Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2018 | Aug. 06, 2018 | |
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, 2018 | |
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 | 37,140,478 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q2 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Current assets | ||
Cash and cash equivalents | $ 259,180 | $ 159,371 |
Accounts receivable and accrued income from related party | 1,037 | 1,586 |
Prepaid expenses | 2,071 | 1,139 |
Other current assets | 418 | 687 |
Total current assets | 262,706 | 162,783 |
Non-current assets | ||
Property, plant and equipment, net | 32,126 | 34,281 |
Intangible assets, net | 10,733 | 9,570 |
Goodwill | 516 | 530 |
Restricted cash | 2,458 | 2,480 |
Total non-current assets | 45,833 | 46,861 |
Total assets | 308,539 | 209,644 |
Current liabilities | ||
Accounts payable | 3,866 | 2,908 |
Accrued expenses and other current liabilities | 8,920 | 8,838 |
Current portion of long-term debt | 8,028 | 1,050 |
Current portion of deferred rent | 1,082 | 737 |
Current portion of deferred revenue | 8,463 | 4,613 |
Current portion of contingent consideration | 1,081 | 1,084 |
Total current liabilities | 31,440 | 19,230 |
Non-current liabilities | ||
Long-term debt, net of current portion | 12,840 | 19,741 |
Deferred rent, net of current portion | 8,464 | 9,114 |
Deferred revenue, net of current portion | 32,853 | 67,408 |
Contingent consideration, net of current portion | 2,704 | 2,880 |
Derivative financial instruments related party | 1,309 | 1,298 |
Other non-current liabilities | 513 | 614 |
Total non-current liabilities | 58,683 | 101,055 |
Total liabilities | 90,123 | 120,285 |
Commitments and contingencies (see note 13) | ||
Shareholders' equity | ||
Ordinary shares, €0.05 par value: 60,000,000 shares authorized at June 30, 2018 and December 31, 2017 and 37,126,741 and 31,339,040 ordinary shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively. | 2,288 | 1,947 |
Additional paid-in-capital | 712,399 | 566,530 |
Accumulated other comprehensive loss | (4,688) | (3,800) |
Accumulated deficit | (491,583) | (475,318) |
Total shareholders' equity | 218,416 | 89,359 |
Total liabilities and shareholders' equity | $ 308,539 | $ 209,644 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - € / shares | Jun. 30, 2018 | Dec. 31, 2017 |
CONSOLIDATED BALANCE SHEETS | ||
Ordinary shares, par value (in euros per share) | € 0.05 | € 0.05 |
Ordinary shares, authorized | 60,000,000 | 60,000,000 |
Ordinary shares, issued | 37,126,741 | 31,339,040 |
Ordinary shares, outstanding | 31,771,816 | 31,339,040 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Total revenues | $ 3,050 | $ 4,942 | $ 6,528 | $ 8,263 |
Operating expenses: | ||||
Research and development expenses | (18,493) | (16,866) | (35,551) | (33,860) |
Selling, general and administrative expenses | (5,896) | (5,410) | (12,197) | (11,768) |
Total operating expenses | (24,389) | (22,276) | (47,748) | (45,628) |
Other income | 565 | 266 | 1,180 | 582 |
Other expense | (429) | (2,640) | (762) | (2,640) |
Loss from operations | (21,203) | (19,708) | (40,802) | (39,423) |
Interest income | 583 | 12 | 836 | 23 |
Interest expense | (565) | (502) | (981) | (1,006) |
Foreign currency gains / (losses), net | 2,255 | (1,071) | 2,433 | (1,164) |
Other non-operating (loss) / income, net | (1,301) | (598) | 29 | |
Loss before income tax expense | (20,231) | (21,269) | (39,112) | (41,541) |
Income tax expense | (361) | (269) | ||
Net loss | (20,592) | (21,269) | (39,381) | (41,541) |
Other comprehensive (loss) / income, net of income tax: | ||||
Foreign currency translation adjustments net of tax impact of $0.4 million and nil for the three months ended June 30, 2018 and 2017, respectively, and $0.3 million and nil for the six months ended June 30, 2018 and 2017, respectively. | (2,513) | 404 | (2,692) | 726 |
Total comprehensive loss | $ (23,105) | $ (20,865) | $ (42,073) | $ (40,815) |
Basic and diluted net loss per ordinary share | $ (0.57) | $ (0.83) | $ (1.16) | $ (1.63) |
Weighted average shares used in computing basic and diluted net loss per ordinary share | 36,205,061 | 25,560,348 | 33,970,195 | 25,502,301 |
License revenues | ||||
Total revenues | $ (226) | $ 8 | ||
License revenues from related party | ||||
Total revenues | $ 2,123 | 987 | $ 4,574 | 1,936 |
Collaborative revenues | ||||
Total revenues | 3,058 | 4,638 | ||
Collaborative revenues from related party | ||||
Total revenues | $ 927 | $ 1,123 | $ 1,954 | $ 1,681 |
CONSOLIDATED STATEMENTS OF OPE5
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Millions | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||
Foreign currency translation adjustments, tax | $ 0.4 | $ 0.3 |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - 6 months ended Jun. 30, 2018 - USD ($) $ in Thousands | Ordinary shares | Additional paid-in capital | Accumulated other comprehensive income/(loss) | Accumulated deficit | Total |
Beginning balance at Dec. 31, 2017 | $ 1,947 | $ 566,530 | $ (3,800) | $ (475,318) | $ 89,359 |
Beginning balance (in shares) at Dec. 31, 2017 | 31,339,040 | 31,339,040 | |||
Increase (decrease) in shareholders' equity | |||||
Cumulative effect of retroactive implementation of ASC 606 Revenue recognition | 1,802 | 23,116 | $ 24,918 | ||
Loss for the period | (39,381) | (39,381) | |||
Other comprehensive loss | (2,690) | (2,690) | |||
Follow-on public offering | $ 309 | 138,182 | 138,491 | ||
Follow-on public offering (in shares) | 5,175,000 | ||||
Exercise of share options | $ 12 | 2,975 | 2,987 | ||
Exercise of share options (in shares) | 267,753 | ||||
Restricted share units distributed during the period | $ 20 | (20) | |||
Restricted share units distributed during the period (in shares) | 344,948 | ||||
Share-based compensation expense | 4,732 | 4,732 | |||
Ending balance at Jun. 30, 2018 | $ 2,288 | $ 712,399 | $ (4,688) | $ (491,583) | $ 218,416 |
Ending balance (in shares) at Jun. 30, 2018 | 37,126,741 | 31,771,816 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Cash flows from operating activities | ||
Net loss | $ (39,381) | $ (41,541) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 3,211 | 4,257 |
Share-based compensation expense | 4,732 | 3,531 |
Change in fair value of derivative financial instruments and contingent consideration | 517 | 397 |
Unrealized foreign exchange (gains) / losses | (3,417) | 1,168 |
Change in deferred taxes | 269 | |
Change in lease incentives | (52) | 1,634 |
Changes in operating assets and liabilities: | ||
Accounts receivable and accrued income, prepaid expenses and other current assets | (202) | 5,096 |
Accounts payable | 717 | (1,334) |
Accrued expenses and other liabilities | 208 | (696) |
Deferred revenue | (4,579) | (3,315) |
Net cash used in operating activities | (37,977) | (30,803) |
Cash flows from investing activities | ||
Purchase of intangible assets | (1,445) | (578) |
Purchase of property, plant and equipment | (1,197) | (2,830) |
Net cash used in investing activities | (2,642) | (3,408) |
Cash flows from financing activities | ||
Proceeds from issuance of shares related to employee stock option plans | 2,987 | 939 |
Proceeds from pubic offering of shares, net of issuance costs | 138,491 | |
Net cash generated from financing activities | 141,478 | 939 |
Currency effect cash, cash equivalents and restricted cash | (1,071) | 4,914 |
Net decrease in cash, cash equivalents and restricted cash | 99,787 | (28,358) |
Cash, cash equivalents and restricted cash at beginning of period | 161,851 | 134,324 |
Cash, cash equivalents and restricted cash at the end of period | 261,638 | 105,966 |
Supplemental cash flow disclosures: | ||
Total cash, cash equivalents and restricted cash | 161,851 | 134,324 |
Cash paid for interest | (851) | (840) |
Non-cash increases / (decreases) in accounts payables related to purchases of intangible assets and property, plant and equipment | $ 316 | $ (1,108) |
General business information
General business information | 6 Months Ended |
Jun. 30, 2018 | |
General business information | |
General business information | 1 uniQure (the “Company”) was incorporated on January 9, 2012 as a private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid) under the laws of the Netherlands. 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’s business was founded in 1998 and was initially operated through its predecessor company, Amsterdam Molecular Therapeutics (AMT) Holding N.V (“AMT”). In 2012, AMT undertook a corporate reorganization, pursuant to which uniQure B.V. acquired the entire business and assets of AMT and completed a share-for-share exchange with the shareholders of AMT. Effective February 10, 2014, in connection with its initial public offering, the Company converted into a public company with limited liability (naamloze vennootschap) and changed its legal name from uniQure B.V. to uniQure N.V. The Company is registered in the trade register of the Chamber of Commerce (Kamer van Koophandel) in Amsterdam, the Netherlands under number 54385229. The Company’s headquarters are 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. The Company’s website address is www.uniqure.com. The Company’s ordinary shares are listed on the NASDAQ Global Select Market and trades under the symbol “QURE”. |
Summary of significant accounti
Summary of significant accounting policies | 6 Months Ended |
Jun. 30, 2018 | |
Summary of significant accounting policies | |
Summary of significant accounting policies | 2 2.1 The Company prepared these unaudited 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 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 interim 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 period presented. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been omitted. The results of operations for the six months ended June 30, 2018, are not necessarily indicative of the results to be expected for the full year ending December 31, 2018, or for any other future year or interim period. The accompanying 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, 2017, filed with the SEC on March 14, 2018. 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 consolidated financial statements are described in the Company’s audited financial statements as of and for the year ended December 31, 2017, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on March 14, 2018. There have been no material changes in the Company’s significant accounting policies during the six months ended June 30, 2018, other than the recent adoption of accounting pronouncements discussed below and changing the description of the line item “other non-current assets” to “restricted cash” in the unaudited consolidated balance sheets. 2.5 Recently Adopted Accounting Pronouncements Effective January 1, 2018 the Company adopted new revenue recognition policies in accordance with ASC 606. The new revenue recognition policies replace the existing policies in accordance with ASC 605. The Company elected to implement ASC 606 by applying it to active collaboration arrangements as of January 1, 2018 and to record a cumulative adjustment of revenue previously recognized to the accumulated loss as of December 31, 2017. The impact of implementing ASC 606 is summarized below: - Recognized $2.1 million and $4.6 million of license revenue during the three and six months ended June 30, 2018, respectively related to the collaboration with BMS compared to $1.1 million and $2.2 million, respectively, that would have been recognized in accordance with the previous revenue recognition policies; - Continued to present revenue recognized during the three and six months ended June 30, 2017, in accordance with the previous revenue recognition policies; - Decreased the accumulated loss by $24.9 million as of January 1, 2018 and decreased deferred revenue as of the same date by $24.9 million. In accordance with the previous revenue recognition policies the Company had concluded that the BMS collaboration agreement consisted of three performance obligations, (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, and (iii) clinical and commercial manufacturing. The Company determined that these three performance obligations are substantially identical with the performance obligations in accordance with its new revenue recognition policies: (i) Providing access to its technology and know-how in the field of gene therapy as well as actively contributing to the target selection, the collaboration as a whole, the development during the target selection, the pre-clinical and the clinical phase through participating in joint steering committee and other governing bodies (“License Revenue”); (ii) Providing pre-clinical research activities (“Collaboration Revenue”); and (iii) Providing clinical and commercial manufacturing services for products (“Manufacturing Revenue”). License Revenue The Company previously recognized License Revenue over the expected performance period on a straight-line basis commencing on May 21, 2015. The Company now recognizes License Revenue over the expected performance period based on its progress toward the completion of its services (see note 4 for a detailed discussion). Collaboration and Manufacturing Revenue The adoption of the new revenue recognition policies did not materially impact the recognition of Collaboration or Manufacturing Revenue. ASU 2017-09: Compensation (topic 718)- scope of modification accounting 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 standard became effective on January 1, 2018 and needs to be applied prospectively. Application of ASU 2017-09 did not have a material impact on the Company’s consolidated financial statements in the three or six month period ended June 30, 2018 . ASU 2016-05: Derivatives and Hedging: Effect of Derivative Contract Novations on Existing Hedge Accounting Relationships In March 2016, the FASB issued ASU 2016-05, Derivatives and Hedging: Effect of Derivative Contract Novations on Existing Hedge Accounting Relationships (“ASU 2016-05”) and ASU 2016-06, Derivatives and Hedging: Contingent Put and Call Options in Debt Instruments. Both ASUs address issues regarding hedge accounting. Application of the standard was effective on January 1, 2018 and did not have a material impact on the Company’s consolidated financial statements in the three or six month period ended June 30, 2018. Recent Accounting Pronouncements Not Yet Effective There have been no new accounting pronouncements or changes to accounting pronouncements during the six months ended June 30, 2018, as compared to the recent accounting pronouncements described in Note 2.3.23 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, which could be expected to materially impact the Company’s unaudited condensed consolidated financial statements except the one discussed below: In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). Under the new guidance, lessees will be required to recognize the assets and liabilities that arise from operating leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. For leases with a term of 12 months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities. Lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. ASU 2016-02 will be effective for the Company beginning in the first quarter of 2019 and early application is permitted. The Company does expect ASU 2016-02 to have a material impact on its consolidated financial statements, primarily from recognition of a right-of-use asset and lease liability in the balance sheet and a shift of cash outflows from operating activities to financing activities. |
Fair value measurement
Fair value measurement | 6 Months Ended |
Jun. 30, 2018 | |
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 can 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, accrued income from related parties, 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, 2018, and December 31, 2017: Quoted prices Significant Significant Total Classification in consolidated in thousands At December 31, 2017 Assets: Cash, cash equivalents and restricted cash $ 161,851 $ — $ — $ 161,851 Total assets 161,851 — — 161,851 Liabilities: Derivative financial instruments - debt — — 337 337 Accrued expenses and other current liabilities Derivative financial instruments - related party — — 1,298 1,298 Contingent consideration — — 3,964 3,964 Total liabilities $ — $ — $ 5,599 $ 5,599 At June 30, 2018 Assets: Cash, cash equivalents and restricted cash $ 261,638 $ — $ — $ 261,638 Total assets 261,638 — — 261,638 Liabilities: Derivative financial instruments - debt — — 916 916 Accrued expenses and other current liabilities Derivative financial instruments - related party — — 1,309 1,309 Contingent consideration — — 3,785 3,785 Total liabilities $ — $ — $ 6,010 $ 6,010 Changes in Level 3 items during the six months ended June 30, 2018, are as follows Derivative Contingent financial consideration instruments Total in thousands Balance at December 31, 2017 $ 3,964 $ 1,635 $ 5,599 (Gains) / losses recognized in profit or loss (81) 598 517 Currency translation effects (98) (8) (106) Balance at June 30, 2018 $ 3,785 $ 2,225 $ 6,010 Contingent consideration In connection with the Company’s acquisition of InoCard GmbH (“InoCard”) in 2014, the Company recorded contingent consideration related to amounts potentially payable to InoCard’s former shareholders. One half of any future milestone can be settled in the form of Company ordinary shares. The amounts payable in accordance with the sale and purchase agreement (as amended in August 2017) are contingent upon realization of the following milestones: · Early candidate nomination of product by third party; · Acceptance of investigational new drug application by the United States Food and Drug Administration or an equivalent filing in defined Western European countries or Japan; · Completion of dosing of all patients in the first clinical study; and · Full proof of concept of the product in humans after finalization of the first clinical 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 three milestones as of the balance sheet date), the time at which the research milestones are expected to be achieved (ranging from 2018 to 2022), as well as the discount rate applied, which represents a Level 3 measurement. Milestones are discounted using the Company’s weighted average rate of capital of 12% (December 31, 2017: 12%). Varying the timing of the milestones, the discount rate and the POS of unobservable inputs results in the following fair value changes: June 30, 2018 in thousands Change in fair value Moving out of all milestones by 6 months $ (202) Increasing the POS for the first milestone by 20% 1,152 Decreasing the POS for the first milestone by 20% (1,152) Reducing the discount rate from 12.0% to 2.0% 1,272 Increasing the discount rate from 12.0% to 22.0% (638) 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, 2018, was $2.2 million (December 31, 2017: $1.6 million), and these derivative financial instruments are described in more detail below. BMS collaboration On April 6, 2015, the Company entered into several 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 ordinary 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 ordinary 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. In March 2018, the Company reduced the probability of the warrants being exercised resulting in a reduction of the warrants fair value by $1.1 million. The Company conducted a sensitivity analysis to assess the impact on changes in assumptions on the fair value. Specifically, the Company examined the impact on the fair market of the warrants by increasing the volatility by 10% to 85%. A further sensitivity analysis was performed assuming the exercise date of the warrants would occur one year later than what was assumed in the initial valuation. The table below illustrates the impact on the fair market valuation associated with these changes in assumptions as of June 30, 2018. Total warrants in thousands Base case $ 1,309 Increase volatility by 10% to 85% 327 Extend exercise dates by one year 38 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. There were no significant changes in the sensitivity of the fair value from (un)observable inputs as of June 30, 2018, compared to December 31, 2017. |
Collaboration arrangements and
Collaboration arrangements and concentration of credit risk | 6 Months Ended |
Jun. 30, 2018 | |
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, 2018, the Company generated all collaboration and license revenues from its Collaboration and License Agreement with BMS. The Company and Chiesi Farmaceutici S.p.A. (“Chiesi”) terminated their collaboration in 2017. Services to BMS are rendered through 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, 2018 2017 2018 2017 in thousands Bristol Myers Squibb $ 3,050 $ 2,110 $ 6,528 $ 3,617 Chiesi Farmaceutici S.p.A (terminated in 2017) — 2,832 — 4,646 Total $ 3,050 $ 4,942 $ 6,528 $ 8,263 Amounts owed by BMS in relation to the collaboration services are as follows: June 30, December 31, 2018 2017 in thousands Bristol Myers Squibb $ 1,037 $ 1,586 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 target-specific) 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 AMT-126, 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 AMT-126. 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 its performance obligations according with its new revenue recognition adopted on January 1, 2018, are as follows: (i) Providing access to its technology and know-how in the field of gene therapy as well as actively contributing to the target selection, the collaboration as a whole, the development during the target selection, the pre-clinical and the clinical phase through participating in joint steering committee and other governing bodies (“License Revenue”); (ii) Providing pre-clinical research activities (“Collaboration Revenue”); and (iii) Providing clinical and commercial manufacturing services for products (“Manufacturing Revenue”). License revenue – BMS The Company recognized $2.1 million and $4.6 million of license revenue for the three and six months ended June 30, 2018, respectively, compared to $1.0 million and $1.9 million during the same periods in 2017 in relation to a $60.1 million upfront payment recorded on May 21, 2015, as well as $15.0 million received in relation to the designation of the second, third and fourth collaboration target in August 2015 (together “Consideration”). The Company also is entitled to an aggregate $16.5 million in target designation payments upon the selection of the fifth to tenth collaboration target. The Company will also be eligible to receive research, development and regulatory milestone payments of up to $254.0 million for AMT-126 and up to $217.0 million for each of the other selected targets, if milestones are achieved. The Company will include the variable consideration related to the selection of the fifth to tenth collaboration target, or any of the milestones, in the transaction price once it is considered probable that including these payments in the transaction price would not result in the reversal of cumulative revenue recognized. The Company will recognize significant amounts of License Revenue for services performed in prior periods if and when the Company considers this probable. Due to the significant uncertainty surrounding the development of gene-therapy product candidates and the dependence on BMS’s performance and decisions the Company does not currently consider this probable. Additionally, the Company is eligible to receive net sales-based milestone payments and tiered high single to low double-digit royalties on product sales. 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 the first commercial sale if there is no such exclusivity. These revenues will be recognized when earned. Under the previous revenue standard, the Company recognized License Revenue over the expected performance period on a straight-line basis commencing on May 21, 2015. In accordance with the new revenue recognition standards, the Company recognizes License Revenue over the expected performance period based on its measure of progress towards the completion of certain activities related to its services. The Company determines such progress by comparing activities performed at the end of each reporting period with total activities expected to be performed. The Company estimates total expected activities using a number of unobservable inputs, such as the probability of BMS designating additional targets, the probability of successfully completing each phase and estimated time required to provide services during the various development stages. If available, the Company uses product candidate-specific research and development plans. Alternatively, the Company assumes that completion of the pre-clinical phase requires an average of four years and that clinical development and commercial launch on average require 8.5 years. The estimation of total services at the end of each reporting period involves considerable judgement. The estimated number of product candidates that BMS will pursue significantly impacts the amount of License Revenue the Company recognizes. For example, if the Company would increase the probability of all additional targets being designated by 10% then the revenue for the six months ended June 30, 2018 would have decreased by approximately $1.3 million to $3.3 million, as the Company would be required to render more services in relation to the Consideration received. Collaboration Revenue – BMS The Company provides research and development services to BMS. Collaboration revenue related to these contracted services is recognized when earned. The Company generated $0.9 million and $2.0 million of collaboration revenue during the three and six months ended June 30, 2018, respectively, compared to $1.1 million and $1.7 million during the same periods in 2017. Manufacturing Revenue – BMS BMS and the Company also entered into Master Clinical Supply Agreement in April 2017 for the Company to supply gene therapy products during the clinical as well as into a binding term sheet to supply gene therapy products during the commercial phase to BMS. Revenues from product sales will be recognized when earned. To date the Company has not supplied any clinical and commercial gene therapy product to BMS. |
Property, plant and equipment
Property, plant and equipment | 6 Months Ended |
Jun. 30, 2018 | |
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, 2018, and December 31, 2017: June 30, December 31, 2018 2017 in thousands Leasehold improvements $ 32,428 $ 32,297 Laboratory equipment 15,620 15,976 Office equipment 2,757 2,304 Construction-in-progress 958 745 Total property, plant, and equipment 51,763 51,322 Less accumulated depreciation (19,637) (17,041) Property, plant and equipment, net $ 32,126 $ 34,281 Total depreciation expense was $1.5 million and $3.0 million during the three and six months ended June 30, 2018, respectively, compared to $1.7 million and $3.4 million during the same periods in 2017. |
Intangible assets
Intangible assets | 6 Months Ended |
Jun. 30, 2018 | |
Intangible assets | |
Intangible assets | 6 Intangible assets The following table presents the Company’s acquired licenses: June 30, December 31, 2018 2017 in thousands Licenses $ 7,426 $ 9,551 Less accumulated amortization and impairment (2,143) (5,575) Licenses, net $ 5,283 $ 3,976 Acquired research and development 5,450 5,594 Intangible assets, net $ 10,733 $ 9,570 Amortization expense was $0.1 million and $0.2 million for the three and six months ended June 30, 2018, respectively, compared to $0.7 million and $0.8 million during the same periods in 2017. During the six months ended June 30, 2018, the Company capitalized $1.6 million of expenditures related to contractual milestone payments under existing license agreements as well as costs incurred in relation to entering into new license agreements. During the same period the Company disposed a number of fully amortized, expired licenses. The Company acquired research and development as part of its acquisition of InoCard in July 2014. The carrying amount as at June 30, 2018 is $5.5 million (December 31, 2017: $5.6 million). |
Accrued expenses and other curr
Accrued expenses and other current liabilities, other non-current expenses | 6 Months Ended |
Jun. 30, 2018 | |
Accrued expenses and other current liabilities, other non-current expenses | |
Accrued expenses and other current liabilities, other non-current expenses | 7 Accrued expenses and other current liabilities, other non-current expenses Accrued expenses and other current liabilities include the following items: June 30, December 31, 2018 2017 in thousands Accruals for services provided by vendors-not yet billed $ 3,365 $ 2,348 Personnel related accruals and liabilities 4,694 5,646 Other current liabilities 861 844 Total $ 8,920 $ 8,838 According to the previously reported Glybera Termination Agreement the Company is responsible for terminating the Phase IV post-approval study. As of June 30, 2018, the accrual related to these obligations was $0.4 million (including a non-current portion of $0.2 million) compared to $0.6 million ($0.3 million non-current) as of December 31, 2017. Restructuring plan In November 2016, the Company announced a plan to restructure its activities resulting from 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. At various dates between December 2016 and February 2018, the Company entered into termination agreements with certain employees. Depending on the circumstances surrounding an employee’s departure, the Company accrued the related termination costs over the service period or at the date of communication to the employee. Changes in accrued termination benefits (included in research and development expenses) for the six months ended June 30, 2018, are detailed in the table below. Accrued termination benefits in thousands Balance at December 31, 2017 $ 625 Accrued through operations 96 Payments (644) Currency translation effects 3 Balance at June 30, 2018 $ 80 |
Long-term debt
Long-term debt | 6 Months Ended |
Jun. 30, 2018 | |
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, 2018, and December 31, 2017, $20.0 million was 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 was initially 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 was extended by 12 months to November 30, 2018 as a result of raising more than $50.0 million in equity financing in October 2017. The amortized cost of the 2016 Amended Facility was $20.8 million as June 30, 2018, compared to $20.8 million as of December 31, 2017, and is recorded net of discount and debt issuance costs. The foreign currency loss on the loan in the three and six months ended June 30, 2018, was $1.1 million and $0.6 million, respectively, compared to a foreign currency gain of $1.3 million and $1.6 million during the same periods in 2017. The fair value of the loan approximates its carrying amount. Interest expense associated with the 2016 Amended Facility during the three and six months ended June 30, 2018 was $0.5 million and $0.9 million, respectively, compared to $0.5 million and $1.0 million during the same periods in 2017. 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 deposit location of the cash reserves, and such cash reserves can be used at the discretion of the Company. In combination with other covenants, 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. |
Shareholders equity
Shareholders equity | 6 Months Ended |
Jun. 30, 2018 | |
Shareholders’ equity | |
Shareholders' equity | 9 Shareholders’ Equity On May 7, 2018, the Company completed a follow-on public offering of 5,175,000 ordinary shares at $28.50 per ordinary share, resulting in gross proceeds to the Company of approximately $147.5 million. The net proceeds to the Company from this offering were approximately $138.5 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. The Company capitalized $0.2 million of expenses related to this offering (which were deducted from additional paid-in capital in the accompanying consolidated balance sheet). On May 2, 2018, the Company and Leerink mutually terminated with immediate effect the September 2017 Sales Agreement with Leerink for an at-the-market offering program (“ATM program”). The ATM program allowed for the offer and sale of up to 5 million ordinary shares at prevailing market prices from time to time. The Company did not offer or sell any ordinary shares under the ATM program. |
Share-based compensation
Share-based compensation | 6 Months Ended |
Jun. 30, 2018 | |
Share-based compensation | |
Share-based compensation | 10 Share-based compensation 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, 2018 2017 2018 2017 in thousands Research and development $ 993 $ 794 $ 1,799 $ 1,481 Selling, general and administrative 1,212 1,132 2,933 2,050 Total $ 2,205 $ 1,926 $ 4,732 $ 3,531 Share-based compensation expense recognized by award type was as follows: Three months ended June 30, Six months ended June 30, 2018 2017 2018 2017 in thousands Award type Share options $ 1,096 $ 883 $ 2,155 $ 1,709 Restricted share units (“RSUs”) 540 716 1,286 1,232 Performance share units (“PSUs”) 569 327 1,291 590 Total $ 2,205 $ 1,926 $ 4,732 $ 3,531 As of June 30, 2018, the unrecognized compensation costs related to unvested awards under the various share-based compensation plans were: Weighted-average Unrecognized remaining compensation period for costs recognition Award type in thousands in years Share options $ 12,237 3.18 Restricted share units 4,683 2.00 Performance share units 6,708 2.10 Total $ 23,628 2.64 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 Select Market with terms similar to the 2014 Plan. At the annual general meeting of shareholders in June 2018, the Company’s shareholders approved amendments of the 2014 Plan, increasing the shares authorized for issuance by 3,000,0000 to a total of 8,601,471. The Company previously had a 2012 Equity Incentive Plan (“2012 Plan”). As of June 30, 2018, 33,467 fully vested share options are outstanding (December 31, 2017: 72,818) under the 2012 Plan. Share options The following table summarizes option activity for the six months ended June 30, 2018: Weighted average Options exercise price Outstanding at December 31, 2017 2,456,433 $ 10.06 Granted 708,137 $ 22.24 Forfeited (227,175) $ 12.52 Expired (10,572) $ 13.29 Exercised (232,082) $ 11.63 Outstanding at June 30, 2018 2,694,741 $ 12.91 Fully vested and exercisable at June 30, 2018 948,888 $ 11.38 Outstanding and expected to vest at June 30, 2018 1,745,853 $ 13.74 Total weighted average grant date fair value of options issued during the period (in $ million) $ 13.1 Granted to directors and officers during the period (options, $ in million) 241,961 $ 2.9 Proceeds from option sales (in $ million) $ 3.0 Share options are granted on the date of grant and, except for certain grants made to non-executive directors, vest over a period of four years, the first 25% vests after one year from the initial grant date and the remainder vests in equal quarterly installments, straight-line over years two, three and four. Any options that vest must be exercised by the tenth anniversary of the initial grant date. 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 2018 2017 2018 2017 Expected volatility 75% 75% 75% 75% Expected terms (in years) 10 years 10 years 10 years 10 years Risk free interest rate 2.99% - 3.07% 2.43% 2.77% - 3.07% 2.43% - 2.81% Expected dividends 0% 0% 0% 0% Restricted Share Units (RSUs) The following table summarizes the RSUs activity for the six months ended June 30, 2018: RSU Weighted average grant-date fair Number of shares value Non-vested at December 31, 2017 683,663 $ 6.38 Granted 212,599 $ 19.41 Vested (276,833) $ 5.99 Forfeited (53,854) $ 11.08 Non-vested at June 30, 2018 565,575 $ 11.03 Total fair value of RSUs awarded during the period (in million) $ 4.1 Granted to directors and officers during the period (shares, $ in million) 98,808 $ 1.9 RSUs vest over one to three years. RSUs granted in March 2017 to the Company’s Chief Executive Officer will vest equally over two years from the date of grant and RSUs granted to non-executive directors will vest one year from the date of grant. Performance Share Units (PSUs) The following table summarizes the PSUs activity for the six months ended June 30, 2018: PSU Weighted average grant-date fair Number of shares value Non-vested at December 31, 2017 511,074 $ 16.73 Granted — Vested (68,115) $ 15.79 Forfeited (64,681) $ 18.24 Non-vested at June 30, 2018 378,278 $ 16.74 PSUs awarded but not yet earned 117,197 $ 23.50 Total non-vested and discretionary PSUs 495,475 $ 18.34 Total weighted average grant date fair value of PSUs awarded during the period (in million) $ 2.8 In January 2018, the Company awarded PSUs to its executives and other members of senior management. These PSUs are earned based on the Board’s assessment of the level of achievement of agreed upon performance targets through December 31, 2018. |
Income taxes
Income taxes | 6 Months Ended |
Jun. 30, 2018 | |
Income taxes | |
Income taxes | 11 Income taxes Deferred tax assets and deferred tax liabilities are recognized based on the expected future tax consequences of 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 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, 2018 | |
Basic and diluted earnings per share | |
Basic and diluted earnings per share | 12 Basic and diluted earnings per share Diluted earnings per share are calculated by adjusting the weighted average number of ordinary shares outstanding, assuming conversion of all potentially dilutive ordinary shares. As the Company has incurred a loss, all potentially dilutive ordinary shares would have an antidilutive effect, if converted, and thus have been excluded from the computation of loss per share. The potentially dilutive ordinary shares are summarized below: June 30, 2018 2017 ordinary shares BMS warrants 7,530,000 5,282,647 Stock options under 2014 Plan and Nasdaq inducement rules 2,694,741 2,627,863 Non-vested RSUs and earned PSUs 943,853 742,202 Stock options under 2012 Plan 33,467 196,702 Warrants 37,175 37,175 Total potential dilutive ordinary shares 11,239,236 8,886,589 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2018 | |
Leases | |
Leases | 13 Leases The Company leases various office space and laboratory space under the following operating lease agreements: Lexington, Massachusetts / United States 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 lease provides for annual minimum increases in rent, based on a consumer price index. Amsterdam / The Netherlands 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. The lease contract provides for annual minimum increases in rent based on a consumer price index. On December 1, 2017, the Company entered into an agreement to sub-lease three of the seven floors of its Amsterdam facility for a ten-year term ending on December 31, 2027, with an option for the sub-lessee to extend until December 31, 2031. The minimum rentals to be received through December 31, 2027 amount to $10.2 million as of June 30, 2018. As of June 30, 2018, aggregate minimum lease payments for the calendar years and lease incentives received were as follows: Lexington Amsterdam Total in thousands 2018 (six months remaining) $ 934 $ 985 $ 1,919 2019 1,903 1,971 3,874 2020 1,956 1,971 3,927 2021 2,009 1,971 3,980 2022 and beyond 4,890 20,029 24,919 Total minimum lease payments $ 11,692 $ 26,927 $ 38,619 Deferred rent related to lease incentives-non current $ 4,440 $ 4,024 $ 8,464 Deferred rent related to lease incentives-current 764 318 1,082 Rent expense is calculated on a straight-line basis over the term of the leases and considers the lease incentives received. Aggregate rent expense was as follows: Three months ended June 30, Six months ended June 30, 2018 2017 2018 2017 in thousands Rent expense-Lexington $ 278 $ 274 $ 556 $ 552 Rent expense-Amsterdam 422 777 851 1,525 Total rent expense $ 700 $ 1,051 $ 1,407 $ 2,077 |
Subsequent event
Subsequent event | 6 Months Ended |
Jun. 30, 2018 | |
Subsequent event | |
Subsequent event | 14 Subsequent event The Company appointed Robert Gut M.D., Ph.D. as Chief Medical Officer effective August 20, 2018. Dr. Gut has served as a non-executive member of the Company’s Board of Directors since June 2018 and the Company expects that Dr. Gut will be appointed as an executive director of the Board pursuant to Dutch law. Contingent on the negotiation and execution of a final employment agreement, the Board approved an annual base salary for Dr. Gut of $425,000, eligibility for an annual bonus of 40% of his base salary, and an initial stock grant of 35,000 restricted stock units and an option to purchase 70,000 ordinary shares of the Company. Dr. Gut has nearly 20 years of experience in the biopharmaceutical industry leading clinical development and medical affairs activities in hematology and other therapeutic areas and will succeed Steven Zelenkofske, who recently resigned effective August 20, 2018 due to personal reasons. |
Summary of significant accoun22
Summary of significant accounting policies (Policies) | 6 Months Ended |
Jun. 30, 2018 | |
Summary of significant accounting policies | |
Basis of preparation | 2.1 The Company prepared these unaudited 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 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. |
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. |
Recent accounting pronouncements | 2.5 Recently Adopted Accounting Pronouncements Effective January 1, 2018 the Company adopted new revenue recognition policies in accordance with ASC 606. The new revenue recognition policies replace the existing policies in accordance with ASC 605. The Company elected to implement ASC 606 by applying it to active collaboration arrangements as of January 1, 2018 and to record a cumulative adjustment of revenue previously recognized to the accumulated loss as of December 31, 2017. The impact of implementing ASC 606 is summarized below: - Recognized $2.1 million and $4.6 million of license revenue during the three and six months ended June 30, 2018, respectively related to the collaboration with BMS compared to $1.1 million and $2.2 million, respectively, that would have been recognized in accordance with the previous revenue recognition policies; - Continued to present revenue recognized during the three and six months ended June 30, 2017, in accordance with the previous revenue recognition policies; - Decreased the accumulated loss by $24.9 million as of January 1, 2018 and decreased deferred revenue as of the same date by $24.9 million. In accordance with the previous revenue recognition policies the Company had concluded that the BMS collaboration agreement consisted of three performance obligations, (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, and (iii) clinical and commercial manufacturing. The Company determined that these three performance obligations are substantially identical with the performance obligations in accordance with its new revenue recognition policies: (i) Providing access to its technology and know-how in the field of gene therapy as well as actively contributing to the target selection, the collaboration as a whole, the development during the target selection, the pre-clinical and the clinical phase through participating in joint steering committee and other governing bodies (“License Revenue”); (ii) Providing pre-clinical research activities (“Collaboration Revenue”); and (iii) Providing clinical and commercial manufacturing services for products (“Manufacturing Revenue”). License Revenue The Company previously recognized License Revenue over the expected performance period on a straight-line basis commencing on May 21, 2015. The Company now recognizes License Revenue over the expected performance period based on its progress toward the completion of its services (see note 4 for a detailed discussion). Collaboration and Manufacturing Revenue The adoption of the new revenue recognition policies did not materially impact the recognition of Collaboration or Manufacturing Revenue. ASU 2017-09: Compensation (topic 718)- scope of modification accounting 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 standard became effective on January 1, 2018 and needs to be applied prospectively. Application of ASU 2017-09 did not have a material impact on the Company’s consolidated financial statements in the three or six month period ended June 30, 2018 . ASU 2016-05: Derivatives and Hedging: Effect of Derivative Contract Novations on Existing Hedge Accounting Relationships In March 2016, the FASB issued ASU 2016-05, Derivatives and Hedging: Effect of Derivative Contract Novations on Existing Hedge Accounting Relationships (“ASU 2016-05”) and ASU 2016-06, Derivatives and Hedging: Contingent Put and Call Options in Debt Instruments. Both ASUs address issues regarding hedge accounting. Application of the standard was effective on January 1, 2018 and did not have a material impact on the Company’s consolidated financial statements in the three or six month period ended June 30, 2018. Recent Accounting Pronouncements Not Yet Effective There have been no new accounting pronouncements or changes to accounting pronouncements during the six months ended June 30, 2018, as compared to the recent accounting pronouncements described in Note 2.3.23 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, which could be expected to materially impact the Company’s unaudited condensed consolidated financial statements except the one discussed below: In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). Under the new guidance, lessees will be required to recognize the assets and liabilities that arise from operating leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. For leases with a term of 12 months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities. Lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. ASU 2016-02 will be effective for the Company beginning in the first quarter of 2019 and early application is permitted. The Company does expect ASU 2016-02 to have a material impact on its consolidated financial statements, primarily from recognition of a right-of-use asset and lease liability in the balance sheet and a shift of cash outflows from operating activities to financing activities |
Fair value measurement (Tables)
Fair value measurement (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
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, 2017 Assets: Cash, cash equivalents and restricted cash $ 161,851 $ — $ — $ 161,851 Total assets 161,851 — — 161,851 Liabilities: Derivative financial instruments - debt — — 337 337 Accrued expenses and other current liabilities Derivative financial instruments - related party — — 1,298 1,298 Contingent consideration — — 3,964 3,964 Total liabilities $ — $ — $ 5,599 $ 5,599 At June 30, 2018 Assets: Cash, cash equivalents and restricted cash $ 261,638 $ — $ — $ 261,638 Total assets 261,638 — — 261,638 Liabilities: Derivative financial instruments - debt — — 916 916 Accrued expenses and other current liabilities Derivative financial instruments - related party — — 1,309 1,309 Contingent consideration — — 3,785 3,785 Total liabilities $ — $ — $ 6,010 $ 6,010 |
Schedule of changes in Level 3 items | Derivative Contingent financial consideration instruments Total in thousands Balance at December 31, 2017 $ 3,964 $ 1,635 $ 5,599 (Gains) / losses recognized in profit or loss (81) 598 517 Currency translation effects (98) (8) (106) Balance at June 30, 2018 $ 3,785 $ 2,225 $ 6,010 |
Schedule of changes in fair value of unobservable inputs | June 30, 2018 in thousands Change in fair value Moving out of all milestones by 6 months $ (202) Increasing the POS for the first milestone by 20% 1,152 Decreasing the POS for the first milestone by 20% (1,152) Reducing the discount rate from 12.0% to 2.0% 1,272 Increasing the discount rate from 12.0% to 22.0% (638) |
Schedule of changes in assumptions for fair value of warrants | Total warrants in thousands Base case $ 1,309 Increase volatility by 10% to 85% 327 Extend exercise dates by one year 38 |
Collaboration arrangements an24
Collaboration arrangements and concentration of credit risk (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Collaboration arrangements and concentration of credit risk | |
Schedule of collaboration and license revenue | Three months ended June 30, Six months ended June 30, 2018 2017 2018 2017 in thousands Bristol Myers Squibb $ 3,050 $ 2,110 $ 6,528 $ 3,617 Chiesi Farmaceutici S.p.A (terminated in 2017) — 2,832 — 4,646 Total $ 3,050 $ 4,942 $ 6,528 $ 8,263 |
Schedule of amounts owed in relation to collaboration | June 30, December 31, 2018 2017 in thousands Bristol Myers Squibb $ 1,037 $ 1,586 |
Property, plant and equipment (
Property, plant and equipment (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Property, plant and equipment | |
Schedule of property, plant and equipment | June 30, December 31, 2018 2017 in thousands Leasehold improvements $ 32,428 $ 32,297 Laboratory equipment 15,620 15,976 Office equipment 2,757 2,304 Construction-in-progress 958 745 Total property, plant, and equipment 51,763 51,322 Less accumulated depreciation (19,637) (17,041) Property, plant and equipment, net $ 32,126 $ 34,281 |
Intangible assets (Tables)
Intangible assets (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Intangible assets | |
Schedule of finite-lived intangible assets | June 30, December 31, 2018 2017 in thousands Licenses $ 7,426 $ 9,551 Less accumulated amortization and impairment (2,143) (5,575) Licenses, net $ 5,283 $ 3,976 Acquired research and development 5,450 5,594 Intangible assets, net $ 10,733 $ 9,570 |
Accrued expenses and other cu27
Accrued expenses and other current liabilities, other non-current expenses (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Accrued expenses and other current liabilities, other non-current expenses | |
Schedule of accrued expenses and other current liabilities | June 30, December 31, 2018 2017 in thousands Accruals for services provided by vendors-not yet billed $ 3,365 $ 2,348 Personnel related accruals and liabilities 4,694 5,646 Other current liabilities 861 844 Total $ 8,920 $ 8,838 |
Schedule of change in accrual of termination benefits | Accrued termination benefits in thousands Balance at December 31, 2017 $ 625 Accrued through operations 96 Payments (644) Currency translation effects 3 Balance at June 30, 2018 $ 80 |
Share-based compensation (Table
Share-based compensation (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
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, 2018 2017 2018 2017 in thousands Research and development $ 993 $ 794 $ 1,799 $ 1,481 Selling, general and administrative 1,212 1,132 2,933 2,050 Total $ 2,205 $ 1,926 $ 4,732 $ 3,531 |
Schedule of share-based compensation expense | Three months ended June 30, Six months ended June 30, 2018 2017 2018 2017 in thousands Award type Share options $ 1,096 $ 883 $ 2,155 $ 1,709 Restricted share units (“RSUs”) 540 716 1,286 1,232 Performance share units (“PSUs”) 569 327 1,291 590 Total $ 2,205 $ 1,926 $ 4,732 $ 3,531 |
Schedule of unrecognized compensation cost related to unvested awards | Weighted-average Unrecognized remaining compensation period for costs recognition Award type in thousands in years Share options $ 12,237 3.18 Restricted share units 4,683 2.00 Performance share units 6,708 2.10 Total $ 23,628 2.64 |
Schedule of weighted-average assumptions for fair value of option issued | Three months ended June 30, Six months ended June 30, Assumptions 2018 2017 2018 2017 Expected volatility 75% 75% 75% 75% Expected terms (in years) 10 years 10 years 10 years 10 years Risk free interest rate 2.99% - 3.07% 2.43% 2.77% - 3.07% 2.43% - 2.81% Expected dividends 0% 0% 0% 0% |
Summary of RSUs activity | RSU Weighted average grant-date fair Number of shares value Non-vested at December 31, 2017 683,663 $ 6.38 Granted 212,599 $ 19.41 Vested (276,833) $ 5.99 Forfeited (53,854) $ 11.08 Non-vested at June 30, 2018 565,575 $ 11.03 Total fair value of RSUs awarded during the period (in million) $ 4.1 Granted to directors and officers during the period (shares, $ in million) 98,808 $ 1.9 |
Summary of PSUs activity | PSU Weighted average grant-date fair Number of shares value Non-vested at December 31, 2017 511,074 $ 16.73 Granted — Vested (68,115) $ 15.79 Forfeited (64,681) $ 18.24 Non-vested at June 30, 2018 378,278 $ 16.74 PSUs awarded but not yet earned 117,197 $ 23.50 Total non-vested and discretionary PSUs 495,475 $ 18.34 Total weighted average grant date fair value of PSUs awarded during the period (in million) $ 2.8 |
2014 Plan | |
Share-based compensation | |
Summary of option activity | Weighted average Options exercise price Outstanding at December 31, 2017 2,456,433 $ 10.06 Granted 708,137 $ 22.24 Forfeited (227,175) $ 12.52 Expired (10,572) $ 13.29 Exercised (232,082) $ 11.63 Outstanding at June 30, 2018 2,694,741 $ 12.91 Fully vested and exercisable at June 30, 2018 948,888 $ 11.38 Outstanding and expected to vest at June 30, 2018 1,745,853 $ 13.74 Total weighted average grant date fair value of options issued during the period (in $ million) $ 13.1 Granted to directors and officers during the period (options, $ in million) 241,961 $ 2.9 Proceeds from option sales (in $ million) $ 3.0 |
Basic and diluted earnings pe29
Basic and diluted earnings per share (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Basic and diluted earnings per share | |
Schedule of potential dilutive common shares | June 30, 2018 2017 ordinary shares BMS warrants 7,530,000 5,282,647 Stock options under 2014 Plan and Nasdaq inducement rules 2,694,741 2,627,863 Non-vested RSUs and earned PSUs 943,853 742,202 Stock options under 2012 Plan 33,467 196,702 Warrants 37,175 37,175 Total potential dilutive ordinary shares 11,239,236 8,886,589 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Leases | |
Schedule of minimum lease payments | Lexington Amsterdam Total in thousands 2018 (six months remaining) $ 934 $ 985 $ 1,919 2019 1,903 1,971 3,874 2020 1,956 1,971 3,927 2021 2,009 1,971 3,980 2022 and beyond 4,890 20,029 24,919 Total minimum lease payments $ 11,692 $ 26,927 $ 38,619 Deferred rent related to lease incentives-non current $ 4,440 $ 4,024 $ 8,464 Deferred rent related to lease incentives-current 764 318 1,082 |
Summary of aggregate rent expense | Three months ended June 30, Six months ended June 30, 2018 2017 2018 2017 in thousands Rent expense-Lexington $ 278 $ 274 $ 556 $ 552 Rent expense-Amsterdam 422 777 851 1,525 Total rent expense $ 700 $ 1,051 $ 1,407 $ 2,077 |
Summary of significant accoun31
Summary of significant accounting policies (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||
Revenue | $ 3,050 | $ 4,942 | $ 6,528 | $ 8,263 | |
Accumulated loss | (491,583) | (491,583) | $ (475,318) | ||
ASU 2014-09 | |||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||
Accumulated loss | 24,900 | 24,900 | |||
Deferred Revenue | (24,900) | (24,900) | |||
License revenues | |||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||
Revenue | 2,100 | 4,600 | |||
Before Topic 606 | License revenues | |||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||
Revenue | $ 1,100 | $ 2,200 |
Fair value measurement - Assets
Fair value measurement - Assets and Liabilities (Details) - Recurring - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Assets, Fair Value Disclosure [Abstract] | ||
Cash and cash equivalents | $ 261,638 | $ 161,851 |
Total assets | 261,638 | 161,851 |
Liabilities, Fair Value Disclosure [Abstract] | ||
Contingent consideration | 3,785 | 3,964 |
Total liabilities | 6,010 | 5,599 |
Related party | ||
Liabilities, Fair Value Disclosure [Abstract] | ||
Derivative financial instruments | 1,309 | 1,298 |
Debt | ||
Liabilities, Fair Value Disclosure [Abstract] | ||
Derivative financial instruments | 916 | 337 |
Fair value hierarchy Level 1 | ||
Assets, Fair Value Disclosure [Abstract] | ||
Cash and cash equivalents | 261,638 | 161,851 |
Total assets | 261,638 | 161,851 |
Level 3 | ||
Liabilities, Fair Value Disclosure [Abstract] | ||
Contingent consideration | 3,785 | 3,964 |
Total liabilities | 6,010 | 5,599 |
Level 3 | Related party | ||
Liabilities, Fair Value Disclosure [Abstract] | ||
Derivative financial instruments | 1,309 | 1,298 |
Level 3 | Debt | ||
Liabilities, Fair Value Disclosure [Abstract] | ||
Derivative financial instruments | $ 916 | $ 337 |
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, 2018 | Dec. 31, 2017 | Dec. 31, 2014 | |
Changes in Level 3 liabilities | |||
Beginning Balance | $ 1,600 | ||
Ending Balance | $ 2,200 | $ 1,600 | |
Contingent consideration | |||
Company's weighted average rate of capital | 12.00% | 12.00% | |
Fair value of derivative financial instruments | $ 1,600 | $ 1,600 | |
Contingent consideration | InoCard | |||
Contingent consideration | |||
Percentage of future milestones that can be settled with ordinary shares, reduced rate | 50.00% | ||
Level 3 | |||
Changes in Level 3 liabilities | |||
Beginning Balance | 5,599 | ||
(Gains) / losses recognized in profit or loss | 517 | ||
Currency translation effects | (106) | ||
Ending Balance | 6,010 | 5,599 | |
Contingent consideration | |||
Fair value of derivative financial instruments | 5,599 | 5,599 | |
Level 3 | Contingent consideration | |||
Changes in Level 3 liabilities | |||
Beginning Balance | 3,964 | ||
(Gains) / losses recognized in profit or loss | (81) | ||
Currency translation effects | (98) | ||
Ending Balance | 3,785 | 3,964 | |
Contingent consideration | |||
Fair value of derivative financial instruments | 3,964 | 3,964 | |
Level 3 | Derivative financial instruments | |||
Changes in Level 3 liabilities | |||
Beginning Balance | 1,635 | ||
(Gains) / losses recognized in profit or loss | 598 | ||
Currency translation effects | (8) | ||
Ending Balance | $ 2,225 | 1,635 | |
Contingent consideration | |||
Moving out of all milestones, in months | 6 months | ||
Increasing the POS for the first milestone | 20.00% | ||
Decreasing the POS for the first milestone | 20.00% | ||
Discount rate | 12.00% | ||
Reduced discount rate | 2.00% | ||
Increased discount rate | 22.00% | ||
Fair value of derivative financial instruments | $ 1,635 | $ 1,635 | |
Moving out of all milestones by 6 months | Level 3 | Derivative financial instruments | |||
Contingent consideration | |||
Change in fair value based on change in variable | (202) | ||
Increasing the POS for the first milestone by 20% | Level 3 | Derivative financial instruments | |||
Contingent consideration | |||
Change in fair value based on change in variable | 1,152 | ||
Decreasing the POS for the first milestone by 20% | Level 3 | Derivative financial instruments | |||
Contingent consideration | |||
Change in fair value based on change in variable | (1,152) | ||
Reducing the discount rate from 12.0% to 2.0% | Level 3 | Derivative financial instruments | |||
Contingent consideration | |||
Change in fair value based on change in variable | 1,272 | ||
Increasing the discount rate from 12.0% to 22.0% | Level 3 | Derivative financial instruments | |||
Contingent consideration | |||
Change in fair value based on change in variable | $ (638) |
Fair value measurement - BMS co
Fair value measurement - BMS collaboration (Details) $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2018USD ($)$ / shares | |
BMS Warrants | |
Collaboration arrangements | |
Exercise price in respect of each warrant | $ / shares | $ 33.84 |
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 |
Decrease in fair value due to reduced probability of warrants being exercised | $ | $ 1.1 |
Compounded annual growth rate used to determine fair value of exercise price | 10.00% |
Increase in volatility rate | 10.00% |
Volatility rate | 85.00% |
uniQure N.V. | BMS | First Six New Targets Or Designation Of Sixth Target | |
Collaboration arrangements | |
Ownership percentage required per agreement | 14.90% |
uniQure N.V. | BMS | First Nine New Targets Or Designation Of Ninth Target | |
Collaboration arrangements | |
Ownership percentage required per agreement | 19.90% |
Fair value measurement - Sensit
Fair value measurement - Sensitivity analysis on warrants (Details) - BMS Warrants $ in Thousands | 6 Months Ended |
Jun. 30, 2018USD ($) | |
Fair value measurements | |
Base case | $ 1,309 |
Increase volatility by 10% to 85% | 327 |
Extend exercise dates by one year | $ 38 |
Collaboration arrangements an36
Collaboration arrangements and concentration of credit risk - Revenues from and amounts owed with collaboration partners (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||
Total | $ 3,050 | $ 4,942 | $ 6,528 | $ 8,263 | |
Amounts owed by BMS in relation to the collaboration services | 1,037 | 1,037 | $ 1,586 | ||
BMS | |||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||
Total | $ 3,050 | 2,110 | $ 6,528 | 3,617 | |
Chiesi Pharmaceutical | |||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||
Total | $ 2,832 | $ 4,646 |
Collaboration arrangements an37
Collaboration arrangements and concentration of credit risk - BMS collaboration (Details) $ in Thousands | May 21, 2015USD ($) | Aug. 31, 2015USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2017USD ($) | Jun. 30, 2018USD ($)item | Jun. 30, 2017USD ($) |
Collaboration arrangements | ||||||
Revenue | $ 3,050 | $ 4,942 | $ 6,528 | $ 8,263 | ||
Minimum | ||||||
Collaboration arrangements | ||||||
Decrease in revenue | 1,300 | |||||
Maximum | ||||||
Collaboration arrangements | ||||||
Decrease in revenue | 3,300 | |||||
BMS | ||||||
Collaboration arrangements | ||||||
Revenue | $ 3,050 | $ 2,110 | $ 6,528 | $ 3,617 | ||
License revenue | BMS | ||||||
Collaboration arrangements | ||||||
Number of potential targets included in collaborative agreement | item | 10 | |||||
Upfront payment recorded | $ 60,100 | |||||
Royalty term after the first commercial sale | 10 years | |||||
Average period for completion of pre-clinical phase | 4 years | |||||
Average period for completion of clinical development and commercial launch | 8 years 6 months | |||||
Percentage of increase in probability of all additional targets | 10 | |||||
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 |
Property, plant and equipment38
Property, plant and equipment (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | |
Property, plant and equipment, net | |||||
Total property, plant, and equipment | $ 51,763 | $ 51,763 | $ 51,322 | ||
Less accumulated depreciation | (19,637) | (19,637) | (17,041) | ||
Property, plant and equipment, net | 32,126 | 32,126 | 34,281 | ||
Depreciation | 1,500 | $ 1,700 | 3,000 | $ 3,400 | |
Leasehold improvements | |||||
Property, plant and equipment, net | |||||
Total property, plant, and equipment | 32,428 | 32,428 | 32,297 | ||
Laboratory equipment | |||||
Property, plant and equipment, net | |||||
Total property, plant, and equipment | 15,620 | 15,620 | 15,976 | ||
Office equipment | |||||
Property, plant and equipment, net | |||||
Total property, plant, and equipment | 2,757 | 2,757 | 2,304 | ||
Construction-in-progress | |||||
Property, plant and equipment, net | |||||
Total property, plant, and equipment | $ 958 | $ 958 | $ 745 |
Intangible assets (Details)
Intangible assets (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | |
Intangible assets | |||||
Intangible assets, net | $ 10,733 | $ 10,733 | $ 9,570 | ||
Amortization expense | 100 | $ 700 | 200 | $ 800 | |
Capitalized expenditures related to milestone payments | 1,600 | ||||
Licenses | |||||
Intangible assets | |||||
Total intangible assets | 7,426 | 7,426 | 9,551 | ||
Less accumulated amortization | (2,143) | (2,143) | (5,575) | ||
Intangible assets, net | 5,283 | 5,283 | 3,976 | ||
Acquired research & development | |||||
Intangible assets | |||||
Intangible assets, net | $ 5,450 | $ 5,450 | $ 5,594 |
Accrued expenses and other cu40
Accrued expenses and other current liabilities, other non-current expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Accrued expenses and other current liabilities | ||
Accruals for services provided by vendors-not yet billed | $ 3,365 | $ 2,348 |
Personnel related accruals and liabilities | 4,694 | 5,646 |
Other current liabilities | 861 | 844 |
Total | 8,920 | 8,838 |
Glybera | ||
Accrued expenses and other current liabilities | ||
Accrual for termination agreement, current portion | 400 | 600 |
Accrual for termination agreement, non-current portion | $ 200 | $ 300 |
Accrued expenses and other cu41
Accrued expenses and other current liabilities, other non-current expenses - Restructuring plan (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2018USD ($) | |
Restructuring Reserve | |
Beginning Balance | $ 625 |
Accrued through profit and loss | 96 |
Payments | (644) |
Currency translation effects | 3 |
Ending Balance | $ 80 |
Long-term debt (Details)
Long-term debt (Details) - USD ($) $ in Millions | May 06, 2016 | Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 |
Long-term Debt | ||||||
Interest rate (as a percent) | 8.25% | |||||
Maximum borrowing capacity | $ 50 | $ 50 | ||||
Foreign currency loss | 1.1 | 0.6 | ||||
Foreign currency gain | $ 1.3 | $ 1.6 | ||||
Interest expense recorded | 0.5 | $ 0.5 | 0.9 | $ 1 | ||
Venture debt loan facility with Hercules | ||||||
Long-term Debt | ||||||
Outstanding debt | 20 | $ 20 | $ 20 | |||
Discount rate (as a percent) | 5.25% | |||||
Back-end fee (as a percent) | 4.85% | |||||
Facility fee (as a percent) | 0.75% | |||||
Percentage of worldwide cash reserves | 50.00% | |||||
Aggregate maturities of loan | ||||||
Amortized cost net of discount and debt issuance costs | $ 20.8 | $ 20.8 | $ 20.8 |
Shareholders_ equity (Details)
Shareholders’ equity (Details) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | May 07, 2018 | May 02, 2018 | Jun. 30, 2018 |
Shareholders’ equity | |||
Offering price per share of shares issued | $ 28.50 | ||
Gross Proceeds From Issuance Initial Public Offering | $ 147,500 | ||
Proceeds from issuance initial public offering | $ 138,491 | ||
Expenses capitalized related to offering | $ 200 | ||
Shares authorized under offering program | 5 |
Share-based compensation - Summ
Share-based compensation - Summary of share-based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Share-based compensation | ||||
Share-based compensation expense | $ 2,205 | $ 1,926 | $ 4,732 | $ 3,531 |
Unrecognized compensation costs | 23,628 | $ 23,628 | ||
Weighted-average remaining period for recognition (in years) | 2 years 7 months 21 days | |||
Research and development expenses | Employees | ||||
Share-based compensation | ||||
Share-based compensation expense | 993 | 794 | $ 1,799 | 1,481 |
Selling, general and administrative expense | Employees | ||||
Share-based compensation | ||||
Share-based compensation expense | 1,212 | 1,132 | 2,933 | 2,050 |
Share options | ||||
Share-based compensation | ||||
Share-based compensation expense | 1,096 | 883 | 2,155 | 1,709 |
Unrecognized compensation costs | 12,237 | $ 12,237 | ||
Weighted-average remaining period for recognition (in years) | 3 years 2 months 5 days | |||
Restricted share units ("RSUs") | ||||
Share-based compensation | ||||
Share-based compensation expense | 540 | 716 | $ 1,286 | 1,232 |
Unrecognized compensation costs | 4,683 | $ 4,683 | ||
Weighted-average remaining period for recognition (in years) | 2 years | |||
Performance share units ("PSUs") | ||||
Share-based compensation | ||||
Share-based compensation expense | 569 | $ 327 | $ 1,291 | $ 590 |
Unrecognized compensation costs | $ 6,708 | $ 6,708 | ||
Weighted-average remaining period for recognition (in years) | 2 years 1 month 6 days |
Share-based compensation - 2014
Share-based compensation - 2014 Plan Share Options (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
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) | 2.99% | 2.77% | 2.43% | ||
Risk free interest rate, maximum (as a percent) | 3.07% | 3.07% | 2.81% | ||
Expected dividend (as a percent) | 0.00% | 0.00% | 0.00% | 0.00% | |
2014 Plan | |||||
Options | |||||
Outstanding at beginning of year (in shares) | 72,818 | ||||
Outstanding at end of year (in shares) | 33,467 | 33,467 | 33,467 | ||
Weighted-average assumptions used to estimate fair value of share options granted during year | |||||
Increase in authorized shares | 30,000,000 | ||||
Authorized shares | 8,601,471 | 8,601,471 | 8,601,471 | ||
2014 Plan | Share options | |||||
Options | |||||
Outstanding at beginning of year (in shares) | 2,456,433 | ||||
Granted (in shares) | 708,137 | ||||
Forfeited (in shares) | (227,175) | ||||
Expired (in shares) | (10,572) | ||||
Exercised (in shares) | (232,082) | ||||
Outstanding at end of year (in shares) | 2,694,741 | 2,694,741 | 2,694,741 | ||
Fully vested and exercisable at end of year (in shares) | 948,888 | 948,888 | 948,888 | ||
Outstanding and expected to vest at end of year (in shares) | 1,745,853 | 1,745,853 | 1,745,853 | ||
Weighted average exercise price | |||||
Outstanding at beginning of year (in dollars per share) | $ 10.06 | ||||
Granted (in dollars per share) | 22.24 | ||||
Forfeited (in dollars per share) | 12.52 | ||||
Expired (in dollars per share) | 13.29 | ||||
Exercised (in dollars per share) | 11.63 | ||||
Outstanding at end of year (in dollars per share) | $ 12.91 | $ 12.91 | 12.91 | ||
Fully vested and exercisable at end of year (in dollars per share) | $ 11.38 | $ 11.38 | 11.38 | ||
Outstanding and expected to vest at end of year (in dollars per share) | $ 13.74 | ||||
Total weighted average grant date fair value of options issued during the period (in $ million) | $ 13.1 | ||||
Proceeds from option sales | $ 3 | ||||
2014 Plan | Non-executive directors | |||||
Weighted average exercise price | |||||
Vesting percentage per year | 25.00% | ||||
Vesting period | 4 years | ||||
2014 Plan | Directors and Officers | Share options | |||||
Options | |||||
Granted (in shares) | 241,961 | ||||
Weighted average exercise price | |||||
Total weighted average grant date fair value of options issued during the period (in $ million) | $ 2.9 | ||||
2014 Plan | One year from grant date | |||||
Weighted average exercise price | |||||
Vesting period | 1 year |
Share-based compensation - 2046
Share-based compensation - 2014 Plan RSUs (Details) - 2014 Plan - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 6 Months Ended |
Mar. 31, 2017 | Jun. 30, 2018 | |
Non-executive directors | ||
Other disclosure | ||
Vesting period | 4 years | |
Restricted share units ("RSUs") | ||
Number of shares | ||
Non-vested at beginning of year (in shares) | 683,663 | |
Granted (in shares) | 212,599 | |
Vested (in shares) | (276,833) | |
Forfeited (in shares) | (53,854) | |
Non-vested at end of year (in shares) | 565,575 | |
Weighted average grant-date fair value | ||
Non-vested at beginning of year (in dollars per share) | $ 6.38 | |
Granted (in dollars per share) | 19.41 | |
Vested (in dollars per share) | 5.99 | |
Forfeited (in dollars per share) | 11.08 | |
Non-vested at end of year (in dollars per share) | $ 11.03 | |
Other disclosure | ||
Total fair value of units awarded during the period (in million) | $ 4.1 | |
Restricted share units ("RSUs") | Chief Executive Officer | ||
Other disclosure | ||
Vesting period | 2 years | |
Restricted share units ("RSUs") | Non-executive directors | ||
Other disclosure | ||
Vesting period | 1 year | |
Restricted share units ("RSUs") | Directors and Officers | ||
Number of shares | ||
Granted (in shares) | 98,808 | |
Other disclosure | ||
Total fair value of units awarded during the period (in million) | $ 1.9 | |
Minimum | Restricted share units ("RSUs") | ||
Other disclosure | ||
Vesting period | 1 year | |
Maximum | Restricted share units ("RSUs") | ||
Other disclosure | ||
Vesting period | 3 years |
Share-based compensation - 2047
Share-based compensation - 2014 Plan PSUs (Details) - Performance share units ("PSUs") - 2014 Plan $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2018USD ($)$ / sharesshares | |
Number of shares | |
Non-vested at beginning of year (in shares) | shares | 511,074 |
Vested (in shares) | shares | (68,115) |
Forfeited (in shares) | shares | (64,681) |
Non-vested at end of year (in shares) | shares | 378,278 |
PSUs awarded but not yet earned | shares | 117,197 |
Total non-vested and discretionary PSUs | shares | 495,475 |
Weighted average grant-date fair value | |
Non-vested at beginning of year (in dollars per share) | $ / shares | $ 16.73 |
Vested (in dollars per share) | $ / shares | 15.79 |
Forfeited (in dollars per share) | $ / shares | 18.24 |
Non-vested at end of year (in dollars per share) | $ / shares | 16.74 |
PSUs awarded but not yet earned (in dollars per share) | $ / shares | 23.50 |
Total non-vested and discretionary PSUs (in dollars per share) | $ / shares | $ 18.34 |
Other disclosure | |
Total fair value of units awarded during the period (in million) | $ | $ 2.8 |
Basic and diluted earnings pe48
Basic and diluted earnings per share (Details) - shares | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Basic and diluted earnings per share | ||
Total potential dilutive common shares | 11,239,236 | 8,886,589 |
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 | 7,530,000 | 5,282,647 |
Stock options | 2014 Plan | ||
Basic and diluted earnings per share | ||
Total potential dilutive common shares | 2,694,741 | 2,627,863 |
Stock options | 2012 Plan | ||
Basic and diluted earnings per share | ||
Total potential dilutive common shares | 33,467 | 196,702 |
Non-vested and earned RSUs and PSUs | ||
Basic and diluted earnings per share | ||
Total potential dilutive common shares | 943,853 | 742,202 |
Leases - Narrative (Details)
Leases - Narrative (Details) $ in Millions | Dec. 01, 2017 | May 31, 2017facility | Jun. 30, 2016 | Mar. 31, 2016 | Nov. 30, 2013item | Jun. 30, 2018USD ($) |
Lexington | ||||||
Leases | ||||||
Lease term (in years) | 10 years | |||||
Number of subsequent renewals | item | 2 | |||||
Renewal term (in years) | 5 years | |||||
Amsterdam | ||||||
Leases | ||||||
Lease term (in years) | 10 years | 16 years | ||||
Renewal term (in years) | 5 years | |||||
Number of facility sites consolidated into new site | facility | 3 | |||||
Minimum rentals to be received | $ | $ 10.2 |
Leases - Minimum Lease Payments
Leases - Minimum Lease Payments and Rent Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Minimum lease payments | ||||
2018 (nine months remaining) | $ 1,919 | $ 1,919 | ||
2,019 | 3,874 | 3,874 | ||
2,020 | 3,927 | 3,927 | ||
2,021 | 3,980 | 3,980 | ||
2022 and beyond | 24,919 | 24,919 | ||
Total minimum lease payments | 38,619 | 38,619 | ||
Deferred rent related to lease incentives-current | 1,082 | 1,082 | ||
Deferred rent related to lease incentives | 8,464 | 8,464 | ||
Aggregate rent expense | ||||
Rent expense | 700 | $ 1,051 | 1,407 | $ 2,077 |
Lexington | ||||
Minimum lease payments | ||||
2018 (nine months remaining) | 934 | 934 | ||
2,019 | 1,903 | 1,903 | ||
2,020 | 1,956 | 1,956 | ||
2,021 | 2,009 | 2,009 | ||
2022 and beyond | 4,890 | 4,890 | ||
Total minimum lease payments | 11,692 | 11,692 | ||
Deferred rent related to lease incentives-current | 764 | 764 | ||
Deferred rent related to lease incentives | 4,440 | 4,440 | ||
Aggregate rent expense | ||||
Rent expense | 278 | 274 | 556 | 552 |
Amsterdam | ||||
Minimum lease payments | ||||
2018 (nine months remaining) | 985 | 985 | ||
2,019 | 1,971 | 1,971 | ||
2,020 | 1,971 | 1,971 | ||
2,021 | 1,971 | 1,971 | ||
2022 and beyond | 20,029 | 20,029 | ||
Total minimum lease payments | 26,927 | 26,927 | ||
Deferred rent related to lease incentives-current | 318 | 318 | ||
Deferred rent related to lease incentives | 4,024 | 4,024 | ||
Aggregate rent expense | ||||
Rent expense | $ 422 | $ 777 | $ 851 | $ 1,525 |
Subsequent event (Details)
Subsequent event (Details) - Subsequent events | Aug. 20, 2018USD ($)shares |
Subsequent event | |
Annual salary | $ | $ 425,000 |
Annual bonus percentage based on annual salary | 40.00% |
Option to purchase ordinary shares | 70,000 |
Restricted Stock Units | |
Subsequent event | |
Granted (in shares) | 35,000 |