Details of the unaudited condensed consolidated interim results
Revenues and other income
Revenues
The following table summarizes our revenues for the three months ended 31 March 2021 and 2020.
|
Three months ended 31 March |
|||
---|---|---|---|---|
(thousands of €) |
Over time |
Point in time |
2021 |
2020 |
Recognition of non-refundable upfront payments and license fees |
|
|
105,226 |
88,287 |
Gilead collaboration agreement for filgotinib |
|
47,405 |
32,105 |
|
Gilead collaboration agreement for drug discovery platform |
|
57,821 |
56,182 |
|
|
|
|
|
|
Milestone payments |
|
|
7,865 |
3,272 |
Gilead collaboration agreement for filgotinib |
|
7,865 |
3,272 |
|
|
|
|
|
|
Reimbursement income |
|
|
- |
3,193 |
Novartis collaboration agreement for MOR106 |
|
- |
3,193 |
|
|
|
|
|
|
Other revenues |
|
|
43 |
66 |
Other revenues |
|
43 |
66 |
|
|
|
|
|
|
Commercial revenues |
|
|
758 |
- |
Sale of goods |
|
79 |
- |
|
Royalties |
|
678 |
- |
|
Total revenues |
|
|
113,892 |
94,817 |
Revenues (€113.9 million for the first three months of 2021, compared to €94.8 million for the first three months of 2020) were higher mainly driven by the increase in revenue recognition of upfront consideration and milestone payments received in the scope of the collaboration with Gilead for filgotinib amounting to €55.3 million for the first three months of 2021 (€35.4 million for the same period last year). The increased cost share and the additional upfront consideration as a consequence of the renegotiated arrangement between Gilead and Galapagos in December 2020, as well as the milestones for the approval of filgotinib in Europe and Japan achieved in the third quarter of 2020, all contributed to this increase in revenues.
The rollforward of the outstanding balance of the current and non-current deferred income between 1 January 2021 and 31 March 2021 can be summarized as follows:
(thousands of €) |
Total |
Gilead collaboration agreement for filgotinib |
Gilead collaboration agreement for drug discovery platform(1) |
Other deferred income (grants) |
||||
---|---|---|---|---|---|---|---|---|
On 31 December 2020 |
2,809,133 |
818,654 |
1,990,412 |
67 |
||||
|
|
|
|
|
||||
Significant financing component(2) |
2,447 |
2,447 |
|
|
||||
|
|
|
|
|
||||
Revenue recognition of upfront payments |
(105,226) |
(47,405) |
(57,821) |
|
||||
Revenue recognition of milestone payments |
(7,865) |
(7,865) |
|
|
||||
|
|
|
|
|
||||
Other movements |
(67) |
|
|
(67) |
||||
|
|
|
|
|
||||
On 31 March 2021 |
2,698,417 |
765,829 |
1,932,589 |
- |
||||
|
Other income
Other income (€10.3 million for the first three months of 2021, compared to €8.7 million for the first three months of 2020) increased by €1.6 million, mainly driven by higher incentives income from the government for R&D activities.
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 in 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 in the first three months of 2020. This increase was due to an increase of €3.4 million 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 AtD program with MOR106. Furthermore, personnel costs increased by €10.1 million from €30.3 million in the first three months of 2020 to €40.4 million in the first three months of 2021. This increase is explained by a planned headcount increase and increased costs of the subscription right plans.
The table below summarizes our R&D expenditure for the three months ended 31 March 2021 and 2020, broken down by program.
|
Three months ended 31 March |
|
---|---|---|
(thousands of €) |
2021 |
2020 |
Filgotinib program |
(36,932) |
(29,296) |
Ziritaxestat program |
(10,513) |
(13,783) |
OA program with GLPG1972 |
(636) |
(6,427) |
Toledo program |
(27,823) |
(16,871) |
AtD program with MOR106 |
(152) |
(4,248) |
Other programs |
(53,904) |
(44,828) |
Total research and development expenditure |
(129,960) |
(115,453) |
Our G&A and S&M expenses were €45.0 million in the first three months of 2021, compared to €34.3 million in the first three months of 2020. This increase mainly resulted from higher personnel costs for €9.6 million (€26.5 million in the first three months of 2021 compared to €16.9 million in the same period last year). This increase was due to a planned headcount increase following the commercial launch of filgotinib in Europe as well as higher costs of the subscription right plans.
In the first three months of 2021, 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 as well as 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 (as compared to €14.8 million in the same period last year), which was primarily attributable to €45.5 million of currency exchange gains on our cash and cash equivalents and current financial investments in U.S. dollars (as compared to €34.3 million in the first three months of 2020) and €3.6 million negative changes in (fair) value of current financial investments (€14.5 million in the same period last year). The other financial expenses also contained the effect of discounting our long term deferred income for €2.4 million (€4.4 million in the same period last year) and the fair value loss of financial assets held at fair value through profit or loss of €2.9 million (€2.7 million in the same period last year).
Cash position
Cash and cash equivalents and current financial investments totaled €5,114.7 million on 31 March 2021 (€5,169.3 million on 31 December 2020, including the cash and cash equivalents included in the assets classified as held for sale).
A net decrease of €54.6 million in cash and cash equivalents and current financial investments was recorded 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 of negative changes in (fair) value of current financial investments and €45.7 million of mainly positive exchange rate differences, and (iv) €28.7 million cash in from disposal of subsidiaries, net of cash disposed of.
The operational cash burn (or operational cash flow if this performance 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, included in the net cash flows generated from/used in (–) investing activities.
This alternative performance measure is in our view an important metric for a biotech company in the development stage.
The following table represents a reconciliation of the operational cash burn (–)/operational cash flow:
|
Three months ended 31 March |
|
---|---|---|
(thousands of €) |
2021 |
2020 |
Increase in cash and cash equivalents (excluding effect of exchange differences) |
379,129 |
864,695 |
Less: |
|
|
Net proceeds from capital and share premium increases |
(2,258) |
(5,355) |
Net sale of current financial investments |
(475,844) |
(942,738) |
Cash in from disposal of subsidiaries, net of cash disposed of |
(28,696) |
- |
Total operational cash burn |
(127,669) |
(83,398) |
Cash and cash equivalents and current financial investments comprised cash at banks, short-term bank deposits, treasury bills 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 monitors and optimizes our liquidity position. Our cash management strategy allows short-term deposits with an original maturity exceeding three months while monitoring all liquidity aspects. Cash and cash equivalents comprised €1,358.0 million of term deposits which all had an original maturity longer than three months. All cash and cash equivalents are available upon maximum three months notice period and without significant penalty. Cash at banks were mainly composed of notice accounts and term deposits. Our credit risk is mitigated by selecting a panel of highly rated financial institutions for our deposits.
Cash invested in highly liquid money market funds represented €1,107.4 million (€1,571.9 million on 31 December 2020) and are presented as current financial investments on 31 March 2021. The current financial investments also include treasury bills, amounting to €1,453.3 million on 31 March 2021 (€1,454.4 million on 31 December 2020). Our portfolio of treasury bills contains only AAA rated paper, issued by Germany and The Netherlands. Our money market funds portfolio consists of AAA short-term money market funds with a diversified and highly rated underlying portfolio managed by established fund management companies with a proven track record leading to an insignificant risk of changes in value.
|
31 March |
31 December |
---|---|---|
(thousands of €) |
2021 |
2020 |
Cash at banks |
1,195,911 |
1,239,993 |
Term deposits |
1,358,039 |
895,194 |
Cash and cash equivalents from continuing operations |
2,553,950 |
2,135,187 |
Cash and cash equivalents included in assets classified as held for sale |
- |
7,884 |
Total cash and cash equivalents |
2,553,950 |
2,143,071 |
On 31 March 2021, our cash and cash equivalents and current financial investments included $1,007.9 million held in U.S. dollars ($1,418.9 million on 31 December 2020) 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. The foreign exchange loss (–)/gain in case of a 10% change in the EUR/U.S. dollar exchange rate amounts to €86.0 million.
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 €142.3 million as at 31 March 2021.
Capital increase
On 31 March 2021, Galapagos NV’s share capital was represented by 65,511,581 shares. All shares were issued, fully paid up and of the same class. The below table summarizes our capital increases for the period ended 31 March 2021.
(thousands of €, except share data) |
Number of shares |
Share capital |
Share premium |
Share capital and share premium |
Average exercise price subscription rights (in €/subscription right) |
Closing share price on date of capital increase (in €/share) |
---|---|---|---|---|---|---|
On 1 January 2021 |
65,411,767 |
291,312 |
2,727,840 |
3,019,153 |
|
|
|
|
|
|
|
|
|
19 March 2021: exercise of subscription rights |
99,814 |
540 |
1,718 |
2,258 |
22.62 |
68.48 |
|
|
|
|
|
|
|
On 31 March 2021 |
65,511,581 |
291,852 |
2,729,558 |
3,021,411 |
|
|
Note to the cash flow statement
|
Three months ended 31 March |
|
---|---|---|
(thousands of €) |
2021 |
2020 |
Adjustment for non-cash transactions |
|
|
Depreciation and amortization |
5,019 |
4,189 |
Share-based compensation expenses |
18,459 |
9,227 |
Increase in retirement benefit obligations and provisions |
95 |
90 |
Unrealized exchange gains (–)/losses and non-cash other financial result |
(38,515) |
(32,856) |
Discounting effect of deferred income |
2,447 |
4,435 |
Fair value re-measurement of warrants |
(1,970) |
20,529 |
Net change in (fair) value of current financial investments |
3,572 |
14,507 |
Fair value adjustment financial assets held at fair value through profit or loss |
2,913 |
2,745 |
Other non-cash expenses |
- |
70 |
Total adjustment for non-cash transactions |
(7,980) |
22,935 |
|
|
|
Adjustment for items to disclose separately under operating cash flow |
|
|
Interest expense |
1,375 |
1,007 |
Interest income |
(740) |
(2,090) |
Tax expense |
157 |
336 |
Total adjustment for items to disclose separately under operating cash flow |
792 |
(747) |
|
|
|
Adjustment for items to disclose under investing and financing cash flows |
|
|
Gain on disposal of subsidiaries |
(22,191) |
- |
Realized exchange gain on sale of current financial investments |
(6,645) |
- |
Interest income on current financial assets |
(6) |
(2,596) |
Total adjustment for items to disclose separately under investing and financing cash flow |
(28,842) |
(2,596) |
|
|
|
Change in working capital other than deferred income |
|
|
Increase in inventories |
(300) |
(62) |
Decrease in receivables |
31,883 |
27,581 |
Increase/decrease (–) in liabilities |
(11,911) |
24,962 |
Total change in working capital other than deferred income |
19,673 |
52,481 |
Fair value re-measurements
Gilead warrants B
The issuance of initial warrant B was approved on 22 October 2019 by the extraordinary general meeting of shareholders and is not yet exercised by Gilead at 31 March 2021. Initial warrant B has been valued on the basis of a Longstaff-Schwartz Monte Carlo model. The input data used in the model were derived from market observations (volatility, discount rate and share price) and from management estimates (number of shares to be issued and applied discount for lack of marketability). The recognized fair value gain of €2.0 million was mainly the result of a decrease in the implied volatility of our share price as well as its evolution between 31 December 2020 and 31 March 2021. The fair value of the financial liability related to the initial warrant B amounted to €1.2 million on 31 March 2021 and was presented as a current financial instrument.
Subsequent warrant B is still subject to approval by an extraordinary general meeting of shareholders and is therefore still presented as issuance liability in our deferred income.
Discontinued operations
The following disclosure illustrates the result of our discontinued operations, related to the sale of our fee-for-service business (Fidelta) to Selvita on 4 January 2021.
1. Disposal of subsidiaries (discontinued operations)
1.1. Consideration received
(thousands of €) |
4 January 2021 |
---|---|
Consideration received in cash and cash equivalents |
37,080 |
Total consideration received |
37,080 |
1.2. Analysis of assets and liabilities over which control was lost
(thousands of €) |
4 January 2021 |
---|---|
Intangible assets |
21 |
Property, plant and equipment |
10,050 |
Other non-current assets |
160 |
Trade and other receivables |
4,428 |
Cash and cash equivalents |
7,884 |
Other current assets |
863 |
Total assets |
23,406 |
|
|
Non-current lease liabilities |
4,115 |
Other non-current liabilities |
70 |
Trade and other liabilities |
4,479 |
Current lease liabilities |
727 |
Income tax payable |
356 |
Total liabilities |
9,747 |
|
|
Net assets disposed of |
13,658 |
1.3. Gain on disposal of subsidiaries
(thousands of €) |
|
---|---|
Consideration received |
37,080 |
Net assets disposed of |
(13,658) |
Effect of cumulative translation adjustments reclassified from equity on loss of control |
(731) |
Costs associated to the sale |
(500) |
Gain on disposal |
22,191 |
1.4. Net cash inflow on disposal of subsidiaries
(thousands of €) |
|
---|---|
Consideration received in cash and cash equivalents |
37,080 |
Less: cash and cash equivalents balances disposed of |
(7,884) |
Total consideration received, net of cash disposed of |
29,196 |
Costs associated to the sale |
(500) |
Cash in from disposal of subsidiaries, net of cash disposed of |
28,696 |
2. Result from discontinued operations
|
Three months ended 31 March |
|
---|---|---|
(thousands of €, except share and per share data) |
2021 |
2020 |
Revenues |
- |
3,356 |
Other income |
- |
- |
Total revenues and other income |
- |
3,356 |
|
|
|
Gain on disposal of subsidiaries |
22,191 |
|
|
|
|
Research and development expenditure |
- |
(1,310) |
Sales and marketing expenses |
- |
|
General and administrative expenses |
- |
(413) |
Total operating expenses |
- |
(1,723) |
|
|
|
Operating profit |
22,191 |
1,633 |
|
|
|
Other financial income |
- |
40 |
Other financial expenses |
- |
(16) |
|
|
|
Profit before tax |
22,191 |
1,657 |
|
|
|
Income taxes |
- |
- |
|
|
|
Net profit |
22,191 |
1,657 |
|
|
|
Basic income per share from discontinued operations |
0.34 |
0.03 |
Diluted income per share from discontinued operations |
0.34 |
0.02 |
Weighted average number of shares - Basic (in thousands of shares) |
65,425 |
64,690 |
Weighted average number of shares - Diluted (in thousands of shares) |
65,944 |
68,123 |
3. Cash flows from discontinued operations
|
Three months ended 31 March |
|
---|---|---|
(thousands of €) |
2021 |
2020 |
Net cash flows generated from operating activities |
- |
1,998 |
Net cash flows generated from/used in (-) investing activities |
28,696 |
(447) |
Net cash flows used in financing activities |
- |
(183) |
Net cash flows from discontinued operations |
28,696 |
1,368 |