Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2017 | Aug. 03, 2017 | |
Document and Entity Information | ||
Entity Registrant Name | uniQure N.V. | |
Entity Central Index Key | 1,590,560 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2017 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 25,629,099 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q2 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Current assets | ||
Cash and cash equivalents | $ 104,087 | $ 132,496 |
Accounts receivable and accrued income | 4,190 | 3,680 |
Accounts receivable and accrued income from related party | 1,627 | 5,500 |
Prepaid expenses | 889 | 996 |
Other current assets | 632 | 1,274 |
Total current assets | 111,425 | 143,946 |
Non-current assets | ||
Property, plant and equipment, net | 35,410 | 35,702 |
Intangible assets, net | 8,746 | 8,324 |
Goodwill | 505 | 465 |
Other non-current assets | 1,879 | 1,828 |
Total non-current assets | 46,540 | 46,319 |
Total assets | 157,965 | 190,265 |
Current liabilities | ||
Accounts payable | 3,458 | 5,524 |
Accrued expenses and other current liabilities | 9,440 | 9,766 |
Current portion of long-term debt | 4,319 | 605 |
Current portion of deferred rent | 710 | 684 |
Current portion of deferred revenue | 5,203 | 6,142 |
Total current liabilities | 23,130 | 22,721 |
Non-current liabilities | ||
Long-term debt, net of current portion | 16,153 | 19,631 |
Deferred rent, net of current portion | 8,494 | 6,781 |
Deferred revenue, net of current portion | 78,728 | 75,612 |
Contingent consideration | 2,415 | 1,838 |
Other non-current liabilities | 1,759 | 51 |
Total non-current liabilities | 107,549 | 103,913 |
Total liabilities | 130,679 | 126,634 |
Commitments and contingencies (See Note 13) | ||
Shareholders' equity | ||
Common shares, €0.05 par value: 60,000,000 shares authorized at June 30, 2017 and December 31, 2016 and 25,620,073 and 25,257,420 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively. | 1,612 | 1,593 |
Additional paid-in-capital | 469,104 | 464,653 |
Accumulated other comprehensive loss | (5,831) | (6,557) |
Accumulated deficit | (437,599) | (396,058) |
Total shareholders' equity | 27,286 | 63,631 |
Total liabilities and shareholders' equity | $ 157,965 | $ 190,265 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - € / shares | Jun. 30, 2017 | Dec. 31, 2016 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Common shares, par value (in euros per share) | € 0.05 | € 0.05 |
Common shares, authorized shares | 60,000,000 | 60,000,000 |
Common shares, issued shares | 25,620,073 | 25,257,420 |
Common shares, outstanding shares | 25,620,073 | 25,257,420 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||
License revenues | $ (226) | $ 250 | $ 8 | $ 491 |
License revenues from related party | 987 | 1,006 | 1,936 | 1,984 |
Collaboration revenues | 3,058 | 1,558 | 4,638 | 2,984 |
Collaboration revenues from related party | 1,123 | 1,637 | 1,681 | 3,287 |
Total revenues | 4,942 | 4,451 | 8,263 | 8,746 |
Operating expenses: | ||||
Research and development expenses | (16,866) | (19,221) | (33,860) | (35,927) |
Selling, general and administrative expenses | (5,410) | (7,834) | (11,768) | (15,132) |
Total operating expenses | (22,276) | (27,055) | (45,628) | (51,059) |
Other income | 266 | 475 | 582 | 920 |
Other expense | (2,640) | (2,640) | ||
Loss from operations | (19,708) | (22,129) | (39,423) | (41,393) |
Interest income | 12 | 15 | 23 | 37 |
Interest expense | (502) | (549) | (1,006) | (1,178) |
Foreign currency gains / (losses), net | (1,071) | 920 | (1,164) | (1,268) |
Other non-operating income, net | 330 | 29 | 647 | |
Loss before income tax expense | (21,269) | (21,413) | (41,541) | (43,155) |
Income tax benefit / (expense) | 333 | (224) | ||
Net loss | (21,269) | (21,080) | (41,541) | (43,379) |
Other comprehensive loss, net of income tax: | ||||
Foreign currency translation adjustments net of tax impact of nil and $0.3 million for the three months ended June 30, 2017 and 2016, respectively, and nil and (0.2) million for the six months ended June 30, 2017 and 2016, respectively. | 404 | (4,101) | 726 | 579 |
Total comprehensive loss | $ (20,865) | $ (25,181) | $ (40,815) | $ (42,800) |
Basic and diluted net loss per common share (in dollars per share) | $ (0.83) | $ (0.84) | $ (1.63) | $ (1.74) |
Weighted average shares used in computing basic and diluted net loss per common share (in shares) | 25,560,348 | 25,077,350 | 25,502,301 | 24,886,996 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Millions | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||
Foreign currency translation adjustments, tax | $ 0.3 | $ (0.2) |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY - 6 months ended Jun. 30, 2017 - USD ($) $ in Thousands | Common shares | Additional paid-in capital | Accumulated other comprehensive income/(loss) | Accumulated deficit | Total |
Beginning balance at Dec. 31, 2016 | $ 1,593 | $ 464,653 | $ (6,557) | $ (396,058) | $ 63,631 |
Beginning balance (in shares) at Dec. 31, 2016 | 25,257,420 | 25,257,420 | |||
Increase (decrease) in shareholders' equity | |||||
Loss for the period | (41,541) | $ (41,541) | |||
Other comprehensive income | 726 | 726 | |||
Exercise of share options | $ 15 | 924 | 939 | ||
Exercise of share options (in shares) | 279,153 | ||||
Shares distributed during the period | $ 4 | (4) | |||
Shares distributed during the period (in shares) | 83,500 | ||||
Share-based compensation expense | 3,531 | 3,531 | |||
Ending balance at Jun. 30, 2017 | $ 1,612 | $ 469,104 | $ (5,831) | $ (437,599) | $ 27,286 |
Ending balance (in shares) at Jun. 30, 2017 | 25,620,073 | 25,620,073 |
CONDENSED CONSOLIDATED STATEME7
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Cash flows from operating activities | ||
Net loss | $ (41,541) | $ (43,379) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 4,257 | 2,989 |
Share-based compensation expense | 3,531 | 4,097 |
Change in fair value of derivative financial instruments | 397 | (393) |
Unrealized foreign exchange results | 1,168 | 1,303 |
Change in deferred taxes | 224 | |
Change in lease incentive | 1,634 | (306) |
Changes in operating assets and liabilities: | ||
Accounts receivable, prepaid expenses and other current assets | 5,096 | (1,307) |
Inventories | 80 | |
Accounts payable | (1,334) | (1,868) |
Accrued expenses and other liabilities | (696) | 2,982 |
Deferred revenue | (3,315) | (2,891) |
Net cash used in operating activities | (30,803) | (38,469) |
Cash flows from investing activities | ||
Restricted cash | (617) | |
Purchase of intangible assets | (578) | |
Purchase of property, plant and equipment | (2,830) | (3,553) |
Net cash used in investing activities | (3,408) | (4,170) |
Cash flows from financing activities | ||
Proceeds from issuance of shares | 939 | 2,195 |
Repayment of capital lease obligations | (98) | |
Net cash generated from financing activities | 939 | 2,097 |
Currency effect cash and cash equivalents | 4,863 | 2,848 |
Net increase / (decrease) in cash and cash equivalents | (28,409) | (37,694) |
Cash and cash equivalents at beginning of period | 132,496 | 221,626 |
Cash and cash equivalents at the end of period | 104,087 | 183,932 |
Supplemental cash flow disclosures: | ||
Cash paid for interest | 840 | 1,118 |
Non-cash adjustments in purchases of intangible assets and property, plant and equipment | $ (1,108) | $ 2,218 |
General business Information
General business Information | 6 Months Ended |
Jun. 30, 2017 | |
General business Information | |
General business Information | 1 General business information uniQure N.V. (“uniQure” or the “Company”) was founded in 1998 by scientists at the Academic Medical Center of the University of Amsterdam. The Company is a leader in the field of gene therapy and seeks to deliver to patients suffering from rare and other devastating diseases single treatments with potentially curative results. The Company initially operated through its predecessor company, Amsterdam Molecular Therapeutics Holding N.V. (“AMT”). The Company was incorporated in January 2012 to acquire and continue the gene therapy business of AMT. Effective February 10, 2014, in connection with its initial public offering, the Company converted into a public company with limited liability and changed its legal name from uniQure B.V. to uniQure N.V. The Company is registered with the Dutch Trade Register of the Chamber of Commerce (“ handelsregister van de Kamer van Koophandel en Fabrieken” ) in Amsterdam, the Netherlands under number 54385229. The Company’s headquarters is in Amsterdam, the Netherlands, and its registered office is located at Paasheuvelweg 25a, Amsterdam 1105 BP, the Netherlands, and its telephone number is +31 20 240 6000. Effective January 1, 2017, the Company ceased to qualify as a foreign private issuer. As a result, as of January 1, 2017, the Company began filing electronically with the Securities and Exchange Commission (the “SEC”) its annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and any amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Prior to this time, the Company filed its annual report on Form 20-F and furnished quarterly financial reports as an exhibit on Form 6-K with the SEC. The Company’s common stock is listed on the NASDAQ Global Market and trades under the symbol “QURE”. |
Summary of significant accounti
Summary of significant accounting policies | 6 Months Ended |
Jun. 30, 2017 | |
Summary of significant accounting policies | |
Summary of significant accounting policies | 2 2.1 The Company prepared these unaudited condensed consolidated financial statements in compliance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting. Any reference in these notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The unaudited condensed consolidated financial statements are presented in U.S. dollars, except where otherwise indicated. Transactions denominated in currencies other than U.S. dollars are presented in the transaction currency with the U.S. dollar amount included in parenthesis, converted at the foreign exchange rate as of the transaction date. 2.2 The accompanying interim condensed financial statements and related disclosures are unaudited, have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the financial position, results of operations and changes in financial position for the periods presented. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted . The condensed results of operations for the six months ended June 30, 2017, are not necessarily indicative of the results to be expected for the full year ending December 31, 2017, or for any other future year or interim period. The accompanying condensed financial statements should be read in conjunction with the audited financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on March 15, 2017. 2.3 The preparation of the financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates. 2.4 The principal accounting policies applied in the preparation of these unaudited condensed consolidated financial statements are described in the Company’s audited financial statements as of and for the year ended December 31, 2016, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on March 15, 2017. There have been no material changes in the Company’s significant accounting policies during the six months ended June 30, 2017. 2.5 There have been no new accounting pronouncements or changes to accounting pronouncements during the six months ended June 30, 2017, compared to the recent accounting pronouncements described in Note 2.3.22 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, which could be expected to materially impact the Company’s unaudited condensed consolidated financial statements except the one discussed below: In May 2017, the FASB issued ASU 2017-09, Compensation-stock compensation (topic 718)- scope of modification accounting (“ASU 2017-09”), which provides clarity regarding the applicability of modification accounting in relation to share-based payment awards. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. The effective date for the standard is for fiscal years beginning after December 15, 2017, which for the Company is January 1, 2018. Early adoption is permitted. The new standard is to be applied prospectively. The Company does not expect ASU 2017-09 to have a material impact on its consolidated financial statements. |
Fair value measurement
Fair value measurement | 6 Months Ended |
Jun. 30, 2017 | |
Fair value measurement | |
Fair value measurement | 3 Fair value measurement The Company measures certain assets and liabilities at fair value, either upon initial recognition or for subsequent accounting or reporting. U.S. GAAP, requires disclosure of methodologies used in determining the reported fair values, and establishes a hierarchy of inputs used when available. The three levels of the fair value hierarchy are described below: · Level 1 - Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. · Level 2 - Valuations based on quoted prices for similar assets or liabilities in markets that are not active or models for which the inputs are observable, either directly or indirectly. · Level 3 - Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and are unobservable. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized as Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Items measured at fair value on a recurring basis include financial instruments and contingent consideration. The carrying amount of cash and cash equivalents, accounts receivable from collaborators, prepaid expenses, other assets, accounts payable, accrued expenses and other current liabilities reflected in the consolidated balance sheets approximate their fair values due to their short-term maturities. The following table sets forth the Company’s assets and liabilities that are required to be measured at fair value on a recurring basis as of June 30, 2017, and December 31, 2016: Quoted prices Significant Significant Total Classification in consolidated in thousands At December 31, 2016 Assets: Cash and cash equivalents $ 132,496 $ — $ — $ 132,496 Total assets 132,496 — — 132,496 Liabilities: Derivative financial instruments - debt — — 11 11 Accrued expenses and other current liabilities Derivative financial instruments - related party — — 51 51 Other non-current liabilities Contingent consideration — — 1,838 1,838 Total liabilities $ — $ — $ 1,900 $ 1,900 At June 30, 2017 Assets: Cash and cash equivalents $ 104,087 $ — $ — $ 104,087 Total assets 104,087 — — 104,087 Liabilities: Derivative financial instruments - debt — — 3 3 Accrued expenses and other current liabilities Derivative financial instruments - related party — — 34 34 Other non-current liabilities Contingent consideration — — 2,415 2,415 Total liabilities $ — $ — $ 2,452 $ 2,452 Changes in Level 3 items during the six months ended June 30, 2017, and 2016, are as follows: Derivative Contingent financial consideration instruments Total in thousands Balance at December 31, 2016 $ 1,838 $ 62 $ 1,900 (Gains) / losses recognized in profit or loss 415 (31) 384 Currency translation effects 162 6 168 Balance at June 30, 2017 $ 2,415 $ 37 $ 2,452 Derivative Contingent financial consideration instruments Total in thousands Balance at December 31, 2015 $ 2,926 $ 837 $ 3,763 (Gains) / losses recognized in profit or loss 254 (647) (393) Currency translation effects 57 18 75 Balance at June 30, 2016 $ 3,237 $ 208 $ 3,445 Contingent consideration In connection with the Company’s acquisition of InoCard GmbH in 2014, the Company recorded contingent consideration related to amounts potentially payable to InoCard’s former shareholders. The amounts payable are contingent upon realization of the following milestones: · Successful completion of GLP safety and toxicology study; · First patient dosed in a clinical study; and · Full proof-of-concept of the product in human patients after finalization of a phase I/II study. The valuation of the contingent liability is based on significant inputs not observable in the market such as the probability of success (“POS”) of achieving certain research milestones (estimated as probable for the first two milestones as of the balance sheet date), the time at which the research milestones are expected to be achieved (ranging from 2018 to 2021), as well as the discount rate applied, which represents a Level 3 measurement. The POS as well as the discount rate both reflect the probability of achieving a milestone as of a specific date. The Company replaced the risk-adjusted discount rate of 30.0% with the Company’s weighted average rate of capital of 14.5% to reflect the full integration of the acquired business into the Company’s operation. This resulted in a $0.3 million increase of the liability. Varying, next to the passing of time, the unobservable inputs results in the following fair value changes: June 30, 2017 in thousands Change in fair value Moving out of all milestones by 6 months $ (152) Increasing the POS for the first milestone by 20% 792 Decreasing the POS for the first milestone by 20% (792) Reducing the discount rate from 14.5% to 10% 312 Increasing the discount rate from 14.5% to 20% (282) December 31, 2016 in thousands Change in fair value Moving out of all milestones by 6 months $ (209) Increasing the POS for the first milestone by 20% 367 Decreasing the POS for the first milestone by 20% (367) Reducing the discount rate from 30% to 20% 638 Increasing the discount rate from 30% to 40% (309) Derivative financial instruments The Company issued derivative financial instruments related to its collaboration with Bristol-Meyers Squibb Company (“BMS”) and in relation to the issuance of the Hercules Technology Growth Corp. (“Hercules”) loan facility. The fair value of these derivative financial instruments as of June 30, 2017, was $0.0 million (December 31, 2016: $0.1 million), and are described in more detail below. There were no significant changes in either (un)observable inputs or in the sensitivity of the fair value from (un)observable inputs as of June 30, 2017, compared to December 31, 2016. BMS collaboration On April 6, 2015, the Company entered into a number of agreements with BMS (the “BMS Agreements”). Pursuant to the terms of the BMS Agreements the Company granted BMS two warrants: · A warrant allowing BMS to purchase a specific number of uniQure common shares such that its ownership will equal 14.9% immediately after such purchase. The warrant can be exercised on the later of (i) the date on which the Company receives from BMS the Target Designation Fees (as defined in the collaboration agreements) associated with the first six New Targets (as defined in the collaboration agreements); and (ii) the date on which BMS designates the sixth New Target. · A warrant allowing BMS to purchase a specific number of uniQure common shares such that its ownership will equal 19.9% immediately after such purchase. The warrant can be exercised on the later of (i) the date on which uniQure receives from BMS the Target Designation Fees associated with the first nine New Targets; and (ii) the date on which BMS designates the ninth New Target. Pursuant to the terms of the BMS Agreements the exercise price, in respect of each warrant, is equal to the greater of (i) the product of (A) $33.84, multiplied by (B) a compounded annual growth rate of 10% and (ii) the product of (A) 1.10 multiplied by (B) the VWAP for the 20 trading days ending on the date that is five trading days prior to the date of a notice of exercise delivered by BMS. Hercules loan facility On June 14, 2013, the Company entered into a venture debt loan facility with (the “Original Facility”) with Hercules Technology Growth Capital, Inc. (“Hercules”) pursuant to a Loan and Security Agreement (the “Loan Agreement”) which included a warrant. The warrant was not closely related to the host contract and was accounted for separately as a derivative financial liability measured at fair value though profit or loss. The warrant included in the Original Facility remained in place following the 2014 and 2016 amendments of the loan. |
Collaboration arrangements and
Collaboration arrangements and concentration of credit risk | 6 Months Ended |
Jun. 30, 2017 | |
Collaboration arrangements and concentration of credit risk | |
Collaboration arrangements and concentration of credit risk | 4 Collaboration arrangements and concentration of credit risk In the three and six months ended June 30, 2017, the Company generated all of its collaboration and license revenues from its Collaboration and License Agreement with BMS, and its Co-Development Agreement for hemophilia B with Chiesi Farmaceutici S.p.A. (“Chiesi”). On April 19, 2017, the Company and Chiesi entered into an agreement to terminate the Glybera Commercialization Agreement following the Company’s decision to not seek renewal with the European Medicines Agency of the marketing authorization for Glybera by October 2017 (“Glybera Termination Agreement”). In July 2017, the Company and Chiesi terminated their co-development agreement in respect of the hemophilia B program (“hemophilia B Termination Agreement”). As a result, the Company will hold the global rights to the development of the hemophilia B program and will not be required to provide any future services in relation to the co-development and active contribution to the collaboration by providing technology access in the field of gene therapy to Chiesi. Since June 2015, BMS has been considered a related party given the significance of its equity investment in the Company (exceeding 5%). Services to the Company’s two collaboration partners are rendered by the Dutch operating entity. Total collaboration and license revenue generated from these partners are as follows: Three months ended June 30, Six months ended June 30, 2017 2016 2017 2016 in thousands Bristol Myers Squibb $ 2,110 $ 2,643 $ 3,617 $ 5,271 Chiesi Farmaceutici S.p.A 2,832 1,808 4,646 3,475 Total $ 4,942 $ 4,451 $ 8,263 $ 8,746 Amounts owed by these partners in relation to the collaboration are as follows: June 30, December 31, 2017 2016 in thousands Bristol Myers Squibb $ 1,627 $ 5,500 Chiesi Farmaceutici S.p.A 4,190 3,680 Total $ 5,817 $ 9,180 BMS collaboration In May 2015, the Company closed a Collaboration and License Agreement with BMS (the “BMS Collaboration Agreement”) that provides exclusive access to the Company’s gene therapy technology platform for multiple targets in cardiovascular (and other) diseases. The collaboration included the Company’s proprietary gene therapy program for congestive heart failure which aims to restore the heart's ability to synthesize S100A1, a calcium sensor and master regulator of heart function, and thereby improve clinical outcomes for patients with reduced ejection fraction. Beyond cardiovascular diseases, the agreement also included the potential for a target exclusive collaboration in other disease areas. In total, the companies may collaborate on ten targets, including S100A1. The Company is conducting the discovery, non-clinical, analytical and process development activities and is responsible for manufacturing of clinical and commercial supplies using the Company’s vector technologies and industrial, proprietary insect-cell based manufacturing platform. BMS reimburses the Company for all its research and development efforts in support of the Collaboration, and will lead the clinical development and regulatory activities across all programs. BMS will also be solely responsible for commercialization of all products from the collaboration. The Company evaluated the BMS Collaboration Agreement and determined that it is a revenue arrangement with multiple elements. The Company’s substantive deliverables under the BMS Collaboration Agreement include an exclusive license to its technology in the field of cardiovascular disease, research and development services for specific targets chosen by BMS and general development of the Company’s proprietary vector technology, participation in the Joint Steering Committee, and clinical and commercial manufacturing. The Company concluded that the BMS Collaboration Agreement consists of three units of accounting, including (i) technology (license and target selections), know-how and manufacturing in the field of gene therapy and development and active contribution to the development through the Joint Steering Committee participations, (ii) provision of employees, goods and services for research activities for specific targets and (iii) clinical and commercial manufacturing. The Company determined that the license does not have stand-alone value to BMS without the Company’s know-how and manufacturing technology through the participation of the Joint Steering Committee and accordingly, they were combined into one unit of accounting. License revenue – BMS As of May 21, 2015, the effective date of the BMS Collaboration Agreement, the Company recorded deferred revenue of $60.1 million. On July 31, 2015, BMS selected the second, third and fourth collaboration targets, triggering a $15.0 million target designation payment to the Company. The Company is entitled to an aggregate of $16.5 million in target designation payments upon the selection of the fifth through tenth collaboration targets. The Company will also be eligible to receive research, development and regulatory milestone payments of up to $254.0 million for S100A1 and up to $217.0 million for each of the other selected targets, if and when milestones are achieved. The Company determined that the contingent payments under the BMS Collaboration Agreement relating to research, development and regulatory milestones do not constitute substantive milestones and will not be accounted for under the milestone method of revenue recognition. The events leading to these payments solely depend on BMS’ performance. Accordingly, any revenue from these contingent payments would be allocated to the first unit of accounting noted above and recognized over the expected performance period. License revenue is recognized over an expected performance period of 19 years on a straight-line basis commencing on May 21, 2015. The expected performance period is reviewed quarterly and adjusted to account for changes, if any, in the Company´s estimated performance period. The estimated performance period did not change in the six months ended June 30, 2017. The Company recognized $1.0 million and $1.9 million of license revenue for the three and six months ended June 30, 2017, respectively, and compared to $1.0 million and $2.0 million during the same periods in 2016. Additionally, the Company is eligible to receive net sales-based milestone payments and tiered high single to low double-digit royalties on product sales. These revenues will be recognized when earned. The royalty term is determined on a licensed-product-by-licensed-product and country-by-country basis and begins on the first commercial sale of a licensed product in a country and ends on the expiration of the last to expire of specified patents or regulatory exclusivity covering such licensed product in such country or, with a customary royalty reduction, ten years after such first commercial sale if there is no such exclusivity. Collaboration revenue – BMS The Company provides target-specific research and development services to BMS. Collaboration revenue related to these contracted services is recognized when earned. The Company generated $1.1 million and $1.7 million of collaboration revenue during the three and six months ended June 30, 2017, respectively, compared to $1.6 million and $3.3 million during the same periods in 2016. Manufacturing revenue – BMS BMS and the Company also entered into a term sheet for the Company to supply gene therapy products during the clinical and commercial phase to BMS. Revenues from product sales will be recognized when earned. To date the Company has not supplied any commercial product to BMS. Chiesi collaboration In 2013, the Company entered into two agreements with Chiesi, a family-owned Italian pharmaceutical company, one for the co-development and commercialization of the hemophilia B program (the “Hemophilia Collaboration Agreement”) and one for the commercialization of Glybera (the “Glybera Agreement”, and together with the Collaboration Agreement, the “Chiesi Agreements”) in Europe and selected territories. The Company had evaluated the Chiesi Agreements and had determined that they were a revenue arrangement with multiple elements. The Company’s substantive deliverables under the Chiesi Agreements included an exclusive license to its technology, research and development services, and commercial manufacturing. The Company concluded that the Chiesi Agreements consisted of three units of accounting, including (i) co-development and active contribution to the collaboration by providing technology access and know-how in the field of gene therapy, (ii) provision of employees, goods and services for research and development activities and (iii) commercial manufacturing. In April 2017, the parties agreed to terminate the Glybera Agreement. Accordingly, the Company will not be required to supply Glybera to Chiesi beyond October 2017. The settlement terms require the Company to repay €2.0 million ($2.3 million) in up-front payments received in 2013. In July 2017, the parties terminated the Hemophilia Collaboration Agreement and the Company reacquired rights associated with its hemophilia B program in Europe and certain other territories (see note 14). License revenue – Chiesi Upon the closing of the Chiesi Agreements on June 30, 2013, the Company received €17.0 million ($22.1 million) in non-refundable up-front payments. The Company determined that the up-front payments constituted a single unit of accounting that should be amortized as license revenue on a straight-line basis over the performance period of July 2013 through September 2032. The Company recognized $(0.2) million and $0.0 million of license revenue during the three and six months ended June 30, 2017, respectively, compared to $0.2 million and $0.5 million during the same periods in 2016. The Company recognized the license revenue for the three and six months ended June 30, 2017, net of a $0.5 million reduction for amounts previously amortized in relation to the $2.3 million up-front payments that the Company will be required to repay in accordance with the Glybera Termination Agreement. The Company also reduced the deferred revenue balance as of June 30, 2017, by $1.8 million for license revenue not yet earned. Collaboration revenue – Chiesi Prior to the termination of the Hemophilia Collaboration Agreement, Chiesi reimbursed the Company for 50% of the agreed research and development efforts related to hemophilia B. These reimbursable amounts have been presented as collaboration revenue. The Company generated $3.1 million and $4.6 million of collaboration revenue from the co-development of hemophilia B during the three and six months ended June 30, 2017, respectively, compared to $1.6 million and $3.0 million during the same periods in 2016. |
Property, plant and equipment
Property, plant and equipment | 6 Months Ended |
Jun. 30, 2017 | |
Property, plant and equipment | |
Property, plant and equipment | 5 Property, plant and equipment The following table presents the Company’s property, plant and equipment as of June 30, 2017, and December 31, 2016: June 30, December 31, 2017 2016 in thousands Leasehold improvements $ 32,405 $ 30,582 Laboratory equipment 15,507 14,166 Office equipment 2,870 2,710 Construction-in-progress 376 313 Total property, plant, and equipment 51,158 47,771 Less accumulated depreciation (15,748) (12,069) Property, plant and equipment, net $ 35,410 $ 35,702 Total depreciation expense was $1.7 million and $3.4 million during the three and six months ended June 30, 2017, respectively, compared to $1.3 million and $2.7 million during the same periods in 2016. Depreciation expense is allocated to research and development to the extent it relates to the Company’s manufacturing facility and equipment. All other depreciation expenses are allocated to selling, general and administrative expense. |
Intangible assets
Intangible assets | 6 Months Ended |
Jun. 30, 2017 | |
Intangible assets | |
Intangible assets | 6 Intangible assets The Company’s intangible assets include acquired licenses and acquired research and development (“Acquired R&D”) and are presented in the following table: June 30, December 31, 2017 2016 in thousands Licenses $ 9,058 $ 7,799 Acquired research & development 5,330 4,908 Total intangible assets 14,388 12,707 Less accumulated amortization and impairment (5,642) (4,383) Intangible assets, net $ 8,746 $ 8,324 Amortization expense was $0.7 million and $0.8 million for the three and six months ended June 30, 2017, respectively, compared to $0.2 million and $0.3 million during the same periods in 2016. All amortization, with the exception of $0.6 million related to the termination of the Chiesi collaboration, which was presented in other expense in the three and six months ended June 30, 2017, were included in research and development expenses. |
Accrued expenses and other curr
Accrued expenses and other current liabilities / other non-current liabilities | 6 Months Ended |
Jun. 30, 2017 | |
Accrued expenses and other current liabilities / other non-current liabilities | |
Accrued expenses and other current liabilities / other non-current liabilities | 7 Accrued expenses and other current liabilities / other non-current liabilities Accrued expenses and other current liabilities include the following items: June 30, December 31, 2017 2016 in thousands Accruals for services provided by vendors-not yet billed $ 3,092 $ 3,824 Personnel related accruals and liabilities 3,974 5,559 Other current liabilities 2,374 383 Total $ 9,440 $ 9,766 Other current liabilities as at June 30, 2017 include accrued rent for the vacated facilities at the Company’s previous site at the Academische Medisch Centrum Amsterdam (see note 12) as well as the current portion of liabilities related to the Glybera withdrawal (see below). Restructuring plan In November 2016, the Company announced a plan to restructure its activities as a result of a company-wide strategic review with the aim of refocusing its pipeline, consolidating its manufacturing capabilities into its Lexington, Massachusetts site, reducing operating costs and enhancing overall execution. In December 2016, the Company accrued $1.1 million of termination benefits associated with the restructuring. At various dates during the six months ended June 30, 2017, the Company entered into termination agreements with additional employees and recognized related termination costs of $0.9 million for services rendered by these employees during 2017. The change in the accrual of termination benefits (recognized within research and development expenses) for the six months ended June 30, 2017 was: Accrued termination benefits in thousands Balance at December 31, 2016 $ 1,148 Accrued through profit and loss 908 Payments (1,435) Currency translation effects 48 Balance at June 30, 2017 $ 669 Other non-current liabilities As part of the Glybera Termination Agreement, the Company agreed to repay €2.0 million ($2.3 million) of the upfront payment it received upon entering into the initial agreement in 2013. The amounts will be payable in installments through January 2019. As of June 30, 2017, the Company accrued €1.5 million ($1.7 million), of which €0.5 million ($0.6 million) is included within other current liabilities. According to the Glybera Termination Agreement the Company will be responsible for terminating the Phase IV post-approval study and accrued $0.9 million (presented as other expenses) in relation to such costs as of June 30, 2017, of which $0.6 million is included within other current liabilities. |
Long-term debt
Long-term debt | 6 Months Ended |
Jun. 30, 2017 | |
Long-term debt | |
Long-term debt | 8 Long-term debt On June 14, 2013, the Company entered into a venture debt loan facility with Hercules, which was amended and restated on June 26, 2014, and again on May 6, 2016 (“2016 Amended Facility”). The 2016 Amended Facility extended the maturity date from June 30, 2018, to May 1, 2020. As at June 30, 2017, and December 31, 2016, $20.0 million were outstanding. The interest rate is adjustable and is the greater of (i) 8.25% or (ii) 8.25% plus the prime rate less 5.25%. Under the 2016 Amended Facility, the interest rate will initially be 8.25% per annum with a back-end fee of 4.85% and a facility fee of 0.75% of the outstanding loan amounts. The interest-only payment period expires on November 2017, but can be extended to May 2018 upon the Company raising a cumulative $30.0 million in up-front corporate payments and/or proceeds from equity financings (“Raisings”), and further extended to November 2018 upon the Company raising a cumulative $50.0 million from such Raisings. The amortized cost of the 2016 Amended Loan, was $20.5 million as of June 30, 2017, compared to $20.2 million as of December 31, 2016, and is recorded net of discount and debt issuance costs. The foreign currency gain on the loan in the three and six months ended June 30, 2017, was $1.3 million and $1.6 million, respectively. The Company recognized a foreign currency loss of $0.7 million and a gain of $0.2 million during the same periods in 2016. The fair value of the loan approximates its carrying amount, as the loan is amortized at a market conforming interest rate and the impact of discounting is insignificant. Interest expense associated with the 2016 Amended Facility during the three and six months ended June 30, 2017, was $0.5 million and $1.0 million, respectively, compared to $0.6 million and $1.2 million, during the same periods in 2016. As a covenant in the 2016 Amended Facility, the Company has periodic reporting requirements and is required to keep a minimum cash balance deposited in bank accounts in the United States, equivalent to the lesser of the outstanding balance of principal due and 50% of worldwide cash reserves. This restriction on the cash reserves only relates to the location of the cash reserves, and such cash reserves can be used at the discretion of the Company. In combination with other convents, the 2016 Amended Facility restricts the Company’s ability to, among other things, incur future indebtedness and obtain additional debt financing, to make investments in securities or in other companies, to transfer assets, to perform certain corporate changes, to make loans to employees, officers and directors, and to make dividend payments and other distributions. The Company secured the facilities by pledging the shares in its subsidiaries, substantially all its receivables, moveable assets as well as the equipment, fixtures, inventory and cash of uniQure Inc. |
Share-based compensation
Share-based compensation | 6 Months Ended |
Jun. 30, 2017 | |
Share-based compensation | |
Share-based compensation | 9 Share-based compensation The Company recognized share-based compensation expense totaling $1.9 million and $3.5 million during the three and six months ended June 30, 2017, respectively, compared to $1.5 million and $4.1 million during the same periods in 2016. Share-based compensation expense recognized by classification included in the consolidated statements of operations and comprehensive loss was as follows: Three months ended June 30, Six months ended June 30, 2017 2016 2017 2016 in thousands Research and development - employees $ 794 $ 918 $ 1,481 $ 1,777 Selling, general and administrative - employees 1,132 531 2,050 1,650 Research and development - non-employees — — — 670 Total $ 1,926 $ 1,449 $ 3,531 $ 4,097 Share-based compensation expense recognized by award type was as follows: Three months ended June 30, Six months ended June 30, 2017 2016 2017 2016 Award type in thousands Share options $ 883 $ 1,306 $ 1,709 $ 3,690 Restricted share units ("RSUs") 716 82 1,232 235 Performance share units ("PSUs") 327 61 590 172 Total $ 1,926 $ 1,449 $ 3,531 $ 4,097 As of June 30, 2017, the unrecognized compensation costs related to unvested awards under the various share-based compensation plans were: Weighted-average remaining Unrecognized period for compensation recognition costs (in years) Award type in thousands Share options $ 7,520 2.74 Restricted share units 4,169 1.87 Performance share units 2,556 2.39 Total $ 14,245 2.42 The Company satisfies the exercise of share options and vesting of RSUs and PSUs through newly issued shares. The Company’s share-based compensation plans include the 2014 Amended and Restated Share Option Plan (the “2014 Plan”) and inducement grants under Rule 5653(c)(4) of the NASDAQ Global Market with characteristics similar to the 2014 Plan (classified as “Other Plans”). The Company previously had a 2012 Equity Incentive Plan (the “2012 Plan”) and issued options to purchase common shares to the shareholders of 4D in connection with a collaboration and license agreement between the Company and 4D dated as of January 2014 (classified as “Other Plans”). 2014 Plan Share options The following table summarizes option activity under the Company’s 2014 Plan for the six months ended June 30, 2017: 2014 plan Weighted average Options exercise price Outstanding at December 31, 2016 1,812,766 $ 12.47 Granted 714,600 $ 5.59 Forfeited (118,739) $ 9.76 Expired (55,764) $ 15.42 Outstanding at June 30, 2017 2,352,863 $ 10.45 Fully vested and exercisable 816,586 $ 12.93 Outstanding and expected to vest 1,536,277 $ 9.12 During the six months ended June 30, 2017, the Company granted options to purchase an aggregate of 714,600 common shares with a total weighted-average grant date fair value of $2.3 million, including an option to purchase 175,000 common shares granted to the Company’s Chief Executive Officer (vesting equally over four years from the date of grant) and options to purchase an aggregate of 80,000 common shares granted to the Company’s non-executive directors (vesting one year from the date of grant). The fair value of each option issued was estimated at the date of grant using the Hull & White option pricing model with the following weighted-average assumptions: Three months ended June 30, Six months ended June 30, Assumptions 2017 2016 2017 2016 Expected volatility 75% 75% 75% 75% Expected terms (in years) 10 years 10 years 10 years 10 years Risk free interest rate 2.43% 1.58% - 1.96% 2.43% - 2.81% 0.16% - 1.96% Expected dividends 0% 0% 0% 0% Restricted Share Units (RSUs) The following table summarizes the RSUs activity for the six months ended June 30, 2017: RSU Weighted average grant-date fair Number of shares value Undistributed at December 31, 2016 307,063 $ 9.11 Granted 408,350 $ 5.83 Distributed (25,000) $ 18.21 Forfeited (2,275) $ 7.98 Undistributed at June 30, 2017 688,138 $ 6.84 During the six months ended June 30, 2017, the Company granted an aggregate of 408,350 RSUs with a total weighted-average grant date fair value of $2.4 million, including 175,000 RSUs granted to the Company’s Chief Executive Officer (vesting equally over two years from the date of grant) and a total of 80,000 RSUs granted to non-executive directors (vesting one year from the date of grant). During the six months ended June 30, 2017, the Company distributed 25,000 common shares in connection with the vesting of RSUs. Performance Share Units (PSUs) The following table summarizes the PSUs activity for the six months ended June 30, 2017: PSU Weighted average grant-date fair Number of shares value Undistributed at December 31, 2016 111,564 $ 5.76 Retired (12,000) $ 5.76 Granted 13,000 $ 4.99 Distributed (58,500) $ 5.76 Undistributed at June 30, 2017 54,064 $ 5.57 During the six months ended June 30, 2017, the Company awarded an aggregate of 426,250 PSUs to members of its senior management, including 162,500 PSUs to its Chief Executive Officer. As the earning of these PSUs is discretionary based on the Board’s assessment of the performance through 2017, these PSUs are not included in the above table. In September 2016, the Company awarded 61,560 PSUs to its Chief Executive Officer, subject to the successful implementation of the strategic plan. As the earning of these PSUs is discretionary based on the Board’s assessment of the Chief Executive Officer’s performance through 2017, these PSUs are also not included in the above table. Other Plans The following table summarizes option activity under the Company’s Other Plans for the six months ended June 30, 2017: Other plans Weighted average Options exercise price Outstanding at December 31, 2016 187,500 $ 17.93 Granted 150,000 $ 5.31 Expired (62,500) $ 27.82 Outstanding at June 30, 2017 275,000 $ 8.80 Fully vested and exercisable 31,250 $ 12.98 Outstanding and expected to vest 243,750 $ 8.26 Under Rule 5653(c)(4) of the NASDAQ Global Market, the Company grants share options and RSUs to certain employees as a material inducement to enter into employment with the Company. During the six months ended June 30, 2017, the Company granted 150,000 options with a weighted-average grant date fair value of $0.5 million and 175,000 RSUs with a grant date fair value of $1.0 million. No inducement grant options were exercised during the six months ended June 30, 2017. The fair value of the inducement grant options was estimated at the date of grant using the Hull & White option pricing model with the same assumptions as used in determining the fair value of options issued under the 2014 Plan. 2012 Plan The following table summarizes option activity under the Company’s 2012 Plan for the six months ended June 30, 2017: 2012 plan Weighted average Options exercise price Outstanding at December 31, 2016 483,006 € 5.13 Exercised (286,304) € 3.07 Outstanding, fully vested and exercisable at June 30, 2017 196,702 € 8.12 Options exercised under the 2012 plan during the six months ended June 30, 2017, resulted in total proceeds to the Company of $0.9 million. |
Income taxes
Income taxes | 6 Months Ended |
Jun. 30, 2017 | |
Income taxes | |
Income taxes | 10 Income taxes Deferred tax assets and deferred tax liabilities are recognized based on the expected future tax consequences temporary differences between the financial statement carrying amounts and the income tax basis of assets and liabilities, using current statutory rates. A valuation allowance is recorded against deferred tax assets if it is more likely than not that some or all of the deferred tax assets will not be realized. Due to the uncertainty surrounding the realization of the favorable tax attributes in future tax returns, the Company has recorded a full valuation allowance against the Company’s otherwise recognizable net deferred tax assets. |
Basic and diluted earnings per
Basic and diluted earnings per share | 6 Months Ended |
Jun. 30, 2017 | |
Basic and diluted earnings per share | |
Basic and diluted earnings per share | 11 Basic and diluted earnings per share Diluted earnings per share is calculated by adjusting the weighted average number of common shares outstanding, assuming conversion of all potentially dilutive common shares. As the Company has incurred a loss, all potentially dilutive common shares would have an antidilutive effect, if converted, and thus have been excluded from the computation of loss per share. The potentially dilutive common shares are summarized below: June 30, June 30, 2017 2016 common shares BMS warrants 5,282,647 3,442,655 Warrants 37,175 37,175 Stock options under 2012 Plan 196,702 687,808 Stock options under 2014 Plan 2,352,863 1,749,760 Stock options (other) 275,000 1,125,000 RSUs and PSUs 742,202 235,638 Total potential dilutive common shares 8,886,589 7,278,036 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2017 | |
Leases | |
Leases | 12 Leases The Company leases various office space and laboratory space under operating lease agreements, expiring at various dates through 2032. These leases are described in more detail below. Aggregate rent expense for the three and six months ended June 30, 2017, respectively, was $1.1 million and $2.1 million compared to $1.1 million and $1.9 million in the same period during 2016, respectively. Rent expense is calculated on a straight-line basis over the term of the leases and takes into account $11.8 million of lease incentives received. As of June 30, 2017, aggregate minimum lease payments for the calendar years ending December 31, 2017, 2018, 2019, 2020 and 2021 and beyond were as follows: in thousands 2017 (six months remaining) $ 907 2018 3,748 2019 3,801 2020 3,854 2021 and beyond 27,781 Total minimum lease payments $ 40,091 Lexington, Massachusetts In July 2013, uniQure entered into a lease for a facility in Lexington, Massachusetts, United States. The term of the lease commenced in November 2013 and was set for 10 years and is non-cancellable. The lease for this facility terminates in 2024, and subject to the provisions of the lease, may be renewed for two subsequent five-year terms. The future aggregate minimum lease payments under the non-cancellable term of the lease amount to $13.5 million. As of June 30, 2017, the Company recorded deferred rent related to lease incentives received of $5.9 million (December 31, 2016: $6.2 million), with a current element of $0.7 million (December 31, 2016: $0.7 million). The lease provides for annual minimum increases in rent, based on a consumer price index. Paasheuvelweg, Amsterdam In March 2016, the Company entered into a 16-year lease for a facility in Amsterdam, the Netherlands, and amended this agreement in June 2016. The Company consolidated its three Amsterdam sites into the new site at the end of May 2017. The lease for this facility terminates in 2032, with an option to extend in increments of five year periods. As a result of a downsizing of personnel in Amsterdam, the Company will seek to sublease parts of the facility. The future aggregate minimum lease payments under the non-cancellable term of the lease amount to $26.6 million. The lease contract provides for annual minimum increases in rent, based on a consumer price index. Meibergdreef, Amsterdam In April 2015, uniQure entered into a lease with Jan Snel B.V. for a laboratory facility of approximately 9,300 square feet, located at the Meibergdreef in Amsterdam, the Netherlands. The minimum lease period terminates September 2018. The facility is expected to be demolished in August 2017. Accordingly, the Company accrued (recognized within other expenses) the cost to exit the lease of $0.8 million in May 2017, when it ceased using the facility. |
Other commitments
Other commitments | 6 Months Ended |
Jun. 30, 2017 | |
Other commitments | |
Other commitments | 13 Other commitments The Company’s predecessor entity received a technical development loan from the Dutch government in relation to the development of Glybera. The Company is required to repay the grant through a percentage of revenue derived from product sales of Glybera up to December 31, 2019. Any grant balance remaining at this date will be forgiven. The Company decided not to renew its marketing authorization for Glybera in the European Union, which expires in October 2017. The Company does not expect to derive any revenue from Glybera. |
Subsequent event
Subsequent event | 6 Months Ended |
Jun. 30, 2017 | |
Subsequent event | |
Subsequent event | 14 Subsequent event Chiesi collaboration On July 26, 2017, the Company and Chiesi terminated their Co-Development Agreement for hemophilia B. uniQure will be responsible for all future development costs related to its hemophilia B program that would have otherwise been shared with Chiesi. The Company expects to receive approximately $2.3 million from Chiesi in August 2017 to settle all outstanding and future amounts. The Company expects to record $13.6 million other income during the three months ended September 30, 2017, related to the full release of the outstanding deferred revenue. |
Summary of significant accoun22
Summary of significant accounting policies (Policies) | 6 Months Ended |
Jun. 30, 2017 | |
Summary of significant accounting policies | |
Basis of preparation | 2.1 The Company prepared these unaudited condensed consolidated financial statements in compliance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting. Any reference in these notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The unaudited condensed consolidated financial statements are presented in U.S. dollars, except where otherwise indicated. Transactions denominated in currencies other than U.S. dollars are presented in the transaction currency with the U.S. dollar amount included in parenthesis, converted at the foreign exchange rate as of the transaction date. |
Unaudited interim financial information | 2.2 The accompanying interim condensed financial statements and related disclosures are unaudited, have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the financial position, results of operations and changes in financial position for the periods presented. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted . The condensed results of operations for the six months ended June 30, 2017, are not necessarily indicative of the results to be expected for the full year ending December 31, 2017, or for any other future year or interim period. The accompanying condensed financial statements should be read in conjunction with the audited financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on March 15, 2017. |
Use of estimates | 2.3 The preparation of the financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates. |
Accounting policies | 2.4 The principal accounting policies applied in the preparation of these unaudited condensed consolidated financial statements are described in the Company’s audited financial statements as of and for the year ended December 31, 2016, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on March 15, 2017. There have been no material changes in the Company’s significant accounting policies during the six months ended June 30, 2017. |
Recent accounting pronouncements | 2.5 There have been no new accounting pronouncements or changes to accounting pronouncements during the six months ended June 30, 2017, compared to the recent accounting pronouncements described in Note 2.3.22 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, which could be expected to materially impact the Company’s unaudited condensed consolidated financial statements except the one discussed below: In May 2017, the FASB issued ASU 2017-09, Compensation-stock compensation (topic 718)- scope of modification accounting (“ASU 2017-09”), which provides clarity regarding the applicability of modification accounting in relation to share-based payment awards. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. The effective date for the standard is for fiscal years beginning after December 15, 2017, which for the Company is January 1, 2018. Early adoption is permitted. The new standard is to be applied prospectively. The Company does not expect ASU 2017-09 to have a material impact on its consolidated financial statements. |
Fair value measurement (Tables)
Fair value measurement (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Fair value measurement | |
Schedule of assets and liabilities measured at fair value on recurring basis | Quoted prices Significant Significant Total Classification in consolidated in thousands At December 31, 2016 Assets: Cash and cash equivalents $ 132,496 $ — $ — $ 132,496 Total assets 132,496 — — 132,496 Liabilities: Derivative financial instruments - debt — — 11 11 Accrued expenses and other current liabilities Derivative financial instruments - related party — — 51 51 Other non-current liabilities Contingent consideration — — 1,838 1,838 Total liabilities $ — $ — $ 1,900 $ 1,900 At June 30, 2017 Assets: Cash and cash equivalents $ 104,087 $ — $ — $ 104,087 Total assets 104,087 — — 104,087 Liabilities: Derivative financial instruments - debt — — 3 3 Accrued expenses and other current liabilities Derivative financial instruments - related party — — 34 34 Other non-current liabilities Contingent consideration — — 2,415 2,415 Total liabilities $ — $ — $ 2,452 $ 2,452 |
Schedule of changes in Level 3 items | Derivative Contingent financial consideration instruments Total in thousands Balance at December 31, 2016 $ 1,838 $ 62 $ 1,900 (Gains) / losses recognized in profit or loss 415 (31) 384 Currency translation effects 162 6 168 Balance at June 30, 2017 $ 2,415 $ 37 $ 2,452 Derivative Contingent financial consideration instruments Total in thousands Balance at December 31, 2015 $ 2,926 $ 837 $ 3,763 (Gains) / losses recognized in profit or loss 254 (647) (393) Currency translation effects 57 18 75 Balance at June 30, 2016 $ 3,237 $ 208 $ 3,445 |
Schedule of changes in fair value of unobservable inputs | June 30, 2017 in thousands Change in fair value Moving out of all milestones by 6 months $ (152) Increasing the POS for the first milestone by 20% 792 Decreasing the POS for the first milestone by 20% (792) Reducing the discount rate from 14.5% to 10% 312 Increasing the discount rate from 14.5% to 20% (282) December 31, 2016 in thousands Change in fair value Moving out of all milestones by 6 months $ (209) Increasing the POS for the first milestone by 20% 367 Decreasing the POS for the first milestone by 20% (367) Reducing the discount rate from 30% to 20% 638 Increasing the discount rate from 30% to 40% (309) |
Collaboration arrangements an24
Collaboration arrangements and concentration of credit risk (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Collaboration arrangements and concentration of credit risk | |
Schedule of collaboration and license revenue | Three months ended June 30, Six months ended June 30, 2017 2016 2017 2016 in thousands Bristol Myers Squibb $ 2,110 $ 2,643 $ 3,617 $ 5,271 Chiesi Farmaceutici S.p.A 2,832 1,808 4,646 3,475 Total $ 4,942 $ 4,451 $ 8,263 $ 8,746 |
Schedule of amounts owed in relation to collaboration | June 30, December 31, 2017 2016 in thousands Bristol Myers Squibb $ 1,627 $ 5,500 Chiesi Farmaceutici S.p.A 4,190 3,680 Total $ 5,817 $ 9,180 |
Property, plant and equipment (
Property, plant and equipment (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Property, plant and equipment | |
Schedule of property, plant and equipment | June 30, December 31, 2017 2016 in thousands Leasehold improvements $ 32,405 $ 30,582 Laboratory equipment 15,507 14,166 Office equipment 2,870 2,710 Construction-in-progress 376 313 Total property, plant, and equipment 51,158 47,771 Less accumulated depreciation (15,748) (12,069) Property, plant and equipment, net $ 35,410 $ 35,702 |
Intangible assets (Tables)
Intangible assets (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Intangible assets | |
Schedule of finite-lived intangible assets | June 30, December 31, 2017 2016 in thousands Licenses $ 9,058 $ 7,799 Acquired research & development 5,330 4,908 Total intangible assets 14,388 12,707 Less accumulated amortization and impairment (5,642) (4,383) Intangible assets, net $ 8,746 $ 8,324 |
Accrued expenses and other cu27
Accrued expenses and other current liabilities (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Accrued expenses and other current liabilities / other non-current liabilities | |
Schedule of accrued expenses and other current liabilities | June 30, December 31, 2017 2016 in thousands Accruals for services provided by vendors-not yet billed $ 3,092 $ 3,824 Personnel related accruals and liabilities 3,974 5,559 Other current liabilities 2,374 383 Total $ 9,440 $ 9,766 |
Schedule of change in accrual of termination benefits | Accrued termination benefits in thousands Balance at December 31, 2016 $ 1,148 Accrued through profit and loss 908 Payments (1,435) Currency translation effects 48 Balance at June 30, 2017 $ 669 |
Share-based compensation (Table
Share-based compensation (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Share-based compensation | |
Schedule of share-based compensation expense by classification included in consolidated statements of operations and comprehensive loss | Three months ended June 30, Six months ended June 30, 2017 2016 2017 2016 in thousands Research and development - employees $ 794 $ 918 $ 1,481 $ 1,777 Selling, general and administrative - employees 1,132 531 2,050 1,650 Research and development - non-employees — — — 670 Total $ 1,926 $ 1,449 $ 3,531 $ 4,097 |
Schedule of share-based compensation expense | Three months ended June 30, Six months ended June 30, 2017 2016 2017 2016 Award type in thousands Share options $ 883 $ 1,306 $ 1,709 $ 3,690 Restricted share units ("RSUs") 716 82 1,232 235 Performance share units ("PSUs") 327 61 590 172 Total $ 1,926 $ 1,449 $ 3,531 $ 4,097 |
Schedule of unrecognized compensation cost related to unvested awards | Weighted-average remaining Unrecognized period for compensation recognition costs (in years) Award type in thousands Share options $ 7,520 2.74 Restricted share units 4,169 1.87 Performance share units 2,556 2.39 Total $ 14,245 2.42 |
2012 Plan | |
Share-based compensation | |
Summary of option activity | 2012 plan Weighted average Options exercise price Outstanding at December 31, 2016 483,006 € 5.13 Exercised (286,304) € 3.07 Outstanding, fully vested and exercisable at June 30, 2017 196,702 € 8.12 |
2014 Plan | |
Share-based compensation | |
Summary of option activity | 2014 plan Weighted average Options exercise price Outstanding at December 31, 2016 1,812,766 $ 12.47 Granted 714,600 $ 5.59 Forfeited (118,739) $ 9.76 Expired (55,764) $ 15.42 Outstanding at June 30, 2017 2,352,863 $ 10.45 Fully vested and exercisable 816,586 $ 12.93 Outstanding and expected to vest 1,536,277 $ 9.12 |
Schedule of weighted-average assumptions for fair value of option issued | Three months ended June 30, Six months ended June 30, Assumptions 2017 2016 2017 2016 Expected volatility 75% 75% 75% 75% Expected terms (in years) 10 years 10 years 10 years 10 years Risk free interest rate 2.43% 1.58% - 1.96% 2.43% - 2.81% 0.16% - 1.96% Expected dividends 0% 0% 0% 0% |
Summary of RSUs activity | RSU Weighted average grant-date fair Number of shares value Undistributed at December 31, 2016 307,063 $ 9.11 Granted 408,350 $ 5.83 Distributed (25,000) $ 18.21 Forfeited (2,275) $ 7.98 Undistributed at June 30, 2017 688,138 $ 6.84 |
Summary of PSUs activity | PSU Weighted average grant-date fair Number of shares value Undistributed at December 31, 2016 111,564 $ 5.76 Retired (12,000) $ 5.76 Granted 13,000 $ 4.99 Distributed (58,500) $ 5.76 Undistributed at June 30, 2017 54,064 $ 5.57 |
Other Plans | |
Share-based compensation | |
Summary of option activity | Other plans Weighted average Options exercise price Outstanding at December 31, 2016 187,500 $ 17.93 Granted 150,000 $ 5.31 Expired (62,500) $ 27.82 Outstanding at June 30, 2017 275,000 $ 8.80 Fully vested and exercisable 31,250 $ 12.98 Outstanding and expected to vest 243,750 $ 8.26 |
Basic and diluted earnings pe29
Basic and diluted earnings per share (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Basic and diluted earnings per share | |
Schedule of potential dilutive common shares | June 30, June 30, 2017 2016 common shares BMS warrants 5,282,647 3,442,655 Warrants 37,175 37,175 Stock options under 2012 Plan 196,702 687,808 Stock options under 2014 Plan 2,352,863 1,749,760 Stock options (other) 275,000 1,125,000 RSUs and PSUs 742,202 235,638 Total potential dilutive common shares 8,886,589 7,278,036 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Leases | |
Schedule of minimum lease payments | in thousands 2017 (six months remaining) $ 907 2018 3,748 2019 3,801 2020 3,854 2021 and beyond 27,781 Total minimum lease payments $ 40,091 |
Fair value measurement - Assets
Fair value measurement - Assets and Liabilities (Details) - Recurring - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Assets, Fair Value Disclosure [Abstract] | ||
Cash and cash equivalents | $ 104,087 | $ 132,496 |
Total assets | 104,087 | 132,496 |
Liabilities, Fair Value Disclosure [Abstract] | ||
Contingent consideration | 2,415 | 1,838 |
Total liabilities | 2,452 | 1,900 |
Related party | ||
Liabilities, Fair Value Disclosure [Abstract] | ||
Derivative financial instruments | 34 | 51 |
Debt | ||
Liabilities, Fair Value Disclosure [Abstract] | ||
Derivative financial instruments | 3 | 11 |
Fair value hierarchy Level 1 | ||
Assets, Fair Value Disclosure [Abstract] | ||
Cash and cash equivalents | 104,087 | 132,496 |
Total assets | 104,087 | 132,496 |
Fair value hierarchy Level 3 | ||
Liabilities, Fair Value Disclosure [Abstract] | ||
Contingent consideration | 2,415 | 1,838 |
Total liabilities | 2,452 | 1,900 |
Fair value hierarchy Level 3 | Related party | ||
Liabilities, Fair Value Disclosure [Abstract] | ||
Derivative financial instruments | 34 | 51 |
Fair value hierarchy Level 3 | Debt | ||
Liabilities, Fair Value Disclosure [Abstract] | ||
Derivative financial instruments | $ 3 | $ 11 |
Fair value measurement - Change
Fair value measurement - Changes in Level 3 Liabilities and Contingent Consideration (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 | |
Changes in Level 3 liabilities | |||
Beginning Balance | $ 1,900 | $ 3,763 | $ 3,763 |
(Gain) Loss recorded due to changes in fair value of derivative liability | 384 | (393) | |
Currency translation effects | 168 | 75 | |
Ending Balance | 2,452 | 3,445 | 1,900 |
Contingent consideration | |||
Changes in Level 3 liabilities | |||
Beginning Balance | 1,838 | 2,926 | 2,926 |
(Gain) Loss recorded due to changes in fair value of derivative liability | 415 | 254 | |
Currency translation effects | 162 | 57 | |
Ending Balance | $ 2,415 | 3,237 | $ 1,838 |
Contingent consideration | InoCard | |||
Contingent consideration | |||
Discount rate (as a percent) | 14.50% | 30.00% | |
Change in fair value | $ 300 | $ 300 | |
The number of months moving out of all milestones | 6 months | 6 months | |
Increase Probability of Success | 20.00% | 20.00% | |
Decrease Probability Of Success | 20.00% | 20.00% | |
Sensitivity down of the discount rate | 10.00% | 20.00% | |
Sensitivity up of the discount rate | 20.00% | 40.00% | |
Level 3 Derivative financial instruments | |||
Changes in Level 3 liabilities | |||
Beginning Balance | $ 62 | 837 | $ 837 |
(Gain) Loss recorded due to changes in fair value of derivative liability | (31) | (647) | |
Currency translation effects | 6 | 18 | |
Ending Balance | 37 | $ 208 | 62 |
Delay in milestones by 6 months | Contingent consideration | InoCard | |||
Contingent consideration | |||
Change in fair value | (152) | (209) | |
Increasing the POS for the first milestone by 20% | Contingent consideration | InoCard | |||
Contingent consideration | |||
Change in fair value | 792 | 367 | |
Decreasing the POS for the first milestone by 20% | Contingent consideration | InoCard | |||
Contingent consideration | |||
Change in fair value | (792) | (367) | |
Reducing the discount rate from 30% to 20% | Contingent consideration | InoCard | |||
Contingent consideration | |||
Change in fair value | 312 | 638 | |
Increasing the discount rate from 30% to 40% | Contingent consideration | InoCard | |||
Contingent consideration | |||
Change in fair value | $ (282) | $ (309) |
Fair value measurement - BMS wa
Fair value measurement - BMS warrants (Details) - USD ($) $ in Millions | Jun. 30, 2017 | Dec. 31, 2016 |
Recurring | Fair value hierarchy Level 3 | BMS Warrants | ||
Fair value measurements | ||
Fair value of derivative asset | $ 0 | $ 0.1 |
Fair value measurement - BMS co
Fair value measurement - BMS collaboration (Details) | 6 Months Ended |
Jun. 30, 2017$ / shares | |
BMS Warrants | |
Collaboration arrangements | |
Number of trading days used to calculate Volume Weighted Average Price ("VWAP") | 20 days |
Number of days prior to purchase or exercise used to calculate Volume Weighted Average Price ("VWAP") | 5 days |
Exercise price in respect of each warrant | $ 33.84 |
Compounded annual growth rate used to determine fair value of exercise price | 10.00% |
uniQure N.V. | First Six New Targets Or Designation Of Sixth Target | BMS | |
Collaboration arrangements | |
Ownership percentage required per agreement | 14.90% |
uniQure N.V. | First Nine New Targets Or Designation Of Ninth Target | BMS | |
Collaboration arrangements | |
Ownership percentage required per agreement | 19.90% |
Collaboration arrangements an35
Collaboration arrangements and concentration of credit risk - Revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Collaboration arrangements | ||||
Revenues | $ 4,942 | $ 4,451 | $ 8,263 | $ 8,746 |
BMS | Minimum | ||||
Collaboration arrangements | ||||
Ownership percentage | 5.00% | 5.00% | ||
Collaboration arrangement | ||||
Collaboration arrangements | ||||
Revenues | $ 4,942 | 4,451 | $ 8,263 | 8,746 |
Collaboration arrangement | BMS | ||||
Collaboration arrangements | ||||
Revenues | 2,110 | 2,643 | 3,617 | 5,271 |
Collaboration arrangement | Chiesi Pharmaceutical | ||||
Collaboration arrangements | ||||
Revenues | $ 2,832 | $ 1,808 | $ 4,646 | $ 3,475 |
Collaboration arrangements an36
Collaboration arrangements and concentration of credit risk - Amounts receivable (Details) - Collaboration arrangement - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Collaboration arrangements | ||
Amounts owed from partners in relation to the collaboration | $ 5,817 | $ 9,180 |
BMS | ||
Collaboration arrangements | ||
Amounts owed from partners in relation to the collaboration | 1,627 | 5,500 |
Chiesi Pharmaceutical | ||
Collaboration arrangements | ||
Amounts owed from partners in relation to the collaboration | $ 4,190 | $ 3,680 |
Collaboration arrangements an37
Collaboration arrangements and concentration of credit risk - BMS (Details) $ in Thousands | Jul. 31, 2015USD ($) | Jun. 30, 2017USD ($) | Jun. 30, 2016USD ($) | Jun. 30, 2017USD ($)item | Jun. 30, 2016USD ($) | Dec. 31, 2016USD ($) | May 21, 2015USD ($) |
Collaboration arrangements | |||||||
Collaboration revenues | $ 3,058 | $ 1,558 | $ 4,638 | $ 2,984 | |||
Collaboration arrangement | BMS | |||||||
Collaboration arrangements | |||||||
Unit of accounting | item | 3 | ||||||
Collaborative revenue | BMS | |||||||
Collaboration arrangements | |||||||
Collaboration revenues | 1,100 | 1,600 | $ 1,700 | 3,300 | |||
License revenue | BMS | |||||||
Collaboration arrangements | |||||||
Number of potential targets included in collaborative agreement | item | 10 | ||||||
Deferred Revenue | $ 60,100 | ||||||
Expected performance term (in years) | 19 years | ||||||
License revenues | $ 1,000 | $ 1,000 | $ 1,900 | $ 2,000 | |||
Royalty term after the first commercial sale | 10 years | ||||||
License revenue | BMS | First Target Selection | |||||||
Collaboration arrangements | |||||||
Milestone payments to be received upon achievement | $ 254,000 | ||||||
License revenue | BMS | Second, Third, and Fourth Targets Selection | |||||||
Collaboration arrangements | |||||||
Target designation payment received | $ 15,000 | ||||||
License revenue | BMS | Fifth through Tenth Targets Selection | |||||||
Collaboration arrangements | |||||||
Maximum target designation payments to which entitled per agreement | 16,500 | ||||||
License revenue | BMS | Other Selected Targets | |||||||
Collaboration arrangements | |||||||
Milestone payments to be received upon achievement | $ 217,000 |
Collaboration arrangements an38
Collaboration arrangements and concentration of credit risk - Chiesi (Details) $ in Thousands, € in Millions | Jun. 30, 2013EUR (€) | Jun. 30, 2013USD ($) | Jun. 30, 2017USD ($) | Jun. 30, 2016USD ($) | Jun. 30, 2017USD ($) | Jun. 30, 2016USD ($) | Dec. 31, 2016 | Dec. 31, 2013EUR (€) | Dec. 31, 2013USD ($) |
Collaboration arrangements | |||||||||
Collaboration revenues | $ 3,058 | $ 1,558 | $ 4,638 | $ 2,984 | |||||
Percentage of costs to be paid by counterparty | 50.00% | ||||||||
Collaborative revenue | Chiesi Pharmaceutical | |||||||||
Collaboration arrangements | |||||||||
Collaboration revenues | 3,100 | $ 1,600 | 4,600 | $ 3,000 | |||||
License revenue | Chiesi Pharmaceutical | |||||||||
Collaboration arrangements | |||||||||
Reduction for amounts previously amortized | 500 | 500 | |||||||
Deferred Revenue | $ 1,800 | $ 1,800 | |||||||
Up-front payment received | € 17 | $ 22,100 | |||||||
Glybera | Chiesi Pharmaceutical | |||||||||
Collaboration arrangements | |||||||||
Repayment of upfront payment | € 2 | $ 2,300 |
Property, plant and equipment,
Property, plant and equipment, net (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 | |
Property, plant and equipment, net | |||||
Total property, plant, and equipment | $ 51,158 | $ 51,158 | $ 47,771 | ||
Less accumulated depreciation | (15,748) | (15,748) | (12,069) | ||
Property, plant and equipment, net | 35,410 | 35,410 | 35,702 | ||
Depreciation | 1,700 | $ 1,300 | 3,400 | $ 2,700 | |
Leasehold improvements | |||||
Property, plant and equipment, net | |||||
Total property, plant, and equipment | 32,405 | 32,405 | 30,582 | ||
Laboratory equipment | |||||
Property, plant and equipment, net | |||||
Total property, plant, and equipment | 15,507 | 15,507 | 14,166 | ||
Office equipment | |||||
Property, plant and equipment, net | |||||
Total property, plant, and equipment | 2,870 | 2,870 | 2,710 | ||
Construction-in-progress | |||||
Property, plant and equipment, net | |||||
Total property, plant, and equipment | $ 376 | $ 376 | $ 313 |
Intangible assets (Details)
Intangible assets (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 | |
Intangible assets | |||||
Total intangible assets | $ 14,388 | $ 14,388 | $ 12,707 | ||
Less accumulated amortization | (5,642) | (5,642) | (4,383) | ||
Intangible assets, net | 8,746 | 8,746 | 8,324 | ||
Amortization expense | 700 | $ 200 | 800 | $ 300 | |
Licenses | |||||
Intangible assets | |||||
Total intangible assets | 9,058 | 9,058 | 7,799 | ||
Acquired research & development | |||||
Intangible assets | |||||
Total intangible assets | 5,330 | 5,330 | $ 4,908 | ||
Chiesi Pharmaceutical | Other Expense | |||||
Intangible assets | |||||
Amortization expense | $ 600 | $ 600 |
Accrued expenses and other cu41
Accrued expenses and other current liabilities (Details) $ in Thousands, € in Millions | Nov. 30, 2016USD ($) | Jun. 30, 2017EUR (€) | Jun. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Dec. 31, 2016USD ($) |
Accrued expenses and other current liabilities | |||||
Accruals for services provided by vendors-not yet billed | $ 3,092 | $ 3,824 | |||
Personnel related accruals and liabilities | 3,974 | 5,559 | |||
Other current liabilities | 2,374 | 383 | |||
Total | 9,440 | $ 9,766 | |||
Severance costs | $ 1,100 | $ 900 | |||
Restructuring Reserve | |||||
Beginning Balance | 1,148 | ||||
Accrued through profit and loss | 908 | ||||
Payments | (1,435) | ||||
Currency translation effects | 48 | ||||
Ending Balance | 669 | ||||
Glybera | |||||
Restructuring Reserve | |||||
Repayment of upfront payment | € 2 | $ 2,300 | |||
Accrued liability towards repayment of installments | 1.5 | 1,700 | |||
Additional payment depending on the number of patients treated before withdrawal | 1.8 | 2,000 | |||
Glybera | Other Current Liabilities | |||||
Restructuring Reserve | |||||
Accrued liability current towards repayment of installments | € 0.5 | 600 | |||
Accrued liability current in relation to Phase IV termination | 600 | ||||
Glybera | Other Expense | |||||
Restructuring Reserve | |||||
Accrued liability in relation to Phase IV termination | $ 900 |
Long-term debt (Details)
Long-term debt (Details) - USD ($) $ in Millions | May 06, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 |
Long-term Debt | ||||||
Interest expense on debt | $ 0.5 | $ 0.6 | $ 1 | $ 1.2 | ||
Venture debt loan facility with Hercules | ||||||
Long-term Debt | ||||||
Outstanding debt | 20 | 20 | $ 20 | |||
Interest rate (as a percent) | 8.25% | |||||
Discount rate (as a percent) | 5.25% | |||||
Back-end fee (as a percent) | 4.85% | |||||
Facility fee (as a percent) | 0.75% | |||||
Amount of first cumulative raisings | $ 30 | |||||
Amount of second cumulative raisings | $ 50 | |||||
Amortized cost net of discount and debt issuance costs | 20.5 | 20.5 | $ 20.2 | |||
Foreign currency gain | $ 1.3 | $ 1.6 | ||||
Foreign currency loss | $ 0.7 | $ 0.2 | ||||
Percentage of worldwide cash reserves | 50.00% |
Share-based compensation - Comp
Share-based compensation - Compensation cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Share-based compensation | ||||
Share-based compensation expense | $ 1,926 | $ 1,449 | $ 3,531 | $ 4,097 |
Unrecognized compensation costs | 14,245 | $ 14,245 | ||
Weighted-average remaining period for recognition (in years) | 2 years 5 months 1 day | |||
Research and development expenses | ||||
Share-based compensation | ||||
Share-based compensation expense | 794 | 918 | $ 1,481 | 1,777 |
Selling, general and administrative expense | ||||
Share-based compensation | ||||
Share-based compensation expense | 1,132 | 531 | 2,050 | 1,650 |
Research and development, excluding 4D | ||||
Share-based compensation | ||||
Share-based compensation expense | 670 | |||
Share options | ||||
Share-based compensation | ||||
Share-based compensation expense | 883 | 1,306 | 1,709 | 3,690 |
Unrecognized compensation costs | 7,520 | $ 7,520 | ||
Weighted-average remaining period for recognition (in years) | 2 years 8 months 27 days | |||
Restricted share units ("RSUs") | ||||
Share-based compensation | ||||
Share-based compensation expense | 716 | 82 | $ 1,232 | 235 |
Unrecognized compensation costs | 4,169 | $ 4,169 | ||
Weighted-average remaining period for recognition (in years) | 1 year 10 months 13 days | |||
Performance share units ("PSUs") | ||||
Share-based compensation | ||||
Share-based compensation expense | 327 | $ 61 | $ 590 | $ 172 |
Unrecognized compensation costs | $ 2,556 | $ 2,556 | ||
Weighted-average remaining period for recognition (in years) | 2 years 4 months 21 days |
Share-based compensation - 2014
Share-based compensation - 2014 Plan Share Options (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Share-based compensation | ||||
Total fair value of shares that vested (in dollars) | $ 0.5 | |||
2014 Plan | Share options | ||||
Share-based compensation | ||||
Total fair value of shares that vested (in dollars) | $ 2.3 | |||
Options | ||||
Outstanding at beginning of year (in shares) | 1,812,766 | |||
Granted (in shares) | 714,600 | |||
Forfeited (in shares) | (118,739) | |||
Expired (in shares) | (55,764) | |||
Outstanding at end of year (in shares) | 2,352,863 | 2,352,863 | ||
Fully vested and exercisable at end of year (in shares) | 816,586 | 816,586 | ||
Outstanding and expected to vest at end of year (in shares) | 1,536,277 | 1,536,277 | ||
Weighted average exercise price | ||||
Outstanding at beginning of year (in euros/dollars per share) | $ 12.47 | |||
Granted (in dollars per share) | 5.59 | |||
Forfeited (in dollars per share) | 9.76 | |||
Expired (in dollars per share) | 15.42 | |||
Outstanding at end of year (in euros/dollars per share) | $ 10.45 | 10.45 | ||
Fully vested and exercisable at end of year (in dollars per share) | $ 12.93 | 12.93 | ||
Outstanding and expected to vest at end of year (in dollars per share) | $ 9.12 | |||
Weighted-average assumptions used to estimate fair value of share options granted during year | ||||
Expected volatility (as a percent) | 75.00% | 75.00% | 75.00% | 75.00% |
Expected terms (in years) | 10 years | 10 years | 10 years | 10 years |
Risk free interest rate (as a percent) | 2.43% | |||
Risk free interest rate, minimum (as a percent) | 1.58% | 2.43% | 0.16% | |
Risk free interest rate, maximum (as a percent) | 1.96% | 2.81% | 1.96% | |
Expected dividend (as a percent) | 0.00% | 0.00% | 0.00% | 0.00% |
2014 Plan | Chief Executive Officer | Share options | ||||
Share-based compensation | ||||
Vesting period | 4 years | |||
Options | ||||
Granted (in shares) | 175,000 | |||
2014 Plan | Non-executive directors | Share options | ||||
Share-based compensation | ||||
Vesting period | 1 year | |||
Options | ||||
Granted (in shares) | 80,000 |
Share-based compensation - 2045
Share-based compensation - 2014 Plan RSUs (Details) - Restricted share units ("RSUs") - 2014 Plan $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2017USD ($)$ / sharesshares | |
Number of shares | |
Undistributed at beginning of year (in shares) | 307,063 |
Granted (in shares) | 408,350 |
Distributed (in shares) | (25,000) |
Forfeited (in shares) | (2,275) |
Undistributed at end of year (in shares) | 688,138 |
Weighted average grant-date fair value | |
Undistributed at beginning of year (in dollars per share) | $ / shares | $ 9.11 |
Granted (in dollars per share) | $ / shares | 5.83 |
Distributed (in dollars per share) | $ / shares | 18.21 |
Forfeited (in dollars per share) | $ / shares | 7.98 |
Undistributed at end of year (in dollars per share) | $ / shares | $ 6.84 |
Other disclosure | |
Total fair value of shares that vested (in dollars) | $ | $ 2.4 |
Chief Executive Officer | |
Number of shares | |
Granted (in shares) | 175,000 |
Other disclosure | |
Vesting period | 2 years |
Non-executive directors | |
Number of shares | |
Granted (in shares) | 80,000 |
Other disclosure | |
Vesting period | 1 year |
Share-based compensation - 2046
Share-based compensation - 2014 Plan PSUs (Details) - 2014 Plan - $ / shares | 1 Months Ended | 6 Months Ended |
Sep. 30, 2016 | Jun. 30, 2017 | |
Performance share units ("PSUs") | ||
Number of shares | ||
Undistributed at beginning of year (in shares) | 111,564 | |
Retired (in shares) | (12,000) | |
Granted (in shares) | 13,000 | |
Distributed (in shares) | (58,500) | |
Undistributed at end of year (in shares) | 54,064 | |
Weighted average grant-date fair value | ||
Undistributed at beginning of year (in dollars per share) | $ 5.76 | |
Retired (in dollars per share) | 5.76 | |
Granted (in dollars per share) | 4.99 | |
Distributed (in dollars per share) | 5.76 | |
Undistributed at end of year (in dollars per share) | $ 5.57 | |
Performance share units, 2017 performance objectives | Executive officers | ||
Number of shares | ||
Granted (in shares) | 426,250 | |
Performance share units, 2017 performance objectives | Chief Executive Officer | ||
Number of shares | ||
Granted (in shares) | 61,560 | 162,500 |
Share-based compensation - Othe
Share-based compensation - Other Plans (Details) $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2017USD ($)$ / sharesshares | |
Other disclosures | |
Total fair value of shares that vested (in dollars) | $ | $ 0.5 |
Other plans | Share options | |
Options | |
Outstanding at beginning of year (in shares) | 187,500 |
Granted (in shares) | 150,000 |
Expired (in shares) | (62,500) |
Outstanding at end of year (in shares) | 275,000 |
Fully vested and exercisable at end of year (in shares) | 31,250 |
Outstanding and expected to vest at end of year (in shares) | 243,750 |
Weighted average exercise price | |
Outstanding at beginning of year (in euros/dollars per share) | $ / shares | $ 17.93 |
Granted (in dollars per share) | $ / shares | 5.31 |
Expired (in dollars per share) | $ / shares | 27.82 |
Outstanding at end of year (in euros/dollars per share) | $ / shares | 8.80 |
Fully vested and exercisable at end of year (in dollars per share) | $ / shares | 12.98 |
Outstanding and expected to vest at end of year (in dollars per share) | $ / shares | $ 8.26 |
Other disclosures | |
Exercised (in shares) | 0 |
Other plans | Restricted share units ("RSUs") | |
Other disclosures | |
Granted (in shares) | 175,000 |
Total fair value of shares that vested (in dollars) | $ | $ 1 |
Share-based compensation - 2012
Share-based compensation - 2012 Plan (Details) - 6 months ended Jun. 30, 2017 - 2012 Plan - Share options $ in Millions | € / shares | USD ($)shares |
Share-based compensation | ||
Proceeds from options exercised | $ | $ 0.9 | |
Options | ||
Outstanding at beginning of year (in shares) | shares | 483,006 | |
Exercised (in shares) | shares | (286,304) | |
Outstanding at end of year (in shares) | shares | 196,702 | |
Weighted average exercise price | ||
Outstanding at beginning of year (in euros/dollars per share) | € / shares | € 5.13 | |
Exercised (in euros per share) | € / shares | 3.07 | |
Outstanding at end of year (in euros/dollars per share) | € / shares | € 8.12 |
Basic and diluted earnings pe49
Basic and diluted earnings per share (Details) - shares | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Basic and diluted earnings per share | ||
Total potential dilutive common shares | 8,886,589 | 7,278,036 |
Warrants | ||
Basic and diluted earnings per share | ||
Total potential dilutive common shares | 37,175 | 37,175 |
Warrants | BMS | ||
Basic and diluted earnings per share | ||
Total potential dilutive common shares | 5,282,647 | 3,442,655 |
Stock options | 2012 Plan | ||
Basic and diluted earnings per share | ||
Total potential dilutive common shares | 196,702 | 687,808 |
Stock options | 2014 Plan | ||
Basic and diluted earnings per share | ||
Total potential dilutive common shares | 2,352,863 | 1,749,760 |
Stock options | Other Plans | ||
Basic and diluted earnings per share | ||
Total potential dilutive common shares | 275,000 | 1,125,000 |
RSUs and PSUs | ||
Basic and diluted earnings per share | ||
Total potential dilutive common shares | 742,202 | 235,638 |
Leases - Minimum Lease Payments
Leases - Minimum Lease Payments and Rent Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Leases | ||||
Rent Expense | $ 1,100 | $ 1,100 | $ 2,100 | $ 1,900 |
Lease incentives | 11,800 | 11,800 | ||
Minimum lease payments | ||||
2017 (six months remaining) | 907 | 907 | ||
2,018 | 3,748 | 3,748 | ||
2,019 | 3,801 | 3,801 | ||
2,020 | 3,854 | 3,854 | ||
2021 and beyond | 27,781 | 27,781 | ||
Total minimum lease payments | $ 40,091 | $ 40,091 |
Leases - Lexington, Massachuset
Leases - Lexington, Massachusetts (Details) $ in Thousands | 1 Months Ended | ||
Jul. 31, 2013item | Jun. 30, 2017USD ($) | Dec. 31, 2016USD ($) | |
Leases | |||
Future minimum lease payments | $ 40,091 | ||
Current deferred rent | 710 | $ 684 | |
Lease for facility in Lexington, Massachusetts, United States | |||
Leases | |||
Lease term (in years) | 10 years | ||
Number of subsequent renewals | item | 2 | ||
Renewal term (in years) | 5 years | ||
Future minimum lease payments | 13,500 | ||
Total deferred rent | 5,900 | 6,200 | |
Current deferred rent | $ 700 | $ 700 |
Leases - Paasheuvelweg, Amsterd
Leases - Paasheuvelweg, Amsterdam (Details) $ in Thousands | 1 Months Ended | 6 Months Ended |
Mar. 31, 2016 | Jun. 30, 2017USD ($)item | |
Leases | ||
Future minimum lease payments | $ 40,091 | |
Lease for Facility in Paasheuvelweg, Amsterdam, Netherlands | ||
Leases | ||
Lease term (in years) | 16 years | |
Number of facility sites consolidated into new site | item | 3 | |
Renewal term (in years) | 5 years | |
Future minimum lease payments | $ 26,600 |
Leases - Meibergdreef, Amsterda
Leases - Meibergdreef, Amsterdam (Details) - Lease for laboratory facility from AMC located at AMC campus in Amsterdam, Netherlands $ in Millions | May 31, 2017USD ($) | Apr. 30, 2015ft² |
Leases | ||
Area of facility subject to lease (in square feet) | ft² | 9,300 | |
Accrued cost to exit the lease | $ | $ 0.8 |
Subsequent event (Details)
Subsequent event (Details) € in Millions, $ in Millions | 3 Months Ended | |||
Sep. 30, 2017USD ($) | Jul. 26, 2017USD ($) | Jun. 30, 2017EUR (€) | Jun. 30, 2017USD ($) | |
Glybera | ||||
Subsequent event | ||||
Additional payment depending on the number of patients treated before withdrawal | € 1.8 | $ 2 | ||
Subsequent events | Chiesi Pharmaceutical | ||||
Subsequent event | ||||
Receivable from Chiesi | $ 2.3 | |||
Outstanding deferred revenue | $ 13.6 |