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Financial highlights

Consolidated Key Figures

(thousands of €, if not stated otherwise)

Six months ended 30 June 2023

Six months ended 30 June 2022

Year ended 31 December 2022

Income statement

 

 

 

Product net sales

54,275

35,356

87,599

Collaboration revenues

274,546

238,601

417,681

Total net revenues

328,821

273,957

505,280

Cost of sales

(7,840)

(5,545)

(12,079)

R&D expenditure

(211,875)

(249,518)

(515,083)

S&M, G&A expenses

(121,597)

(134,009)

(292,486)

Other operating income

23,770

17,637

46,848

Operating profit/loss (-)

11,279

(97,478)

(267,520)

Net financial results

30,639

67,676

52,373

Taxes

(13,610)

(2,536)

(2,844)

Net profit/loss (-)

28,308

(32,338)

(217,991)

 

 

 

 

Balance sheet

 

 

 

Cash and cash equivalents

98,024

972,796

508,117

Current financial investments

3,776,913

3,456,184

3,585,945

R&D incentives receivables

156,341

155,771

146,067

Assets

4,522,340

5,040,085

4,734,351

Shareholders’ equity

2,583,948

2,646,898

2,526,026

Deferred income

1,726,704

2,159,553

1,989,230

Other liabilities

211,688

233,634

219,094

 

 

 

 

Cash flow

 

 

 

Operational cash burn

(224,323)

(217,102)

(513,774)

Cash flow used in operating activities

(220,286)

(203,740)

(500,544)

Cash flow used in investing activities

(187,760)

(1,081,057)

(1,245,514)

Cash flow used in financing activities

(1,741)

(361)

(1,487)

Decrease in cash and cash equivalents

(409,788)

(1,285,158)

(1,747,545)

Effect of currency exchange rate fluctuation on cash and cash equivalents

(307)

24,586

22,293

Cash and cash equivalents at end of the period

98,024

972,796

508,117

Current financial investments at the end of the period

3,776,913

3,456,184

3,585,945

Total current financial investments and cash and cash equivalents at the end of the period

3,874,937

4,428,980

4,094,062

 

 

 

 

Financial ratios

 

 

 

Number of shares issued at the end of the period

65,897,071

65,728,511

65,835,511

Basic and diluted income/loss (-) per share (in €)

0.43

(0.49)

(3.32)

Share price at the end of the period (in €)

37.37

53.04

41.35

Total group employees at the end of the period (number)

1,233

1,344

1,338

On 30 June 2023, we had 1,233 employees (including the 121 employees in our Galapagos entity in France that were transferred to NovAliX on 1 July 2023 as a result of the closing of the integrated drug discovery collaboration transaction).

H1 2023 financial results

We reported product net sales of Jyseleca® in Europe for the first six months of 2023 amounting to €54.3 million (€35.4 million in the first half-year of 2022).

Cost of sales related to Jyseleca® net sales in the first six months of 2023 amounted to €7.8 million.

Collaboration revenues amounted to €274.5 million for the first six months of 2023, compared to €238.6 million for the first six months of 2022.

Revenues recognized related to the collaboration agreement with Gilead for the filgotinib development were €154.9 million in the first six months of 2023 compared to €115.3 million for the same period last year. This increase is primarily driven by a positive catch up of revenue explained by a decrease in the total estimated remaining costs to complete the filgotinib development. This was a consequence of the topline results from Phase 3 DIVERSITY trial of filgotinib in CD and our decision not to submit a Marketing Authorization Application in Europe.

The revenue recognition related to the exclusive access rights for Gilead to our drug discovery platform amounted to €115.2 million for the first six months of 2023 (€114.9 million for the same period last year).

We have recognized royalty income from Gilead for Jyseleca® for €3.5 million in the first six months of 2023 (compared to €6.3 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 receivable of €1.0 million triggered by the first sale of Jyseleca® in Poland by our distribution and commercialization partner Sobi, in the first half-year of 2023.

Our deferred income balance on 30 June 2023 includes €1.4 billion allocated to our drug discovery platform that is recognized linearly over the remaining period of our 10 year collaboration, and €0.3 billion allocated to filgotinib development that is recognized over time until the end of the development period.

Our R&D expenditure in the first six months of 2023 amounted to €211.9 million, compared to €249.5 million for the first six months of 2022. Depreciation and impairment amounted to €13.1 million for the first six months of 2023 (€32.6 million for the same period last year). This decrease was primarily due to an impairment of €26.7 million in the first six months of 2022 of previously capitalized upfront fees related to our collaboration with Molecure on the dual chitinase inhibitor OATD-01 (GLPG4716), as it was decided to return all rights to OATD-01 to Molecure. The decrease in R&D expenditure was also explained by a decrease in subcontracting costs from €104.1 million in the first half-year of 2022 to €90.3 million in the first half-year of 2023, primarily due to reduced spend on our SIKi-program, filgotinib and other programs. This was partly offset by costs increase for our CAR-T program and TYK2 program, on a six month basis compared to the same period in 2022. Personnel costs decreased from €86.0 million in the first half of 2022 to €80.5 million for the same period this year.

Our S&M expenses were €58.3 million in the first six months of 2023, compared to €71.0 million in the first six months of 2022. The cost decrease was explained by a decrease in personnel costs (€29.1 million for the first six months of 2023 compared to €35.7 million for the same period last year) primarily explained by a decrease in the cost for bonuses and our subscription right plans. External outsourcing costs also decreased from €25.7 million in the first six months of 2022 to €20.0 million in the first six months of 2023.

Our G&A expenses were €63.3 million in the first six months of 2023, compared to €63.0 million in the first six months of 2022.

Other operating income (€23.8 million for the first six months of 2023, compared to €17.6 million for the first six months of 2022) increased by €6.2 million, mainly driven by higher grant and rent income.

We reported an operating profit amounting to €11.3 million for the first six months of 2023, compared to an operating loss of €97.5 million for the same period last year.

Net financial income in the first six months of 2023 amounted to €30.6 million (as compared to net financial income of €67.7 million in the same period last year) and consisted mainly of €33.4 million interest income (as compared to €3.6 million interest income in the same period last year) due to the increased interest rates. Net financial income in the first six months of 2023 also included €11.4 million of unrealized currency exchange loss on our cash and cash equivalents and current financial investments at amortized cost in U.S. dollar (as compared to €57.4 million currency exchange gain on cash and cash equivalents and current financial investments in the first six months of 2022), as a result of the fluctuation of the U.S. dollar, and €12.7 million positive changes in (fair) value of current financial investments (€11.8 million positive changes in the same period last year). The other financial expenses also contained the effect of discounting our long term deferred income of €2.4 million (€3.8 million in the same period last year).

We had €13.6 million of tax expenses for the first six months of 2023 (as compared to €2.5 million for the same period last year). This increase was primarily due to the re-assessment of net deferred tax liabilities and corporate income tax payables as a result of a one-off intercompany transaction.  

We reported a group net profit for the first six months of 2023 of €28.3 million, compared to a net loss of €32.3 million for the same period last year.

Cash, cash equivalents and current financial investments

Cash and cash equivalents and current financial investments totaled €3,874.9 million on 30 June 2023 (€4,094.1 million on 31 December 2022).

A net decrease of €219.1 million in cash and cash equivalents and current financial investments was recorded during the first six months of 2023, compared to a net decrease of €274.2 million during the first six months of 2022. This net decrease was composed of (i) €224.3 million of operational cash burn, (ii) €9.3 million of mainly negative exchange rate differences, offset by (iii) €1.8 million of cash proceeds from capital and share premium increases from exercise of subscription rights in the first six months of 2023, and (iv) €12.7 million of positive changes in (fair) value of current financial investments.

The operational cash burn (or operational cash flow if this liquidity measure is positive) is a financial measure that is not calculated in accordance with IFRS. Operational cash burn/cash flow is defined as the increase or decrease in our cash and cash equivalents (excluding the effect of exchange rate differences on cash and cash equivalents), minus:

i. the net proceeds, if any, from share capital and share premium increases included in the net cash flows generated from/used in (–) financing activities

ii. the net proceeds or cash used, if any, in acquisitions or disposals of businesses; the movement in restricted cash and movement in current financial investments, if any, the loans and advances given to third parties, if any, included in the net cash flows generated from/used in (–) investing activities

iii. the cash used for other liabilities related to the acquisition of businesses, if any, included in the net cash flows generated from/used in (–) operating activities.

This alternative liquidity measure is in our view an important metric for a biotech company in the development stage.

The following table provides a reconciliation of the operational cash burn:

 

Six months ended 30 June

(thousands of €)

2023

2022

Decrease in cash and cash equivalents (excluding effect of exchange differences)

(409,788)

(1,285,158)

Less:

 

 

Net proceeds from capital and share premium increases

(1,770)

(3,619)

Net purchase of current financial investments

187,235

938,732

Cash out from acquisition of subsidiaries, net of cash acquired

-

115,178

Cash advances and loans to third parties

-

10,000

Cash used for other liabilities related to the acquisition of subsidiaries

-

7,765

Total operational cash burn

(224,323)

(217,102)

CAR-T
Chimeric antigen receptor T cells (also known as CAR-T cells) are T cells that have been genetically engineered to produce an artificial T cell receptor for use in immunotherapy
Crohn's disease (CD)
An IBD involving inflammation of the small and large intestines, leading to pain, bleeding, and ultimately in some cases surgical removal of parts of the bowel
DIVERSITY
Phase 3 program evaluating filgotinib in CD
Development
All activities required to bring a new drug to the market. This includes preclinical and clinical development research, chemical and pharmaceutical development and regulatory filings of product candidates
Discovery
Process by which new medicines are discovered and/or designed. At Galapagos, this is the department that oversees target and drug discovery research through to nomination of preclinical candidates
Filgotinib
Formerly known as GLPG0634, commercial name is Jyseleca®. Small molecule preferential JAK1 inhibitor, approved in RA and UC in the European Union, Great-Britain and Japan. Phase 4 studies in both RA and UC, and a Phase 3 study in AxSpA are ongoing
G&A expenses
General & administrative expenses
Jyseleca®
Jyseleca® is the brand name for filgotinib
Milestone
Major achievement in a project or program; in our alliances, this is usually associated with a payment
Outsourcing
Contracting work to a third party
Phase 3
Large clinical trials, usually conducted in several hundred to several thousand patients to gain a definitive understanding of the efficacy and tolerability of the candidate treatment; serves as the principal basis for regulatory approval
S&M expenses
Sales and marketing expenses
Ulcerative colitis (UC)
UC is an IBD causing chronic inflammation of the lining of the colon and rectum (unlike CD with inflammation throughout the gastrointestinal tract)