a net decrease of 54.6 million during the first three months of 2021. This net decrease was composed of (i) 77.4 million of operational cash burn,
(ii) offset by 2.2 million of cash proceeds from capital and share premium increase from exercise of subscription rights in the first three months of 2022, and (iii) 0.2 million negative changes in (fair) value of current
financial investments and 15.6 million of mainly positive exchange rate differences.
For 2022, we anticipate a significantly
lower cash burn compared to 2021 of 450- 490 million, including anticipated net sales for Jyseleca between 65 and 75 million.
Expected regulatory events:
We expect reimbursement decisions
in most key European markets for Jyseleca in UC this year and anticipate that Sobi will further progress with reimbursement discussions in RA and UC in Eastern and Central Europe, Greece, and the Baltic countries. Following the ongoing article 20
pharmacovigilance procedure on all JAK inhibitors, we expect that the EMA will give its opinion by end of September 2022.
Anticipated R&D milestones:
We expect the read out from a Phase 1b trial with JAK1 inhibitor GLPG0555 and a Phase 1 trial with JAK1/TYK2i GLPG3121 in healthy volunteers. In addition,
we aim to progress TYK2 inhibitor GLPG3667 into a Phase 2 program, considering the current regulatory and competitive landscape for TYK2 as a class, and to advance selected compounds with optimized pharmacology and selectivity from our SIKi
portfolio into the clinic. Furthermore, we are evaluating the start of a Phase 2 trial with chitinase inhibitor GLPG4716 in lung fibrosis.
push forward our internal programs and further roll-out Jyseleca in RA and UC, we continue to diligently scout for external opportunities. We are confident that in 2022 we will make significant progress to
accelerate our innovative pipeline with the aim to address unmet medical needs, and we look forward to presenting an in-depth update on our future plans later this year.
First quarter 2022 financial report
financial report for the first three months ended 31 March 2022, including details of the unaudited consolidated results, is accessible on the financial reports section of our website.
Conference call and webcast presentation
host a conference call and webcast presentation with Q&A tomorrow 6 May 2022, at 14:00 CET / 8 AM ET. To participate in the conference call, please dial one of the following numbers ten minutes prior to the start:
| Standard International: | +44 2071 928338 | |
| USA: | +1 646 741 3167 | |
| UK: | +44 844 481 9752 | |
| Netherlands: | +31 207 95 66 14 | |
| France: | +33 1 70 70 0781 | |
| Belgium: | +32 2 793 38 47 |
The live webcast can be accessed on the investors section of the Galapagos website, and a replay will
be made available shortly after the close of the call.
Financial calendar 2022
Galapagos NV discovers, develops, and commercializes small molecule medicines with novel modes of action. Our pipeline comprises discovery through Phase 3
programs in inflammation, fibrosis 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
Except for filgotinib s approval for the treatment of rheumatoid arthritis and ulcerative colitis by the European
Commission, Great Britain s Medicines and Healthcare products Regulatory Agency and Japanese Ministry of Health, Labour and Welfare, our drug candidates are investigational; their efficacy and safety have not been fully evaluated by any
regulatory authority.
Jyseleca is a trademark of Galapagos NV and Gilead Sciences, Inc. or
its related companies.
Head of Investor Relations
Director Investor Relations
Head of Corporate Communication
Forward-looking statements
This release may contain
forward-looking statements, including, among other things, statements regarding the global R&D collaboration with Gilead, the amount and timing of potential future milestones, opt-in and/or royalty
payments by Gilead, Galapagos strategic R&D ambitions, including progress on our fibrosis portfolio and SIK platform, and potential changes of such ambitions, the guidance from management (including guidance regarding the expected
operational use of cash during financial year 2022), financial results, statements regarding the expected timing, design and readouts of ongoing and planned clinical trials, including recruitment for trials and topline results for our trials and
studies in our inflammation portfolio, statements regarding the strategic re-evaluation, statements related to the EMA s planned safety review of JAK inhibitors used to treat certain inflammatory
disorders, including filgotinib, initiated at the request of the European Commission (EC) under article 20 of Regulation (EC) No 726/2004, statements relating to interactions with regulatory authorities, the timing or likelihood of additional
regulatory authorities approval of marketing authorization for filgotinib for RA, UC or any other indication, including UC and IBD indications for filgotinib in Europe, Great-Britain, Japan, and the U.S., such additional regulatory authorities
requiring additional studies, statements regarding changes in our board of directors, and key personnel, our ability to effectively transfer knowledge during this period of transition, the search and recruitment
of a CSO, the risk that Galapagos will be unable to successfully achieve the anticipated benefits from its leadership transition plan, the possibility that Galapagos will encounter challenges