Details of the unaudited condensed consolidated interim results
Revenues and other income
Revenues
The following table summarizes our revenues for the six months ended 30 June 2019 and 2018.
|
Six months ended 30 June |
|
(thousands of €) |
2019 |
2018 |
Recognition of non-refundable upfront payments and license fees |
42,113 |
52,753 |
Gilead collaboration agreement for filgotinib |
41,069 |
49,331 |
AbbVie collaboration agreement for CF |
1,044 |
3,422 |
Milestone payments |
33,383 |
28,567 |
Gilead collaboration agreement for filgotinib |
10,034 |
16,023 |
AbbVie collaboration agreement for CF |
23,349 |
12,544 |
Reimbursement income |
11,344 |
558 |
Novartis collaboration agreement for MOR106 |
10,595 |
– |
AbbVie collaboration agreement for CF |
749 |
558 |
Other revenues |
4,944 |
5,705 |
Fee-for-services revenues |
4,878 |
5,641 |
Other |
66 |
64 |
Total revenues |
91,785 |
87,583 |
Revenues (€91.8 million for the first six months of 2019 vs €87.6 million for the first six months of 2018) were higher due to a milestone achieved in June 2019 related to the CF program with AbbVie and higher reimbursement income mainly from Novartis in the scope of our collaboration for MOR106. This was partly compensated by a lower over time recognition in revenue of the upfront payments and milestone payments related to the filgotinib program with Gilead.
For the first six months of 2019, €51.1 million of deferred income related to the Gilead collaboration agreement was recognized in revenue in function of costs incurred, applying the percentage of completion method. This consisted of the over time revenue recognition of (i) €36.0 million related to the upfront license fee, (ii) €5.1 million related to the deferred income triggered by the accounting treatment of the share subscription agreement under IAS 39 Financial Instruments: recognition and measurement, at the time of signing of the agreement in 2015, and (iii) €10.0 million related to milestone payments. The outstanding balance of deferred income from the Gilead collaboration agreement at 30 June 2019 amounted to €94.7 million all reported as current deferred income, as we expect to reach, at the end of 2019, the predetermined level of development study costs further described hereafter.
In December 2015, we entered into a license and collaboration agreement to co-develop filgotinib with Gilead in rheumatoid arthritis, Crohn’s disease, ulcerative colitis and other indications. We are responsible for funding 20% of the associated global development costs of the program. We have retained certain mechanisms to give us cost protection as filgotinib advances in clinical development. We can defer our portion of the global co-development study costs if they exceed a predetermined level, which we expect to reach at the end of 2019, and this deferment would be credited against future milestones, royalties or profit sharing at our option. If there are no future amounts to be paid by Gilead, we will not be obligated to make any payments to Gilead for such deferment.
We refer to the section 'Events after the end of the reporting period' of this interim report for the latest development in our collaboration with Gilead, which did not affect our financial statements for the first six months of 2019.
For the first six months of 2019, €2.2 million of the remaining deferred income related to the AbbVie collaboration agreement was recognized in revenue in function of costs incurred, applying the percentage of completion method. This consisted of the over time revenue recognition of (i) €1.1 million related to the upfront license fees, and (ii) €1.1 million related to milestone payments received in previous years. Additionally we achieved a milestone of $25 million (€22.4 million) of which €22.2 million were recognized in revenue in the first half of 2019. The remaining outstanding balance of current deferred income from the AbbVie collaboration agreement at 30 June 2019 amounted to €1.2 million.
For the first six months of 2019, €10.6 million of reimbursement income was recognized as revenue related to our R&D activities in the scope of our collaboration agreement with Novartis and MorphoSys for MOR106.
Other revenues amounting to €4.9 million mainly consisted of service revenues from our fee-for-service business.
Other income
Other income increased to €16.7 million in the first six months of 2019 compared to €14.3 million in the first six months of 2018, mainly driven by higher income from R&D incentives.
Results
We realized a net loss of €95.9 million for the first six months of 2019, compared to a net loss of €59.1 million in the first six months of 2018.
We reported an operating loss amounting to €97.6 million for the first six months of 2019, compared to an operating loss of €65.8 million for the first six months of 2018.
Our R&D expenditure in the first six months of 2019 amounted to €177.6 million, compared to €151.4 million in the first six months of 2018. This planned increase was mainly due to an increase of €10.2 million in subcontracting costs primarily related to our IPF program and other proprietary programs. Furthermore, personnel costs increased explained by a planned headcount increase and higher costs related to warrant plans as a result of the increase in the number of beneficiaries and of the Galapagos share price.
The table below summarizes our R&D expenditure for the six months ended 30 June 2019 and 2018, broken down by program.
|
Six months ended 30 June |
|
(thousands of €) |
2019 |
2018 |
Filgotinib program (partnered) |
(30,406) |
(32,210) |
CF program (partnered) |
(1,793) |
(21,014) |
IPF program on GLPG1690 (proprietary) |
(41,668) |
(24,107) |
OA program on GLPG1972 (partnered) |
(9,733) |
(7,621) |
AtD program on MOR106 (partnered) |
(12,460) |
(7,661) |
Other |
(81,507) |
(58,832) |
Total R&D expenditure |
(177,567) |
(151,444) |
Our G&A and S&M expenses were €28.6 million in the first six months of 2019, compared to €16.2 million in the first six months of 2018. This increase mainly resulted from higher personnel costs due to a planned headcount increase as well as higher costs for warrant plans as a result of the increase in the number of beneficiaries and of the Galapagos share price.
Net financial income in the first six months of 2019 amounted to €1.8 million compared to net financial income of €6.9 million in the first six months of 2018, and was primarily attributable to €1.9 million of unrealized exchange gain on our cash position in U.S. dollars (€5.3 million of unrealized exchange gain on our cash position in U.S. dollars in the first six months of 2018).
Segment information
We have two reportable segments: R&D and our fee-for-service business Fidelta, located in Croatia.
|
Six months ended 30 June 2019 |
|||||
(thousands of €) |
R&D |
Fee-for-services |
Inter-segment |
Group |
||
|
||||||
External revenue |
86,907 |
4,878 |
|
91,785 |
||
Internal revenue |
|
3,581 |
(3,581) |
– |
||
Other income |
16,717 |
7 |
|
16,724 |
||
Revenues & other income |
103,624 |
8,466 |
(3,581) |
108,509 |
||
|
|
|
|
|
||
Segment result |
(81,269) |
410 |
|
(80,859) |
||
Unallocated expenses(1) |
|
|
|
(16,751) |
||
Operating loss |
|
|
|
(97,610) |
||
Financial (expenses)/income |
|
|
|
1,834 |
||
Result before tax |
|
|
|
(95,776) |
||
Income taxes |
|
|
|
(129) |
||
Net loss |
|
|
|
(95,905) |
|
Six months ended 30 June 2018 |
|||||
(thousands of €) |
R&D |
Fee-for-services |
Inter-segment |
Group |
||
|
||||||
External revenue |
81,942 |
5,641 |
|
87,583 |
||
Internal revenue |
|
4,126 |
(4,126) |
– |
||
Other income |
14,287 |
2 |
|
14,289 |
||
Revenues & other income |
96,229 |
9,770 |
(4,126) |
101,872 |
||
|
|
|
|
|
||
Segment result |
(57,446) |
2,200 |
|
(55,246) |
||
Unallocated expenses(1) |
|
|
|
(10,540) |
||
Operating loss |
|
|
|
(65,786) |
||
Financial (expenses)/income |
|
|
|
6,867 |
||
Result before tax |
|
|
|
(58,919) |
||
Income taxes |
|
|
|
(137) |
||
Net loss |
|
|
|
(59,056) |
The basis of accounting for any transactions between reportable segments is consistent with the valuation rules and with transactions with third parties.
Liquid assets position
Cash and cash equivalents totaled €1,147.9 million on 30 June 2019.
A net decrease of €142.9 million in cash and cash equivalents was recorded during the first six months of 2019, compared to a net decrease of €84.4 million during the first six months of 2018. This net decrease was composed of €152.5 million of operational cash burn, offset by (i) €7.8 million of cash proceeds from capital and share premium increases from exercise of warrants in the first six months of 2019 and (ii) €1.9 million of unrealized positive exchange rate differences.
Cash and cash equivalents amounted to €1,147.9 million at the end of June 2019 and comprised cash and cash at banks, short term bank deposits and money market funds that are readily convertible to cash and are subject to an insignificant risk of changes in value. Our cash management strategy may allow short term deposits with an original maturity exceeding three months while monitoring all liquidity aspects. Cash and cash equivalents comprised €514.7 million of term deposits with an original maturity longer than three months but which are available upon one month notice period. Cash at banks were mainly composed of savings accounts and current accounts. We maintain our bank deposits in highly rated financial institutions to reduce credit risk. Cash invested in highly liquid money market funds represented €199.0 million and aim at meeting short-term cash commitments, while reducing the counterparty risk of investment.
|
30 June |
31 December |
(thousands of €) |
2019 |
2018 |
Cash at banks |
434,228 |
358,016 |
Term deposits |
514,701 |
733,537 |
Money market funds |
198,993 |
199,243 |
Total cash and cash equivalents |
1,147,923 |
1,290,796 |
On 30 June 2019, our cash and cash equivalents included $279.4 million held in U.S. dollars which could generate foreign exchange gains or losses in our financial results in accordance with the fluctuation of the EUR/U.S. dollar exchange rate as our functional currency is EUR.
Finally, our balance sheet held R&D incentives receivables from the French government (Crédit d’Impôt Recherche), to be received in four yearly tranches, and R&D incentives receivables from the Belgian Government, for a total of €94.3 million as at 30 June 2019.
Capital increase
On 30 June 2019, Galapagos NV’s share capital was represented by 54,823,101 shares. All shares were issued, fully paid up and of the same class. The below table summarizes our capital increases for the half-year ended 30 June 2019.
(thousands of €, |
Number of shares |
Share capital |
Share premium |
Share capital and share premium |
Average exercise price warrants |
Closing share price on date of capital increase |
On 1 January 2019 |
54,465,421 |
236,540 |
1,277,780 |
1,514,320 |
|
|
|
|
|
|
|
|
|
20 March 2019: exercise of warrants |
149,370 |
808 |
2,673 |
3,481 |
23.30 |
90.32 |
|
|
|
|
|
|
|
20 June 2019: exercise of warrants |
208,310 |
1,127 |
3,198 |
4,325 |
20.76 |
113.55 |
|
|
|
|
|
|
|
On 30 June 2019 |
54,823,101 |
238,475 |
1,283,650 |
1,522,125 |
|
|
Note to the cash flow statement
|
Six months ended 30 June |
|
(thousands of €) |
2019 |
2018 |
Adjustment for non-cash transactions |
|
|
Depreciation and amortization |
5,653 |
3,684 |
Share-based compensation |
16,751 |
10,540 |
Increase in retirement benefit liabilities and provisions |
168 |
149 |
Unrealised exchange gains (–) /losses and non-cash other financial expenses |
(1,424) |
(5,241) |
Fair value adjustment financial assets held at fair value through profit or loss |
2,130 |
(154) |
Total adjustment for non-cash transactions |
23,278 |
8,978 |
|
|
|
Adjustment for items to disclose separately under operating cash flow |
|
|
Interest expense |
452 |
415 |
Interest income |
(3,445) |
(1,892) |
Tax expense |
129 |
137 |
Total adjustment for items to disclose separately under operating cash flow |
(2,864) |
(1,340) |
|
|
|
Adjustment for items to disclose under investing and financing cash flows |
|
|
Gain on sale of assets |
(3) |
– |
Total adjustment for items to disclose under investing and financing cash flows |
(3) |
– |
|
|
|
Change in working capital other than deferred income |
|
|
Decrease in inventories |
3 |
12 |
Increase in receivables |
(32,895) |
(3,204) |
Increase in payables |
16,974 |
21,357 |
Total change in working capital other than deferred income |
(15,918) |
18,165 |