Details of the unaudited condensed consolidated interim results

Notes
CSR report

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

-

(1)

The outstanding balance at 31 March 2021 and at 31 December 2020 comprises the issuance liability for the subsequent warrant B and the upfront payment allocated to the drug discovery platform.

(2)

With regard to the additional consideration received for the extended cost sharing for filgotinib, we assume the existence of a significant financing component reflecting the time value of money on the estimated recognition period.

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