Details of the unaudited interim results
Revenues and other income
Revenues
The following table summarizes our revenues for the three months ended 31 March 2018 and 2017.
|
Three months ended 31 March |
|
(thousands of €) |
2018 |
2017 |
Recognition of non-refundable upfront payments and license fees |
25,824 |
15,225 |
Milestone payments |
8,809 |
16,564 |
Reimbursement income |
192 |
104 |
Other revenues |
3,081 |
2,099 |
Total revenues |
37,907 |
33,992 |
Revenues (€37.9 million vs €34.0 million for the same period last year) were higher due to an increase in the recognition of the upfront payment from Gilead related to the filgotinib program, which is recognized in function of the costs incurred for this program, but also due to the adoption of IFRS 15 – Revenue from contract with customers, on 1 January 2018, resulting in the recognition for the first quarter of 2018 of €10.4 million of deferred revenues related to previously recognized upfront and milestones under the former applicable standards of IAS 18.
The following table summarizes the recognition of the upfront, license fees and milestones payments received for the three months ended 31 March 2018 and 2017.
|
|
|
|
IAS 18 |
|
IFRS 15 |
IFRS 15 |
IAS 18 |
IAS 18 |
IFRS 15 |
||
Agreement |
Consideration received |
Consideration received |
Collaboration start date |
Outstanding balance in deferred income as at 31 December 2017 |
Deferred income reclassified from equity following adoption of IFRS 15 |
Outstanding balance in deferred income as at 1 January 2018 |
Revenue recognized, three months ended 31 March 2018 |
Revenue recognized, three months ended 31 March 2018 |
Revenue recognized, three months ended 31 March 2017 |
Outstanding balance in deferred income as at 31 March 2018 |
||
|
(thousands of $) |
(thousands of €) |
|
(thousands of €) |
||||||||
|
||||||||||||
Gilead collaboration agreement for filgotinib – Upfront payment |
300,000 |
275,558 |
January 2016 |
187,449 |
|
187,449 |
20,914 |
20,914 |
13,337 |
166,535 |
||
Gilead collaboration agreement for filgotinib – Subscription agreement(1) |
N.A. |
39,003 |
January 2016 |
26,532 |
|
26,532 |
2,960 |
2,960 |
1,888 |
23,572 |
||
Servier collaboration agreement for osteoarthritis – License fee |
N.A. |
6,000 |
June 2010 |
5,362 |
(5,362) |
– |
|
383 |
|
– |
||
AbbVie collaboration agreement for CF – Upfront payments |
45,000 |
34,001 |
September 2013 |
|
14,872 |
14,872 |
1,950 |
|
|
12,922 |
||
Total upfront and license fees: |
|
219,343 |
9,510 |
228,853 |
25,824 |
24,257 |
15,225 |
203,028 |
||||
|
|
|
|
|
|
|
|
|
|
|
||
Gilead collaboration agreement for filgotinib – Milestone payments |
70,000 |
64,435 |
January 2016 |
|
43,832 |
43,832 |
4,891 |
|
|
38,941 |
||
AbbVie collaboration agreement for CF – Milestone payments |
77,500 |
68,310 |
September 2013 |
|
29,878 |
29,878 |
3,918 |
|
16,564 |
25,960 |
||
Total milestones: |
|
|
– |
73,710 |
73,710 |
8,809 |
– |
16,564 |
64,901 |
|||
Total: |
|
|
219,343 |
83,220 |
302,563 |
34,633 |
24,257 |
31,789 |
267,929 |
The first adoption of IFRS 15 Revenue from contracts with customers negatively impacted the accumulated losses and increased the amount of deferred income (contract liabilities) with an amount of €83.2 million, as shown in the table above (column “Deferred income reclassified from equity following adoption of IFRS 15”). We elected the modified retrospective method for the transition which foresees that prior period figures remain as reported under the previous standard and the cumulative effect of applying IFRS 15 is recognized as an adjustment to the opening balance of equity as at the date of initial application (beginning of the year 2018).
The revenues recognized for the three months ended 31 March 2018 are presented in the table above under IFRS 15 standard as well as under IAS 18 standard, with a comparison to last year’s period under IAS 18 standard.
We applied the five step model detailed in the IFRS 15 standard to determine when, how and at what amount revenue is to be recognized depending on whether certain criteria are met. The significant judgements made in applying this standard are detailed below:
The substance of our current arrangements is that Galapagos is licensing its IP to collaborative partner entities and conducts research and development (“R&D”) activities. Such activities result in a service that is the output of Galapagos’ ordinary activities. We generate revenue through a number of these arrangements which include license fees, milestone payments, reimbursement income and future sales based milestones and sales based royalties. We assessed that the revenues from our current material licensing and collaboration agreements are in the scope of IFRS 15.
Collaboration with Gilead
We concluded as follows:
- We assessed that there is one single performance obligation under the new standards of IFRS 15; the transfer of a license combined with performance of R&D activities. This is because we considered that the license is not distinct in the context of the contract.
- The transaction price of our agreement is currently composed of a fixed part, being an upfront license fee and a variable part, being milestone payments and cost reimbursements for R&D activities delivered. Milestone payments are included in our revenues only when achieved. Sales based milestones and sales based royalties are a part of our arrangement but are not yet included in our revenues as our program is still in phase 3 of development.
- The transaction price has been allocated to the single performance obligation and revenues have been recognized over the estimated service period based on a pattern that reflects the transfer of the license and progress to complete satisfaction of the R&D activities. This is because we considered that there is a transformational relationship between the license and the R&D activities to be delivered.
- We have chosen an input model to measure the satisfaction of the single performance obligation that considers percentage of costs incurred for this program that are completed each period (% of completion method).
- Costs reimbursements received from Gilead are to be recognized in revenues when costs are incurred and agreed by the parties as we are acting as a principal in the scope of our stake of the R&D activities of our ongoing license and collaboration agreements.
As a result of this analysis, for the first three months of 2018, €28.8 million of deferred income related to the Gilead collaboration agreement were recognized in revenue under IFRS 15 in function of costs incurred, applying the percentage of completion method. This revenue recognition consisted of (i) €20.9 million related to the upfront license fee, (ii) €3.0 million related to the deferred income triggered by the accounting treatment of the share subscription agreement under IAS 39 Financial Instruments: recognition and measurement, and (iii) €4.9 million related to milestone payments received. The outstanding balance of deferred income from the Gilead collaboration agreement at the end of March 2018 amounted to €229.0 million of which €83.9 million reported as non-current deferred income.
As reflected in the table above, the impact of the IFRS 15 adoption on our revenues generated from our collaboration with Gilead was only related to the deferral of previously recognized milestones.
Collaboration with AbbVie
We concluded as follows:
- We assessed that there is one single performance obligation under the new standards of IFRS 15; the transfer of a license combined with performance of R&D activities. This is because we considered that the license is not capable of being distinct and is not distinct in the context of the contract.
- The transaction price of our agreement is currently composed of a fixed part, being an upfront license fee, and a variable part, being milestone payments and cost reimbursements for R&D activities delivered. Milestone payments are included in our revenues only when achieved. Sales based milestones and sales based royalties are a part of our arrangement but are not yet included in our revenues as our program is still in phase 1 & 2 of development.
- The transaction price has been allocated to the single performance obligation and revenues have been recognized over the estimated service period based on a pattern that reflects the transfer of the license and progress to complete satisfaction of the R&D activities. This is because we considered that there is a transformational relationship between the license and the R&D activities to be delivered.
- We have chosen an input model to measure the satisfaction of the single performance obligation that considers a percentage of costs incurred for this program that are completed each period (% of completion method).
- Costs reimbursements received from AbbVie could be recognized in revenues when costs are incurred and agreed by the parties as we are acting as a principal in the scope of our stake of the R&D activities of our ongoing license and collaboration agreements.
As a result of this analysis, for the first three months of 2018, €5.9 million of deferred income related to the AbbVie collaboration agreement were recognized in revenue under IFRS 15 in function of costs incurred, applying the percentage of completion method. This revenue recognition consisted of (i) €2.0 million related to the upfront license fee and (ii) €3.9 million related to milestone payments received in previous years. The outstanding balance of deferred income from the AbbVie collaboration agreement at the end of March 2018 amounted to €38.9 million of which €18.6 million reported as non-current deferred income.
As reflected in the table above, the impact of the IFRS 15 adoption on our revenues generated from our collaboration with AbbVie was related to the deferral of previously recognized upfront fee and milestones.
Finally, the deferred income balance on 31 December 2017 related to the license fee received from Servier in the scope of our license and collaboration agreement in the field of osteoarthritis (€5.4 million) was fully reclassified to equity as a consequence of the adoption of the new standard.
Other revenues
Other revenues mainly consisted in service revenues from our fee-for-service business for €3.0 million, as reported under the segment information disclosure below.
Other income
The following table summarizes our other income for the three months ended 31 March 2018 and 2017.
|
Three months ended 31 March |
|
(thousands of €) |
2018 |
2017 |
Grant income |
549 |
293 |
Other income |
6,382 |
5,578 |
Total other income |
6,931 |
5,871 |
Other income increased (€6.9 million vs €5.9 million last year) in the first three months of 2018, mainly driven by higher income from R&D incentives.
Results
We realized a net loss of €37.3 million for the first three months of 2018, compared to a net loss of €13.6 million in the first three months of 2017.
We reported an operating loss amounting to €32.0 million for the first three months of 2018, compared to an operating loss of €11.2 million for the same period last year.
Our R&D expenses in the first three months of 2018 were €69.8 million, compared to €44.9 million in 2017. This planned increase was due mainly to an increase of €20.4 million in subcontracting costs primarily on our filgotinib and GLPG1690 programs. Furthermore, personnel costs increased, explained by a planned headcount increase.
Our G&A and S&M expenses were €7.1 million in the first quarter of 2018, compared to €6.2 million in the first quarter of 2017. This increase mainly resulted from higher personnel costs due to a planned headcount increase.
Net financial expenses in the first three months of 2018 amounted to €5.2 million compared to net financial expenses of €2.4 million in 2017, and were primarily attributable to €5.6 million of unrealized exchange loss on our cash position in U.S. dollars. We expect to use this cash held in U.S. dollars to settle our future payables in U.S. dollars, which will be primarily linked to our global collaboration with Gilead for the development of filgotinib.
Segment information
We have two reportable segments: R&D and our fee-for-service business Fidelta, located in Croatia.
|
Segment information for the three months ended 31 March 2018 |
|||||||
(thousands of €) |
R&D |
Fee-for-services |
Inter-segment elimination |
Group |
||||
|
||||||||
External revenue |
34,888 |
3,019 |
|
37,907 |
||||
Internal revenue |
|
2,175 |
(2,175) |
– |
||||
Other income |
6,931 |
– |
|
6,931 |
||||
Revenues & other income |
41,819 |
5,194 |
(2,175) |
44,838 |
||||
|
|
|
|
|
||||
Segment result |
(29,424) |
1,330 |
|
(28,093) |
||||
Unallocated expenses(1) |
|
|
|
(3,943) |
||||
Operating loss |
|
|
|
(32,036) |
||||
Financial (expenses) / income(2) |
|
|
|
(5,184) |
||||
Result before tax |
|
|
|
(37,221) |
||||
Income taxes(2) |
|
|
|
(62) |
||||
Net loss |
|
|
|
(37,283) |
|
Segment information for the three months ended 31 March 2017 |
|||||||
(thousands of €) |
R&D |
Fee-for-services |
Inter-segment elimination |
Group |
||||
|
||||||||
External revenue |
31,950 |
2,042 |
|
33,992 |
||||
Internal revenue |
|
1,005 |
(1,005) |
– |
||||
Other income |
5,859 |
12 |
|
5,871 |
||||
Revenues & other income |
37,809 |
3,059 |
(1,005) |
39,863 |
||||
|
|
|
|
|
||||
Segment result |
(7,745) |
(457) |
|
(8,202) |
||||
Unallocated expenses(1) |
|
|
|
(3,023) |
||||
Operating loss |
|
|
|
(11,225) |
||||
Financial (expenses) / income(2) |
|
|
|
(2,380) |
||||
Result before tax |
|
|
|
(13,605) |
||||
Income taxes(2) |
|
|
|
– |
||||
Net loss |
|
|
|
(13,605) |
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 €1,108.2 million on 31 March 2018.
A net decrease of €43.0 million in cash and cash equivalents was recorded during the first three months of 2018, compared to a decrease of €19.9 million during the same period last year. Net cash flows used in operating activities amounted to €39.8 million in the first quarter 2018. Exercise of warrants in the first quarter of 2018 generated a financing cash inflow of €3.9 million. Furthermore €1.5 million was used in investing activities and €5.6 million unrealized negative exchange rate differences were reported on cash and cash equivalents.
Cash and cash equivalents amounted to €1,108.2 million at the end of March 2018 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 €662.4 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 €149.6 million and aim at meeting short-term cash commitments, while reducing the counterparty risk of investment.
|
31 March |
31 December |
(thousands of €) |
2018 |
2017 |
Cash at banks |
296,226 |
288,052 |
Term deposits |
662,355 |
713,446 |
Money market funds |
149,602 |
149,711 |
Cash on hand |
3 |
3 |
Total cash and cash equivalents |
1,108,186 |
1,151,211 |
On 31 March 2018, our cash and cash equivalents included $247.4 million held in U.S. dollars which could generate foreign exchange gain or loss in our financial results in accordance with the fluctuation of the EUR/U.S. dollar exchange rate as our functional currency is EUR. We expect to use this cash held in U.S. dollars to settle our future payables in U.S. dollars which will be primarily linked to our global collaboration with Gilead for the development of filgotinib.
Finally, our balance sheet held R&D incentives receivables from the French government (Crédit d’Impôt Recherche) amounting to €39.1 million as of 31 March 2018, to be received in four yearly tranches. Our balance sheet also held R&D incentives receivables from the Belgian Government amounting to €41.7 million as at 31 March 2018.
Capital increase
On 31 March 2018, Galapagos NV’s share capital was represented by 51,234,962 shares. All shares were issued, fully paid up and of the same class. The below table summarizes our capital increases for the quarter ended 31 March 2018.
(thousands of €, except share data) |
Number |
Share |
Share |
Share capital and share premium |
Average exercise price warrants |
Closing share price on date of capital increase |
On 1 January 2018 |
50,936,778 |
233,414 |
993,025 |
1,226,439 |
|
|
|
|
|
|
|
|
|
20 March 2018: exercise of warrants |
298,184 |
1,613 |
2,311 |
3,924 |
13.16 |
83.72 |
|
|
|
|
|
|
|
On 31 March 2018 |
51,234,962 |
235,027 |
995,336 |
1,230,363 |
|
|