Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Feb. 25, 2017 | Jun. 30, 2016 | |
Document And Entity Information | |||
Entity Registrant Name | Accelerate Diagnostics, Inc. | ||
Entity Central Index Key | 727,207 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2016 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 383.1 | ||
Entity Common Stock, Shares Outstanding | 51,895,049 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2,016 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 19,244 | $ 120,585 |
Investments | 58,519 | 11,839 |
Trade accounts receivable | 34 | 77 |
Prepaid expenses | 468 | 1,638 |
Other current assets | 183 | 12 |
Total current assets | 78,448 | 134,151 |
Property and equipment, net | 4,258 | 5,016 |
Intellectual property, net | 146 | 157 |
Total assets | 82,852 | 139,324 |
Current liabilities: | ||
Accounts payable | 992 | 2,623 |
Accrued liabilities | 3,009 | 2,543 |
Deferred revenue and income | 35 | 127 |
Capital lease obligations | 0 | 13 |
Total current liabilities | 4,036 | 5,306 |
Long-term deferred income | 1,000 | 1,000 |
Total liabilities | 5,036 | 6,306 |
Commitments and contingencies see Note 16, Commitments | 0 | 0 |
Stockholders' equity: | ||
Common stock, $0.001 par value | 52 | 51 |
Preferred shares, $0.001 par value | 0 | 0 |
Contributed capital | 255,257 | 243,894 |
Accumulated deficit | (177,289) | (110,915) |
Accumulated other comprehensive loss | (204) | (12) |
Total stockholders' equity | 77,816 | 133,018 |
Total liabilities and stockholders' equity | $ 82,852 | $ 139,324 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 75,000,000 | 55,000,000 |
Common stock, shares issued | 51,516,309 | 51,191,184 |
Common stock, shares outstanding | 51,516,309 | 51,191,184 |
Preferred shares, par value (dollars per share) | $ 0 | $ 0 |
Preferred shares, shares authorized | 5,000,000 | 5,000,000 |
Preferred shares, shares issued | 0 | 0 |
Preferred shares, shares outstanding | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Revenues: | |||
Product revenue | $ 163 | $ 76 | $ 0 |
Licensing and royalty revenues | 83 | 71 | 122 |
Total revenues | 246 | 147 | 122 |
Costs and expenses: | |||
Research and development | 28,196 | 26,022 | 19,526 |
Sales, general and administrative | 36,200 | 17,882 | 10,695 |
Amortization | 11 | 10 | 71 |
Depreciation | 2,340 | 1,782 | 817 |
Impairment of intangibles | 0 | 3 | |
Total costs and expenses | 66,747 | 45,696 | 31,112 |
Loss from operations | (66,501) | (45,549) | (30,990) |
Interest expense and other | (23) | (4) | (7) |
Interest and dividend income | 494 | 74 | 64 |
Foreign currency exchange loss | (77) | (19) | 0 |
Total other income | 394 | 51 | 57 |
Net loss before income taxes | (66,107) | (45,498) | (30,933) |
Provision from income taxes | (267) | 0 | 0 |
Net loss | $ (66,374) | $ (45,498) | $ (30,933) |
Basic and diluted net loss per share (dollars per share) | $ (1.29) | $ (1.01) | $ (0.71) |
Weighted average shares outstanding (shares) | 51,276 | 44,998 | 43,626 |
Other comprehensive loss: | |||
Net loss | $ (66,374) | $ (45,498) | $ (30,933) |
Net unrealized loss on available-for-sale investments | (64) | (20) | (15) |
Foreign currency translation adjustment | (128) | 1 | 0 |
Comprehensive loss | $ (66,566) | $ (45,517) | $ (30,948) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Contributed Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) |
Beginning Balance, amount at Dec. 31, 2013 | $ 41,517 | $ 42 | $ 75,937 | $ (34,484) | $ 22 |
Beginning Balance (shares) at Dec. 31, 2013 | 41,650,000 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (30,933) | (30,933) | |||
Issuance of common stock | 44,875 | $ 3 | 44,872 | ||
Issuance of common stock (shares) | 2,678,000 | ||||
Exercise of options and warrants | 923 | 923 | |||
Exercise of options and warrants (shares) | 312,000 | ||||
Unrealized loss on available-for-sale securities | (15) | (15) | |||
Foreign currency translation adjustment | 0 | ||||
Equity-based compensation | 9,624 | 9,624 | |||
Ending Balance, amount at Dec. 31, 2014 | 65,991 | $ 45 | 131,356 | (65,417) | 7 |
Ending Balance (shares) at Dec. 31, 2014 | 44,640,000 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (45,498) | (45,498) | |||
Issuance of common stock | 103,351 | $ 6 | 103,345 | ||
Issuance of common stock (shares) | 6,426,000 | ||||
Exercise of options and warrants | $ 805 | 805 | |||
Exercise of options and warrants (shares) | 124,884 | 125,000 | |||
Unrealized loss on available-for-sale securities | $ (20) | (20) | |||
Foreign currency translation adjustment | 1 | 1 | |||
Equity-based compensation | 8,388 | 8,388 | |||
Ending Balance, amount at Dec. 31, 2015 | 133,018 | $ 51 | 243,894 | (110,915) | (12) |
Ending Balance (shares) at Dec. 31, 2015 | 51,191,000 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (66,374) | (66,374) | |||
Exercise of options and warrants | $ 1,497 | $ 1 | 1,496 | ||
Exercise of options and warrants (shares) | 158,743 | 314,000 | |||
Short swing profits (net of costs) | $ 866 | 866 | |||
Issuance of common stock under employee purchase plan | 226 | 226 | |||
Issuance of common stock under employee purchase plan (shares) | 11,000 | ||||
Unrealized loss on available-for-sale securities | (64) | (64) | |||
Foreign currency translation adjustment | (128) | (128) | |||
Equity-based compensation | 8,775 | 8,775 | |||
Ending Balance, amount at Dec. 31, 2016 | $ 77,816 | $ 52 | $ 255,257 | $ (177,289) | $ (204) |
Ending Balance (shares) at Dec. 31, 2016 | 51,516,000 |
Consolidated Statement of Cash
Consolidated Statement of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Cash flows from operating activities: | |||
Net loss | $ (66,374) | $ (45,498) | $ (30,933) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 2,340 | 1,782 | 817 |
Amortization of intangible assets | 11 | 10 | 71 |
Amortization of investment discount | 374 | 188 | 269 |
Equity-based compensation | 8,775 | 8,388 | 9,624 |
Impairment loss | 0 | 0 | 3 |
Realized gain on available-for-sale securities | (6) | 0 | 0 |
Loss on disposal of property & equipment | 23 | 0 | 0 |
(Increase) decrease in assets: | |||
Accounts receivable | 43 | 1 | (54) |
Prepaid expense and other | 1,292 | (1,241) | (166) |
Other current assets | (171) | (12) | 0 |
Increase (decrease) in liabilities: | |||
Accounts payable | (1,242) | 329 | 1,336 |
Accrued liabilities | 1,619 | 827 | 80 |
Deferred revenue and income | (92) | 100 | 168 |
Net cash used in operating activities | (53,408) | (35,126) | (18,785) |
Cash flows from investing activities: | |||
Purchases of equipment | (2,409) | (3,656) | (1,933) |
Purchase of available-for-sale securities | (74,075) | (12,418) | (7,657) |
Sales of available-for-sale securities | 9,716 | 141 | 861 |
Maturity of available-for-sale securities | 17,200 | 13,258 | 5,357 |
Net cash used in investing activities | (49,568) | (2,675) | (3,372) |
Cash flows from financing activities: | |||
Exercise of warrants and options | 1,497 | 805 | 923 |
Common stock issuance cost | (814) | 0 | 0 |
Issuance of common stock and warrants | 226 | 104,165 | 44,875 |
Recovery of related party short-swing profits | 866 | 0 | 0 |
Payments on capital lease obligations | (13) | (147) | (107) |
Net cash provided by financing activities | 1,762 | 104,823 | 45,691 |
Effect of exchange rate on cash | (127) | 0 | 0 |
Increase (decrease) in cash and cash equivalents | (101,341) | 67,022 | 23,534 |
Cash and cash equivalents, beginning of period | 120,585 | 53,563 | 30,029 |
Cash and cash equivalents, end of period | $ 19,244 | $ 120,585 | $ 53,563 |
Organization and Nature of Busi
Organization and Nature of Business; Basis of Presentation; Principles of Consolidation | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Organization and Nature of Business; Basis of Presentation; Principles of Consolidation | NOTE 1. ORGANIZATION AND NATURE OF BUSINESS; BASIS OF PRESENTATION; PRINCIPLES OF CONSOLIDATION Accelerate Diagnostics, Inc. (“we” or “us” or “our” or “Accelerate” or “the Company”) is an in vitro diagnostics company dedicated to providing solutions which improve patient outcomes and lower healthcare costs through the rapid diagnosis of serious infections. Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, (“U.S. GAAP”), and applicable rules and regulations of the United States Securities and Exchange Commission (“SEC”), regarding annual financial reporting. All amounts are rounded to the nearest thousand dollars unless otherwise indicated. Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries after elimination of intercompany transactions and balances. During the fiscal year ending December 31, 2016 , new entities were formed based in Europe. Reclassification Certain prior year amounts have been reclassified for consistency with the current year presentation and had no effect on our net income, stockholders' equity or cash flows. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Estimated Fair Value of Financial Instruments The Company follows ASC Topic 820, Fair Value Measurements and Disclosures which has defined fair value and requires the Company to establish a framework for measuring fair value and disclose fair value measurements. The framework requires the valuation of assets and liabilities subject to fair value measurements using a three tiered approach and fair value measurement be classified and disclosed in one of the following three categories: • Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; • Level 2: Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs that are observable, either directly or indirectly, for substantially the full term of the asset or liability; • Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e. supported by little or no market activity). The carrying amounts of financial instruments such as cash and cash equivalents, trade accounts receivable, prepaid expenses, accounts payable, accrued liabilities, and other current liabilities approximate the related fair values due to the short-term maturities of these instruments. See Note 4, Fair Value of Financial Instruments for further information and related disclosures regarding the Company’s fair value measurements. Cash and Cash Equivalents All highly liquid investments with an original maturity of three months or less at time of purchase are considered to be cash equivalents. Cash and cash equivalents include overnight repurchase agreement accounts and other investments. As part of our cash management process, excess operating cash is invested in overnight repurchase agreements with our bank. Repurchase agreements and other investments classified as cash and cash equivalents are not deposits and are not insured by the U.S. Government, the FDIC or any other government agency and involve investment risk including possible loss of principal. We believe however, that the market risk arising from holding these financial instruments is minimal. Investments The Company invests excess funds in various investments which are primarily held in the custody of major financial institutions. Investments consist of debt securities in U.S. government and agency securities, corporate debt securities, certificates of deposit, and commercial paper. Management classifies its investments as available-for-sale investments and records these investments in the consolidated balance sheet at fair value. The Company considers all available-for-sale securities, including those with maturity dates beyond 12 months, as available to support current operational liquidity needs. Unrealized gains or losses for available-for-sale securities are included in accumulated other comprehensive income or loss, a component of stockholders’ equity. The Company classifies its investments as current based on the nature of the investments and their availability for use in current operations. The Company assesses whether an other-than-temporary impairment loss has occurred due to declines in fair value or other market conditions when an investment’s fair value remains less than its cost for more than twelve months. This assessment includes a determination of whether the investment is expected to recover in value and whether the Company has the intent and ability to hold the investment until the anticipated recovery in value occurs. When an investment is identified as having an other-than-temporary impairment loss, we adjust the cost basis of the investment down to fair value resulting in a realized loss. The new cost basis is not changed for subsequent recoveries in fair value and temporary future increases or decreases in fair value are included in other comprehensive income. Inventory The Company currently purchases and produces inventory prior to U.S. Food and Drug Administration (“FDA”) or other regulatory agency approval. We do not believe probable future economic benefit can be asserted prior to the de novo request being granted by the U.S. FDA unless the regulatory review process has progressed to a point that objective and persuasive evidence of regulatory approval is sufficiently probable ("Regulatory Approval"). Accordingly, the Company does not capitalize pre-launch inventory prior to Regulatory Approval and future economic benefit can be asserted. Costs associated with the Company’s purchase of inventory are either reported as research and development costs, or if the inventory is used in marketing evaluations, as sales, general and administrative costs on the consolidated statements of operations and comprehensive loss. Accounts Receivable Allowances Allowances on accounts receivable are recorded when circumstances indicate collection is doubtful for a particular accounts receivable. Receivables are written off if reasonable collection efforts prove unsuccessful. The Company provides for allowances on a specific account basis. Property and Equipment Property and equipment are recorded at cost. Maintenance and repairs are charged to expense as incurred and expenditures for major improvements are capitalized. Gains and losses from retirement or replacement are included in costs and expenses. Depreciation of property and equipment is computed using the straight-line method over the estimated useful life of the assets, ranging from one to seven years. Leasehold improvements are depreciated over the remaining life of the lease or the life of the asset, whichever is less. See Note 6, Property and Equipment below. Long-lived Assets Long-lived assets and certain identifiable intangibles to be held and used by the Company are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company continuously evaluates the recoverability of its long-lived assets based on estimated future cash flows from and the estimated fair value of such long-lived assets, and provides for impairment if such undiscounted cash flows or the estimated fair value are insufficient to recover the carrying amount of the long-lived asset. Warranty Reserve A limited warranty of a year or less is covered under selected contracts. Accordingly, a provision for the estimated cost of the limited warranty repair is recorded at the time revenue is recognized. Our estimated warranty provision is based on our estimate of future repair events and the related estimated cost of repairs. We periodically assess the adequacy of the warranty reserve and adjust the amount as necessary. The expense incurred for these provisions is included in sales, general and administrative on the consolidated statements of operations and comprehensive loss. Revenue Recognition The Company recognizes revenue in accordance with ASC 605, “Revenue Recognition,” when persuasive evidence of an arrangement exists, the price is fixed or determinable, collection is reasonably assured and delivery of products has occurred or services have been rendered. Additional considerations include whether the applicable fee arrangement contains future delivery or performance obligations that should be divided into separate accounting units, whether the arrangement requires the Company to retain risks consistent with a collaborative arrangement, and/or whether any of the fees are contingent on the achievement of future milestones. Product revenue is derived from the sale or rental of our instruments and sales of related consumable products. When an instrument is sold, revenue is generally recognized upon installation of the unit consistent with contract terms, which do not include a right of return. When a consumable product is sold, revenue is generally recognized upon shipment. We also provide instruments to customers under bundled rental agreements. Under these agreements, we install the instrument in the customer's facility and provide service and training without a fee. The customer agrees to purchase consumable products at a stated price over the term of the agreement which varies but is under seven years. Contracts sometimes have renewal clauses but such clauses do not provide for a bargain renewal option or penalize the customer if they don't renew. The instrument remains our property throughout the term of the agreement and there is no transfer of title upon expiration. Revenue is recognized as consumable products are shipped or delivered, depending on contract terms. Deferred revenue represents amounts received but not yet earned under existing agreements. Leases The Company accounts for leases in accordance with ASC 840, Leases, which requires leases to be classified as either operating or capital leases. In general, the Company classifies leases as capital leases when there is either a transfer of ownership at the end of the lease term, the lease contains a bargain purchase option, the lease term is seventy-five percent or more of the estimated economic life of the leased property or the minimum lease payments are ninety percent or more of the fair value at lease inception. Other leases are classified as operating leases. Operating lease rent is recorded as an operating expense monthly. For capital leases, both an asset and liability are recorded at the inception of the lease based on the present value of lease payments. The asset is included with property and equipment on the Balance Sheet and amortization is recorded on a straight-line basis over the term of the lease with the amortization expense included with depreciation on the Statements of Operations and Comprehensive Loss. For the liability, the amount due within the next year is recorded as capital lease obligations and the amount due in more than a year is recorded as long-term capital lease obligation on the Balance Sheet. Interest expense is recorded based on the implicit or explicit interest rate used in the lease and is included as non-operating interest expense on the Statements of Operations and Comprehensive Loss. Equity-Based Compensation The Company awards stock options and other equity-based instruments to its employees, directors and consultants. Compensation cost related to equity-based instruments is based on the fair value of the instrument on the grant date, and is recognized over the requisite service period on a straight-line basis over the vesting period for each tranche (an accelerated attribution method). For unvested consultant grants, the assumptions are updated at the end of each reporting period until the grant is vested. The Company estimates the fair value of stock option awards, including modifications of stock option awards, using the Black-Scholes option pricing model. This model derives the fair value of stock options based on certain assumptions related to expected stock price volatility, expected option life, risk-free interest rate and dividend yield. • Volatility: The expected volatility is based on the historical volatility of the Company's stock price over the most recent period commensurate with the expected term of the stock option award. • Expected term: The estimated expected term for employee awards is based on the calculation published by the SEC in SAB110 for use when there is not a sufficient history of employee exercise patterns. For consultant awards, the estimated expected term is the same as the life of the award. • Risk-free interest rate: The risk-free interest rate is based on published U.S. Treasury rates for a term commensurate with the expected term. • Dividend yield: The dividend yield is estimated as zero as the Company has not paid dividends in the past and does not have any plans to pay any dividends in the foreseeable future. The Company estimates the forfeiture rate of unvested awards based on the forfeitures in the previous twelve-month period. The rate is calculated separately for awards to the board of directors/executives and all other awards. The Company also has an employee stock purchase program whereby eligible employees can elect payroll deductions that are subsequently used to purchase common stock at a discounted price. There is no compensation recorded for this program as (i) the purchase discount does not exceed the issuance costs that would have been incurred to raise a significant amount of capital by a public offering, (ii) substantially all employees that meet limited employment qualifications may participate on an equitable basis, and (iii) the plan doesn't incorporate option features that would require compensation to be recorded. See Note 14, Employee and Consultant Equity-Based Compensation for further information. Income Taxes and Deferred Tax Assets Deferred tax assets and liabilities are recorded for the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the accompanying balance sheets. The change in deferred tax assets and liabilities for the period represents the deferred tax provision or benefit for the period. Effects of changes in enacted tax laws in deferred tax assets and liabilities are reflected as an adjustment to the tax provision or benefit in the period of enactment. The Company follows the provisions of ASC 740, Income Taxes , to account for any uncertainty in income taxes with respect to the accounting for all tax positions taken (or expected to be taken) on any income tax return. This guidance applies to all open tax periods in all tax jurisdictions in which the Company is required to file an income tax return. Under U.S. GAAP, in order to recognize an uncertain tax benefit the taxpayer must be more likely than not certain of sustaining the position, and the measurement of the benefit is calculated as the largest amount that is more than 50% likely to be realized upon resolution of the position. Interest and penalties, if any, would be recorded as tax expense in general and administrative expenses. Foreign Currency Translation and Foreign Currency Transactions The Company follows ASC 830 Foreign Currency Matters , which provides guidance on foreign currency transactions and translation of financial statements. Adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars are included in the foreign currency translation adjustment, a component of accumulated other comprehensive income (loss) in the consolidated statements of stockholder's equity. The Company has assets and liabilities, including receivables and payables, which are denominated in currencies other than their functional currency. These balance sheet items are subject to re-measurement, the impact of which is recorded in interest expense and other, within the consolidated statement of operations and comprehensive loss. Earnings Per Share The Company follows ASC 260, Earnings Per Share , which requires companies to present basic earnings per share and diluted earnings per share. Basic earnings (loss) per share includes no dilution and is computed by dividing income (loss) available to common stockholders by the weighted average number of common shares outstanding for the period. Diluted earnings per share are computed similarly to basic earnings (loss) per share except the denominator includes additional common shares that would have been outstanding if warrants and share-based payments had been issued. Diluted earnings are not presented when the effect of adding such additional common shares is antidilutive. Earnings per share are restated when certain transactions or events, including rights offerings determined to have bonus elements have occurred. See Note 13, Earnings Per Share for further information. Comprehensive Loss The Company follows ASC 220, Reporting Comprehensive Income , which establishes standards for reporting and displaying comprehensive income (loss) and its components (revenues, expenses, gains and losses) in a full set of general-purpose financial statements. The Company holds investments classified as available-for-sale securities and records the change in fair market value as a component of comprehensive income (loss). The Company also has adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars which is included as a component of comprehensive income (loss). Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments-Credit Losses (Topic 326) Measurement of Credit Losses on Financial Instruments, which amends the guidance on measuring credit losses on financial assets (including trade accounts receivable and available for sale debt securities) held at amortized cost. Currently, an “incurred loss” methodology is used for recognizing credit losses which delays recognition until it is probable a loss has been incurred. The amendment requires assets valued at amortized cost to be presented at the net amount expected to be collected using an allowance for credit losses. Reversal of credit losses on available for sale debt securities will be recorded in the current period net income. The amendment will be effective for us on January 1, 2020, with early adoption permitted. We do not anticipate this guidance will have a significant impact on our financial statements and plan to adopt on the effective date. In March 2016, the FASB issued ASU 2016-09, Compensation-Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting. This guidance requires the recognition of the income tax effects of awards in the income statement when the awards vest or are settled, thus eliminating additional paid in capital pools. The guidance also allows for the employer to repurchase more of an employee’s shares for tax withholding purposes without triggering liability accounting. In addition, the guidance allows for a policy election to account for forfeitures as they occur rather than on an estimated basis. We will implement this guidance on January 1, 2017, effective date and have elected to account for forfeitures as they occur. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). This replaces the existing standards relating to leases for both lessees and lessors. For lessees, the new standard requires most leases to be recorded on the balance sheet with expenses recognized much like the existing standard. For lessors, the new standard modifies the classification criteria and accounting for sales-type and direct financing leases and eliminates leveraged leases. For both lessees and lessors, the standard eliminates real estate-specific provisions, changes some of the presentation and disclosure requirements, and changes sale and leaseback criteria. The ASU is required for us on January 1, 2019, with early adoption permitted. We are currently assessing the impact this will have on our consolidated financial statements and the timing of adoption. In January, 2016, the FASB issued ASU 2016-01, Financial Instruments - Overall. This standard requires equity investments, with some exceptions, be measured at fair value with valuation changes recognized in net income, simplifies the impairment assessment of some equity investments, eliminates the requirement to disclose the methods and significant assumptions used to estimate the fair value for financial instruments measured at amortized cost, requires the use of the exit price notion when measuring the fair value of financial instruments, requires separate presentation of some changes in other comprehensive income, requires separate presentation of financial assets and financial liabilities by measurement category and form of financial assets, and clarifies the need for a valuation allowance on some deferred tax assets. The ASU is required for us on January 1, 2018. We do not expect the adoption of ASU 2016-01 to have a significant impact on our consolidated financial statements. In November 2015, the FASB issued ASU 2015-17, Income Taxes-Balance Sheet Classification of Deferred Taxes. The new standard required that deferred income tax liabilities and assets be classified as noncurrent in a classified statement of financial position rather than separating these amounts between current and noncurrent amounts. The deferred tax liabilities and assets continue to be offset and presented as a single amount. The ASU was required for us on January 1, 2017, and we adopted this standard retrospectively for the period ended December 31, 2015. There was no significant impact on our consolidated financial statements as a result of adopting this ASU. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements - Going Concern. The new standard required management of public and private companies to evaluate whether there is substantial doubt about the entity’s ability to continue as a going concern and, if so, disclose that fact. Management is also required to evaluate and disclose whether its plans alleviate that doubt. The new standard became effective for us on January 1, 2016 and the adoption did not have an impact on our consolidated financial statements. In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606), which will supersede nearly all existing revenue recognition guidance under U.S. GAAP. The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In August 2015, the FASB issued ASU 2015-14, Revenue from Contracts with Customers Deferral of the Effective Date, which deferred the effective date resulting in a new effective date of January 1, 2018, for us. We are permitted to adopt early but not before the original effective date of January 1, 2017. FASB has issued several other ASU's which provide further guidance on Topic 606 and have the same effective date. The standard allows for either “full retrospective” adoption, meaning the standard is applied to all of the periods presented, or “modified retrospective” adoption, meaning the standard is applied only to the most current period presented in the financial statements. We will implement ASU 2014-09 and all relevant subsequently issued ASU's on Topic 606 concurrently on January 1, 2018, and are currently evaluating the transitions method. We are carefully evaluating our existing revenue recognition practices to determine whether any contracts in the scope of the guidance will be affected by the new requirements. The effects may include identifying performance obligations in existing arrangements, determining the transaction price and allocating the transaction price to each separate performance obligation. We will also establish practices to determine when a performance obligation has been satisfied, and recognize revenue in accordance with the new requirements. As no material revenues have been recognized to date, we do not anticipate the adoption of this standard to have a material effect. |
Concentration of Credit Risk
Concentration of Credit Risk | 12 Months Ended |
Dec. 31, 2016 | |
Risks and Uncertainties [Abstract] | |
Concentration of Credit Risk | NOTE 3. CONCENTRATION OF CREDIT RISK Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, short-term investments and accounts receivable, including receivables from major customers. The Company’s main financial institution for banking operations held 57% and 100% of the Company’s cash and cash equivalents as of December 31, 2016 , and December 31, 2015 , respectively. The Company grants credit to domestic and international clients in various industries. Exposure to losses on accounts receivable is principally dependent on each client's financial position. At December 31, 2016 , and 2015 , 29% and 66% , respectively, of the outstanding receivable balance was with one customer. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | NOTE 4. FAIR VALUE OF FINANCIAL INSTRUMENTS The following tables represent the financial instruments measured at fair value on a recurring basis on the financial statements of the Company and the valuation approach applied to each class of financial instruments at December 31, 2016 , and 2015 (see Note 2, Summary of Significant Accounting Policies for further information): December 31, 2016 (in thousands) Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets: Cash and cash equivalents: Money market funds $ 10,970 $ — $ — $ 10,970 Investments: Certificates of deposit — 7,257 — 7,257 US Treasury securities 8,544 — — 8,544 US Agency securities — 4,501 — 4,501 Asset-backed securities — 5,557 — 5,557 Corporate notes and bonds — 32,660 — 32,660 Total investments 8,544 49,975 — 58,519 Total assets measured at fair value $ 19,514 $ 49,975 $ — $ 69,489 December 31, 2015 (in thousands) Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets: Cash and cash equivalents: Money market funds $ 5,221 $ — $ — $ 5,221 Investments: Asset-backed securities — 2,507 — 2,507 Corporate notes and bonds — 9,332 — 9,332 Total investments — 11,839 — 11,839 Total assets measured at fair value $ 5,221 $ 11,839 $ — $ 17,060 Money market funds are included in cash and cash equivalents on the consolidated balance sheet. Level 1 assets are priced using quoted prices in active markets for identical assets which include money market funds and U.S. Treasury securities as these specific assets are liquid. Level 2 available-for-sale securities are priced using quoted market prices for similar instruments or nonbinding market prices that are corroborated by observable market data. The Company uses inputs such as actual trade data, benchmark yields, broker/dealer quotes, and other similar data, which are obtained from quoted market prices, independent pricing vendors, or other sources, to determine the ultimate fair value of these assets and liabilities. The Company uses such pricing data as the primary input to make its assessments and determinations as to the ultimate valuation of its investment portfolio and has not made, during the periods presented, any material adjustments to such inputs. There were no transfers between levels during the year ended December 31, 2016 . |
Investments
Investments | 12 Months Ended |
Dec. 31, 2016 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | NOTE 5. INVESTMENTS The following tables summarize the Company’s available-for-sale investments at December 31, 2016 , and 2015 (in thousands): AVAILABLE-FOR-SALE INVESTMENTS December 31, 2016 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Certificates of deposit $ 7,257 $ — $ — $ 7,257 US Treasury securities 8,553 1 (10 ) 8,544 US Agency securities 4,514 — (13 ) 4,501 Asset-backed securities 5,554 3 — 5,557 Corporate notes and bonds 32,717 3 (60 ) 32,660 Total $ 58,595 $ 7 $ (83 ) $ 58,519 AVAILABLE-FOR-SALE INVESTMENTS December 31, 2015 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Asset-backed securities $ 2,510 $ — $ (3 ) $ 2,507 Corporate notes and bonds 9,341 1 (10 ) 9,332 Total $ 11,851 $ 1 $ (13 ) $ 11,839 The following table summarizes the maturities of the Company’s available-for-sale securities at December 31, 2016 , and 2015 (in thousands): AVAILABLE-FOR-SALE INVESTMENT MATURITIES (in thousands) At December 31, 2016 At December 31, 2015 Amortized Cost Fair Value Amortized Cost Fair Value Due in less than 1 year $ 45,391 $ 45,344 $ 11,851 $ 11,839 Due in 1-5 years 13,204 13,175 — — Total $ 58,595 $ 58,519 $ 11,851 $ 11,839 Proceeds from sales of marketable securities (including principal paydowns) for the years ended December 31, 2016 , and 2015 , were $9.7 million and $141,000 , respectively. The Company determines gains and losses of marketable securities based on specific identification of the securities sold. There were $6,000 of realized gains from sales of marketable securities the year ended December 31, 2016 , and no gross realized gains or losses from sales of marketable securities for year ended December 31, 2015 . The gross proceeds associated with the realized gains for the year ended December 31, 2016 were $7.2 million . No material balances were reclassified out of accumulated other comprehensive income for the years ended December 31, 2016 , and 2015 . No other-than-temporary impairments are recorded as no investments had a fair value that remained less than its cost for more than twelve months as of December 31, 2016 , and 2015 . The Company does not intend to sell investments and it is more likely than not that we will not be required to sell investments before recovering the amortized cost. Additional information regarding the fair value of our financial instruments is included in Item 8, Note 4, Fair Value of Financial Instruments . |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | NOTE 6. PROPERTY AND EQUIPMENT Property and equipment are recorded at cost and consisted of the following at December 31, 2016 , and 2015 (in thousands). PROPERTY AND EQUIPMENT (in thousands) 12/31/2016 12/31/2015 Computer equipment $ 2,270 $ 1,877 Technical equipment 2,427 1,806 Facilities 3,387 1,772 Capital projects in progress 1,010 2,183 Total property and equipment $ 9,094 $ 7,638 Accumulated depreciation - other (4,836 ) (2,622 ) Net property and equipment $ 4,258 $ 5,016 Depreciation expense (which includes amortization of capital lease assets) for the years ended December 31, 2016 , 2015 and 2014 , was $2.3 million , $1.8 million and $817,000 , respectively. |
License Agreements and Grants
License Agreements and Grants | 12 Months Ended |
Dec. 31, 2016 | |
Research and Development [Abstract] | |
License Agreements and Grants | NOTE 7. LICENSE AGREEMENTS AND GRANTS Defense Medical Research and Development Program In May 2012, the Company and Denver Health were notified that the Defense Medical Research and Development Program (“DMRDP”) recommended $2.0 million of funding for a proposed 35 -month project. The joint proposal became the sole recipient under the Military Infectious Diseases Applied Research Award program for rapid detection of serious antibiotic-resistant infections. The project applied the Accelerate Pheno™ system to wound infections and other serious infections secondary to trauma. The Company has invoiced a cumulative total of $612,000 under this grant which is recorded as an offset to research and development expenses. The amount invoiced for the years ended December 31, 2016 , 2015 , 2014 was $54,000 , $179,000 , $221,000 , respectively. The period of performance for this grant was complete as of September 30, 2016. National Institute of Health Grant In February 2015, the National Institute of Health awarded Denver Health and the Company a five year, $5.0 million grant to develop a fast and reliable identification and categorical susceptibility test for carbepenem-resistant Enterobacteriaceae directly from whole blood. The Company completed the first subaward agreement with Denver Health for services provided as part of this grant on January 31, 2016. A second subaward was obtained which continued the period of performance through January 31, 2017. The cumulative award amount under these subawards is $818,000 . The amounts invoiced for the years ended December 31, 2016 , 2015 and 2014 , were $74,000 , $483,000 and $0 , respectively. Arizona Commerce Authority In August 2012, the Company entered into a Grant Agreement (the “Grant Agreement”) with the Arizona Commerce Authority, an agency of the State of Arizona (the “Authority”), pursuant to which the Authority provided certain state and county sponsored incentives for the Company to relocate its corporate headquarters to, and expand its business within, the State of Arizona (the “Project”). Pursuant to the Grant Agreement, the Authority agreed to provide a total grant in the amount of $1.0 million (the “Grant”) for the use by the Company in the advancement of the Project. The Grant is payable out of an escrow account in four installments, upon the achievement of the following milestones: • Milestone 1 – Relocation of Company’s operations and corporate headquarters to Arizona and creation of 15 Qualified Jobs (as defined below). • Milestone 2 – Creation of 30 Qualified Jobs (including Qualified Jobs under Milestone 1). • Milestone 3 – Creation of 40 Qualified Jobs (including Qualified Jobs under Milestones 1 and 2). • Milestone 4 – Creation of 65 Qualified Jobs (including Qualified Jobs under Milestones 1, 2 and 3) and capital investment of at least $4.5 million . For purposes of the Grant Agreement, a “Qualified Job” is a job that is permanent, full-time, new to Arizona, and for which the Company pays average (across all Qualified Jobs identified by the Company in its discretion) annual wages of at least $63,000 and offers health insurance benefits and pays at least 65% of the premiums associated with such benefits. The amount of each installment payment will be determined in accordance with a formula specified in the Grant Agreement. The Grant Agreement also contains other customary provisions, including representations, warranties and covenants of both parties. As of December 31, 2016 , the Company has collected all of the $1.0 million in milestones. The full amount is recorded in long-term deferred income until the economic development provisions of the grant have been satisfied in full, as there are “claw-back” provisions which would require repayment of certain amounts received if employment levels are not sustained during the term of the arrangement. Once the “claw-back” provisions expire in January 2018, we will recognize the grant as an offset to expense. Further details are included in Note 8, Deferred Revenue and Income . Arizona R&D Refundable Tax Credit Program The Company has applied for and met the program requirements to receive a “Certificate of Qualification” from the Arizona Commerce Authority (“Authority”) which allows the Company to be eligible for a partial refund of research and development investments ("Arizona R&D Refundable Tax Credit Program"). The amounts collected under this program are recorded as an offset to research and development expenses, and for the years ended December 31, 2016 , 2015 and 2014 , were $1.2 million , $647,000 and $527,000 , respectively. If the amount received for this program is later determined to be incorrect or invalid, the excess may need to be repaid. |
Deferred Revenue and Income
Deferred Revenue and Income | 12 Months Ended |
Dec. 31, 2016 | |
Deferred Revenue Disclosure [Abstract] | |
Deferred Revenue and Income | NOTE 8. DEFERRED REVENUE AND INCOME Deferred revenue consists of amounts received for products or services not yet delivered or earned. Deferred income consists of amounts received for commitments not yet fulfilled. If we anticipate that the revenue or income will not be earned within the following twelve months, the amount is reported as long-term deferred income. A summary of the balances as of December 31, 2016 , and 2015 follows (in thousands): Deferred Revenue and Income (in thousands) 12/31/2016 12/31/2015 Fisher agreement $ — $ 13 Products not yet delivered 35 114 Total current deferred revenue and income $ 35 $ 127 Arizona Commerce Authority grant $ 1,000 $ 1,000 Total long-term deferred income $ 1,000 $ 1,000 Through December 31, 2016 , we received $1.0 million in milestone payments from the Arizona Commerce Authority under the Grant Agreement described in Note 7, License Agreements and Grants . As of December 31, 2016 , no such payments have been recognized in income, and we do not anticipate recognizing such payments as income until the “claw-back” provisions under the Grant Agreement expire in January 2018. The deferred income of $114,000 for products not yet delivered as of December 31, 2015 , was recognized as product revenue for the year ended December 31, 2016 . |
Stock Purchase
Stock Purchase | 12 Months Ended |
Dec. 31, 2016 | |
Securities Financing Transactions Disclosures [Abstract] | |
Stock Purchase | NOTE 9. STOCK PURCHASE In April 2012, we entered into a Securities Purchase Agreement with Abeja Ventures, LLC (“Abeja”), pursuant to which the Company agreed to sell and issue to Abeja at a purchase price of $1.03 per share for an aggregate purchase price of $14.4 million ; (i) 14.0 million shares of the Company’s common stock (“Common Stock”); (ii) a warrant to purchase 7.0 million shares of Common Stock at an exercise price of $1.03 per share (the “ $1.03 " Warrant”); and (iii) another warrant to purchase 7.0 million shares of Common Stock at an exercise price of $2.00 per share (the “ $2.00 " Warrant”), with each warrant exercisable prior to the fifth anniversary of the closing of the transactions contemplated by the Securities Purchase Agreement (collectively, the “Investment”). The purchase of Common Stock and warrants pursuant to the Investment, which was consummated in June, 2012, qualified for equity treatment under U.S. GAAP. The respective values of the warrants and Common Stock were calculated using their relative fair values and both are classified under Contributed Capital. The value therefore recorded for the warrants was $5.9 million and for the Common Stock was $8.5 million . Both warrants are exercisable until June 26, 2017, which was the fifth anniversary of the date on which the warrants were issued. Other significant terms and conditions of the warrants are as follows: • the warrants provide for partial exercises, but they do not provide for a “cashless” exercise feature (i.e., they may only be exercised for cash); • the warrants do not contain anti-dilution provisions that would trigger exercise price or other adjustments as a result of subsequent issuances of the Company’s equity securities, but they do contain customary provisions for equitable adjustments in connection with stock dividends, stock splits or reclassifications of Common Stock; • following certain types of fundamental transactions involving the Company (e.g., a transaction resulting in a change in control of the Company), the holder of the warrants would continue to be entitled to exercise the warrants in exchange for the equity securities or alternate consideration receivable by a holder of Common Stock as a result of the fundamental transaction; and • the holder of the warrants is entitled to certain demand and piggy-back registration rights, including for shelf registrations, with respect to the shares of Common Stock issuable upon its exercise of the warrants. In March 2013, Abeja exercised in full its warrant to purchase 7.0 million shares of Common Stock at an exercise price of $1.03 per share. On the same date, Abeja also exercised the 92% of its warrant to purchase an additional 7.0 million shares of Common Stock at an exercise price of $2.00 per share (Abeja exercised such warrant for 6.4 million shares, leaving 571,160 shares unexercised on that date). The Company received aggregate funds of $20.1 million in connection with such exercises. Shares issued by the Company in connection with the warrant exercises were issued directly to the members of Abeja on a pro rata basis in accordance with their membership interests and written exercise instructions provided to the Company by Abeja. Immediately after giving effect to the warrant exercises, Abeja also distributed in kind to its members (on a pro rata basis in accordance with their membership interests) the remaining shares of Common Stock held by that entity. In September and October 2016, warrants to purchase 155,289 shares were exercised at an exercise price of $2.00 leaving 415,871 warrants for shares unexercised at December 31, 2016 . The Company received funds totaling $311,000 in connection with these exercises which are recorded as common stock and contributed capital in the Consolidated Balance Sheet. |
Public Offering
Public Offering | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Public Offering | NOTE 10. PUBLIC OFFERING On December 9, 2015, the Company published a prospectus supplement underwritten by J.P. Morgan and Piper Jaffray ("Underwriters") offering 5.6 million shares of common stock with an option for the Underwriters to purchase up to 838,000 additional shares of common stock for a total of 6.4 million shares. The public offering price was $17.00 per share and underwriting discounts and commissions were $1.19 per share. Affiliates, including entities affiliated with one of Company's directors, Jack Schuler, and which together are our largest stockholders, purchased 2.9 million of the offered shares at the public offering price of $17.00 per share. These shares were subject to lock-up agreements for a period of 90 days starting December 9, 2015. In general, the lock-up agreement, with limited exceptions, requires J.P. Morgan Securities LLC's prior written approval for the sale (directly or indirectly) of AXDX common stock. This includes various types of sales or offers to sell. The underwriters did not receive any underwriting discount or commissions on the sale of 2.4 million shares to such affiliates. The public offering was finalized and 6.4 million shares of common stock were delivered to the purchasers on or around December 15, 2015. Proceeds from the sale totaled $109.3 million less underwriting and other expenses of $5.9 million for net proceeds of $103.4 million . The net proceeds will be used for general corporate purposes. We may also use a portion of the net proceeds to acquire or invest in complementary businesses, technologies, product candidates or other intellectual property, although we have no present commitments or agreements to do so. Accordingly, we will retain broad discretion over the use of these proceeds. NOTE 11. RIGHTS OFFERING April 2014 Offering On April 7, 2014, the Company commenced a rights offering to raise $45.0 million to fund continued operations, clinical trials, and product commercialization efforts. Under the terms of the rights offering, the Company distributed, at no charge to the holders of its Common Stock as of March 14, 2014, which was established as the record date for the rights offering, 0.063921 non-transferable subscription rights for each share of Common Stock owned on the record date. Each whole subscription right allowed the holder to subscribe to purchase one share of Common Stock at a subscription price of $16.80 per share which was lower than the market price of $17.64 per share on the date of the rights offering commencement and the $17.54 per share on the date the rights offering period expired. In the aggregate, the Company intended to issue 2.7 million shares of Common Stock in connection with the rights offering. The purpose of the rights offering was to raise equity capital in a cost-effective manner that gives all of the Company’s existing stockholders the opportunity to participate on a pro rata basis. In connection with the rights offering, the Company received standby commitments from the Jack W. Schuler Living Trust and the Schuler Family Foundation. The standby purchasers agreed to purchase any and all shares of Common Stock that were not subscribed for by stockholders in connection with the rights offering. On May 1, 2014, the Company entered into an Assignment and Assumption Agreement with the standby purchasers, Oracle Institutional Partners, L.P. and Oracle Partners, L.P., pursuant to which each standby purchaser assigned and transferred its respective rights, responsibilities, liabilities and obligations under the Standby Purchase Agreement to purchase 297,619 shares of Common Stock not subscribed for by the Company’s stockholders in connection with the rights offering to (i) Oracle Institutional Partners, L.P., with respect to 119,047 shares of such Common Stock, and (ii) Oracle Partners, L.P., with respect to the remaining 178,572 shares of such Common Stock. The rights offering period expired on April 28, 2014, and the transactions contemplated by the rights offering and the Standby Purchase Agreement described above (including the Company’s issuance of an aggregate of 2.7 million shares of its Common Stock to the rights offering participants and standby purchasers) were completed on May 19, 2014. The Company received gross proceeds of $45.0 million before costs associated with the transactions which totaled $125,000 and are treated as a reduction of contributed capital in the Stockholders’ Equity section of the Balance Sheets. Because the exercise price of the rights offering of $16.80 was less than the fair value of the Company’s shares of Common Stock at the expiration of the offering, there is a bonus element that is treated similar to a stock dividend. The weighted average shares outstanding, as well as the basic and diluted loss per share for the year ended December 31, 2013, has been revised for those effects. |
Rights Offering
Rights Offering | 12 Months Ended |
Dec. 31, 2016 | |
Warrants and Rights Note Disclosure [Abstract] | |
Rights Offering | NOTE 10. PUBLIC OFFERING On December 9, 2015, the Company published a prospectus supplement underwritten by J.P. Morgan and Piper Jaffray ("Underwriters") offering 5.6 million shares of common stock with an option for the Underwriters to purchase up to 838,000 additional shares of common stock for a total of 6.4 million shares. The public offering price was $17.00 per share and underwriting discounts and commissions were $1.19 per share. Affiliates, including entities affiliated with one of Company's directors, Jack Schuler, and which together are our largest stockholders, purchased 2.9 million of the offered shares at the public offering price of $17.00 per share. These shares were subject to lock-up agreements for a period of 90 days starting December 9, 2015. In general, the lock-up agreement, with limited exceptions, requires J.P. Morgan Securities LLC's prior written approval for the sale (directly or indirectly) of AXDX common stock. This includes various types of sales or offers to sell. The underwriters did not receive any underwriting discount or commissions on the sale of 2.4 million shares to such affiliates. The public offering was finalized and 6.4 million shares of common stock were delivered to the purchasers on or around December 15, 2015. Proceeds from the sale totaled $109.3 million less underwriting and other expenses of $5.9 million for net proceeds of $103.4 million . The net proceeds will be used for general corporate purposes. We may also use a portion of the net proceeds to acquire or invest in complementary businesses, technologies, product candidates or other intellectual property, although we have no present commitments or agreements to do so. Accordingly, we will retain broad discretion over the use of these proceeds. NOTE 11. RIGHTS OFFERING April 2014 Offering On April 7, 2014, the Company commenced a rights offering to raise $45.0 million to fund continued operations, clinical trials, and product commercialization efforts. Under the terms of the rights offering, the Company distributed, at no charge to the holders of its Common Stock as of March 14, 2014, which was established as the record date for the rights offering, 0.063921 non-transferable subscription rights for each share of Common Stock owned on the record date. Each whole subscription right allowed the holder to subscribe to purchase one share of Common Stock at a subscription price of $16.80 per share which was lower than the market price of $17.64 per share on the date of the rights offering commencement and the $17.54 per share on the date the rights offering period expired. In the aggregate, the Company intended to issue 2.7 million shares of Common Stock in connection with the rights offering. The purpose of the rights offering was to raise equity capital in a cost-effective manner that gives all of the Company’s existing stockholders the opportunity to participate on a pro rata basis. In connection with the rights offering, the Company received standby commitments from the Jack W. Schuler Living Trust and the Schuler Family Foundation. The standby purchasers agreed to purchase any and all shares of Common Stock that were not subscribed for by stockholders in connection with the rights offering. On May 1, 2014, the Company entered into an Assignment and Assumption Agreement with the standby purchasers, Oracle Institutional Partners, L.P. and Oracle Partners, L.P., pursuant to which each standby purchaser assigned and transferred its respective rights, responsibilities, liabilities and obligations under the Standby Purchase Agreement to purchase 297,619 shares of Common Stock not subscribed for by the Company’s stockholders in connection with the rights offering to (i) Oracle Institutional Partners, L.P., with respect to 119,047 shares of such Common Stock, and (ii) Oracle Partners, L.P., with respect to the remaining 178,572 shares of such Common Stock. The rights offering period expired on April 28, 2014, and the transactions contemplated by the rights offering and the Standby Purchase Agreement described above (including the Company’s issuance of an aggregate of 2.7 million shares of its Common Stock to the rights offering participants and standby purchasers) were completed on May 19, 2014. The Company received gross proceeds of $45.0 million before costs associated with the transactions which totaled $125,000 and are treated as a reduction of contributed capital in the Stockholders’ Equity section of the Balance Sheets. Because the exercise price of the rights offering of $16.80 was less than the fair value of the Company’s shares of Common Stock at the expiration of the offering, there is a bonus element that is treated similar to a stock dividend. The weighted average shares outstanding, as well as the basic and diluted loss per share for the year ended December 31, 2013, has been revised for those effects. |
Related Party Transaction
Related Party Transaction | 12 Months Ended |
Dec. 31, 2016 | |
Related Party Transactions [Abstract] | |
Related Party Transaction | NOTE 12. RELATED PARTY TRANSACTION In June 2016 , the Company recorded a net amount of $866,000 related to the recovery of short-swing profits under Section 16(b) of the Securities Exchange Act of 1934, as amended. The Company recognized these related party proceeds as an increase to contributed capital on the consolidated balance sheet. |
Earnings Per Share
Earnings Per Share | 12 Months Ended |
Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |
Earnings Per Share | NOTE 13. EARNINGS PER SHARE The financial statements show basic earnings (loss) per share. The Company’s net loss for the periods presented caused the inclusion of all outstanding warrants, restricted stocks and options to purchase our Common Stock to be antidilutive. As of December 31, 2016 , 2015 and 2014 , there were Common Stock options, restricted stocks and warrants exercisable for 7,313,245 , 6,778,580 and 6,174,886 shares of Common Stock, respectively, which were not included in diluted loss per share as the effect was antidilutive. |
Employee and Consultant Equity-
Employee and Consultant Equity-Based Compensation | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Employee and Consultant Equity-Based Compensation | NOTE 14. EMPLOYEE AND CONSULTANT EQUITY-BASED COMPENSATION The Company has three stock option equity-based compensation plans, which are discussed below: Non-Qualified Stock Option Plan The Non-Qualified Stock Option Plan (the “Non-Qualified Plan”) was a stockholder-approved plan that provided for stock option grants to independent contractors, technical advisors and directors of the Company. The exercise price of each option, which has a maximum 10 year life, was established by the Company's Compensation Committee on the date of grant. As of December 31, 2016 , there were 273,900 options exercised under the Non-Qualified Plan and 6,100 that remain outstanding. The Non-Qualified Plan has been replaced by the 2012 Omnibus Equity Incentive Plan, so no further options are available for grant. 2004 Omnibus Stock Option Plan In December 2004, the Company’s stockholders approved the Omnibus Stock Option Plan and reserved 500,000 shares of its authorized but unissued Common Stock for stock options to be granted to employees, independent contractors, technical advisors and directors of the Company. The authorized shares in this plan were increased by 5,000,000 shares to an aggregate amount of 5,500,000 upon stockholder approval during the fiscal year ended July 31, 2012. As of December 31, 2016 , there were 428,907 options exercised under the 2004 Omnibus Stock Option Plan and 3,511,093 that remain outstanding. The 2004 Omnibus Stock Option Plan has been replaced by the 2012 Omnibus Equity Incentive Plan, so no further options are available for grant. 2012 Omnibus Equity Incentive Plan In December 2012, the Company’s stockholders approved the Company’s 2012 Omnibus Equity Incentive Plan to replace all prior plans ("Prior Plans"). The Prior Plans remain in effect until all awards granted under those plans have been exercised, forfeited, canceled, expired or otherwise terminated. In connection with the approval of such plan, all stock options, totaling 1,677,500 formerly available for new awards under the Prior Plans were transferred to the 2012 Omnibus Equity Incentive Plan. At the Company’s 2014 Annual Meeting of Stockholders held in May 2014, stockholders approved an amendment to the Company’s 2012 Omnibus Equity Incentive Plan increasing the number of stock options of Common Stock reserved and available for grant by 4,000,000 to 5,677,500 shares. Stock options granted under this plan typically vest either (i) one year after grant date, (ii) monthly over a one year period, (iii) annually over a five year period, or (iv) 40% two years after grant date and the remaining 60% monthly over the next three years. The maximum term is ten years. As of December 31, 2016 , there were 200,557 options exercised under the 2012 Omnibus Equity Incentive Plan and 3,380,181 that remain outstanding, leaving 2,096,762 available for grant. In December 2015, the Board of Directors voted to restrict new grants under the 2012 Omnibus Equity Incentive Plan to 200,000 shares until such time as the Company’s total available shares are increased. The Company's total available shares were increased in March 2016 terminating the restriction of new grants. Combined Stock Option Plans The following table summarizes option activity under all plans during the years ending December 31, 2016 , and December 31, 2015 and shows the exercisable shares as of December 31, 2016 : Stock Option Activity Number of Shares Weighted Average Exercise Price per Share Options Outstanding January 1, 2015 5,628,726 $ 5.20 Granted 717,833 20.59 Forfeited (54,505 ) 11.71 Exercised (124,884 ) 6.44 Expired — — Options Outstanding December 31, 2015 6,167,170 6.91 Granted 1,024,050 14.05 Forfeited (147,663 ) 18.43 Exercised (158,743 ) 7.47 Expired (27,690 ) 4.87 Options Outstanding December 31, 2016 6,857,124 7.72 Exercisable December 31, 2016 4,566,005 4.94 The cash received from the exercise of options during the year ending December 31, 2016 , was $1.2 million and the tax benefit realized was $0 for the same period. Upon exercise, shares are issued from shares authorized and held in reserve. The intrinsic value of options exercised was $2.2 million , $2.0 million and $3.8 million for the years ending December 31, 2016 , 2015 and 2014 , respectively. The total fair value of shares vesting during the period was $6.6 million , $7.3 million , and $3.8 million for the years ending December 31, 2016 , 2015 and 2014 , respectively. As discussed in Note 2, Summary of Significant Accounting Policies , the Company accounts for all option grants using the Black-Scholes option pricing model in accordance with ASC 718 for options granted or extended. Note 2 also describes the significant assumptions utilized for estimating the various inputs required this pricing model. The table below summarizes the resulting weighted average inputs used to calculate the estimated fair value of options awarded for during the periods shown below: Black-Scholes Assumptions for Option Granted 12 months 12 months 12 months 12/31/2016 12/31/2015 12/31/2014 Expected term (in years) 6.43 6.26 6.25 Volatility 86 % 91 % 96 % Expected dividends — — — Risk free interest rates 1.6 % 1.7 % 1.9 % Estimated forfeitures 8.5 % 5.6 % 0.4 % Weighted average fair value $ 10.35 $ 16.69 $ 12.63 In general, option awards have a requisite service period and unvested options are forfeited upon employee or consultant termination. The Company estimates a forfeiture rate which is applied to outstanding options to determine options expected to be forfeited with the remaining outstanding options being those expected to vest. Further information regarding the forfeiture rate calculation is included in Note 2, Summary of Significant Accounting Policies . The following table shows summary information for outstanding options, options that are exercisable (vested) and outstanding options that are either vested or expected to vest as of December 31, 2016 : Stock Option Supplemental Information Options Outstanding Options Exercisable Options Vested and Expected to Vest Number of options 6,857,124 4,566,005 6,711,021 Weighted average remaining contractual term (in years) 6.57 5.83 6.52 Weighted average exercise price $ 7.72 $ 4.94 $ 7.55 Weighted average fair value $ 5.95 $ 3.72 $ 5.82 Aggregate intrinsic value (in millions) $ 82.0 $ 70.4 $ 81.6 The aggregate intrinsic value in the table above represents the total pretax intrinsic value that would have been received by the option holders had all option holders exercised their options on that date. It is calculated as the difference between the Company’s closing stock price of $20.75 on the last trading day of 2016 and the exercise price multiplied by the number of shares for options where the exercise price is below the closing stock price. This amount changes based on the fair market value of the Company’s stock. In December 2015, in connection with the Company's public offering, we modified the stock options of three of our executive officers to restrict the ability to exercise until such time as additional available unissued shares have been authorized. Such authorization was obtained from a majority of our shareholders as of December 31, 2015, and was filed with the State of Delaware in March 2016. There was an immaterial amount of incremental compensation associated with this modification. The following table summarizes restricted stock unit activity during the years ending December 31, 2016 , and December 31, 2015 : Restricted Stock Unit (RSU) Activity Number of Shares Weighted Average Grant Date Fair Value per Share RSU's outstanding January 1, 2015 — — Granted 40,250 20.91 Forfeited — — Vested/released — — RSU's outstanding December 31, 2015 40,250 20.91 Granted — — Forfeited — — Vested/released — — RSU's outstanding December 31, 2016 40,250 20.91 The expense and tax benefits recognized on Company’s Statements of Operations and Comprehensive Loss related to options is summarized below (in thousands): Equity-Based Compensation Expenses and Tax Benefit (in thousands) 12 months 12 months 12 months 12/31/2016 12/31/2015 12/31/2014 Research and development $ 1,585 $ 2,479 $ 4,334 Sales, general and administrative 7,190 5,909 5,290 Equity-based compensation expense 8,775 8,388 9,624 Recognized tax benefit $ — $ — $ — As of December 31, 2016 , unrecognized equity-based compensation cost related to unvested stock options and unvested restricted stock was $10.3 million . This is expected to be recognized over the years 2017 through 2021 . Employee Stock Purchase Plan In May 2016, the Company's stockholders approved the Company's 2016 Employee Stock Purchase Plan ("ESPP") which permits eligible employees to purchase common stock at a discount through payroll deductions. Eligible employees include employees of the Company and subsidiaries as designated by the Compensation Committee of the Board ("Committee") who (i) are employed more than twenty hours per week and (ii) are not owners of 5% or more of the total combined voting power or value of Company stock including the ESPP stock. In addition, the Committee has the discretion to exclude highly compensated employees. Eligible employees enroll in the ESPP and can contribute between 2% and 15% of compensation up to a maximum of $25,000 of the fair market value of shares for each calendar year. The payroll deductions are accumulated during each offering period. Generally, each offering period will be for a period of three months as determined by the Committee provided that no offering period may extend more than 27 months. On the last trading day of the offering period, the accumulated payroll deductions for each employee are used to purchase as many shares of stock as possible up to a maximum of 100,000 shares or as otherwise determined by the Committee. The price at which stock is purchased is equal to 90% of closing price for the common stock on the date of the purchase. A total of 500,000 shares of the Company’s common stock are reserved for issuance under the ESPP. As of December 31, 2016 , 11,093 shares were issued and 488,907 shares of common stock are available for issuance. As the ESPP is not a compensatory plan as defined by the authoritative guidance for stock compensation, there is no stock-based compensation expense recorded related to the ESPP. See Note 2, Summary of Significant Accounting Policies for further information. A summary of ESPP activity for the year ended December 31, 2016 is as follows: Shares issued 11,093 Weighted average fair value 20.40 Employee purchases (in thousands) 226 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | NOTE 15. INCOME TAXES The components of the pretax loss from operations for the years ended December 31, 2016 , 2015 and 2014 , are as follows (in thousands): Components of the Pretax Loss From Operations (in thousands) 12/31/2016 12/31/2015 12/31/2014 U.S. Domestic $ (48,539 ) $ (44,415 ) $ (30,933 ) Foreign (17,568 ) (1,083 ) — Pretax loss from operations $ (66,107 ) $ (45,498 ) $ (30,933 ) The components of the provision for income taxes is presented in the following table: Provision for Income Taxes (in thousands) 12/31/2016 12/31/2015 12/31/2014 Current: Federal $ — $ — $ — State — — — Foreign 267 — — Total current provision 267 — — Deferred: Federal — — — State — — — Foreign — — — Total deferred provision — — — Total provision $ 267 $ — $ — Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s net deferred income taxes for the years ended December 31, 2016 , and 2015 , are as follows (in thousands): Deferred Income Tax Components (in thousands) 12/31/2016 12/31/2015 Deferred tax assets: Net operating loss carryforward $ 42,013 $ 28,584 Property & equipment 690 339 Inventory 1,735 864 Stock options 7,208 5,208 Intangible assets, definite-lived 220 333 General business credit 3,984 1,915 Deferred revenue 370 372 Other 121 205 Valuation allowance (56,341 ) (37,820 ) Deferred tax assets $ — $ — As of December 31, 2016 , the Company has generated regular tax federal net operating losses of approximately $125.1 million . The Company's ability to realize tax benefit from the net operating loss is subject to annual limitation under Internal Revenue Code Section 382. Due to the change in control which occurred as a result of Abeja Ventures, LLC’s investment in the Company on June 26, 2012, the Company estimates that the annual Section 382 limitation on utilization of net operating losses generated prior to the transaction will be $420,000 . As such, the Company will never get the benefit of $4.2 million of the net operating losses generated prior to June 26, 2012. The deferred tax asset has been adjusted to reflect the Section 382 limitation. Section 382 also applies to built-in losses at the time of the transaction. The amounts of any unrealized built-in losses or gains were not calculated at the date of the transaction. The net operating losses available for future use are approximately $120.9 million . For federal purposes, net operating losses can be carried forward for up to 20 years. The Company’s federal net operating losses will begin to expire in 2023. The Company relocated its headquarters to Arizona in January 2013. As of December 31, 2016 , the Company has generated Arizona net operating losses of approximately $102.5 million . The Company's Arizona net operating losses will begin to expire in 2033. The net deferred tax asset valuation allowance is $56.3 million as of December 31, 2016 , compared to $37.8 million as of December 31, 2015 . The valuation allowance is based on management’s assessment that it is more likely than not that the Company will not have taxable income in the foreseeable future. Under current GAAP, in a classified statement of financial position, deferred tax assets and liabilities are separated into current amounts and a non-current amounts on the basis of the classification of the related assets or liabilities for financial reporting. Deferred tax assets and liabilities that are not related to an asset or liability for financial reporting are classified according to the expected reversal date of the temporary difference. On November 20, 2015, the FASB issued Accounting Standards Update 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes which requires noncurrent classification of all deferred tax assets and liabilities for all public entities for annual periods beginning after December 15, 2016. Accounting Standards Update 2015-17 also provides for early adoption for all entities as of the beginning of an annual period. For the year ended December 31, 2015, the Company elected to early adopt Accounting Standards Update 2015-17 and presents all of its deferred tax assets and liabilities as non-current for the periods ended December 31, 2016 , and 2015 . The Company has applied the Standard on a prospective basis. Therefore, the classification of deferred tax assets and liabilities in periods prior to the period ended December 31, 2015 have not been changed from the original presentation. The Company began commercialization of its products in Europe in 2016 and has subsidiaries in the Netherlands, France, Germany, Italy, Spain and the United Kingdom. The Company intends to treat earnings from its foreign subsidiaries as permanently reinvested. As of December 31, 2016 , there would be no US tax effect of a repatriation of the earnings of its foreign subsidiaries, due to the Company’s loss position. The difference between the U.S. federal statutory income tax rate and the Company’s effective tax rate for years ending December 31, 2016 , 2015 and 2014 , is as follows: Effective Tax Rate 12/31/2016 12/31/2015 12/31/2014 U.S. federal statutory income tax rate (34.00 )% (34.00 )% (34.00 )% State taxes, net of federal tax benefit (1.69 ) (2.93 ) (3.20 ) Permanent and other differences (0.17 ) 0.11 — Change in tax rates 0.67 — — Tax rate differential 8.62 0.42 — Unrecognized tax benefits 1.09 0.40 — Nondeductible equity and other compensation 1.17 2.86 3.70 Limitation on net operating losses due to §382 — — 0.50 Credit for increased research activities (3.31 ) (2.67 ) (0.80 ) Change in Valuation allowance 28.02 35.81 33.80 0.40 % — % — % At December 31, 2016 , the Company had uncertain tax positions of $1.1 million , determined as follows (in thousands): Uncertain Tax Positions (in thousands) 12/31/2016 12/31/2015 12/31/2014 Balance at beginning of year $ 343 $ 161 $ — Increases for prior positions 37 — 78 Increases for current year positions 721 182 83 Other Increases — — — Decreases due to settlements — — — Expiration of the statute of limitations for the assessment of taxes — — — Other Decreases — — — Balance at end of year $ 1,101 $ 343 $ 161 These uncertain positions are not expected to change within the next twelve months. Of the $1.1 million of uncertain tax positions, $57,000 would impact the effective tax rate, if reversed. The Company accounts for interest on uncertain tax positions within tax expense. The Company's foreign subsidiaries are subject to applicable jurisdiction examination for all years of operations. The Company did not accrue interest or penalties for these uncertain tax positions as of December 31, 2016 . The Company has incurred federal net operating losses dating to the tax year ended July 31, 2004. As such, all loss carryovers are subject to adjustment under IRS and state examination, depending on the jurisdiction in which they were incurred. In 2016, the IRS began an examination of the Company’s 2014 income tax return. Management does not believe the examination will result in a material change to its tax position. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | NOTE 16. COMMITMENTS Leases The Company has entered into lease agreements, lease amendments, and lease extensions ("Lease Agreements") for office, laboratory and manufacturing space located in Tucson, Arizona and Europe, the last of which expires in 2018. Total rent expense including common area charges was $1.1 million , $685,000 and $293,000 for the years ended December 31, 2016 , 2015 and 2014 , respectively. Future minimum lease payments under this agreement are as follows (in thousands): Operating Lease Obligations (in thousands) Year ending December 31: 2017 $ 1,004 2018 79 2019 — 2020 — Thereafter — Total operating lease obligations $ 1,083 Clinical Trial Agreements The Company has entered into master agreements with clinical trial sites in which we typically pay a set amount for start-up costs and then pay for work performed. These agreements typically indemnify the clinical trial sites from any and all losses arising from third party claims as a result of the Company's negligence, willful misconduct or misrepresentation. Clinical trial master agreement expense was $2.1 million and $1.6 million for years ended December 31, 2016 , and 2015 , respectively. No amounts were incurred for these arrangements through December 31, 2014. The expense incurred as part of the clinical trial is included in research and development on the consolidated statements of operations and comprehensive loss. Marketing Study Agreements The Company has entered into marketing study agreements with research institutions and hospitals in which we typically pay a set amount for start-up costs and then pay for work performed. These agreements typically indemnify the sites from any and all losses arising from third party claims as a result of the Company's negligence, willful misconduct or misrepresentation. Marketing study agreement expense was $233,000 and $66,000 for years ended December 31, 2016 , and 2015 , respectively. No amounts were incurred for these arrangements through December 31, 2014. The expense incurred as part of these studies is included in sales, general and administrative on the consolidated statements of operations and comprehensive loss. Legal Matters On March 19, 2015, a putative securities class action lawsuit was filed against Accelerate Diagnostics, Inc., Lawrence Mehren, and Steve Reichling, and is captioned as Rapp v. Accelerate Diagnostics, Inc., et al. , U.S. District Court, District of Arizona, 2:2015-cv-00504. The complaint alleges that we violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and SEC Rule 10b-5, by making false or misleading statements about our Accelerate Pheno™ system, formerly called the BACcel System. Plaintiff purports to bring the action on behalf of a class of persons who purchased or otherwise acquired our stock between March 7, 2014, and February 17, 2015. On June 9, 2015, Julia Chang was appointed Lead Plaintiff of the purported class. On June 23, 2015, Plaintiff filed an amended complaint alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5, by making false or misleading statements or omissions about our Accelerate Pheno™ system and by allegedly employing schemes to defraud. Plaintiff sought certification of the action as a class action, compensatory damages for the class in an unspecified amount, legal fees and costs, and such other relief as the court may order. Defendants moved to dismiss the amended complaint on July 21, 2015. The Court granted the motion and dismissed the case with prejudice on January 28, 2016. On February 26, 2016, Plaintiff filed a notice of appeal with the United States Court of Appeals for the Ninth Circuit, which challenges the dismissal of the amended complaint. See Chang v. Accelerate Diagnostics, Inc., et al. , No. 2:15-CV-00504-SPL (9th Cir. filed Feb. 26, 2016). The appeal has been fully briefed and is pending. See Item 8, Note 18, Subsequent Events for an update on this lawsuit. We do not anticipate this will have a material impact on our financial statements. |
Segments
Segments | 12 Months Ended |
Dec. 31, 2016 | |
Segment Reporting [Abstract] | |
Segments | NOTE 17. SEGMENTS The Company operates as one operating segment. Operating segments are defined as components of an enterprise for which separate financial information is evaluated regularly by the chief operating decision maker, who is the chief executive officer, in deciding how to allocate resources and assessing performance. The Company’s business operates in one operating segment because the Company’s chief operating decision maker evaluates the Company’s financial information and resources and assesses the performance of these resources on a consolidated basis. Since the Company operates in one operating segment, all required financial segment information can be found in the consolidated financial statements. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Events | NOTE 18. SUBSEQUENT EVENTS FDA Clearance On February 23, 2017, the U.S. Food and Drug Administration granted Accelerate's de novo request to market the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit for identification and antibiotic susceptibility testing of pathogens directly from positive blood culture samples. Legal Matters As described in Item 8, Note 16, Commitments , Legal Matters, on February 26, 2016, Plaintiff filed a notice of appeal with the United States Court of Appeals for the Ninth Circuit, which challenges the dismissal of the amended complaint. See Chang v. Accelerate Diagnostics, Inc., et al. , No. 2:15-CV-00504-SPL (9th Cir. filed Feb. 26, 2016). The appeal has been fully briefed and is pending. On January 27, 2017, the appellate Court informed the Company that this case is being considered for oral argument, possibly as early as May 2017, although the exact date has not yet been set. We do not anticipate this will have a material impact on our financial statements. |
Supplemental Data Quarterly Fin
Supplemental Data Quarterly Financial Information | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Supplemental Quarterly Financial Information | NOTE 19. SUPPLEMENTAL DATA QUARTERLY FINANCIAL INFORMATION (UNAUDITED) QUARTERLY FINANCIAL INFORMATION (in thousands, except per share data) Unaudited For the quarters ending: 12/31/2016 9/30/2016 6/30/2016 3/31/2016 12/31/2015 9/30/2015 6/30/2015 3/31/2015 Revenue $ 39 $ 24 $ 20 $ 163 $ 22 $ 92 $ 19 $ 14 Net loss (16,135 ) (17,299 ) (17,866 ) (15,074 ) (13,163 ) (11,186 ) (12,252 ) (8,897 ) Basic and diluted net loss per share (0.31 ) (0.34 ) (0.35 ) (0.29 ) (0.29 ) (0.25 ) (0.27 ) (0.20 ) |
Summary of Significant Accoun26
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, (“U.S. GAAP”), and applicable rules and regulations of the United States Securities and Exchange Commission (“SEC”), regarding annual financial reporting. All amounts are rounded to the nearest thousand dollars unless otherwise indicated. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries after elimination of intercompany transactions and balances. |
Reclassification | Reclassification Certain prior year amounts have been reclassified for consistency with the current year presentation and had no effect on our net income, stockholders' equity or cash flows. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Estimated Fair Value of Financial Instruments | Estimated Fair Value of Financial Instruments The Company follows ASC Topic 820, Fair Value Measurements and Disclosures which has defined fair value and requires the Company to establish a framework for measuring fair value and disclose fair value measurements. The framework requires the valuation of assets and liabilities subject to fair value measurements using a three tiered approach and fair value measurement be classified and disclosed in one of the following three categories: • Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; • Level 2: Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs that are observable, either directly or indirectly, for substantially the full term of the asset or liability; • Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e. supported by little or no market activity). The carrying amounts of financial instruments such as cash and cash equivalents, trade accounts receivable, prepaid expenses, accounts payable, accrued liabilities, and other current liabilities approximate the related fair values due to the short-term maturities of these instruments. |
Cash and Cash Equivalents | Cash and Cash Equivalents All highly liquid investments with an original maturity of three months or less at time of purchase are considered to be cash equivalents. Cash and cash equivalents include overnight repurchase agreement accounts and other investments. As part of our cash management process, excess operating cash is invested in overnight repurchase agreements with our bank. Repurchase agreements and other investments classified as cash and cash equivalents are not deposits and are not insured by the U.S. Government, the FDIC or any other government agency and involve investment risk including possible loss of principal. We believe however, that the market risk arising from holding these financial instruments is minimal. |
Investments | Investments The Company invests excess funds in various investments which are primarily held in the custody of major financial institutions. Investments consist of debt securities in U.S. government and agency securities, corporate debt securities, certificates of deposit, and commercial paper. Management classifies its investments as available-for-sale investments and records these investments in the consolidated balance sheet at fair value. The Company considers all available-for-sale securities, including those with maturity dates beyond 12 months, as available to support current operational liquidity needs. Unrealized gains or losses for available-for-sale securities are included in accumulated other comprehensive income or loss, a component of stockholders’ equity. The Company classifies its investments as current based on the nature of the investments and their availability for use in current operations. The Company assesses whether an other-than-temporary impairment loss has occurred due to declines in fair value or other market conditions when an investment’s fair value remains less than its cost for more than twelve months. This assessment includes a determination of whether the investment is expected to recover in value and whether the Company has the intent and ability to hold the investment until the anticipated recovery in value occurs. When an investment is identified as having an other-than-temporary impairment loss, we adjust the cost basis of the investment down to fair value resulting in a realized loss. The new cost basis is not changed for subsequent recoveries in fair value and temporary future increases or decreases in fair value are included in other comprehensive income. |
Inventory | Inventory The Company currently purchases and produces inventory prior to U.S. Food and Drug Administration (“FDA”) or other regulatory agency approval. We do not believe probable future economic benefit can be asserted prior to the de novo request being granted by the U.S. FDA unless the regulatory review process has progressed to a point that objective and persuasive evidence of regulatory approval is sufficiently probable ("Regulatory Approval"). Accordingly, the Company does not capitalize pre-launch inventory prior to Regulatory Approval and future economic benefit can be asserted. Costs associated with the Company’s purchase of inventory are either reported as research and development costs, or if the inventory is used in marketing evaluations, as sales, general and administrative costs on the consolidated statements of operations and comprehensive loss. |
Accounts Receivable Allowances | Accounts Receivable Allowances Allowances on accounts receivable are recorded when circumstances indicate collection is doubtful for a particular accounts receivable. Receivables are written off if reasonable collection efforts prove unsuccessful. The Company provides for allowances on a specific account basis. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost. Maintenance and repairs are charged to expense as incurred and expenditures for major improvements are capitalized. Gains and losses from retirement or replacement are included in costs and expenses. Depreciation of property and equipment is computed using the straight-line method over the estimated useful life of the assets, ranging from one to seven years. Leasehold improvements are depreciated over the remaining life of the lease or the life of the asset, whichever is less. |
Long-lived Assets | Long-lived Assets Long-lived assets and certain identifiable intangibles to be held and used by the Company are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company continuously evaluates the recoverability of its long-lived assets based on estimated future cash flows from and the estimated fair value of such long-lived assets, and provides for impairment if such undiscounted cash flows or the estimated fair value are insufficient to recover the carrying amount of the long-lived asset. |
Warranty Reserve | Warranty Reserve A limited warranty of a year or less is covered under selected contracts. Accordingly, a provision for the estimated cost of the limited warranty repair is recorded at the time revenue is recognized. Our estimated warranty provision is based on our estimate of future repair events and the related estimated cost of repairs. We periodically assess the adequacy of the warranty reserve and adjust the amount as necessary. The expense incurred for these provisions is included in sales, general and administrative on the consolidated statements of operations and comprehensive loss. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with ASC 605, “Revenue Recognition,” when persuasive evidence of an arrangement exists, the price is fixed or determinable, collection is reasonably assured and delivery of products has occurred or services have been rendered. Additional considerations include whether the applicable fee arrangement contains future delivery or performance obligations that should be divided into separate accounting units, whether the arrangement requires the Company to retain risks consistent with a collaborative arrangement, and/or whether any of the fees are contingent on the achievement of future milestones. Product revenue is derived from the sale or rental of our instruments and sales of related consumable products. When an instrument is sold, revenue is generally recognized upon installation of the unit consistent with contract terms, which do not include a right of return. When a consumable product is sold, revenue is generally recognized upon shipment. We also provide instruments to customers under bundled rental agreements. Under these agreements, we install the instrument in the customer's facility and provide service and training without a fee. The customer agrees to purchase consumable products at a stated price over the term of the agreement which varies but is under seven years. Contracts sometimes have renewal clauses but such clauses do not provide for a bargain renewal option or penalize the customer if they don't renew. The instrument remains our property throughout the term of the agreement and there is no transfer of title upon expiration. Revenue is recognized as consumable products are shipped or delivered, depending on contract terms. Deferred revenue represents amounts received but not yet earned under existing agreements. |
Leases | Leases The Company accounts for leases in accordance with ASC 840, Leases, which requires leases to be classified as either operating or capital leases. In general, the Company classifies leases as capital leases when there is either a transfer of ownership at the end of the lease term, the lease contains a bargain purchase option, the lease term is seventy-five percent or more of the estimated economic life of the leased property or the minimum lease payments are ninety percent or more of the fair value at lease inception. Other leases are classified as operating leases. Operating lease rent is recorded as an operating expense monthly. For capital leases, both an asset and liability are recorded at the inception of the lease based on the present value of lease payments. The asset is included with property and equipment on the Balance Sheet and amortization is recorded on a straight-line basis over the term of the lease with the amortization expense included with depreciation on the Statements of Operations and Comprehensive Loss. For the liability, the amount due within the next year is recorded as capital lease obligations and the amount due in more than a year is recorded as long-term capital lease obligation on the Balance Sheet. Interest expense is recorded based on the implicit or explicit interest rate used in the lease and is included as non-operating interest expense on the Statements of Operations and Comprehensive Loss. |
Equity-Based Compensation | Equity-Based Compensation The Company awards stock options and other equity-based instruments to its employees, directors and consultants. Compensation cost related to equity-based instruments is based on the fair value of the instrument on the grant date, and is recognized over the requisite service period on a straight-line basis over the vesting period for each tranche (an accelerated attribution method). For unvested consultant grants, the assumptions are updated at the end of each reporting period until the grant is vested. The Company estimates the fair value of stock option awards, including modifications of stock option awards, using the Black-Scholes option pricing model. This model derives the fair value of stock options based on certain assumptions related to expected stock price volatility, expected option life, risk-free interest rate and dividend yield. • Volatility: The expected volatility is based on the historical volatility of the Company's stock price over the most recent period commensurate with the expected term of the stock option award. • Expected term: The estimated expected term for employee awards is based on the calculation published by the SEC in SAB110 for use when there is not a sufficient history of employee exercise patterns. For consultant awards, the estimated expected term is the same as the life of the award. • Risk-free interest rate: The risk-free interest rate is based on published U.S. Treasury rates for a term commensurate with the expected term. • Dividend yield: The dividend yield is estimated as zero as the Company has not paid dividends in the past and does not have any plans to pay any dividends in the foreseeable future. The Company estimates the forfeiture rate of unvested awards based on the forfeitures in the previous twelve-month period. The rate is calculated separately for awards to the board of directors/executives and all other awards. The Company also has an employee stock purchase program whereby eligible employees can elect payroll deductions that are subsequently used to purchase common stock at a discounted price. There is no compensation recorded for this program as (i) the purchase discount does not exceed the issuance costs that would have been incurred to raise a significant amount of capital by a public offering, (ii) substantially all employees that meet limited employment qualifications may participate on an equitable basis, and (iii) the plan doesn't incorporate option features that would require compensation to be recorded. |
Income Taxes and Deferred Tax Assets | Income Taxes and Deferred Tax Assets Deferred tax assets and liabilities are recorded for the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the accompanying balance sheets. The change in deferred tax assets and liabilities for the period represents the deferred tax provision or benefit for the period. Effects of changes in enacted tax laws in deferred tax assets and liabilities are reflected as an adjustment to the tax provision or benefit in the period of enactment. The Company follows the provisions of ASC 740, Income Taxes , to account for any uncertainty in income taxes with respect to the accounting for all tax positions taken (or expected to be taken) on any income tax return. This guidance applies to all open tax periods in all tax jurisdictions in which the Company is required to file an income tax return. Under U.S. GAAP, in order to recognize an uncertain tax benefit the taxpayer must be more likely than not certain of sustaining the position, and the measurement of the benefit is calculated as the largest amount that is more than 50% likely to be realized upon resolution of the position. Interest and penalties, if any, would be recorded as tax expense in general and administrative expenses. |
Foreign Currency Translation and Foreign Currency Transactions | Foreign Currency Translation and Foreign Currency Transactions The Company follows ASC 830 Foreign Currency Matters , which provides guidance on foreign currency transactions and translation of financial statements. Adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars are included in the foreign currency translation adjustment, a component of accumulated other comprehensive income (loss) in the consolidated statements of stockholder's equity. The Company has assets and liabilities, including receivables and payables, which are denominated in currencies other than their functional currency. These balance sheet items are subject to re-measurement, the impact of which is recorded in interest expense and other, within the consolidated statement of operations and comprehensive loss. |
Earnings Per Share | Earnings Per Share The Company follows ASC 260, Earnings Per Share , which requires companies to present basic earnings per share and diluted earnings per share. Basic earnings (loss) per share includes no dilution and is computed by dividing income (loss) available to common stockholders by the weighted average number of common shares outstanding for the period. Diluted earnings per share are computed similarly to basic earnings (loss) per share except the denominator includes additional common shares that would have been outstanding if warrants and share-based payments had been issued. Diluted earnings are not presented when the effect of adding such additional common shares is antidilutive. Earnings per share are restated when certain transactions or events, including rights offerings determined to have bonus elements have occurred. |
Comprehensive loss | Comprehensive Loss The Company follows ASC 220, Reporting Comprehensive Income , which establishes standards for reporting and displaying comprehensive income (loss) and its components (revenues, expenses, gains and losses) in a full set of general-purpose financial statements. The Company holds investments classified as available-for-sale securities and records the change in fair market value as a component of comprehensive income (loss). The Company also has adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars which is included as a component of comprehensive income (loss). |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments-Credit Losses (Topic 326) Measurement of Credit Losses on Financial Instruments, which amends the guidance on measuring credit losses on financial assets (including trade accounts receivable and available for sale debt securities) held at amortized cost. Currently, an “incurred loss” methodology is used for recognizing credit losses which delays recognition until it is probable a loss has been incurred. The amendment requires assets valued at amortized cost to be presented at the net amount expected to be collected using an allowance for credit losses. Reversal of credit losses on available for sale debt securities will be recorded in the current period net income. The amendment will be effective for us on January 1, 2020, with early adoption permitted. We do not anticipate this guidance will have a significant impact on our financial statements and plan to adopt on the effective date. In March 2016, the FASB issued ASU 2016-09, Compensation-Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting. This guidance requires the recognition of the income tax effects of awards in the income statement when the awards vest or are settled, thus eliminating additional paid in capital pools. The guidance also allows for the employer to repurchase more of an employee’s shares for tax withholding purposes without triggering liability accounting. In addition, the guidance allows for a policy election to account for forfeitures as they occur rather than on an estimated basis. We will implement this guidance on January 1, 2017, effective date and have elected to account for forfeitures as they occur. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). This replaces the existing standards relating to leases for both lessees and lessors. For lessees, the new standard requires most leases to be recorded on the balance sheet with expenses recognized much like the existing standard. For lessors, the new standard modifies the classification criteria and accounting for sales-type and direct financing leases and eliminates leveraged leases. For both lessees and lessors, the standard eliminates real estate-specific provisions, changes some of the presentation and disclosure requirements, and changes sale and leaseback criteria. The ASU is required for us on January 1, 2019, with early adoption permitted. We are currently assessing the impact this will have on our consolidated financial statements and the timing of adoption. In January, 2016, the FASB issued ASU 2016-01, Financial Instruments - Overall. This standard requires equity investments, with some exceptions, be measured at fair value with valuation changes recognized in net income, simplifies the impairment assessment of some equity investments, eliminates the requirement to disclose the methods and significant assumptions used to estimate the fair value for financial instruments measured at amortized cost, requires the use of the exit price notion when measuring the fair value of financial instruments, requires separate presentation of some changes in other comprehensive income, requires separate presentation of financial assets and financial liabilities by measurement category and form of financial assets, and clarifies the need for a valuation allowance on some deferred tax assets. The ASU is required for us on January 1, 2018. We do not expect the adoption of ASU 2016-01 to have a significant impact on our consolidated financial statements. In November 2015, the FASB issued ASU 2015-17, Income Taxes-Balance Sheet Classification of Deferred Taxes. The new standard required that deferred income tax liabilities and assets be classified as noncurrent in a classified statement of financial position rather than separating these amounts between current and noncurrent amounts. The deferred tax liabilities and assets continue to be offset and presented as a single amount. The ASU was required for us on January 1, 2017, and we adopted this standard retrospectively for the period ended December 31, 2015. There was no significant impact on our consolidated financial statements as a result of adopting this ASU. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements - Going Concern. The new standard required management of public and private companies to evaluate whether there is substantial doubt about the entity’s ability to continue as a going concern and, if so, disclose that fact. Management is also required to evaluate and disclose whether its plans alleviate that doubt. The new standard became effective for us on January 1, 2016 and the adoption did not have an impact on our consolidated financial statements. In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606), which will supersede nearly all existing revenue recognition guidance under U.S. GAAP. The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In August 2015, the FASB issued ASU 2015-14, Revenue from Contracts with Customers Deferral of the Effective Date, which deferred the effective date resulting in a new effective date of January 1, 2018, for us. We are permitted to adopt early but not before the original effective date of January 1, 2017. FASB has issued several other ASU's which provide further guidance on Topic 606 and have the same effective date. The standard allows for either “full retrospective” adoption, meaning the standard is applied to all of the periods presented, or “modified retrospective” adoption, meaning the standard is applied only to the most current period presented in the financial statements. We will implement ASU 2014-09 and all relevant subsequently issued ASU's on Topic 606 concurrently on January 1, 2018, and are currently evaluating the transitions method. We are carefully evaluating our existing revenue recognition practices to determine whether any contracts in the scope of the guidance will be affected by the new requirements. The effects may include identifying performance obligations in existing arrangements, determining the transaction price and allocating the transaction price to each separate performance obligation. We will also establish practices to determine when a performance obligation has been satisfied, and recognize revenue in accordance with the new requirements. As no material revenues have been recognized to date, we do not anticipate the adoption of this standard to have a material effect. |
Concentration of Credit Risk | Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, short-term investments and accounts receivable, including receivables from major customers. The Company’s main financial institution for banking operations held 57% and 100% of the Company’s cash and cash equivalents as of December 31, 2016 , and December 31, 2015 , respectively. The Company grants credit to domestic and international clients in various industries. Exposure to losses on accounts receivable is principally dependent on each client's financial position. |
Fair Value of Financial Instr27
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | The following tables represent the financial instruments measured at fair value on a recurring basis on the financial statements of the Company and the valuation approach applied to each class of financial instruments at December 31, 2016 , and 2015 (see Note 2, Summary of Significant Accounting Policies for further information): December 31, 2016 (in thousands) Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets: Cash and cash equivalents: Money market funds $ 10,970 $ — $ — $ 10,970 Investments: Certificates of deposit — 7,257 — 7,257 US Treasury securities 8,544 — — 8,544 US Agency securities — 4,501 — 4,501 Asset-backed securities — 5,557 — 5,557 Corporate notes and bonds — 32,660 — 32,660 Total investments 8,544 49,975 — 58,519 Total assets measured at fair value $ 19,514 $ 49,975 $ — $ 69,489 December 31, 2015 (in thousands) Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets: Cash and cash equivalents: Money market funds $ 5,221 $ — $ — $ 5,221 Investments: Asset-backed securities — 2,507 — 2,507 Corporate notes and bonds — 9,332 — 9,332 Total investments — 11,839 — 11,839 Total assets measured at fair value $ 5,221 $ 11,839 $ — $ 17,060 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Available-for-sale Investments | The following tables summarize the Company’s available-for-sale investments at December 31, 2016 , and 2015 (in thousands): AVAILABLE-FOR-SALE INVESTMENTS December 31, 2016 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Certificates of deposit $ 7,257 $ — $ — $ 7,257 US Treasury securities 8,553 1 (10 ) 8,544 US Agency securities 4,514 — (13 ) 4,501 Asset-backed securities 5,554 3 — 5,557 Corporate notes and bonds 32,717 3 (60 ) 32,660 Total $ 58,595 $ 7 $ (83 ) $ 58,519 AVAILABLE-FOR-SALE INVESTMENTS December 31, 2015 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Asset-backed securities $ 2,510 $ — $ (3 ) $ 2,507 Corporate notes and bonds 9,341 1 (10 ) 9,332 Total $ 11,851 $ 1 $ (13 ) $ 11,839 |
Summary of Maturities of Available-for-sale Investments | The following table summarizes the maturities of the Company’s available-for-sale securities at December 31, 2016 , and 2015 (in thousands): AVAILABLE-FOR-SALE INVESTMENT MATURITIES (in thousands) At December 31, 2016 At December 31, 2015 Amortized Cost Fair Value Amortized Cost Fair Value Due in less than 1 year $ 45,391 $ 45,344 $ 11,851 $ 11,839 Due in 1-5 years 13,204 13,175 — — Total $ 58,595 $ 58,519 $ 11,851 $ 11,839 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment are recorded at cost and consisted of the following at December 31, 2016 , and 2015 (in thousands). PROPERTY AND EQUIPMENT (in thousands) 12/31/2016 12/31/2015 Computer equipment $ 2,270 $ 1,877 Technical equipment 2,427 1,806 Facilities 3,387 1,772 Capital projects in progress 1,010 2,183 Total property and equipment $ 9,094 $ 7,638 Accumulated depreciation - other (4,836 ) (2,622 ) Net property and equipment $ 4,258 $ 5,016 |
Deferred Revenue and Income (Ta
Deferred Revenue and Income (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Deferred Revenue Disclosure [Abstract] | |
Deferred Revenue and Income Summary | A summary of the balances as of December 31, 2016 , and 2015 follows (in thousands): Deferred Revenue and Income (in thousands) 12/31/2016 12/31/2015 Fisher agreement $ — $ 13 Products not yet delivered 35 114 Total current deferred revenue and income $ 35 $ 127 Arizona Commerce Authority grant $ 1,000 $ 1,000 Total long-term deferred income $ 1,000 $ 1,000 |
Employee and Consultant Equit31
Employee and Consultant Equity-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Option Activity | The following table summarizes option activity under all plans during the years ending December 31, 2016 , and December 31, 2015 and shows the exercisable shares as of December 31, 2016 : Stock Option Activity Number of Shares Weighted Average Exercise Price per Share Options Outstanding January 1, 2015 5,628,726 $ 5.20 Granted 717,833 20.59 Forfeited (54,505 ) 11.71 Exercised (124,884 ) 6.44 Expired — — Options Outstanding December 31, 2015 6,167,170 6.91 Granted 1,024,050 14.05 Forfeited (147,663 ) 18.43 Exercised (158,743 ) 7.47 Expired (27,690 ) 4.87 Options Outstanding December 31, 2016 6,857,124 7.72 Exercisable December 31, 2016 4,566,005 4.94 |
Black-Scholes Assumptions for Option Granted | The table below summarizes the resulting weighted average inputs used to calculate the estimated fair value of options awarded for during the periods shown below: Black-Scholes Assumptions for Option Granted 12 months 12 months 12 months 12/31/2016 12/31/2015 12/31/2014 Expected term (in years) 6.43 6.26 6.25 Volatility 86 % 91 % 96 % Expected dividends — — — Risk free interest rates 1.6 % 1.7 % 1.9 % Estimated forfeitures 8.5 % 5.6 % 0.4 % Weighted average fair value $ 10.35 $ 16.69 $ 12.63 |
Stock Option Supplemental Information | The following table shows summary information for outstanding options, options that are exercisable (vested) and outstanding options that are either vested or expected to vest as of December 31, 2016 : Stock Option Supplemental Information Options Outstanding Options Exercisable Options Vested and Expected to Vest Number of options 6,857,124 4,566,005 6,711,021 Weighted average remaining contractual term (in years) 6.57 5.83 6.52 Weighted average exercise price $ 7.72 $ 4.94 $ 7.55 Weighted average fair value $ 5.95 $ 3.72 $ 5.82 Aggregate intrinsic value (in millions) $ 82.0 $ 70.4 $ 81.6 |
Restricted Stock Activity | The following table summarizes restricted stock unit activity during the years ending December 31, 2016 , and December 31, 2015 : Restricted Stock Unit (RSU) Activity Number of Shares Weighted Average Grant Date Fair Value per Share RSU's outstanding January 1, 2015 — — Granted 40,250 20.91 Forfeited — — Vested/released — — RSU's outstanding December 31, 2015 40,250 20.91 Granted — — Forfeited — — Vested/released — — RSU's outstanding December 31, 2016 40,250 20.91 |
Equity-Based Compensation Expense and Tax Benefit | The expense and tax benefits recognized on Company’s Statements of Operations and Comprehensive Loss related to options is summarized below (in thousands): Equity-Based Compensation Expenses and Tax Benefit (in thousands) 12 months 12 months 12 months 12/31/2016 12/31/2015 12/31/2014 Research and development $ 1,585 $ 2,479 $ 4,334 Sales, general and administrative 7,190 5,909 5,290 Equity-based compensation expense 8,775 8,388 9,624 Recognized tax benefit $ — $ — $ — |
Summary of ESPP Activity | A summary of ESPP activity for the year ended December 31, 2016 is as follows: Shares issued 11,093 Weighted average fair value 20.40 Employee purchases (in thousands) 226 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Pretax Loss from Operations | The components of the pretax loss from operations for the years ended December 31, 2016 , 2015 and 2014 , are as follows (in thousands): Components of the Pretax Loss From Operations (in thousands) 12/31/2016 12/31/2015 12/31/2014 U.S. Domestic $ (48,539 ) $ (44,415 ) $ (30,933 ) Foreign (17,568 ) (1,083 ) — Pretax loss from operations $ (66,107 ) $ (45,498 ) $ (30,933 ) |
Schedule of Provision for Income Taxes | The components of the provision for income taxes is presented in the following table: Provision for Income Taxes (in thousands) 12/31/2016 12/31/2015 12/31/2014 Current: Federal $ — $ — $ — State — — — Foreign 267 — — Total current provision 267 — — Deferred: Federal — — — State — — — Foreign — — — Total deferred provision — — — Total provision $ 267 $ — $ — |
Deferred Income Tax Components | Significant components of the Company’s net deferred income taxes for the years ended December 31, 2016 , and 2015 , are as follows (in thousands): Deferred Income Tax Components (in thousands) 12/31/2016 12/31/2015 Deferred tax assets: Net operating loss carryforward $ 42,013 $ 28,584 Property & equipment 690 339 Inventory 1,735 864 Stock options 7,208 5,208 Intangible assets, definite-lived 220 333 General business credit 3,984 1,915 Deferred revenue 370 372 Other 121 205 Valuation allowance (56,341 ) (37,820 ) Deferred tax assets $ — $ — |
Effective Tax Rate | The difference between the U.S. federal statutory income tax rate and the Company’s effective tax rate for years ending December 31, 2016 , 2015 and 2014 , is as follows: Effective Tax Rate 12/31/2016 12/31/2015 12/31/2014 U.S. federal statutory income tax rate (34.00 )% (34.00 )% (34.00 )% State taxes, net of federal tax benefit (1.69 ) (2.93 ) (3.20 ) Permanent and other differences (0.17 ) 0.11 — Change in tax rates 0.67 — — Tax rate differential 8.62 0.42 — Unrecognized tax benefits 1.09 0.40 — Nondeductible equity and other compensation 1.17 2.86 3.70 Limitation on net operating losses due to §382 — — 0.50 Credit for increased research activities (3.31 ) (2.67 ) (0.80 ) Change in Valuation allowance 28.02 35.81 33.80 0.40 % — % — % |
Uncertain Tax Positions | At December 31, 2016 , the Company had uncertain tax positions of $1.1 million , determined as follows (in thousands): Uncertain Tax Positions (in thousands) 12/31/2016 12/31/2015 12/31/2014 Balance at beginning of year $ 343 $ 161 $ — Increases for prior positions 37 — 78 Increases for current year positions 721 182 83 Other Increases — — — Decreases due to settlements — — — Expiration of the statute of limitations for the assessment of taxes — — — Other Decreases — — — Balance at end of year $ 1,101 $ 343 $ 161 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Operating Leases Obligations | Future minimum lease payments under this agreement are as follows (in thousands): Operating Lease Obligations (in thousands) Year ending December 31: 2017 $ 1,004 2018 79 2019 — 2020 — Thereafter — Total operating lease obligations $ 1,083 |
Supplemental Data Quarterly F34
Supplemental Data Quarterly Financial Information (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Unaudited Quarterly Financial Information | QUARTERLY FINANCIAL INFORMATION (in thousands, except per share data) Unaudited For the quarters ending: 12/31/2016 9/30/2016 6/30/2016 3/31/2016 12/31/2015 9/30/2015 6/30/2015 3/31/2015 Revenue $ 39 $ 24 $ 20 $ 163 $ 22 $ 92 $ 19 $ 14 Net loss (16,135 ) (17,299 ) (17,866 ) (15,074 ) (13,163 ) (11,186 ) (12,252 ) (8,897 ) Basic and diluted net loss per share (0.31 ) (0.34 ) (0.35 ) (0.29 ) (0.29 ) (0.25 ) (0.27 ) (0.20 ) |
Summary of Significant Accoun35
Summary of Significant Accounting Policies (Details) | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Line Items] | |
Bundled rental agreement, term (under) | 7 years |
Dividend yield (percent) | 0.00% |
Minimum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 1 year |
Maximum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 7 years |
Concentration of Credit Risk (D
Concentration of Credit Risk (Details) - Concentration of Credit Risk | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Cash and Cash Equivalents | ||
Concentration Risk [Line Items] | ||
Risk concentration | 57.00% | 100.00% |
Accounts Receivable | One Customer | ||
Concentration Risk [Line Items] | ||
Risk concentration | 29.00% | 66.00% |
Fair Value of Financial Instr37
Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Investment [Line Items] | ||
Total investments | $ 69,489 | $ 17,060 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Investment [Line Items] | ||
Total investments | 19,514 | 5,221 |
Significant Other Observable Inputs (Level 2) | ||
Investment [Line Items] | ||
Total investments | 49,975 | 11,839 |
Significant Unobservable Inputs (Level 3) | ||
Investment [Line Items] | ||
Total investments | 0 | 0 |
Money market funds | ||
Investment [Line Items] | ||
Total investments | 10,970 | 5,221 |
Money market funds | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Investment [Line Items] | ||
Total investments | 10,970 | 5,221 |
Money market funds | Significant Other Observable Inputs (Level 2) | ||
Investment [Line Items] | ||
Total investments | 0 | 0 |
Money market funds | Significant Unobservable Inputs (Level 3) | ||
Investment [Line Items] | ||
Total investments | 0 | 0 |
Certificates of deposit | ||
Investment [Line Items] | ||
Total investments | 7,257 | |
Certificates of deposit | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Investment [Line Items] | ||
Total investments | 0 | |
Certificates of deposit | Significant Other Observable Inputs (Level 2) | ||
Investment [Line Items] | ||
Total investments | 7,257 | |
Certificates of deposit | Significant Unobservable Inputs (Level 3) | ||
Investment [Line Items] | ||
Total investments | 0 | |
US Treasury securities | ||
Investment [Line Items] | ||
Total investments | 8,544 | |
US Treasury securities | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Investment [Line Items] | ||
Total investments | 8,544 | |
US Treasury securities | Significant Other Observable Inputs (Level 2) | ||
Investment [Line Items] | ||
Total investments | 0 | |
US Treasury securities | Significant Unobservable Inputs (Level 3) | ||
Investment [Line Items] | ||
Total investments | 0 | |
US Agency securities | ||
Investment [Line Items] | ||
Total investments | 4,501 | |
US Agency securities | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Investment [Line Items] | ||
Total investments | 0 | |
US Agency securities | Significant Other Observable Inputs (Level 2) | ||
Investment [Line Items] | ||
Total investments | 4,501 | |
US Agency securities | Significant Unobservable Inputs (Level 3) | ||
Investment [Line Items] | ||
Total investments | 0 | |
Asset-backed securities | ||
Investment [Line Items] | ||
Total investments | 5,557 | 2,507 |
Asset-backed securities | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Investment [Line Items] | ||
Total investments | 0 | 0 |
Asset-backed securities | Significant Other Observable Inputs (Level 2) | ||
Investment [Line Items] | ||
Total investments | 5,557 | 2,507 |
Asset-backed securities | Significant Unobservable Inputs (Level 3) | ||
Investment [Line Items] | ||
Total investments | 0 | 0 |
Corporate notes and bonds | ||
Investment [Line Items] | ||
Total investments | 32,660 | 9,332 |
Corporate notes and bonds | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Investment [Line Items] | ||
Total investments | 0 | 0 |
Corporate notes and bonds | Significant Other Observable Inputs (Level 2) | ||
Investment [Line Items] | ||
Total investments | 32,660 | 9,332 |
Corporate notes and bonds | Significant Unobservable Inputs (Level 3) | ||
Investment [Line Items] | ||
Total investments | 0 | 0 |
Total investments | ||
Investment [Line Items] | ||
Total investments | 58,519 | 11,839 |
Total investments | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Investment [Line Items] | ||
Total investments | 8,544 | 0 |
Total investments | Significant Other Observable Inputs (Level 2) | ||
Investment [Line Items] | ||
Total investments | 49,975 | 11,839 |
Total investments | Significant Unobservable Inputs (Level 3) | ||
Investment [Line Items] | ||
Total investments | $ 0 | $ 0 |
Investments - Schedule of Avail
Investments - Schedule of Available-for-sale Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Investment [Line Items] | ||
Amortized Cost | $ 58,595 | $ 11,851 |
Gross Unrealized Gains | 7 | 1 |
Gross Unrealized Losses | (83) | (13) |
Fair Value | 58,519 | 11,839 |
Certificates of deposit | ||
Investment [Line Items] | ||
Amortized Cost | 7,257 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | 7,257 | |
US Treasury securities | ||
Investment [Line Items] | ||
Amortized Cost | 8,553 | |
Gross Unrealized Gains | 1 | |
Gross Unrealized Losses | (10) | |
Fair Value | 8,544 | |
US Agency securities | ||
Investment [Line Items] | ||
Amortized Cost | 4,514 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (13) | |
Fair Value | 4,501 | |
Asset-backed securities | ||
Investment [Line Items] | ||
Amortized Cost | 5,554 | 2,510 |
Gross Unrealized Gains | 3 | 0 |
Gross Unrealized Losses | 0 | (3) |
Fair Value | 5,557 | 2,507 |
Corporate notes and bonds | ||
Investment [Line Items] | ||
Amortized Cost | 32,717 | 9,341 |
Gross Unrealized Gains | 3 | 1 |
Gross Unrealized Losses | (60) | (10) |
Fair Value | $ 32,660 | $ 9,332 |
Investments - Schedule of Ava39
Investments - Schedule of Available-For-Sale Investment Maturities (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Amortized Cost | ||
Due in less than 1 year | $ 45,391 | $ 11,851 |
Due in 1-5 years | 13,204 | 0 |
Total | 58,595 | 11,851 |
Fair Value | ||
Due in less than 1 year | 45,344 | 11,839 |
Due in 1-5 years | 13,175 | 0 |
Total | $ 58,519 | $ 11,839 |
Investments - Narrative (Detail
Investments - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Investments, Debt and Equity Securities [Abstract] | |||
Proceeds from sales of marketable securities | $ 9,716,000 | $ 141,000 | $ 861,000 |
Realized gain on available-for-sale securities | 6,000 | 0 | $ 0 |
Gross realized gains or losses from sales of marketable securities | $ 0 | ||
Gross proceeds associated with realized gains | $ 7,200,000 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 9,094 | $ 7,638 | |
Accumulated depreciation - other | (4,836) | (2,622) | |
Net property and equipment | 4,258 | 5,016 | |
Depreciation expense | 2,340 | 1,782 | $ 817 |
Computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 2,270 | 1,877 | |
Technical equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 2,427 | 1,806 | |
Facilities | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 3,387 | 1,772 | |
Capital projects in progress | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 1,010 | $ 2,183 |
License Agreements and Grants -
License Agreements and Grants - Defense Medical Research and Development Program (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | 56 Months Ended | ||
May 31, 2012 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2016 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Offset to research and development project | $ 1,200 | $ 647 | $ 527 | ||
Defense Medical Research and Development Program | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Total grant funding | $ 2,000 | ||||
Length of project (months) | 35 years | ||||
Offset to research and development project | $ 54 | $ 179 | $ 221 | $ 612 |
License Agreements and Grants43
License Agreements and Grants - National Institute of Health Grant (Details) - National Institute of Health Grant - USD ($) | 1 Months Ended | 12 Months Ended | |||
Feb. 28, 2015 | Dec. 31, 2016 | Jan. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Length of project (years) | 5 years | ||||
Total grant funding | $ 5,000,000 | $ 74,000 | $ 818,000 | $ 483,000 | $ 0 |
License Agreements and Grants44
License Agreements and Grants - Arizona Commerce Authority and R&D Refundable Tax Credit Program (Details) | 1 Months Ended | 12 Months Ended | ||
Aug. 31, 2012USD ($)jobmilestone | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Research and Development [Abstract] | ||||
Arizona Commerce Authority grant | $ | $ 1,000,000 | $ 1,000,000 | $ 1,000,000 | |
Number of milestones | milestone | 4 | |||
Qualified jobs created, milestone 1 | job | 15 | |||
Qualified jobs created, milestone 2 | job | 30 | |||
Qualified jobs created, milestone 3 | job | 40 | |||
Qualified jobs created, milestone 4 | job | 65 | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Offset to research and development project | $ | $ 1,200,000 | $ 647,000 | $ 527,000 | |
Minimum | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Capital investment milestone | $ | $ 4,500,000 | |||
Grant related minimum annual wages | $ | $ 63,000 | |||
Percent of company paid premiums | 65.00% |
Deferred Revenue and Income (De
Deferred Revenue and Income (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Aug. 31, 2012 | |
Deferred Revenue Disclosure [Abstract] | |||
Fisher agreement | $ 0 | $ 13 | |
Products not yet delivered | 35 | 114 | |
Total current deferred revenue and income | 35 | 127 | |
Arizona Commerce Authority grant | 1,000 | 1,000 | $ 1,000 |
Total long-term deferred income | 1,000 | $ 1,000 | |
Deferred revenue recognized | $ 114 |
Stock Purchase (Details)
Stock Purchase (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 2 Months Ended | |||
Mar. 31, 2013USD ($)$ / shares$ / warrantshares | Apr. 30, 2012USD ($)$ / shares$ / warrantshares | Oct. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2016shares | Mar. 14, 2014$ / shares | |
Securities Financing Transactions Disclosures [Abstract] | |||||
Price per share (dollars per share) | $ / shares | $ 1.03 | $ 16.80 | |||
Stock and warrants purchase price | $ | $ 14,400 | ||||
Shares of common stock (shares) | 14,000,000 | ||||
Warrants to purchase common stock (shares) | 7,000,000 | ||||
Price per warrant (dollars per share) | $ / warrant | 1.03 | 1.03 | |||
Additional warrant to purchase common stock (shares) | 7,000,000 | 7,000,000 | |||
Price per warrant (dollars per share) | $ / warrant | 2 | ||||
Value of warrants | $ | $ 5,900 | ||||
Value of common stock | $ | $ 8,500 | ||||
Exercised warrant per purchase agreement (shares) | 7,000,000 | ||||
Exercised warrants (percent) | 92.00% | ||||
Price per warrant (dollars per share) | $ / shares | $ 2 | $ 2 | |||
Additional exercised warrant per purchase agreement (shares) | 6,400,000 | ||||
Unexercised warrants (shares) | 571,160 | 415,871 | |||
Proceeds from warrants | $ | $ 20,100 | $ 311 | |||
Additional exercised warrant per purchase agreement (shares) | 155,289 |
Public Offering (Details)
Public Offering (Details) - USD ($) $ / shares in Units, $ in Thousands | Dec. 15, 2015 | Dec. 09, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Apr. 28, 2014 | Apr. 07, 2014 |
Class of Stock [Line Items] | |||||||
Public offering price (dollars per share) | $ 17 | $ 20.75 | $ 17.54 | $ 17.64 | |||
Lock-up agreement (period) | 90 days | ||||||
Underwriting discount and commission fees (dollars per share) | $ 1.19 | ||||||
Gross proceeds from sale of common stock | $ 109,300 | ||||||
Stock issuance costs | 5,900 | $ 814 | $ 0 | $ 0 | |||
Proceeds from common stock issuance | $ 103,400 | ||||||
Common stock | |||||||
Class of Stock [Line Items] | |||||||
Issuance of common stock and warrants (shares) | 6,400,000 | 6,426,000 | 2,678,000 | ||||
Common stock | Affiliated entity | |||||||
Class of Stock [Line Items] | |||||||
Issuance of common stock and warrants (shares) | 2,900,000 | ||||||
Public offering | Common stock | |||||||
Class of Stock [Line Items] | |||||||
Issuance of common stock and warrants (shares) | 5,600,000 | ||||||
Underwriters | Common stock | |||||||
Class of Stock [Line Items] | |||||||
Issuance of common stock and warrants (shares) | 838,000 | ||||||
Offering exempt from underwriter commission | Common stock | Affiliated entity | |||||||
Class of Stock [Line Items] | |||||||
Issuance of common stock and warrants (shares) | 2,400,000 |
Rights Offering (Details)
Rights Offering (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | |||||||
May 19, 2014 | Dec. 31, 2016 | Dec. 09, 2015 | May 01, 2014 | Apr. 28, 2014 | Apr. 07, 2014 | Mar. 14, 2014 | Apr. 30, 2012 | |
Class of Warrant or Right [Line Items] | ||||||||
Warrants and rights outstanding | $ 45,000 | |||||||
Non-transferable subscription rights for each share of common stock owned on the record date (shares) | 0.063921 | |||||||
Subscription right to purchase common stock (dollars per share) | $ 16.80 | $ 1.03 | ||||||
Share price (dollars per share) | $ 20.75 | $ 17 | $ 17.54 | $ 17.64 | ||||
Standby purchase agreement issuance of unsubscribed shares to related party (shares) | 2,700,000 | 2,700,000 | ||||||
Gross proceeds from issuance of warrants | $ 45,000 | |||||||
Costs associated with rights offering | $ 125 | |||||||
Standby Purchasers | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Standby purchase agreement issuance of unsubscribed shares to related party (shares) | 297,619 | |||||||
Oracle Institutional Partners, L.P. | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Standby purchase agreement issuance of unsubscribed shares to related party (shares) | 119,047 | |||||||
Oracle Partners, L.P. | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Standby purchase agreement issuance of unsubscribed shares to related party (shares) | 178,572 |
Related Party Transaction (Deta
Related Party Transaction (Details) $ in Thousands | 1 Months Ended |
Jun. 30, 2016USD ($) | |
Recovery of short-swing profit | |
Related Party Transaction [Line Items] | |
Recovery of related party short-swing profits | $ 866 |
Earnings Per Share (Details)
Earnings Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Earnings Per Share [Abstract] | |||
Antidilutive common stock instruments outstanding (shares) | 7,313,245 | 6,778,580 | 6,174,886 |
Employee and Consultant Equit51
Employee and Consultant Equity-Based Compensation - Non-Qualified Stock Option Plan (Details) - shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise of options (shares) | 158,743 | 124,884 | |
Outstanding (shares) | 6,857,124 | 6,167,170 | 5,628,726 |
Non-Qualified Stock Option Plan | Stock Option | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expiration period | 10 years | ||
Exercise of options (shares) | 273,900 | ||
Outstanding (shares) | 6,100 | ||
Options available (shares) | 0 |
Employee and Consultant Equit52
Employee and Consultant Equity-Based Compensation - 2004 Omnibus Stock Option Plan (Details) - shares | 12 Months Ended | ||||
Dec. 31, 2016 | Dec. 31, 2015 | Jul. 31, 2012 | Dec. 31, 2014 | Dec. 31, 2004 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise of options (shares) | 158,743 | 124,884 | |||
Outstanding (shares) | 6,857,124 | 6,167,170 | 5,628,726 | ||
2004 Omnibus Stock Option Plan | Stock Option | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares authorized (shares) | 5,500,000 | 500,000 | |||
Additional shares authorized (shares) | 5,000,000 | ||||
Exercise of options (shares) | 428,907 | ||||
Outstanding (shares) | 3,511,093 | ||||
Options available (shares) | 0 |
Employee and Consultant Equit53
Employee and Consultant Equity-Based Compensation - 2012 Omnibus Equity Incentive Plan (Details) - shares | 1 Months Ended | 12 Months Ended | |||
May 31, 2014 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2012 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Options exercised (shares) | 158,743 | 124,884 | |||
Outstanding (shares) | 6,857,124 | 6,167,170 | 5,628,726 | ||
2012 Omnibus Equity Incentive Plan | Stock Option | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Options available (shares) | 5,677,500 | 2,096,762 | 1,677,500 | ||
Additional shares authorized (shares) | 4,000,000 | ||||
Expiration period | 10 years | ||||
Options exercised (shares) | 200,557 | ||||
Outstanding (shares) | 3,380,181 | ||||
Restricted new grants (shares) | 200,000 | ||||
2012 Omnibus Equity Incentive Plan | Stock Option | Vesting terms (i), cliff vesting | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 1 year | ||||
2012 Omnibus Equity Incentive Plan | Stock Option | Vesting terms (ii), monthly vesting | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 1 year | ||||
2012 Omnibus Equity Incentive Plan | Stock Option | Vesting terms (iv), annual vesting | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 5 years | ||||
2012 Omnibus Equity Incentive Plan | Stock Option | Vesting terms (iv), two years after grant date | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 2 years | ||||
Vesting percentage | 40.00% | ||||
2012 Omnibus Equity Incentive Plan | Stock Option | Vesting terms (iv), monthly over next three years | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 3 years | ||||
Vesting percentage | 60.00% |
Employee and Consultant Equit54
Employee and Consultant Equity-Based Compensation - Stock Option Activity (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Number of Shares | |||
Outstanding, beginning balance (shares) | 6,167,170 | 5,628,726 | |
Granted (shares) | 1,024,050 | 717,833 | |
Forfeited (shares) | (147,663) | (54,505) | |
Exercised (shares) | (158,743) | (124,884) | |
Expired (shares) | (27,690) | 0 | |
Outstanding, ending balance (shares) | 6,857,124 | 6,167,170 | 5,628,726 |
Exercisable, ending balance (shares) | 4,566,005 | ||
Weighted Average Exercise Price per Share | |||
Outstanding, beginning balance (dollars per share) | $ 6.91 | $ 5.20 | |
Granted (dollars per share) | 14.05 | 20.59 | |
Forfeited (dollars per share) | 18.43 | 11.71 | |
Exercised (dollars per share) | 7.47 | 6.44 | |
Expired (dollars per share) | 4.87 | 0 | |
Outstanding, ending balance (dollars per share) | 7.72 | $ 6.91 | $ 5.20 |
Exercisable, ending balance (dollars per share) | $ 4.94 | ||
Cash received from the exercise of options | $ 1,200,000 | ||
Tax benefit from share-based compensation | 0 | ||
Intrinsic value of options exercised | 2,200,000 | $ 2,000,000 | $ 3,800,000 |
Fair value of shares vesting | $ 6,600,000 | $ 7,300,000 | $ 3,800,000 |
Employee and Consultant Equit55
Employee and Consultant Equity-Based Compensation - Black-Scholes Assumptions for Option Granted (Details) | 12 Months Ended | ||
Dec. 31, 2016USD ($)yr$ / shares | Dec. 31, 2015USD ($)yr$ / shares | Dec. 31, 2014USD ($)yr$ / shares | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Expected term (in years) | yr | 6.43 | 6.26 | 6.25 |
Volatility | 86.00% | 91.00% | 96.00% |
Expected dividends | $ | $ 0 | $ 0 | $ 0 |
Risk free interest rates | 1.60% | 1.70% | 1.90% |
Estimated forfeitures | 8.50% | 5.60% | 0.40% |
Weighted average fair value (dollars per share) | $ / shares | $ 10.35 | $ 16.69 | $ 12.63 |
Employee and Consultant Equit56
Employee and Consultant Equity-Based Compensation - Stock Option Supplemental Information (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||||
Dec. 31, 2016 | Dec. 09, 2015 | Apr. 28, 2014 | Apr. 07, 2014 | Apr. 30, 2012 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Aggregate intrinsic value (in millions) | $ 5.9 | ||||
Share price (dollars per share) | $ 20.75 | $ 17 | $ 17.54 | $ 17.64 | |
Options Outstanding | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of options (shares) | 6,857,124 | ||||
Weighted average remaining contractual term (in years) | 6 years 6 months 26 days | ||||
Weighted average exercise price (dollars per share) | $ 7.72 | ||||
Weighted average fair value (dollars per share) | $ 5.95 | ||||
Aggregate intrinsic value (in millions) | $ 82 | ||||
Options Exercisable | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of options (shares) | 4,566,005 | ||||
Weighted average remaining contractual term (in years) | 5 years 9 months 29 days | ||||
Weighted average exercise price (dollars per share) | $ 4.94 | ||||
Weighted average fair value (dollars per share) | $ 3.72 | ||||
Aggregate intrinsic value (in millions) | $ 70.4 | ||||
Options Vested and Expected to Vest | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of options (shares) | 6,711,021 | ||||
Weighted average remaining contractual term (in years) | 6 years 6 months 7 days | ||||
Weighted average exercise price (dollars per share) | $ 7.55 | ||||
Weighted average fair value (dollars per share) | $ 5.82 | ||||
Aggregate intrinsic value (in millions) | $ 81.6 |
Employee and Consultant Equit57
Employee and Consultant Equity-Based Compensation - Restricted Stock Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Number of Shares | ||
Beginning balance (shares) | 40,250 | 0 |
Granted (shares) | 0 | 40,250 |
Forfeited (shares) | 0 | 0 |
Vested/Released (shares) | 0 | 0 |
Ending balance (shares) | 40,250 | 40,250 |
Weighted Average Grant Date Fair Value per Share | ||
Beginning balance (dollars per share) | $ 20.91 | $ 0 |
Granted (dollars per share) | 0 | 20.91 |
Forfeited (dollars per share) | 0 | 0 |
Vested/Released (dollars per share) | 0 | 0 |
Ending balance (dollars per share) | $ 20.91 | $ 20.91 |
Employee and Consultant Equit58
Employee and Consultant Equity-Based Compensation - Equity-Based Compensation Expense and Tax Benefit (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Equity-based compensation expense | $ 8,775 | $ 8,388 | $ 9,624 |
Recognized tax benefit | 0 | 0 | 0 |
Unrecognized equity-based compensation cos | 10,300 | ||
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Equity-based compensation expense | 1,585 | 2,479 | 4,334 |
Sales, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Equity-based compensation expense | $ 7,190 | $ 5,909 | $ 5,290 |
Employee and Consultant Equit59
Employee and Consultant Equity-Based Compensation - Employee Stock Purchase Plan (Details) - 2016 ESPP - Employee Stock | 1 Months Ended | 12 Months Ended |
May 31, 2016USD ($)hourshares | Dec. 31, 2016shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Offering period | 3 months | |
Maximum number of shares per employee | 100,000 | |
Purchase price of common stock (percent) | 90.00% | |
Shares authorized (shares) | 500,000 | |
Shares issued (shares) | 11,093 | |
Options available (shares) | 488,907 | |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Employee contribution (percent) | 2.00% | |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Hours worked per week | hour | 20 | |
Threshold of percentage of voting interests | 5.00% | |
Employee contribution (percent) | 15.00% | |
Employee contribution | $ | $ 25,000 | |
Offering period | 27 months |
Employee and Consultant Equit60
Employee and Consultant Equity-Based Compensation - Summary of ESPP Activity (Details) - 2016 ESPP - Employee Stock $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Shares issued (shares) | shares | 11,093 |
Weighted average fair value (dollars per share) | $ / shares | $ 20.40 |
Employee purchases (in thousands) | $ | $ 226 |
Income Taxes - Components of th
Income Taxes - Components of the Pretax Loss From Operations (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Disclosure [Abstract] | |||
U.S. Domestic | $ (48,539) | $ (44,415) | $ (30,933) |
Foreign | (17,568) | (1,083) | 0 |
Net loss before income taxes | $ (66,107) | $ (45,498) | $ (30,933) |
Income Taxes - Provision for In
Income Taxes - Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Current: | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 0 | 0 | 0 |
Foreign | 267 | 0 | 0 |
Total current provision | 267 | 0 | 0 |
Deferred: | |||
Federal | 0 | 0 | 0 |
State | 0 | 0 | 0 |
Foreign | 0 | 0 | 0 |
Total deferred provision | 0 | 0 | 0 |
Total provision | $ 267 | $ 0 | $ 0 |
Income Taxes - Deferred Income
Income Taxes - Deferred Income Taxes Components (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Deferred tax assets: | ||
Net operating loss carryforward | $ 42,013 | $ 28,584 |
Property & equipment | 690 | 339 |
Inventory | 1,735 | 864 |
Stock options | 7,208 | 5,208 |
Intangible assets, definite-lived | 220 | 333 |
General business credit | 3,984 | 1,915 |
Deferred revenue | 370 | 372 |
Other | 121 | 205 |
Valuation allowance | (56,341) | (37,820) |
Deferred tax assets | $ 0 | $ 0 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Operating Loss Carryforwards [Line Items] | ||||
Valuation allowance | $ 56,341 | $ 37,820 | ||
Unrecognized tax benefits | 1,101 | $ 343 | $ 161 | $ 0 |
Uncertain tax positions that would impact the effective tax rate | 57 | |||
Domestic Tax Authority | Internal Revenue Service (IRS) | ||||
Operating Loss Carryforwards [Line Items] | ||||
Operating loss carryforwards, Sec. 382 limitation | 125,100 | |||
Operating loss carryforwards, expected to be unrealized | 420 | |||
Gross operating loss carryforwards | 4,200 | |||
Operating loss carryforwards | 120,900 | |||
State and Local Jurisdiction | Arizona Department of Revenue | ||||
Operating Loss Carryforwards [Line Items] | ||||
Operating loss carryforwards | $ 102,500 |
Income Taxes - Effective Tax Ra
Income Taxes - Effective Tax Rate (Details) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Disclosure [Abstract] | |||
U.S. federal statutory income tax rate | (34.00%) | (34.00%) | (34.00%) |
State taxes, net of federal tax benefit | (1.69%) | (2.93%) | (3.20%) |
Permanent and other differences | (0.17%) | 0.11% | (0.00%) |
Change in tax rates | 0.67% | (0.00%) | (0.00%) |
Tax rate differential | 8.62% | 0.42% | (0.00%) |
Unrecognized tax benefits | 1.09% | 0.40% | (0.00%) |
Nondeductible equity and other compensation | 1.17% | 2.86% | 3.70% |
Limitation on net operating losses due to §382 | (0.00%) | (0.00%) | 0.50% |
Credit for increased research activities | (3.31%) | (2.67%) | (0.80%) |
Change in Valuation allowance | 28.02% | 35.81% | 33.80% |
Effective tax rate | 0.40% | (0.00%) | (0.00%) |
Income Taxes - Uncertain Tax Po
Income Taxes - Uncertain Tax Positions (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Uncertain Tax Positions | |||
Balance at beginning of year | $ 343 | $ 161 | $ 0 |
Increases for prior positions | 37 | 0 | 78 |
Increases for current year positions | 721 | 182 | 83 |
Other Increases | 0 | 0 | 0 |
Decreases due to settlements | 0 | 0 | 0 |
Expiration of the statute of limitations for the assessment of taxes | 0 | 0 | 0 |
Other Decreases | 0 | 0 | 0 |
Balance at end of year | $ 1,101 | $ 343 | $ 161 |
Commitments - (Details Narrativ
Commitments - (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Rent expense | $ 1,100,000 | $ 685,000 | $ 293,000 |
Clinical trial master agreement expense | 2,100,000 | 1,600,000 | 0 |
Marketing study agreement expense | $ 233,000 | $ 66,000 | $ 0 |
Commitments - Operating Lease O
Commitments - Operating Lease Obligations (Details) $ in Thousands | Dec. 31, 2016USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,017 | $ 1,004 |
2,018 | 79 |
2,019 | 0 |
2,020 | 0 |
Thereafter | 0 |
Total operating lease obligations | $ 1,083 |
Segments (Details)
Segments (Details) | 12 Months Ended |
Dec. 31, 2016segment | |
Segment Reporting [Abstract] | |
Number of operating segments | 1 |
Supplemental Data Quarterly F70
Supplemental Data Quarterly Financial Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenue | $ 39 | $ 24 | $ 20 | $ 163 | $ 22 | $ 92 | $ 19 | $ 14 | $ 246 | $ 147 | $ 122 |
Net loss | $ (16,135) | $ (17,299) | $ (17,866) | $ (15,074) | $ (13,163) | $ (11,186) | $ (12,252) | $ (8,897) | $ (66,374) | $ (45,498) | $ (30,933) |
Basic and diluted net loss per share (dollars per share) | $ (0.31) | $ (0.34) | $ (0.35) | $ (0.29) | $ (0.29) | $ (0.25) | $ (0.27) | $ (0.20) |