Full Press Release Details
Galapagos refocuses pipeline and rightsizes operations
Webcast presentation tomorrow, 07 May 2021, at 14.00 CET / 8 AM ET,
www.glpg.com, +32 2 793 38 47, code 5042688
Mechelen, Belgium; 06 May 2021, 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) announces its unaudited Q1 results
and operational highlights, which are further detailed in the Q1 2021 report available on the Galapagos website, www.glpg.com.
months, we completed a review of our portfolio and development plans with the goal to select a more risk-balanced pipeline. We decided to retain our focus on novel targets to address unmet medical needs in inflammation, fibrosis, and kidney
diseases. We also remain fully committed to the launch of Jyseleca in Europe. Moving forward with confidence, we decided to:
We believe that our strong cash position, expert teams, and solid scientific foundation position us well for future growth, said
Onno van de Stolpe, CEO of Galapagos.
In the revision exercise, Galapagos set goals to focus and adjust the overall risk profile of its clinical pipeline. Consequently, we prioritized those assets
with what we believe have enhanced chances of clinical success in our core therapeutic areas. As such, we announce:
We remain well on track in launching
filgotinib in Europe. In the first quarter, we successfully completed the transitions of commercial and medical teams from Gilead in Germany, the UK, Spain, and Italy. We believe everything is in place to complete the final transitions from Gilead
to us by year-end. Q1 also saw progress on access and reimbursement for filgotinib in rheumatoid arthritis (RA). Gilead submitted the new drug application in Japan for the treatment of ulcerative colitis (UC).
We are encouraged by the primary endpoint outcome with the MANTA/RAy semen parameter studies as we await the Committee for Medicinal Products for Human Use (CHMP) opinion in UC.
Bart Filius, President and COO, added, In line with our review, we decided to discontinue or cancel certain studies and consequently identified
opportunities to reduce operational costs, for a total potential savings of 150M on a full-year basis. Roughly half of these savings will be realized in 2021, resulting in a 2021 cash burni
guidance of between 580 million and 620 million. We are working towards a right-sized, refocused version of Galapagos, setting us on a path towards success with our first commercial
product, new R&D opportunities, substantial clinical news flow, and a lengthened cash runway for validation of our early pipeline assets.
Key figures first quarter report 2021 (unaudited)
( millions, except basic & diluted gain/loss (-) per share)
| 31 March 2021 group total | 31 March 2020 group total (*) | |||||||
| Revenues and other income | 124.2 | 103.6 | ||||||
| R&D expenditure | (130.0 | ) | (115.5 | ) | ||||
| G&A ii and S&M iii expenses | (45.0 | ) | (34.3 | ) | ||||
| Operating loss | (50.8 | ) | (46.2 | ) | ||||
| Fair value re-measurement of financial instruments | 2.0 | (20.5 | ) | |||||
| Net other financial result | 36.2 | 14.8 | ||||||
| Income taxes | (0.2 | ) | (0.3 | ) | ||||
| Net loss from continuing operations | (12.8 | ) | (52.3 | ) | ||||
| Net profit from discontinued operations | 22.2 | 1.7 | ||||||
| Net profit/loss (-) of the period | 9.4 | (50.6 | ) | |||||
| Basic gain/loss (-) per share ( ) | 0.14 | (0.78 | ) | |||||
| Diluted gain/loss (-) per share ( ) | 0.14 | (0.78 | ) | |||||
| Current financial investments and cash and cash equivalents | 5,114.7 | 5,722.4 |
(*) The 2020 comparatives have been restated to consider the impact of classifying the Fidelta business as discontinued
Details of the financial results
Due to the sale of our fee-for-service business (Fidelta) to Selvita on
4 January 2021 for a total consideration of 37.1 million (including customary adjustments for net cash and working capital), the results of Fidelta are presented as Net profit from discontinued operations in our
consolidated income statements for the three months ended 31 March 2021 and 31 March 2020.
Revenues and other income from continuing
Our revenues and other income from continuing operations for the first three months of 2021 increased to 124.2 million compared
to 103.6 million in the first three months of 2020. Our revenues from the Gilead collaboration in the first three months of 2021 ( 113.7 million) related to (i) the exclusive access to our drug discovery platform ( 57.8
million), (ii) the filgotinib revenue recognition ( 55.3 million) and (iii) royalties ( 0.7 million).
Our deferred income balance on
31 March 2021 includes 1.9 billion allocated to our drug discovery platform that is recognized linearly over 10 years, and 0.8 billion allocated for the filgotinib development (including considerations for the previous and
the renegotiated collaboration combined) that is recognized over time until the end of the development period.
Results from continuing operations
We realized a net loss from continuing operations of 12.8 million for the first three months of 2021, compared to a net loss of
52.3 million for the first three months of 2020.
We reported an operating loss amounting to 50.8 million for the first three months
of 2021, compared to an operating loss of 46.2 million for the same period last year.
Our R&D expenditure in the first three months of
2021 amounted to 130.0 million, compared to 115.5 million for the first three months of 2020. This increase was due to an increase in subcontracting costs primarily related to our filgotinib program, our Toledo program and
other clinical programs, compensated by a decrease for ziritaxestat, the OA program with GLPG1972 and the program in atopic dermatitis (AtD) with MOR106. Furthermore, the increase in personnel costs is explained by a planned headcount increase
following the growth in our activities, and increased cost of the subscription right plans. This factor, and the increased cost of the commercial launch of filgotinib in Europe, contributed to the increase in our S&M and G&A expenses, which
were respectively 14.6 million and 30.4 million in the first three months of 2021, compared to respectively 9.8 million and 24.5 million in the first three months of 2020.
We reported a non-cash fair value gain from the re-measurement of initial
warrant B issued to Gilead, amounting to 2.0 million, mainly due to the decreased implied volatility of the Galapagos share price and its evolution between 31 December 2020 and 31 March 2021.
Net other financial income in the first three months of 2021 amounted to 36.2 million, compared to net other financial income of
14.8 million for the first three months of 2020, which was primarily attributable to 45.5 million of currency exchange gain on our cash and cash equivalents and current financial investments in U.S. dollars, and to
6.5 million of negative changes in (fair) value of current financial investments and financial assets.
Results from discontinued operations
The net profit from discontinued operations for the three months ended 31March 2021 consisted of the gain on the sale of Fidelta, our fee-for-services business, for 22.2 million.
We reported a group net profit for the first three months of 2021 of 9.4 million, compared to a group net loss of 50.6 million for the
first three months of 2020.
financial investments and cash and cash equivalents totaled 5,114.7 million on 31 March 2021, as compared to 5,169.3 million on 31 December 2020.
Total net decrease in cash and cash equivalents and current financial investments amounted to 54.6 million during the first three months of 2021,
compared to a net decrease of 58.4 million during the first three months of 2020. This net decrease was composed of (i) 127.7 million of operational cash burn, (ii) offset by 2.3 million of cash proceeds from
capital and share premium increase from exercise of subscription rights in the first three months of 2021, (iii) 3.6 million negative changes in (fair) value of current financial investments and 45.7 million of mainly positive
exchange rate differences, (iv) 28.7 million cash in from disposal of subsidiaries, net of cash disposed.
Finally, our balance sheet on
31 March 2021 held a receivable from the French government (Cr dit d Imp t Rechercheiv) and a receivable from the Belgian Government for R&D incentives, for a
total of both receivables of 142.3 million.
We anticipate several regulatory announcements on filgotinib as well as progress in our differentiated pipeline of novel target-based candidates.
We expect reimbursement decisions in most key European markets for filgotinib in RA this year, as we complete the transition to a full European commercial
operation by year end. We anticipate a CHMP opinion and a European Commission decision for filgotinib in UC. We expect that our collaboration partner Gilead will complete recruitment for the global DIVERSITY Phase 3 trial in Crohn s disease
Within our broader inflammation portfolio, we expect to report topline results from several trials this year, including a Phase 1b trial with
TYK2 inhibitor 3667 in psoriasis, and three Proof of Concept studies with lead Toledo candidate SIK2/3 inhibitor 3970 in psoriasis, UC, and RA.
Within our fibrosis portfolio, we expect to progress early clinical compounds with novel mechanisms of action, with the aim to develop novel treatments to
help patients suffering from this debilitating condition.
Following the review of our plans for 2021, we give guidance for full year 2021 operational
cash burn of 580 to 620 million.
First quarter report 2021
Galapagos financial report for the first three months ended 31 March 2021, including details of the unaudited consolidated results, is accessible
Results of annual ordinary shareholders meeting
On 28 April 2021, Galapagos held its annual ordinary shareholders meeting. All agenda items were approved, including the re-appointments of Ms. Katrine Bosley and Dr. Raj Parekh as members of the supervisory board, and approval of the remuneration report. All documents relating to the shareholders meeting are posted on
our website at https://www.glpg.com/shareholders-meetings.
Conference call and webcast presentation
Galapagos will conduct a conference call open to the public tomorrow, 07 May 2021, at 14:00 CET / 8 AM ET, which will also be webcasted. To
participate in the conference call, please call one of the following numbers ten minutes prior to commencement:
| Standard International: | +44 (0) 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 |
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.
| 05 August 2021 | Half year 2021 results | (webcast 06 August 2021) | ||
| 04 November 2021 | Third quarter 2021 results | (webcast 05 November 2021) | ||
| 24 February 2022 | Full year 2021 results | (webcast 25 February 2022) |
Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in
late-stage development in multiple diseases. 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 www.glpg.com.
Except for filgotinib s approval for the
treatment of rheumatoid arthritis by the European Commission 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.
VP Investor Relations
Senior Director Investor Relations
Global Head of Communications & Public
Senior Director Corporate Communications
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 potential
changes of such ambitions,
the guidance from management (including guidance regarding the expected operational use of cash during financial year 2021), 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