Details of the unaudited interim results

Details of the unaudited interim results

Revenues and other income

Revenues

The following table summarizes our revenues for the nine months ended 30 September 2016 and 2015.

 

Nine months ended 30 September

(thousands of €)

2016

2015

Recognition of non-refundable upfront payments

17,562

26,419

Milestone payments

17,567

200

Reimbursement income

9,238

1,901

Other revenues

5,641

3,851

Total revenues

50,009

32,371

Revenues (€50.0 million vs €32.4 million for the same period last year) were higher due to milestone payments received from AbbVie for our CF program and to an increase of contractually agreed costs recharges on partnered programs (i.e. reimbursement income).

In the first nine months of 2016, reimbursement income amounting to €9.2 million mainly comprised of the reimbursement of certain research and development costs related to the development work under the Galapagos’ collaboration agreements for our CF program with AbbVie for €5.6 million and for filgotinib with Gilead for €3.6 million.

Cost reimbursements resulting from Research & Development collaborations are recognized as reimbursement income in revenue as the related costs are incurred. The corresponding R&D expenses are included in the Research & Development expenditures in the consolidated financial statements.

The following table summarizes the upfront payments recognition for the nine months ended 30 September 2016 and 2015.

Agreement

Upfront received

Upfront received

Date of receipt

Revenue recognized, nine months ended 30 September 2016

Revenue recognized, nine months ended 30 September 2015

Outstanding balance in deferred income as at 30 September 2016

 

(thousands of $)

(thousands of €)

 

(thousands of €)

(*)

deferred income of €39 million booked upon signing of the Share Subscription Agreement with Gilead as required under IAS 39.

AbbVie Collaboration Agreement for CF

45,000

34,001

September 2013

 

11,401

 

AbbVie Collaboration Agreement for RA and CD (filgotinib)

150,000

111,582

February 2012

 

12,045

 

First Amendment to AbbVie Collaboration Agreement for RA and CD (filgotinib)

20,000

15,619

March 2013

 

2,973

 

Gilead Collaboration Agreement for filgotinib

300,000

275,558

January 2016

14,500

 

261,058

Gilead Collaboration Agreement for filgotinib

N.A.

39,003(*)

January 2016

2,052

 

36,950

ThromboGenics License Agreement for integrin antagonists

N.A.

1,000

April 2016

1,000

 

 

Sirion Biotech License Agreement for RNA interference (RNAi) technologies

N.A.

10

June 2016

10

 

 

Total recognition of non-refundable upfront payments

17,562

26,419

298,008

Revenue recognized in 2015 from upfront non-refundable payments related to the CF collaboration agreement with AbbVie signed in September 2013 and the contract signed with AbbVie in February 2012 for our filgotinib program (including the extension signed in March 2013). Those upfront payments were fully recognized into revenues by the end of August 2015.

In September 2015 AbbVie decided not to opt in, which ended the collaboration agreement regarding our filgotinib program and consequently the period of our involvement. There are no outstanding commitments for us regarding this terminated collaboration for our filgotinib program.

On 16 December 2015, we entered into a global collaboration with Gilead Sciences, Inc. for the development and commercialization of the JAK1-selective inhibitor filgotinib for inflammatory indications. On 19 January 2016, we completed the closing of the global collaboration agreement with Gilead, in the framework of which Gilead made a $425 million (or €392 million) equity investment in Galapagos NV by subscribing to new shares at a price of €58 per share, including issuance premium. This resulted in Gilead owning 6,760,701 ordinary shares of Galapagos NV, representing 14.75% percent of the then-outstanding share capital of Galapagos. We also received a license fee of $300 million. In addition, we are eligible for payments of up to $755 million in development and regulatory milestones and $600 million in sales milestones, with tiered royalties starting at 20% and a profit split in co-promotion territories. Finally, we agreed on a 20-80 cost split for development costs of the licensed product, i.e. we will support 20% of all development costs. As we do not expect to have a statutory taxable base in the foreseeable future, we did not recognize any additional deferred tax asset following the signing of this new collaboration.

The global collaboration with Gilead foresees continuous involvement from us, since we will perform certain R&D activities in the development phase of the filgotinib program; therefore, management assessed that the upfront payment of $300 million (or €275.6 million) received in January 2016 from Gilead should be spread as a function of the costs incurred for this program, applying the percentage of completion method. In the first nine months of 2016, €14.5 million revenues were recognized regarding this upfront payment.

In connection with the agreement with Gilead, we recognized a deferred income and an offsetting short-term financial asset (derivative) of €39 million upon signing of the Share Subscription Agreement with Gilead, as required under IAS 39. We refer to the note below for further detail. The deferred income will be recognized in function of the costs incurred for this program, applying the percentage of completion method, along with the upfront payment. In the first nine months of 2016, €2.1 million revenues were recognized in the income statement.

In 2016, Galapagos signed a license agreement with Thrombogenics for an integrin antagonist (formerly GLPG0187), for which an upfront payment of €1 million was invoiced and fully recognized, as Galapagos has no further involvement or obligation in the contract.

Other income

The following table summarizes our other income for the nine months ended 30 September 2016 and 2015.

 

Nine months ended 30 September

(thousands of €)

2016

2015

Grant income

1,451

2,430

Other income

13,581

12,418

Total other income

15,031

14,848

Other income was stable (€15.0 million vs €14.8 million last year) in the first nine months of 2016.

Results

We realized a net profit of €8.1 million for the first nine months of 2016, compared to a net loss of €61.4 million in the first nine months of 2015.

We reported an operating loss amounting to €48.5 million for the first nine months of 2016, compared to an operating loss of €63.3 million for the same period last year.

Our R&D expenses in the first nine months of 2016 were €96.7 million, compared to €96.9 million in 2015.

Our G&A and S&M expenses were €16.8 million in the first nine months of 2016, compared to €13.6 million in the first nine months of 2015. This increase mainly resulted from higher costs recognized in relation to the warrant plans as a result of the increase of our share price in the past year as well as a slight headcount increase and higher other operational costs

Financial results were primarily driven by the fair value re-measurement of the Share Subscription Agreement, which is explained under the next caption below. Net other financial costs in the first nine months of 2016 amounted to €0.9 million compared to a net other financial income of €0.4 million in 2015; this increase was primarily attributable to €2.4 million of exchange loss on our cash position in USD due to the fluctuation of the USD exchange rate in the first nine months of 2016.

Finally, the income tax expense in the first nine months of 2016 represented a tax expense in a French subsidiary while the income tax profit of €1.4 million in the first nine months of 2015 mainly reflected the setup of an additional deferred tax asset for a French subsidiary for €1.5 million. We had a total of €1.7 million deferred tax assets on the balance sheet for two subsidiaries at the end of the first nine months of 2015 and 2016.

Fair value re-measurement of Share Subscription Agreement

On 16 December 2015, Gilead and Galapagos entered into a global collaboration for the development and commercialization of filgotinib, in the framework of which Gilead committed to an upfront payment of $725 million consisting of a license fee of $300 million and a $425 million equity investment in Galapagos NV by subscribing to new shares at a price of €58 per share, including issuance premium. This agreement was effectively completed and entered into force on 19 January 2016, and the full payment was received.

In connection with this agreement, we recognized in December 2015 a short term financial asset (derivative) and an offsetting deferred income of €39 million upon signing of the Share Subscription Agreement with Gilead as required under IAS 39. This financial asset initially reflected the share premium that Gilead committed to pay above our closing share price on the day of entering into the Share Subscription Agreement. Under IAS 39 the fair value of the financial asset was re-measured at year-end and again upon closing of the Share Subscription Agreement on 19 January 2016, when the financial asset expired. Variations in fair value of the financial asset are recorded in the income statement.

The decrease in the fair value of the financial asset resulting from the increase in the Galapagos share price between signing of the Share Subscription Agreement and 31 December 2015 resulted in a negative, non-cash adjustment fair value charge of €30.6 million in the financial results of 2015.

The subsequent increase in the fair value of the financial asset resulting from the decrease in our share price between 1 January 2016 and 19 January 2016 resulted in a positive non-cash gain of €57.5 million in the financial result of the first quarter of 2016.

On 19 January 2016, the value of the financial asset at maturity amounted to €65.9 million, reflecting the share premium that Gilead paid above our closing share price on the day of the capital increase. This amount was composed of (1) the initial measurement on the day of entering into the Share Subscription Agreement for an amount of €39 million which was reported in deferred income and (2) the subsequent re-measurements of the financial asset, reported as financial result under IAS 39: €30.6 million fair value loss reported in the year 2015 and €57.5 million fair value gain reported in the first quarter of 2016, together a net fair value gain of €26.8 million. This financial asset expired on the effective date of the Share Subscription Agreement.

Segment information

Since the last quarter of 2015, the IFRS 8 threshold of 10% of the combined revenues, external and intersegment, of all segments was met by the external and internal revenues reported by our fee-for-service business Fidelta, located in Croatia. Consequently, there are two reportable segments: R&D and fee-for-service business.

 

Segment information for the nine months ended 30 September 2016

 

(thousands of €)

R&D

Fee-For-Services

Inter-segment elimination

Group

(1)

Unallocated expenses consist mainly of expenses for warrant plans under IFRS 2.

External revenue

44,525

5,484

50,009

Internal revenue

3,901

(3,901)

Other income

14,898

133

15,031

Revenues & other income

59,423

9,518

(3,901)

65,040

 

 

 

 

 

Segment result

(40,546)

(736)

 

(41,281)

Unallocated expenses(1)

 

 

 

(7,201)

Operating loss

 

 

 

(48,482)

Financial (expenses) / income

 

 

 

56,621

Result before tax

 

 

 

8,138

Income taxes

 

 

 

(71)

Net income / loss (–)

 

 

 

8,067

 

Segment information for the nine months ended 30 September 2015

 

(thousands of €)

R&D

Fee-For-Services

Inter-segment elimination

Group

(1)

Unallocated expenses consist of €2,716 thousand of expenses for warrant plans under IFRS 2 and €370 thousand of positive adjustment on depreciation charges reported by Fee-For-Services reflecting the expected useful lifetime of certain fixed assets following the purchase accounting of the acquisition of Fidelta in 2010.

External revenue

28,580

3,791

32,371

Internal revenue

3,872

(3,872)

Other income

14,654

194

14,848

Revenues & other income

43,234

7,857

(3,872)

47,219

 

 

 

 

 

Segment result

(58,894)

(2,014)

 

(60,908)

Unallocated expenses(1)

 

 

 

(2,346)

Operating loss

 

 

 

(63,254)

Financial (expenses) / income

 

 

 

438

Result before tax

 

 

 

(62,816)

Income taxes

 

 

 

1,411

Net income / loss (–)

 

 

 

(61,406)

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, cash equivalents and restricted cash totaled €938.8 million on 30 September 2016.

A net increase of €590.5 million in cash and cash equivalents was recorded during the first nine months of 2016, compared to an increase of €178.8 million during the same period last year. Net cash flows from financing activities were generated for €395.2 million mainly through the share subscription by Gilead. Furthermore, a net cash inflow from operating activities was realized for €204.3 million in the first nine months of 2016 resulting from the license fee of $300 million (€275.6 million) received from Gilead and, by difference, from an operating cash burn of €71.3 million. Finally, €6.7 million was used in investing activities and €2.4 million negative exchange rate differences were generated on cash and cash equivalents.

Restricted cash amounted to €7.9 million at the end of December 2015, and remained stable at the end of September 2016.

Restricted cash on 30 September 2016 was composed of (1) €0.4 million and €0.7 million bank guarantees on real estate lease obligations in Belgium and in the Netherlands respectively, and (2) €6.9 million escrow account containing part of the proceeds from the sale of the service division in 2014 for which the release will be possible after final agreement between the parties on the exposure regarding one outstanding claim. An amount of €0.3 million was accrued in March 2015 based on a preliminary estimate of the exposure.

Cash and cash equivalents amounted to €930.8 million at the end of September 2016 and comprised 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 3 months while monitoring all liquidity aspects. Cash and cash equivalents comprised €387.5 million of term deposits with an original maturity longer than 3 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 €100.0 million and was aimed at meeting short-term cash commitments, while reducing the counterparty risk of investment.

 

As at 30 September

As at 31 December

(thousands of €)

2016

2015

Cash at banks

443,307

240,292

Term deposits

387,520

100,000

Money market funds

99,979

Cash on hand

2

22

Total cash and cash equivalents

930,807

340,314

On 30 September 2016, our cash and cash equivalents included $124 million held in USD which could generate unrealized exchange gain or loss in our financial results in accordance with the fluctuation of the EUR/USD exchange rate as our functional currency is EUR. We expect to use this cash held in USD to settle our future payables in USD which will be primarily linked to our global collaboration with Gilead for the development of filgotinib.

Furthermore, our balance sheet holds an unconditional and unrestricted receivable from the French government (Crédit d’Impôt Recherche2Crédit d’Impôt Recherche refers to an innovation incentive system underwritten by the French government.) amounting to €39.0 million as of 30 September 2016, to be received in yearly tranches from 2016 to 2020. Our balance sheet also holds a receivable from the Belgian Government for R&D incentives amounting to €28.3 million as of 30 September 2016, to be received in yearly tranches from 2017 until 2026.

Capital increase

On 19 January 2016, Gilead made a $425 million equity investment in Galapagos NV by subscribing to 6,760,701 new ordinary shares at a price of €58 per share, including issuance premium.

Galapagos received €392.1 million of gross proceeds, decreased by €0.26 million of expenses, of which all has been paid at 30 September 2016. The total net cash proceeds from the share subscription by Gilead amounts to €391.9 million.

The €65.9 million current financial asset from the Share Subscription Agreement reflecting the premium that Gilead paid compared to the closing price of our shares on 19 January 2016 were derecognized via the share premium account.

On 1 April 2016, warrants were exercised at various exercise prices (with an average exercise price of €10.70 per warrant) resulting in a share capital increase (including issuance premium) of €1,409.3 thousand and the issuance of 131,695 new shares. The closing price of the Galapagos share on this date was €36.64.

On 19 May 2016, warrants were exercised at various exercise prices (with an average exercise price of €10.49 per warrant) resulting in a share capital increase (including issuance premium) of €1,476.4 thousand and the issuance of 140,770 new shares. The closing price of the Galapagos share on this date was €45.41.

On 19 September 2016, warrants were exercised at various exercise prices (with an average exercise price of €10.00 per warrant) resulting in a share capital increase (including issuance premium) of €603.3 thousand and the issuance of 60,320 new shares. The closing price of the Galapagos share on this date was €58.62.

On 30 September 2016, Galapagos NV’s share capital was represented by 46,169,828 shares. All shares were issued, fully paid up and of the same class.

(thousands of €, except number of shares)

Number of shares

Share capital

Share premium

Share capital and share premium

On 1 January 2016

39,076,342

185,399

357,402

542,801

 

 

 

 

 

19 January 2016: share subscription from Gilead

 

 

 

 

Ordinary shares (fully paid)

6,760,701

36,575

355,546

392,121

Derecognition of financial asset from Share Subscription Agreement

 

 

(65,850)

(65,850)

Capital increase expenses (fully paid)

 

(269)

 

(269)

Total share subscription by Gilead

6,760,701

36,306

289,696

326,002

 

 

 

 

 

1 April 2016: exercise of warrants

131,695

668

741

1,409

 

 

 

 

 

19 May 2016: exercise of warrants

140,770

762

715

1,476

 

 

 

 

 

19 September 2016: exercise of warrants

60,320

326

277

603

 

 

 

 

 

On 30 September 2016

46,169,828

223,462

648,830

872,292

The number of warrants outstanding per 30 September 2016 amounted to 3,552,657, of which 755,954 were exercisable. During the third quarter of 2016, 634,250 warrants were granted, 2,500 warrants were forfeited and 60,320 were exercised. All warrants offered to the members of the Board of Directors and of the Executive Committee during the third quarter of 2016 (i.e. an aggregate amount of 327,500 warrants) were accepted as per 30 September 2016.

2Crédit d’Impôt Recherche refers to an innovation incentive system underwritten by the French government.