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 July 2017
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 offices)
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): ☐
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): ☐
First Half-Year 2017 Results
On July 27, 2017, the Company announced its unaudited first half-year results for 2017, which are further described in an H1 2017 report.
Exhibit |
Description | |
99.1 | Press Release dated July 27, 2017 | |
99.2 | H1 Report 2017 |
The information contained in this Report on Form 6-K, including the exhibits, except for the quotes of Onno van de Stolpe and the quote of Bart Filius contained in Exhibit 99.1, is hereby incorporated by reference into the Companys Registration Statements on Forms F-3 (File No. 333-211765) and S-8 (File Nos. 333-204567, 333-208697, 333-211834, 333-215783, and 333-218160).
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 | ||||||
Date: July 31, 2017 | By: | /s/ Xavier Maes | ||||
Xavier Maes | ||||||
Company Secretary |
Exhibit 99.1
Solid financials support R&D progress
| First half-year financial results: |
| Revenues 73.0 M, an increase of 24.3 M compared to H1 2016 |
| Operating loss 32.9 M, an increase of 8.6 M compared to H1 2016 |
| Cash on 30 June 2017 of 1,263.2 M |
| Raised 363.9 M gross proceeds in the U.S. public equity offering |
| Substantial progress in R&D |
| Consistent filgotinib profile in RA in DARWIN 3 interim readout |
| Expansion of filgotinib Ph2 patient trials |
| Ph1 evaluation completed for individual components of first triple combo in CF |
| Initiation of Ph1b trial in U.S. with GLPG1972 in osteoarthritis patients |
| FDA orphan status for GLPG1690 in IPF |
| Nomination of fully proprietary pre-clinical candidates in inflammation, fibrosis, and other indications |
| Appointment of Michele Manto as Senior Vice President Commercial Operations |
| In-licensing of GLPG1972 by Servier triggers 6 million license fee |
Webcast presentation tomorrow, 28 July 2017, at 14.00 CET/8 AM ET, www.glpg.com, +32 2 403 7297, code 4659682
Mechelen, Belgium; 27 July 2017, 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) announces its unaudited first half-year results, which are further detailed in its H1 2017 report available on the Galapagos website, www.glpg.com.
I am pleased with the results over the first six months, both financially and in our R&D, said Onno van de Stolpe, CEO. We note the consistency of the DARWIN 3 results and are excited to see Gileads rapid rollout of inflammation studies with filgotinib. We expect more Phase 2 study starts with filgotinib. In cystic fibrosis we are making progress towards initiating patient evaluations of our first triple combo therapy. Most exciting for us is that we expect two patient study readouts from novel mechanism of action candidates this coming half year: the GLPG1690 FLORA study in IPF and the MOR106 study in atopic dermatitis.
In the first half of 2017 Galapagos continued to invest in its R&D pipeline to produce substantial progress. The U.S. public equity offering in April confirmed shareholders confidence in the future of our company and in our ability to execute, said Bart Filius, CFO. With a cash position of close to 1.3 billion, we are well positioned to advance our wide range of R&D programs. We confirm our cash burn guidance for the full year within the range of 135 155 million.
Key figures first half-year report 2017 (unaudited)
( millions, except basic & diluted income/loss per share)
30 June 2017 group total |
30 June 2016 group total |
|||||||
Revenues |
73.0 | 48.8 | ||||||
R&D expenditure |
(92.9 | ) | (62.4 | ) | ||||
G&A and S&M expenses |
(13.0 | ) | (10.7 | ) | ||||
Operating loss |
(32.9 | ) | (24.3 | ) | ||||
Non-cash adjustment on short term financial asset1 |
57.5 | |||||||
Other net financial result |
(16.2 | ) | (0.9 | ) | ||||
Taxes |
(0.1 | ) | | |||||
Net result for the period |
(49.2 | ) | 32.2 | |||||
Basic income/loss (-) per share () |
(1.03 | ) | 0.71 | |||||
Diluted income/loss (-) per share () |
(1.03 | ) | 0.69 | |||||
Cash, cash equivalents and restricted cash |
1,263.2 | 968.5 |
Notes:
1) | reflects non-cash financial asset adjustment resulting from the Gilead subscription agreement |
Appointment of SVP Commercial Operations
Galapagos announces the hire of Michele Manto, formerly Rheumatology Global Marketing General Manager at AbbVie, where he was responsible for Humira and preparation of the launch strategy of ABT-494. Prior to that Michele held several commercial roles at AbbVie starting in 2004, most recently General Manager of the Netherlands operations and Business Unit Director Immunology at AbbVies German and Swiss operations. Joining on 1 September as SVP Commercial Operations at Galapagos, Michele will be responsible for envisioning, scoping and operationalizing the commercial strategy for the organization. Michele will have the operational task of building the commercial organization for the company, recruiting the right talent across Europe and leading these commercial teams in our alliance with Gilead for filgotinib.
We welcome Michele to the Galapagos team. Michele brings valuable commercial experience and is the right person to spearhead build-up of our new commercial operations. The new SVP Commercial Operations will be a critical addition to the senior team and a key contributor to Galapagos transition to a fully integrated biotech company, commented Onno van de Stolpe.
First half-year report 2017
Galapagos financial report for the first half-year ended 30 June 2017 can be accessed via www.glpg.com/financial-reports.
Conference call and webcast presentation
Galapagos will conduct a conference call open to the public tomorrow, 28 July 2017 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: 4659682
USA: | +1 719 325 2213 | |
UK: | +44 330 336 9411 | |
Netherlands: | +31 20 703 8261 | |
France: | +33 1 76 77 22 57 | |
Belgium: | +32 2 400 6926 |
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
26 October 2017 | Third quarter 2017 results (webcast 27 October 2017) | |
22 February 2018 | Full year 2017 results (webcast 23 February 2018) |
About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Our pipeline comprises Phase 3, Phase 2, Phase 1, pre-clinical, and discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. We have discovered and developed filgotinib: in collaboration with Gilead we aim to bring this JAK1-selective inhibitor for inflammatory indications to patients all over the world. Galapagos is focused on the development and commercialization of novel medicines that will improve peoples lives. The
Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 550 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. More information at www.glpg.com.
Contacts
Investors:
Elizabeth Goodwin
VP IR & Corporate Communications
+1 781 460 1784
Paul van der Horst
Director IR & Business Development
+31 71 750 6707
ir@glpg.com
Media:
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 guidance from management (including guidance regarding the expected operational cash burn during financial year 2017), financial results, timing and/or results of clinical trials, 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 2017 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, 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.
Exhibit 99.2
CONTENTS
Contents
The Galapagos group | ||||
Letter from the management | 4 | |||
At a glance | 7 | |||
Risk factors | 9 | |||
The Galapagos share | 9 | |||
Related party transactions | 10 | |||
Statement of the board of directors | 11 | |||
Disclaimer and other information | 12 | |||
Financial statements |
||||
Consolidated interim financial statements | 15 | |||
Notes |
22 | |||
Auditors report |
||||
Report on the limited review of the consolidated interim financial results | 29 | |||
Other information |
||||
Glossary of terms | 30 | |||
Financial calendar | 42 | |||
Colophon | 42 | |||
Contact | 42 |
2
Galapagos NV H1 Report 2017
The Galapagos group
An overview of
Galapagos, its strategy
and portfolio in H1 2017
David Amantini
Therapeutic Area Head
THE GALAPAGOS GROUP
Letter from the management
Dear shareholders,
The Galapagos team continues to push the limits, with progress across our pipeline in the first half of 2017.
In addition to the Phase 3 programs initiated in rheumatoid arthritis, Crohns disease and ulcerative colitis last year with filgotinib, Gilead started additional Phase 2 studies in small bowel and fistulizing Crohns disease, Sjögrens syndrome, cutaneous lupus erythematosus, and uveitis. Galapagos started Phase 2 studies with filgotinib in psoriatic arthritis and ankylosing spondylitis earlier this year, making filgotinib widely explored in inflammation indications. We expect more studies with filgotinib in new indications to be initiated later this year. We now have nearly 1,900 patient years experience in RA patients, as DARWIN 3 continues; in the first interim readout, presented at EULAR 2017, we reported continued activity with safety in line with the core studies.
In cystic fibrosis, we and AbbVie developed a large portfolio of potentiators and correctors that provides the opportunity to develop distinct triple combination therapies. At our R&D update in June, we reported that Phase 1 results on GLPG2451, GLPG2222 and GLPG2737 showed favorable findings relating to safety and tolerability of the individual components that constitute our current most advanced potential triple combination therapy. These results led us to initiate that triple combination program, including start of the regulatory review process in Europe this month, which we expect to allow for a patient study with 2737 in combination with Orkambi®1 and the first patient study with the triple combination 2451, 2222, and 2737 to start in the fourth quarter. In addition, we announced the plan to start two additional triple combination studies in 2018, potentially enriching our future offering to CF patients. |
But this is only part of what we reported at our R&D update. We received orphan status from the U.S. FDA for our proprietary autotaxin inhibitor GLPG1690, and we expect to report topline results for the FLORA Phase 2a study in IPF patients this quarter. We also plan to report topline results from MOR106 in atopic dermatitis patients later this year. We initiated a Phase 1b patient study in the U.S. with novel osteoarthritis candidate GLPG1972. We also added several pre-clinical candidates, to grow our proprietary pipeline to seven clinical-stage programs today.
In April we raised 364 million gross proceeds in a U.S. public offering. We reported a cash balance of 1,263 million on 30 June 2017, further strengthening our solid financial position to invest in our promising R&D programs. With your continued support, we look forward to keeping you informed on execution of our strategy the rest of this year, on our way to becoming a fully integrated biopharmaceutical company.
Operational overview Q1 2017
We refer to our Q1 2017 report.
Operational overview Q2 2017
Inflammation
| We reported the first interim readout with filgotinib in RA patients in long-term extension study DARWIN 3 at EULAR 2017: continued activity and safety in line with the core studies |
1 | Orkambi® is a registered drug of Vertex Pharmaceuticals |
4
Galapagos NV H1 Report 2017
THE GALAPAGOS GROUP
| Our collaboration partner Gilead initiated new Phase 2 studies with filgotinib in cutaneous lupus erythematosus, uveitis, and Sjögrens syndrome |
| We initiated Phase 2 studies with filgotinib in psoriatic arthritis and ankylosing spondylitis, initiation of the former triggering a $10 million milestone payment from our collaboration partner Gilead |
| We disclosed the target of GLPG1972 to be ADAMTS-5 during OARSI 2017 |
| We dosed the first osteoarthritis patient with GLPG1972 in a Phase 1b study in the U.S. |
| We expect to report topline results with MOR106, a human monoclonal antibody targeting IL-17C, in a Phase 1b trial in atopic dermatitis patients later in 2017 |
| We nominated fully proprietary pre-clinical candidates GLPG3121 and GLPG3312 with undisclosed targets in inflammation |
Cystic fibrosis (CF)
| We reported favorable findings relating to safety and tolerability of C2 corrector GLPG2737 and potentiator GLPG2451 |
| We reported initiation of the first triple combination patient program, starting with regulatory process in July |
| We reported plans to initiate patient studies with two additional triple combinations out of our deep CF candidate portfolio |
Idiopathic pulmonary fibrosis (IPF)
| We received orphan drug status from the U.S. FDA for GLPG1690 in IPF |
| We completed the Phase 2a FLORA study with GLPG1690; we expect results in the third quarter |
| We nominated fully proprietary pre-clinical candidate GLPG3499 in fibrosis, replacing GLPG2938 |
Additional pipeline progress
| We announced plans to initiate a new study with GPR84 inhibitor GLPG1205 in an undisclosed indication later in 2017 |
| We nominated pre-clinical candidate GLPG2384 in an undisclosed indication |
| We nominated pre-clinical candidate GLPG3535 for pain in the alliance with collaboration partner Calchan |
Corporate
| We raised 364 million gross proceeds from a U.S. public offering and 4.7 million from warrant exercises, resulting in the issue of 4,611,600 new shares |
| We received shareholder approval for all proposed resolutions at the 25 April 2017 AGM and EGM |
Recent events
| We announced the appointment of Michele Manto as SVP Commercial Operations |
| On 27 July 2017, Servier announced the inlicensing of GLPG1972, triggering a 6 million license fee payment to Galapagos |
H1 2017 financial result
Revenues and other income
Our revenues and other income for the first six months of 2017 amounted to 73.0 million, compared to 48.8 million in the same period of 2016. Revenues (60.9 million vs 38.8 million for the same period last year) were higher due to increased revenue recognition of upfront payments, which were related to our filgotinib program with Gilead. Other income increased slightly (12.1 million vs 10.0 million for the same period last year), mainly driven by higher income from R&D incentives.
5
Galapagos NV H1 Report 2017
THE GALAPAGOS GROUP
Results
We realized a net loss of 49.2 million for the first six months of 2017, compared to a net profit of 32.2 million in the first six months of 2016. Last years result was primarily driven by a 57.5 million non-cash fair value gain from the re-measurement of the financial asset triggered by the share subscription agreement with Gilead.
We reported an operating loss amounting to 32.9 million for the first half of 2017, compared to an operating loss of 24.3 million for the same period last year.
Our R&D expenses in the first six months of 2017 were 92.9 million, compared to 62.4 million for the first half of 2016. This planned increase was due mainly to an increase of 21.3 million in subcontracting costs for our filgotinib and cystic fibrosis programs. Furthermore, personnel costs increased, explained by a planned headcount increase, as well as higher costs for warrants and bonus plans as a result of the increase of our share price.
Our G&A and S&M expenses were 13.0 million in the first six months of 2017, compared to 10.7 million in the first half of 2016. This increase primarily resulted from higher costs recognized for warrants and bonus plans as a result of the increase of our share price.
Net other financial expenses in the first six months of 2017 amounted to 16.2 million, compared to net other financial expenses of 0.9 million for the same period last year, and were primarily attributable to 17.1 million of unrealized exchange loss on our cash position in U.S. dollar. We expect to use this cash held in U.S. dollar to settle our future payables in U.S. dollar, which will be primarily linked to our global collaboration with Gilead for the development of filgotinib.
Liquid assets position
Cash, cash equivalents and restricted cash totaled 1,263.2 million at 30 June 2017.
A net increase of 288.8 million in cash and cash equivalents was recorded during the first six months of 2017, compared to an increase of 620.2 million during the same period last year. Net cash flows used in operating activities amounted to 51.3 million during the first six months of 2017. Furthermore 4.5 million was generated in investing activities primarily driven by the release of restricted cash to cash and cash equivalents for 6.6 million. Financing activities generated 352.8 million of cash, consisting of 348.1 million proceeds from the U.S. public offering and 4.7 million proceeds from warrant exercises. Finally 17.1 million of unrealized negative exchange rate differences were reported on cash and cash equivalents.
On 30 June 2017, our balance sheet held a receivable from the French government (Crédit dImpôt Recherche2) amounting to 39.6 million, to be received in yearly tranches from 2017 to 2021. Our balance sheet also held a receivable from the Belgian government for R&D incentives amounting to 31.9 million, to be received in yearly tranches from 2018 to 2027.
Outlook 2017
Looking to the second half of the year, we aim to dose the first CF patient with our first triple combination therapy in Q4, and to launch new clinical studies with CF candidates and combinations throughout the half year. Together with our collaboration partner Gilead we plan to start additional proof-of-concept studies with filgotinib. Topline results from the FLORA Phase 2a study with GLPG1690 in IPF (Q3) and from the Phase 1b study with MOR106 in atopic dermatitis patients are expected later this year. We expect to complete recruitment for a Phase 1b study with GLPG1972 in osteoarthritis patients in the U.S. We maintain our guidance for an operational use of cash of 135-155 million during 2017.
We thank you again for your support of Galapagos. We aim to discover and develop more novel medications, bring the successful therapies to the market, and improve patients lives.
Onno van de Stolpe
CEO
2 | Crédit dImpôt Recherche refers to an innovation incentive system underwritten by the French government. |
6
Galapagos NV H1 Report 2017
THE GALAPAGOS GROUP
At a glance
Key figures (IFRS) Galapagos group (unaudited)
(in thousands of , if not stated otherwise) | 30/06/2017 | 30/06/2016 | ||||||
Results |
||||||||
Revenues and other income |
73,031 | 48,764 | ||||||
R&D expenditure |
(92,913 | ) | (62,412 | ) | ||||
S, G&A expenses |
(13,020 | ) | (10,702 | ) | ||||
Personnel expenses (including share-based compensation) |
(33,885 | ) | (25,058 | ) | ||||
Capital expenditure |
2,464 | 2,932 | ||||||
Depreciation and amortization of (in)tangible assets |
(2,144 | ) | (2,001 | ) | ||||
Operating loss |
(32,903 | ) | (24,349 | ) | ||||
Net financial result |
(16,254 | ) | 56,554 | |||||
Taxes |
(92 | ) | 24 | |||||
Net income / loss () |
(49,249 | ) | 32,229 | |||||
|
|
|
|
|||||
Galapagos share |
||||||||
Number of shares issued on 30 June |
50,867,678 | 46,109,508 | ||||||
Basic income / loss () per share (in ) |
(1.03 | ) | 0.71 | |||||
Diluted income / loss () per share (in ) |
(1.03 | ) | 0.69 | |||||
Share price on 30 June (in ) |
66.86 | 49.46 | ||||||
|
|
|
|
|||||
Personnel data |
||||||||
Total group employees on 30 June (number) |
550 | 462 | ||||||
|
|
|
|
Balance sheet
(thousands of ) |
30/06/2017 | 31/12/2016 | ||||||
Total assets |
1,368,355 | 1,083,338 | ||||||
Cash, cash equivalents and restricted cash |
1,263,198 | 980,909 | ||||||
Total liabilities |
299,329 | 324,637 | ||||||
Stockholders equity |
1,069,026 | 758,701 |
7
Galapagos NV H1 Report 2017
THE GALAPAGOS GROUP
Employees per site as of 30 June 2017
8
Galapagos NV H1 Report 2017
THE GALAPAGOS GROUP
Risk factors
We refer to the description of risk factors in the 2016 annual report, pp. 42-50, as supplemented by the description of risk factors in our most recent annual report on Form 20-F filed with the U.S. Securities and Exchange Commission, pp. 5-47. In summary, the principal risks and uncertainties faced by us relate to: product development, regulatory approval and commercialization; our reliance on third parties; our financial position and need for additional capital; our competitive position; our intellectual property; our organization, structure and operation (including but not limited to certain risks related to our status as a U.S. publicly listed company following the public offering of shares (in the form of ADSs) and listing on NASDAQ in May 2015) and market risks relating to our shares and ADSs.
We also refer to the description of the groups financial risk management given in the 2016 annual report, pp. 130-134, which remains valid.
The Galapagos share
Performance of the Galapagos share on Euronext and NASDAQ
9
Galapagos NV H1 Report 2017
THE GALAPAGOS GROUP
Related party transactions
On 6 April 2017, the acceptance of the 150,000 warrants offered on 20 January 2017 to our new Chief Medical Officer, Walid Abi-Saab, under Warrant Plan 2016 (B) was enacted. These warrants have a term of eight years as of the date of the offer. The exercise price of the warrants is 62.50. Each warrant gives the right to subscribe for one new Galapagos share. The warrants vest only and fully on the third anniversary of the notary deed enacting the acceptance of the warrants. The warrants are not transferable and can in principle not be exercised prior to 6 April 2020.
On 17 May 2017, the members of the board of directors and the executive committee were offered new warrants under Warrant Plan 2017, subject to acceptance. As of the date of this report, the acceptance period for Warrant Plan 2017 is still ongoing, so the final number of warrants granted to members of the board of directors and the executive committee cannot be determined yet. Under Warrant Plan 2017, the warrants have an exercise term of eight years as of the date of the offer. The exercise price of the warrants is 80.57. Each warrant gives the right to subscribe for one new Galapagos share. As regards the directors, the warrants vest over a period of 36 months at a rate of 1/36th per month. As regards the other beneficiaries, the warrants vest only and fully on the first day of the fourth calendar year following the calendar year in which the grant was made. The warrants are not transferable and can in principle not be exercised prior to 1 January 2021.
The table below sets forth the number of warrants offered under Warrant Plan 2017 to each member of the board and executive committee in office during the first six months of 2017:
Name |
Title |
Number of 2017 Warrants offered | ||
Onno van de Stolpe |
Chief Executive Officer; Executive director | 100,000 | ||
Raj Parekh |
Non-executive director; Chairman of the board | 15,000 | ||
Werner Cautreels |
Non-executive director | 7,500 | ||
Harrold van Barlingen |
Non-executive director | 7,500 | ||
Howard Rowe |
Non-executive director | 7,500 | ||
Katrine Bosley |
Non-executive director | 7,500 | ||
Christine Mummery |
Non-executive director | 7,500 | ||
Mary Kerr |
Non-executive director | 7,500 | ||
Piet Wigerinck |
Chief Scientific Officer | 60,000 | ||
Bart Filius |
Chief Financial Officer | 60,000 | ||
Andre Hoekema |
Senior Vice President Corporate Development | 60,000 | ||
Walid Abi-Saab |
Chief Medical Officer | 45,000 |
During the first six months of 2017, there were no changes to related party transactions disclosed in the 2016 annual report that potentially had a material impact on the financials of the first six months of 2017.
10
Galapagos NV H1 Report 2017
THE GALAPAGOS GROUP
Statement of the board of directors
The board of directors of Galapagos NV declares that, as far as it is aware, the financial statements in this H1 report are prepared according to the applicable standards for financial statements, and give a true and fair view of the equity, financial position and the results of Galapagos NV and its consolidated companies.
The board of directors of Galapagos NV further declares that this H1 report gives a true and fair view on the important developments and significant transactions with related parties in the period under review and their impact on the interim financial statements, as well as on the most important risks and uncertainties pertaining to the remainder of the current financial year.
On behalf of the board of directors,
Onno van de Stolpe | Raj Parekh | |
CEO | Chairman of the board of directors |
11
Galapagos NV H1 Report 2017
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.
This report is published in Dutch and in English. In case of inconsistencies 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 to the public 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 2017, guidance from management regarding the expected operational use of cash during financial year 2017, statements regarding the development of a potential triple combination therapy for Class II cystic fibrosis patients and the possible activity and clinical utility of such potential triple combination therapy, statements regarding the expected timing, design and readouts of ongoing and planned clinical trials and the potential activity of filgotinib in inflammatory indications, GLPG2222, GLPG2451, GLPG2737, GLPG3067, GLPG2851, GLPG3221, GLPG1837 and of potential triple combinations including any of these compounds for cystic fibrosis, the anticipated timing of clinical studies and the potential activity of GLPG1972 for osteoarthritis, the further development of GLPG1690 and GLPG3499 for idiopathic pulmonary fibrosis, MOR106 and GLPG2534 for atopic dermatitis, GLPG3121 and GLPG3312 in inflammation, GLPG3535, GLPG1205, and GLPG2384. 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,
12
Galapagos NV H1 Report 2017
THE GALAPAGOS GROUP
financial condition and 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, performance or achievements, 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 2017 operating expenses may be incorrect (including because one or more of our assumptions underlying our 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 in rheumatoid arthritis, Crohns disease, cystic fibrosis, idiopathic pulmonary fibrosis, osteoarthritis, and other inflammatory indications 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 cystic fibrosis, AbbVie, and our collaboration partner for osteoarthritis, Servier), 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 Securities and Exchange Commission filing and reports, including in our most recent annual report on Form 20-F filed with the SEC and our subsequent filings and reports filed with the SEC. 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.
13
Galapagos NV H1 Report 2017
Financial Statements
Consolidated interim
financial statements for the
first half-year 2017
Ellen Voorspoels
Senior Development Lead
FINANCIAL STATEMENTS
Consolidated interim financial statements
Consolidated statements of income and comprehensive income
(unaudited)
Consolidated income statement
Six months ended 30 June | ||||||||
(thousands of , except share and per share data) |
2017 | 2016 | ||||||
Revenues |
60,925 | 38,795 | ||||||
Other income |
12,106 | 9,969 | ||||||
|
|
|
|
|||||
Total revenues and other income |
73,031 | 48,764 | ||||||
|
|
|
|
|||||
Research and development expenditure |
(92,913 | ) | (62,412 | ) | ||||
General and administrative expenses |
(11,930 | ) | (9,826 | ) | ||||
Sales and marketing expenses |
(1,090 | ) | (876 | ) | ||||
|
|
|
|
|||||
Total operating expenses |
(105,933 | ) | (73,114 | ) | ||||
|
|
|
|
|||||
Operating loss |
(32,903 | ) | (24,349 | ) | ||||
|
|
|
|
|||||
Fair value re-measurement of share subscription agreement |
| 57,479 | ||||||
Other financial income |
2,319 | 2,081 | ||||||
Other financial expenses |
(18,573 | ) | (3,006 | ) | ||||
|
|
|
|
|||||
Profit / loss () before tax |
(49,157 | ) | 32,205 | |||||
|
|
|
|
|||||
Income taxes |
(92 | ) | 24 | |||||
|
|
|
|
|||||
Net income / loss () |
(49,249 | ) | 32,229 | |||||
|
|
|
|
|||||
Net income / loss () attributable to: |
||||||||
Owners of the parent |
(49,249 | ) | 32,229 | |||||
|
|
|
|
|||||
Basic income / loss () per share |
(1.03 | ) | 0.71 | |||||
|
|
|
|
|||||
Diluted income / loss () per share |
(1.03 | ) | 0.69 | |||||
|
|
|
|
|||||
Weighted average number of shares basic (in thousands of shares) |
48,043 | 45,229 | ||||||
Weighted average number of shares diluted (in thousands of shares) |
49,987 | 46,756 |
15
Galapagos NV H1 Report 2017
FINANCIAL STATEMENTS
Consolidated statements of comprehensive income
Six months ended 30 June | ||||||||
(thousands of ) |
2017 | 2016 | ||||||
Net income / loss () |
(49,249 | ) | 32,229 | |||||
|
|
|
|
|||||
Items that may be reclassified subsequently to profit or loss: |
||||||||
Fair value adjustment of available-for-sale financial assets |
191 | |||||||
Translation differences, arisen from translating foreign activities |
(316 | ) | (573 | ) | ||||
|
|
|
|
|||||
Other comprehensive income, net of income tax |
(125 | ) | (573 | ) | ||||
|
|
|
|
|||||
Total comprehensive income attributable to: |
||||||||
Owners of the parent |
(49,374 | ) | 31,656 |
16
Galapagos NV H1 Report 2017
FINANCIAL STATEMENTS
Consolidated statements of financial position
(unaudited)
30 June | 31 December | |||||||
(thousands of ) |
2017 | 2016 | ||||||
Assets |
||||||||
Intangible assets |
859 | 1,023 | ||||||
Property, plant and equipment |
15,506 | 14,961 | ||||||
Deferred tax assets |
1,957 | 1,957 | ||||||
Non-current R&D incentives receivables |
61,242 | 54,188 | ||||||
Non-current restricted cash |
1,137 | 1,098 | ||||||
Other non-current assets |
2,697 | 2,880 | ||||||
|
|
|
|
|||||
Non-currents assets |
83,398 | 76,107 | ||||||
|
|
|
|
|||||
Inventories |
318 | 300 | ||||||
Trade and other receivables |
5,383 | 9,728 | ||||||
Current R&D incentives receivables |
10,259 | 10,154 | ||||||
Cash and cash equivalents |
1,262,061 | 973,241 | ||||||
Current restricted cash |
| 6,570 | ||||||
Other current assets |
6,936 | 7,239 | ||||||
|
|
|
|
|||||
Current assets |
1,284,957 | 1,007,232 | ||||||
|
|
|
|
|||||
Total assets |
1,368,355 | 1,083,338 | ||||||
|
|
|
|
|||||
Equity and liabilities |
||||||||
Share capital |
233,018 | 223,928 | ||||||
Share premium account |
992,776 | 649,135 | ||||||
Other reserves |
(809 | ) | (1,000 | ) | ||||
Translation differences |
(1,406 | ) | (1,090 | ) | ||||
Accumulated losses |
(154,553 | ) | (112,272 | ) | ||||
|
|
|
|
|||||
Total equity |
1,069,026 | 758,701 | ||||||
|
|
|
|
|||||
Pension liabilities |
3,663 | 3,520 | ||||||
Provisions |
57 | 63 | ||||||
Finance lease liabilities |
| 9 | ||||||
Other non-current liabilities |
1,962 | 2,469 | ||||||
Non-current deferred income |
162,970 | 214,785 | ||||||
|
|
|
|
|||||
Non-current liabilities |
168,652 | 220,846 | ||||||
|
|
|
|
17
Galapagos NV H1 Report 2017
FINANCIAL STATEMENTS
30 June | 31 December | |||||||
(thousands of ) |
2017 | 2016 | ||||||
Finance lease liabilities |
37 | 54 | ||||||
Trade and other payables |
36,686 | 31,269 | ||||||
Current tax payable |
1,018 | 1,022 | ||||||
Accrued charges |
1,044 | 619 | ||||||
Deferred income |
91,893 | 70,827 | ||||||
|
|
|
|
|||||
Current liabilities |
130,678 | 103,791 | ||||||
|
|
|
|
|||||
Total liabilities |
299,329 | 324,637 | ||||||
|
|
|
|
|||||
Total equity and liabilities |
1,368,355 | 1,083,338 | ||||||
|
|
|
|
18
Galapagos NV H1 Report 2017
FINANCIAL STATEMENTS
Consolidated cash flow statements
(unaudited)
Six months ended 30 June | ||||||||
(thousands of ) |
2017 | 2016 | ||||||
Cash and cash equivalents at beginning of year |
973,241 | 340,314 | ||||||
|
|
|
|
|||||
Net income / loss () |
(49,249 | ) | 32,229 | |||||
Adjustments for: |
||||||||
Tax expense / income () |
92 | (24 | ) | |||||
Other net financial expenses |
16,254 | 925 | ||||||
Fair value remeasurement of share subscription agreement |
| (57,479 | ) | |||||
Depreciation of property, plant and equipment |
1,780 | 1,574 | ||||||
Amortization of intangible fixed assets |
364 | 427 | ||||||
Net realized loss on foreign exchange transactions and net other financial expenses paid |
(464 | ) | (294 | ) | ||||
Sharebased compensation |
6,968 | 4,242 | ||||||
Decrease in provisions |
(8 | ) | (5 | ) | ||||
Increase in pension liabilities |
143 | 122 | ||||||
Gain on sale of fixed assets |
(0 | ) | (13 | ) | ||||
|
|
|
|
|||||
Operating cash flows before movements in working capital |
(24,120 | ) | (18,298 | ) | ||||
|
|
|
|
|||||
Increase () / decrease in inventories |
(18 | ) | 3 | |||||
Increase in receivables |
(2,248 | ) | (10,141 | ) | ||||
Increase / decrease () in payables |
5,307 | (8,308 | ) | |||||
Increase / decrease () in deferred income |
(30,752 | ) | 267,037 | |||||
|
|
|
|
|||||
Cash generated / used () in operations |
(51,830 | ) | 230,293 | |||||
|
|
|
|
|||||
Interest paid |
(25 | ) | (25 | ) | ||||
Interest received |
557 | 357 | ||||||
Income taxes paid |
| (443 | ) | |||||
|
|
|
|
|||||
Net cash flows generated / used () in operating activities |
(51,298 | ) | 230,182 | |||||
|
|
|
|
|||||
Purchase of property, plant and equipment |
(2,260 | ) | (2,829 | ) | ||||
Purchase of and expenditure in intangible fixed assets |
(204 | ) | (103 | ) | ||||
Proceeds from disposal of property, plant and equipment |
12 | 16 | ||||||
Increase () / decrease in restricted cash |
6,531 | (110 | ) | |||||
Proceeds from sale of availableforsale financial assets |
372 | | ||||||
|
|
|
|
|||||
Net cash flows generated / used () in investing activities |
4,451 | (3,026 | ) | |||||
|
|
|
|
19
Galapagos NV H1 Report 2017
FINANCIAL STATEMENTS
Six months ended 30 June | ||||||||
(thousands of ) |
2017 | 2016 | ||||||
Repayment of obligations under finance leases and other debts |
(33 | ) | (27 | ) | ||||
Proceeds from capital and share premium increases, net of issue costs |
348,140 | 391,953 | ||||||
Proceeds from capital and share premium increases from exercise of warrants |
4,666 | 2,885 | ||||||
|
|
|
|
|||||
Net cash flows generated in financing activities |
352,773 | 394,811 | ||||||
|
|
|
|
|||||
Effect of exchange rate differences on cash and cash equivalents |
(17,107 | ) | (1,801 | ) | ||||
|
|
|
|
|||||
Increase in cash and cash equivalents |
288,820 | 620,167 | ||||||
|
|
|
|
|||||
Cash and cash equivalents at end of the period |
1,262,061 | 960,481 | ||||||
|
|
|
|
20
Galapagos NV H1 Report 2017
FINANCIAL STATEMENTS
Consolidated statements of changes in equity
(unaudited)
(thousands of ) |
Share capital |
Share premium account |
Translation differences |
Other reserves |
Accumul. losses |
Total | ||||||||||||||||||
On 1 January 2016 |
185,399 | 357,402 | (467 | ) | (18 | ) | (177,317 | ) | 364,999 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Net income |
32,229 | 32,229 | ||||||||||||||||||||||
Other comprehensive income |
(573 | ) | (573 | ) | ||||||||||||||||||||
Total comprehensive income |
(573 | ) | 32,229 | 31,656 | ||||||||||||||||||||
Share-based compensation |
4,242 | 4,242 | ||||||||||||||||||||||
Issue of new shares |
36,575 | 289,696 | 326,271 | |||||||||||||||||||||
Share issue costs |
(255 | ) | (255 | ) | ||||||||||||||||||||
Exercise of warrants |
1,430 | 1,455 | 2,885 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
On 30 June 2016 |
223,149 | 648,553 | (1,039 | ) | (18 | ) | (140,845 | ) | 729,800 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
On 1 January 2017 |
223,928 | 649,135 | (1,090 | ) | (1,000 | ) | (112,272 | ) | 758,701 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Net loss |
(49,249 | ) | (49,249 | ) | ||||||||||||||||||||
Other comprehensive income |
(316 | ) | 191 | (125 | ) | |||||||||||||||||||
Total comprehensive income |
(316 | ) | 191 | (49,249 | ) | (49,374 | ) | |||||||||||||||||
Share-based compensation |
6,968 | 6,968 | ||||||||||||||||||||||
Issue of new shares |
23,331 | 340,593 | 363,924 | |||||||||||||||||||||
Share issue costs |
(15,859 | ) | (15,859 | ) | ||||||||||||||||||||
Exercise of warrants |
1,618 | 3,048 | 4,666 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
On 30 June 2017 |
233,018 | 992,776 | (1,406 | ) | (809 | ) | (154,553 | ) | 1,069,026 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
21
Galapagos NV H1 Report 2017
FINANCIAL STATEMENTS
Notes
Basis of preparation
These condensed interim financial statements have been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union. The condensed interim financial statements do not contain all information required for an annual report and should therefore be read in conjunction with Galapagos 2016 annual report.
The condensed interim financial statements were subject to a limited review by the statutory auditor, but have not been audited.
Details of the unaudited interim results
Revenues and other income
Revenues
The following table summarizes our revenues for the six months ended 30 June 2017 and 2016.
Six months ended 30 June | ||||||||
(thousands of ) |
2017 | 2016 | ||||||
Recognition of non-refundable upfront payments |
30,952 | 9,829 | ||||||
Milestone payments |
25,920 | 17,586 | ||||||
Reimbursement income |
107 | 8,029 | ||||||
Other revenues |
3,945 | 3,351 | ||||||
|
|
|
|
|||||
Total revenues |
60,925 | 38,795 | ||||||
|
|
|
|
Revenues (60.9 million vs 38.8 million for the same period last year) were higher due to increased revenue recognition of the upfront payment from Gilead related to the filgotinib program, which is recognized in function of the costs incurred.
The following table summarizes the upfront payments revenue recognition for the six months ended 30 June 2017 and 2016.
Agreement |
Upfront received |
Upfront received |
Date of receipt | Revenue recognized, six months ended 30 June 2017 |
Revenue recognized, six months ended 30 June 2016 |
Outstanding balance in deferred income as at 30 June 2017 |
||||||||||||||||||
(thousands of $) | (thousands of ) | (thousands of ) | ||||||||||||||||||||||
Gilead collaboration agreement for filgotinib |
300,000 | 275,558 | January 2016 | 27,114 | 7,726 | 222,823 | ||||||||||||||||||
Gilead collaboration agreement for filgotinib |
N.A. | 39,003 | (*) | January 2016 | 3,838 | 1,094 | 31,539 | |||||||||||||||||
ThromboGenics license agreement for integrin antagonists |
N.A. | 1,000 | April 2016 | 1,000 | ||||||||||||||||||||
Sirion Biotech license agreement for RNA interference (RNAi) technologies |
N.A. | 10 | June 2016 | 10 | ||||||||||||||||||||
|
|
|
|
|
|
|||||||||||||||||||
Total recognition of non-refundable upfront payments |
30,952 | 9,829 | 254,362 | |||||||||||||||||||||
|
|
|
|
|
|
(*) | deferred income of 39 million recognized upon signing of the share subscription agreement with Gilead as required under IAS 39. |
22
Galapagos NV H1 Report 2017
FINANCIAL STATEMENTS
For the first six months of 2017, 31.0 million of deferred income related to the Gilead collaboration agreement were recognized in revenue in function of costs incurred, applying the percentage of completion method. This revenue recognition consisted of 27.1 million related to the upfront license fee and 3.8 million related to the deferred income triggered by the accounting treatment of the share subscription agreement with Gilead under IAS 39. The outstanding balance of deferred income from the Gilead collaboration agreement at the end of June 2017 amounted to 254.4 million, of which 163.0 million reported as non-current deferred income.
Other income
The following table summarizes our other income for the six months ended 30 June 2017 and 2016.
Six months ended 30 June | ||||||||
(thousands of ) |
2017 | 2016 | ||||||
Grant income |
424 | 928 | ||||||
Other income |
11,682 | 9,041 | ||||||
|
|
|
|
|||||
Total other income |
12,106 | 9,969 | ||||||
|
|
|
|
Other income increased slightly (12.1 million vs 10.0 million last year) in the first six months of 2017, mainly driven by higher income from R&D incentives.
Results
We realized a net loss of 49.2 million for the first six months of 2017, compared to a net profit of 32.2 million in the first six months of 2016. Last years result was primarily driven by 57.5 million non-cash fair value gain from the re-measurement of the financial asset triggered by the share subscription agreement with Gilead.
We reported an operating loss amounting to 32.9 million for the first six months of 2017, compared to an operating loss of 24.3 million for the same period last year.
Our R&D expenses in the first six months of 2017 were 92.9 million, compared to 62.4 million for the same period in 2016. This planned increase was due mainly to an increase of 21.3 million in subcontracting costs for our filgotinib and cystic fibrosis programs. Furthermore, personnel costs increased, explained by a planned increase in headcount, as well as higher costs for warrants and bonus plans as a result of the increase of our share price.
Our G&A and S&M expenses were 13.0 million in the first half of 2017, compared to 10.7 million in the first half- year of 2016. This increase mainly resulted from higher costs recognized in relation to the warrants and bonus plans as a result of the increase of the Galapagos share price, as well as a planned slight headcount increase.
Net other financial expenses in the first six months of 2017 amounted to 16.2 million, compared to net other financial expenses of 0.9 million for the same period in 2016, and were primarily attributable to 17.1 million of unrealized exchange loss on our cash position in U.S. dollar as a consequence of the fluctuation of the U.S. dollar exchange rate in the first half-year of 2017. We expect to use this cash held in U.S. dollar to settle our future payables in U.S. dollar, which will be primarily linked to our global collaboration with Gilead for the development of filgotinib.
Financial results in 2016 were primarily driven by the fair value re-measurement of the share subscription agreement.
23
Galapagos NV H1 Report 2017
FINANCIAL STATEMENTS
Segment information
Segment information for the six months ended 30 June 2017 | ||||||||||||||||
(thousands of ) |
R&D | Fee-for-services | Inter-segment elimination |
Group | ||||||||||||
External revenue |
57,048 | 3,877 | 60,925 | |||||||||||||
Internal revenue |
2,475 | (2,475 | ) | |||||||||||||
Other income |
12,094 | 12 | 12,106 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Revenues & other income |
69,142 | 6,364 | (2,475 | ) | 73,031 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Segment result |
(25,424 | ) | (510 | ) | (25,935 | ) | ||||||||||
|
|
|
|
|
|
|||||||||||
Unallocated expenses(1) |
(6,968 | ) | ||||||||||||||
|
|
|||||||||||||||
Operating loss |
(32,903 | ) | ||||||||||||||
|
|
|||||||||||||||
Financial (expenses) / income |
(16,254 | ) | ||||||||||||||
|
|
|||||||||||||||
Result before tax |
(49,157 | ) | ||||||||||||||
|
|
|||||||||||||||
Income taxes |
(92 | ) | ||||||||||||||
|
|
|||||||||||||||
Net loss |
(49,249 | ) | ||||||||||||||
|
|
(1) | Unallocated expenses consist of expenses for warrant plans under IFRS 2. |
Segment information for the six months ended 30 June 2016 | ||||||||||||||||
(thousands of ) |
R&D | Fee-for-services | Inter-segment elimination |
Group | ||||||||||||
External revenue |
35,490 | 3,305 | 38,795 | |||||||||||||
Internal revenue |
2,656 | (2,656 | ) | |||||||||||||
Other income |
9,849 | 120 | 9,969 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Revenues & other income |
45,339 | 6,081 | (2,656 | ) | 48,764 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Segment result |
(19,315 | ) | (792 | ) | (20,107 | ) | ||||||||||
|
|
|
|
|
|
|||||||||||
Unallocated expenses(1) |
(4,242 | ) | ||||||||||||||
|
|
|||||||||||||||
Operating loss |
(24,349 | ) | ||||||||||||||
|
|
|||||||||||||||
Financial (expenses) / income |
56,554 | |||||||||||||||
|
|
|||||||||||||||
Result before tax |
32,205 | |||||||||||||||
|
|
|||||||||||||||
Income taxes |
24 | |||||||||||||||
|
|
|||||||||||||||
Net income |
32,229 | |||||||||||||||
|
|
(1) | Unallocated expenses consist of expenses for warrant plans under IFRS 2. |
The basis of accounting for any transactions between reportable segments is consistent with the valuation rules and with transactions with third parties.
Liquid assets position
Cash, cash equivalents and restricted cash totaled 1,263.2 million at 30 June 2017.
A net increase of 288.8 million in cash and cash equivalents was recorded during the first six months of 2017, compared to an increase of 620.2 million during the same period last year. Net cash used in operating activities amounted to 51.3 million in the first half-year of 2017. Furthermore, 4.5 million was generated in investing activities primarily driven by the release of restricted cash to cash and cash equivalents for 6.6 million.
24
Galapagos NV H1 Report 2017
FINANCIAL STATEMENTS
Financing activities generated 352.8 million of cash, consisting of 348.1 million proceeds from the U.S. public offering and 4.7 million proceeds from warrant exercises. Finally 17.1 million of negative unrealized exchange rate differences were reported on cash and cash equivalents.
Restricted cash amounted to 7.7 million at the end of December 2016, and decreased by 6.6 million to 1.1 million at the end of June 2017. This decrease was explained by the full release of the escrow account containing the remaining 6.6 million of proceeds from the sale of the service division to Charles River Laboratories International, Inc. in 2014, as final agreement between the parties was reached.
On 30 June 2017, restricted cash was composed of 0.5 million and 0.7 million bank guarantees on real estate lease obligations in Belgium and in the Netherlands, respectively.
Cash and cash equivalents amounted to 1,262.1 million at the end of June 2017 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 832.5 million of term deposits with an original maturity longer than three months but which are available upon one month notice period. Cash at banks were mainly composed of savings accounts and current accounts. We maintain our bank deposits in highly rated financial institutions to reduce credit risk. Cash invested in highly liquid money market funds represented 149.9 million and aim at meeting short-term cash commitments, while reducing the counterparty risk of investment.
30 June | 31 December | |||||||
(thousands of ) |
2017 | 2016 | ||||||
Cash at banks |
279,620 | 357,630 | ||||||
Term deposits |
832,549 | 515,632 | ||||||
Money market funds |
149,889 | 99,977 | ||||||
Cash on hand |
2 | 2 | ||||||
|
|
|
|
|||||
Total cash and cash equivalents |
1,262,061 | 973,241 | ||||||
|
|
|
|
On 30 June 2017, our cash and cash equivalents included $261.2 million held in U.S. dollar, which could generate unrealized exchange gain or loss in our financial results in accordance with the fluctuation of the EUR/U.S. dollar exchange rate as our functional currency is EUR. We expect to use this cash held in U.S. dollar to settle our future payables in U.S. dollar, which will be primarily linked to our global collaboration with Gilead for the development of filgotinib.
Furthermore, our balance sheet held R&D incentives receivables from the French government (Crédit dImpôt Recherche3) amounting to 39.6 million as of 30 June 2017, to be received in yearly tranches from 2017 to 2021. Our balance sheet also held R&D incentives receivables from the Belgian government amounting to 31.9 million as of 30 June 2017, to be received in yearly tranches from 2018 until 2027.
Capital increase
On 6 April 2017, 247,070 warrants were exercised at various exercise prices (with an average exercise price of 16.33 per warrant) resulting in a share capital increase (including issuance premium) of 4.0 million and the issuance of 247,070 new shares. The closing price of the Galapagos share on that date was 84.60.
3 | Crédit dImpôt Recherche refers to an innovation incentive system underwritten by the French government. |
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Galapagos NV H1 Report 2017
FINANCIAL STATEMENTS
On 21 April 2017 our U.S. public offering of 4,312,500 American Depositary Shares (ADSs) was fully underwritten, at a price of $90.00 per ADS, before underwriting discounts, for gross proceeds of 363.9 million. Underwriting discounts and offering expenses amount to 15.9 million, of which 15.8 million had been paid at 30 June 2017 and 0.1 million remains to be settled in cash. As such, net proceeds amount to 348.1 million.
On 20 June 2017, 52,030 warrants were exercised at various exercise prices (with an average exercise price of 12.14 per warrant) resulting in a share capital increase (including issuance premium) of 0.6 million and the issuance of 52,030 new shares. The closing price of the Galapagos share on that date was 70.66.
On 30 June 2017, Galapagos NVs share capital was represented by 50,867,678 shares. All shares were issued, fully paid up and of the same class.
(thousands of , except share data) |
Number of shares |
Share capital |
Share premium |
Share capital and share premium |
||||||||||||
On 1 January 2017 |
46,256,078 | 223,928 | 649,135 | 873,063 | ||||||||||||
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|
|
|
|
|
|
|
|||||||||
6 April 2017: exercise of warrants |
247,070 | 1,337 | 2,697 | 4,034 | ||||||||||||
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|
|
|
|
|
|
|
|||||||||
21 April 2017: U.S. public offering |
||||||||||||||||
ADSs (fully paid) |
4,312,500 | 23,331 | 340,593 | 363,924 | ||||||||||||
Underwriter discounts and offering expenses (paid) |
(15,784 | ) | (15,784 | ) | ||||||||||||
Offering expenses still to be paid at 30 June 2017 |
(75 | ) | (75 | ) | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total U.S. public offering |
4,312,500 | 7,472 | 340,593 | 348,065 | ||||||||||||
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|
|
|
|
|
|
|
|||||||||
20 June 2017: exercise of warrants |
52,030 | 281 | 350 | 632 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
On 30 June 2017 |
50,867,678 | 233,018 | 992,776 | 1,225,794 | ||||||||||||
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|
|
|
|
|
|
|
Contingencies and commitments
Contractual obligations and commitments
We entered into lease agreements for offices and laboratories which qualify as operating leases. We also have certain purchase commitments, principally with CRO subcontractors.
On 30 June 2017, we had outstanding obligations for future minimum rent payments and purchase commitments, which become due as follows:
(thousands of ) |
Total | Less than 1 year |
13 years | 35 years | More than 5 years |
|||||||||||||||
Operating lease obligations |
28,176 | 4,156 | 7,893 | 6,307 | 9,820 | |||||||||||||||
Purchase commitments |
41,310 | 36,479 | 4,780 | 50 | | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total contractual obligations & commitments |
69,486 | 40,635 | 12,674 | 6,358 | 9,820 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
26
Galapagos NV H1 Report 2017
FINANCIAL STATEMENTS
On 31 December 2016, we had outstanding obligations for future minimum rent payments and purchase commitments, which become due as follows:
(thousands of ) |
Total | Less than 1 year |
13 years | 35 years | More than 5 years |
|||||||||||||||
Operating lease obligations |
27,263 | 4,114 | 6,494 | 5,504 | 11,151 | |||||||||||||||
Purchase commitments |
27,579 | 27,084 | 495 | | | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total contractual obligations & commitments |
54,842 | 31,198 | 6,989 | 5,504 | 11,151 | |||||||||||||||
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|
|
|
|
|
|
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|
|
Contingent liabilities and assets
On 13 March 2014, we announced the signing of a definitive agreement to sell the service division operations to Charles River Laboratories International, Inc., or CRL, for a total consideration of up to 134 million. CRL agreed to pay us an immediate cash consideration of 129 million. The potential earn-out of 5 million due upon achievement of a revenue target 12 months after transaction closing has not been obtained. Approximately 5% of the total consideration, including price adjustments, was being held on an escrow account. Four claims were introduced by CRL, which all have been settled for a total amount of 1.3 million. In the first half-year of 2017, the remaining balance of the escrow account of 6.6 million was released in full, as final agreement between the parties was reached.
Following the divestment, we remained guarantor until early February 2017 in respect of lease obligations for certain U.K. premises. Finally, following common practice, we gave representations and warranties which are capped and limited in time (since 1 April 2016, CRL can only introduce a claim under the Tax Deed (during a period of 5 years)), and other claims related to the sale cannot be submitted anymore).
In the course of 2008, a former director of one of the subsidiaries sued for wrongful termination and seeks damages of 1.5 million. We believe that the amount of damages claimed is unrealistically high. In 2014, the court requested an external advisor to evaluate the exact amount of damages. On 29 January 2016, the court made a 1st degree judgment, dismissing all claims in full. In appeal, the 2nd degree court instructed the 1st degree court to conduct a new trial, which is currently pending. A first hearing, initially scheduled on 12 July 2017, was postponed to an undefined date. Considering the defense elements provided, as well as the fact that so far the court has made no decision indicating that the claim would be sustained, our board and management evaluated the risk to be remote to possible, but not likely. Accordingly, it was decided not to record any provision, as the exposure was considered to be limited.
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 financial statements of 2016, except for the adoption of new standards and interpretations described below.
New standards and interpretations applicable for the annual period beginning on 1 January 2017
| Amendments to IAS 12 Recognition of Deferred Tax Assets for Unrealized Losses |
| Amendments to IAS 7 Disclosure Initiative |
| Annual Improvements to IFRS Standards 2014-2016 Cycle Amendments to IFRS 12 |
The nature and the effect of these changes were taken into consideration, but the above amendments did not affect the interim condensed consolidated financial statements. We have not early adopted any other standard, interpretation, or amendment that has been issued but is not yet effective.
The assessment of the impact of IFRS 15 Revenue from Contracts with Customers (applicable for annual periods beginning on or after 1 January 2018) is still ongoing as the company assesses all contracts, performance obligations and allocation of revenues. The company plans to adopt IFRS 15 on its effective date.
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Galapagos NV H1 Report 2017
FINANCIAL STATEMENTS
We are currently evaluating the guidance to determine the impact of IFRS 16 Leases (applicable for annual periods beginning on or after 1 January 2019). We plan to adopt IFRS 16 on its effective date.
Seasonality
The impact of seasonality or cyclicality on our operations is not regarded as applicable to the unaudited interim condensed consolidated financial statements.
Events after the end of the reporting period
On 27 July 2017, Servier announced the inlicensing of GLPG1972, triggering a 6 million license fee payment to Galapagos.
Approval of interim financial statements
The interim financial statements were approved by the board of directors on 24 July 2017.
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Galapagos NV H1 Report 2017
AUDITORS REPORT
Report on review of the consolidated interim financial information for the six-month period ended 30 June 2017
In the context of our appointment as the companys statutory auditor, we report to you on the consolidated interim financial information. This consolidated interim financial information comprises the consolidated statement of financial position as at 30 June 2017, the consolidated statement of income and comprehensive income, the consolidated cash flow statement and the consolidated statement of changes in equity for the period of six months then ended, as well as selective notes.
Report on the consolidated interim financial information
We have reviewed the consolidated interim financial information of Galapagos NV (the company) and its subsidiaries (jointly the group), prepared in accordance with International Financial Reporting Standard IAS 34 Interim Financial Reporting as adopted by the European Union.
The consolidated condensed statement of financial position shows total assets of 1 368 355 (000) EUR and the consolidated condensed income statement shows a consolidated loss for the period then ended of 49 249 (000) EUR.
The board of directors of the company is responsible for the preparation and fair presentation of the consolidated interim financial information in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union. Our responsibility is to express a conclusion on this consolidated interim financial information based on our review.
Scope of review
We conducted our review of the consolidated interim financial information in accordance with International Standard on Review Engagements (ISRE) 2410 Review of interim financial information performed by the independent auditor of the entity. A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit performed in accordance with the International Standards on Auditing (ISA) and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion on the consolidated interim financial information.
Conclusion
Based on our review, nothing has come to our attention that causes us to believe that the consolidated interim financial information of Galapagos NV has not been prepared, in all material respects, in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union.
Zaventem, 24 July 2017
The statutory auditor
DELOITTE Bedrijfsrevisoren / Réviseurs dEntreprises
BV o.v.v.e. CVBA / SC s.f.d. SCRL
Represented by Gert Vanhees
The original text of this report is in Dutch.
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Galapagos NV H1 Report 2017
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 Crohns disease 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)
ADR
American Depositary Receipt; Galapagos has a Level 3 ADR listed on NASDAQ with ticker symbol GLPG and CUSIP number 36315X101. One ADR is equivalent to one ordinary share in Galapagos NV
AFM
Dutch Authority for the Financial Markets
Anemia
Condition in which there are 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
Atherogenic index
Total cholesterol over HDL ratio. Improvement of the atherogenic index may be a forecast of cardiovascular health
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
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Galapagos NV H1 Report 2017
OTHER INFORMATION
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 signalling molecule lypophosphatidic acid (LPA). GLPG1690 targets autotaxin for IPF
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 candidate drug 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 mouse model
A pre-clinical model involving use of bleomycin (a cancer medication) to induce IPF symptoms
Candidate drug
Substance that has satisfied the requirements of early pre-clinical testing and has been selected for development, starting with formal pre-clinical safety evaluation followed by clinical testing for the treatment of a certain disorder in humans
CDAI
Crohns Disease Activity Index, evaluating patients on 8 different factors, each of which has a pre-defined weight as a way to quantify the impact of Crohns disease
CFTR
Cystic Fibrosis Transmembrane conductance Regulator protein. CFTR is an ion channel that transports chloride and thiocyanate ions across epithelial cell membranes. Mutations in the CFTR gene, that codes for the CFTR protein, cause cystic fibrosis
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Galapagos NV H1 Report 2017
OTHER INFORMATION
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
Class II mutation
A genetic mutation in cystic fibrosis resulting in errors in CFTR folding, transport of functional CFTR to the cell membrane, and CFTR channel opening, whereby chloride ion flow at the cell surface in the membrane of affected organs is impacted negatively. More than 90% of cystic fibrosis patients are carriers of the Class II mutation. It is believed that a potentiator and multiple correctors will be needed to address the CFTR malfunction of Class II mutation patients. Orkambi is the only approved disease-modifying therapy for Class II mutation patients today
Class III mutation
A genetic mutation in cystic fibrosis resulting in errors in CFTR channel opening, whereby chloride ion flow at the cell surface in the membrane of affected organs is impacted negatively. Approximately 4% of cystic fibrosis patients are carriers of the Class III mutation. It is believed that a potentiator is needed to address the malfunction of Class III mutation patients. Kalydeco is the only approved disease-modifying therapy for Class III mutation patients today
Clinical Proof of Concept (PoC)
Point in the drug development process where the candidate drug shows efficacy in a therapeutic setting
Compound
A chemical substance, often a small molecule with drug-like properties
Contract research organization
Organization which provides drug discovery and development services
Corrector drug
Drug that restores the correct protein formation in cystic fibrosis patients. In most CF patients, a potentiator and corrector drug are needed in combination to restore the channel function of the CFTR. Galapagos and AbbVie are planning to combine a potentiator with two correctors to investigate in CF patients with the most prevalent mutation of CFTR
Crohns disease (CD)
An inflammatory bowel disease 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 erythematosus (CLE)
Lupus is an autoimmune disease affecting multiple organs and systems in the body, resulting in a wide variety of signs and symptoms. CLE is a form of lupus in the skin which can be triggered or exacerbated by exposure to sunlight
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Galapagos NV H1 Report 2017
OTHER INFORMATION
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
DARWIN
Phase 2 program for filgotinib in rheumatoid arthritis: completed and reported in 2015 (except for the currently still ongoing DARWIN 3 study). DARWIN 1 explored three doses, in bid and qd 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 qd 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 c-reactive protein the score calculation: scores range from 2.0 to 10.0, with scores below 2.6 being considered remission
Development
All activities required to bring a new drug to the market. This includes pre-clinical and clinical development research, chemical and pharmaceutical development and regulatory filings of drug 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 pre-clinical candidates
Disease-modifying
Addresses the cause of disease and modifying the disease progression, not just the symptoms of the disease
DIVERSITY
Phase 3 program evaluating filgotinib in Crohns disease
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
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Galapagos NV H1 Report 2017
OTHER INFORMATION
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
Esbriet
An approved drug (pirfenidone) for IPF, marketed by Roche
FDA
The U.S. Food and Drug Administration is an agency responsible for protecting and promoting public health and in charge of American market authorization of new medication
Fee-for-service
Payment system where the service provider is paid a specific amount for each procedure or service performed
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 candidate drug
Filgotinib
Formerly known as GLPG0634. Small molecule selective JAK1 inhibitor which showed promising safety and activity profile in RA and Crohns disease 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. Gilead initiated Phase 2 studies with filgotinib in small bowel Crohns disease, fistulizing Crohns disease, Sjögrens syndrome, cutaneous lupus erythematosus, uveitis; Galapagos initiated Phase 2 studies with filgotinib in ankylosing spondylitis and psoriatic arthritis. We expect to initiate more Phase 2 trials with filgotinib in new indications in the course of 2017. Filgotinib is an investigational drug and its efficacy and safety have not been established
FINCH
Phase 3 program evaluating filgotinib in RA
Fistulizing Crohns disease
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.
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Galapagos NV H1 Report 2017
OTHER INFORMATION
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 are expected in Q3 2017
FSMA
The Belgian market authority: Financial Services and Markets Authority, or Autoriteit voor Financiële Diensten en Markten
FTE
Fulltime equivalent; a way to measure a workers 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
GLPG0634
Molecule number currently known as filgotinib
GLPG1205
A GPR84 inhibitor fully proprietary to us. We plan to initiate a patient study with GLPG1205 in an undisclosed indication in 2017
GLPG1690
A novel product candidate targeting autotaxin, with potential application in idiopathic pulmonary fibrosis. Fully proprietary to us. Testing in Phase 2 proof-of-concept FLORA study in IPF is completed, with topline results expected in Q3 2017
GLPG1837
A potentiator product candidate which showed activity and favorable safety in the SAPHIRA 1 and 2 trials in Phase 2 in Class III CF mutation patients
GLPG1972
A novel mode-of-action product candidate that is part of the OA alliance with Servier. GLPG1972 was well- tolerated and showed no emerging safety signals in a Phase 1 trial with healthy volunteers. In addition, GLPG1972 showed up to 60% reduction in a relevant OA biomarker within 14 days in these volunteers. We initiated a Phase 1b trial with GLPG1972 in OA patients in the U.S. in June 2017
GLPG2222
A C1 (early) corrector product candidate which showed favorable safety in Phase 1 and is currently being tested in the ALBATROSS Phase 2 study in combination with Kalydeco in Class III mutation patients and in the FLAMINGO Phase 2 study in Class II mutation patients. In June 2017 we announced that the study of GLPG2222 with GLPG2451 in healthy volunteers was successfully completed. GLPG2222 is expected to be combined with a potentiator and C2 (late) corrector in future triple combination therapies
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Galapagos NV H1 Report 2017
OTHER INFORMATION
GLPG2384
A pre-clinical candidate molecule targeting GPR84. The indication for GLPG2384 remains undisclosed
GLPG2451
A potentiator product candidate currently undergoing a Phase 1 safety trial. In June 2017 we announced that the study of GLPG2222 with GLPG2451 in healthy volunteers was successfully completed. GLPG2451 is expected to be combined with a C1 (early) corrector and C2 (late) corrector in future triple combination therapies
GLPG2534
A pre-clinical candidate with novel mode of action with potential application in AtD
GLPG2737
A C2 (late) corrector product candidate currently in a Phase 1 safety trial. In June 2017 we announced the successful completion of Phase 1 trials with GLPG2737. GLPG2737 is expected to be combined with a potentiator and a C1 (early) corrector in future triple combination therapies
GLPG2851
A C1 (early) corrector product candidate currently at the pre-clinical stage
GLPG2938
A pre-clinical candidate with novel mode of action with potential application in IPF
GLPG3067
A potentiator drug candidate. GLPG3067 started a Phase 1 trial in March 2017
GLPG3121
A pre-clinical candidate with undisclosed novel mode of action directed toward inflammation
GLPG3221
A C2 (late) corrector drug candidate currently at the pre-clinical stage
GLPG3312
A pre-clinical candidate with undisclosed mode of action directed toward inflammation
GLPG3499
A pre-clinical candidate with undisclosed mode of action, replaces GLPG2938 in the IPF program
GLPG3535
A pre-clinical candidate with undisclosed mode of action directed toward pain in the alliance with Calchan
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
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Galapagos NV H1 Report 2017
OTHER INFORMATION
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
Heterozygous
Genetic term meaning a cell containing different alleles for a gene
Histopathology
Microscopic examination of tissues for manifestations of a disease
Homozygous
Genetic term meaning identical alleles of the gene are present on both homologous chromosomes
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
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
Intellectual property
Creations of the mind that have commercial value and are protected by patents, trademarks or copyrights
Intersegment
Occurring between the different operations of a company
Investigational New Drug (IND) application
U.S. 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
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Galapagos NV H1 Report 2017
OTHER INFORMATION
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
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 rheumatoid arthritis. Filgotinib is a selective JAK1 inhibitor
Kalydeco
A potentiator drug marketed by Vertex Pharmaceuticals
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, or LPA, is a signaling molecule involved in fibrosis
Lymphocyte
Type of white blood cell that is part of the immune system
Milestone
Major achievement in a project or program; in Galapagos 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 being evaluated in AtD patients in a Phase 1b trial. MOR106 acts on IL-17C, a novel antibody target discovered by Galapagos. MOR106 is part of the alliance with MorphoSys
MTX
Methotrexate; a first-line therapy for inflammatory diseases
NDA
New Drug Application
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Galapagos NV H1 Report 2017
OTHER INFORMATION
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
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
Orkambi
A combination potentiator-corrector therapy marketed by Vertex Pharmaceuticals
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
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
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Galapagos NV H1 Report 2017
OTHER INFORMATION
Placebo-controlled
A substance having no pharmacological effect but administered as a control in testing of a biologically active preparation
Potentiator drug
Drug that restores the CFTR ion channel opening in CF patients. In most CF patients, a potentiator and corrector drug are needed in combination to restore the genetic defect causing CF. Galapagos and AbbVie are planning to combine a potentiator with two correctors to investigate CF patients with the most prevalent mutation of CFTR
Pre-clinical
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
Pre-clinical candidate (PCC)
A new molecule and potential drug that meets chemical and biological criteria to begin the development process
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
Psoriatic arthritis is an inflammatory form of arthritis, affecting up to 30 percent of psoriasis patients.
QD dosing
Once daily dosing (quaque die)
R&D operations
Research and development operations; unit responsible for discovery and developing new candidate drugs for internal pipeline or as part of risk/reward sharing alliances with collaboration partners
Rheumatoid arthritis (RA)
A chronic, systemic inflammatory disease that causes joint inflammation, and usually leads to cartilage destruction, bone erosion and disability
SAPHIRA
A Phase 2 trial of potentiator GLPG1837 in cystic fibrosis patients carrying a Class III mutation. Results were reported in 2016, showing activity and favorable safety in two Class III mutations
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OTHER INFORMATION
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 2/3 program evaluating filgotinib in UC patients
Service operations
Business unit primarily focused on delivering products and conducting fee-for-service work for clients. Galapagos 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 Crohns Disease, involving review of 5 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.
Small bowel CD
Crohns disease causes chronic inflammation and erosion of the intestines. It can affect different regions of GI 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 (SB), particularly the ileum, is common
Target
Protein that has been shown to be involved in a disease process and forms the basis of therapeutic intervention or drug discovery
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)
Ulcerative colitis (UC)
UC is an inflammatory bowel disease (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
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