Full Press Release Details
First key steps in pipeline rebuild and strong commercial progress in H1 2022
presentation tomorrow, 5 August 2022, at 14.00 CET / 8 AM ET, www.glpg.com,
Mechelen, Belgium; 4 August 2022, 22.01 CET;
regulated information Galapagos NV (Euronext & NASDAQ: GLPG) today announced its first half-year 2022 financial results, a year-to-date business update
and its outlook for the remainder of 2022. The results are further detailed in the H1 2022 financial report available on the financial reports section of the website.
This quarter, we took a first key step in our strategic transformation by entering the field of oncology with the acquisitions of CellPoint and
AboundBio. The combined transactions offer the potential for a paradigm shift in CAR-T1 therapy through CellPoint s breakthrough, decentralized point-of-care supply model, developed in a global strategic collaboration with Lonza, and AboundBio s cutting-edge fully
human antibody-based capabilities to design next-generation CAR-Ts. Patient enrolment in the ongoing Phase 1/2a trials in rrNHL and rrCLL2 is
progressing well, and we expect topline results in the first half of next year. Our near-term goal is to bring three additional differentiated, next-generation CAR-T candidates in the clinic over the next
three years, said Dr. Paul Stoffels3, CEO and chairman of the board of directors of Galapagos. We strongly believe that we are taking the right steps in our transformation to
accelerate value creation, and we look forward to presenting an in-depth update on our strategy later this year.
Our Jyseleca franchise is performing very well with robust sales momentum, supported by the regulatory approvals in ulcerative colitis (UC) in Great
Britain and Japan earlier this year. The adoption of Jyseleca is strong across Europe with reimbursement for rheumatoid arthritis (RA) in 15 and for UC in 6 countries, added Bart Filius, President, COO and CFO of Galapagos. Following the
acquisitions of CellPoint and AboundBio, we expect that second half operating expenses will increase by approximately 30 million. Therefore, we revised our cash burni guidance of
450- 490 million for the full year 2022 to 480- 520 million. As a result of the strong Jyseleca performance, we increase our full-year net sales guidance of 65- 75 million to 75- 85 million.
Year-to-date operational
Commercial & regulatory progress:
First half-year 2022 financial highlights (unaudited)
( millions, except basic & diluted income/loss per share)
| 30 June 2022 group total | 30 June 2021 group total | Variance | ||||||||||
| Product net sales | 35.4 | 0.5 | 34.9 | |||||||||
| Collaboration revenues | 238.6 | 253.2 | (14.6 | ) | ||||||||
| Total net revenues | 274.0 | 253.7 | 20.3 | |||||||||
| Cost of sales | (5.5 | ) | (0.1 | ) | (5.4 | ) | ||||||
| R&D expenditure | (249.5 | ) | (268.8 | ) | 19.3 | |||||||
| G&A ii and S&M iii expenses | (134.0 | ) | (105.8 | ) | (28.2 | ) | ||||||
| Other operating income | 17.6 | 23.6 | (5.9 | ) | ||||||||
| Operating loss | (97.5 | ) | (97.6 | ) | 0.1 | |||||||
| Net financial result | 67.7 | 19.9 | 47.8 | |||||||||
| Income taxes | (2.5 | ) | 0.5 | (3.0 | ) | |||||||
| Net loss from continuing operations | (32.3 | ) | (77.2 | ) | 44.9 | |||||||
| Net profit from discontinued operations | 22.2 | (22.2 | ) | |||||||||
| Net loss of the period | (32.3 | ) | (55.0 | ) | 22.7 | |||||||
| Basic and diluted loss per share ( ) | (0.49 | ) | (0.84 | ) | ||||||||
| Basic and diluted loss per share from continuing operations ( ) | (0.49 | ) | (1.18 | ) | ||||||||
| Current financial investments and cash and cash equivalents | 4,429.0 | 5,006.6 |
H1 2022 financial results
We reported product net sales of Jyseleca in Europe for the first six months of 2022 amounting to 35.4 million ( 0.5 million in the first
six months of 2021). Our counterparties for the sales of Jyseleca were mainly hospitals and wholesalers located in Belgium, the Netherlands, France, Italy, Spain, Germany, Great Britain, Ireland, Austria, Norway, Sweden and Finland.
Cost of sales related to Jyseleca net sales in the first six months of 2022 amounted to 5.5 million.
Collaboration revenues amounted to 238.6 million for the first six months of 2022, compared to 253.2 million for the first six months of
Revenues recognized related to the collaboration agreement with Gilead for the filgotinib development were 115.3 million in the first
six months of 2022 compared to 136.1 million for the same period last year. This decrease was due to a lower increase in the percentage of completion, partly offset by a higher revenue recognition of milestone payments, strongly
influenced by the milestone achieved related to the regulatory approval in Japan for UC in the first half-year of 2022. The revenue recognition related to the exclusive access rights for Gilead to our drug discovery platform amounted to
114.9 million for the first six months of 2022 ( 115.7 million for the same period last year).
We have recognized royalty income from Gilead for Jyseleca for 6.3 million in the first six months
of 2022 (compared to 1.4 million in the same period last year) of which 3.6 million royalties on milestone income for UC approval in Japan.
Additionally, we recorded milestones of 2.0 million triggered by the first sale of Jyseleca in the Czech Republic and Portugal by our distribution
and commercialization partner Sobi, in the first half-year of 2022.
Our deferred income balance on 30 June 2022 includes 1.6 billion
allocated to our drug discovery platform that is recognized linearly over the remaining period of our 10-year collaboration, and 0.5 billion allocated to the filgotinib development that is
recognized over time until the end of the development period.
Our R&D expenditure in the first six months of 2022 amounted to
249.5 million, compared to 268.8 million for the first six months of 2021. This decrease was primarily explained by a decrease in subcontracting costs from 139.2 million in the first six months of 2021 to
104.1 million in the first six months of 2022, primarily due to the winding down of the ziritaxestat (IPF) program and reduced spend on our Toledo (SIKi) and TYK2 programs. This was partly offset by cost increases for our filgotinib
program, on a six month basis compared to the same period in 2021. Personnel costs decreased from 94.2 million in the first half of 2021 to 86.0 million for the same period this year mainly due to a lower number of FTEs as well
as lower costs for our subscription right plans. Depreciation and impairment amounted to 32.6 million for the first six months of 2022 ( 8.1 million for the same period last year). This increase was primarily due to an
impairment of 26.7 million of previously capitalized upfront fees related to our collaboration with Molecure on the dual chitinase inhibitor OATD-01 (GLPG4716). As part of an ongoing strategic
exercise to renew and accelerate our portfolio, we decided to return all rights to OATD-01 to Molecure.
G&A and S&M expenses amounted to 134.0 million in the first six months of 2022, compared to 105.8 million in the first six months of 2021. This increase was primarily due to the termination of our 50/50 filgotinib co-commercialization cost sharing agreement with Gilead for filgotinib in 2022. The cost increase was also explained by an increase in personnel costs for the first six months of 2022 compared to the same period
last year explained by an increase in the commercial work force driven by the commercial launch of filgotinib in Europe.
Other operating income
( 17.6 million vs 23.6 million for the same period last year) decreased, mainly driven by lower grant and R&D incentives income.
Net financial income in the first six months of 2022 amounted to 67.7 million, compared to net financial income of 19.9 million for the
first six months of 2021. Net financial income in the first six months of 2022 was primarily attributable to 57.4 million of unrealized currency exchange gains on our cash and cash equivalents and current financial investments at
amortized cost in U.S. dollars, and to 11.8 million of positive changes in (fair) value of current financial investments. The financial expenses also contained the effect of discounting our long term deferred income of
We realized a net loss from continuing operations of 32.3 million for the first six months of 2022, compared to a net
loss of 77.2 million for the first six months of 2021.
The net profit from discontinued operations for the six months ended 30 June 2021
consisted of the gain on the sale of Fidelta, our fee-for-services business, for 22.2 million.
We reported a group net loss for the first six months of 2022 of 32.3 million, compared to a group
net loss of 55.0 million for the first six months of 2021.
Current financial investments and cash and cash equivalents totaled 4,429.0 million on 30 June 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 274.2 million during the
first six months of 2022, compared to a net decrease of 162.7 million during the first six months of 2021. This net decrease was composed of (i) 217.1 million of operational cash burn, (ii) offset by 3.6 million
of cash proceeds from capital and share premium increase from exercise of subscription rights in the first six months of 2022, (iii) 11.8 million positive changes in (fair) value of current financial investments and
60.4 million of mainly positive exchange rate differences, and (iv) the cash out from the acquisitions of CellPoint and AboundBio, net of cash acquired, of 132.9 million.
Acquisitions of CellPoint and AboundBio
accounting of the acquisitions of CellPoint and AboundBio are included in our H1 2022 condensed consolidated financial statements. To date, we have performed a preliminary fair value analysis of the business combinations. We expect the provisional
amount of goodwill to change significantly upon the completion of the purchase price allocation, resulting from the valuation of the different assets and liabilities acquired.
Following the acquisitions of CellPoint and AboundBio, we revised our cash burn guidance for full year 2022 from
450- 490 million to 480- 520 million. Additionally, we increased our anticipated net sales guidance for Jyseleca from 65- 75 million to between 75 and 85 million.
Expected regulatory events:
We anticipate a Committee for Medicinal Products for Human Use (CHMP) opinion on the type II variation for the Jyseleca label, based on the data from the MANTA
and MANTA-RAy studies around year-end. We also expect reimbursement decisions in most key European markets in UC and anticipate that Sobi will further progress with reimbursement discussions in RA and UC in
Eastern and Central Europe, Greece, and the Baltic countries. As part of the ongoing article 20 pharmacovigilance procedure on all JAK inhibitors approved in Europe, we expect a CHMP opinion by the end of the year, followed by an adoption by the
European Commission shortly afterwards.
Anticipated R&D milestones:
Patient enrolment in the Phase 1/2a trials in rrNHL and rrCLL is progressing well and we anticipate that additional clinical sites will be active by year-end. We are on track to report topline results of both trials in the first half of next year.
TYK2 inhibitor GLPG3667 into a Phase 2 program in dermatomyositis with first patients potentially recruited around year-end.
We continue to explore additional business development opportunities to further leverage our internal capabilities and renew our portfolio, and we look
forward to presenting an in-depth update on our corporate strategy later this year.
First half-year 2022
Galapagos financial report for the first six months ended 30 June 2022, including details of the unaudited consolidated
results, is accessible on the financial reports section of our website.
Conference call and webcast presentation
Management will host a conference call and webcast presentation followed by Q&A tomorrow 5 August 2022, at 14:00 CET / 8 AM ET. To
participate in the conference call, please register in advance using this link. Upon registration, the dial-in numbers will be provided. The conference call can be accessed 10 minutes prior to the start
time by using the conference access information provided in the e-mail received at the point of registering, or by selecting the call me feature.
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 is a fully integrated biotechnology company focused on discovering, developing, and commercializing innovative medicines. We are committed to
improving patients lives worldwide by targeting diseases with high unmet needs. Our R&D capabilities cover multiple drug modalities, including small molecules and cell therapies. Our portfolio comprises discovery through to Phase 3
programs in inflammation, oncology, fibrosis, and other indications. Our first medicine for rheumatoid arthritis and ulcerative colitis is approved and available in the European Union (including Norway), Great Britain and Japan. For additional
Except for filgotinib s approval as Jyseleca 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 press release includes forward-looking statements. These statements are often, but are not always, made through the use of words or phrases such as
believe, anticipate, expect, intend, plan, seek, estimate, may, will, could, would, potential,
forward, goal, next, stand to, continue, should, encouraging, aim, explore, further, as well as similar expressions. These
statements include, but are not limited to, the information provide in the sections Year-to-date operation overview and outlook 2022 , the