UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of October 2019.
Commission File Number: 001-37384
GALAPAGOS NV
(Translation of registrants name into English)
Generaal De Wittelaan L11 A3
2800 Mechelen, Belgium
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrants home country), or under the rules of the home country exchange on which the registrants securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrants security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Third Quarter 2019 Results
On October 24, 2019, Galapagos NV (the Company) announced its unaudited third quarter results for 2019, which are further described in a Q3 2019 report.
Exhibit |
Description | |
99.1 | Press Release issued on October 24, 2019 | |
99.2 | Third Quarter Report 2019 |
The information contained in this Current Report on Form 6-K, including the exhibits, except for the quotes of Onno van de Stolpe and Bart Filius contained in Exhibit 99.1, is hereby incorporated by reference into the Companys Registration Statements on Forms F-3 (File No. 333-230639) and S-8 (File Nos. 333-204567, 333-208697,333-211834, 333-215783, 333-218160, 333-225263, and 333-231765).
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
GALAPAGOS NV (Registrant) | ||||||
Date: October 25, 2019 | /s/ Xavier Maes | |||||
Xavier Maes Company Secretary |
Exhibit 99.1
Solid third quarter 2019 performance with strong balance sheet for continued R&D growth
| First nine month financial results: |
| Group revenues of 752.5 million |
| Operating profit of 393.0 million |
| Net profit of 265.3 million |
| Cash and cash equivalents on 30 Sept 2019 of 5.6 billion |
| Established unique collaboration with Gilead, securing capital and anchoring independent R&D for years to come |
| Filgotinib submitted by Gilead for approval in RA in Europe and Japan |
Webcast presentation tomorrow, 25 October 2019, at 14.00 CET/8 AM ET, www.glpg.com, +32 2 404 0659, code 6653712
Mechelen, Belgium; 24 October 2019, 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) announces its unaudited Q3 results, which are further detailed in its Q3 2019 report available on the Galapagos website, www.glpg.com.
There is no question that the third quarter of 2019 was defined by the unique and landmark deal with our long-time collaboration partner Gilead, announced mid-July. This 10-year research collaboration is about maximizing innovation based on the identification and development of new mode of action medicines. Thanks to the upfront payment of $3.95 billion and a $1.1 billion equity investment by Gilead, this deal gives us the financial strength and the independence to greatly expand our research engine and build a broader pipeline of new mode of action medicines. Gilead will have option rights on our programs outside of Europe, and as part of the agreement, they have already executed that right for our late-stage IPF compound, GLPG1690. We will benefit greatly from Gileads science expertise and infrastructure, said Onno van de Stolpe, CEO of Galapagos. Thanks to the progress made with filgotinib this past quarter, we and Gilead are on track for potential new drug approvals as of the second half of 2020, and we are very excited by the prospect of bringing filgotinib as a new treatment option to RA patients.
Bart Filius, COO and CFO added, Following the upfront payment of $3.95 billion and a $1.1 billion equity investment received in the Gilead transaction, we have an exceptionally strong balance sheet. As we continue to expand our organization to support our broad pipeline and build a commercial organization for potential launch of filgotinib in Europe next year, our financial guidance for full year 2019 operational cash burn1 between 320 and 340 million is unchanged, excluding the impact from our new collaboration agreement with Gilead.
Outlook 2019
Following on regulatory submissions in Europe and Japan, Gilead remains on track to submit filgotinib for approval in RA the US before year-end.
We will continue recruitment in our proprietary ISABELA, NOVESA and PINTA trials, and plan to provide an update on recruitment timelines for the ISABELA program in H2 2019. Together with our collaboration partner Servier, we continue towards completion of the ROCCELLA trial in osteoarthritis, on track for topline results in the second half of next year. For MOR106, together with our collaboration partners MorphoSys and Novartis, we continue executing the Phase 1 and 2 trials currently ongoing.
We continue to execute on our Toledo program in order to deliver Phase 1 results and plan to start several Phase 2a trials in 2020.
Key figures third quarter report 2019 (unaudited)
( millions, except basic & diluted gain / loss (-) per share)
30 Sept 2019 group total |
30 Sept 2018 group total |
|||||||
Revenues |
752.5 | 205.1 | ||||||
R&D expenditure |
(298.2 | ) | (231.8 | ) | ||||
G&A and S&M expenses |
(61.2 | ) | (26.8 | ) | ||||
Operating profit / loss (-) |
393.0 | (53.5 | ) | |||||
Fair value re-measurement of share subscription agreement |
(142.3 | ) | ||||||
Net other financial result |
(2.1 | ) | 9.0 | |||||
Taxes |
16.7 | 0.3 | ||||||
Net result for the period |
265.3 | (44.2 | ) | |||||
Basic gain / loss (-) per share () |
4.77 | (0.86 | ) | |||||
Diluted gain / loss (-) per share () |
4.59 | (0.86 | ) | |||||
Cash and cash equivalents |
5,599.8 | 1,343.7 |
Revenues and other income
Our revenues and other income for the first nine months of 2019 amounted to 752.5 million. The impact of the Gilead collaboration on our revenues is 596.4 million, which is related to (i) the GLPG1690 program (667.0 million) and (ii) the access and option rights to our drug discovery platform (23.9 million), offset by (iii) a negative impact on filgotinib revenue recognition when compared to the original filgotinib agreement (-94.0 million).
Primarily as a result of the upfront received from Gilead, on 30 September 2019 our deferred income balance includes 2.3 billion allocated to our drug discovery platform that will be recognized linearly over 10 years, and 0.80 billion allocated to filgotinib (2015 filgotinib contract and recent revised collaboration combined) that will be recognized over a period of 4 to 5 years.
Results
We realized a net profit of 265.3 million for the first nine months of 2019, compared to a net loss of 44.2 million for the first nine months of 2018.
We reported an operating profit amounting to 393.0 million for the first nine months of 2019, compared to an operating loss of 53.5 million for the first nine months of 2018.
Our R&D expenditure in the first nine months of 2019 amounted to 298.2 million, compared to 231.8 million for the first nine months of 2018. This planned increase was mainly due to an increase of 29.1 million in subcontracting costs primarily related to our IPF program, filgotinib and other programs. Furthermore, personnel costs increased explained by a planned headcount increase and higher costs related to bonuses and the warrant plans as a result of the increase in the Galapagos share price. These factors also contributed to the increase in our G&A and S&M expenses, which were 61.2 million in the first nine months of 2019, compared to 26.8 million in the first nine months of 2018.
We reported a non-cash fair value loss from the re-measurement of a derivative financial instrument triggered by the share subscription agreement with Gilead between signing and closing of the agreement amounting to 142.3 million. Such amount reflects the increase in the Galapagos share price between signing and closing of the Gilead agreement.
Net other financial loss in the first nine months of 2019 amounted to 2.0 million, compared to net other financial income of 9.0 million for the first nine months of 2018, which was primarily attributable to 34.9 million realized exchange loss on the U.S. dollars upfront payment from Gilead, which was partly compensated by a 32.4 million of unrealized exchange gain on our cash position in U.S. dollars (compared to 6.6 million of unrealized exchange gain on our cash position in U.S. dollars in the first nine months of 2018).
We reported a tax income amounting to 16.7 million primarily from the recognition of deferred tax assets as a consequence of the deal with Gilead.
Third quarter report 2019
Galapagos financial report for the first nine months ended September 2019, including new accounting policies as a result of recent transactions and details of the unaudited consolidated results, is accessible via www.glpg.com/financial-reports.
Results of special and extraordinary shareholders meetings
Following the collaboration with Gilead Sciences, Inc., Gilead Biopharmaceutics Ireland UC, and Gilead Therapeutics A1 Unlimited Company announced on 14 July 2019, Galapagos held special and extraordinary shareholders meetings on Tuesday 22 October 2019.
At these meetings, all proposed resolutions were approved, including the appointment of Mr. Daniel ODay and Dr. Linda Higgins as non-independent directors of Galapagos and the approval of the issuance of two warrants for the benefit of Gilead Therapeutics A1 Unlimited Company.
All documents relating to the shareholders meetings will be posted on our website at https://www.glpg.com/shareholders-meetings.
Conference call and webcast presentation
Galapagos will conduct a conference call open to the public tomorrow, 25 October at 14:00 CET / 8 AM ET, which will also be webcast. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement:
CODE: 6653712 | ||
USA: | +1 323 701 0225 | |
UK: | +44 330 336 9105 | |
Netherlands: | +31 20 721 9251 | |
France: | +33 1 76 77 2274 | |
Belgium: | +32 2 404 0659 |
A question and answer session will follow the presentation of the results. Go to www.glpg.com to access the live audio webcast. The archived webcast will also be available for replay shortly after the close of the call.
Financial calendar
20 February 2020 Full year 2019 results (webcast 21 February 2020)
Filgotinib and all other drug candidates mentioned in this report are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.
About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) discovers and develops small molecule medicines with novel modes of action, three of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, osteoarthritis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.
Contacts
Investors:
Elizabeth Goodwin
VP Investor Relations
+1 781 460 1784
Sofie Van Gijsel
Director IR
+32 485 19 14 15
ir@glpg.com
Media:
Carmen Vroonen
Senior Director Communications & Public Affairs
+32 473 824 874
Evelyn Fox
Director Communications
+31 6 53 591 999
communications@glpg.com
Forward-looking statements
This release may contain forward-looking statements, including, among other things, statements regarding the global R&D collaboration with Gilead, the amount and timing of potential future milestone, opt-in and/or royalty payments by Gilead, Galapagos strategic R&D ambitions, the guidance from management (including guidance regarding the expected operational cash burn during financial year 2019), financial results, timing and/or results of clinical trials, mechanisms of action and potential commercialization of our product candidates, interaction with regulators, and build-up and development of commercial operations. Galapagos cautions the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition and liquidity, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Galapagos results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that Galapagos expectations regarding its 2019 operating expenses may be incorrect (including because one or more of its assumptions underlying its expense expectations may not be realized), Galapagos expectations regarding its development programs may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from Galapagos ongoing clinical research programs may not support registration or further development of its product candidates due to safety, efficacy or other reasons), Galapagos reliance on collaborations with third parties (including our collaboration partner for filgotinib, Gilead, our collaboration partner for GLPG1972, Servier and our collaboration partners for MOR106, Novartis and MorphoSys), and estimating the commercial potential of its development programs. A further list and description of these risks, uncertainties and other risks can be found in Galapagos Securities and Exchange Commission (SEC) filings and reports, including in Galapagos most recent annual report on Form 20-F filed with the SEC and other filings and reports filed by Galapagos with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.
1 | The operational cash burn (or operational cash flow if this performance measure is positive) is equal to 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 / used (-) in financing activities and; |
(ii) | the net proceeds or cash used, if any, in acquisitions or disposals of businesses; and the movement in restricted cash, if any, included in the net cash flows generated / used (-) in investing activities. |
This alternative performance measure is in our view an important metric for a biotech company in the development stage.
Exhibit 99.2
CONTENTS
2
Galapagos NV Q3 Report 2019
THE GALAPAGOS GROUP
Letter from the management
Dear shareholders,
There is no question that the third quarter of 2019 was defined by the unique and landmark deal with our long-time collaboration partner Gilead, announced mid-July. This 10-year research collaboration is about maximizing innovation based on the identification and development of new mode of action medicines. Thanks to the upfront payment of $3.95 billion and a $1.1 billion equity investment by Gilead, the deal gives us the financial strength and the independence to greatly expand our research engine and build a broader pipeline of new mode of action medicines. Gilead will have option rights on our programs outside of Europe, and as part of the agreement, they have already executed that right for our late-stage IPF compound, GLPG1690. We will also benefit greatly from Gileads scientific expertise and infrastructure.
Gilead and we strongly believe that this collaboration will provide an accelerated path to advance our pipeline, and thus provide the opportunity to fast track our mission to bring innovation to patients worldwide.
In Q3, together with Gilead, we took important steps forward with our flagship program, filgotinib. Early July, Gilead announced the outcome of the pre-NDA meeting with the FDA. Gilead discussed with the agency the Phase 3 FINCH trials, as well as the ongoing Phase 2 MANTA safety trial, and concluded that they intend to submit filgotinib for approval in RA in the US in 2019. Together with Gilead, we also announced that the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for filgotinib in RA for the European market. In early October, Gilead announced submission of filgotinib to the Japanese Ministry of Health, Labor and Welfare, for approval in RA. Gilead remains on track to submit filgotinib for approval in RA to the FDA before year-end. |
Thanks to the progress made, we are on track for potential new drug approvals as of the second half of 2020, and we are excited by the prospect of bringing filgotinib as a new treatment option to RA patients.
We are also proud that the FINCH 2 results for filgotinib in RA were published in JAMA1, which is a further recognition of the importance of the program. Just recently, recruitment commenced for the PENGUIN Phase 3 program with filgotinib in psoriatic arthritis, an important next step to expand our filgotinib inflammation franchise to additional indications.
We also continue our plans to become a fully integrated biotechnology company. The core commercial team for Belgium, the Netherlands, and Luxembourg is firmly in place, and we hired key people for our commercial operations in France, Italy and Spain, following our revised filgotinib agreement with Gilead.
In the meantime, we work hard on progressing our late stage portfolio of other drug candidates. This includes our fully recruited Phase 2b trial with GLPG1972 in osteoarthritis, ROCCELLA, for which we expect data in the second half of next year. We experience good recruitment of the ISABELA 1 & 2 Phase 3 trials with autotaxin inhibitor GLPG1690 in idiopathic pulmonary fibrosis. The enthusiasm for the ISABELA program amongst clinicians, centers, and patients is palpable, as we noticed again at the recent ERS conference. Together with Gilead, we are fully committed to seeking new approaches to meet the large unmet medical need in IPF. Together with our collaboration partners Novartis and MorphoSys, we also continue the Phase 2 trials GECKO and IGUANA with MOR106 in atopic dermatitis, and we recently started a Japanese ethnobridging study.
1 Journal of the American Medical Association
4
Galapagos NV Q3 Report 2019
THE GALAPAGOS GROUP
Furthermore, we are progressing our first Phase 1 trial from the next-generation Toledo program for inflammation, with GLPG3312, and we recently announced the start of a Phase 1 trial with Toledo compound GLPG3970.
Following the upfront payment of $3.95 billion and a $1.1 billion equity investment received in the Gilead transaction, we have an exceptionally strong balance sheet. As we continue to grow our organization to support our broad pipeline and build a commercial organization for the anticipated launch of filgotinib in Europe next year, our financial guidance for full year 2019 operational cash burn2 between 320 and 340 million is unchanged, excluding the impact from the Gilead collaboration.
Operational overview H1 2019
We refer to our H1 2019 report.
Operational overview Q3 2019
Inflammation
| Gilead and Galapagos announced that the EMA validated the MAA for filgotinib in RA in Europe |
| Gilead announced the outcome of the pre-NDA meeting with the FDA, concluding that a path has been established to submit an NDA for filgotinib in RA in the US in 2019 |
| Publication of the detailed FINCH 2 results in JAMA, a top-tier peer-reviewed journal |
| Initiated the Japanese ethnobridging trial with MOR106, together with collaboration partners Novartis and MorphoSys, in Japanese patients with atopic dermatitis |
| Initiated a Phase 1 trial with GLPG3970, a second generation Toledo compound against a novel and undisclosed inflammation target class discovered by Galapagos |
Corporate & other
| Gilead and Galapagos entered into a 10-year global R&D collaboration; Gilead increased their shareholding in Galapagos to 22.04% of the then issued and outstanding shares of Galapagos NV |
| We received transparency notices which can be consulted on our website |
| Galapagos raised 6.7 million through warrant exercises in the third quarter of 2019 |
Recent events
| Together with collaboration partner Gilead, we announced that Week 52 data3 from the Phase 3 FINCH 1 and FINCH 3 trials of filgotinib for the treatment of RA are consistent with and support the profiles observed in the Week 12 and 24 analyses presented earlier this year |
| Gilead commenced patient recruitment for PENGUIN, a Phase 3 trial with filgotinib in psoriatic arthritis |
| Started Phase 1 trial with GLPG3667, a novel candidate with an undisclosed mode of action directed towards inflammation |
| Gilead announced submission of filgotinib for approval in RA in Japan |
2 | The operational cash burn (or operational cash flow if this performance measure is positive) is equal to 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 / used () in financing activities |
ii. | the net proceeds or cash used, if any, in acquisitions or disposals of businesses; and the movement in restricted cash, if any, included in the net cash flows generated / used () in investing activities. |
This alternative performance measure is in our view an important metric for a biotech company in the development stage.
3 | Data on file |
5
Galapagos NV Q3 Report 2019
THE GALAPAGOS GROUP
Q3 2019 financial result
Revenues and other income
Our revenues and other income for the first nine months of 2019 amounted to 752.5 million, compared to 205.1 million for the first nine months of 2018. Revenues represented 725.7 million for the first nine months of 2019 compared to 182.5 million for the first nine months of 2018 and were higher due to the revenue recognition of the upfront payment received in August 2019 from Gilead related to (i) the GLPG1690 program and (ii) the access and option rights to our drug discovery platform, offset by (iii) a negative catch-up effect for revenues related to the previously received upfront and milestones due to the revised filgotinib collaboration agreement.
Other income increased by 4.1 million, mainly driven by higher incentives income from the government for our R&D activities.
Results
We realized a net profit of 265.3 million for the first nine months of 2019, compared to a net loss of 44.2 million for the first nine months of 2018.
We reported an operating profit amounting to 393.0 million for the first nine months of 2019, compared to an operating loss of 53.5 million for the first nine months of 2018.
Our R&D expenditure in the first nine months of 2019 amounted to 298.2 million, compared to 231.8 million for the first nine months of 2018. This planned increase was mainly due to an increase of 29.1 million in subcontracting costs primarily related to our IPF program, filgotinib and other programs. Furthermore, personnel costs increased explained by a planned headcount increase and higher costs related to bonuses and to warrant plans as a result of the increase of the Galapagos share price. These factors also contributed to the increase in our G&A and S&M expenses which were 61.2 million in the first nine months of 2019, compared to 26.8 million in the first nine months of 2018.
We reported a non-cash fair value loss from the re-measurement of a derivative financial instrument triggered by the share subscription agreement with Gilead between signing and closing of the agreement amounting to 142.3 million. Such amount reflects the increase in the Galapagos share price between signing and closing of the Gilead agreement.
Net other financial loss in the first nine months of 2019 amounted to 2.0 million, compared to net other financial income of 9.0 million for the first nine months of 2018, which was primarily attributable to 34.9 million realized exchange loss on the U.S. dollars upfront payment from Gilead, which was partly compensated by a 32.4 million of unrealized exchange gain on our cash position in U.S. dollars (compared to 6.6 million of unrealized exchange gain on our cash position in U.S. dollars in the first nine months of 2018).
We reported a tax income amounting to 16.7 million primarily from the recognition of deferred tax assets as a consequence of the deal with Gilead.
Liquid assets position
Cash and cash equivalents totaled 5,599.8 million on 30 September 2019.
A net increase of 4,309.0 million in cash and cash equivalents was recorded during the first nine months of 2019, compared to a net increase of 192.5 million during the first nine months of 2018. This net increase was composed of (i) 3,302.0 million of operational cash flow, of which 3,535.0 million cash inflow from the Gilead collaboration and 233.0 million remaining cash outflow from operating activities, (ii) 960.1 million cash proceeds related to the share subscription by Gilead, (iii) 14.5 million of cash proceeds from capital and share premium increase from exercise of warrants in the first nine months of 2019 and (iii) 32.4 million of unrealized positive exchange rate differences.
6
Galapagos NV Q3 Report 2019
THE GALAPAGOS GROUP
Finally, our balance sheet as at 30 September 2019 held a receivable from the French government (Crédit dImpôt Recherche4), payable in 4 yearly tranches, and a receivable from the Belgian Government for R&D incentives, for a total of 99.7 million.
Outlook 2019
Following on regulatory submissions in Europe and Japan, Gilead is on track to submit filgotinib for approval in RA in the US before year-end.
We will continue recruitment in our proprietary ISABELA, NOVESA and PINTA trials, and plan to provide an update on recruitment timelines for the ISABELA program in H2 2019. We and our collaboration partner Servier continue towards completion of the ROCCELLA trial in osteoarthritis, on track for topline results in the second half of next year. For MOR106, together with our collaboration partners MorphoSys and Novartis, we continue executing the Phase 1 and 2 trials currently ongoing.
We continue to execute on our Toledo program in order to deliver Phase 1 results and plan to start several Phase 2a trials start in 2020.
Our guidance for an operational cash burn between 320 - 340 million in 2019 is unchanged, excluding the impact from the Gilead collaboration.
Following the closing of our new collaboration with Gilead, we envision a significant scaling up of our R&D efforts, strengthening our target discovery platform capabilities and substantially growing our R&D team. In other words, stay tuned for Galapagos 2.0, powered for an exciting future. At this exceptional phase in our history, we want to express our sincere thanks for your support of Galapagos, as we focus on delivering innovation with the aim to improve patients lives worldwide.
Onno van de Stolpe
CEO
4 | Crédit dImpôt Recherche refers to an innovation incentive system underwritten by the French government. |
7
Galapagos NV Q3 Report 2019
THE GALAPAGOS GROUP
At a glance
Consolidated key figures
(thousands of , if not stated otherwise) |
Third quarter of 2019 |
Third quarter of 2018 |
Nine months ended 30 September 2019 |
Nine months ended 30 September 2018 |
Full year 2018 | |||||||||||||||
Income statement |
||||||||||||||||||||
Revenues |
633,934 | 94,874 | 725,719 | 182,457 | 288,836 | |||||||||||||||
Other income |
10,020 | 8,334 | 26,744 | 22,623 | 29,009 | |||||||||||||||
R&D expenditure |
(120,680 | ) | (80,314 | ) | (298,247 | ) | (231,758 | ) | (322,875 | ) | ||||||||||
S, G&A expenses |
(32,643 | ) | (10,623 | ) | (61,195 | ) | (26,837 | ) | (39,776 | ) | ||||||||||
Operating expenses |
(153,323 | ) | (90,937 | ) | (359,442 | ) | (258,595 | ) | (362,652 | ) | ||||||||||
Operating profit / loss () |
490,631 | 12,271 | 393,021 | (53,515 | ) | (44,807 | ) | |||||||||||||
Net financial results |
(146,226 | ) | 2,091 | (144,391 | ) | 8,958 | 15,598 | |||||||||||||
Taxes |
16,828 | 480 | 16,699 | 343 | (50 | ) | ||||||||||||||
Net profit / net loss () |
361,233 | 14,841 | 265,329 | (44,215 | ) | (29,259 | ) | |||||||||||||
Balance sheet |
||||||||||||||||||||
Cash and cash equivalents |
5,599,787 | 1,343,668 | 5,599,787 | 1,343,668 | 1,290,796 | |||||||||||||||
R&D incentives receivables |
99,711 | 80,447 | 99,711 | 80,447 | 84,646 | |||||||||||||||
Assets (1) |
5,851,752 | 1,485,551 | 5,851,752 | 1,485,551 | 1,439,496 | |||||||||||||||
Shareholders equity (1) |
2,535,281 | 1,188,222 | 2,535,281 | 1,188,222 | 1,214,249 | |||||||||||||||
Deferred income |
3,127,777 | 209,742 | 3,127,777 | 209,742 | 149,801 | |||||||||||||||
Other liabilities (1) |
188,695 | 87,587 | 188,695 | 87,587 | 75,446 | |||||||||||||||
Cash flow |
||||||||||||||||||||
Operational cash flow / burn () (2) |
3,454,585 | (5,571 | ) | 3,302,041 | (100,581 | ) | (158,384 | ) | ||||||||||||
Cash flow generated / used () in operating activities (1) |
3,470,495 | (3,640 | ) | 3,328,758 | (94,918 | ) | (142,466 | ) | ||||||||||||
Cash flow used in investing activities |
(14,221 | ) | (1,933 | ) | (22,881 | ) | (5,657 | ) | (15,914 | ) | ||||||||||
Cash flow generated in financing activities (1) |
965,072 | 281,181 | 970,733 | 286,435 | 287,876 | |||||||||||||||
Increase in cash and cash equivalents |
4,421,347 | 275,608 | 4,276,610 | 185,860 | 129,497 | |||||||||||||||
Effect of currency exchange rate fluctuation on cash and cash equivalents |
30,514 | 1,292 | 32,380 | 6,596 | 10,089 | |||||||||||||||
Cash and cash equivalents at the end of the period |
5,599,787 | 1,343,668 | 5,599,787 | 1,343,668 | 1,290,796 |
8
Galapagos NV Q3 Report 2019
THE GALAPAGOS GROUP
(thousands of , if not stated otherwise) |
Third quarter of 2019 |
Third quarter of 2018 |
Nine months ended 30 September 2019 |
Nine months ended 30 September 2018 |
Full year 2018 | |||||||||||||||
Financial ratios |
||||||||||||||||||||
Number of shares issued at the end of the period |
61,953,831 | 54,299,136 | 61,953,831 | 54,299,136 | 54,465,421 | |||||||||||||||
Basic gain / loss () per share (in ) |
6.26 | 0.29 | 4.77 | (0.86 | ) | (0.56 | ) | |||||||||||||
Diluted gain / loss () per share (in ) |
6.03 | 0.28 | 4.59 | (0.86 | ) | (0.56 | ) | |||||||||||||
Share price at the end of the period (in ) |
139.80 | 97.42 | 139.80 | 97.42 | 80.56 | |||||||||||||||
Total group employees at the end of the period (number) |
918 | 712 | 918 | 712 | 725 |
(1) | Our assets, shareholders equity, other liabilities, cash flow generated / used () in operating activities and cash flow generated in financing activities for the period ended 30 September 2019 were influenced by the adoption of the new standard IFRS 16 Leases, on 1 January 2019. We refer to the notes of this condensed consolidated interim financial report for additional information. |
(2) | The operational cash burn (or operational cash flow if this performance measure is positive) is equal to 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 / used () in financing activities |
(ii) | the net proceeds or cash used, if any, in acquisitions or disposals of businesses; and the movement in restricted cash, if any, included in the net cash flows generated / used () in investing activities. |
This alternative performance measure is in our view an important metric for a biotech company in the development stage.
Employees per site as of 30 September 2019 (total: 918 employees)
9
Galapagos NV Q3 Report 2019
THE GALAPAGOS GROUP
Risk factors
We refer to the description of risk factors in the 2018 annual report, pp. 57-66, as supplemented by the description of risk factors in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission, pp. 4-45. In summary, the principal risks and uncertainties faced by us relate to: product development, regulatory approval and commercialization; our financial position and need for additional capital; our reliance on third parties; our competitive position; our intellectual property; our organization, structure and operation and market risks relating to our shares and ADSs.
We also refer to the description of the groups financial risk management given in the 2018 annual report, pp.
161-163, which remains valid.
The Galapagos share
Related party transactions
We refer to the statements included under the heading Related party transactions in the Notes to the unaudited condensed consolidated interim financial statements for the first nine months of 2019 part of this report.
10
Galapagos NV Q3 Report 2019
THE GALAPAGOS GROUP
Disclaimer and other information
Galapagos NV is a limited liability company organized under the laws of Belgium, having its registered office at Generaal De Wittelaan L11 A3, 2800 Mechelen, Belgium. Throughout this report, the term Galapagos NV refers solely to the non-consolidated Belgian company and references to we, our, the group or Galapagos include Galapagos NV together with its subsidiaries.
Filgotinib and all other drug candidates mentioned in this report are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.
This report is published in Dutch and in English. In case of inconsistency between the Dutch and the English versions, the Dutch version shall prevail. Galapagos is responsible for the translation and conformity between the Dutch and English version.
This report is available free of charge and upon request addressed to:
Galapagos NV
Investor Relations
Generaal De Wittelaan L11 A3
2800 Mechelen, Belgium
Tel: +32 15 34 29 00
Email: ir@glpg.com
A digital version of this report is available on our website, www.glpg.com.
We will use reasonable efforts to ensure the accuracy of the digital version, but do not assume responsibility if inaccuracies or inconsistencies with the printed document arise as a result of any electronic transmission. Therefore, we consider only the printed version of this report to be legally valid. Other information on our website or on other websites does not form a part of this report.
Listings
Euronext Amsterdam and Brussels: GLPG
Nasdaq: GLPG
Forward-looking statements
This report contains forward-looking statements, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as believe, anticipate, expect, intend, plan, seek, estimate, may, will, could, stand to, continue, as well as similar expressions. Forward-looking statements contained in this report include, but are not limited to, statements made in the Letter from the management; the information provided in the section captioned Outlook 2019; guidance from management regarding the expected operational use of cash during financial year 2019, statements regarding the amount and timing of potential future milestone, opt-in and/or royalty payments by Gilead; regarding the expected timing, design and readouts of ongoing and planned clinical trials (i) with filgotinib in rheumatoid arthritis, Crohns disease, ulcerative colitis and other indications, (ii) with GLPG1690 in IPF and SSc and GLPG1205 in IPF, (iii) with GLPG1972 in osteoarthritis, (iv) with MOR106 in atopic dermatitis, and (v) with GLPG3312, GLPG3970 and GLPG3667 in inflammation, and statements regarding the regulatory pathway for filgotinib and the timing of regulatory filings and potential approval thereof. We caution the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause our actual results, financial condition and
11
Galapagos NV Q3 Report 2019
THE GALAPAGOS GROUP
liquidity, performance or achievements, or the development of the industry in which we operate, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that our expectations regarding our 2019 revenues and financial results and our 2019 operating expenses may be incorrect (including because one or more of our assumptions underlying our revenue or expense expectations may not be realized); the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from our clinical research programs may not support registration or further development of our product candidates due to safety, efficacy or other reasons); our reliance on collaborations with third parties (including our collaboration partner for filgotinib, Gilead, our collaboration partner for GLPG1972, Servier and our collaboration partners for MOR106, Novartis and MorphoSys), and estimating the commercial potential of our product candidates. A further list and description of these risks, uncertainties and other risks can be found in our U.S. Securities and Exchange Commission filings and reports, including in our most recent Annual Report on Form 20-F filed with the SEC and our other filings and reports. We also refer to the Risk factors section of this report. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We expressly disclaim any obligation to update any such forward-looking statements in this document to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.
12
Galapagos NV Q3 Report 2019
Financial statements Consolidated interim financial statements for the first nine months of 2019
FINANCIAL STATEMENTS
Unaudited condensed consolidated interim financial statements for the first nine months of 2019
Consolidated statements of income and comprehensive income
(unaudited)
Consolidated income statement
Third quarter of | Nine months ended 30 September |
|||||||||||||||
(thousands of , except share and per share data) |
2019 | 2018 | 2019 | 2018 | ||||||||||||
Revenues |
633,934 | 94,874 | 725,719 | 182,457 | ||||||||||||
Other income |
10,020 | 8,334 | 26,744 | 22,623 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total revenues and other income |
643,954 | 103,208 | 752,463 | 205,080 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Research and development expenditure |
(120,680 | ) | (80,314 | ) | (298,247 | ) | (231,758 | ) | ||||||||
General and administrative expenses |
(28,565 | ) | (9,725 | ) | (51,497 | ) | (24,925 | ) | ||||||||
Sales and marketing expenses |
(4,078 | ) | (899 | ) | (9,699 | ) | (1,912 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses |
(153,323 | ) | (90,937 | ) | (359,442 | ) | (258,595 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Operating profit / loss () |
490,631 | 12,271 | 393,021 | (53,515 | ) | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Fair value re-measurement of share subscription agreement |
(142,349 | ) | | (142,349 | ) | | ||||||||||
Other financial income |
34,755 | 2,558 | 40,405 | 10,667 | ||||||||||||
Other financial expenses |
(38,631 | ) | (467 | ) | (42,448 | ) | (1,708 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Profit / loss () before tax |
344,405 | 14,362 | 248,630 | (44,557 | ) | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Income taxes |
16,828 | 480 | 16,699 | 343 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net profit / loss () |
361,233 | 14,841 | 265,329 | (44,215 | ) | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net profit / loss () attributable to: |
||||||||||||||||
Owners of the parent |
361,233 | 14,841 | 265,329 | (44,215 | ) | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Basic gain / loss () per share |
6.26 | 0.29 | 4.77 | (0.86 | ) | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Diluted gain / loss () per share |
6.03 | 0.28 | 4.59 | (0.86 | ) | |||||||||||
|
|
|
|
The accompanying notes form an integral part of these condensed consolidated financial statements.
14
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Consolidated statement of comprehensive income / loss ()
Third quarter of | Nine months ended 30 September |
|||||||||||||||
(thousands of ) |
2019 | 2018 | 2019 | 2018 | ||||||||||||
Net profit / loss () |
361,233 | 14,841 | 265,329 | (44,215 | ) | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Items that may be reclassified subsequently to profit or loss: |
||||||||||||||||
Translation differences, arisen from translating foreign activities |
238 | 5 | 290 | 156 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Other comprehensive income / loss (), net of income tax |
238 | 5 | 290 | 156 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total comprehensive income / loss () attributable to: |
||||||||||||||||
Owners of the parent |
361,471 | 14,846 | 265,618 | (44,059 | ) |
The accompanying notes form an integral part of these condensed consolidated financial statements.
15
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Consolidated statements of financial position
(unaudited)
30 September | 31 December | |||||||
(thousands of ) |
2019 | 2018 | ||||||
Assets |
||||||||
Intangible assets |
23,492 | 3,632 | ||||||
Property, plant and equipment |
61,883 | 23,137 | ||||||
Non-current deferred tax assets |
19,406 | 2,514 | ||||||
Non-current R&D incentives receivables |
89,965 | 73,443 | ||||||
Other non-current assets |
5,993 | 7,919 | ||||||
|
|
|
|
|||||
Non-current assets |
200,739 | 110,645 | ||||||
|
|
|
|
|||||
Trade and other receivables |
32,642 | 18,609 | ||||||
Current R&D incentives receivables |
9,746 | 11,203 | ||||||
Cash and cash equivalents |
5,599,787 | 1,290,796 | ||||||
Other current assets |
8,837 | 8,244 | ||||||
|
|
|
|
|||||
Current assets |
5,651,013 | 1,328,851 | ||||||
|
|
|
|
|||||
Total assets |
5,851,752 | 1,439,496 | ||||||
|
|
|
|
|||||
Equity and liabilities |
||||||||
Share capital |
272,605 | 236,540 | ||||||
Share premium account |
2,268,585 | 1,277,780 | ||||||
Other reserves |
(735 | ) | (735 | ) | ||||
Translation differences |
(1,267 | ) | (1,557 | ) | ||||
Accumulated losses |
(3,907 | ) | (297,779 | ) | ||||
|
|
|
|
|||||
Total equity |
2,535,281 | 1,214,249 | ||||||
|
|
|
|
|||||
Retirement benefit liabilities |
4,026 | 3,764 | ||||||
Non-current lease liabilities |
19,661 | | ||||||
Non-current deferred income |
2,659,013 | | ||||||
Other non-current liabilities |
2,471 | 1,578 | ||||||
|
|
|
|
|||||
Non-current liabilities |
2,685,171 | 5,342 | ||||||
|
|
|
|
16
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
30 September | 31 December | |||||||
(thousands of ) |
2019 | 2018 | ||||||
Current lease liabilities |
5,251 | | ||||||
Trade and other liabilities |
156,254 | 68,928 | ||||||
Current tax payable |
1,032 | 1,175 | ||||||
Current deferred income |
468,764 | 149,801 | ||||||
|
|
|
|
|||||
Current liabilities |
631,300 | 219,905 | ||||||
|
|
|
|
|||||
Total liabilities |
3,316,472 | 225,247 | ||||||
|
|
|
|
|||||
Total equity and liabilities |
5,851,752 | 1,439,496 | ||||||
|
|
|
|
The accompanying notes form an integral part of these condensed consolidated financial statements.
17
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Consolidated cash flow statements
(unaudited)
Nine months ended 30 September | ||||||||
(thousands of ) |
2019 | 2018 | ||||||
Net profit / loss () of the period |
265,329 | (44,215 | ) | |||||
|
|
|
|
|||||
Adjustment for non-cash transactions |
151,366 | 16,278 | ||||||
Adjustment for items to disclose separately under operating cash flow |
(23,432 | ) | (2,887 | ) | ||||
Adjustment for items to disclose under investing and financing cash flows |
(3 | ) | 3 | |||||
Change in working capital other than deferred income |
41,127 | 27,053 | ||||||
Increase / decrease () in deferred income |
2,890,286 | (93,370 | ) | |||||
|
|
|
|
|||||
Cash generated / used () in operations |
3,324,674 | (97,137 | ) | |||||
|
|
|
|
|||||
Interest paid |
(901 | ) | (1,026 | ) | ||||
Interest received |
5,129 | 3,252 | ||||||
Corporate taxes paid |
(145 | ) | (7 | ) | ||||
|
|
|
|
|||||
Net cash flows generated / used () in operating activities |
3,328,758 | (94,918 | ) | |||||
|
|
|
|
|||||
Purchase of property, plant and equipment |
(17,322 | ) | (4,259 | ) | ||||
Purchase of intangible fixed assets |
(5,465 | ) | (1,533 | ) | ||||
Proceeds from disposal of property, plant and equipment |
1 | 1 | ||||||
Acquisition of financial assets held at fair value through profit or loss |
(177 | ) | | |||||
Proceeds from sale of financial assets held at fair value through profit or loss |
82 | 134 | ||||||
|
|
|
|
|||||
Net cash flows used in investing activities |
(22,881 | ) | (5,657 | ) | ||||
|
|
|
|
|||||
Payment of lease liabilities |
(3,834 | ) | (6 | ) | ||||
Proceeds from capital and share premium increases, gross amount |
960,087 | 296,188 | ||||||
Issue costs paid related to capital and share premium increases |
| (15,008 | ) | |||||
Proceeds from capital and share premium increases from exercise of warrants |
14,480 | 5,261 | ||||||
|
|
|
|
|||||
Net cash flows generated in financing activities |
970,733 | 286,435 | ||||||
|
|
|
|
|||||
Increase in cash and cash equivalents |
4,276,610 | 185,860 | ||||||
|
|
|
|
18
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Nine months ended 30 September | ||||||||
(thousands of ) |
2019 | 2018 | ||||||
Cash and cash equivalents at beginning of the period |
1,290,796 | 1,151,211 | ||||||
|
|
|
|
|||||
Increase in cash and cash equivalents |
4,276,610 | 185,860 | ||||||
|
|
|
|
|||||
Effect of exchange rate differences on cash and cash equivalents |
32,380 | 6,596 | ||||||
|
|
|
|
|||||
Cash and cash equivalents at end of the period |
5,599,787 | 1,343,668 | ||||||
|
|
|
|
The accompanying notes form an integral part of these condensed consolidated financial statements.
19
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Consolidated statements of changes in equity
(unaudited)
(thousands of ) |
Share capital |
Share premium account |
Translation differences |
Other reserves |
Accum. Losses |
Total | ||||||||||||||||||
On 1 January 2018 |
233,414 | 993,025 | (1,754 | ) | (1,260 | ) | (211,441 | ) | 1,011,983 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Change in accounting policy (modified retrospective application IFRS 15) |
(83,220 | ) | (83,220 | ) | ||||||||||||||||||||
Change in accounting policy (modified retrospective application IFRS 9) |
619 | (619 | ) | | ||||||||||||||||||||
Restated total equity at 1 January 2018 |
233,414 | 993,025 | (1,754 | ) | (641 | ) | (295,279 | ) | 928,766 | |||||||||||||||
Net loss |
(44,215 | ) | (44,215 | ) | ||||||||||||||||||||
Other comprehensive income |
156 | 156 | ||||||||||||||||||||||
Total comprehensive income |
| | 156 | | (44,215 | ) | (44,059 | ) | ||||||||||||||||
Share-based compensation |
18,001 | 18,001 | ||||||||||||||||||||||
Issue of new shares |
16,021 | 280,167 | 296,188 | |||||||||||||||||||||
Share issue costs |
(15,932 | ) | (15,932 | ) | ||||||||||||||||||||
Exercise of warrants |
2,169 | 3,092 | 5,261 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
On 30 September 2018 |
235,672 | 1,276,284 | (1,598 | ) | (641 | ) | (321,495 | ) | 1,188,222 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
On 1 January 2019 |
236,540 | 1,277,780 | (1,557 | ) | (735 | ) | (297,779 | ) | 1,214,249 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Change in accounting policy (modified retrospective application IFRS 16) |
416 | 416 | ||||||||||||||||||||||
Restated total equity at 1 January 2019 |
236,540 | 1,277,780 | (1,557 | ) | (735 | ) | (297,363 | ) | 1,214,665 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Net profit |
265,329 | 265,329 | ||||||||||||||||||||||
Other comprehensive income |
290 | 290 | ||||||||||||||||||||||
Total comprehensive income |
| | 290 | | 265,329 | 265,618 | ||||||||||||||||||
Share-based compensation |
28,128 | 28,128 | ||||||||||||||||||||||
Derecognition of financial liability from share subscription agreement |
56,749 | 56,749 | ||||||||||||||||||||||
Issue of new shares |
36,945 | 923,142 | 960,087 | |||||||||||||||||||||
Share issue costs |
(4,447 | ) | (4,447 | ) | ||||||||||||||||||||
Exercise of warrants |
3,567 | 10,913 | 14,480 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
On 30 September 2019 |
272,605 | 2,268,585 | (1,267 | ) | (735 | ) | (3,907 | ) | 2,535,281 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes form an integral part of these condensed consolidated financial statements.
20
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Notes to the unaudited condensed consolidated interim financial statements for the first nine months of 2019
Basis of preparation
These condensed consolidated interim financial statements have been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union and as issued by the IASB. The condensed consolidated interim financial statements do not contain all information required for an annual report and should therefore be read in conjunction with Galapagos Annual Report 2018.
Summary of significant transaction
On 14 July 2019 we and Gilead announced that we have entered into a 10-year global research and development collaboration. Through this agreement, Gilead gained exclusive access to our innovative portfolio of compounds, including six molecules currently in clinical trials, more than 20 preclinical programs and a proven drug discovery platform.
The transaction was subject to certain closing conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and receipt of merger control approval from the Austrian Federal Competition Authority. On 23 August 2019 all approvals were obtained and the transaction was closed.
We were entitled to an upfront payment 3,569.8 million ($3.95 billion) and a 960.1 million ($1.1 billion) equity investment from Gilead on closing of the transaction. We will use the proceeds to expand and accelerate our research and development programs. We identified the following three performance obligations: (i) the transfer of an extended license on GLPG1690, (ii) the granting of exclusive access to our drug discovery platform (i.e. the IP, technology, expertise and capabilities) during the collaboration period and exclusive option rights on our current and future clinical programs after Phase 2 outside Europe and (iii) an increased cost share from 20/80 to 50/ 50 on the global future development activities of filgotinib, until we reach the new joint predetermined level of costs, as a result of the revised license and collaboration agreement. As part of the collaboration, Gilead also received option rights for GLPG1972, a Phase 2b candidate for osteoarthritis, in the United States. We refer to the management judgments and estimates section of this report explaining managements judgments and estimates made.
Gilead will also nominate two individuals to our board of directors. This appointment will be on the agenda of the special general meeting of shareholders that will take place on 22 October 2019.
Terms of the collaboration
We will fund and lead all discovery and development autonomously until the end of Phase 2. After the completion of a qualifying Phase 2 study, Gilead will have the option to acquire a license to the compound outside Europe. If the option is exercised, we and Gilead will co-develop the compound and share costs equally. Gilead will maintain option rights to our programs through the 10-year term of the collaboration and for up to an additional three years thereafter for those programs that have entered clinical development prior to the end of the collaboration term. If GLPG1690 is approved in the United States, Gilead will pay us an additional $325 million milestone fee. For GLPG1972, after the completion of the ongoing Phase 2b study in osteoarthritis, Gilead has the option to pay a $250 million fee to license the compound in the United States. If certain secondary efficacy endpoints are met, Gilead will pay us up to an additional $200 million. Following opt-in on GLPG1972, we are eligible to receive up to $550 million in regulatory and commercial milestones. For all other programs resulting from the collaboration,
21
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Gilead will make a $150 million opt-in payment per program and will owe no subsequent milestones. We will receive tiered royalties ranging from 20-24% on net sales of all our products licensed by Gilead in all countries outside Europe as part of the agreement.
Filgotinib collaboration
Under the revised agreement, we will have greater involvement in filgotinibs global strategy and participate more broadly in the commercialization of the product in Europe, providing the opportunity to build a commercial presence on an accelerated timeline. We and Gilead will co-commercialize filgotinib in France, Germany, Italy, Spain and the United Kingdom and retain the 50/50 profit share in these countries that was part of the original filgotinib license agreement, and under the revised agreement, we will have an expanded commercial role. We will be the lead commercialization party for filgotinib in France, Italy and Spain for rheumatology indications and Gilead will be the lead commercialization party for gastro indications. In Germany and the United Kingdom, Gilead will lead the rheumatology indications and Galapagos will lead the gastro indications. We retain exclusive commercialization responsibility in Belgium, the Netherlands and Luxembourg, where the 50/50 profit share also applies. The companies will share future global development costs for filgotinib equally until a predetermined level, in lieu of the 80/20 cost split provided by the original agreement. Other terms of the original license agreement remain in effect, including the remaining $1.27 billion in total potential milestones and tiered royalties ranging from 20-30% payable in territories outside of Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Spain and the United Kingdom.
Terms of the equity investment
Gileads equity investment consists of a subscription for new Galapagos shares at a price of 140.59 per share, representing at 14 July 2019 a 20% premium to Galapagos 30-day, volume-weighted average price. This equity subscription took place at closing of the transaction, on 23 August 2019 and increased Gileads stake in Galapagos from approximately 12.3% to 22.04% of the then issued and outstanding shares in Galapagos.
In addition, we intend to seek shareholder approval to issue two warrants allowing Gilead to further increase its ownership of Galapagos to up to 29.9% of the companys issued and outstanding shares. The agreement also includes a 10-year standstill restricting Gileads ability to seek to acquire Galapagos or increase its stake in Galapagos beyond 29.9% of the companys issued and outstanding shares, subject to limited exceptions. The issuance of the two warrants will be on the agenda of the extraordinary general meeting of shareholders that will take place on 22 October 2019.
Significant accounting policies
There were no significant changes in accounting policies applied by us in these condensed consolidated interim financial statements compared to those used in the most recent annual consolidated financial statements of 31 December 2018, except for the adoption of new standards and interpretations described below and the application of accounting policies that were previously not yet disclosed.
| IFRS 16 Leases (applicable for annual periods beginning on or after 1 January 2019) |
The nature and the effect of these changes were taken into consideration, and the above amendments affected the condensed consolidated interim financial statements as follows:
We adopted IFRS 16 on 1 January 2019, in accordance with the transitional provisions of IFRS 16, using the modified retrospective approach. Consequently, the cumulative effect of adopting IFRS 16 was recognized as an adjustment to the opening balance of retained earnings as at 1 January 2019, with no restatement of the comparative figures.
22
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
On adoption of IFRS 16, we recognized lease liabilities in relation to leases which had previously been classified as operating leases under IAS 17. These liabilities were measured at the present value of the remaining lease payments and discounted using our incremental borrowing rate as of 1 January 2019. Our weighted average incremental borrowing rate applied to the lease liabilities on 1 January 2019 was 1.55%.
The differences between our total operating lease commitments as reported in note 25 of our consolidated financial statements of 31 December 2018 and the total lease liabilities recognized in our statement of financial position as at 1 January 2019 are summarized below.
(thousands of ) |
||||
Operating lease commitments disclosed as at 31 December 2018 |
27,704 | |||
|
|
|||
Less: discounting effect using the lessees incremental borrowing rate at the date of initial application |
(1,223 | ) | ||
Less: other |
(569 | ) | ||
|
|
|||
Lease liability recognized as at 1 January 2019 |
25,912 | |||
|
|
|||
Of which are: |
||||
current lease liabilities |
4,516 | |||
non-current lease liabilities |
21,396 |
The change in accounting policy affected the statement of financial position as at 1 January 2019 as follows:
(thousands of ) |
1 January 2019 | |||
Property, plant and equipment (right-of-use assets) |
26,406 | |||
Other current assets (prepaid expenses) |
(494 | ) | ||
|
|
|||
Effect on total assets |
25,912 | |||
|
|
|||
Accumulated losses |
416 | |||
Lease liabilities (current and non-current) |
25,912 | |||
Deferred income |
(416 | ) | ||
|
|
|||
Effect on total equity and liabilities |
25,912 | |||
|
|
We applied the following practical expedients, as permitted by IFRS 16, on transition date:
| Reliance on the previous definition of a lease (as provided by IAS 17) for all contracts that existed on the date of initial application; |
| The use of a single discount rate to a portfolio of leases with reasonably similar characteristics; |
| Reliance on previous assessments on whether leases are onerous instead of performing an impairment review; |
| The accounting for operating leases with a remaining lease term of less than 12 months as at 1 January 2019 as short-term leases. |
Other new standards and interpretations applicable for the annual period beginning on 1 January 2019 did not have any impact on our condensed consolidated interim financial statements.
We have not early adopted any other standard, interpretation, or amendment that has been issued but is not yet effective.
23
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Change in accounting policies with effect from 1 January 2019 as a result of the adoption of IFRS 16:
Whereas until the end of 2018, we made a distinction between finance leases (presented on the balance sheet) and operating leases (off-balance sheet commitments), we recognized as from 1 January 2019 right-of-use assets on the balance sheet and corresponding lease liabilities (measured on a present value basis). These liabilities reflect the expected lease payments to be made in the future, estimated at the commencement date of the leases. After initial recognition, these lease liabilities are measured at amortized cost.
The right-of-use assets (mainly comprising the initial lease liability) are measured at cost and depreciated over their useful life on a straight-line basis. The right-of-use assets are presented in the statement of financial position under the caption Property, plant and equipment and the lease liabilities are presented as current and non-current lease liabilities.
Each lease payment is allocated between the lease liability and financial expenses.
New accounting policies as a result of recent transactions:
Financial instruments: derivative assets/liabilities
Financial assets and financial liabilities are recognized on our balance sheet when we become a party to the contractual provisions of the instrument.
Derivative assets and liabilities are initially measured at fair value. After initial measurement we will measure the derivatives at fair value through profit or loss.
These accounting policies are also expected to be reflected in our consolidated financial statements as at and for the year ending 31 December 2019.
Management judgments and estimates
Preparing interim financial statements in compliance with IFRS requires management to make judgments and estimates and to use assumptions that may significantly influence the reported amounts of assets and liabilities, the notes on contingent assets and liabilities on the date of the financial statements and the reported amounts of income and expenses during the reporting period. Actual results may differ from these estimates. We refer to our annual report 2018, except for the judgments and estimates as a result of the application of IFRS 16 and the judgments made as a consequence of accounting for the Option, License and Collaboration agreement, the revised collaboration agreement for filgotinib and the equity subscription agreement, each signed with Gilead, as described below.
Critical judgments in applying accounting policies
Accounting for warrant A and warrant B
As the issuance of warrants A and B is subject to the approval of our shareholders, management came to the judgmental view that a financial instrument as defined under IAS 32 shall not be recognized until such an approval is voted. The issuance of warrant A and initial warrant B will be on the agenda of the extraordinary general meeting of shareholders that will take place on 22 October 2019. On the closing date of the transaction (23 August 2019) we however received from Gilead the upfront payment that implicitly includes a premium for the future issuance of the warrants. In accordance with IFRS 15, management took the view that the expected value of the warrants to be issued shall be treated as a contract liability (warrant issuance liability) reducing the transaction price. At the date the shareholders approve the issuance of the warrants, the contract liability becomes a financial liability (derivative) measured at fair value through profit or loss in accordance with IFRS 9.
24
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
IFRS 15 Revenue recognition Gilead
Our critical judgments were as follows:
Determination of the total transaction price
| In connection with this agreement with Gilead, we recognized a deferred income and an offsetting short-term financial asset (derivative) of 85.6 million upon signing of the share subscription agreement with Gilead as required under IFRS 9. The deferred income has been added to the transaction price at inception of the agreement because it is considered to be part of the overall consideration received for the three performance obligations. |
| We considered that the transaction price included a premium paid by Gilead (through the upfront payment) to acquire warrants (warrant A and warrant B) in the future, upon approval by the shareholders. We measured both warrants at fair value and recognized a liability at closing of the transaction for the same amount (as part of the current deferred income line). This liability is re-measured at each reporting period with a corresponding impact on the allocation of the transaction price to the performance obligation relating to the drug discovery platform. At 30 September 2019, the value of the warrants amounted to 44.8 million for warrant A and 5.5 million for warrant B. |
Performance obligation: License on GLPG1690
| The transaction price allocated to this performance obligation reflects our assessment of the stand-alone selling price of this performance obligation and was valued based on a discounted cash flow approach including, amongst others, assumptions on the estimated market share and size, peak sales and probability of success. |
| After granting the license for GLPG1690, we will share Phase 3 costs equally with Gilead. We consider this part of the contract as a collaboration between us and Gilead which is not in scope of IFRS 15. |
Performance obligation: Filgotinib amendment
| Revenues are recognized over time through satisfaction of the performance obligation. Management determined the cost-to-cost input model, previously applied, remains appropriate, considering the new joint predetermined cost level, to measure the progress of the satisfaction of this performance obligation. The predetermined level of costs has increased and as a result, the percentage of completion has decreased leading to the recognition in revenue of a negative cumulative catch-up in the third quarter of 2019. |
25
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Performance obligation: Access rights to the drug discovery platform, option rights and R&D activities
| Management determined that Gileads right to opt-in on drug discovery platform programs at the end of Phase 2 (including GLPG1972), to obtain co-exclusive development and commercialisation rights for the optioned program outside Europe, did not represent a material right as the amounts payable to exercise such rights are estimated to represent fair value when comparing the terms of the contract to previous contracts concluded at arms length. Therefore none of the upfront payment was allocated to such rights. |
| The revenue allocated to the drug discovery platform will be recognized over time as Gilead receives exclusive access to our drug discovery platform and option rights on our current and future pipeline as well as R&D activities during the collaboration term. We assessed that the granting of exclusive access and option rights delivered over the entire period is the predominant component of the transaction price. Moreover, no budget (amounts and spread) nor performance measures were agreed regarding the R&D activities as we remain free to conduct those activities and spend on those activities at our own discretion. Finally, R&D platform investments (inputs) are difficult to predict accurately over the collaboration period. Therefore, input methods were not retained and management concluded that an equal spread over the collaboration period is the most reliable and appropriate recognition method. We also considered that Gilead is more interested in obtaining access to the output of our R&D activities over the collaboration period than in the input (which is why the input is not being reported upon or agreed between the parties). We considered that innovation output is not directly linked to the extent of the input hence we have not retained a cost input method to measure the progress of this performance obligation. |
Critical accounting estimates
Recognition period for the performance obligation: Access rights to the drug discovery platform, option rights and R&D activities
Management assessed the appropriate period over which to recognize the drug discovery platform revenue to be 10 years. This is because we granted exclusive rights over a 10-year period. However, if at the end of the 10-year period, some programs in existence as of this time would have reached the clinic (i.e. IND filed with regulatory authorities), the rights for those specific programs may be extended, for a maximum of three years. We will re-assess this critical estimate at each year-end based on the evolution of our pipeline.
26
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Details of the unaudited condensed consolidated interim results
Revenues and other income
Revenues
The following table summarizes our revenues for the nine months ended 30 September 2019 and 2018.
Nine months ended 30 September | ||||||||||||||||
(thousands of ) |
Over time | Point in time | 2019 | 2018 | ||||||||||||
Recognition of non-refundable upfront payments and license fees |
709,819 | 124,616 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Gilead collaboration agreement for GLPG1690 |
✓ | 666,968 | | |||||||||||||
Gilead collaboration agreement for filgotinib (1) |
✓ | 17,561 | 72,355 | |||||||||||||
Gilead collaboration agreement for drug discovery platform |
✓ | 23,922 | | |||||||||||||
AbbVie collaboration agreement for CF |
✓ | 1,368 | 4,761 | |||||||||||||
Novartis collaboration agreement for MOR106 |
✓ | | 47,500 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Milestone payments |
(7,932 | ) | 46,219 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Gilead collaboration agreement for filgotinib (1) |
✓ | (31,722 | ) | 21,648 | ||||||||||||
AbbVie collaboration agreement for CF |
✓ | 23,790 | 15,571 | |||||||||||||
Servier collaboration agreement for osteoarthritis |
✓ | | 9,000 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Reimbursement income |
16,437 | 3,872 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Novartis collaboration agreement for MOR106 |
✓ | 15,837 | 2,879 | |||||||||||||
AbbVie collaboration agreement for CF |
✓ | 600 | 989 | |||||||||||||
Other reimbursement income |
| 4 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Other revenues |
7,395 | 7,750 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Fee-for-services revenues |
✓ | 7,329 | 7,687 | |||||||||||||
Other revenues |
66 | 63 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total revenues |
725,719 | 182,457 | ||||||||||||||
|
|
|
|
|
|
(1) | Following the contract amendment, the revenue recognized for filgotinib includes a negative catch-up effect resulting from the decrease in the percentage of completion applied to previously received upfront and milestones for that program. |
Revenues (725.7 million for the first nine months of 2019, compared to 182.5 million for the first nine months of 2018) were higher due to the revenue recognition of the upfront payment received in August 2019 from Gilead related to (i) the GLPG1690 program and (ii) the access and option rights to our drug discovery platform, offset by (iii) a negative catch-up effect for revenues related to previously received upfront and milestones due to the revised filgotinib collaboration agreement.
27
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
The transaction price received from Gilead of 3,569.8 million ($3.95 billion) and the impact of the initial valuation of the share subscription of 85.6 million recognized as a deferred income upon signing of the share subscription agreement with Gilead as required under IFRS 9 were allocated to the three performance obligations identified as follows:
(thousands of ) |
||||
Upfront received |
3,569,815 | |||
Impact of initial valuation of share subscription |
85,601 | |||
|
|
|||
3,655,416 | ||||
|
|
|||
GLPG1690 |
666,968 | |||
Filgotinib additional consideration (1) |
641,664 | |||
Warrant A |
44,820 | |||
Warrant B |
5,468 | |||
|
|
|||
Drug discovery platform |
2,296,496 | |||
|
|
(1) | With regard to the additional consideration received for the extended cost sharing for filgotinib, we assume the existence of a significant financing component estimated to 44.5 million reflecting the time value of money on the estimated recognition period. We applied the accounting treatment foreseen under IFRS 15 for this additional component. |
The outstanding balance of the current and non-current deferred income as at 30 September 2019 can be allocated as follows:
30 September | 31 December | |||||||
(thousands of ) |
2019 | 2018 | ||||||
Deferred income related to contracts |
||||||||
Gilead collaboration agreement for filgotinib |
803,714 | 145,798 | ||||||
Gilead collaboration agreement for drug discovery platform |
2,272,574 | | ||||||
Warrant A issuance liability |
44,820 | | ||||||
Warrant B issuance liability |
5,468 | | ||||||
AbbVie collaboration for CF |
475 | 3,223 | ||||||
Deferred income related to contracts in our fee-for-service segment |
481 | 471 | ||||||
|
|
|
|
|||||
Other deferred income (grants) |
245 | 309 | ||||||
|
|
|
|
|||||
Total deferred income (long term & current) |
3,127,777 | 149,801 | ||||||
|
|
|
|
For the first nine months of 2019, 15.8 million of reimbursement income was recognized as revenue related to our R&D activities in the scope of our collaboration agreement with Novartis and MorphoSys for MOR106.
Other revenues amounting to 7.4 million mainly consisted of service revenues from our fee-for-service business.
Other income
Other income increased by 4.1 million, mainly driven by higher incentives income from the government for R&D activities.
28
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Results
We realized a net profit of 265.3 million for the first nine months of 2019, compared to a net loss of 44.2 million in the first nine months of 2018.
We reported an operating profit amounting to 393.0 million for the first nine months of 2019, compared to an operating loss of 53.5 million for the first nine months of 2018.
Our R&D expenditure in the first nine months of 2019 amounted to 298.2 million, compared to 231.8 million in the first nine months of 2018. This planned increase was mainly due to an increase of 29.1 million in subcontracting costs primarily related to our IPF program, filgotinib and other programs. Furthermore, personnel costs increased explained by a planned headcount increase and higher costs related to bonuses and warrant plans as a result of the increase of the Galapagos share price.
The table below summarizes our R&D expenditure for the nine months ended 30 September 2019 and 2018, broken down by program.
Nine months ended 30 September | ||||||||
(thousands of ) |
2019 | 2018 | ||||||
Filgotinib program (partnered) |
(58,840 | ) | (48,505 | ) | ||||
CF program (partnered) |
(3,028 | ) | (25,743 | ) | ||||
IPF program on GLPG1690 (partnered) |
(58,552 | ) | (45,932 | ) | ||||
OA program on GLPG1972 (partnered) |
(15,144 | ) | (11,885 | ) | ||||
AtD program on MOR106 (partnered) |
(19,771 | ) | (9,969 | ) | ||||
Other |
(142,912 | ) | (89,724 | ) | ||||
|
|
|
|
|||||
Total R&D expenditure |
(298,247 | ) | (231,758 | ) | ||||
|
|
|
|
Our G&A and S&M expenses were 61.2 million in the first nine months of 2019, compared to 26.8 million in the first nine months of 2018. This increase mainly resulted from higher personnel costs due to a planned headcount increase as well as higher costs for bonuses and warrant plans as a result of the increase of the Galapagos share price.
We reported a non-cash fair value loss from the re-measurement of a derivative financial instrument triggered by the share subscription agreement with Gilead between signing and closing of the agreement amounting to 142.3 million. Such amount reflects the increase in the Galapagos share price between signing and closing of the Gilead agreement.
Net other financial loss in the first nine months of 2019 amounted to 2.0 million, compared to net other financial income of 9.0 million for the first nine months of 2018, which was primarily attributable 34.9 million realized exchange loss on the U.S. dollars upfront payment from Gilead, which was partly compensated by a 32.4 million of unrealized exchange gain on our cash position in U.S. dollars (compared to 6.6 million of unrealized exchange gain on our cash position in U.S. dollars in the first nine months of 2018).
We reported a tax income amounting to 16.7 million primarily from the recognition of deferred tax assets as a consequence of the deal with Gilead.
29
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Segment information
We have two reportable segments: R&D and our fee-for-service business Fidelta, located in Croatia.
Nine months ended 30 September 2019 | ||||||||||||||||
(thousands of ) |
R&D | Fee-for-services | Inter-segment elimination |
Group | ||||||||||||
External revenue |
718,390 | 7,329 | 725,719 | |||||||||||||
Internal revenue |
5,548 | (5,548 | ) | | ||||||||||||
Other income |
26,737 | 7 | 26,744 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Revenues & other income |
745,127 | 12,884 | (5,548 | ) | 752,463 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Segment result |
419,963 | 1,186 | 421,149 | |||||||||||||
|
|
|
|
|
|
|||||||||||
Unallocated expenses (1) |
(28,128 | ) | ||||||||||||||
|
|
|||||||||||||||
Operating profit |
393,021 | |||||||||||||||
|
|
|||||||||||||||
Financial (expenses)/income |
(144,391 | ) | ||||||||||||||
|
|
|||||||||||||||
Result before tax |
248,630 | |||||||||||||||
|
|
|||||||||||||||
Income taxes |
16,699 | |||||||||||||||
|
|
|||||||||||||||
Net profit |
265,329 | |||||||||||||||
|
|
(1) | Unallocated expenses consist of expenses for warrant plans under IFRS 2 Share based payments. |
Nine months ended 30 September 2018 | ||||||||||||||||
(thousands of ) |
R&D | Fee-for-services | Inter-segment elimination |
Group | ||||||||||||
External revenue |
174,770 | 7,687 | 182,457 | |||||||||||||
Internal revenue |
5,826 | (5,826 | ) | | ||||||||||||
Other income |
22,614 | 9 | 22,623 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Revenues & other income |
197,384 | 13,522 | (5,826 | ) | 205,080 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Segment result |
(38,186 | ) | 2,672 | (35,514 | ) | |||||||||||
|
|
|
|
|
|
|||||||||||
Unallocated expenses (1) |
(18,001 | ) | ||||||||||||||
|
|
|||||||||||||||
Operating loss |
(53,515 | ) | ||||||||||||||
|
|
|||||||||||||||
Financial (expenses)/income |
8,958 | |||||||||||||||
|
|
|||||||||||||||
Result before tax |
(44,557 | ) | ||||||||||||||
|
|
|||||||||||||||
Income taxes |
343 | |||||||||||||||
|
|
|||||||||||||||
Net loss |
(44,215 | ) | ||||||||||||||
|
|
(1) | Unallocated expenses consist of expenses for warrant plans under IFRS 2 Share based payments. |
The basis of accounting for any transactions between reportable segments is consistent with the valuation rules and with transactions with third parties.
30
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Liquid assets position
Cash and cash equivalents totaled 5,599.8 million on 30 September 2019.
A net increase of 4,309.0 million in cash and cash equivalents was recorded during the first nine months of 2019, compared to a net increase of 192.5 million during the first nine months of 2018. This net increase was composed of (i) 3,302.0 million of operational cash flow, of which 3,535.0 million cash inflow from the Gilead collaboration and 233.0 million remaining cash outflow from operating activities, and (ii) 960.1 million cash proceeds related to the share subscription by Gilead, (iii) 14.5 million of cash proceeds from capital and share premium increase from exercise of warrants in the first nine months of 2019 and (iv) 32.4 million of unrealized positive exchange rate differences.
Cash and cash equivalents amounted to 5,599.8 million at the end of September 2019 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 899.0 million of term deposits that 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 4,270.7 million and aim at meeting short-term cash commitments, while reducing the counterparty risk of investment.
30 September | 31 December | |||||||
(thousands of ) |
2019 | 2018 | ||||||
Cash at banks |
430,035 | 358,016 | ||||||
Term deposits |
899,028 | 733,537 | ||||||
Money market funds |
4,270,724 | 199,243 | ||||||
|
|
|
|
|||||
Total cash and cash equivalents |
5,599,787 | 1,290,796 | ||||||
|
|
|
|
On 30 September 2019, our cash and cash equivalents included $1,533.6 million held in U.S. dollars 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% increase / decrease in the EUR/U.S. dollar exchange rate amounts to a loss of 135.4 million / gain of 135.4 million.
Finally, our balance sheet held R&D incentives receivables from the French government (Crédit dImpôt Recherche), to be received in four yearly tranches, and R&D incentives receivables from the Belgian Government, for a total of 99.7 million as at 30 September 2019.
31
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Capital increase
On 30 September 2019, Galapagos NVs share capital was represented by 61,953,831 shares. All shares were issued, fully paid up and of the same class. The below table summarizes our capital increases for the period ended 30 September 2019.
(thousands of , except share data) |
Number of shares |
Share capital |
Share premium |
Share capital and share premium |
Average exercise price warrants |
Closing share price on date of capital increase |
||||||||||||||||||
On 1 January 2019 |
54,465,421 | 236,540 | 1,277,780 | 1,514,320 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||||||
20 March 2019: exercise of warrants |
149,370 | 808 | 2,673 | 3,481 | 23.30 | 90.32 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
20 June 2019: exercise of warrants |
208,310 | 1,127 | 3,198 | 4,325 | 20.76 | 113.55 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
23 August 2019: share subscription from Gilead |
||||||||||||||||||||||||
Ordinary shares (fully paid) |
6,828,985 | 36,945 | 923,142 | 960,087 | 148.90 | |||||||||||||||||||
Derecognition of financial liability from share subscription agreement |
56,749 | 56,749 | ||||||||||||||||||||||
Capital increase expenses not yet settled in cash at 30 September 2019 |
(4,447 | ) | (4,447 | ) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total share subscription by Gilead |
6,828,985 | 32,498 | 979,891 | 1,012,389 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||||||
19 September 2019: exercise of warrants |
301,745 | 1,632 | 5,043 | 6,676 | 22.12 | 145.25 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
On 30 September 2019 |
61,953,831 | 272,605 | 2,268,585 | 2,541,190 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
32
Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Note to the cash flow statement
Nine months ended 30 September | ||||||||
(thousands of ) |
2019 | 2018 | ||||||
Adjustment for non-cash transactions |
||||||||
Depreciation and amortization |
8,837 | 4,816 | ||||||
Share-based compensation |
28,128 | 18,001 | ||||||
Increase in retirement benefit obligations and provisions |
255 | 228 | ||||||
Unrealized exchange gains () /losses and non-cash other financial expenses |
(32,272 | ) | (6,512 | ) | ||||
Discounting effect of deferred income |
2,090 | | ||||||
Fair value re-measurement share subscription agreement |
142,349 | | ||||||
Fair value adjustment financial assets held at fair value through profit or loss |
1,979 | (255 | ) | |||||
|
|
|
|
|||||
Total adjustment for non-cash transactions |
151,366 | 16,278 | ||||||
|
|
|
|
|||||
Adjustment for items to disclose separately under operating cash flow |
||||||||
Interest expense |
697 | 574 | ||||||
Interest income |
(7,430 | ) | (3,118 | ) | ||||
Tax expense |
(16,699 | ) | (343 | ) | ||||
|
|
|
|
|||||
Total adjustment for items to disclose separately under operating cash flow |
(23,432 | ) | (2,887 | ) | ||||
|
|
|
|
|||||
Adjustment for items to disclose under investing and financing cash flows |
||||||||
Gain / loss () on sale of assets |
(3 | ) | 3 | |||||
|
|
|
|
|||||
Total adjustment for items to disclose under investing and financing cash flows |
(3 | ) | 3 | |||||
|
|
|
|
|||||
Change in working capital other than deferred income |
||||||||
Increase () / decrease in inventories |
3 | (1 | ) | |||||
Increase in receivables |
(28,142 | ) | (3,317 | ) | ||||
Increase in payables |
69,265 | 30,371 | ||||||
|
|
|
|
|||||
Total change in working capital other than deferred income |
41,127 | 27,053 | ||||||
|
|
|
|
Fair value measurements
Gilead share subscription agreement
On 23 August 2019, Gilead made a 960.1 million equity investment in Galapagos NV by subscribing to 6,828,985 new ordinary shares at a price of 140.59 per share, including issuance premium. The equity subscription was already accounted for as a financial asset at signing of the contract on 14 July 2019 and was subsequently remeasured at fair value through the income statement until 23 August 2019. The fair value measurement of this derivative financial instrument is categorized as a level 3 in the fair value hierarchy because of the following unobservable assumptions:
| Between the date that the deal is signed (14 July 2019) until the date the deal is complete, there was a firm commitment from Galapagos to issue the shares. |
| At the initial valuation date (signing of the deal) it was assumed that the date when the deal would be completed was 15 September 2019. This was the forward date from where all the market data is taken from. |
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Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Fair value re-measurement of the Gilead share subscription agreement
(thousands of ) |
||||
Fair value of financial asset at inception |
85,601 | |||
|
|
|||
Movement of period 14 July -23 August 2019 ( recognized in the income statement) |
(142,350 | ) | ||
|
|
|||
Fair value of financial liability per 23 August 2019 |
(56,749 | ) | ||
|
|
|||
Derecognition of the financial liability through the share premium account on 23 August 2019 |
56,749 | |||
|
|
|||
Fair value per 30 September 2019 |
| |||
|
|
The 56.7 million current financial liability from the share subscription agreement reflecting the difference between the price paid by Gilead compared to the closing price of our shares on 23 August 2019 was derecognized through share premium.
Gilead warrants A and B
We measured both warrants at fair value (level 3) and recognized a liability at inception of the agreement for the same amount (as part of the deferred income line). This variable consideration was remeasured at 30 September 2019 with a corresponding impact on the transaction price allocated to the performance obligation relating to our drug discovery platform.
The fair value of warrant A amounted to 44.8 million at 30 September 2019. The fair value of warrant B amounted to 5.5 million at 30 September 2019.
Warrant A
Warrant A have been valued using a standard option model (Black & Scholes Merton). The input data used in the model were coming from market observations (volatility, discount rate and share price) and from management estimates (number of shares to be issued, applied discount for lack of marketability).
A change in the unobservable inputs would have the following effect on the fair value of warrant A at 30 September 2019:
| If the number of shares issued through the exercise of the warrant A would be increased by 100,000, the value of the warrant A would increase by 1.6m. |
| If the discount for lack of marketability had been estimated at 10% instead of 15%, the value of the liability would have increased by 2.6m. |
Warrant B
Warrant B issued to Gilead have been valued on the basis of a Longstaff-Schwartz Monte Carlo model. The input data used in the model were coming from market observations (volatility, discount rate and share price) and from management estimates (number of shares to be issued, applied discount for lack of marketability).
A change in the unobservable inputs would have the following effect on the fair value of warrant B at 30 September 2019:
| If the number of shares issued through the exercise of the warrant B would be increased by 100,000, the value of the warrant B would increase by 0.1m. |
| If the discount for lack of marketability had been estimated at 30% instead of 35%, the value of the liability would have increased by 0.4m. |
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Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Contingencies and commitments
Contractual obligations and commitments
We entered into lease agreements for offices, laboratories and cars. As a consequence of the adoption of IFRS 16 Leases, on 1 January 2019, lease obligations in the scope of the new standard are presented as lease liabilities in the statements of financial position and no longer disclosed separately as off-balance sheet commitments.
We also have certain purchase commitments principally with CRO subcontractors and certain collaboration partners.
On 30 September 2019, we had outstanding obligations for purchase commitments, which become due as follows:
(thousands of ) |
Total | Less than 1 year |
1 -3 years | 3 -5 years | More than 5 years |
|||||||||||||||
Purchase commitments |
231,717 | 144,682 | 69,723 | 16,406 | 906 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
In addition to the table above, we have a contractual cost sharing obligation related to our collaboration agreement with Gilead for filgotinib. The contractual cost sharing commitment amounted to 655.3 million at 30 September 2019 for which we have direct purchase commitments of 21.9 million at 30 September 2019 reflected in the table above.
Contingent liabilities and assets
We refer to our Annual Report 2018 for a description of our contingent liabilities and assets except for the following changes as a result of the Gilead transaction.
As a result of the filgotinib amendment, we are now responsible for funding 50% (instead of the originally agreed 20%) of the associated global development costs of the program. We have retained certain mechanisms to give us cost protection as filgotinib advances in clinical development. We are not obligated to bear any further costs if they exceed a predetermined level.
As explained in the summary of the Gilead agreement in the beginning of this report, Gilead received exclusive option rights to acquire a license on compounds. Exercising such an option would trigger an opt-in payment, a 50-50 cost share mechanism for the future development activities, development and sales milestones and royalties. We are also entitled to an additional milestone for GLPG1690 upon approval in the United States.
Related party transactions
Gilead is exercising significant influence over Galapagos as from the equity subscription on 23 August 2019. As a result of the equity subscription we received a transparency notification from Gilead on 28 August 2019 confirming they held 22.04% of the then issued and outstanding shares of Galapagos. The presumption of significant influence is also confirmed by the fact that Gilead has the right, for as long as it holds more than 20% of Galapagos share capital, to appoint two Investor Board Designees to Galapagos board of directors. The appointment of Mr. Daniel ODay and Dr. Linda Higgins as directors of the company is on the agenda of the special general meeting of shareholders taking place on 22 October 2019.
All transactions with Gilead are explained in this report.
The board of directors resolved, upon recommendation of the nomination and remuneration committee, in the meeting of 24 September 2019, to award all employees of Galapagos an exceptional bonus for the successful closing of the Gilead alliance transaction, amounting to approximately 30 million in aggregate. For executive committee members the bonus amounted to 10.5 million in cash payable in October 2019, and 10.5 million in Restricted
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Galapagos NV Q3 Report 2019
FINANCIAL STATEMENTS
Stock Units (RSUs) granted in October 2019 (for an equivalent of 71,074 RSUs in aggregate). 50% of the RSUs have a vesting period of two years and 50% of the RSUs have a vesting period of three years. Each RSU reflects the value of one Galapagos share and will be payable, at the companys discretion in cash or in shares, upon vesting.
During the first nine months of 2019, there were no other related party transactions than those disclosed above and in the H1 2019 report that potentially had a material impact on the financials of the first nine months of 2019.
Events after the end of the reporting period
There were no adjusting events nor material non-adjusting events to be reported.
Approval of interim financial statements
The interim financial statements were approved by the board of directors on 21 October 2019.
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Galapagos NV Q3 Report 2019
OTHER INFORMATION
Glossary of terms
100 points clinical response
Percentage of patients achieving a 100-point decrease in CDAI score during a clinical trial in CD patients
ACR
American College of Rheumatology
ACR20 (ACR 20/50/70)
American College of Rheumatology 20% response rate signifies a 20% or greater improvement in the number of swollen and tender joints as well as a 20% or greater improvement in three out of five other disease-activity measures. ACR50 and ACR70 reflect the same, for 50% and 70% response rates, respectively
ADAMTS-5
ADAMTS-5 is a key enzyme involved in cartilage breakdown (Larkin 2015)
ADS
American Depositary Share; Galapagos has a Level 3 ADS listed on Nasdaq with ticker symbol GLPG and CUSIP number 36315X101. One ADS is equivalent to one ordinary share in Galapagos NV
AFM
Dutch Authority for the Financial Markets
Anemia
Condition in which the patient has an inadequate number of red blood cells to carry oxygen to the bodys tissues
Ankylosing spondylitis (AS)
AS is a systemic, chronic, and progressive spondyoloarthropathy primarily affecting the spine and sacroiliac joints, and progressing into severe inflammation that fuses the spine, leading to permanent painful stiffness of the back
(Anti-)TNF
Tumor necrosis factor. An anti-TNF drug acts by modulation of TNF
ASDAS
Ankylosing Spondylitis Disease Activity Score, a composite score of symptoms such as back pain, duration of morning stiffness, and peripheral pain and swelling. We measured ASDAS scores in the TORTUGA trial with filgotinib in AS
Atherogenic index
Total cholesterol over HDL ratio. Improvement of the atherogenic index may be a forecast of cardiovascular health
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Galapagos NV Q3 Report 2019
OTHER INFORMATION
Atopic dermatitis (AtD)
Also known as atopic eczema, atopic dermatitis is a common pruritis inflammatory condition affecting the skin, which most frequently starts in childhood
Attrition rate
The historical success rate for drug discovery and development, based on publicly known development paths. Statistically seen, investment in at least 12 target-based programs is required to ensure that at least one of these will reach a Phase 3 study. Most new drug R&D programs are discontinued before reaching Phase 3 because they are not successful enough to be approved
Autotaxin (ATX)
An enzyme important for generating the signaling molecule lypophosphatidic acid (LPA). GLPG1690 targets autotaxin for IPF and SSc
BID dosing
Twice-daily dosing (bis in die)
Bioavailability
Assessment of the amount of product candidate that reaches a bodys systemic circulation after (oral) administration
Biomarker
Substance used as an indicator of a biological process, particularly to determine whether a product candidate has a biological effect
Black & Scholes model
A mathematical description of financial markets and derivative investment instruments that is widely used in the pricing of European options and warrants
Bleomycin model
A preclinical model involving use of bleomycin (a cancer medication) to induce IPF symptoms
CDAI
Crohns Disease Activity Index, evaluating patients on eight different factors, each of which has a pre-defined weight as a way to quantify the impact of CD
CDAI remission
In the FITZROY trial, the percentage of patients with CD who showed a reduction of CDAI score to <150
CIR
Crédit dImpôt Recherche, or research credit. Under the CIR, the French government refunds up to 30% of the annual investment in French R&D operations, over a period of three years. Galapagos benefits from the CIR through its operations in Romainville, just outside Paris
Clinical proof-of-concept (PoC)
Point in the drug development process where the product candidate first shows efficacy in a therapeutic setting
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Galapagos NV Q3 Report 2019
OTHER INFORMATION
Compound
A chemical substance, often a small molecule with drug-like properties
Contract research organization
Organization which provides drug discovery and development services
Crohns disease (CD)
An IBD involving inflammation of the small and large intestines, leading to pain, bleeding, and ultimately in some cases surgical removal of parts of the bowel
CRP
C-reactive protein is a protein found in the blood, the levels of which rise in response to inflammation
Cutaneous lupus
Cutaneous lupus is a heterogeneous autoimmune skin disease that can present itself as an organ-specific disease (e.g., in the skin only) or as a systemic disease involving multiple organs
Cystic fibrosis (CF)
A life-threatening genetic disease that affects approximately 80,000 people worldwide. Although the disease affects the entire body, difficulty breathing is the most serious symptom as a result of clogging of the airways due to mucus build-up and frequent lung infections
Cytokine
A category of small proteins which play important roles in signaling in processes in the body
Dactylitis
Dactylitis is inflammation of a digit (either finger or toe) and is derived from the Greek word dactylos meaning finger. The affected fingers and/or toes swell up into a sausage shape and can become painful. Dactylitis was measured in the EQUATOR trial with filgotinib in psoriatic arthritis
DARWIN
Phase 2 program for filgotinib in RA. Completed and reported in 2015 (except for the currently ongoing DARWIN 3 study). DARWIN 1 explored three doses, in twice-daily and once-daily administration, for up to 24 weeks in RA patients with insufficient response to methotrexate (MTX) and who remained on their stable background treatment with MTX. DARWIN 2 explored three once-daily doses for up to 24 weeks in RA patients with insufficient response to methotrexate (MTX) and who washed out of their treatment with MTX. DARWIN 1 and 2 were double-blind, placebo-controlled trials which recruited approximately 900 patients globally. DARWIN 3 is a long term extension trial currently ongoing; all patients are on 200 mg filgotinib, except for U.S. males who are on 100 mg
DAS28 (CRP)
DAS28 is an RA Disease Activity Score based on a calculation that uses tender and swollen joint counts of 28 defined joints, the physicians global health assessment and a serum marker for inflammation, such as C-reactive protein. DAS28 (CRP) includes the C-reactive protein score calculation: scores range from 2.0 to 10.0, with scores below 2.6 being considered remission
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Galapagos NV Q3 Report 2019
OTHER INFORMATION
Development
All activities required to bring a new drug to the market. This includes preclinical and clinical development research, chemical and pharmaceutical development and regulatory filings of product candidates
Discovery
Process by which new medicines are discovered and/or designed. At Galapagos, this is the department that oversees target and drug discovery research through to nomination of preclinical candidates
Disease-modifying
Addresses the disease itself, modifying the disease progression, not just the symptoms of the disease
DIVERSITY
Phase 3 program evaluating filgotinib in CD
DLCO
DLCO (diffusion capacity of the lung for carbon monoxide) is the extent to which oxygen passes from the air sacs of the lungs into the blood. This is measured in IPF patients
Dose-range finding study
Phase 2 clinical study exploring the balance between efficacy and safety among various doses of treatment in patients. Results are used to determine doses for later studies
Double-blind
Term to characterize a clinical trial in which neither the physician nor the patient knows if the patient is taking placebo or the treatment being evaluated
Efficacy
Effectiveness for intended use
EMA
European Medicines Agency, in charge of European market authorization of new medications
Endoscopy
A non-surgical procedure involving use of an endoscope to examine a persons digestive tract
Enthesitis
Inflammation of the tendons or ligaments; this is one of the key symptoms of psoriatic arthritis and was also measured in the EQUATOR trial with filgotinib
EQUATOR
A Phase 2 trial with filgotinib in psoriatic arthritis patients
Esbriet
An approved drug (pirfenidone) for IPF, marketed by Roche
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Galapagos NV Q3 Report 2019
OTHER INFORMATION
FALCON
A phase 1b, open-label, non-randomized study to assess the safety, tolerability, pharmacokinetics, and efficacy of a novel combination treatment in up to 24 adult patients with CF
FDA
The U.S. Food and Drug Administration is an agency responsible for protecting and promoting public health and in charge of American market approval of new medications
Fee-for-service
Payment system where the service provider is paid a specific amount for each procedure or service performed
FEV
Forced expiratory volume measures how much air a person can exhale during a forced breath. The amount of air exhaled may be measured during the first (FEV1), second (FEV2), and/or third seconds (FEV3) of the forced breath
Fibrotic score
The Ashcroft fibrotic score involves measuring pulmonary fibrosis through examination of histopathology tissue
FIH
First-in-human clinical trial, usually conducted in healthy volunteers with the aim to assess the safety, tolerability and pharmacokinetics of the product candidate
Filgotinib
Formerly known as GLPG0634. Small molecule selective JAK1 inhibitor which showed activity and favorable tolerability in RA, PsA, AS and CD patients in Phase 2 trials. Filgotinib is partnered with Gilead. Galapagos and Gilead are running Phase 3 trials with filgotinib in RA, CD, and UC and Phase 2 trials with filgotinib in additional indications. Filgotinib is an investigational drug and its efficacy and safety have not been established
FINCH
Phase 3 program evaluating filgotinib in RA
Fistulizing CD
Fistulae are inflammatory tracts that most often occur between the distal colon and the perianal region. Fistulae are one of the most severe sequelae of luminal CD and the lifetime risk of occurrence is close to 50% of those with active CD
FITZROY
A double-blind, placebo controlled Phase 2 trial with filgotinib in 177 CD patients for up to 20 weeks. Full results were published in The Lancet in 2016
FLORA
A double-blind, placebo-controlled exploratory Phase 2a trial with GLPG1690 in up to 24 IPF patients; topline results were reported in August 2017
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Galapagos NV Q3 Report 2019
OTHER INFORMATION
FRI
Functional respiratory imaging is a technology which enhances 3D visualization and quantification of a patients airway and lung geometry
FSMA
The Belgian market authority: Financial Services and Markets Authority, or Autoriteit voor Financiële Diensten en Markten
FTE
Full-time equivalent; a way to measure an employees involvement in a project. For example, an FTE of 1.0 means that the equivalent work of one full-time worker was used on the project
FVC
Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC is used to help determine both the presence and severity of lung diseases such as IPF
GECKO
A Phase 2 trial evaluating a subcutaneaous formulation of MOR106 in combination with topical corticosteroids. This Phase 2 trial was initiated early 2019
GLPG0555
A clinical candidate with undisclosed mode of action directed toward inflammation
GLPG0634
Molecule number currently known as filgotinib
GLPG1205
A GPR84 inhibitor fully proprietary to us. We initiated the PINTA patient trial with GLPG1205 in IPF
GLPG1690
A novel drug targeting autotaxin, with potential application in IPF & SSc. Topline results from the Phase 2a FLORA trial were reported in August 2017. The ISABELA Phase 3 program was initiated in 2018 and the NOVESA Phase 2 trial in SSc was initiated in early 2019
GLPG1972/S201086
GLPG1972/S201086, also referred to as GLPG1972, is a novel mode-of-action product candidate that is part of the OA collaboration with Servier. Galapagos and Servier are recruiting the ROCCELLA global Phase 2b trial with GLPG1972/S201086
GLPG2534
A preclinical candidate with undisclosed mode of action. GLPG2534 is expected to enter Phase 1 trials in 2020
GLPG2737
A clinical candidate with undisclosed novel mode of action. This compound is part of the CF collaboration with AbbVie but Galapagos regained rights outside of CF
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Galapagos NV Q3 Report 2019
OTHER INFORMATION
GLPG3312
A compound currently in Phase 1 with an undisclosed mode of action directed towards inflammation (IBD). GLPG3312 is a Toledo compound and the first one to enter Phase 1
GLPG3667
A compound currently in Phase 1 with an undisclosed mode of action directed toward inflammation
GLPG3970
A compound currently in Phase 1 with an undisclosed mode of action. GLPG3970 is part of the Toledo target family
HDL
High-density lipoprotein. HDL scavenges and reduces low-density lipoprotein (LDL) which contributes to heart disease at high levels. High levels of HDL reduce the risk for heart disease, while low levels of HDL increase the risk of heart disease
Hemoglobin
A protein inside red blood cells that carries oxygen from the lungs to tissues and organs in the body and carries carbon dioxide back to the lungs
Histopathology
Microscopic examination of tissues for manifestations of a disease
IBD
Inflammatory Bowel Disease. This is a general term for an autoimmune disease affecting the bowel, including CD and UC. CD affects the small and large intestine, while UC affects the large intestine. Both diseases involve inflammation of the intestinal wall, leading to pain, bleeding, and ultimately, in some cases, surgical removal of part of the bowel
IGUANA
Phase 2 trial together with our partners MophoSys and Novartis, investigating MOR106 in AtD patients
IL-17C
IL-17C has been shown to be distinct from other members of the IL-17 family of cytokines. IL-17C has been shown to be an important mediator in inflammatory skin diseases, and is the target of MOR106
In-/out-licensing
Receiving/granting permission from/to another company or institution to use a brand name, patent, or other proprietary right, in exchange for a fee and/or royalty
In vitro
Studies performed with cells outside their natural context, for example in a laboratory
Inflammatory diseases
A large, unrelated group of disorders associated with abnormalities in inflammation
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Galapagos NV Q3 Report 2019
OTHER INFORMATION
Inspiratory capacity
Total lung capacity or the amount of gas contained in the lung at the end of a maximal inhalation
Intellectual property
Creations of the mind that have commercial value and are protected or protectable, including by patents, trademarks or copyrights
Intersegment
Occurring between the different operations of a company
Investigational New Drug (IND) Application
United States Federal law requires a pharmaceutical company to obtain an exemption to ship an experimental drug across state lines, usually to clinical investigators, before a marketing application for the drug has been approved. The IND is the means by which the sponsor obtains this exemption, allowing them to perform clinical studies
IPF
Idiopathic pulmonary fibrosis. A chronic and ultimately fatal disease characterized by a progressive decline in lung function. Pulmonary fibrosis involves scarring of lung tissue and is the cause of shortness of breath. Fibrosis is usually associated with a poor prognosis. The term idiopathic is used because the cause of pulmonary fibrosis is still unknown
ISABELA
Phase 3 clinical program investigating GLPG1690 in IPF patients. The ISABELA Phase 3 program consists of two identically designed trials, ISABELA 1 and ISABELA 2, and will enroll a total of 1,500 IPF patients combined
JAK
Janus kinases (JAK) are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in RA. Filgotinib is a selective JAK1 inhibitor
LDL
Low-density lipoprotein. LDL contributes to heart disease at high levels
Liver enzymes
Inflamed or injured liver cells secrete higher than normal amounts of certain chemicals, including liver enzymes, into the bloodstream
LPA
Lysophosphatidic acid (LPA) is a signaling molecule involved in fibrosis
Lymphocyte
Type of white blood cell that is part of the immune system
MANTA
A Phase 2 trial with filgotinib to evaluate male testicular safety in patients with UC and CD
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Galapagos NV Q3 Report 2019
OTHER INFORMATION
MANTA-RAy
A Phase 2 trial with filgotinib to evaluate male testicular safety in patients with RA, PsA and AS
MHLW
Japanese Ministry of Health, Labor and Welfare (MHLW), in charge of Japanese market authorization of new medications
Milestone
Major achievement in a project or program; in our alliances, this is usually associated with a payment
Molecule collections
Chemical libraries, usually consisting of drug-like small molecules that are designed to interact with specific target classes. These collections can be screened against a target to generate initial hits in a drug discovery program
MOR106
A novel mode-of-action antibody product candidate currently in a Phase 2 trial in AtD patients. MOR106 acts on IL-17C, a novel antibody target discovered by Galapagos. MOR106 is part of the alliance with MorphoSys and Novartis
MTX
Methotrexate; a first-line therapy for inflammatory diseases
NDA
New Drug Application
Neutrophil
Type of immune system cell which is one of the first cell types to travel to the site of an infection in the body. Neutrophils are another type of white blood cell which fight infection by ingesting and killing microorganisms
NK cells
Natural killer cells, type of white blood cell with granules of enzymes which can attack tumors or viruses
NOVESA
A Phase 2 trial to evaluate GLPG1690 in systemic sclerosis (SSc)
Ofev
An approved drug (nintedanib) for IPF, marketed by Boehringer Ingelheim
Oral dosing
Administration of medicine by the mouth, either as a solution or solid (capsule, pill) form
Organoids
Miniature organ produced from cells from a donor; organoids have all the phenotypic characteristics of the patient donor, making them useful tools for in vitro drug research
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Galapagos NV Q3 Report 2019
OTHER INFORMATION
Osteoarthritis (OA)
The most common form of arthritis, usually occurring after middle age, marked by chronic breakdown of cartilage in the joints leading to pain, stiffness, and swelling
Outsourcing
Contracting work to a third party
PENGUIN
A Phase 3 trial with filgotinib in psoriatic arthritis patients
Pharmacokinetics (PK)
Study of what a body does to a drug; the fate of a substance delivered to a body. This includes absorption, distribution to the tissues, metabolism and excretion. These processes determine the blood concentration of the drug and its metabolite(s) as a function of time from dosing
Phase 1
First stage of clinical testing of an investigational drug designed to assess the safety and tolerability, pharmacokinetics of a drug, usually performed in a small number of healthy human volunteers
Phase 2
Second stage of clinical testing, usually performed in no more than several hundred patients, in order to determine efficacy, tolerability and the dose to use
Phase 3
Large clinical trials, usually conducted in several hundred to several thousand patients to gain a definitive understanding of the efficacy and tolerability of the candidate treatment; serves as the principal basis for regulatory approval
PINTA
Phase 2 trial with GPR84 inhibitor GLPG1205 in IPF patients
Placebo-controlled
A substance having no pharmacological effect but administered as a control in testing a biologically active preparation
Preclinical
Stage of drug research development, undertaken prior to the administration of the drug to humans. Consists of in vitro and in vivo screening, pharmacokinetics, toxicology, and chemical upscaling
Preclinical candidate (PCC)
A new molecule and potential drug that meets chemical and biological criteria to begin the development process
Product candidate
Substance that has satisfied the requirements of early preclinical testing and has been selected for development, starting with formal preclinical safety evaluation followed by clinical testing for the treatment of a certain disorder in humans
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Galapagos NV Q3 Report 2019
OTHER INFORMATION
Proof-of-concept study
Phase 2 patient study in which activity as well as safety in patients is evaluated, usually for a new mechanism of action
Pruritis
Extreme itching, as observed in AtD patients
Psoriatic arthritis (PsA)
Psoriatic arthritis or PsA is an inflammatory form of arthritis, affecting up to 30% of psoriasis patients. Psoriatic arthritis can cause swelling, stiffness and pain in and around the joints, and cause nail changes and overall fatigue
QD dosing
Once-daily dosing (qd from the Latin quaque die)
R&D operations
Research and development operations; unit responsible for discovery and developing new product candidates for internal pipeline or as part of risk/reward sharing alliances with partners
Rheumatoid arthritis (RA)
A chronic, systemic inflammatory disease that causes joint inflammation, and usually leads to cartilage destruction, bone erosion and disability
ROCCELLA
Global Phase 2b trial, together with our collaboration partner Servier, evaluating GLPG1972/S201086 (GLPG1972) in osteoarthritis (OA)
Screening
Method usually applied at the beginning of a drug discovery campaign, where a target is tested in a biochemical assay against a series of small molecules or antibodies to obtain an initial set of hits that show activity against the target. These hits are then further tested or optimized
SELECTION
Phase 3 program evaluating filgotinib in UC patients
Service operations
Business unit primarily focused on delivering products and conducting fee-for-service work for clients. Our service operations included the BioFocus and Argenta business units, which were both sold in April 2014 to Charles River Laboratories
SES-CD scores
Simple endoscopic score for CD, involving review of five pre-defined bowel segments, assigning values from 0 (unaffected) to 3 (highly affected)
Sjögrens syndrome
Sjögrens Syndrome is a systemic inflammatory disease which can be felt throughout the body, often resulting in chronic dryness of the eyes and mouth
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Galapagos NV Q3 Report 2019
OTHER INFORMATION
Small bowel CD (SBCD)
CD causes chronic inflammation and erosion of the intestines. It can affect different regions of gastrointestinal tract including the stomach and small and large intestines. While isolated SBCD is an uncommon presentation of CD, involvement of some portion of the small bowel, particularly the ileum, is common
Spondylitis
About 20% of patients with psoriatic arthritis will develop spinal involvement, which is called psoriatic spondylitis. Inflammation of the spine can lead to complete fusion, as in AS, or affect only certain areas such as the lower back or neck. We measured spondylitis in the EQUATOR trial with filgotinib in psoriatic arthritis
Systemic sclerosis (SSc)
Systemic sclerosis (SSc) or scleroderma is an autoimmune disease. One of the most visible manifestations is hardening of the skin. In diffuse cutaneous SSc, which has one of the highest mortality rates among rheumatic diseases, fibrosis occurs in multiple organs, such as the lung
Target
Proteïn that has been shown to play a role in a disease process and that forms the basis of a therapeutic intervention or discovery of a medicine
Target discovery
Identification and validation of proteins that have been shown to play a role in a disease process
Technology access fee
License payment made in return for access to specific technology (e.g. compound or virus collections)
Tendinitis
Tendinitis is inflammation or irritation of a tendon, the thick fibrous cords that attach muscle to bone. The condition causes pain and tenderness just outside a joint. We measured tendinitis in the EQUATOR trial with filgotinib in psoriatic arthritis
Toledo
Toledo is a code name for a target family with a novel, undisclosed mode of action. GLPG3312 is the first of the Toledo compounds for which a Phase 1-trial has been initiated early 2019
TORTUGA
Phase 2 trial with filgotinib in patients with ankylosing spondylitis. In 2018, we and Gilead reported that TORTUGA met its primary endpoint
Ulcerative colitis (UC)
UC is an IBD causing chronic inflammation of the lining of the colon and rectum (unlike CD with inflammation throughout the gastrointestinal tract)
Uveitis
Uveitis is the term that refers to inflammation inside the eye. This inflammation can be caused by infection, autoimmune reaction, or by conditions confined primarily to the eye
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OTHER INFORMATION
Contact
Elizabeth Goodwin | Sofie Van Gijsel | Carmen Vroonen | ||
Vice President Investor Relations | Director Investor Relations | Senior Director Corporate | ||
Galapagos NV | Galapagos NV | Communications | ||
230 Third Ave | Generaal De Wittelaan L11 A3 | Galapagos NV | ||
Waltham, MA 02451, | 2800 Mechelen, Belgium | Generaal De Wittelaan L11 A3 | ||
United States | Tel. +32 485 19 14 15 | 2800 Mechelen, Belgium | ||
Tel. +1 781 522 0002 | Email: ir@glpg.com | Tel. +32 15 34 28 24 | ||
Mob. +1 781 460 1784 | Email: | |||
Email: ir@glpg.com | communications@glpg.com |
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Galapagos NV Q3 Report 2019