Document and Entity Information
Document and Entity Information - shares | 12 Months Ended | |
Dec. 31, 2016 | Mar. 10, 2017 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | Strongbridge Biopharma plc | |
Entity Central Index Key | 1,634,432 | |
Document Type | 20-F | |
Document Period End Date | Dec. 31, 2016 | |
Amendment Flag | false | |
Entity Voluntary Filers | No | |
Entity Well-known Seasoned Issuer | No | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 35,335,026 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | FY |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 66,837 | $ 51,623 |
Prepaid expenses and other current assets | 764 | 1,253 |
Total current assets | 67,601 | 52,876 |
Property and equipment, net | 25 | 35 |
Deferred tax asset | 1,599 | |
Intangible assets, net | 60,900 | 36,551 |
Goodwill | 7,256 | 7,256 |
Other assets | 150 | 612 |
Total assets | 137,531 | 97,330 |
Current liabilities: | ||
Accounts payable | 1,089 | 2,792 |
Accrued liabilities | 14,868 | 2,685 |
Total current liabilities | 15,957 | 5,477 |
Long-term debt | 18,434 | |
Warrant liability | 11,090 | |
Supply agreement liability, noncurrent | 25,078 | |
Deferred tax liabilities | 926 | |
Total liabilities | 70,559 | 6,403 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity: | ||
Deferred shares, $1.098 par value, 40,000 shares authorized, issued and outstanding at December 31, 2016 and December 31, 2015 | 44 | 44 |
Ordinary shares, $0.01 par value, 600,000,000 shares authorized at December 31, 2016 and December 31, 2015; 35,335,026 and 21,205,382 shares issued and outstanding at December 31, 2016 and December 31, 2015 | 353 | 212 |
Additional paid-in capital | 195,975 | 170,910 |
Accumulated deficit | (129,400) | (80,803) |
Non-controlling interest | 564 | |
Total stockholders’ equity | 66,972 | 90,927 |
Total liabilities and stockholders’ equity | $ 137,531 | $ 97,330 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2016 | Dec. 31, 2015 |
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 | 35,335,026 | 21,205,382 |
Ordinary shares, shares outstanding | 35,335,026 | 21,205,382 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Operating expenses: | |||
Research and development | $ 20,023 | $ 20,135 | $ 5,844 |
General and administrative | 14,875 | 22,719 | 4,588 |
Impairment of intangible assets | 15,828 | ||
Total operating expenses | 50,726 | 42,854 | 10,432 |
Operating loss | (50,726) | (42,854) | (10,432) |
Other (expense) income, net: | |||
Foreign exchange loss | (69) | (124) | (204) |
Unrealized gain on fair value of warrants | 638 | ||
Interest expense | (20) | ||
Other (expense) income, net | (1,180) | (1,105) | 486 |
Total other (expense) income, net | (631) | (1,229) | 282 |
Loss before income taxes | (51,357) | (44,083) | (10,150) |
Income tax benefit | 2,638 | 450 | 480 |
Net loss | (48,719) | (43,633) | (9,670) |
Net loss attributable to non-controlling interest | 122 | 53 | |
Net loss attributable to Strongbridge Biopharma | (48,597) | (43,580) | (9,670) |
Comprehensive loss | (48,597) | (43,580) | (9,670) |
Net loss attributable to ordinary shareholders: | |||
Basic | (48,597) | (43,580) | (9,670) |
Diluted | $ (49,236) | $ (43,580) | $ (9,670) |
Net loss per share attributable to ordinary shareholders: | |||
Basic (in dollars per share) | $ (2.26) | $ (2.62) | $ (1.20) |
Diluted (in dollars per share) | $ (2.27) | $ (2.62) | $ (1.20) |
Weighted-average shares used in computing net loss per share attributable to ordinary shareholders: | |||
Basic (in shares) | 21,550,353 | 16,606,669 | 8,043,175 |
Diluted (in shares) | 21,655,564 | 16,606,669 | 8,043,175 |
Consolidated Statement of Share
Consolidated Statement of Shareholders' Equity - USD ($) $ in Thousands | Ordinary Shares | Deferred Shares | Additional Paid-In Capital | Accumulated Deficit | Non Controlling Interest | Total |
Balance at beginning of period at Dec. 31, 2013 | $ 79 | $ 45,273 | $ (27,553) | $ 24 | $ 17,823 | |
Balance (in shares) at Dec. 31, 2013 | 7,939,608 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Net loss | (9,670) | (9,670) | ||||
Shares exchanged for BioPancreate non-controlling interest | 19 | (24) | (5) | |||
Shares exchanged for BioPancreate non-controlling interest (in shares) | 5,272 | |||||
Stock-based compensation | 480 | 480 | ||||
Issuance of shares | $ 18 | 10,175 | 10,193 | |||
Issuance of shares (in shares) | 1,755,909 | |||||
Balance at end of period at Dec. 31, 2014 | $ 97 | 55,947 | (37,223) | 18,821 | ||
Balance (in shares) at Dec. 31, 2014 | 9,700,789 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Net loss | (43,580) | (53) | (43,633) | |||
Stock-based compensation | 3,581 | 3,581 | ||||
Reclass of stock-based liability award to equity | 1,542 | 1,542 | ||||
Issuance of shares | $ 91 | 91,418 | 91,509 | |||
Issuance of shares (in shares) | 9,108,169 | |||||
U.S. non-accredited shares repurchased | (412) | (412) | ||||
U.S. non-accredited shares repurchased (in shares) | (24,955) | |||||
Issuance of shares in initial public offering, net | $ 25 | 19,450 | 19,475 | |||
Issuance of shares in initial public offering, net (in shares) | 2,500,000 | |||||
Noncontrolling interest resulting from exchange offer | $ (1) | (616) | 617 | |||
Noncontrolling interest resulting from exchange offer (in shares) | (78,621) | |||||
Beneficial shares issued | $ 44 | 44 | ||||
Beneficial shares issued (in shares) | 40,000 | |||||
Balance at end of period at Dec. 31, 2015 | $ 212 | $ 44 | 170,910 | (80,803) | 564 | 90,927 |
Balance (in shares) at Dec. 31, 2015 | 21,205,382 | 40,000 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Net loss | (48,597) | (122) | (48,719) | |||
Stock-based compensation | 4,606 | 4,606 | ||||
Acquisition of non-controlling interest | (972) | $ (442) | (1,414) | |||
Issuance of shares, net of offering costs | $ 140 | 20,430 | 20,570 | |||
Issuance of shares (in shares) | 14,000,000 | |||||
Exercise of stock options | $ 1 | 119 | 120 | |||
Exercise of stock options (in shares) | 129,644 | |||||
Issuance of warrants related to the loan agreement | 882 | 882 | ||||
Balance at end of period at Dec. 31, 2016 | $ 353 | $ 44 | $ 195,975 | $ (129,400) | $ 66,972 | |
Balance (in shares) at Dec. 31, 2016 | 35,335,026 | 40,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flow - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Cash flows from operating activities: | |||
Net loss | $ (48,719) | $ (43,633) | $ (9,670) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 10 | 11 | 9 |
Stock-based compensation | 4,606 | 3,940 | 251 |
Deferred income tax benefit | (2,638) | (450) | (480) |
Impairment of intangible assets | 15,828 | ||
Impairment/loss on investment in Antisense Therapeutics | 550 | 551 | |
Change in fair value of warrant liability | (638) | ||
Change in fair value of foreign currency forward contracts | 438 | (279) | |
Changes in operating assets and liabilities: | |||
Accounts payable | (1,702) | 1,737 | 236 |
Accrued liabilities and other liabilities | 475 | 1,263 | 736 |
Other assets | (88) | (52) | 2 |
Prepaid expenses and other current assets | 602 | (1,165) | (309) |
Net cash used in operating activities | (31,714) | (37,360) | (9,504) |
Cash flows from investing activities: | |||
Payments for acquisitions | (3,392) | (3,168) | |
Investment in Antisense Therapeutics | (1,101) | ||
Purchase of equipment | (25) | (24) | |
Net cash used in investing activities | (3,392) | (4,294) | (24) |
Cash flows from financing activities: | |||
Proceeds from initial public offering, net | 19,475 | ||
Proceeds from issuance of ordinary shares and warrants, net | 32,298 | 58,341 | 10,193 |
Proceeds from exercise of stock options | 120 | ||
Proceeds from long-term debt | 19,316 | ||
Acquisition of non-controlling interest | (1,414) | (412) | |
Net cash provided by financing activities | 50,320 | 77,404 | 10,193 |
Effect of exchange rate changes on cash and cash equivalents | 241 | 70 | |
Net increase in cash and cash equivalents | 15,214 | 35,991 | 735 |
Cash and cash equivalents-beginning of period | 51,623 | 15,632 | 14,897 |
Cash and cash equivalents-end of period | 66,837 | 51,623 | 15,632 |
Supplemental Disclosures of Cash Flow Information - Cash paid during the year for: | |||
Interest | 20 | ||
Supplemental non-cash investing and financing activities: | |||
Ordinary shares issued for acquisition of COR-005 | $ 33,211 | ||
Ordinary shares exchanged for BioPancreate | $ 43 | ||
Supply agreement liability for intangible asset | $ 29,285 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2016 | |
Organization | |
Organization | 1. Organizatio Strongbridge Biopharma plc is 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 ("FDA") for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis. Keveyis, for which we hold the U.S. marketing rights, has orphan drug exclusivity status in the United States through August 7, 2022. In addition to this neuromuscular disease product, we have two clinical-stage product candidates for rare endocrine diseases, Recorlev and veldoreotide. Recorlev (levoketoconazole, and formerly called COR-003) is a cortisol synthesis inhibitor currently being studied for the treatment of endogenous Cushing's syndrome. Veldoreotide (formerly called COR-005) is a next-generation somatostatin analog (SSA) being investigated for the treatment of acromegaly, with potential additional applications in Cushing's syndrome and neuroendocrine tumors. 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 use a small, focused sales force to effectively market our products, if approved, in the United States, the European Union and other key global markets. We believe that our ability to execute on this strategy is enhanced by the significant commercial and clinical development experience of key members of our management team. We will continue to identify and evaluate the acquisition of products and product candidates 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. On October 15, 2015, a registration statement was declared effective by the U.S. Securities and Exchange Commission and on October 16, 2015 we initiated our initial U.S. public offering (IPO) of 2,500,000 ordinary shares at a price of $10.00 per share. The aggregate net proceeds received by us from the IPO were $19.5 million. Our shares began trading on The NASDAQ Global Select Market under the symbol "SBBP". On October 20, 2015, trading ceased on the Norwegian Over‑The‑Counter Market, or NOTC. Exchange offer On May 26, 2015, Strongbridge Biopharma plc (then named Cortendo plc), was incorporated under the laws of Ireland. On August 7, 2015, Strongbridge Biopharma plc initiated an exchange offer for the outstanding shares of Cortendo AB. The exchange offer was structured as a one‑for‑one exchange offer in which shareholders of Cortendo AB exchanged their common shares, with a par value of $0.15, for beneficial interests in ordinary shares of Strongbridge Biopharma plc, with a par value of $0.01, in the form of Norwegian depositary receipts and, as the case may be, Swedish depositary receipts (except for non‑accredited investors who hold Cortendo AB shares located in the United States, who were offered cash in an amount equivalent to the value of the Strongbridge Biopharma plc shares such investors would otherwise receive for their Cortendo AB shares exchanged). The exchange offer was settled on September 8, 2015, and Cortendo AB became a subsidiary with 99.582% of its shares being owned by Strongbridge Biopharma plc. Accordingly, Strongbridge Biopharma plc is a continuation of Cortendo AB, the predecessor, and the consolidated financial statements represent the assets, liabilities and results of operations of Cortendo AB, for all periods presented. On September 8, 2015, Strongbridge Biopharma plc effected a 1‑for‑11 reverse stock split of its ordinary shares. Accordingly, the consolidated financial statements and notes retroactively reflect the capital structure of Strongbridge Biopharma plc after giving effect to the exchange offer and the reverse stock split. With affect from September 8, 2015, the 0.418% of Cortendo AB not owned by Strongbridge Biopharma plc, is accounted for as a non‑controlling interest. In September 2016, we acquired the non-controlling interest in Cortendo AB, after which Cortendo AB became a wholly-owned subsidiary of Strongbridge Biopharma plc. Total consideration paid per share was $13.66 resulting in an aggregate payment of $1.4 million. Liquidity We believe that our cash resources of $66.8 million at December 31, 2016 will be sufficient to allow us to fund planned operations into 2019, which is after the expected receipt of data from the Recorlev SONICS and LOGICS Phase 3 clinical trials. We expect our funding requirements for operating activities to increase in 2017 and possibly beyond due to expenses associated with the commercialization of Keveyis, the execution of the Phase 3 SONICS and LOGICS clinical trials for Recorlev, and selling, general and administrative expenses. 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. In addition, beginning in June 2018, we will be required to make monthly 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. 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 $20.0 million at December 31, 2016, contains financial and non-financial covenants including minimum amounts of net revenue in 2017 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 48 month loan term (see Note 6). |
Summary of significant accounti
Summary of significant accounting policies and basis of presentation | 12 Months Ended |
Dec. 31, 2016 | |
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 and principles of consolidation The accompanying consolidated financial statements include the accounts of our wholly owned subsidiaries, BioPancreate Inc. (Trevose, Pennsylvania, United States), Cortendo AB (Gothenburg, Sweden) and Cortendo Cayman (Georgetown, Cayman Islands). All intercompany balances and transactions have been eliminated in consolidation. These audited consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States (U.S. GAAP). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB). Foreign currency translation The consolidated financial statements are reported in United States dollars, which is the functional currency of our subsidiaries and Cortendo AB. 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 about 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. Our material long‑lived assets, which primarily consists of in‑process research and development, reside in the United States, Sweden and Cayman Islands. Cash and cash equivalents We consider all short‑term highly liquid investments with an original maturity at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents consist of account balances at banks and money market accounts, respectively. Concentration of credit risk and other risks and uncertainties As part of our cash and investment management processes, we perform periodic evaluations of the credit standing of the financial institutions with which we deposit our cash or purchase cash equivalents, and we have not sustained any credit losses from instruments held at these financial institutions. Fair value of financial instruments Fair value accounting is applied for all financial assets and liabilities and non‑financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually). We are required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. FASB ASC Topic 820, Fair Value Measurements and Disclosures (ASC 820), establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of us. Unobservable inputs are inputs that reflect our assumptions about the inputs that market participants would use in pricing the asset or liability, and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The three levels of the fair value hierarchy are described as follows: Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability to access at the measurement date. Level 2—Valuations based on quoted prices for similar assets or liabilities, or quoted prices in markets that are not active, and for which all significant inputs are observable, either directly or indirectly. Level 3—Valuations that require inputs that reflect our own assumptions that are both significant to the fair value measurement and 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 we exercise in determining fair value is greatest for instruments categorized in 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. In December 2016, we issued warrants in connection with our private placement of ordinary shares. Pursuant to the terms of the warrant agreement, the Company could be required to settle the warrants in cash in the event of an acquisition of the Company and, as a result, the warrants are required to be measured at fair value and reported as a liability in the consolidated balance sheet. We recorded the fair value of the warrants upon issuance using the Black-Scholes Model and are required to revalue the warrants at each reporting date with any changes in fair value recorded on our statement of operations.. We consider both the initial valuation as well as our year-end valuation under Level 3 of the fair value hierarchy. The change in the fair value of the level 3 warrant liabilities is reflected in the statement of operations and comprehensive loss for the year ended December 31, 2016. Through June 30, 2015, we entered into foreign currency forward contracts to offset some of the foreign exchange risks we bear on operating expenses that were not denominated in U.S. dollars. These instruments were not entered into for speculative purposes and, although we believe they served as effective economic hedges, we did not seek to qualify for hedge accounting. The forward contracts settled on June 30, 2015, and we have not entered into new forward contracts. These forward contracts were recorded at fair value on the accompanying consolidated balance sheets as prepaid expenses and other current assets. These forward contracts were measured using observable quoted prices for similar instruments. The gain and loss recognized in other income, net, for these forward contracts was a loss of $0.4 million and a gain of $0.3 million for the years ended December 31, 2015 and 2014, respectively. These amounts represent the net gain or loss on the forward contracts and do not include changes in the related exposures, which generally offset a portion of the gain or loss on the forward contracts. We considered our foreign currency forward contracts under Level 2 of the fair value hierarchy. On May 13, 2015, as part of our agreement to acquire an exclusive license agreement from Antisense Therapeutics Limited (Antisense), we purchased 15,025,075 shares of Antisense common stock that had a fair value of $0.095 per share, which was the quoted market price of the Antisense common stock on the Australian Securities Exchange (ASX). Because we were contractually prohibited from selling the shares for 24 months from the date of purchase, we estimated a discount for the lack of marketability of $0.022 per share using an option pricing model that estimated the value of a protective put option using inputs that included quoted market prices and observable inputs other than quoted market prices. We initially recorded the net fair value amount of $1.1 million as a non-current other asset in our consolidated balance sheet. As of December 31, 2015, the non-current other asset was valued using the ASX closing market price of $0.051 per share and an updated discount for the lack of marketability of $0.014 per share using an option pricing model, resulting in an impairment charge recorded as a valuation allowance against the non-current other asset of $550,000. We considered both the initial valuation as well as our year-end valuation under Level 2 of the fair value hierarchy. In April 2016, we executed an agreement (the "Settlement Agreement") with Antisense to terminate the exclusive license agreement. Pursuant to the terms of the Settlement Agreement, we made a one-time payment of approximately $770,000 to Antisense and returned to Antisense, for no consideration, the shares of Antisense owned by us. T herefore no remeasurement was needed as of December 31, 2016. Property and equipment, net Property and equipment, net, consists of office equipment such as furniture, fixtures and computers. Depreciation expense for the years ended December 31, 2016 and 2015 was not significant. The following useful lives were used for the various classifications of property and equipment, net: Amortization Periods Computer hardware - years Computer software - years Furniture and fixtures - years Business combinations When acquiring new enterprises over which we obtain control, the acquisition method is applied. Under this method, we identify assets and liabilities of these enterprises and measure them at fair value at the acquisition date. Allowance is made for the tax effect of the adjustments made. The excess of the consideration transferred, the amount of the non‑controlling interest in the acquiree and the acquisition date fair value of previous equity interest in the acquiree over the fair value of the identifiable net assets acquired is recorded as goodwill. Intangible Assets Certain intangible assets were acquired as part of an asset purchase, and have been capitalized at their acquisition date fair value. Acquired definite life intangible assets are amortized using the straight line method over their respective estimated useful lives. The Company evaluates the potential impairment of intangible assets if events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. Purchased identifiable intangible assets with indefinite lives, such as our in‑process research and development, are evaluated for impairment annually in accordance with our policy and whenever events or changes in circumstances indicate that it is more likely than not that the fair value of these assets may not be recovered. To test these assets for impairment, we compare the fair value of the asset to its carrying value. The method we use to estimate the fair value measurements of indefinite‑lived intangible assets is based on the income approach. For the impairment analysis for the year ended December 31, 2016, significant unobservable inputs used in the income approach valuation method including a discount rates, royalty rates and probabilities of product candidate advancement from one clinical trial phase to the next. The determination of fair value of indefinite lived assets is considered Level 3 for fair value measurement . Goodwill We test goodwill for impairment on an annual basis or whenever events occur that may indicate possible impairment. This analysis requires us to make a series of critical assumptions to (1) evaluate whether any impairment exists and (2) measure the amount of impairment. Because we have one operating segment, when testing for a potential impairment of goodwill, we are required to estimate the fair value of our business and determine the carrying value. If the estimated fair value is less than the carrying value of our business, then we are required to estimate the fair value of all identifiable assets and liabilities in a manner similar to a purchase price allocation for an acquired business. Only after this process is completed can the goodwill impairment be determined, if any. To estimate the fair value of the business, primarily a market‑based approach is applied, utilizing our public market value. We did not record a charge for impairment for the years ended December 31, 2016, 2015 and 2014. Research and development expenses Research and development costs are expensed as incurred. Research and development expenses consist of internal and external expenses. Internal expenses include compensation and related expenses. External expenses include development, clinical trials, report writing and regulatory compliance costs incurred with clinical research organizations and other third‑party vendors. At the end of the reporting period, we compare payments made to third‑party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that we estimate has been made as a result of the service provided, we may record net prepaid or accrued expense relating to these costs. Upfront and milestone payments made to third parties who perform research and development services on our behalf are expensed as services are rendered. Stock‑based compensation We account for stock‑based compensation awards in accordance with FASB ASC Topic 718, Compensation—Stock Compensation (ASC 718). ASC 718 requires all stock‑based payments including grants of stock options and restricted stock and modifications to existing stock options, to be recognized in the consolidated statements of operations based on their fair values. Our stock‑based awards are subject to either service‑based or performance‑based vesting conditions. Vesting of certain awards could also be accelerated upon achievement of defined market‑based vesting conditions. Certain awards also contain a combination of service and market conditions or performance and market conditions. We account for employee stock‑based awards at grant‑date fair value. If we issue awards with an exercise price denominated in a currency other than our functional currency, trading currency or the currency for which we compensate our employee, we account for these as liabilities. We account for non‑employee and liability‑classified stock‑based awards based on the then‑current fair values at each financial reporting date until the performance is complete for non‑employee awards, or until the award is settled (exercised) for liability‑classified awards. Changes in the amounts attributed to these awards between the reporting dates are included in stock‑based compensation expense (credit) in our statements of operations. We include liability‑classified stock options in non‑current liabilities in our balance sheets as their settlement (exercise) does not require use of cash, cash equivalents or other current assets. We record compensation expense for service‑based awards over the vesting period of the award on a straight‑line basis. Compensation expense related to awards with performance‑based vesting conditions is recognized over the requisite service period using the accelerated attribution method to the extent achievement of the performance condition is probable. For those awards in which the performance condition was the completion of our IPO, we did not recognize compensation expense until the close of the IPO as we did not deem the IPO probable until it occurred. Compensation expense for awards with service and market‑based vesting conditions is recognized using the accelerated attribution method over the shorter of the requisite service period or the implied period associated with achievement of the market‑based vesting provisions. We estimate the fair value of our awards with service conditions using the Black‑Scholes option pricing model, which requires the input of subjective assumptions, including (i) the expected stock price volatility, (ii) the expected term of the award, (iii) the risk‑free interest rate and (iv) expected dividends. Due to the lack of historical and implied volatility data of our common stock, we based our estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. We selected companies with comparable characteristics to us, including enterprise value, risk profiles and position within the industry, and with historical share price information sufficient to meet the expected term of the stock‑based awards. We compute historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock‑based awards. We estimate the fair value of our awards with market conditions using a Monte Carlo simulation to determine the probability of satisfying the market condition. We make this estimate using the conditions that exist at the grant date. The derived service period, which may be the requisite service period, is also determined at this time. Compensation cost for our awards with a market condition is recognized ratably using the accelerated attribution method if the award is subject to graded vesting over the requisite service period. The compensation cost for our awards with a market condition is not reversed if the market condition is not satisfied. We have estimated the expected term of employee service‑based stock options using the “simplified” method, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option, due to our lack of sufficient historical data. We have estimated the expected term of employee awards with market conditions using a Monte‑Carlo simulation model. This approach involves generating random stock‑price paths through a lattice‑type structure. Each path results in a certain financial outcome, such as accelerated vesting or specific option payout. We have estimated the expected term of nonemployee service‑ and performance‑based awards based on the remaining contractual term of such awards. The risk‑free interest rates for periods within the expected term of the option are based on the Swedish Government Bond rate or the U.S. Treasury Bond rate with a maturity date commensurate with the expected term of the associated award. We have never paid dividends, and do not expect to pay dividends in the foreseeable future. We are also required to estimate forfeitures at the time of grant, and revise those estimates in subsequent periods if actual forfeitures differ from estimates. We record stock‑based compensation expense only for those awards that are expected to vest. To the extent that actual forfeitures differ from our estimates, the differences are recorded as a cumulative adjustment in the period the estimates were revised. Income taxes We use the asset and liability method of accounting for income taxes in accordance with FASB ASC Topic 740, Income Taxes (ASC 740). Under this method, income tax expense is recognized for the amount of (1) taxes payable or refundable for the current year and (2) deferred tax consequences of temporary differences resulting from matters that have been recognized in an entity’s financial statements or tax returns. 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 be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the results of operations in the period that includes the enactment date. A valuation allowance is provided to reduce the deferred tax assets reported if, based on the weight of the available positive and negative evidence, it is more likely than not some portion or all of the deferred tax assets will not be realized. ASC 740 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC 740 also provides guidance on de‑recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. We have no material uncertain tax positions for any of the reporting periods presented. We recognize interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2016, 2015 and 2014, we had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in our statements of operations. Net loss per share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted‑average number of shares of common stock 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 common equivalent shares, which currently consist of outstanding stock options and warrants. Due to the Company operating at a net loss these anti‑dilutive shares of common stock totaled 3,249,784 shares, 2,591,520 shares and 925,077 shares for the years ended December 31, 2016, 2015 and 2014, respectively. While these common equivalent shares are currently anti‑dilutive, they could be dilutive in the future. Recently adopted accounting pronouncements In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers , which requires entities to recognize revenue in a way that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The new guidance also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. The FASB has subsequently issued ASU No. 2016-10, Revenue from Contracts with Customer (Topic 606): Identifying Performance Obligations and Licensing, to address issues arising from implementation of the new revenue recognition standard. ASU 2014-09 and ASU 2016-10 are effective for interim and annual periods beginning January 1, 2018, and may be adopted earlier. The revenue standards are required to be adopted by taking either a full retrospective or a modified retrospective approach. The Company currently is evaluating the effect that this guidance may have on its consolidated financial statements as it relates to our launch of Keveyis. In September 2014, the FASB issued ASU No. 2014‑15 , Presentation of Financial Statements—Going Concern: Disclosures of Uncertainties about an Entity’s Ability to Continue as a Going Concern . The new guidance addresses management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. Management’s evaluation should be based on relevant conditions and events that are known and reasonably knowable at the date that the financial statements are issued. The Company adopted ASU 2014‑15 and it did not have an impact on our financial position or results of operations. In September 2015, the FASB issued ASU 2015-16, Business Combinations — Simplifying the Accounting Measurement-Period Adjustments that eliminates the requirement to restate prior period financial statements for measurement period adjustments for business combinations. The new guidance requires that the cumulative impact of a measurement period adjustment (including the impact on prior periods) be recognized in the reporting period in which the adjustment is identified. The guidance is effective for fiscal years beginning on or after December 15, 2015, and interim periods within those years and should be applied prospectively to measurement period adjustments that occur after the effective date. The Company will prospectively apply the guidance to applicable transactions. In November 2015, the FASB issued ASU 2015-17, Income Taxes: Balance Sheet Classification of Deferred Taxes that amends the balance sheet classification of deferred taxes. The new guidance requires that deferred tax liabilities and assets be classified as noncurrent on the balance sheet. Previous guidance required deferred tax liabilities and assets to be separated into current and noncurrent amounts on the balance sheet. The guidance is effective for fiscal years beginning on or after December 15, 2016, and interim periods within those years. The Company is currently evaluating the impact that the new guidance will have on our consolidated financial statements. In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments – Overall: Recognition and Measurement of Financial Assets and Financial Liabilities , that modifies certain aspects of the recognition, measurement, presentation, and disclosure of financial instruments. The accounting standard update is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017, and early adoption is permitted. The Company are currently assessing the impact that adopting this new accounting guidance will have on our consolidated financial statements. In March 2016, the FASB issued ASU 2016-09, Compensation – Stock Compensation: Improvements to Employee Share-Based Payments Accounting , which effects all entities that issue share-based payment awards to their employees. The amendments in this ASU cover such areas as the recognition of excess tax benefits and deficiencies, the classification of those excess tax benefits on the statement of cash flows, an accounting policy election for forfeitures, the amount an employer can withhold to cover income taxes and still qualify for equity classification and the classification of those taxes paid on the statement of cash flows. This ASU is effective for annual and interim periods beginning after December 15, 2016. This guidance can be applied either prospectively, retrospectively or using a modified retrospective transition method. Early adoption is permitted. The Company does not expect that this new guidance will have a material impact on the Company’s Consolidated Financial Statements. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments, which simplifies certain elements of cash flow classification. The new guidance is intended to reduce diversity in practice in how certain transactions are classified in the statement of cash flows. The ASU is effective for annual periods beginning after December 15, 2017. The Company is currently evaluating the impact the adoption of the ASU will have on its consolidated financial statements. In January 2017, the FASB issued ASU 2017-01, Business Combinations - C larifying the Definition of a Business, which clarified the definition of a business to assist entities with evaluating whether transactions should be accounted for as acquisitions of assets or businesses. The guidance is effective for interim and annual periods beginning after December 31, 2017, and early adoption is permitted. The Company elected to early adopt this guidance in the current period and has applied it to its evaluation of our asset purchase from Taro Pharmaceutical Industries Ltd. (see note 4 ). In January 2017, the FASB issued 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 the Company beginning in the first quarter of fiscal year 2021, 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. The Company is currently evaluating the impact this standard will have on its financial statements. |
Fair value measurement
Fair value measurement | 12 Months Ended |
Dec. 31, 2016 | |
Fair value measurement | |
Fair value measurement | 3. Fair value measurement The following table sets forth the fair value measurements by level within the fair value hierarchy, that are measured on a recurring basis. The noncurrent asset comprising of our investment in Antisense common stock, up until the time our investment was returned to Antisense was classified as Level II as we discounted the active market quoted price of the security to reflect our contractual restriction on selling the investment. Level 3 instruments consist of the common stock warrant liability. 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. Because of their short term nature, the amounts reported in the balance sheet for cash and cash equivalents, and accounts payable approximate fair value. The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis for the periods presented (in thousands) : As of December 31, 2016 Level I Level II Level III Total Warrant Liabilities — — Total liabilities $ — $ — $ $ As of December 31, 2015 Level I Level II Level III Total Assets Cash equivalents $ $ — $ — $ Noncurrent asset — — Total assets $ $ $ — $ |
Intangible assets and goodwill
Intangible assets and goodwill | 12 Months Ended |
Dec. 31, 2016 | |
Intangible assets and goodwill | |
In-process research and development and goodwill | 4. Intangible assets and goodwill The gross carrying amount of in‑process research and development, acquired developed product rights and goodwill is as follows (in thousands): As of December 31, 2016 Beginning of Period Additions Impairment End of Period IPR&D $ $ — $ $ Acquired product rights — — Goodwill — — Total $ $ $ $ As of December 31, 2015 Beginning of Period Additions Impairment End of Period IPR&D $ $ $ — $ Acquired product rights — — — — Goodwill — Total $ $ $ — $ Goodwill and in‑process research and development as of December 31, 2016 and 2015 resulted from our acquisition of BioPancreate and our 2015 acquisition of veldoreotide (formerly called COR-005) from Aspireo Pharmaceuticals, Ltd. (see Note 8). In‑process research and development is initially measured at its fair value and is not amortized until commercialization. Once commercialization occurs, in‑process research and development will be amortized over its estimated useful life. We recorded $5.2 million of impairment relating to our BioPancreate IPR&D (See note 8) and $10.6 million impairment for our veldoreotide IPR&D during the year ended December 31, 2016. The significant inputs to the fair value measurement were future revenues expected to be generated, estimated costs to manufacture and appropriate risk adjusted discount rate. The impairment of veldoreotide is due to increased costs estimated and longer time lines related to the development process; resulting in a decrease in the valuation of our intangible asset. Our finite lived intangible asset consist of acquired developed product rights obtained from the asset acquisition of Keveyis® (dichlorphenamide) from a subsidiary of Taro Pharmaceutical Industries Ltd. (“Taro”). Keveyis is approved in the U.S. to treat hyperkalemic, hypokalemic and related variants of primary periodic paralysis, a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis. Keveyis has received orphan drug exclusivity status in the U.S through August 7, 2022. In connection with the Asset Purchase and Supply Agreement we entered into with Taro Pharmaceutical Industries Ltd, we have paid Taro an upfront payment in two installments of $1 million in December 2016 and $7.5 million in March 2017. We have concluded that the supply price payable by us exceeds fair value and, therefore, have 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 amortized as we purchase inventory over the term of the agreement. In addition, we incurred transaction costs of $2.4 million resulting in the recording of an Intangible Asset of $40.2 million. This asset will be amortized as units are sold over an estimated 8 year period. |
Accrued liabilities
Accrued liabilities | 12 Months Ended |
Dec. 31, 2016 | |
Accrued liabilities | |
Accrued liabilities | 5. Accrued liabilities Accrued liabilities consist of the following (in thousands): December 31, December 31, 2016 2015 Consulting and professional fees $ $ Accrued payable due Taro Pharmaceuticals Industries Ltd. — Supply agreement - current portion — Employee compensation Other Total accrued liabilities $ $ |
Long Term Debt
Long Term Debt | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Long Term Debt | 6. Long Term Debt On December 28, 2016, the Company entered into a loan and security agreement (the “Loan Agreement”) with Oxford Finance LLC (“Oxford”) and Horizon Technology Finance Corporation (“Horizon”). The Loan Agreement provided for a $40 million credit facility, of which $20 million was borrowed initially. Under the Loan Agreement, the Company has access to two additional tranches of $10 million each, which would be available to the Company subject to the achievement of certain specified milestones. The borrowings pursuant to the Loan Agreement mature after 48 months. The Loan Agreement provides for interest-only payments initially for the first 18 months of the loan followed by an amortization period of 30 months, a final payment fee equal to 8% of the amount borrowed, and interest payable at an annual rate equal to the sum of 8.22% plus the greater of 0.53% or the 30-day US LIBOR rate. The credit facility provides that if the Company satisfies certain milestones and borrows the final $10 million tranche, the interest-only period would be extended by an additional six months and the amortization period would be 24 months. The Company has granted a security interest in substantially all of its existing assets and assets acquired by the Company 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 events of default and restricts the payment of cash dividends. The Loan Agreement contains a material adverse change clause whereby a material adverse change in the Company’s business, operations or financial condition would be considered an event of default whereby the lenders could declare all amounts under the Loan Agreement as immediately due and payable. We incurred $1.3 million in debt discounts and $0.3 million of debt issuance costs relating to this 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. In connection with the execution of the Loan Agreement, we issued warrants to the Lenders to purchase an aggregate of 428,571 ordinary shares at an exercise price equal to $2.45 per share. The warrants are immediately exercisable and expire after ten years. We accounted for these warrants as equity, and the fair value was recorded into APIC. Future principal payments due under the Loan Agreement are as follows (in thousands) : Principal Payments 2017 $ — 2018 2019 2020 Total future payments $ |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2016 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrants | 7. Warrants Common stock warrants are accounted for in accordance with applicable accounting guidance provided in ASC Topic 815, Derivatives and Hedging — Contracts in Entity’s Own Equity (ASC Topic 815), as either derivative liabilities or as equity instruments depending on the specific terms of the warrant agreement. Warrants outstanding and warrant activity for the year ended December 31, 2016 is as follows: Exercise Expiration Warrants Warrants December 31, Classification Price Date Issued Exercised 2016 Warrants in connection with private equity placement Liability $ 6/28/2022 — Warrants in connection with loan agreement Equity $ 12/28/2026 — |
Commitments and contingencies
Commitments and contingencies | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and contingencies | |
Commitments and contingencies | 8. Commitments and contingencies (a) Lease On April 22, 2014, we entered into a 48‑month building lease for approximately 3,000 square feet of space in Radnor, Pennsylvania. The lease has annual rent escalations. We obtained access to the newly leased space on August 1, 2014, 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. In March 2015, the Company 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. As a result of this lease, we vacated the previously leased Radnor, Pennsylvania facility as of April 13, 2015 and determined that the Radnor, Pennsylvania facility was not likely to be utilized during the remaining lease term and as such we commenced efforts to sublease the facility. The Company recorded a liability as of the April 13, 2015 cease‑use date of $0.1 million for the estimated fair value of its obligations under the lease. The most significant assumptions used in determining the amount of the estimated liability are the potential sublease revenues and the credit‑adjusted risk‑free rate utilized to discount the estimated future cash flows. As of December 31, 2016, future minimum commitments under facility operating leases were as follows (in thousands): Operating leases 2017 $ 2018 2019 Total minimum lease payments $ Rent expense recognized under our operating lease, including additional rent charges for utilities, parking, maintenance and real estate taxes, was $275,000, $254,000 and $83,000 for the years ended December 31, 2016, 2015 and 2014, respectively. (b) License Agreements Cornell Center for Technology Enterprise and Commercialization In 2011, a license agreement was executed between BioPancreate and the Cornell Center for Technology Enterprise and Commercialization (CCTEC). Under the terms of the license agreement, BioPancreate obtained certain rights from the CCTEC for commercial development, use and sale of products that use the technology associated with the license. We are obligated to make milestone payments upon the achievement of certain regulatory and clinical milestones up to $2.6 million in the aggregate. For years in which licensed products are sold, we are required to pay a royalty based on a low single‑digit percentage of net sales. The minimum annual royalty in such years is $100,000. In the event the product is sublicensed, up to $3.5 million of certain fees we receive that are not earned royalties or reimbursements for direct costs are due to CCTEC upon achievement of certain regulatory and clinical milestones. In October 2016, our wholly owned subsidiary, BioPancreate Inc., provided a notice to Cornell University, through its Cornell Center for Technology Enterprise and Commercialization ("CCTEC"), in accordance with the terms of its agreement with CCTEC entered into in March 2011, of the termination of the agreement. The notice was provided in accordance with our decision to terminate our development program for BP-2002, a gene-modified probiotic in pre-clinical development for the potential treatment of type 1 and 2 diabetes that was the subject of the agreement. We recorded an impairment charge of $5.2 million during the year ended December 31, 2016, which represented the value of the intangible asset we had previously capitalized related to the license agreement. Antisense Therapeutics In May 2015, we entered into an exclusive license agreement, or the Antisense License Agreement, with Antisense Therapeutics that provided us with development and commercialization rights to Antisense Therapeutics’ product candidate, ATL1103, for endocrinology applications (specifically excluding the treatment of any form of cancer and the treatment of any complications of diabetes). We refer to this product candidate as COR‑004. Under the terms of the Antisense License Agreement, we paid Antisense Therapeutics an initial upfront license fee of $3.0 million in cash which was recorded as research and development expenses. We also invested $2.0 million in Antisense Therapeutics equity which was initially recorded as a non-current other asset for $1.1 million with the difference constituting the cost of the license which was recorded as research and development expense. The terms of the Antisense License Agreement provided that we could terminate the Antisense License Agreement upon 90 days’ prior written notice to Antisense Therapeutics if we believed the further development and commercialization of COR‑004 was no longer feasible due to a material change that was beyond our control. If, however, it is determined that we terminated the Antisense License Agreement for convenience, we would be required to pay Antisense Therapeutics a $2.0 million termination fee. In April 2016, we executed an agreement (the "Settlement Agreement") with Antisense Therapeutics ("Antisense") to terminate the exclusive license agreement (the "Antisense License Agreement") that we and Antisense entered into in May 2015. Pursuant to the terms of the Settlement Agreement, we have made a one-time payment of approximately $770,000 to Antisense and returned to Antisense, for no consideration, the shares of Antisense owned by us. We also agreed to transfer to Antisense all data, reports, records and materials resulting from our development activities and all ATL1103 drug compound in our possession. The settlement agreement provides for the release by each party of all obligations and liabilities under the Antisense License Agreement. In connection with the settlement and return of shares, we recorded $1.1 million of expense within other (expense)/income. (c) Commitments to Taro Pharmaceuticals Industries Ltd. In December 2016, we acquired the U.S. marketing rights to Keveyis® (dichlorphenamide) from a subsidiary of Taro Pharmaceutical Industries Ltd. (“Taro”). Keveyis is approved in the U.S. to treat hyperkalemic, hypokalemic and related variants of primary periodic paralysis, a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis. Keveyis has received orphan drug exclusivity status in the U.S through August 7, 2022. Under the terms of an 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. |
Business combinations
Business combinations | 12 Months Ended |
Dec. 31, 2016 | |
Business combinations | |
Business combinations | 9. Business combinations BioPancreate On October 29, 2013, we exercised our option to acquire the remaining interest in BioPancreate. As consideration for this acquisition of shares, we issued 336,136 shares of our ordinary shares in October 2013 and an additional 5,272 ordinary shares in January 2014. The transaction was recorded as an equity transaction and the previously held non‑controlling interest in BioPancreate was reclassified to equity. Aspireo Pharmaceuticals Ltd. Acquisition On June 30, 2015, we acquired veldoreotide from Aspireo Pharmaceuticals Ltd., an Israeli company. Veldoreotide was formerly called COR-005 by us and DG3173 by Aspireo Pharmaceuticals. We also acquired from Aspireo the rights and obligations to the on‑going research and development contracts, which combined with veldoreotide represented “substantially all” of the Aspireo business. Under the terms of the acquisition agreement, we issued to Aspireo 2,062,677 common shares, which had a value of $33.2 million on June 30, 2015. In connection with this acquisition, we also made a payment to the Office of the Chief Scientist of the Israeli Ministry of Economy, or OCS, in the amount of $3.0 million, which represents the repayment of amounts granted by the OCS to Aspireo, plus interest, that were used in support of research and development conducted by Aspireo for the development of DG3173. The acquisition was accounted for using the acquisition method of accounting for business combinations. The total consideration transferred was allocated to the assets acquired and liabilities assumed based on their respective fair values. The fair value of $16.10 per ordinary share of the 2,062,677 ordinary shares issued was determined based on the closing market price on the NOTC of our ordinary shares on the acquisition date. To determine the fair value of the acquired in‑process research and development intangible asset, we applied the income approach using the multi‑period excess earnings method. The following table summarizes the fair values of the assets acquired and liabilities assumed (in thousands): In process research and development $ Liabilities assumed: Other liabilities (net) OCS liability Total fair values of assets and liabilities Fair value of total consideration transferred Goodwill $ The excess of the consideration transferred over net assets acquired was assigned to goodwill in an amount of $5.1 million and is primarily related to expected synergies. A deferred tax liability was not recorded for the difference between the book and cost basis of the in‑process research and development intangible asset because the asset is domiciled in the Cayman Islands and therefore we do not expect to pay income tax. The goodwill is not deductible for income tax purposes. We incurred $2.2 million in acquisition‑related transaction costs for the period ended December 31, 2015, which is included as general and administration expense in the accompanying consolidated statements of operations. |
Income taxes
Income taxes | 12 Months Ended |
Dec. 31, 2016 | |
Income taxes | |
Income taxes | 10. Income taxes For the years ended December 31, 2016, 2015 and 2014, the components of loss before income taxes were as follows (in thousands): Year Ended December 31, 2016 2015 2014 Sweden $ $ $ Ireland — Cayman Islands — U.S. Total $ $ $ The components of income tax expense (benefit) for the years ended December 31, 2016, 2015 and 2014 were as follows (in thousands): Year Ended December 31, 2016 2015 2014 Current tax expense (benefit): Sweden $ — $ — $ — Ireland — — U.S. Federal — — State — — Total $ $ — $ — Deferred tax expense (benefit): Sweden $ — $ $ Ireland — — U.S. Federal State Change in valuation allowance Total $ $ $ With the exception of Strongbridge U.S. Inc., we have incurred net operating losses since inception. For the Ireland and Swedish operations, we have not reflected any benefit of net operating loss carryforwards (NOLs) in the accompanying financial statements. For Strongbridge U.S. Inc., as a result of the intercompany service agreements, it is more likely than not this entity will have taxable income and recognize all deferred tax assets. Due to the recording of a full impairment of the BioPancreate intellectual property in the current year at BioPancreate, we have established a full valuation allowance against all prior deferred tax assets. Deferred taxes are recognized for temporary differences between the bases of assets and liabilities for financial statement and income tax purposes. The tax effect of temporary differences that give rise to significant portions of the deferred tax assets are as follows (in thousands): Year Ended December 31, 2016 2015 Deferred tax assets: Net operating loss carryforwards $ $ Stock based compensation — Other deferred activity — Tax credits Capitalized research and development costs Total deferred tax assets Valuation allowance Deferred tax assets recognized Deferred tax liabilities: Warrants — Acquired intangible assets — Total deferred tax liabilities Net deferred tax assets (liabilities) $ $ We have evaluated the positive and negative evidence bearing upon the realizability of our deferred tax assets. Based on our history of operating losses in Ireland and Sweden, we have concluded that it is more likely than not that the benefit of our deferred tax assets will not be realized. Currently, as a result of intercompany service agreements that provide a source of taxable income going forward, Strongbridge U.S. Inc. is more likely than not to realize its deferred tax assets. Separately, as a result of recording a full impairment of the BioPancreate intellectual property, we have recorded a full valuation allowance against the prior federal attributes and all existing state attributes related to BioPancreate. The valuation allowance increased by approximately $3.6 million and $18.1 million during the year ended December 31, 2016 and 2015, respectively, due primarily to net operating losses. The Company’s effective income tax rate differs from the ultimate parent company, Strongbridge Biopharma plc, Irish domestic statutory rate of 12.5% for the year ended December 31, 2016 and 2015. In December 31, 2014, the effective income tax rate differs from the previous ultimate parent company, Cortendo AB’s, Swedish domestic tax rate of 22% as follows: Year Ended December 31, 2016 2015 2014 Ireland statutory income tax rate % % — Swedish statutory income tax rate — — % Foreign tax differential between Sweden, U.S., Cayman Island and Ireland Federal tax credits — Change in valuation allowance State income taxes — — Permanent differences — — Fx remeasurement of Swedish DTS — Other Effective income tax rate % % % At December 31, 2016, we had approximately $70.4 million of Swedish NOLs and approximately $12.5 million of Ireland NOLs, which have an indefinite life, and approximately $37.1 million of U.S. federal and $37.2 million of state NOLs, which begin to expire in 2031. Through December 31, 2015 we operated through a permanent establishment in both Sweden and the United States. Relief is granted by way of crediting the U.S. tax against the Swedish tax. This tax credit can never exceed the Swedish tax on the income. Since the tax rate is higher in the United States than in Sweden, the Swedish taxable carryforward losses of $70.4 million can only generate a tax benefit if income is derived from sources other than the permanent establishment in the United States. Beginning January 1, 2016, the US operations that were not part of BioPancreate Inc occurred in a newly formed US corporation. There were no operating losses generated during 2016 in the U.S. except for a minor state NOL at BioPancreate. At December 31, 2016, we had $8.9 million of U.S. federal orphan drug tax credit carryforwards, which begin to expire in 2032, and $167,000 of U.S. federal research and development tax credit carryforwards, which begin to expire in 2031. The orphan drug credit carryforward is attributable to the permanent establishment of the Swedish entity within the U.S. Utilization of the NOLs may be subject to limitations under Swedish tax regulations or U.S. Internal Revenue Code Section 382 if there is a greater than 50% ownership change as determined under applicable regulations. |
Ordinary shares
Ordinary shares | 12 Months Ended |
Dec. 31, 2016 | |
Ordinary shares. | |
Ordinary shares | 11. Ordinary shares Voting rights and privileges As of December 31, 2016, and December 31, 2015, there are 600,000,000 authorized shares and 35,335,026 and 21,205,382 outstanding shares, respectively. The holders of shares of our ordinary shares are entitled to one vote for each ordinary share held at all meetings of shareholders without limitation and written actions in lieu of meetings. The holders are entitled to receive dividends if and when declared by our Board of Directors. No dividends have been declared or paid since our inception. The holders are entitled to share ratably in our assets available for distribution to stockholders, in the event of any voluntary or involuntary liquidation. In addition, on May 26, 2015 the Company issued 40,000 deferred shares with a €1.00 euro par value per share (US$1.098). The deferred shares are issued in order to satisfy an Irish legislative requirement to maintain a minimum level of issued share capital denominated in euro. The deferred shares carry no voting rights and are not entitled to any dividend or distribution. Equity financings On December 22, 2016, we raised $32.7 million, net of transaction costs, in a private placement of ordinary shares and warrants. We issued and sold 14,000,000 ordinary shares of common stock at a purchase price of $2.50 per ordinary share as well as warrants to purchase 7,000,000 shares. The warrants are exercisable at a price of $2.50 per share beginning on June 28, 2017 and expire in five years from June 28, 2017. In the event of a sale of the Company, the terms of the warrants require us to use our best efforts to ensure the holders of such warrants will have a continuing right to purchase shares of the acquirer and, if our efforts are unsuccessful, to make a payment to such warrant holders based on a Black-Scholes valuation (using variables as specified in the warrant agreements). Therefore we are required to account for these warrants as liabilities and record at fair value at each reporting period. Fair value for these warrants was initially determined upon issuance using the Black-Scholes Model and were revalued at fair value as of December 31, 2016. The resulting decrease in fair value resulted in an unrealized gain of $0.6 million. As of December 31, 2016, the fair value of these warrants of $11.1 million was recorded as a long-term liability on our consolidated balance sheet. On October 22, 2015, we closed on our initial U.S. public offering of 2,500,000 ordinary shares at a price to the public of $10.00 per ordinary share for aggregate gross proceeds of $25 million, before deducting the underwriting commission and estimated offering expenses of $5.5 million. In June 2015, we raised $32.6 million, net of transaction costs, in a private placement of 2,284,414 shares of our common stock. The subscription price was $14.54 per share. In February 2015, we raised $25.8 million, net of transaction costs, in a private placement of 4,761,078 shares of our common stock. The subscription price was $5.54 per share. Shares reserved for issuance There were 1,951,022 and 2,591,520 shares of common stock reserved for future issuance upon exercise of stock options as of December 31, 2016 and 2015, respectively. As of December 31, 2016, we have 7,428,571 shares reserved for outstanding warrants. |
Stock-based compensation
Stock-based compensation | 12 Months Ended |
Dec. 31, 2016 | |
Stock-based compensation | |
Stock based compensation | 12. Stock‑based compensation The Board of Directors approve the granting of awards to our officers, directors, employees and third party‑consultants. Under these grants, the beneficiaries are given the right to acquire new shares of common stock at a pre‑determined option price. The purpose of the grants is to assist us in attracting, retaining and motivating officers, employees, directors and consultants. In addition, these awards provide us with the ability to provide incentives that are directly linked to the performance of our business and the related increase in shareholder value. Our awards have terms that range from five to ten years. As determined by our Board of Directors, our awards vest over service periods ranging up to four years or upon achievement of defined performance or market criteria such as the vesting of certain awards upon our IPO or awards that are accelerated when the fair value of our stock price reaches defined targets. The exercise price for each stock option is determined by the Board of Directors based upon considerations such as the fair value of the underlying ordinary shares and certain market conditions. For options granted prior to our October 22, 2015, IPO, the determination of the fair value of our common stock takes into account the price at which our shares were being quoted on the NOTC, recent equity financings and our valuations calculated with the assistance of third‑parties. On July 21, 2015, we cancelled 465,262 of our options for certain employees that were not vested and for which service was expected to be rendered and concurrently replaced these with 586,710 options. We accounted for the cancellation and replacement as a modification whereby we determined value of the original options based on current assumptions, without regard to the assumptions made on the grant date. We then compared the fair value of the modified award to the fair value of the original options immediately before the terms were modified, measured based on the share price and other pertinent factors on the date of the modification The incremental value of $468,000 was recorded over the remaining requisite service periods as these awards are expected to vest. On September 8, 2015, we effected a 1-for-11 reverse stock split of our ordinary shares. In conjunction with the reverse stock split, we adjusted our outstanding stock options by the same ratio. On October 22, 2015, we converted all of our Cortendo AB awards which were previously denominated in Swedish Krona (SEK) and Norwegian Kroner (NOK), into awards to acquire shares in Strongbridge Biopharma plc which were denominated in U.S. dollars. For the stock options denominated in NOK, the calculation was based on 8.1935 NOK per U.S. dollars. Due to the effects of foreign exchange related to the exercise price, we accounted for the conversion as a modification whereby we determined value of the original options based on current assumptions, without regard to the assumptions made on the grant date. We then compared the fair value of the modified award to the fair value of the original options immediately before the terms were modified, measured based on the share price and other pertinent factors on the date of the modification. Because the effected options were vested, the incremental value of $325,000 was recorded as expense during the period ended December 31, 2015. For the awards denominated in SEK which were classified as liability awards, we accounted for the conversion as a modification whereby we determined the value of the original options based on current assumptions, without regard to the assumptions made on the grant date. We then compared the fair value of the modified award to the fair value of the original options immediately before the terms were modified, measured based on the share price and other pertinent factors on the date of the modification. The incremental value was recorded as expense in the statement of operations. The liability awards were fully vested as of October 22, 2015 and therefore the resulting liability after modification of $1.5 million, was reclassified from liability to additional paid-in capital on October 22, 2015. As these stock options are now equity-classified and fully vested, we will not remeasure these stock options in the future. A summary of the outstanding stock options activity for the year ended December 31, 2016 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, 2016 $ $ Granted $ Forfeited and cancelled $ Expired — — Exercised $ Outstanding—December 31, 2016 $ $ — Vested and exercisable—December 31, 2016 $ $ — Vested and expected to vest—December 31, 2016 $ $ — Included in the stock options outstanding at December 31, 2016, are unvested stock options to purchase 88,909 shares at a weighted average exercise $18.80 per share for which the vesting of certain tranches will accelerate if the fair value per share of our stock reaches $16.11, $31.46 or $37.62 for the respective grantee. In addition, the options outstanding include 97,652 shares that vest upon a market appreciation event so long as it occurs prior to May 26, 2019 of which all were unvested as of December 31, 2016 and 97,652 shares that will vest upon the one year anniversary of the market appreciation event of which all were unvested as of December 31, 2016. The market appreciation event is defined as the last trading day in the period in which the 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. The aggregate intrinsic values of options outstanding, vested and exercisable, and vested and expected to vest were calculated as the difference between the exercise price of the options and the estimated fair value of our common stock as of December 31, 2016, since the estimated fair value is less than the exercise price for all stock options, there is not any intrinsic value. Stock‑based compensation expense We recognized stock‑based compensation expense for employees and non‑employees in the accompanying consolidated statements of operations as follows (in thousands): Year Ended December 31, 2016 2015 2014 Research and development $ $ $ General and administrative Total stock-based compensation $ $ Included in these amounts was stock compensation expense (credit) attributed to liability‑classified awards of, $0, $359,000 and $(229,000), for the years ended December 31, 2016, 2015 and 2014, respectively. The total income tax benefit recognized in the income statement for share-based compensation arrangements was $1.9 million, $0, and $0 for 2016, 2015 and 2014, respectively. As of December 31, 2016, the total unrecognized compensation expense related to unvested options, net of estimated forfeitures, was $6.8 million, which we expect to recognize over an estimated weighted‑average period of 2.46 years. In determining the estimated fair value of the stock‑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 stock option awards was estimated with the following assumptions: Year Ended December 31, 2016 2015 2014 Expected term (in years) 5.9 3.23 3.23 Risk-free interest rate 1.21% - 2.23% 0.0% - 0.6% 0.0% - 0.6% Expected volatility 78.1% - 83.6% 79.0% - 83.1% 68.3% - 80.7% Dividend rate —% —% —% |
Summary of significant accoun19
Summary of significant accounting policies and basis of presentation (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Summary of significant accounting policies and basis of presentation | |
Basis of presentation | Basis of presentation and principles of consolidation The accompanying consolidated financial statements include the accounts of our wholly owned subsidiaries, BioPancreate Inc. (Trevose, Pennsylvania, United States), Cortendo AB (Gothenburg, Sweden) and Cortendo Cayman (Georgetown, Cayman Islands). All intercompany balances and transactions have been eliminated in consolidation. These audited consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States (U.S. GAAP). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB). |
Principles of consolidation | Basis of presentation and principles of consolidation The accompanying consolidated financial statements include the accounts of our wholly owned subsidiaries, BioPancreate Inc. (Trevose, Pennsylvania, United States), Cortendo AB (Gothenburg, Sweden) and Cortendo Cayman (Georgetown, Cayman Islands). All intercompany balances and transactions have been eliminated in consolidation. These audited consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States (U.S. GAAP). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB). |
Foreign currency translation | Foreign currency translation The consolidated financial statements are reported in United States dollars, which is the functional currency of our subsidiaries and Cortendo AB. 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 about 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. Our material long‑lived assets, which primarily consists of in‑process research and development, reside in the United States, Sweden and Cayman Islands. |
Cash and cash equivalents | Cash and cash equivalents We consider all short‑term highly liquid investments with an original maturity at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents consist of account balances at banks and money market accounts, respectively. |
Concentration of credit risk and other risks and uncertainties | Concentration of credit risk and other risks and uncertainties As part of our cash and investment management processes, we perform periodic evaluations of the credit standing of the financial institutions with which we deposit our cash or purchase cash equivalents, and we have not sustained any credit losses from instruments held at these financial institutions. |
Fair value of financial instruments | Fair value of financial instruments Fair value accounting is applied for all financial assets and liabilities and non‑financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually). We are required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. FASB ASC Topic 820, Fair Value Measurements and Disclosures (ASC 820), establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of us. Unobservable inputs are inputs that reflect our assumptions about the inputs that market participants would use in pricing the asset or liability, and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The three levels of the fair value hierarchy are described as follows: Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability to access at the measurement date. Level 2—Valuations based on quoted prices for similar assets or liabilities, or quoted prices in markets that are not active, and for which all significant inputs are observable, either directly or indirectly. Level 3—Valuations that require inputs that reflect our own assumptions that are both significant to the fair value measurement and 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 we exercise in determining fair value is greatest for instruments categorized in 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. In December 2016, we issued warrants in connection with our private placement of ordinary shares. Pursuant to the terms of the warrant agreement, the Company could be required to settle the warrants in cash in the event of an acquisition of the Company and, as a result, the warrants are required to be measured at fair value and reported as a liability in the consolidated balance sheet. We recorded the fair value of the warrants upon issuance using the Black-Scholes Model and are required to revalue the warrants at each reporting date with any changes in fair value recorded on our statement of operations.. We consider both the initial valuation as well as our year-end valuation under Level 3 of the fair value hierarchy. The change in the fair value of the level 3 warrant liabilities is reflected in the statement of operations and comprehensive loss for the year ended December 31, 2016. Through June 30, 2015, we entered into foreign currency forward contracts to offset some of the foreign exchange risks we bear on operating expenses that were not denominated in U.S. dollars. These instruments were not entered into for speculative purposes and, although we believe they served as effective economic hedges, we did not seek to qualify for hedge accounting. The forward contracts settled on June 30, 2015, and we have not entered into new forward contracts. These forward contracts were recorded at fair value on the accompanying consolidated balance sheets as prepaid expenses and other current assets. These forward contracts were measured using observable quoted prices for similar instruments. The gain and loss recognized in other income, net, for these forward contracts was a loss of $0.4 million and a gain of $0.3 million for the years ended December 31, 2015 and 2014, respectively. These amounts represent the net gain or loss on the forward contracts and do not include changes in the related exposures, which generally offset a portion of the gain or loss on the forward contracts. We considered our foreign currency forward contracts under Level 2 of the fair value hierarchy. On May 13, 2015, as part of our agreement to acquire an exclusive license agreement from Antisense Therapeutics Limited (Antisense), we purchased 15,025,075 shares of Antisense common stock that had a fair value of $0.095 per share, which was the quoted market price of the Antisense common stock on the Australian Securities Exchange (ASX). Because we were contractually prohibited from selling the shares for 24 months from the date of purchase, we estimated a discount for the lack of marketability of $0.022 per share using an option pricing model that estimated the value of a protective put option using inputs that included quoted market prices and observable inputs other than quoted market prices. We initially recorded the net fair value amount of $1.1 million as a non-current other asset in our consolidated balance sheet. As of December 31, 2015, the non-current other asset was valued using the ASX closing market price of $0.051 per share and an updated discount for the lack of marketability of $0.014 per share using an option pricing model, resulting in an impairment charge recorded as a valuation allowance against the non-current other asset of $550,000. We considered both the initial valuation as well as our year-end valuation under Level 2 of the fair value hierarchy. In April 2016, we executed an agreement (the "Settlement Agreement") with Antisense to terminate the exclusive license agreement. Pursuant to the terms of the Settlement Agreement, we made a one-time payment of approximately $770,000 to Antisense and returned to Antisense, for no consideration, the shares of Antisense owned by us. T herefore no remeasurement was needed as of December 31, 2016. |
Property and equipment, net | Property and equipment, net Property and equipment, net, consists of office equipment such as furniture, fixtures and computers. Depreciation expense for the years ended December 31, 2016 and 2015 was not significant. The following useful lives were used for the various classifications of property and equipment, net: Amortization Periods Computer hardware - years Computer software - years Furniture and fixtures - years |
Business combinations | Business combinations When acquiring new enterprises over which we obtain control, the acquisition method is applied. Under this method, we identify assets and liabilities of these enterprises and measure them at fair value at the acquisition date. Allowance is made for the tax effect of the adjustments made. The excess of the consideration transferred, the amount of the non‑controlling interest in the acquiree and the acquisition date fair value of previous equity interest in the acquiree over the fair value of the identifiable net assets acquired is recorded as goodwill. |
Intangible Assets | Intangible Assets Certain intangible assets were acquired as part of an asset purchase, and have been capitalized at their acquisition date fair value. Acquired definite life intangible assets are amortized using the straight line method over their respective estimated useful lives. The Company evaluates the potential impairment of intangible assets if events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. Purchased identifiable intangible assets with indefinite lives, such as our in‑process research and development, are evaluated for impairment annually in accordance with our policy and whenever events or changes in circumstances indicate that it is more likely than not that the fair value of these assets may not be recovered. To test these assets for impairment, we compare the fair value of the asset to its carrying value. The method we use to estimate the fair value measurements of indefinite‑lived intangible assets is based on the income approach. For the impairment analysis for the year ended December 31, 2016, significant unobservable inputs used in the income approach valuation method including a discount rates, royalty rates and probabilities of product candidate advancement from one clinical trial phase to the next. The determination of fair value of indefinite lived assets is considered Level 3 for fair value measurement . |
Goodwill | Goodwill We test goodwill for impairment on an annual basis or whenever events occur that may indicate possible impairment. This analysis requires us to make a series of critical assumptions to (1) evaluate whether any impairment exists and (2) measure the amount of impairment. Because we have one operating segment, when testing for a potential impairment of goodwill, we are required to estimate the fair value of our business and determine the carrying value. If the estimated fair value is less than the carrying value of our business, then we are required to estimate the fair value of all identifiable assets and liabilities in a manner similar to a purchase price allocation for an acquired business. Only after this process is completed can the goodwill impairment be determined, if any. To estimate the fair value of the business, primarily a market‑based approach is applied, utilizing our public market value. We did not record a charge for impairment for the years ended December 31, 2016, 2015 and 2014. |
Research and development expenses | Research and development expenses Research and development costs are expensed as incurred. Research and development expenses consist of internal and external expenses. Internal expenses include compensation and related expenses. External expenses include development, clinical trials, report writing and regulatory compliance costs incurred with clinical research organizations and other third‑party vendors. At the end of the reporting period, we compare payments made to third‑party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that we estimate has been made as a result of the service provided, we may record net prepaid or accrued expense relating to these costs. Upfront and milestone payments made to third parties who perform research and development services on our behalf are expensed as services are rendered. |
Stock-based compensation | Stock‑based compensation We account for stock‑based compensation awards in accordance with FASB ASC Topic 718, Compensation—Stock Compensation (ASC 718). ASC 718 requires all stock‑based payments including grants of stock options and restricted stock and modifications to existing stock options, to be recognized in the consolidated statements of operations based on their fair values. Our stock‑based awards are subject to either service‑based or performance‑based vesting conditions. Vesting of certain awards could also be accelerated upon achievement of defined market‑based vesting conditions. Certain awards also contain a combination of service and market conditions or performance and market conditions. We account for employee stock‑based awards at grant‑date fair value. If we issue awards with an exercise price denominated in a currency other than our functional currency, trading currency or the currency for which we compensate our employee, we account for these as liabilities. We account for non‑employee and liability‑classified stock‑based awards based on the then‑current fair values at each financial reporting date until the performance is complete for non‑employee awards, or until the award is settled (exercised) for liability‑classified awards. Changes in the amounts attributed to these awards between the reporting dates are included in stock‑based compensation expense (credit) in our statements of operations. We include liability‑classified stock options in non‑current liabilities in our balance sheets as their settlement (exercise) does not require use of cash, cash equivalents or other current assets. We record compensation expense for service‑based awards over the vesting period of the award on a straight‑line basis. Compensation expense related to awards with performance‑based vesting conditions is recognized over the requisite service period using the accelerated attribution method to the extent achievement of the performance condition is probable. For those awards in which the performance condition was the completion of our IPO, we did not recognize compensation expense until the close of the IPO as we did not deem the IPO probable until it occurred. Compensation expense for awards with service and market‑based vesting conditions is recognized using the accelerated attribution method over the shorter of the requisite service period or the implied period associated with achievement of the market‑based vesting provisions. We estimate the fair value of our awards with service conditions using the Black‑Scholes option pricing model, which requires the input of subjective assumptions, including (i) the expected stock price volatility, (ii) the expected term of the award, (iii) the risk‑free interest rate and (iv) expected dividends. Due to the lack of historical and implied volatility data of our common stock, we based our estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. We selected companies with comparable characteristics to us, including enterprise value, risk profiles and position within the industry, and with historical share price information sufficient to meet the expected term of the stock‑based awards. We compute historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock‑based awards. We estimate the fair value of our awards with market conditions using a Monte Carlo simulation to determine the probability of satisfying the market condition. We make this estimate using the conditions that exist at the grant date. The derived service period, which may be the requisite service period, is also determined at this time. Compensation cost for our awards with a market condition is recognized ratably using the accelerated attribution method if the award is subject to graded vesting over the requisite service period. The compensation cost for our awards with a market condition is not reversed if the market condition is not satisfied. We have estimated the expected term of employee service‑based stock options using the “simplified” method, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option, due to our lack of sufficient historical data. We have estimated the expected term of employee awards with market conditions using a Monte‑Carlo simulation model. This approach involves generating random stock‑price paths through a lattice‑type structure. Each path results in a certain financial outcome, such as accelerated vesting or specific option payout. We have estimated the expected term of nonemployee service‑ and performance‑based awards based on the remaining contractual term of such awards. The risk‑free interest rates for periods within the expected term of the option are based on the Swedish Government Bond rate or the U.S. Treasury Bond rate with a maturity date commensurate with the expected term of the associated award. We have never paid dividends, and do not expect to pay dividends in the foreseeable future. We are also required to estimate forfeitures at the time of grant, and revise those estimates in subsequent periods if actual forfeitures differ from estimates. We record stock‑based compensation expense only for those awards that are expected to vest. To the extent that actual forfeitures differ from our estimates, the differences are recorded as a cumulative adjustment in the period the estimates were revised. |
Income taxes | Income taxes We use the asset and liability method of accounting for income taxes in accordance with FASB ASC Topic 740, Income Taxes (ASC 740). Under this method, income tax expense is recognized for the amount of (1) taxes payable or refundable for the current year and (2) deferred tax consequences of temporary differences resulting from matters that have been recognized in an entity’s financial statements or tax returns. 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 be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the results of operations in the period that includes the enactment date. A valuation allowance is provided to reduce the deferred tax assets reported if, based on the weight of the available positive and negative evidence, it is more likely than not some portion or all of the deferred tax assets will not be realized. ASC 740 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC 740 also provides guidance on de‑recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. We have no material uncertain tax positions for any of the reporting periods presented. We recognize interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2016, 2015 and 2014, we had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in our statements of operations. |
Net loss per share | Net loss per share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted‑average number of shares of common stock 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 common equivalent shares, which currently consist of outstanding stock options and warrants. Due to the Company operating at a net loss these anti‑dilutive shares of common stock totaled 3,249,784 shares, 2,591,520 shares and 925,077 shares for the years ended December 31, 2016, 2015 and 2014, respectively. While these common equivalent shares are currently anti‑dilutive, they could be dilutive in the future. |
Recent accounting pronouncements | Recently adopted accounting pronouncements In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers , which requires entities to recognize revenue in a way that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The new guidance also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. The FASB has subsequently issued ASU No. 2016-10, Revenue from Contracts with Customer (Topic 606): Identifying Performance Obligations and Licensing, to address issues arising from implementation of the new revenue recognition standard. ASU 2014-09 and ASU 2016-10 are effective for interim and annual periods beginning January 1, 2018, and may be adopted earlier. The revenue standards are required to be adopted by taking either a full retrospective or a modified retrospective approach. The Company currently is evaluating the effect that this guidance may have on its consolidated financial statements as it relates to our launch of Keveyis. In September 2014, the FASB issued ASU No. 2014‑15 , Presentation of Financial Statements—Going Concern: Disclosures of Uncertainties about an Entity’s Ability to Continue as a Going Concern . The new guidance addresses management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. Management’s evaluation should be based on relevant conditions and events that are known and reasonably knowable at the date that the financial statements are issued. The Company adopted ASU 2014‑15 and it did not have an impact on our financial position or results of operations. In September 2015, the FASB issued ASU 2015-16, Business Combinations — Simplifying the Accounting Measurement-Period Adjustments that eliminates the requirement to restate prior period financial statements for measurement period adjustments for business combinations. The new guidance requires that the cumulative impact of a measurement period adjustment (including the impact on prior periods) be recognized in the reporting period in which the adjustment is identified. The guidance is effective for fiscal years beginning on or after December 15, 2015, and interim periods within those years and should be applied prospectively to measurement period adjustments that occur after the effective date. The Company will prospectively apply the guidance to applicable transactions. In November 2015, the FASB issued ASU 2015-17, Income Taxes: Balance Sheet Classification of Deferred Taxes that amends the balance sheet classification of deferred taxes. The new guidance requires that deferred tax liabilities and assets be classified as noncurrent on the balance sheet. Previous guidance required deferred tax liabilities and assets to be separated into current and noncurrent amounts on the balance sheet. The guidance is effective for fiscal years beginning on or after December 15, 2016, and interim periods within those years. The Company is currently evaluating the impact that the new guidance will have on our consolidated financial statements. In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments – Overall: Recognition and Measurement of Financial Assets and Financial Liabilities , that modifies certain aspects of the recognition, measurement, presentation, and disclosure of financial instruments. The accounting standard update is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017, and early adoption is permitted. The Company are currently assessing the impact that adopting this new accounting guidance will have on our consolidated financial statements. In March 2016, the FASB issued ASU 2016-09, Compensation – Stock Compensation: Improvements to Employee Share-Based Payments Accounting , which effects all entities that issue share-based payment awards to their employees. The amendments in this ASU cover such areas as the recognition of excess tax benefits and deficiencies, the classification of those excess tax benefits on the statement of cash flows, an accounting policy election for forfeitures, the amount an employer can withhold to cover income taxes and still qualify for equity classification and the classification of those taxes paid on the statement of cash flows. This ASU is effective for annual and interim periods beginning after December 15, 2016. This guidance can be applied either prospectively, retrospectively or using a modified retrospective transition method. Early adoption is permitted. The Company does not expect that this new guidance will have a material impact on the Company’s Consolidated Financial Statements. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments, which simplifies certain elements of cash flow classification. The new guidance is intended to reduce diversity in practice in how certain transactions are classified in the statement of cash flows. The ASU is effective for annual periods beginning after December 15, 2017. The Company is currently evaluating the impact the adoption of the ASU will have on its consolidated financial statements. In January 2017, the FASB issued ASU 2017-01, Business Combinations - C larifying the Definition of a Business, which clarified the definition of a business to assist entities with evaluating whether transactions should be accounted for as acquisitions of assets or businesses. The guidance is effective for interim and annual periods beginning after December 31, 2017, and early adoption is permitted. The Company elected to early adopt this guidance in the current period and has applied it to its evaluation of our asset purchase from Taro Pharmaceutical Industries Ltd. (see note 4 ). In January 2017, the FASB issued 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 the Company beginning in the first quarter of fiscal year 2021, 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. The Company is currently evaluating the impact this standard will have on its financial statements. |
Summary of significant accoun20
Summary of significant accounting policies and basis of presentation (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Summary of significant accounting policies and basis of presentation | |
Schedule of useful lives of various classification of property and equipment, net | Amortization Periods Computer hardware - years Computer software - years Furniture and fixtures - years |
Fair value measurement (Tables)
Fair value measurement (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Fair value measurement | |
Schedule of fair value of financial assets by level | The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis for the periods presented (in thousands) : As of December 31, 2016 Level I Level II Level III Total Warrant Liabilities — — Total liabilities $ — $ — $ $ As of December 31, 2015 Level I Level II Level III Total Assets Cash equivalents $ $ — $ — $ Noncurrent asset — — Total assets $ $ $ — $ |
Intangible assets and goodwill
Intangible assets and goodwill (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Intangible assets and goodwill | |
Schedule of gross carrying amount of in process research and development and goodwill | The gross carrying amount of in‑process research and development, acquired developed product rights and goodwill is as follows (in thousands): As of December 31, 2016 Beginning of Period Additions Impairment End of Period IPR&D $ $ — $ $ Acquired product rights — — Goodwill — — Total $ $ $ $ As of December 31, 2015 Beginning of Period Additions Impairment End of Period IPR&D $ $ $ — $ Acquired product rights — — — — Goodwill — Total $ $ $ — $ |
Accrued liabilities (Tables)
Accrued liabilities (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Accrued liabilities | |
Schedule of accrued liabilities | Accrued liabilities consist of the following (in thousands): December 31, December 31, 2016 2015 Consulting and professional fees $ $ Accrued payable due Taro Pharmaceuticals Industries Ltd. — Supply agreement - current portion — Employee compensation Other Total accrued liabilities $ $ |
Long Term Debt (Tables)
Long Term Debt (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Future principal payments | Future principal payments due under the Loan Agreement are as follows (in thousands) : Principal Payments 2017 $ — 2018 2019 2020 Total future payments $ |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrants outstanding and warrant activity | Exercise Expiration Warrants Warrants December 31, Classification Price Date Issued Exercised 2016 Warrants in connection with private equity placement Liability $ 6/28/2022 — Warrants in connection with loan agreement Equity $ 12/28/2026 — |
Commitments and contingencies (
Commitments and contingencies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and contingencies | |
Schedule of future minimum commitments under facility operating leases | As of December 31, 2016, future minimum commitments under facility operating leases were as follows (in thousands): Operating leases 2017 $ 2018 2019 Total minimum lease payments $ |
Business combinations (Tables)
Business combinations (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Business combinations | |
Schedule of estimated fair values of the assets acquired and liabilities assumed | The following table summarizes the fair values of the assets acquired and liabilities assumed (in thousands): In process research and development $ Liabilities assumed: Other liabilities (net) OCS liability Total fair values of assets and liabilities Fair value of total consideration transferred Goodwill $ |
Income taxes (Tables)
Income taxes (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income taxes | |
Schedule of components of loss before income taxes | For the years ended December 31, 2016, 2015 and 2014, the components of loss before income taxes were as follows (in thousands): Year Ended December 31, 2016 2015 2014 Sweden $ $ $ Ireland — Cayman Islands — U.S. Total $ $ $ |
Schedule of components of income tax (benefit) | The components of income tax expense (benefit) for the years ended December 31, 2016, 2015 and 2014 were as follows (in thousands): Year Ended December 31, 2016 2015 2014 Current tax expense (benefit): Sweden $ — $ — $ — Ireland — — U.S. Federal — — State — — Total $ $ — $ — Deferred tax expense (benefit): Sweden $ — $ $ Ireland — — U.S. Federal State Change in valuation allowance Total $ $ $ |
Schedule of tax effect of temporary differences that give rise to significant portions of the deferred tax assets | The tax effect of temporary differences that give rise to significant portions of the deferred tax assets are as follows (in thousands): Year Ended December 31, 2016 2015 Deferred tax assets: Net operating loss carryforwards $ $ Stock based compensation — Other deferred activity — Tax credits Capitalized research and development costs Total deferred tax assets Valuation allowance Deferred tax assets recognized Deferred tax liabilities: Warrants — Acquired intangible assets — Total deferred tax liabilities Net deferred tax assets (liabilities) $ $ |
Schedule of effective tax rate reconciliation to statutory rate | Year Ended December 31, 2016 2015 2014 Ireland statutory income tax rate % % — Swedish statutory income tax rate — — % Foreign tax differential between Sweden, U.S., Cayman Island and Ireland Federal tax credits — Change in valuation allowance State income taxes — — Permanent differences — — Fx remeasurement of Swedish DTS — Other Effective income tax rate % % % |
Stock-based compensation (Table
Stock-based compensation (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
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, 2016 $ $ Granted $ Forfeited and cancelled $ Expired — — Exercised $ Outstanding—December 31, 2016 $ $ — Vested and exercisable—December 31, 2016 $ $ — Vested and expected to vest—December 31, 2016 $ $ — |
Schedule of stock-based compensation | We recognized stock‑based compensation expense for employees and non‑employees in the accompanying consolidated statements of operations as follows (in thousands): Year Ended December 31, 2016 2015 2014 Research and development $ $ $ General and administrative Total stock-based compensation $ $ |
Schedule of assumptions for estimating fair value of stock option awards | Year Ended December 31, 2016 2015 2014 Expected term (in years) 5.9 3.23 3.23 Risk-free interest rate 1.21% - 2.23% 0.0% - 0.6% 0.0% - 0.6% Expected volatility 78.1% - 83.6% 79.0% - 83.1% 68.3% - 80.7% Dividend rate —% —% —% |
Organization - IPO (Details)
Organization - IPO (Details) - USD ($) $ / shares in Units, $ in Thousands | Oct. 16, 2015 | Dec. 31, 2015 | Dec. 22, 2016 | Oct. 22, 2015 | Jun. 30, 2015 | Feb. 28, 2015 |
Organization | ||||||
Price per share (in dollars per share) | $ 2.50 | $ 10 | $ 14.54 | $ 5.54 | ||
Proceeds from initial public offering, net | $ 19,475 | |||||
Ordinary Shares | ||||||
Organization | ||||||
Price per share (in dollars per share) | $ 10 | |||||
Ordinary Shares | IPO | ||||||
Organization | ||||||
Number of shares in offering | 2,500,000 |
Organization - Exchange offer (
Organization - Exchange offer (Details) $ / shares in Units, $ in Thousands | Sep. 08, 2015 | Aug. 07, 2015$ / shares | Sep. 30, 2016USD ($)$ / shares | Dec. 31, 2016USD ($)$ / shares | Dec. 31, 2015USD ($)$ / shares |
Exchange offer | |||||
Exchange ratio (as a percent) | 1 | ||||
Par value (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | ||
Reverse stock split conversion ratio (as a percent) | 0.09090 | ||||
Aggregate payment | $ | $ 3,392 | $ 3,168 | |||
Cortendo AB | |||||
Exchange offer | |||||
Par value (in dollars per share) | $ 0.15 | ||||
Shares owned (as a percent) | 99.582% | ||||
Shares not owned (as a percent) | 0.418% | ||||
Amount paid for acquisition (in dollars per share) | $ 13.66 | ||||
Aggregate payment | $ | $ 1,400 |
Organization - Liquidity (Detai
Organization - Liquidity (Details) - USD ($) $ in Thousands | Dec. 28, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Liquidity | |||||
Cash | $ 66,837 | $ 51,623 | $ 15,632 | $ 14,897 | |
Outstanding borrowings | 20,000 | ||||
Credit Facility | |||||
Liquidity | |||||
Outstanding borrowings | $ 20,000 | ||||
Credit facility term | 48 months |
Summary of significant accoun33
Summary of significant accounting policies and basis of presentation - Segments (Details) | 12 Months Ended |
Dec. 31, 2016segment | |
Segment information | |
Number of operating segments | 1 |
Summary of significant accoun34
Summary of significant accounting policies and basis of presentation - Fair value (Details) - USD ($) | May 13, 2015 | Apr. 30, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | May 31, 2015 |
Antisense Therapeutics | |||||
Fair value of financial instruments | |||||
Share market price (in dollars per share) | $ 0.095 | $ 0.051 | |||
Discount (in dollars per share) | $ 0.022 | $ 0.014 | |||
Antisense Therapeutics | License agreement | |||||
Fair value of financial instruments | |||||
Shares purchased | 15,025,075 | ||||
Period from date of purchase entity may not sell shares | 24 months | ||||
Antisense Therapeutics | Settlement agreement | |||||
Fair value of financial instruments | |||||
One-time payment as settlement for termination | $ 770,000 | ||||
Consideration for return of Antisense shares | $ 0 | ||||
Noncurrent other assets | Antisense Therapeutics | License agreement | |||||
Fair value of financial instruments | |||||
Net fair value of shares | $ 1,100,000 | ||||
Foreign currency forward contracts | Not designated as hedging instrument | Other Income | |||||
Fair value of financial instruments | |||||
Gain (loss) recognized | $ (400,000) | $ 300,000 | |||
Level II | Noncurrent other assets | Antisense Therapeutics | |||||
Fair value of financial instruments | |||||
Net fair value of shares | $ 1,100,000 | $ 550,000 |
Summary of significant accoun35
Summary of significant accounting policies and basis of presentation - Property and equipment, net (Details) | 12 Months Ended |
Dec. 31, 2016 | |
Computer hardware | Minimum | |
Property and equipment, net | |
Amortization Periods | 3 years |
Computer hardware | Maximum | |
Property and equipment, net | |
Amortization Periods | 5 years |
Computer software | Minimum | |
Property and equipment, net | |
Amortization Periods | 2 years |
Computer software | Maximum | |
Property and equipment, net | |
Amortization Periods | 5 years |
Furniture and fixtures | Minimum | |
Property and equipment, net | |
Amortization Periods | 2 years |
Furniture and fixtures | Maximum | |
Property and equipment, net | |
Amortization Periods | 5 years |
Summary of significant accoun36
Summary of significant accounting policies and basis of presentation - Goodwill, Income taxes and Net loss per share (Details) | 12 Months Ended | ||
Dec. 31, 2016USD ($)segmentshares | Dec. 31, 2015USD ($)shares | Dec. 31, 2014shares | |
Goodwill | |||
Number of operating segments | segment | 1 | ||
Income taxes | |||
Accrued interest or penalties related to uncertain tax positions | $ 0 | $ 0 | |
Interest or penalties related to uncertain tax positions | $ 0 | $ 0 | |
Net loss per share | |||
Anti-dilutive shares of common stock (in shares) | shares | 3,249,784 | 2,591,520 | 925,077 |
Fair value measurement (Details
Fair value measurement (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Liabilities | ||
Warrant liabilities | $ 11,090 | |
Recurring | ||
Assets | ||
Cash equivalents | $ 45,296 | |
Noncurrent asset | 550 | |
Total Assets | 45,846 | |
Liabilities | ||
Warrant liabilities | 11,090 | |
Total liabilities | 11,090 | |
Recurring | Level I | ||
Assets | ||
Cash equivalents | 45,296 | |
Total Assets | 45,296 | |
Recurring | Level II | ||
Assets | ||
Noncurrent asset | 550 | |
Total Assets | $ 550 | |
Recurring | Level III | ||
Liabilities | ||
Warrant liabilities | 11,090 | |
Total liabilities | $ 11,090 |
Intangible assets and goodwil38
Intangible assets and goodwill (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
In-process research and development and Goodwill | ||
Goodwill, Beginning of Period | $ 7,256 | $ 2,200 |
Goodwill, Additions | 5,056 | |
Goodwill, End of Period | 7,256 | 7,256 |
Total, Beginning of Period | 43,807 | 7,428 |
Total, Additions | 40,177 | 36,379 |
Total Impairment | (15,828) | |
Total, End of Period | 68,156 | 43,807 |
Acquired product rights | ||
In-process research and development and Goodwill | ||
Acquired product rights, Additions | 40,177 | |
Acquired product rights, End of Period | 40,177 | |
IPR&D | ||
In-process research and development and Goodwill | ||
IPR&D, Beginning of Period | 36,551 | 5,228 |
IPR&D, Additions | 31,323 | |
IPR&D, Impairment | (15,828) | |
IPR&D, End of Period | $ 20,723 | $ 36,551 |
Intangible assets and goodwil39
Intangible assets and goodwill - Components (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Mar. 31, 2017USD ($) | Dec. 31, 2016USD ($)payment | Dec. 31, 2016USD ($)payment | |
Acquired product rights | |||
In-process research and development and Goodwill | |||
Acquired product rights | $ 40,177 | $ 40,177 | |
Estimated life | 8 years | ||
IPR&D | |||
In-process research and development and Goodwill | |||
IPR&D, Impairment | (15,828) | ||
BioPancreate Acquisition | IPR&D | |||
In-process research and development and Goodwill | |||
IPR&D, Impairment | (5,200) | ||
Aspireo Acquisition | IPR&D | |||
In-process research and development and Goodwill | |||
IPR&D, Impairment | (10,600) | ||
Keveyis | Taro | Acquired product rights | |||
In-process research and development and Goodwill | |||
Acquired product rights | $ 40,200 | 40,200 | |
Transaction costs | $ 2,400 | $ 2,400 | |
Asset Purchase Agreement | Keveyis | Taro | Acquired product rights | |||
In-process research and development and Goodwill | |||
Number of installment payments | payment | 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 | $ 29,300 |
Accrued liabilities (Details)
Accrued liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Accrued liabilities | ||
Consulting and professional fees | $ 1,110 | $ 1,288 |
Accrued payable due Taro Pharmaceuticals Industries Ltd | 7,500 | |
Supply agreement current portion | 4,207 | |
Employee compensation | 1,554 | 1,172 |
Other | 497 | 225 |
Total accrued liabilities | $ 14,868 | $ 2,685 |
Long Term Debt (Details)
Long Term Debt (Details) $ / shares in Units, $ in Millions | Dec. 28, 2016USD ($)item$ / sharesshares | Dec. 31, 2016$ / shares |
Credit Facility | ||
Loan agreement | ||
Maximum credit facility | $ 40 | |
Line of credit proceeds | $ 20 | |
Number of additional tranches | item | 2 | |
Credit facility term | 48 months | |
Interest-only payment period | 18 months | |
Amortization period | 30 months | |
Final payment fee (as a percent) | 8.00% | |
Fixed interest rate (as a percent) | 8.22% | |
Variable interest rate (as a percent) | 0.53% | |
Debt discounts | $ 1.3 | |
Debt issuance costs | 0.3 | |
Credit Facility-Tranche One | ||
Loan agreement | ||
Additional contingent borrowing capacity | 10 | |
Credit Facility-Tranche Two | ||
Loan agreement | ||
Additional contingent borrowing capacity | $ 10 | |
Amortization period | 24 months | |
Interest payment only extension period | 6 months | |
Warrants in connection with loan agreement | ||
Loan agreement | ||
Warrant exercise price (in dollars per share) | $ / shares | $ 2.45 | |
Warrants in connection with loan agreement | Credit Facility | ||
Loan agreement | ||
Securities that warrants may purchase (in shares) | shares | 428,571 | |
Warrant exercise price (in dollars per share) | $ / shares | $ 2.45 | |
Warrant expiration period | 10 years |
Long Term Debt - Maturities (De
Long Term Debt - Maturities (Details) $ in Thousands | Dec. 31, 2016USD ($) |
Future principal payments | |
2,018 | $ 4,667 |
2,019 | 8,000 |
2,020 | 7,333 |
Total future payments | $ 20,000 |
Warrants (Details)
Warrants (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2016 | Dec. 22, 2016 | |
Warrants | ||
Warrants Issued (in shares) | 7,428,571 | |
Warrants Outstanding (in shares) | 7,428,571 | |
Warrants in connection with private equity placement | ||
Warrants | ||
Exercise Price (in dollars per share) | $ 2.50 | $ 2.50 |
Warrants Issued (in shares) | 7,000,000 | |
Warrants Outstanding (in shares) | 7,000,000 | |
Warrants in connection with loan agreement | ||
Warrants | ||
Exercise Price (in dollars per share) | $ 2.45 | |
Warrants Issued (in shares) | 428,571 | |
Warrants Outstanding (in shares) | 428,571 |
Commitments and contingencies -
Commitments and contingencies - Lease (Details) | Apr. 22, 2014ft² | Mar. 31, 2015ft² | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Apr. 13, 2015USD ($) |
Future minimum commitments under facility operating leases | ||||||
2,017 | $ 311,000 | |||||
2,018 | 319,000 | |||||
2,019 | 184,000 | |||||
Total minimum lease payments | 814,000 | |||||
Rent expense | $ 275,000 | $ 254,000 | $ 83,000 | |||
Building lease, April 2014 | ||||||
Lease | ||||||
Lease term | 48 months | |||||
Amount of space leased (in square feet) | ft² | 3,000 | |||||
Building lease, March 2015 | ||||||
Lease | ||||||
Lease term | 52 months | |||||
Amount of space leased (in square feet) | ft² | 14,743 | |||||
Recorded liability for vacated leased space | $ 100,000 |
Commitments and contingencies45
Commitments and contingencies - License Agreements - CCTEC (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2011 | |
License agreement | ||
Impairment of intangible assets | $ 15,828,000 | |
BioPancreate | License agreement | CCTEC | ||
License agreement | ||
Maximum milestone payments | $ 2,600,000 | |
Minimum annual royalty | 100,000 | |
Maximum amount due in the event product is sublicensed | $ 3,500,000 | |
BioPancreate Acquisition | IPR&D | ||
License agreement | ||
Impairment of intangible assets | $ 5,200,000 |
Commitments and contingencies46
Commitments and contingencies - License Agreements - Antisense (Details) - Antisense Therapeutics - USD ($) | 1 Months Ended | |
Apr. 30, 2016 | May 31, 2015 | |
License agreement | ||
License agreement | ||
Amount invested | $ 2,000,000 | |
Prior written notice period for termination of agreement | 90 days | |
Termination fee if terminated for convenience | $ 2,000,000 | |
License agreement | Noncurrent other assets | ||
License agreement | ||
Value of equity investment | 1,100,000 | |
Settlement agreement | ||
License agreement | ||
One-time payment as settlement for termination | $ 770,000 | |
Consideration for return of Antisense shares | 0 | |
Research and development | License agreement | ||
License agreement | ||
Upfront license fee paid | $ 3,000,000 | |
Other (expense)/income | Settlement agreement | ||
License agreement | ||
Expense recorded in connection with settlement agreement | $ 1,100,000 |
Commitments and contingencies47
Commitments and contingencies - Commitments to Taro (Details) - Acquired product rights - Taro - Keveyis $ in Millions | 1 Months Ended | |
Mar. 31, 2017USD ($) | Dec. 31, 2016USD ($)payment | |
Asset Purchase Agreement | ||
Other Commitments | ||
Number of installment payments | payment | 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 |
Business combinations - BioPanc
Business combinations - BioPancreate (Details) - shares | 1 Months Ended | |
Jan. 31, 2014 | Oct. 31, 2013 | |
BioPancreate Acquisition | ||
Business combinations | ||
Shares issued for acquisition (in shares) | 5,272 | 336,136 |
Business combinations - Aspireo
Business combinations - Aspireo Pharmaceuticals Ltd. (Details) - USD ($) $ / shares in Units, $ in Thousands | Jun. 30, 2015 | Jun. 30, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Liabilities assumed: | |||||
Goodwill | $ (7,256) | $ (7,256) | $ (2,200) | ||
Aspireo Acquisition | |||||
Business combinations | |||||
Shares issued for acquisition (in shares) | 2,062,677 | ||||
Shares issued for acquisition (in dollars) | $ 33,200 | ||||
Amount of payment to OCS | $ 3,000 | ||||
Fair value of common stock (in dollars per share) | $ 16.10 | $ 16.10 | |||
Estimated fair values of the assets acquired and liabilities assumed | |||||
In-process research and development | $ 31,323 | $ 31,323 | |||
Liabilities assumed: | |||||
Other liabilities (net) | (195) | (195) | |||
OCS liability | (2,973) | (2,973) | |||
Total fair values of assets and liabilities | 28,155 | 28,155 | |||
Fair value of total consideration transferred | (33,211) | ||||
Goodwill | $ (5,056) | $ (5,056) | |||
Acquisition-related transaction costs | $ 2,200 |
Income taxes - Components of lo
Income taxes - Components of loss (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Components of loss before income taxes | |||
Loss before income taxes | $ (51,357) | $ (44,083) | $ (10,150) |
Sweden | |||
Components of loss before income taxes | |||
Loss before income taxes | (16,433) | (33,960) | (9,165) |
Ireland | |||
Components of loss before income taxes | |||
Loss before income taxes | (11,653) | (191) | |
Cayman Islands | |||
Components of loss before income taxes | |||
Loss before income taxes | (19,550) | (8,722) | |
U.S. | |||
Components of loss before income taxes | |||
Loss before income taxes | $ (3,721) | $ (1,210) | $ (985) |
Income taxes - Components of in
Income taxes - Components of income tax (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Components of income tax (benefit) provision | |||
Current tax expense (benefit) | $ 246 | ||
Deferred tax expense (benefit) | (2,638) | $ (450) | $ (480) |
Change in valuation allowance | 3,587 | 18,138 | 3,321 |
Total income tax (benefit) | (2,638) | (450) | (480) |
Sweden | |||
Components of income tax (benefit) provision | |||
Deferred tax expense (benefit) | 212 | (648) | |
Ireland | |||
Components of income tax (benefit) provision | |||
Current tax expense (benefit) | 22 | ||
Deferred tax expense (benefit) | (24) | ||
U.S. | Federal | |||
Components of income tax (benefit) provision | |||
Current tax expense (benefit) | 151 | ||
Deferred tax expense (benefit) | (5,793) | (17,543) | (2,433) |
U.S. | State | |||
Components of income tax (benefit) provision | |||
Current tax expense (benefit) | 73 | ||
Deferred tax expense (benefit) | $ (678) | $ (1,233) | $ (720) |
Income taxes - Deferred taxes (
Income taxes - Deferred taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 24,433 | $ 22,039 |
Stock based compensation | 1,870 | |
Other deferred activity | 96 | |
Tax credits | 9,135 | 9,135 |
Capitalized research and development costs | 161 | 161 |
Total deferred tax assets | 35,695 | 31,335 |
Valuation allowance | (33,738) | (30,150) |
Deferred tax assets recognized | 1,957 | 1,185 |
Deferred tax liabilities: | ||
Warrants | (358) | |
Acquired intangible assets | (2,111) | |
Total deferred tax liabilities | (358) | (2,111) |
Net deferred tax assets | 1,599 | |
Net deferred tax (liabilities) | (926) | |
Increase in valuation allowance | $ 3,600 | $ 18,100 |
Income taxes - Effective tax ra
Income taxes - Effective tax rate (Details) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Schedule of effective tax rate of our benefit for income taxes differs from the statutory rate | |||
Foreign tax differential between Sweden, U.S., Cayman Island and Ireland | 2.28% | 15.70% | (4.60%) |
Federal tax credits | 12.10% | 20.90% | |
Change in valuation allowance | (6.69%) | (41.20%) | (32.70%) |
State income taxes | 0.92% | ||
Permanent differences | 1.59% | ||
Fx remeasurement of Swedish DTS | (5.42%) | (5.41%) | |
Other | (0.04%) | 7.31% | (0.90%) |
Effective income tax rate | 5.14% | 1.00% | 4.70% |
Ireland | |||
Schedule of effective tax rate of our benefit for income taxes differs from the statutory rate | |||
Domestic statutory income tax rate | 12.50% | 12.50% | |
Sweden | |||
Schedule of effective tax rate of our benefit for income taxes differs from the statutory rate | |||
Domestic statutory income tax rate | 22.00% |
Income taxes - NOLs (Details)
Income taxes - NOLs (Details) $ in Millions | Dec. 31, 2016USD ($) |
Sweden | |
Operating Loss Carryforwards | |
NOLs | $ 70.4 |
Ireland | |
Operating Loss Carryforwards | |
NOLs | 12.5 |
U.S. | Federal | |
Operating Loss Carryforwards | |
NOLs | 37.1 |
U.S. | State | |
Operating Loss Carryforwards | |
NOLs | $ 37.2 |
Income taxes - Tax credit carry
Income taxes - Tax credit carryfowards (Details) | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Sweden | |
Tax credit carryforward | |
Ownership change threshold (as a percent) | 50.00% |
U.S. | |
Tax credit carryforward | |
Ownership change threshold (as a percent) | 50.00% |
U.S. | Orphan drug tax credit carryforward | Federal | |
Tax credit carryforward | |
Tax credit carryforward | $ 8,900,000 |
U.S. | Research and development tax credit carryforward | Federal | |
Tax credit carryforward | |
Tax credit carryforward | $ 167,000 |
Ordinary shares - Voting rights
Ordinary shares - Voting rights and privileges (Details) | May 26, 2015€ / sharesshares | Dec. 31, 2016item$ / sharesshares | Dec. 31, 2015$ / sharesshares | Dec. 31, 2016$ / sharesshares | May 26, 2015$ / shares |
Voting rights and privileges | |||||
Ordinary shares, shares authorized | shares | 600,000,000 | 600,000,000 | 600,000,000 | ||
Ordinary shares, shares outstanding | shares | 35,335,026 | 21,205,382 | 35,335,026 | ||
Number of votes per ordinary share | item | 1 | ||||
Dividends declared (in dollars per share) | $ / shares | $ 0 | ||||
Dividends paid (in dollars per share) | $ / shares | 0 | ||||
Deferred shares, par value (in dollars/euro per share) | $ / shares | $ 1.098 | $ 1.098 | $ 1.098 | ||
Deferred Shares | |||||
Voting rights and privileges | |||||
Beneficial shares issued (in shares) | shares | 40,000 | 40,000 | |||
Deferred shares, par value (in dollars/euro per share) | (per share) | € 1 | $ 1.098 | |||
Number of votes per deferred share | item | 0 |
Ordinary shares - Equity financ
Ordinary shares - Equity financings (Details) - USD ($) $ / shares in Units, $ in Thousands | Jun. 28, 2017 | Dec. 22, 2016 | Oct. 22, 2015 | Jun. 30, 2015 | Feb. 28, 2015 | Dec. 31, 2016 |
Equity financings | ||||||
Proceeds from private placement, net | $ 32,700 | |||||
Issuance of shares (in shares) | 14,000,000 | 2,284,414 | 4,761,078 | |||
Price per share (in dollars per share) | $ 2.50 | $ 10 | $ 14.54 | $ 5.54 | ||
Unrealized gain on fair value of warrants | $ 638 | |||||
Warrant liabilities | $ 11,090 | |||||
Issuance of shares in initial public offering, net (in shares) | 2,500,000 | |||||
Aggregate gross proceeds | $ 25,000 | |||||
Offering expenses | $ 5,500 | |||||
Proceeds, net of transaction costs | $ 32,600 | $ 25,800 | ||||
Warrants in connection with private equity placement | ||||||
Equity financings | ||||||
Securities that warrants may purchase (in shares) | 7,000,000 | |||||
Warrant exercise price (in dollars per share) | $ 2.50 | $ 2.50 | ||||
Warrants in connection with private equity placement | Forecast | ||||||
Equity financings | ||||||
Warrant expiration period | 5 years |
Ordinary shares - Shares reserv
Ordinary shares - Shares reserved for issuance (Details) - shares | Dec. 31, 2016 | Dec. 31, 2015 |
Stock Options | ||
Shares reserved for issuance | ||
Common stock reserved for future issuance (in shares) | 1,951,022 | 2,591,520 |
Warrants issued in private equity placement or loan agreement | ||
Shares reserved for issuance | ||
Common stock reserved for future issuance (in shares) | 7,428,571 |
Stock-based compensation - Gene
Stock-based compensation - General (Details) | Oct. 22, 2015USD ($)NOK / $ | Sep. 08, 2015 | Jul. 21, 2015shares | Dec. 31, 2016shares | Dec. 31, 2015USD ($) | Dec. 31, 2016USD ($) |
Stock-based compensation | ||||||
Vesting period | 4 years | |||||
Forfeited and cancelled (in shares) | (329,518) | |||||
Granted (in shares) | 1,169,600 | |||||
Reverse stock split conversion ratio (as a percent) | 0.09090 | |||||
Foreign currency exchange rate | NOK / $ | 8.1935 | |||||
Reclass of stock-based liability award to equity | $ | $ 1,500,000 | $ 1,542,000 | ||||
Certain employees | ||||||
Stock-based compensation | ||||||
Forfeited and cancelled (in shares) | (465,262) | |||||
Granted (in shares) | 586,710 | |||||
Incremental fair value recorded (in dollars) | $ | $ 468,000 | |||||
Cortendo AB Plan | ||||||
Stock-based compensation | ||||||
Incremental fair value recorded (in dollars) | $ | $ 325,000 | |||||
Minimum | ||||||
Stock-based compensation | ||||||
Award term | 5 years | |||||
Maximum | ||||||
Stock-based compensation | ||||||
Award term | 10 years |
Stock-based compensation - Stoc
Stock-based compensation - Stock options (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Summary of outstanding stock options | ||
Outstanding at beginning of period (in shares) | 2,591,520 | |
Granted (in shares) | 1,169,600 | |
Forfeited and cancelled (in shares) | (329,518) | |
Exercised (in shares) | 181,818 | |
Outstanding at end of period (in shares) | 3,249,784 | 2,591,520 |
Vested and exercisable at end of period (in shares) | 1,158,660 | |
Vested and expected to vest at end of the period (in shares) | 2,860,743 | |
Weighted-Average Exercise Price | ||
Granted (in dollars per share) | $ 4.28 | |
Forfeited and cancelled (in dollars per share) | 12.85 | |
Exercised (in dollars per share) | 1.32 | |
Outstanding (in dollars per share) | 11 | $ 13.59 |
Vested and exercisable at end of period (in dollars per share) | 11.37 | |
Vested and expected to vest at end of period (in dollars per share) | $ 10.73 | |
Additional Disclosures | ||
Weighted Average Remaining Contractual Term, Outstanding | 6 years 10 months 21 days | 5 years 11 months 19 days |
Weighted Average Remaining Contractual Term, Vested and exercisable | 4 years 10 months 28 days | |
Weighted Average Remaining Contractual Term, Vested and expected to vest | 6 years 6 months 7 days | |
Aggregate Intrinsic Value (in dollars) | $ 1,844 |
Stock-based compensation - Opti
Stock-based compensation - Options outstanding (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Stock options | ||
Options outstanding (in shares) | 3,249,784 | 2,591,520 |
Options outstanding, weighted-average exercise price (in dollars per share) | $ 11 | $ 13.59 |
Vesting subject to acceleration | ||
Stock options | ||
Options outstanding (in shares) | 88,909 | |
Options outstanding, weighted-average exercise price (in dollars per share) | $ 18.80 | |
Vesting subject to acceleration | Grantee, One | ||
Stock options | ||
Share price threshold | 16.11 | |
Vesting subject to acceleration | Grantee, Two | ||
Stock options | ||
Share price threshold | 31.46 | |
Vesting subject to acceleration | Grantee, Three | ||
Stock options | ||
Share price threshold | 37.62 | |
Vesting based on market appreciation event | Grantee, Four | ||
Stock options | ||
Share price threshold | 30.14 | |
Vesting based on market appreciation event | Grantee, Five | ||
Stock options | ||
Share price threshold | $ 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 - St62
Stock-based compensation - Stock-based compensation expense (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Stock-based compensation expense | |||
Total stock-based compensation | $ 4,606,000 | $ 3,940,000 | $ 251,000 |
Income tax benefit recognized | 1,900,000 | 0 | 0 |
Total unrecognized compensation expense | $ 6,800,000 | ||
Estimated weighted average period over which expense is expected to be recognized | 2 years 5 months 16 days | ||
Stock options accounted for as liabilities | |||
Stock-based compensation expense | |||
Total stock-based compensation | $ 0 | 359,000 | (229,000) |
Research and development | |||
Stock-based compensation expense | |||
Total stock-based compensation | 601,000 | 793,000 | 268,000 |
General and administration expense | |||
Stock-based compensation expense | |||
Total stock-based compensation | $ 4,005,000 | $ 3,147,000 | $ (17,000) |
Stock-based compensation - Fair
Stock-based compensation - Fair value assumptions (Details) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Fair value assumptions | |||
Expected term (in years) | 5 years 10 months 24 days | 3 years 2 months 23 days | 3 years 2 months 23 days |
Minimum Risk-free interest rate (as a percent) | 1.21% | 0.00% | 0.00% |
Maximum Risk-free interest rate (as a percent) | 2.23% | 0.60% | 0.60% |
Minimum Expected volatility (as a percent) | 78.10% | 79.00% | 68.30% |
Maximum Expected volatility (as a percent) | 83.60% | 83.10% | 80.70% |