Strongbridge Biopharma (SBBP) 10-Q 31 Oct 18 2018 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2018	Oct. 29, 2018
Document and Entity Information [Abstract]
Entity Registrant Name	Strongbridge Biopharma plc
Entity Central Index Key	1,634,432
Document Type	10-Q
Document Period End Date	Sep. 30, 2018
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Current Reporting Status	Yes
Entity Filer Category	Accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	true
Entity Common Stock, Shares Outstanding		47,185,048
Document Fiscal Year Focus	2,018
Document Fiscal Period Focus	Q3

Consolidated Balance Sheets

Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2018	Dec. 31, 2017
Current assets:
Cash and cash equivalents	$ 67,383	$ 57,510
Accounts receivable	2,542	1,584
Inventory	6,261	511
Prepaid expenses and other current assets	2,342	1,208
Total current assets	78,528	60,813
Property and equipment, net	297	15
Intangible assets, net	54,463	35,155
Goodwill	7,256	7,256
Other assets	305	686
Total assets	140,849	103,925
Current liabilities:
Accounts payable	3,227	1,247
Accrued liabilities	19,985	11,232
Total current liabilities	23,212	12,479
Long-term debt	79,061	37,794
Warrant liability	22,721	41,308
Supply agreement liability, noncurrent	22,111	24,258
Total liabilities	147,105	115,839
Commitments and contingencies (Note 8)
Stockholders’ deficit:
Deferred shares, $1.098 par value, 40,000 shares authorized, issued and outstanding at September 30, 2018 and December 31, 2017	44	44
Ordinary shares, $0.01 par value, 600,000,000 shares authorized at September 30, 2018 and December 31, 2017; 47,185,048 and 40,149,812 shares issued and outstanding at September 30, 2018 and December 31, 2017	472	401
Additional paid-in capital	288,316	230,524
Accumulated deficit	(295,088)	(242,883)
Total stockholders’ deficit	(6,256)	(11,914)
Total liabilities and stockholders’ deficit	$ 140,849	$ 103,925

Consolidated Balance Sheets (Pa

Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2018	Dec. 31, 2017
Consolidated Balance Sheets
Deferred shares, par value (in dollars per share)	$ 1.098	$ 1.098
Deferred shares, shares authorized	40,000	40,000
Deferred shares, shares issued	40,000	40,000
Deferred shares, shares outstanding	40,000	40,000
Ordinary shares, par value (in dollars per share)	$ 0.01	$ 0.01
Ordinary shares, shares authorized	600,000,000	600,000,000
Ordinary shares, shares issued	47,185,048	40,149,812
Ordinary shares, shares outstanding	47,185,048	40,149,812

Consolidated Statements of Oper

Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Revenues:
Net product sales	$ 5,347	$ 2,533	$ 13,513	$ 4,062
Total revenues	5,347	2,533	13,513	4,062
Cost and expenses:
Cost of sales (excluding amortization of intangible assets)	1,441	591	2,861	968
Selling, general and administrative	19,564	8,484	47,137	26,068
Research and development	7,198	4,504	17,532	12,113
Amortization of intangible assets	1,876	1,256	5,517	3,767
Impairment of intangible assets		20,723		20,723
Total cost and expenses	30,079	35,558	73,047	63,639
Operating loss	(24,732)	(33,025)	(59,534)	(59,577)
Other income (expense), net:
Unrealized gain (loss) on fair value of warrants	7,131	1,953	16,448	(28,194)
Interest expense	(3,387)	(1,364)	(9,550)	(2,838)
Foreign exchange loss	(15)	(11)	(22)	(36)
Loss on extinguishment of debt		(3,545)	(500)	(3,545)
Other income, net	445	82	954	107
Total other income (expense), net	4,174	(2,885)	7,330	(34,506)
Loss before income taxes	(20,558)	(35,910)	(52,204)	(94,083)
Income tax benefit (expense)		850	(1)	(652)
Net loss	(20,558)	(35,060)	(52,205)	(94,735)
Net loss attributable to ordinary shareholders:
Basic	(20,558)	(35,060)	(52,205)	(94,735)
Diluted	$ (27,690)	$ (35,060)	$ (68,653)	$ (94,735)
Net loss per share attributable to ordinary shareholders:
Basic (in dollars per share)	$ (0.44)	$ (0.98)	$ (1.14)	$ (2.67)
Diluted (in dollars per share)	$ (0.55)	$ (0.98)	$ (1.37)	$ (2.67)
Weighted-average shares used in computing net loss per share attributable to ordinary shareholders:
Basic (in shares)	46,978,472	35,716,247	45,916,177	35,463,496
Diluted (in shares)	50,317,423	35,716,247	49,985,483	35,463,496

Consolidated Statements of Shar

Consolidated Statements of Shareholders' Deficit - 9 months ended Sep. 30, 2018 - USD ($) $ in Thousands	Ordinary SharesIssuance of shares	Ordinary SharesATM Facility	Ordinary SharesMaximum	Ordinary Shares	Deferred Shares	Additional Paid-In CapitalIssuance of shares	Additional Paid-In CapitalATM Facility	Additional Paid-In Capital	Accumulated Deficit	Issuance of shares	ATM Facility	Total
Balance at beginning of period at Dec. 31, 2017				$ 401	$ 44			$ 230,524	$ (242,883)			$ (11,914)
Balance (in shares) at Dec. 31, 2017				40,149,812	40,000
Increase (Decrease) in Stockholders' Equity
Net loss									(52,205)			(52,205)
Stock-based compensation								5,789				5,789
Issuance of shares	$ 53	$ 12				$ 33,455	$ 7,939			$ 33,508	$ 7,951
Issuance of shares (in shares)	5,255,683	1,172,557									1,172,557
Exercise of warrants				$ 5				3,309				3,314
Exercise of warrants (in shares)				470,000
Issuance of warrants related to the loan agreements								7,663				7,663
Exercise of stock options			$ 1					79				79
Exercise of stock options (in shares)				45,007
Common stock issued, net of shares withheld for employee taxes				$ 1				(442)				(441)
Common stock issued, net of shares withheld for employee taxes (in shares)				91,989
Balance at end of period at Sep. 30, 2018				$ 472	$ 44			$ 288,316	$ (295,088)			$ (6,256)
Balance (in shares) at Sep. 30, 2018				47,185,048	40,000

Consolidated Statements of Cash

Consolidated Statements of Cash Flow - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017	Dec. 31, 2017
Cash flows from operating activities:
Net loss			$ (52,205)	$ (94,735)
Adjustments to reconcile net loss to net cash used in operating activities:
Change in fair value of warrant liability	$ (7,131)	$ (1,953)	(16,448)	28,194
Impairment of intangible assets		20,723		20,723
Stock-based compensation			5,789	3,864
Amortization of intangible assets	1,876	1,256	5,517	3,767	$ 5,022
Interest and related guarantee fees paid in kind			2,890	408
Amortization of debt discounts and debt issuance costs			1,109	371
Loss on extinguishment of debt		3,545	500	3,545
Deferred income tax benefit				804
Depreciation			28	8
Changes in operating assets and liabilities:
Accounts receivable			(958)	(979)
Inventory			(5,750)	(1,003)
Prepaid expenses and other current assets			(1,134)	(923)
Other assets			381	(237)
Accounts payable			1,980	333
Accrued liabilities and other liabilities			6,437	1,410
Net cash used in operating activities			(51,864)	(34,450)
Cash flows from investing activities:
Payment for acquisitions			(24,655)	(7,500)
Purchases of property and equipment			(310)
Net cash used in investing activities			(24,965)	(7,500)
Cash flows from financing activities:
Proceeds from long-term debt, net			44,930	39,986
Payment for loss on extinguishment of debt			(500)	(1,300)
Payment of long-term debt				(22,261)
Proceeds from issuance of ordinary shares, net			33,508	2,981
Proceeds from issuance of ordinary shares in connection with at-the-market offering			7,951	73
Proceeds from exercise of warrants			1,175
Proceeds from exercise of stock options			79
Payments related to tax withholding for net-share settled equity awards			(441)
Net cash provided by financing activities			86,702	19,479
Net increase (decrease) in cash and cash equivalents			9,873	(22,471)
Cash and cash equivalents—beginning of period			57,510	66,837	66,837
Cash and cash equivalents—end of period	$ 67,383	$ 44,366	67,383	$ 44,366	$ 57,510
Supplemental non-cash financing activities:
Issuance of shares from vested restricted share units			$ 1,048

Organization

Organization	9 Months Ended
	Sep. 30, 2018
Organization
Organization	1. Organization We are a global, commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Our first commercial product is Keveyis (dichlorphenamide), the first and only treatment approved by the U.S. Food and Drug Administration (the “FDA”) for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis (“PPP”), a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis. Our second commercial product, Macrilen (macimorelin), is an oral growth hormone secretagogue receptor agonist, and is the first and only oral test approved by the FDA for the diagnosis of patients with adult growth hormone deficiency (“AGHD”). We acquired the U.S. and Canadian rights to Macrilen in January 2018 and launched Macrilen in the United States in July 2018. In addition to our two commercial products, we have two clinical-stage product candidates for rare endocrine diseases, Recorlev and veldoreotide. Recorlev (levoketoconazole) is a cortisol synthesis inhibitor currently being studied for the treatment of endogenous Cushing's syndrome. Veldoreotide is a next-generation somatostatin analog being investigated for the treatment of acromegaly and potential additional applications in other conditions amenable to somatostatin receptor activation. Both Recorlev and veldoreotide have received orphan designation from the FDA and the European Medicines Agency (“EMA”). Given the well-identified and concentrated prescriber base addressing our target markets, we intend to continue to use a small, focused sales force to market Keveyis, Macrilen and any future products, in the United States, the European Union and other key global markets. We believe that our ability to execute on our strategy is enhanced by the significant commercial and clinical development experience of key members of our management team. We are building a rare disease, franchise-based business model focused on expansion through a disciplined in-licensing and acquisition strategy. In pursuit of our growth strategy, we have raised over $283 million in equity and debt financings since December 2014. We will continue to identify and evaluate the acquisition of products and product candidates for licensing or acquisition that would be complementary to our existing rare neuromuscular and endocrine franchises or that would form the basis for new rare disease franchises. We believe this approach will enable us to maximize our commercial potential by further leveraging our existing resources and expertise. Liquidity We believe that our cash resources of $67.4 million at September 30, 2018 will be sufficient to allow us to fund planned operations for at least 12 months beyond the issuance date of the financial statements included in this Quarterly Report. We also expect our cash needs to increase to fund potential in‑licenses, acquisitions or similar transactions as we pursue our strategy. These expenses may be offset only in part by sales of Keveyis and Macrilen . In addition, beginning in March 2021, we may be required to make quarterly principal payments to repay amounts borrowed under our credit facility. We may never achieve profitability, and unless and until we do, we will continue to need to raise additional capital. We plan to continue to fund our operations and capital funding needs through equity or debt financing along with revenues from Keveyis and Macrilen . There can be no assurances, however, that additional funding will be available on terms acceptable to us. Our loan and security agreement, under which outstanding borrowings were $88.3 million at September 30, 2018, contains financial and non-financial covenants including minimum annual amounts of net revenue in 2018 and beyond. Failure to comply with the covenants could result in the lenders declaring the loan immediately due and payable. Our liquidity requirements are predicated on maintaining compliance with the debt covenants and repaying outstanding borrowings in accordance with the loan term, see Note 7 “Long-term debt”.

Summary of significant accounti

Summary of significant accounting policies and basis of presentation	9 Months Ended
	Sep. 30, 2018
Summary of significant accounting policies and basis of presentation
Summary of significant accounting policies and basis of presentation	2. Summary of significant accounting policies and basis of presentation Basis of presentation These unaudited consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States (“U.S. GAAP”). The unaudited consolidated financial statements reflect all adjustments, which include only normal recurring adjustments that are, in the opinion of management, necessary to present a fair statement of the operating results and financial position for the periods presented. The preparation of the unaudited consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts and disclosures in the consolidated financial statements. Actual results could differ from those estimates. Results for the three months ended September 30, 2018 are not necessarily indicative of the results that may be expected for the year ending December 31, 2018. These unaudited consolidated financial statements should be read in conjunction with the accounting policies and notes to the audited consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017 filed with the U.S. Securities and Exchange Commission on March 12, 2018 (the “2017 Annual Report”). Our significant accounting policies are described in Note 2 of the notes to the audited consolidated financial statements included in our 2017 Annual Report. Since the date of those financial statements, there have been no changes to our significant accounting policies. Revenue recognition We follow Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers, effective April 1, 2017. Topic 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We apply the five-step model to contracts only when it is probable that we will collect the consideration we are entitled to receive in exchange for the goods or services we transfer to our customers. At contract inception, once the contract is determined to be within the scope of Topic 606, we assess the goods or services promised within each contract and determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for net product revenue, see Note 3, "Revenue recognition". Foreign currency translation The consolidated financial statements are reported in United States dollars, which is our functional currency, including each of our consolidated subsidiaries. Transactions in foreign currencies are remeasured into our functional currency at the rate of exchange prevailing at the date of the transaction. Any monetary assets and liabilities arising from these transactions are remeasured into our functional currency at exchange rates prevailing at the balance sheet date or on settlement. Resulting gains and losses are recorded in foreign exchange loss in our consolidated statements of operations. Use of estimates The preparation of financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. We must apply significant judgment in this process. Actual results could materially differ from those estimates. Segment information Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions on how to allocate resources and assess performance. We view our operations and manage our business in one operating segment. Prior to March 31, 2018, our material long‑lived intangible assets resided in Ireland, Sweden and the Cayman Islands. Effective March 31, 2018, all of our material long-lived intangible assets reside in Ireland. As of September 30, 2018, $67.3 million of our cash and cash equivalents consisted primarily of bank deposits in the United States. For the nine months ended September 30, 2018, revenues from product sales were derived entirely from the United States. Net loss per share Basic net loss per share is calculated by dividing the net loss attributable to shareholders by the weighted average number of ordinary shares outstanding during the period. Diluted net loss per share is calculated by dividing the net loss attributable to shareholders by the weighted‑average number of ordinary shares outstanding for the period, including any dilutive effect from outstanding stock options or other equity-based awards. Shares used in the diluted net loss per share calculations exclude anti‑dilutive ordinary share equivalents, which currently consist of outstanding stock options, unvested restricted stock units (“RSUs”) and warrants. The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of September 30, 2018 and 2017, as they would be anti-dilutive: Nine Months Ended September 30, 2018 2017 Warrants 1,803,253 7,764,569 Stock options issued and outstanding 8,719,156 6,176,647 Unvested RSUs 173,400 274,250 Recent accounting pronouncements In January 2017, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (“ ASU’) 2017-04, Intangibles - Goodwill and Other : Simplifying the Accounting for Goodwill Impairment . ASU 2017-04 removes Step 2 of the goodwill impairment test, which requires a hypothetical purchase price allocation. A goodwill impairment will now be the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. This standard, which will be effective for us beginning in the first quarter of fiscal year 2020, is required to be applied prospectively. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. We are currently evaluating the impact this new accounting guidance will have on our consolidated financial statements. In February 2016, the FASB issued ASU No. 2016-02, Leases , that discusses how an entity should account for lease assets and lease liabilities. The guidance specifies that an entity who is a lessee under lease agreements should recognize lease assets and lease liabilities for those leases classified as operating leases under previous FASB guidance. Accounting for leases by lessors is largely unchanged under the new guidance. The guidance is effective for us beginning in the first quarter of fiscal year 2019. Early adoption is permitted. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. We are currently evaluating the impact this new accounting guidance will have on our consolidated financial statements but do not expect it will have a material impact on us.

Revenue recognition

Revenue recognition	9 Months Ended
	Sep. 30, 2018
Revenue recognition
Revenue recognition	3. Revenue recognition Product sales, net We launched our second commercial product, Macrilen, in July 2018. Our product sales result from sales of Keveyis and Macrilen. We recognize net product sales at the time our products are received by our customers (primarily wholesalers and specialty pharmacies). The products are subsequently sold to patients, who are covered by payors that may provide for government-mandated or privately negotiated rebates with respect to the purchase of our products. Revenues from sales of our products are recognized when we satisfy a performance obligation by transferring control of the product to our customers. Transfer of control occurs upon receipt of the product by the customer. We expense incremental costs related to the set-up of contracts with our customers when incurred, as these costs do not meet the criteria for capitalization. Disaggregation of Revenue The following table summarizes revenue by product for the three and nine months ended September 30, 2018 (in thousands) : Three Months Nine Months Ended Ended September 30, September 30, Products Keveyis $ 4,207 $ 12,373 Macrilen 1,140 1,140 Total $ 5,347 $ 13,513 Reserves for variable consideration Revenues from sales of our products are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and that result from rebates, co-pay assistance and other allowances that are offered by us and the patients’ payors. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to our customer) or a current liability (if the amount is payable to a party other than our customer). Where appropriate, these estimates may take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from our estimates. We reassess our estimates on an ongoing basis. If actual results in the future vary from our estimates, we will adjust our estimates. Any such adjustments would affect net product revenue and earnings in the period such variances become known. Trade Discount : Our contracts with our customers provide for a discount, that is recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, we receive sales order management, data and distribution services from our customers. To the extent the services received are distinct from our sale of products to our customers, these payments are classified in selling, general and administrative expenses in our consolidated statement of operations and comprehensive loss. Prompt Pay Discount : We offer cash discounts to our customers, generally 2% of the sales price, as an incentive for prompt payment. We estimate for cash discounts using the most likely amount method by reducing accounts receivable by the prompt pay discount amount. The discount is recognized as a reduction of revenue in the same period as the related revenue. Funded Co-pay Assistance Program : We contract with a third-party to manage the co-pay assistance program intended to provide financial assistance to qualified insured patients. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that we expect to receive associated with the product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. These payments are consideration payable to our customers and the related reserve is recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses on the consolidated balance sheet. Government Rebates : We are subject to discount obligations under state Medicaid programs and Medicare. We estimate our Medicaid and Medicare rebates based upon a range of possible outcomes that are probability-weighted for the estimated patient mix. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in accrued expenses on the consolidated balance sheet. For Medicaid, accruals are based on estimates of future Medicaid beneficiary utilization applied to the Medicaid unit rebate formula established by the Center for Medicaid and Medicare Services. Effective January 1, 2011, manufacturers of pharmaceutical products are responsible for 50% of the patient’s cost of branded prescription drugs related to the Medicare Part D Coverage Gap. In order to estimate the cost to us of this Medicare coverage gap responsibility, we estimate the number of patients in the prescription drug coverage gap for whom we will owe an additional liability under the Medicare Part D program. Our liability for these rebates consists of estimates of claims for the current quarter and estimated future claims that will be made that have been recognized as revenue, but remain in the distribution channel inventories at the end of each reporting period. Temporary Supply and Patient Assistance Programs : We provide free product to uninsured patients who satisfy pre-established criteria for either the Temporary Supply Program for Keveyis or the Patient Assistance Program for Keveyis and Macrilen. Patients who meet the Temporary Supply Program eligibility criteria may receive a temporary supply of free Keveyis for no more than sixty days while we determine the patient’s third-party insurance, prescription drug benefit or other third-party coverage for Keveyis. The Patient Assistance Program provides free Keveyis for up to twelve months to patients who satisfy pre-established criteria for financial need. We do not recognize any revenue related to these free products and the associated costs are classified in selling, general and administrative expenses in our consolidated statements of operations and comprehensive loss.

Fair value measurement

Fair value measurement	9 Months Ended
	Sep. 30, 2018
Fair value measurement
Fair value measurement	4. Fair value measurement We follow FASB accounting guidance on fair value measurements for financial assets and liabilities measured on a recurring basis. Because of their short-term nature, the amounts reported in the balance sheet for cash and accounts payable approximate fair value. The guidance requires fair value measurements to maximize the use of “observable inputs.” The three-level hierarchy of inputs to measure fair value are as follows: Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. Because of their short-term nature, the amounts reported in the balance sheet for cash and accounts payable approximate fair value. Level 2: Significant observable inputs other than Level 1 prices such as quoted prices in markets that are not active, or inputs that are observable, either directly or indirectly, for substantially the full term of the asset or liability Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). The fair values of the outstanding warrants were measured using the Black-Scholes option-pricing model. Inputs used to determine estimated fair value of the warrant liabilities include the estimated fair value of the underlying stock at the valuation date, the estimated term of the warrants, risk-free interest rates, expected dividends and the expected volatility of the underlying stock. The significant unobservable inputs used in the fair value measurement of the warrant liabilities were the volatility rate and the estimated term of the warrants. Generally, increases (decreases) in the fair value of the underlying stock and estimated term would result in a directionally similar impact to the fair value measurement. We did not have any transfers between the different levels. The following table presents our assets and liabilities that are measured at fair value on a recurring basis for the periods presented (in thousands) : As of September 30, 2018 Level I Level II Level III Total Cash equivalents 66,996 — — 66,996 Total assets $ 66,996 $ — $ — $ 66,996 Warrant liability — — 22,721 22,721 Total liabilities $ — $ — $ 22,721 $ 22,721 As of December 31, 2017 Level I Level II Level III Total Cash equivalents 57,024 — — 57,024 Total assets $ 57,024 $ — $ — $ 57,024 Warrant liability — — 41,308 41,308 Total liabilities $ — $ — $ 41,308 $ 41,308

Intangible assets and goodwill

Intangible assets and goodwill	9 Months Ended
	Sep. 30, 2018
Intangible assets and goodwill
Intangible assets and goodwill	5. Intangible assets and goodwill The following represents the balance of our intangible assets as follows (in thousands): As of September 30, 2018 Beginning of Period Additions Impairment Amortization End of Period Keveyis 35,155 — — (3,767) 31,388 Macrilen — 24,825 — (1,750) 23,075 Goodwill 7,256 — — — 7,256 Total $ 42,411 $ 24,825 $ — $ (5,517) $ 61,719 As of December 31, 2017 Beginning of Period Additions Impairment Amortization End of Period IPR&D $ 20,723 $ — $ (20,723) $ — $ — Keveyis 40,177 — — (5,022) 35,155 Goodwill 7,256 — — — 7,256 Total $ 68,156 $ — $ (20,723) $ (5,022) $ 42,411 Our finite lived intangible assets consist of acquired developed product rights obtained from our acquisitions of Keveyis (dichlorphenamide) from a subsidiary of Taro Pharmaceutical Industries Ltd. (“Taro”) and Macrilen from Aeterna Zentaris GmbH . Pursuant to the terms of the Asset Purchase Agreement and Supply Agreement that we entered into with Taro, we paid Taro an upfront payment in two installments of $1 million in December 2016 and $7.5 million in March 2017. We concluded that the supply price payable by us exceeds fair value and, therefore, used a discounted cash flow method with a probability assumption to value the payments in excess of fair value at $29.3 million, for which we have recorded an intangible asset and corresponding liability. This liability will be reduced as we purchase inventory over the term of the Supply Agreement. In addition, we incurred transaction costs of $2.4 million. The overall recording of the transaction resulted in the recording of an intangible asset of $40.2 million. This asset is being amortized over an eight-year period using the straight-line method. We entered into a License and Assignment Agreement in 2018 with Aeterna Zentaris GmbH, pursuant to which we acquired the U.S. and Canadian rights to manufacture and commercialize Macrilen (macimorelin) for $24 million and incurred transaction costs of $0.7 million, resulting in an initial intangible of $24.7 million. We record any royalty liability as an increase to the intangible asset. This asset is being amortized over a ten-year period using the straight-line method. We recorded amortization expense of $1.9 million and $5.5 for the three and nine months ended September 30, 2018, respectively, compared to $1.3 million and $3.8 million for the three and nine months ended September 30, 2017, respectively.

Accrued liabilities

Accrued liabilities	9 Months Ended
	Sep. 30, 2018
Accrued liabilities
Accrued liabilities	6. Accrued liabilities Accrued liabilities consist of the following (in thousands): September 30, December 31, 2018 2017 Consulting and professional fees $ 5,550 $ 2,465 Supply agreement - current portion 4,783 4,237 Employee compensation 3,813 3,668 Accrued sales allowances 2,204 742 Accrued inventory 1,734 — Accrued royalties 1,210 — Other 691 120 Total accrued liabilities $ 19,985 $ 11,232

Long-term debt

Long-term debt	9 Months Ended
	Sep. 30, 2018
Long-term debt
Long-term debt	7. Long-term debt On January 16, 2018 (the “First Loan Amendment Effective Date”), we and our subsidiaries, Strongbridge U.S. Inc., Strongbridge Ireland Limited , Cortendo AB (publ) and Cortendo Cayman Ltd., entered into an amendment (the “First Loan Amendment”), to the Term Loan Agreement (the “Loan Agreement”), dated July 14, 2017, with CRG Servicing LLC (“CRG”), as administrative agent and collateral agent, and the lenders named therein (the “Lenders”). The primary purpose of the First Loan Amendment was to increase the total potential borrowing under the Loan Agreement from $50 million to $100 million. The First Loan Amendment provided for (i) an additional disbursement of $45.0 million (the “Second Tranche”) to the Company on the First Loan Amendment Effective Date, and (ii) an additional disbursement of $5.0 million (the “Fourth Tranche”) to us at our election, contingent upon our achievement of certain revenue milestones and a market capitalization condition on or before December 31, 2018, as described in the First Loan Amendment. Under the First Loan Amendment, we continued to be eligible to borrow up to an additional $10.0 million (the “Third Tranche”), contingent upon our achievement of certain revenue milestones on or before June 30, 2018, as previously provided in the Loan Agreement; provided, however, that under the Loan Agreement, as amended, the Third Tranche would be subject to a market capitalization condition, as described in the First Loan Amendment. As a condition to the addition of the Second Tranche under the First Loan Amendment, we issued to the Lenders on the First Loan Amendment Effective Date warrants to purchase an aggregate of 1,248,250 of our ordinary shares, at an exercise price of $10.00 per share. On June 6, 2018, we and our subsidiaries, Strongbridge U.S. Inc., Cortendo Cayman Ltd., Strongbridge Ireland Limited and Cortendo AB (publ), entered into a second amendment (the “Second Loan Amendment”), to the Loan Agreement. The primary purposes of the Second Loan Amendment (as requested by the Company) was to reduce the aggregate commitments under the Loan Agreement from $100 million to $95 million and to combine the Third Tranche and the Fourth Tranche under the Loan Agreement into one final borrowing tranche for up to $10 million (the “Final Tranche”). Under the terms of the Second Loan Amendment, the Final Tranche borrowing must occur on or before March 19, 2019. The Final Tranche is subject to the Company’s achievement of a certain revenue milestone, which under the Second Loan Amendment must be satisfied on or prior to December 31, 2018, and satisfaction of a market capitalization condition for the 20 consecutive trading days ending on the trading day immediately prior to the Final Tranche borrowing date (as described in the Loan Agreement, as amended). Pursuant to the terms of the Second Loan Amendment, if we borrow the Final Tranche, we must issue to the Lenders, or their designees, one or more warrants to purchase a number of our ordinary shares equal to an aggregate of (i) 0.10% of our ordinary shares outstanding following such issuance on a fully diluted basis (inclusive of the ordinary shares underlying all such warrants issued), at an exercise price equal to 110% of the closing price of our ordinary shares on the date immediately preceding the Final Tranche borrowing date and (ii) 0.25% of our ordinary shares outstanding following such issuance on a fully diluted basis (inclusive of the ordinary shares underlying all such warrants issued), at an exercise price equal to 140% of the 10-day volume weighted-average price (VWAP) per share of our ordinary shares for the consecutive 10-trading-day period ending on the trading day prior to the Final Tranche borrowing date. The term of the Loan Agreement, as amended, is six years, with interest-only payments until December 31, 2020, after which quarterly principal and interest payments will be due through the June 30, 2023 maturity date. We have the option to extend the interest-only period to six years based upon the achievement of certain milestones during the interest-only period. The Loan Agreement provides for interest payable at an annual rate of 12.5% and a final payment fee of 5% of the principal balance. The Loan Agreement includes a payment-in-kind (“PIK”) provision, which allows us to defer 4.0% of the 12.5% annual interest payable under the loan during the first three years of the term of the loan (which may be extended for the entire term of the loan, subject to the satisfaction of certain conditions) by adding such amount to the principal loan amount. We have elected to PIK each period so far, resulting in an additional $3.3 million added to our outstanding principal balance as of September 30, 2018. We have granted a security interest in substantially all of our existing assets and assets acquired by us in the future, including intellectual property. The Loan Agreement contains facility and prepayment fees, and customary affirmative and negative covenants, including a financial covenant regarding minimum amounts of net revenue and restrictions on our ability to pay cash dividends, and a list of events that will constitute “events of default” under the loan agreement, and permit the lenders to declare all amounts under the Loan Agreement immediately due and payable, including a material adverse change in our business, operations or financial condition. We recorded $10.6 million in debt discounts and $0.2 million of debt issuance costs relating to the Loan Agreement which have been recorded as a reduction to the long-term debt. These amounts will be amortized over the outstanding period of the debt to interest expense using the effective interest rate method. Due to a greater than 10% change in cash flows as compared to the original debt instrument under the First Loan Amendment, the First Loan Amendment was accounted for as a debt extinguishment, which resulted in a $0.5 million loss during the nine months ended September 30, 2018. Future principal payments due under the Loan Agreement are as follows (in thousands) : Principal Payments 2018 $ — 2019 — 2020 — 2021 35,320 2022 35,320 2023 17,660 Total future payments $ 88,300

Commitments and contingencies

Commitments and contingencies	9 Months Ended
	Sep. 30, 2018
Commitments and contingencies
Commitments and contingencies	8. Commitments and contingencies Lease obligations In March 2015, we entered into a 52‑month building sublease agreement for 14,743 square feet of office space in Trevose, Pennsylvania. The lease has annual rent escalations and is recognized on a straight‑line basis over the term of the lease. In November 2017, the Company entered into a 60‑month building lease agreement for an additional 7,326 square feet of office space in the same building in Trevose, Pennsylvania. The lease has annual rent escalations. We obtained access to this newly leased space on November 27, 2017, and this was considered the lease commencement date for accounting purposes. Thus, rent expense began on this date and is recognized on a straight‑line basis over the term of the lease. The lease provides for us the ability to continue leasing its currently subleased office space upon expiration of the sublease described above. As of September 30, 2018, future minimum commitments under facility operating leases were as follows (in thousands): Operating leases 2018 113 2019 439 2020 470 2021 481 2022 492 2023 207 Total minimum lease payments $ 2,202 Rent expense recognized under our operating lease was approximately $535,000 and $205,000 for the nine months ended September 30, 2018 and 2017, respectively. Commitments to Taro Pharmaceuticals Industries Ltd. In December 2016, we acquired the U.S. marketing rights to Keveyis (dichlorphenamide) from a subsidiary of Taro. Under the terms of the Asset Purchase Agreement, we paid Taro an upfront payment in two installments of $1 million in December 2016 and $7.5 million in March 2017, and will pay an aggregate of $7.5 million in potential milestones upon the achievement of certain product sales targets. Taro has agreed to continue to manufacture Keveyis for us under an exclusive supply agreement through the orphan exclusivity period. We are obligated to purchase certain annual minimum amounts of product totaling approximately $29 million over a six-year period. The Supply Agreement may extend beyond the orphan exclusivity period unless terminated by either party pursuant to the terms of the agreement. If terminated by Taro at the conclusion of the orphan exclusivity period, we have the right to manufacture the product on our own or have the product manufactured by a third party on our behalf. We are required to reimburse Taro for their royalty obligation resulting from their sale of Keveyis to us. Commitments to Aeterna Zentaris GmbH In January 2018, we acquired the U.S. and Canadian rights to Macrilen (macimorelin) from Aeterna Zentaris GmbH. Under the terms of the License and Assignment Agreement, we paid Aeterna Zentaris GmbH $24 million and will pay tiered royalties of 15%-18% on net sales as well as an aggregate of $174 million in potential milestones upon the achievement of certain product sales targets. Additionally, Aeterna Zentaris GmbH will remain responsible for a pediatric development program to support regulatory submission for approval with Strongbridge sharing oversight and paying for 70 percent of the cost of the program, or approximately $4 million over a three-year period as well as $5 million upon the receipt of regulatory approval for the use of Macrilen in pediatric patients in the United States and Canada.

Income taxes

Income taxes	9 Months Ended
	Sep. 30, 2018
Income taxes
Income taxes	9. Income taxes Deferred tax assets and liabilities are recognized for the future tax consequences of differences between the carrying amounts and tax bases of assets and liabilities and operating loss carryforwards and other attributes using enacted rates expected to be in effect when those differences reverse. Valuation allowances are provided against deferred tax assets that are not more likely than not to be realized. We assess our ability to realize deferred tax assets. Changes in future earnings projections, among other factors, may cause us to adjust our valuation allowance on deferred tax assets. Any such adjustments would impact our income tax expense in the period in which it is determined that these factors have changed. For the nine months ended September 30, 2018, we recorded full valuation allowances against our deferred tax asset and deferred tax liability, resulting in no income tax expense. On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act makes broad and complex changes to the U.S. tax code, including, but not limited to, reducing the top U.S. federal corporate tax rate from 35 percent to 21 percent; requiring companies to pay a onetime transition tax on certain un-repatriated earnings of foreign subsidiaries; generally eliminating U.S. federal income taxes on dividends from foreign subsidiaries; requiring a current inclusion in U.S. federal taxable income of certain earnings of controlled foreign corporations; eliminating the corporate alternative minimum tax (AMT) and changing how existing AMT credits can be realized; creating the base erosion anti-abuse tax (BEAT), a new minimum tax; creating a new limitation on deductible interest expense; and changing rules related to uses and limitations of net operating loss carryforwards created in tax years beginning after December 31, 2017. The Tax Act reduces our U.S. corporate income tax rate from 34% to 21%, effective January 1, 2018. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to reverse. As a result of the reduction in the U.S. corporate income tax rate from 34% to 21% under the Tax Act, we revalued our ending net deferred tax assets and liabilities at December 31, 2017. The Tax Act provided for a one-time transition tax on the deemed repatriation of post-1986 undistributed foreign subsidiary earnings and profits (“E&P”). We did not have to recognize any income tax expense related to the transition tax as we own no controlled foreign corporations. The global intangible low-taxed income tax and base erosion provisions are effective for taxable years beginning after December 31, 2017. We do not currently expect these provisions to have a material impact on our tax rate as we do not own any controlled foreign corporations and they are currently below the gross receipts threshold for purposes of the base erosion provisions.

Ordinary shares

Ordinary shares	9 Months Ended
	Sep. 30, 2018
Ordinary shares.
Ordinary shares	10. Ordinary shares Equity transactions On January 30, 2018, we sold 5,000,000 ordinary shares in a public offering at a price to the public of $6.75 per ordinary share for net proceeds of approximately $31.8 million, after deducting underwriting discounts and commissions and offering expenses payable by us. On February 27, 2018, we sold an additional 255,683 ordinary shares to the underwriters of our January 2018 public offering in connection with their partial exercise of their option to purchase additional shares to cover over-allotments at a price of $6.75 per ordinary share for net proceeds of approximately $1.7 million, after deducting underwriting discounts and commissions and offering expenses payable by us. We entered into an equity distribution agreement with JMP Securities LLC (“JMP”) on April 28, 2017, pursuant to which we may sell, at our option, from time to time, up to an aggregate of $40 million of our ordinary shares through JMP, as sales agent. We will pay JMP a commission equal to 3% of the gross proceeds from the sale of our ordinary shares under this at-the-market (“ATM”) facility. Pursuant to the terms of the equity distribution agreement, we reimbursed JMP for certain out-of-pocket expenses, including the fees and disbursements of counsel to JMP, incurred in connection with establishing the ATM facility and have provided JMP with customary indemnification rights. During the nine months ended September 30, 2018, we sold an aggregate of 1,172,557 ordinary shares under the ATM facility at an average selling price of $7.00 per share, resulting in net proceeds of approximately $8.0 million after payment of fees to JMP of $246,000. As of September 30, 2018, we have approximately $32 million available for sale under our ATM facility. Warrants During the three months ended September 30, 2018, a warrant previously issued in connection with a private equity placement was exercised in full, resulting in the issuance of 470,000 ordinary shares. Our outstanding warrants as of September 30, 2018 are as follows: Warrants Outstanding Exercise Expiration Warrants Warrants September 30, Classification Price Date Issued Exercised 2018 Warrants in connection with private equity placement Liability $ 2.50 6/28/2022 7,000,000 (470,000) 6,530,000 Warrants in connection with Horizon and Oxford loan agreement Equity $ 2.45 12/28/2026 428,571 (267,857) 160,714 Warrants in connection with CRG loan agreement Equity $ 7.37 7/14/2024 394,289 — 394,289 Warrants in connection with CRG loan amendment in January 2018 Equity $ 10.00 1/16/2025 1,248,250 — 1,248,250 9,071,110 8,333,253

Stock-based compensation

Stock-based compensation	9 Months Ended
	Sep. 30, 2018
Stock-based compensation
Stock based compensation	11. Stock‑based compensation Our board of directors has adopted the 2017 Inducement Plan (the “Inducement Plan”). The Inducement Plan provides for the grant of equity-based awards to new employees. The purpose of the Inducement Plan is to attract valued employees by offering them a greater stake in our success and a closer identity with us, and to encourage ownership of our ordinary shares by such employees. The Inducement Plan became effective on February 23, 2017. As of September 30, 2018, 620,200 shares are available for issuance pursuant to the Inducement Plan. Our board of directors has adopted, and our shareholders have approved, the 2015 Equity Compensation Plan (the “2015 Plan”). The 2015 Plan provides for the grant of incentive stock options to our employees and any parent or subsidiary corporation’s employees, and for the grant of nonstatutory stock options, stock awards, and RSUs to our employees, directors and consultants and our parent or subsidiary corporations’ employees and consultants. The 2015 Plan became effective on September 3, 2015. As of September 30, 2018, 163,006 shares are available for issuance pursuant to the 2015 Plan. Our board of directors has adopted, and our shareholders have approved, the Non‑Employee Director Equity Compensation Plan (the “Non‑Employee Director Plan”). The Non‑Employee Director Plan provides for the grant of nonstatutory stock options, stock awards, and RSUs to our non‑employee directors. The Non‑Employee Director Plan became effective on September 3, 2015. As of September 30, 2018, 1,541 shares are available for issuance pursuant to the Non‑Employee Director Plan. A summary of our outstanding stock options as of September 30, 2018 is as follows: Options Outstanding Weighted- Average Weighted- Remaining Average Contractual Number of Exercise Term Aggregate Shares Price (Years) Intrinsic Value (in thousands) Outstanding—January 1, 2018 6,104,715 $ 7.50 7.70 $ 14,021 Granted 2,881,255 $ 6.78 Forfeited and cancelled (196,871) $ 6.24 Exercised (69,943) $ 4.31 Outstanding—September 30, 2018 8,719,156 $ 7.33 7.79 $ 4,541 Vested and exercisable—September 30, 2018 3,547,271 $ 9.08 6.30 $ 1,749 Included in the stock options outstanding at September 30, 2018 are unvested stock options to purchase 88,908 shares at a weighted average exercise price of $18.80 per share for which the vesting of certain tranches will accelerate if the fair value per share of our stock reaches $31.46. In addition, the options outstanding as of September 30, 2018 include 97,652 shares that vest upon a market appreciation event, so long as it occurs prior to the date specified in the applicable award agreement and 97,652 shares that will vest upon the one year anniversary of the market appreciation event. The market appreciation event, which had not yet occurred as of September 30, 2018, is defined as the last trading day in the period in which our closing stock price on each of 20 consecutive trading days reported on Nasdaq has been at least $30.14 or $33.66 for the respective grantee. Stock‑based compensation expense We recognized stock‑based compensation expense for employees and directors for stock options and RSUs as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2018 2017 2018 2017 Selling, general and administrative $ 1,649 $ 1,007 $ 4,450 $ 3,042 Research and development 467 324 1,339 822 Total stock-based compensation $ 2,116 $ 1,331 $ 5,789 $ 3,864 As of September 30, 2018, the total unrecognized compensation expense related to unvested stock options, net of estimated forfeitures, is $17.9 million, which we expect to recognize over an estimated weighted‑average period of 2.85 years. In determining the estimated fair value of our service-based awards, we use the Black‑Scholes option‑pricing model and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment. The fair value of our service-based awards that were granted during the years was estimated with the following assumptions: Nine Months Ended September 30, 2018 2017 Expected term (in years) 6.13 5.96 Risk-free interest rate 2.25% - 2.99% 1.78% - 2.26% Expected volatility 78.19% - 85% 78.2% - 105.9% Dividend rate —% —% Restricted stock units Our board of directors have approved grants of RSUs to employees. These RSUs vest two years from the date of issuance, provided that the employee is employed by us on such vesting date. All RSUs will fully vest upon a change of control of our company. If and when the RSUs vest, we will issue one ordinary share for each whole RSU that has vested, subject to satisfaction of the executive’s tax withholding obligations. The RSUs will cease to be outstanding upon such issuance of ordinary shares. We recorded expense, which is included in the stock-based compensation table above, of $126,000 and $124,000 for the three months ended September 30, 2018 and 2017, respectively, and $390,000 and $309,000 for the nine months ended September 30, 2018 and 2017, respectively. As of September 30, 2018, the total unrecognized compensation expense related to unvested RSUs is $0.5 million, which we expect to recognize over an estimated weighted‑average period of 1.2 years. A summary of our unvested RSUs as of September 30, 2018 is as follows: Number of Shares Outstanding—January 1, 2018 267,250 Granted 69,150 Forfeited (4,000) Vested (159,000) Unvested—September 30, 2018 173,400

Subsequent events

Subsequent events	9 Months Ended
	Sep. 30, 2018
Subsequent events
Subsequent Events	12. Subsequent Events Macrilen Acquisition Agreement On October 31, 2018, we entered into the Macrilen Acquisition Agreement with Novo Nordisk Healthcare AG, a Swiss corporation, ("Novo") (the "Macrilen Acquisition Agreement"). Under the Macrilen Acquisition Agreement, the Company grants Novo a call option and Novo grants the Company a put option, in each case with respect to the entire issued share capital of Strongbridge Ireland Limited, a wholly-owned subsidiary of the Company, which holds the Company’s Macrilen product. The exercise price of each of the put and call options is $145,000,000 (the "Acquisition"), plus a future royalty on sales of the pharmaceutical product for assessing growth hormone deficiency in adults and children known as Macrilen. Each party has the right to exercise its put option or call option, as applicable, before May 1, 2019 and only after all conditions in the Macrilen Acquisition Agreement have been satisfied or waived. Upon exercise of the put or call option, Strongbridge Ireland Limited will become a wholly-owned subsidiary of Novo. We expect the transaction to close in December 2018. The foregoing description of the Macrilen Acquisition Agreement is not complete and is subject to and qualified in its entirety by reference to the copy of the Macrilen Acquisition Agreement, which will be filed with the Company's Current Report on Form 8-K. Share Purchase Agreement On October 31, 2018, we entered into a Share Purchase Agreement with Novo Nordisk A/S, a company organized and existing under the law of Denmark, providing for the sale of 5,242,000 shares of our ordinary shares for $7.00 per share and an aggregate purchase price of $36,694,000 (the “Investor Agreement”). As a condition to the closing of the Investor Agreement, we will enter into a Registration Rights Agreement with Novo Nordisk A/S, and certain parties that execute a joinder to that agreement, in which we will provide Novo Nordisk A/S with certain registration rights to the shares they own in the Company pursuant to the Investor Agreement. We expect the transaction to close in December 2018. The foregoing description of the Investor Agreement is not complete and is subject to and qualified in its entirety by reference to the copy of the Investor Agreement, which will be filed with the Company's Current Report on Form 8-K.

Summary of significant accoun_2

Summary of significant accounting policies and basis of presentation (Policies)	9 Months Ended
	Sep. 30, 2018
Summary of significant accounting policies and basis of presentation
Basis of presentation	Basis of presentation These unaudited consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States (“U.S. GAAP”). The unaudited consolidated financial statements reflect all adjustments, which include only normal recurring adjustments that are, in the opinion of management, necessary to present a fair statement of the operating results and financial position for the periods presented. The preparation of the unaudited consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts and disclosures in the consolidated financial statements. Actual results could differ from those estimates. Results for the three months ended September 30, 2018 are not necessarily indicative of the results that may be expected for the year ending December 31, 2018. These unaudited consolidated financial statements should be read in conjunction with the accounting policies and notes to the audited consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017 filed with the U.S. Securities and Exchange Commission on March 12, 2018 (the “2017 Annual Report”). Our significant accounting policies are described in Note 2 of the notes to the audited consolidated financial statements included in our 2017 Annual Report. Since the date of those financial statements, there have been no changes to our significant accounting policies.
Revenue recognition	Revenue recognition We follow Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers, effective April 1, 2017. Topic 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We apply the five-step model to contracts only when it is probable that we will collect the consideration we are entitled to receive in exchange for the goods or services we transfer to our customers. At contract inception, once the contract is determined to be within the scope of Topic 606, we assess the goods or services promised within each contract and determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for net product revenue, see Note 3, "Revenue recognition".
Foreign currency translation	Foreign currency translation The consolidated financial statements are reported in United States dollars, which is our functional currency, including each of our consolidated subsidiaries. Transactions in foreign currencies are remeasured into our functional currency at the rate of exchange prevailing at the date of the transaction. Any monetary assets and liabilities arising from these transactions are remeasured into our functional currency at exchange rates prevailing at the balance sheet date or on settlement. Resulting gains and losses are recorded in foreign exchange loss in our consolidated statements of operations.
Use of estimates	Use of estimates The preparation of financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. We must apply significant judgment in this process. Actual results could materially differ from those estimates.
Segment information	Segment information Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions on how to allocate resources and assess performance. We view our operations and manage our business in one operating segment. Prior to March 31, 2018, our material long‑lived intangible assets resided in Ireland, Sweden and the Cayman Islands. Effective March 31, 2018, all of our material long-lived intangible assets reside in Ireland. As of September 30, 2018, $67.3 million of our cash and cash equivalents consisted primarily of bank deposits in the United States. For the nine months ended September 30, 2018, revenues from product sales were derived entirely from the United States.
Net loss per share	Net loss per share Basic net loss per share is calculated by dividing the net loss attributable to shareholders by the weighted average number of ordinary shares outstanding during the period. Diluted net loss per share is calculated by dividing the net loss attributable to shareholders by the weighted‑average number of ordinary shares outstanding for the period, including any dilutive effect from outstanding stock options or other equity-based awards. Shares used in the diluted net loss per share calculations exclude anti‑dilutive ordinary share equivalents, which currently consist of outstanding stock options, unvested restricted stock units (“RSUs”) and warrants. The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of September 30, 2018 and 2017, as they would be anti-dilutive: Nine Months Ended September 30, 2018 2017 Warrants 1,803,253 7,764,569 Stock options issued and outstanding 8,719,156 6,176,647 Unvested RSUs 173,400 274,250
Recent accounting pronouncements	Recent accounting pronouncements In January 2017, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (“ ASU’) 2017-04, Intangibles - Goodwill and Other : Simplifying the Accounting for Goodwill Impairment . ASU 2017-04 removes Step 2 of the goodwill impairment test, which requires a hypothetical purchase price allocation. A goodwill impairment will now be the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. This standard, which will be effective for us beginning in the first quarter of fiscal year 2020, is required to be applied prospectively. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. We are currently evaluating the impact this new accounting guidance will have on our consolidated financial statements. In February 2016, the FASB issued ASU No. 2016-02, Leases , that discusses how an entity should account for lease assets and lease liabilities. The guidance specifies that an entity who is a lessee under lease agreements should recognize lease assets and lease liabilities for those leases classified as operating leases under previous FASB guidance. Accounting for leases by lessors is largely unchanged under the new guidance. The guidance is effective for us beginning in the first quarter of fiscal year 2019. Early adoption is permitted. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. We are currently evaluating the impact this new accounting guidance will have on our consolidated financial statements but do not expect it will have a material impact on us.

Summary of significant accoun_3

Summary of significant accounting policies and basis of presentation (Tables)	9 Months Ended
	Sep. 30, 2018
Summary of significant accounting policies and basis of presentation
Schedule of potentially dilutive securities excluded from computations of diluted weighted average shares outstanding	Nine Months Ended September 30, 2018 2017 Warrants 1,803,253 7,764,569 Stock options issued and outstanding 8,719,156 6,176,647 Unvested RSUs 173,400 274,250

Revenue recognition (Tables)

Revenue recognition (Tables)	9 Months Ended
	Sep. 30, 2018
Revenue recognition
Schedule of disaggregation of revenue	The following table summarizes revenue by product for the three and nine months ended September 30, 2018 (in thousands) : Three Months Nine Months Ended Ended September 30, September 30, Products Keveyis $ 4,207 $ 12,373 Macrilen 1,140 1,140 Total $ 5,347 $ 13,513

Fair value measurement (Tables)

Fair value measurement (Tables)	9 Months Ended
	Sep. 30, 2018
Fair value measurement
Schedule of fair value of financial assets by level	The following table presents our assets and liabilities that are measured at fair value on a recurring basis for the periods presented (in thousands) : As of September 30, 2018 Level I Level II Level III Total Cash equivalents 66,996 — — 66,996 Total assets $ 66,996 $ — $ — $ 66,996 Warrant liability — — 22,721 22,721 Total liabilities $ — $ — $ 22,721 $ 22,721 As of December 31, 2017 Level I Level II Level III Total Cash equivalents 57,024 — — 57,024 Total assets $ 57,024 $ — $ — $ 57,024 Warrant liability — — 41,308 41,308 Total liabilities $ — $ — $ 41,308 $ 41,308

Intangible assets and goodwill

Intangible assets and goodwill (Tables)	9 Months Ended
	Sep. 30, 2018
Intangible assets and goodwill
Schedule of gross carrying amount of in process research and development and goodwill	The following represents the balance of our intangible assets as follows (in thousands): As of September 30, 2018 Beginning of Period Additions Impairment Amortization End of Period Keveyis 35,155 — — (3,767) 31,388 Macrilen — 24,825 — (1,750) 23,075 Goodwill 7,256 — — — 7,256 Total $ 42,411 $ 24,825 $ — $ (5,517) $ 61,719 As of December 31, 2017 Beginning of Period Additions Impairment Amortization End of Period IPR&D $ 20,723 $ — $ (20,723) $ — $ — Keveyis 40,177 — — (5,022) 35,155 Goodwill 7,256 — — — 7,256 Total $ 68,156 $ — $ (20,723) $ (5,022) $ 42,411

Accrued liabilities (Tables)

Accrued liabilities (Tables)	9 Months Ended
	Sep. 30, 2018
Accrued liabilities
Schedule of accrued liabilities	Accrued liabilities consist of the following (in thousands): September 30, December 31, 2018 2017 Consulting and professional fees $ 5,550 $ 2,465 Supply agreement - current portion 4,783 4,237 Employee compensation 3,813 3,668 Accrued sales allowances 2,204 742 Accrued inventory 1,734 — Accrued royalties 1,210 — Other 691 120 Total accrued liabilities $ 19,985 $ 11,232

Long-term debt (Tables)

Long-term debt (Tables)	9 Months Ended
	Sep. 30, 2018
Long-term debt
Future principal payments	Future principal payments due under the Loan Agreement are as follows (in thousands) : Principal Payments 2018 $ — 2019 — 2020 — 2021 35,320 2022 35,320 2023 17,660 Total future payments $ 88,300

Commitments and contingencies (

Commitments and contingencies (Tables)	9 Months Ended
	Sep. 30, 2018
Commitments and contingencies
Schedule of future minimum commitments under facility operating leases	As of September 30, 2018, future minimum commitments under facility operating leases were as follows (in thousands): Operating leases 2018 113 2019 439 2020 470 2021 481 2022 492 2023 207 Total minimum lease payments $ 2,202

Ordinary shares (Tables)

Ordinary shares (Tables)	9 Months Ended
	Sep. 30, 2018
Ordinary shares.
Schedule of warrants	Warrants Outstanding Exercise Expiration Warrants Warrants September 30, Classification Price Date Issued Exercised 2018 Warrants in connection with private equity placement Liability $ 2.50 6/28/2022 7,000,000 (470,000) 6,530,000 Warrants in connection with Horizon and Oxford loan agreement Equity $ 2.45 12/28/2026 428,571 (267,857) 160,714 Warrants in connection with CRG loan agreement Equity $ 7.37 7/14/2024 394,289 — 394,289 Warrants in connection with CRG loan amendment in January 2018 Equity $ 10.00 1/16/2025 1,248,250 — 1,248,250 9,071,110 8,333,253

Stock-based compensation (Table

Stock-based compensation (Tables)	9 Months Ended
	Sep. 30, 2018
Stock-based compensation
Schedule of summary of outstanding stock options activity	Options Outstanding Weighted- Average Weighted- Remaining Average Contractual Number of Exercise Term Aggregate Shares Price (Years) Intrinsic Value (in thousands) Outstanding—January 1, 2018 6,104,715 $ 7.50 7.70 $ 14,021 Granted 2,881,255 $ 6.78 Forfeited and cancelled (196,871) $ 6.24 Exercised (69,943) $ 4.31 Outstanding—September 30, 2018 8,719,156 $ 7.33 7.79 $ 4,541 Vested and exercisable—September 30, 2018 3,547,271 $ 9.08 6.30 $ 1,749
Schedule of stock-based compensation	We recognized stock‑based compensation expense for employees and directors for stock options and RSUs as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2018 2017 2018 2017 Selling, general and administrative $ 1,649 $ 1,007 $ 4,450 $ 3,042 Research and development 467 324 1,339 822 Total stock-based compensation $ 2,116 $ 1,331 $ 5,789 $ 3,864
Schedule of assumptions for estimating fair value of stock option awards	Nine Months Ended September 30, 2018 2017 Expected term (in years) 6.13 5.96 Risk-free interest rate 2.25% - 2.99% 1.78% - 2.26% Expected volatility 78.19% - 85% 78.2% - 105.9% Dividend rate —% —%
Schedule of summary of unvested RSUs	Number of Shares Outstanding—January 1, 2018 267,250 Granted 69,150 Forfeited (4,000) Vested (159,000) Unvested—September 30, 2018 173,400

Organization (Detail)

Organization (Detail) $ in Millions	46 Months Ended
	Sep. 30, 2018USD ($)product
Organization
Number of commercial products	2
Number of clinical-stage product candidates	2
Minimum
Financing
Amount raised in equity and debt financings | $	$ 283

Organization - Liquidity (Detai

Organization - Liquidity (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2018	Dec. 31, 2017
Liquidity
Cash and cash equivalents	$ 67,383	$ 57,510
Substantial doubt about going concern, within one year	false
Outstanding borrowings	$ 88,300

Summary of significant accoun_4

Summary of significant accounting policies and basis of presentation - Segment information (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2018USD ($)segment	Dec. 31, 2017USD ($)
Segment information
Number of operating segments | segment	1
Cash and cash equivalents | $	$ 67,383	$ 57,510

Summary of significant accoun_5

Summary of significant accounting policies and basis of presentation - Net loss per share (Details) - shares	9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Warrants
Net loss per share
Anti-dilutive shares of common stock (in shares)	1,803,253	7,764,569
Stock options
Net loss per share
Anti-dilutive shares of common stock (in shares)	8,719,156	6,176,647
RSUs
Net loss per share
Anti-dilutive shares of common stock (in shares)	173,400	274,250

Revenue recognition - Disaggreg

Revenue recognition - Disaggregation of Revenue (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Revenue by product
Total revenue	$ 5,347	$ 2,533	$ 13,513	$ 4,062
Keveyis
Revenue by product
Total revenue	4,207		12,373
Macrilen
Revenue by product
Total revenue	$ 1,140		$ 1,140

Revenue recognition - Reserves

Revenue recognition - Reserves (Details)	9 Months Ended
	Sep. 30, 2018
Revenue recognition
Prompt payment discount (as a percent)	2.00%
Percentage of patient’s cost of branded prescription drugs related to the Medicare Part D Coverage Gap for which manufacturers of pharmaceutical products are responsible	50.00%
Temporary supply period	60 days
Financial need period	12 months

Fair value measurement (Details

Fair value measurement (Details) - USD ($) $ in Thousands	Sep. 30, 2018	Dec. 31, 2017
Liabilities
Warrant liabilities	$ 22,721	$ 41,308
Recurring
Assets
Cash equivalents	66,996	57,024
Total Assets	66,996	57,024
Liabilities
Warrant liabilities	22,721	41,308
Total liabilities	22,721	41,308
Recurring | Level I
Assets
Cash equivalents	66,996	57,024
Total Assets	66,996	57,024
Recurring | Level III
Liabilities
Warrant liabilities	22,721	41,308
Total liabilities	$ 22,721	$ 41,308

Intangible assets and goodwil_2

Intangible assets and goodwill - Components (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017	Dec. 31, 2017
Intangible assets and goodwill
IPRandD, Beginning of Period				$ 20,723	$ 20,723
IPRandD, Impairment					(20,723)
Finite-lived intangible assets, Amortization	$ (1,876)	$ (1,256)	$ (5,517)	(3,767)	(5,022)
Goodwill, Beginning of Period			7,256	7,256	7,256
Goodwill, End of Period	7,256		7,256		7,256
Total, Beginning of Period			42,411	68,156	68,156
Total, Additions			24,825
Total Impairment					(20,723)
Amortization	(1,876)	$ (1,256)	(5,517)	(3,767)	(5,022)
Total, End of Period	61,719		61,719		42,411
Keveyis
Intangible assets and goodwill
Finite-lived intangible assets, Beginning of Period			35,155	$ 40,177	40,177
Finite-lived intangible assets, Amortization			(3,767)		(5,022)
Finite-lived intangible assets, End of Period	31,388		31,388		35,155
Amortization			(3,767)		$ (5,022)
Macrilen
Intangible assets and goodwill
Finite-lived intangible assets, Additions			24,825
Finite-lived intangible assets, Amortization			(1,750)
Finite-lived intangible assets, End of Period	$ 23,075		23,075
Amortization			$ (1,750)

Intangible assets and goodwil_3

Intangible assets and goodwill - Asset purchase (Details) $ in Thousands	1 Months Ended			3 Months Ended		9 Months Ended		12 Months Ended
	Jan. 31, 2018USD ($)	Mar. 31, 2017USD ($)	Dec. 31, 2016USD ($)installment	Sep. 30, 2018USD ($)	Sep. 30, 2017USD ($)	Sep. 30, 2018USD ($)	Sep. 30, 2017USD ($)	Dec. 31, 2017USD ($)	Dec. 31, 2016item	Dec. 31, 2016USD ($)
In-process research and development and Goodwill
IPRandD, Impairment								$ (20,723)
Amortization of intangible assets				$ 1,876	$ 1,256	$ 5,517	$ 3,767	5,022
Keveyis
In-process research and development and Goodwill
Acquired product rights				31,388		31,388		35,155		$ 40,177
Amortization of intangible assets						3,767		$ 5,022
Keveyis | Taro | Acquired product rights
In-process research and development and Goodwill
Acquired product rights										40,200
Transaction costs										2,400
Estimated life			8 years
Macrilen
In-process research and development and Goodwill
Acquired product rights				23,075		23,075
Amortization of intangible assets						1,750
Asset Purchase Agreement | Keveyis | Taro | Acquired product rights
In-process research and development and Goodwill
Number of installment payments			2						2
Installment payment		$ 7,500	$ 1,000
Supply Agreement | Keveyis | Taro | Acquired product rights
In-process research and development and Goodwill
Acquired product rights										$ 29,300
License and assignment agreement | Macrilen | Aeterna Zentaris GmbH | Acquired product rights
In-process research and development and Goodwill
Acquired product rights				24,700		24,700
Collaborative arrangement consideration paid	$ 24,000					24,000
Transaction costs				$ 700		$ 700
Estimated life						10 years

Accrued liabilities (Details)

Accrued liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2018	Dec. 31, 2017
Accrued liabilities
Consulting and professional fees	$ 5,550	$ 2,465
Supply agreement - current portion	4,783	4,237
Employee compensation	3,813	3,668
Accrued sales allowances	2,204	742
Accrued inventory	1,734
Accrued royalties	1,210
Other	691	120
Total accrued liabilities	$ 19,985	$ 11,232

Long-term debt - Agreements (De

Long-term debt - Agreements (Details) $ / shares in Units, $ in Thousands	Jun. 06, 2018USD ($)item	Sep. 30, 2017USD ($)	Sep. 30, 2018USD ($)$ / shares	Sep. 30, 2017USD ($)	Jun. 05, 2018USD ($)	Jan. 16, 2018USD ($)$ / sharesshares	Jan. 15, 2018USD ($)
Loan agreement
Loss on extinguishment of debt		$ 3,545	$ 500	$ 3,545
Minimum
Loan agreement
Change in cash flow (as a percent)			10.00%
CRG credit facility
Loan agreement
Maximum borrowing capacity	$ 95,000				$ 100,000	$ 100,000	$ 50,000
Consecutive trading period	20 days
Credit facility term	6 years
Interest only term option upon achievement of milestone	6 years
Fixed interest rate (as a percent)	12.50%
Final payment fee (as a percent)	5.00%
Deferral percentage	4.00%
Interest-only payment period	3 years
Additional outstanding balance due to PIK provision			$ 3,300
Debt discounts	$ 10,600
Debt issuance costs	200
Loss on extinguishment of debt			$ 500
CRG credit facility, Second Tranche
Loan agreement
Additional borrowing capacity on achievement of milestones						45,000
CRG credit facility, Final tranche
Loan agreement
Additional borrowing capacity on achievement of milestones	$ 10,000
Number of borrowing tranches | item	1
CRG credit facility, Fourth Tranche
Loan agreement
Additional borrowing capacity on achievement of milestones						5,000
CRG credit facility, Third Tranche
Loan agreement
Additional borrowing capacity on achievement of milestones						$ 10,000
Warrants in connection with CRG credit facility
Loan agreement
Warrant exercise price (in dollars per share) | $ / shares			$ 7.37
Warrants in connection with CRG loan agreement, Second Tranche | CRG credit facility
Loan agreement
Securities that warrants may purchase (in shares) | shares						1,248,250
Warrant exercise price (in dollars per share) | $ / shares						$ 10
Warrants in connection with CRG loan agreement, Final tranche | Minimum
Loan agreement
Number of warrants required to be to be issued | item	1
Warrants in connection with CRG loan agreement, Final tranche | CRG credit facility
Loan agreement
Warrants to be issued as a percentage of ordinary shares, one	0.10%
Exercise price of warrants, one (as a percent)	110.00%
Warrants to be issued as a percentage of ordinary shares, two	0.25%
Exercise price of warrants, two (as a percent)	140.00%
Period of volume weighted average price (VWAP) per ordinary share	10 days

Long-term debt - Future princip

Long-term debt - Future principal payments (Details) $ in Thousands	Sep. 30, 2018USD ($)
Future principal payments
2,021	$ 35,320
2,022	35,320
2,023	17,660
Total future payments	$ 88,300

Commitments and contingencies -

Commitments and contingencies - Lease (Details)	9 Months Ended
	Sep. 30, 2018USD ($)	Sep. 30, 2017USD ($)	Nov. 30, 2017ft²	Mar. 31, 2015ft²
Future minimum commitments under facility operating leases
2,018	$ 113,000
2,019	439,000
2,020	470,000
2,021	481,000
2,022	492,000
2,023	207,000
Total minimum lease payments	2,202,000
Rent expense	$ 535,000	$ 205,000
Building lease, March 2015
Lease
Lease term				52 months
Amount of space leased (in square feet) | ft²				14,743
Building lease, November 2017
Lease
Lease term			60 months
Amount of space leased (in square feet) | ft²			7,326

Commitments and contingencies_2

Commitments and contingencies - Commitments to Taro (Details) - Acquired product rights - Taro - Keveyis $ in Millions	1 Months Ended
	Mar. 31, 2017USD ($)	Dec. 31, 2016USD ($)installment	Dec. 31, 2016item	Dec. 31, 2016USD ($)
Asset Purchase Agreement
Other Commitments
Number of installment payments		2	2
Installment payment	$ 7.5	$ 1
Potential milestone payments				$ 7.5
Supply Agreement
Other Commitments
Minimum amount of purchases obligated				$ 29
Purchase obligation period		6 years

Commitments and contingencies_3

Commitments and contingencies - Commitments to Aeterna Zentaris GmbH (Details) - Acquired product rights - Aeterna Zentaris GmbH - Macrilen - License and assignment agreement - USD ($) $ in Millions	1 Months Ended	9 Months Ended
	Jan. 31, 2018	Sep. 30, 2018
Other Commitments
Collaborative arrangement consideration paid	$ 24	$ 24
Potential milestone payments	$ 174
Amount paid by counterparty for program costs (as a percent)	70.00%
Amount paid by counterparty for program costs	$ 4
Cost payment period	3 years
Amount to be paid to entity upon regulatory approval	$ 5
Minimum
Other Commitments
Royalty payments as a percent of net sales	15.00%
Maximum
Other Commitments
Royalty payments as a percent of net sales	18.00%

Income taxes (Details)

Income taxes (Details) - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2018	Dec. 31, 2017
Components of income tax (benefit)
Deferred income tax expense	$ 0
U.S.
Components of income tax (benefit)
Federal corporate tax rate	21.00%	34.00%
Maximum | U.S.
Components of income tax (benefit)
Federal corporate tax rate		35.00%

Ordinary shares - Equity transa

Ordinary shares - Equity transactions (Details) - USD ($)	Feb. 27, 2018	Jan. 30, 2018	Apr. 28, 2017	Sep. 30, 2018	Sep. 30, 2017
Equity transactions
Proceeds from issuance of ordinary shares, net				$ 33,508,000	$ 2,981,000
Public offering
Equity transactions
Proceeds from issuance of ordinary shares, net		$ 31,800,000
Over-allotment option, Underwriters
Equity transactions
Proceeds from issuance of ordinary shares, net	$ 1,700,000
ATM Facility
Equity transactions
Issuance of shares (in shares)				1,172,557
Price per share (in dollars per share)				$ 7
Proceeds from issuance of ordinary shares, net				$ 8,000,000
Aggregate shares issuable (in dollars)			$ 40,000,000
Commission on gross proceeds from sale of shares (as a percent)			3.00%
Payment of fees on issuance of ordinary shares				246,000
Amount available				$ 32,000,000
Ordinary Shares | Public offering
Equity transactions
Issuance of shares (in shares)		5,000,000
Price per share (in dollars per share)		$ 6.75
Ordinary Shares | Over-allotment option, Underwriters
Equity transactions
Issuance of shares (in shares)	255,683
Price per share (in dollars per share)	$ 6.75
Ordinary Shares | ATM Facility
Equity transactions
Issuance of shares (in shares)				1,172,557

Ordinary shares - Warrants (Det

Ordinary shares - Warrants (Details)	3 Months Ended	9 Months Ended
	Sep. 30, 2018$ / sharesshares	Sep. 30, 2018$ / sharesshares
Warrants
Warrants issued		9,071,110
Warrants Outstanding (in shares)	8,333,253	8,333,253
Warrants in connection with private equity placement
Warrants
Warrant exercise price (in dollars per share) | $ / shares	$ 2.50	$ 2.50
Warrants issued		7,000,000
Warrants Exercised		(470,000)
Warrants Outstanding (in shares)	6,530,000	6,530,000
Warrants in connection with Horizon and Oxford loan agreement
Warrants
Warrant exercise price (in dollars per share) | $ / shares	$ 2.45	$ 2.45
Warrants issued		428,571
Warrants Exercised		(267,857)
Warrants Outstanding (in shares)	160,714	160,714
Warrants in connection with CRG credit facility
Warrants
Warrant exercise price (in dollars per share) | $ / shares	$ 7.37	$ 7.37
Warrants issued		394,289
Warrants Outstanding (in shares)	394,289	394,289
Warrants in connection with CRG loan amendment in January 2018
Warrants
Warrant exercise price (in dollars per share) | $ / shares	$ 10	$ 10
Warrants issued		1,248,250
Warrants Outstanding (in shares)	1,248,250	1,248,250
Ordinary Shares
Warrants
Shares issued in exercise of warrants (in shares)		470,000
Ordinary Shares | Warrants in connection with private equity placement
Warrants
Shares issued in exercise of warrants (in shares)	470,000

Stock-based compensation - Gene

Stock-based compensation - General (Details)	Sep. 30, 2018shares
Inducement Plan
Stock-based compensation
Number of shares available for issuance	620,200
2015 Plan
Stock-based compensation
Number of shares available for issuance	163,006
Non-Employee Director Plan
Stock-based compensation
Number of shares available for issuance	1,541

Stock-based compensation - Stoc

Stock-based compensation - Stock options activity (Details) - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2018	Dec. 31, 2017
Summary of outstanding stock options
Outstanding at beginning of period (in shares)	6,104,715
Granted (in shares)	2,881,255
Forfeited and cancelled (in shares)	(196,871)
Exercised (in shares)	(69,943)
Outstanding at end of period (in shares)	8,719,156	6,104,715
Vested and exercisable at end of period (in shares)	3,547,271
Weighted-Average Exercise Price
Granted (in dollars per share)	$ 6.78
Forfeited and cancelled (in dollars per share)	6.24
Exercised (in dollars per share)	4.31
Outstanding (in dollars per share)	7.33	$ 7.50
Vested and exercisable at end of period (in dollars per share)	$ 9.08
Additional Disclosures - Options
Weighted Average Remaining Contractual Term, Outstanding	7 years 9 months 15 days	7 years 8 months 12 days
Weighted Average Remaining Contractual Term, Vested and exercisable	6 years 3 months 18 days
Aggregate Intrinsic Value, Outstanding (in dollars)	$ 4,541	$ 14,021
Aggregate Intrinsic Value, Vested and exercisable at end of the period (in dollars)	$ 1,749

Stock-based compensation - Opti

Stock-based compensation - Options outstanding (Details) - $ / shares	9 Months Ended
	Sep. 30, 2018	Dec. 31, 2017
Stock options
Options outstanding (in shares)	8,719,156	6,104,715
Options outstanding, weighted-average exercise price (in dollars per share)	$ 7.33	$ 7.50
Vesting subject to acceleration
Stock options
Options outstanding (in shares)	88,908
Options outstanding, weighted-average exercise price (in dollars per share)	$ 18.80
Share price vesting threshold (in dollars per share)	31.46
Vesting based on market appreciation event | Grantee, One
Stock options
Share price vesting threshold (in dollars per share)	30.14
Vesting based on market appreciation event | Grantee, Two
Stock options
Share price vesting threshold (in dollars per share)	$ 33.66
Vesting based on market appreciation event | Vesting at market appreciation event
Stock options
Options outstanding (in shares)	97,652
Consecutive trading days threshold	20 days
Vesting based on market appreciation event | Vesting at one year anniversary of market appreciation event
Stock options
Options outstanding (in shares)	97,652
Vesting period following event	1 year
Consecutive trading days threshold	20 days

Stock-based compensation - St_2

Stock-based compensation - Stock-based compensation expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Stock-based compensation expense
Total stock-based compensation	$ 2,116	$ 1,331	$ 5,789	$ 3,864
Stock options
Stock-based compensation expense
Total unrecognized compensation expense	17,900		$ 17,900
Estimated weighted average period over which expense is expected to be recognized			2 years 10 months 6 days
Selling, general and administrative
Stock-based compensation expense
Total stock-based compensation	1,649	1,007	$ 4,450	3,042
Research and development
Stock-based compensation expense
Total stock-based compensation	$ 467	$ 324	$ 1,339	$ 822

Stock-based compensation - Fair

Stock-based compensation - Fair value assumptions (Details)	9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Fair value assumptions
Expected term (in years)	6 years 1 month 17 days	5 years 11 months 16 days
Minimum Risk-free interest rate (as a percent)	2.25%	1.78%
Maximum Risk-free interest rate (as a percent)	2.99%	2.26%
Minimum Expected volatility (as a percent)	78.19%	78.20%
Maximum Expected volatility (as a percent)	85.00%	105.90%

Stock-based compensation - Rest

Stock-based compensation - Restricted stock units (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Stock-based compensation
Stock-based compensation	$ 2,116,000	$ 1,331,000	$ 5,789,000	$ 3,864,000
RSUs
Stock-based compensation
Vesting period			2 years
Number of shares issued for each stock award vested			1
Stock-based compensation	126,000	$ 124,000	$ 390,000	$ 309,000
Total unrecognized compensation expense	$ 500,000		$ 500,000
Estimated weighted average period over which expense is expected to be recognized			1 year 2 months 12 days
Summary of unvested RSUs
Unvested - Beginning of period (in shares)			267,250
Granted (in shares)			69,150
Forfeited (in shares)			(4,000)
Vested (in shares)			(159,000)
Unvested - End of period (in shares)	173,400		173,400

Subsequent events (Details)

Subsequent events (Details) - Subsequent event	Oct. 31, 2018USD ($)$ / shares$ / itemshares
Novo Nordisk AS | Forecast | Share Purchase Agreement
Subsequent events
Issuance of shares (in shares) | shares	5,242,000
Price per share (in dollars per share) | $ / shares	$ 7
Aggregate purchase price | $	$ 36,694,000
Macrilen Acquisition Agreement | Novo Nordisk Healthcare AG
Subsequent events
Exercise price of each put and call option | $ / item	145,000,000