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 €) |
||||
|
||||||||
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 |
||
|
||||||
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 |
||
|
||||||
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.