Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Nov. 01, 2017 | |
Document And Entity Information | ||
Entity Registrant Name | Accelerate Diagnostics, Inc. | |
Entity Central Index Key | 727,207 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2017 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 55,397,563 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2,017 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEET - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 34,431 | $ 19,244 |
Investments | 86,889 | 58,519 |
Trade accounts receivable | 1,111 | 34 |
Inventory | 7,341 | 0 |
Prepaid expenses | 1,048 | 468 |
Other current assets | 460 | 183 |
Total current assets | 131,280 | 78,448 |
Property and equipment, net | 4,690 | 4,258 |
Intellectual property, net | 137 | 146 |
Total assets | 136,107 | 82,852 |
Current liabilities: | ||
Accounts payable | 1,369 | 992 |
Accrued liabilities | 3,733 | 3,009 |
Deferred revenue and income | 1,081 | 35 |
Total current liabilities | 6,183 | 4,036 |
Long-term deferred income | 0 | 1,000 |
Total liabilities | 6,183 | 5,036 |
Commitments and contingencies see Note 16, Commitments | ||
Stockholders’ equity: | ||
Common stock | 55 | 52 |
Preferred shares | 0 | 0 |
Contributed capital | 355,458 | 255,257 |
Accumulated deficit | (225,676) | (177,289) |
Accumulated other comprehensive (loss) | 87 | (204) |
Total stockholders’ equity | 129,924 | 77,816 |
Total liabilities and stockholders’ equity | $ 136,107 | $ 82,852 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEET (Parenthetical) - $ / shares | Sep. 30, 2017 | Dec. 31, 2016 |
Statement of Financial Position [Abstract] | ||
Common Stock, par value (usd per share) | $ 0.001 | $ 0.001 |
Common Stock, shares authorized (shares) | 75,000,000 | 75,000,000 |
Common Stock, shares issued (shares) | 55,397,563 | 51,516,309 |
Common Stock, shares outstanding (shares) | 55,397,563 | 51,516,309 |
Preferred Stock, par value (usd per share) | $ 0.001 | $ 0.001 |
Preferred Stock, shares authorized (shares) | 5,000,000 | 5,000,000 |
Preferred Stock, shares outstanding (shares) | 0 | 0 |
CONDENSED CONSOLIDATEDSTATEMENT
CONDENSED CONSOLIDATEDSTATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Income Statement [Abstract] | ||||
Net sales | $ 828 | $ 24 | $ 2,058 | $ 207 |
Cost of sales | 191 | 0 | 352 | 0 |
Gross Profit | 637 | 24 | 1,706 | 207 |
Costs and expenses: | ||||
Research and development | 6,351 | 7,874 | 16,166 | 23,974 |
Sales, general and administrative | 11,601 | 9,566 | 33,589 | 26,710 |
Total costs and expenses | 17,952 | 17,440 | 49,755 | 50,684 |
Loss from operations | (17,315) | (17,416) | (48,049) | (50,477) |
Interest expense and other | 2 | 0 | (3) | 0 |
Foreign currency exchange loss | (40) | (42) | (73) | (115) |
Interest and dividend income | 323 | 159 | 612 | 353 |
Total other income | 285 | 117 | 536 | 238 |
Net loss before income taxes | (17,030) | (17,299) | (47,513) | (50,239) |
Provision from income taxes | (45) | 0 | (220) | 0 |
Net loss | $ (17,075) | $ (17,299) | $ (47,733) | $ (50,239) |
Basic and diluted net loss per share (usd per share) | $ (0.31) | $ (0.34) | $ (0.89) | $ (0.98) |
Weighted average shares outstanding (shares) | 55,316 | 51,239 | 53,603 | 51,216 |
Other comprehensive loss: | ||||
Net loss | $ (17,075) | $ (17,299) | $ (47,733) | $ (50,239) |
Net unrealized gain loss on available-for-sale investments | (7) | (70) | (4) | 11 |
Foreign currency translation adjustment | 91 | (8) | 295 | (8) |
Comprehensive loss | $ (16,991) | $ (17,377) | $ (47,442) | $ (50,236) |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Cash flows from operating activities: | ||
Net loss | $ (47,733) | $ (50,239) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 1,595 | 1,745 |
Amortization of intangible assets | 9 | 8 |
Amortization of investment discount | 298 | 251 |
Equity-based compensation | 10,970 | 6,591 |
Realized (gain) on sale of investments | 0 | (6) |
Loss on disposal of property & equipment | 3 | 0 |
(Increase) decrease in assets: | ||
Accounts receivable | (1,077) | (82) |
Inventory | (7,079) | 0 |
Prepaid expense and other | (392) | 525 |
Other current assets | (277) | (90) |
Increase (decrease) in liabilities: | ||
Accounts payable | 359 | 103 |
Accrued liabilities | 780 | 670 |
Deferred revenue and income | 46 | (83) |
Net cash used in operating activities | (42,498) | (40,607) |
Cash flows from investing activities: | ||
Purchases of equipment | (2,055) | (2,301) |
Purchases of available-for-sale securities | (68,423) | (73,585) |
Sales of available-for-sale securities | 9,522 | 8,716 |
Maturity of available-for-sale securities | 30,049 | 14,955 |
Net cash used in investing activities | (30,907) | (52,215) |
Cash flows from financing activities: | ||
Issuance of common stock net issuance costs | 83,741 | 80 |
Exercise of options and warrants | 4,562 | 864 |
Common stock issuance costs | 0 | (814) |
Payments on capital lease obligations | 0 | (13) |
Recovery of related party short-swing profits | 0 | 866 |
Net cash provided by financing activities | 88,303 | 983 |
Effect of exchange rate on cash: | 289 | (15) |
Increase (decrease) in cash and cash equivalents | 15,187 | (91,854) |
Cash and cash equivalents, beginning of period | 19,244 | 120,585 |
Cash and cash equivalents, end of period | $ 34,431 | $ 28,731 |
Organization and Nature of Busi
Organization and Nature of Business; Basis of Presentation; Principles of Consolidation; Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Organization and Nature of Business; Basis of Presentation; Principles of Consolidation; Significant Accounting Policies | NOTE 1. ORGANIZATION AND NATURE OF BUSINESS; BASIS OF PRESENTATION; PRINCIPLES OF CONSOLIDATION; SIGNIFICANT ACCOUNTING POLICIES 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 unaudited condensed 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 interim financial reporting. Certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. Therefore, these condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 , as filed with the SEC on February 28, 2017. The condensed consolidated balance sheet as of December 31, 2016 included herein was derived from the audited financial statements as of that date, but does not include all disclosures such as notes required by U.S. GAAP. The accompanying unaudited condensed consolidated financial statements reflect all normal recurring adjustments necessary to present fairly the financial position, results of operations, and cash flows for the interim periods presented, but are not necessarily indicative of the results of operations to be anticipated for the entire year ending December 31, 2017 , or any future period. All amounts are rounded to the nearest thousand dollars unless otherwise indicated. 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. 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. 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 and certificates of deposit. Management classifies its investments as available-for-sale investments and records these investments in the condensed 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 . 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. In the current period presentation and the revised prior period presentation, depreciation and amortization expenses are reported as a component of the individual costs and expenses as part of the condensed consolidated statements of operations and comprehensive loss. The amount of depreciation and amortization expenses now reported as a component of research and development costs for the three months ended September 30, 2017 and 2016 were $303,000 and $342,000 , respectively, and for the nine months ended September 30, 2017 and 2016 were $1,086,000 and $1,026,000 , respectively. The amount of depreciation and amortization expenses now reported as a component of sales, general and administrative costs for the three months ended September 30, 2017 and 2016 were $168,000 and $259,000 , respectively, and for the nine months ended September 30, 2017 and 2016 were $435,000 and $727,000 , respectively. In the current and revised prior period presentation, product sales and licensing and royalty revenues are reported as net sales as part of the condensed consolidated statements of operations and comprehensive loss. The amounts that have been reclassified had no effect on our net income, stockholders’ equity or cash flows. Inventory Inventory is stated at the lesser of cost or net realizable value, with cost determined on the first-in-first-out method. The allocation of production overhead to inventory costs is based on normal production capacity. Abnormal amounts of idle facility expense and spoilage are expensed as incurred and not included in overhead subject to capitalization. The Company maintains provisions for excess and obsolete inventory based on management’s estimates of forecasted demand and, where applicable, product expiration. The Company adopted Accounting Standards Update (“ASU”) 2015-11, Simplifying the Measurement of Inventory (Topic 310) Inventory on January 1, 2017. This ASU simplifies the subsequent measurement of inventory by using only the lower of cost or net realizable value. The adoption did not have an effect on the Company’s consolidated financial statements. 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 greater than one year to seven years. Leasehold improvements are depreciated over the remaining life of the lease or the life of the asset, whichever is less. Property and equipment includes diagnostic instruments used for sales demonstrations and instruments under rental agreements. The Company retains title to the instruments under these arrangements. Revenue 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. The customer agrees to purchase consumable products at a stated price over the term of the agreement which is typically less than seven years. Contracts sometimes have renewal clauses but such clauses do not provide for a bargain renewal option or penalize the customer if they do not renew. The instrument remains the Company’s 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. For multiple element arrangements, the total consideration for an arrangement is allocated among the separate elements in the arrangement based on a selling price hierarchy. The selling price hierarchy for a deliverable is based on: (1) vendor specific objective evidence (“VSOE”), if available; (2) third party evidence of selling price if VSOE is not available; or (3) an estimated selling price, if neither VSOE nor third party evidence is available. Estimated selling price is our best estimate of the selling price of an element in a transaction. The Company limits the amount of revenue recognized for delivered elements to the amount that is not contingent on the future delivery of products or services or other future performance obligations. 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 condensed consolidated balance sheet and amortization is recorded on a straight-line basis over the term of the lease reported as a component of the individual costs and expenses as part of the condensed consolidated 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 condensed consolidated 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 condensed consolidated 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 implemented ASU 2016-09, Compensation-Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting on January 1, 2017. Pursuant to this guidance, we made a policy election to account for forfeitures as they occur rather than on an estimated basis. For periods prior to the adoption of this ASU, the Company estimated the forfeiture rate of unvested awards based on the forfeitures in the previous twelve-month period. The rate was calculated separately for awards to the board of directors/executives and all other awards. Further information regarding this change is included in Note 14, Employee Equity-Based Compensation . 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 does not incorporate option features that would require compensation to be recorded. See Note 14, Employee Equity-Based Compensation for further information. Cost of Sales Cost of sales consists of raw materials, depreciation, direct labor and stock-based compensation expense, manufacturing overhead, facility costs and warranty costs. Warranty Instruments are typically sold with a one year limited warranty, while kits and accessories are typically sold with a sixty days limited warranty. 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. The Company periodically assesses the adequacy of the warranty reserve and adjusts the amount as necessary. The expense incurred for these provisions is included in cost of sales on the condensed consolidated statements of operations and comprehensive loss. Shipping and Handling Shipping and handling costs billed to customers are included as a component of revenue. The corresponding expense incurred with third party carriers is included as a component of sales, general and administrative costs on the condensed consolidated statements of operations and comprehensive loss. 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, within the condensed consolidated statements of operations and comprehensive loss. The Company has assets and liabilities, primarily 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 foreign currency exchange gain or loss, within the condensed consolidated statements of operations and comprehensive loss. |
Recently Issued Accounting Pron
Recently Issued Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2017 | |
New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | |
Recently Issued Accounting Pronouncements | NOTE 2. RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS In May 2017, the Financial Accounting Standards Board (“FASB”) issued ASU 2017-09, Compensation—Stock Compensation (Topic 718) Scope of Modification Accounting. This amendment clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. It is effective prospectively for the annual period ending December 31, 2018 and interim periods within that annual period. Early adoption is permitted. Historically, modifications to our share-based awards is rare. As such, we do not expect the application of this standard to have a significant impact on our consolidated financial statements . In March 2017, the FASB issued ASU 2017-08, Receivable-Nonrefundable Fees and Other Costs (Topic 310-20) Premium Amortization on Purchased Callable Debt Securities. This amendment shortens the amortization period for certain callable debt securities held at a premium. Specifically, the amendment requires premiums to be amortized to the earliest call date. The amendments do not require an accounting change for securities held at a discount; the discount continues to be amortized to maturity. The guidance is effective for public business entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. Early adoption is permitted, including adoption in an interim period. If an entity early adopts in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. The amendments should be applied on a modified retrospective basis, with a cumulative-effect adjustment directly to retained earnings as of the beginning of the period of adoption. We are currently assessing the impact this will have on our consolidated financial statements and the timing of adoption. In October 2016, the FASB issued ASU 2016-16, Income Taxes (Topic 740) Intra-Entity Transfers of Assets Other Than Inventory. The update amends accounting guidance for intra-entity transfers of assets other than inventory to require the recognition of income tax consequences when the transfer occurs. The update is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017, with early adoption permitted. A modified retrospective approach should be applied. We are currently assessing the impact this will have on our consolidated financial statements and the timing of adoption. In June 2016, the FASB issued 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 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. 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 for us of January 1, 2018. Early adoption is permitted. 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 transition method. We are carefully evaluating our existing revenue recognition practices to determine the extent to which our 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. Given limited revenues have been recognized to date, we have not yet determined the effect of the standard on our future consolidated financial statements. |
FDA Clearance
FDA Clearance | 9 Months Ended |
Sep. 30, 2017 | |
Research and Development [Abstract] | |
FDA Clearance | NOTE 3. FDA CLEARANCE On February 23, 2017, the U.S. Food and Drug Administration (“FDA”) 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. Due to various factors, the Company manufactured inventory in advance of regulatory approval (pre-launch inventory). On January 1, 2017, the regulatory review process had progressed to a point that objective and persuasive evidence of approval was sufficiently probable, and a future economic benefit existed. On January 1, 2017, the Company started capitalizing pre-launch inventory. Additional information regarding inventory is included in Note 7, Inventory . Prior to January 1, 2017, all pre-launch inventory was not capitalized because a future economic benefit could not be asserted. Costs associated with the Company’s purchase of inventory were reported as research and development costs, or if the inventory was used in marketing evaluations, as sales, general and administrative costs on the consolidated statements of operations and comprehensive loss. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2017 | |
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 September 30, 2017 , and December 31, 2016 . September 30, 2017 (in thousands) Quoted Prices Significant Significant Total Assets: Cash and cash equivalents Money market funds $ 19,610 $ — $ — $ 19,610 Commercial paper — 1,800 — 1,800 Total cash and cash equivalents 19,610 1,800 — 21,410 Investments: Certificates of deposit — 14,367 — 14,367 US Treasury securities 12,009 — — 12,009 US Agency securities — 7,485 — 7,485 Commercial paper — 10,456 — 10,456 Asset-backed securities — 5,024 — 5,024 Corporate notes and bonds — 37,548 — 37,548 Total investments 12,009 74,880 — 86,889 Total assets measured at fair value $ 31,619 $ 76,680 $ — $ 108,299 December 31, 2016 (in thousands) Quoted Prices Significant Significant 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 Money market funds are included in cash and cash equivalents on the condensed 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 nine months ended September 30, 2017 . |
Concentration of Credit Risk
Concentration of Credit Risk | 9 Months Ended |
Sep. 30, 2017 | |
Risks and Uncertainties [Abstract] | |
Concentration of Credit Risk | NOTE 5. CONCENTRATION OF CREDIT RISK Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, investments and accounts receivable including receivables from major customers. The Company’s main financial institution for banking operations held 76% and 57% of the Company’s cash and cash equivalents as of September 30, 2017 , and December 31, 2016 , respectively. |
Investments
Investments | 9 Months Ended |
Sep. 30, 2017 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | NOTE 6. INVESTMENTS The following tables summarize the Company’s available-for-sale investments at September 30, 2017 , and December 31, 2016 : AVAILABLE-FOR-SALE INVESTMENTS September 30, 2017 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Certificates of deposit $ 14,367 $ — $ — $ 14,367 US Treasury securities 12,035 — (26 ) 12,009 US Agency securities 7,511 — (26 ) 7,485 Commercial paper 10,456 — — 10,456 Asset-backed securities 5,023 1 — 5,024 Corporate notes and bonds 37,577 — (29 ) 37,548 Total $ 86,969 $ 1 $ (81 ) $ 86,889 AVAILABLE-FOR-SALE INVESTMENTS December 31, 2016 (in thousands) Amortized Gross Gross 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 The following table summarizes the maturities of the Company’s available-for-sale securities at September 30, 2017 , and December 31, 2016 : AVAILABLE-FOR-SALE INVESTMENT MATURITIES (in thousands) September 30, 2017 December 31, 2016 Amortized Fair Value Amortized Fair Value Due in less than 1 year $ 60,999 $ 60,974 $ 45,391 $ 45,344 Due in 1-5 years 25,970 25,915 13,204 13,175 Total $ 86,969 $ 86,889 $ 58,595 $ 58,519 Proceeds from sales of marketable securities (including principal paydowns), for the three months ended September 30, 2017 and 2016 were $3.0 million and $7.7 million , respectively, and for the for the nine months ended September 30, 2017 and 2016 were $9.5 million and $8.7 million , 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 for the three and nine months ended September 30, 2016 , and no gross realized gains or losses from sales of marketable securities for the three and nine months ended September 30, 2017 . The gross proceeds associated with the realized gains for the three and nine months ended September 30, 2016 were $7.2 million . No other-than-temporary impairments are recorded as no material investment had a fair value that remained less than its cost for more than twelve months as of September 30, 2017 , and there have been no other indicators of impairment. 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 Note 4, Fair Value of Financial Instruments . |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2017 | |
Inventory Disclosure [Abstract] | |
Inventory | NOTE 7. INVENTORY Inventory is stated at the lesser of cost or net realizable value, with cost determined on the first-in-first-out method. The allocation of production overhead to inventory costs is based on normal production capacity. Abnormal amounts of idle facility expense and spoilage are expensed as incurred, and not included in overhead subject to capitalization. The Company maintains provisions for excess and obsolete inventory based on management’s estimates of forecasted demand and, where applicable, product expiration. The components of inventories were as follows (in thousands): September 30, December 31, 2017 2016 Raw materials $ 4,607 $ — Work in process 429 — Finished goods 2,305 — Inventory, net $ 7,341 $ — |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | NOTE 8. PROPERTY AND EQUIPMENT Property and equipment are recorded at cost and consisted of the following at September 30, 2017 , and December 31, 2016 . PROPERTY AND EQUIPMENT (in thousands) September 30, December 31, 2017 2016 Computer equipment $ 2,865 $ 2,270 Technical equipment 3,267 2,427 Facilities 3,512 3,387 Instruments 1,015 — Capital projects in progress 464 1,010 Total property and equipment $ 11,123 $ 9,094 Accumulated depreciation - other (6,433 ) (4,836 ) Net property and equipment $ 4,690 $ 4,258 Depreciation expense (which includes amortization of capital lease assets) for the three months ended September 30, 2017 and 2016 was $550,000 and $598,000 , respectively, and for the nine months ended September 30, 2017 and 2016 was $1.6 million and $1.7 million , respectively. |
License Agreements and Grants
License Agreements and Grants | 9 Months Ended |
Sep. 30, 2017 | |
Research and Development [Abstract] | |
License Agreements and Grants | NOTE 9. LICENSE AGREEMENTS AND GRANTS 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 carbepenem-resistant Enterobacteriaceae directly from whole blood. The cumulative sub-award amount is $885,000 , under which the Company has invoiced a total of $740,000 , which is recorded as an offset to research and development expenses. The amounts invoiced for the three months ended September 30, 2017 and 2016 were $180,000 and $8,000 , respectively, and for the nine months ended September 30, 2017 and 2016 were $183,000 and $67,000 , 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 September 30, 2017 , the Company has collected all of the $1.0 million in milestones. The full amount is recorded in current deferred revenue and 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 10, Deferred Revenue and Income . Arizona R&D Refundable Tax Credit Program The Company received a “Certificate of Qualification” from the Authority, which allowed the Company a partial refund of research and development investments. The amounts incurred under this program are recorded as an offset to research and development expenses, and for the nine months ended September 30, 2017 and 2016 were $0 and $1.2 million , respectively, and no amounts were incurred for three months ended September 30, 2017 and 2016 , 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 | 9 Months Ended |
Sep. 30, 2017 | |
Deferred Revenue Disclosure [Abstract] | |
Deferred Revenue and Income | NOTE 10. 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 September 30, 2017 , and December 31, 2016 , follows: Deferred Revenue and Income (in thousands) September 30, December 31, 2017 2016 Products and services not yet delivered $ 81 $ 35 Arizona Commerce Authority grant 1,000 — Total current deferred revenue and income $ 1,081 $ 35 Arizona Commerce Authority grant — 1,000 Total long-term deferred income $ — $ 1,000 We have received $1.0 million in milestone payments from the Authority under the Grant Agreement described in Note 9, License Agreements and Grants . As of September 30, 2017 , 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. |
Stock Purchase
Stock Purchase | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Stock Purchase | NOTE 11. STOCK PURCHASE In April 2012, we entered into a Securities Purchase Agreement with Abeja Ventures, LLC pursuant to which the Company agreed, among other things, to issue a warrant to purchase shares of the Company’s common stock. Further details of this agreement are included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 , as filed with the SEC on February 28, 2017. As of December 31, 2016 , there were warrants to purchase 415,871 shares unexercised. During the nine months ended September 30, 2017 , warrants to purchase 370,307 shares were exercised at an exercise price of $2.00 per share. Proceeds from the exercise of such warrants totaling $741,000 are recorded as common stock and contributed capital in the condensed consolidated balance sheet. The remaining warrants to purchase 45,564 shares expired unexercised on June 26, 2017. |
Public Offering
Public Offering | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Public Offering | NOTE 12. PUBLIC OFFERING On May 9, 2017 , the Company published a prospectus supplement underwritten by J.P. Morgan Securities LLC, William Blair & Company, L.L.C., Piper Jaffray & Co. and BTIG, LLC ("Underwriters") offering 2.8 million shares of common stock with an option for the Underwriters to purchase up to 413,000 additional shares of common stock for a total of 3.2 million shares. The public offering price was $28.850 per share and underwriting discounts and commissions were $1.731 per share for net proceeds of $27.119 per share. The public offering was finalized and 2.8 million shares of common stock were delivered to the purchasers on or around May 15, 2017 . The Underwriters partially exercised their option to purchase an additional 335,000 shares, with the sale closing on June 14, 2017 , and the option as to the remaining shares expired June 15, 2017 . Proceeds from the sales totaled $89.0 million less underwriting discounts, commissions and other costs of $5.8 million for net proceeds of $83.2 million . The net proceeds will be used for general corporate purposes and to fund our commercialization efforts. 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. |
Earnings Per Share
Earnings Per Share | 9 Months Ended |
Sep. 30, 2017 | |
Earnings Per Share [Abstract] | |
Earnings Per Share | NOTE 13. EARNINGS PER SHARE The financial statements show basic and diluted loss per share. The Company’s net loss for the periods presented caused the inclusion of all outstanding warrants, restricted stock and options to purchase our common stock to be antidilutive. As of September 30, 2017 , and December 31, 2016 , there were common stock options, restricted stock units and warrants exercisable for 7,472,734 and 7,313,245 shares of common stock, respectively, which were not included in diluted loss per share as the effect was antidilutive. |
Employee Equity-Based Compensat
Employee Equity-Based Compensation | 9 Months Ended |
Sep. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Employee Equity-Based Compensation | NOTE 14. EMPLOYEE EQUITY-BASED COMPENSATION The following table summarizes option activity under all plans during the nine -month period ending September 30, 2017 : Stock Option Activity Number of Shares Weighted Average Exercise Price per Share Options outstanding December 31, 2016 6,857,124 $ 7.72 Granted 1,113,861 24.49 Forfeited (131,167 ) 21.41 Exercised (384,812 ) 9.93 Expired (6,422 ) 24.45 Options Outstanding September 30, 2017 7,448,584 9.86 The table below summarizes the resulting weighted average inputs used to calculate the estimated fair value of options awarded during the periods shown below: Black-Scholes Assumptions for Options Granted Three Months Ended September 30, 2017 September 30, 2016 Expected term (in years) 6.46 6.46 Volatility 74 % 89 % Expected dividends — — Risk free interest rates 2.02 % 1.30 % Weighted average fair value $ 15.74 $ 15.40 The following table shows summary information for outstanding options and options that are exercisable (vested) as of September 30, 2017 : Stock Option Supplemental Information Options Outstanding Options Exercisable Number of options 7,448,584 5,214,464 Weighted average remaining contractual term (in years) 6.32 5.40 Weighted average exercise price $ 9.86 $ 6.02 Weighted average fair value $ 7.31 $ 4.51 Aggregate intrinsic value (in thousands) $ 96,074 $ 86,005 The following table summarizes restricted stock unit and restricted stock award activity during the nine -month period ending September 30, 2017 : Restricted Stock Unit (RSU) and Restricted Stock Award (RSA) Activity Number of Shares Weighted Average Grant Date Fair Value per Share RSUs & RSAs Outstanding December 31, 2016 40,250 $ 20.91 Granted 1,911 22.40 Forfeited — — Vested/released (18,011 ) 21.07 RSUs & RSAs outstanding September 30, 2017 24,150 20.91 The expense recognized on the Company’s condensed consolidated statements of operations and comprehensive loss related to options is summarized below: Equity-Based Compensation Expenses (in thousands) Three Months Ended Nine Months Ended September 30, 2017 September 30, 2016 September 30, 2017 September 30, 2016 Cost of sales $ 22 $ — $ 44 $ — Research and development 994 504 2,886 1,168 Sales, general and administrative 2,504 2,166 8,040 5,423 Equity-based compensation expense $ 3,520 $ 2,670 $ 10,970 $ 6,591 As of September 30, 2017 , $262,000 and $33,000 of equity-based compensation expense was a component of capitalized inventory and property and equipment respectively. As of September 30, 2017 , unrecognized equity-based compensation cost related to unvested stock options and unvested restricted stock units was $16.7 million and $ 216,000 respectively. This is expected to be recognized over the years 2017 through 2022 . As discussed in Note 1 , we implemented ASU 2016-09, Compensation-Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting on January 1, 2017. Pursuant to this guidance, we made a policy election to account for forfeitures as they occur rather than on an estimated basis and, therefore, equity based compensation expense for the three and nine months ended September 30, 2017 has been calculated based on actual forfeitures in our condensed consolidated statements of operations and comprehensive loss, rather than our previous approach which was net of estimated forfeitures. Share-based compensation expense for the three and nine months ended September 30, 2016 is recorded net of estimated forfeitures, which were based on historical forfeitures and adjusted to reflect changes in facts and circumstances, if any. This change was accounted for using the modified retrospective transition method. This election resulted in a cumulative-effect adjustment which increased our accumulated deficit and additional paid-in capital by $655,000 for all outstanding awards as of January 1, 2017. We believe this election simplifies several aspects of the accounting for share-based payment transactions. This new guidance requires that we record excess tax benefits and tax deficiencies related to the settlement of employee stock-based compensation to the income tax expense line item on our condensed consolidated statements of operations and comprehensive loss. The new guidance also states that previously unrecognized excess tax benefits should be recognized on a modified retrospective basis as of the beginning of the annual period of adoption. At January 1, 2017, we recorded approximately $1.5 million of additional deferred tax assets, which are fully offset by a valuation allowance. Accordingly, the adoption of ASU 2016-09 did not result in an adjustment to retained earnings for the cumulative effect of the tax benefit of the stock compensation. The new guidance also requires excess tax benefits to be classified as an operating activity in the statement of cash flows rather than as a financing activity. Additionally, ASU 2016-09 requires that the minimum tax withholding paid on behalf of employees for share-based awards be classified as a financing activity in the statement of cash flows. Adoption of ASU 2016-09 did not result in any adjustments to prior period disclosures on the condensed consolidated statement of cash flows. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | NOTE 15. INCOME TAXES For the nine months ended September 30, 2017 , the Company recorded a provision for income taxes of $220,000 , which primarily related to a profitable foreign jurisdiction without any net operating loss carryforwards. The Company’s tax expense for the nine months ended September 30, 2017 differs from the tax expense computed by applying the U.S. statutory tax rate to its year-to-date pre-tax loss of $47.5 million as no tax benefits were recorded for tax losses generated in the U.S. and other foreign jurisdictions. At September 30, 2017 , the Company had deferred tax assets primarily related to U.S. federal and state tax loss carryforwards. The Company provided a full valuation allowance against its deferred tax assets as future realization of such assets is not more likely than not to occur. At September 30, 2017 , the Company had gross unrecognized tax benefits of $1.1 million . The Company is not currently under examination by taxing authorities and does not believe the amount of unrecognized tax benefits will significantly increase or decrease over the next 12 months. |
Commitments
Commitments | 9 Months Ended |
Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | NOTE 16. COMMITMENTS Leases The Company has entered into lease agreements, lease amendments, and lease extensions the last of which expires in 2022. Total rent expense, including common area charges was $308,000 and $286,000 for the three months ended September 30, 2017 and 2016 , respectively, and for the nine months ended September 30, 2017 and 2016 was $933,000 and $826,000 , respectively. Future minimum lease payments under operating lease agreements are as follows: Operating Lease Obligations (in thousands) Year ending December 31: 2017 $ 264 2018 1,022 2019 180 2020 65 2021 30 Thereafter 4 Total operating lease obligations $ 1,565 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. The Company incurred clinical trial expense of $0 and $354,000 for the three months ended September 30, 2017 and 2016 , respectively, and $27,000 and $1.8 million for the nine months ended September 30, 2017 and 2016 , respectively. The expense incurred as part of the clinical trial is included in research and development on the condensed 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, 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 ID/AST 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. Chang v. Accelerate Diagnostics, Inc., et al., No. 2:15-CV-00504-SPL (9th Cir. filed Feb. 26, 2016). On September 13, 2017, Plaintiff voluntarily dismissed the appeal and the case has been dismissed with prejudice. |
Segments
Segments | 9 Months Ended |
Sep. 30, 2017 | |
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. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2017 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | NOTE 18. RELATED PARTY TRANSACTIONS 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 condensed consolidated balance sheet. |
Organization and Nature of Bu24
Organization and Nature of Business; Basis of Presentation; Principles of Consolidation; Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed 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 interim financial reporting. Certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. Therefore, these condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 , as filed with the SEC on February 28, 2017. The condensed consolidated balance sheet as of December 31, 2016 included herein was derived from the audited financial statements as of that date, but does not include all disclosures such as notes required by U.S. GAAP. The accompanying unaudited condensed consolidated financial statements reflect all normal recurring adjustments necessary to present fairly the financial position, results of operations, and cash flows for the interim periods presented, but are not necessarily indicative of the results of operations to be anticipated for the entire year ending December 31, 2017 , or any future period. All amounts are rounded to the nearest thousand dollars unless otherwise indicated. |
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. |
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. |
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 and certificates of deposit. Management classifies its investments as available-for-sale investments and records these investments in the condensed 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 . |
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. In the current period presentation and the revised prior period presentation, depreciation and amortization expenses are reported as a component of the individual costs and expenses as part of the condensed consolidated statements of operations and comprehensive loss. The amount of depreciation and amortization expenses now reported as a component of research and development costs for the three months ended September 30, 2017 and 2016 were $303,000 and $342,000 , respectively, and for the nine months ended September 30, 2017 and 2016 were $1,086,000 and $1,026,000 , respectively. The amount of depreciation and amortization expenses now reported as a component of sales, general and administrative costs for the three months ended September 30, 2017 and 2016 were $168,000 and $259,000 , respectively, and for the nine months ended September 30, 2017 and 2016 were $435,000 and $727,000 , respectively. In the current and revised prior period presentation, product sales and licensing and royalty revenues are reported as net sales as part of the condensed consolidated statements of operations and comprehensive loss. The amounts that have been reclassified had no effect on our net income, stockholders’ equity or cash flows. |
Inventory | Inventory Inventory is stated at the lesser of cost or net realizable value, with cost determined on the first-in-first-out method. The allocation of production overhead to inventory costs is based on normal production capacity. Abnormal amounts of idle facility expense and spoilage are expensed as incurred and not included in overhead subject to capitalization. The Company maintains provisions for excess and obsolete inventory based on management’s estimates of forecasted demand and, where applicable, product expiration. The Company adopted Accounting Standards Update (“ASU”) 2015-11, Simplifying the Measurement of Inventory (Topic 310) Inventory on January 1, 2017. This ASU simplifies the subsequent measurement of inventory by using only the lower of cost or net realizable value. The adoption did not have an effect on the Company’s consolidated financial statements. |
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 greater than one year to seven years. Leasehold improvements are depreciated over the remaining life of the lease or the life of the asset, whichever is less. Property and equipment includes diagnostic instruments used for sales demonstrations and instruments under rental agreements. The Company retains title to the instruments under these arrangements. |
Revenue | Revenue 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. The customer agrees to purchase consumable products at a stated price over the term of the agreement which is typically less than seven years. Contracts sometimes have renewal clauses but such clauses do not provide for a bargain renewal option or penalize the customer if they do not renew. The instrument remains the Company’s 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. For multiple element arrangements, the total consideration for an arrangement is allocated among the separate elements in the arrangement based on a selling price hierarchy. The selling price hierarchy for a deliverable is based on: (1) vendor specific objective evidence (“VSOE”), if available; (2) third party evidence of selling price if VSOE is not available; or (3) an estimated selling price, if neither VSOE nor third party evidence is available. Estimated selling price is our best estimate of the selling price of an element in a transaction. The Company limits the amount of revenue recognized for delivered elements to the amount that is not contingent on the future delivery of products or services or other future performance obligations. |
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 condensed consolidated balance sheet and amortization is recorded on a straight-line basis over the term of the lease reported as a component of the individual costs and expenses as part of the condensed consolidated 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 condensed consolidated 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 condensed consolidated 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 implemented ASU 2016-09, Compensation-Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting on January 1, 2017. Pursuant to this guidance, we made a policy election to account for forfeitures as they occur rather than on an estimated basis. For periods prior to the adoption of this ASU, the Company estimated the forfeiture rate of unvested awards based on the forfeitures in the previous twelve-month period. The rate was calculated separately for awards to the board of directors/executives and all other awards. Further information regarding this change is included in Note 14, Employee Equity-Based Compensation . 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 does not incorporate option features that would require compensation to be recorded. |
Cost of Sales | Cost of Sales Cost of sales consists of raw materials, depreciation, direct labor and stock-based compensation expense, manufacturing overhead, facility costs and warranty costs. |
Warranty | Warranty Instruments are typically sold with a one year limited warranty, while kits and accessories are typically sold with a sixty days limited warranty. 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. The Company periodically assesses the adequacy of the warranty reserve and adjusts the amount as necessary. The expense incurred for these provisions is included in cost of sales on the condensed consolidated statements of operations and comprehensive loss. |
Shipping and Handling | Shipping and Handling Shipping and handling costs billed to customers are included as a component of revenue. The corresponding expense incurred with third party carriers is included as a component of sales, general and administrative costs on the condensed consolidated statements of operations and comprehensive loss. |
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, within the condensed consolidated statements of operations and comprehensive loss. The Company has assets and liabilities, primarily 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 foreign currency exchange gain or loss, within the condensed consolidated statements of operations and comprehensive loss. |
Recently Issued Accounting Pronouncements | In May 2017, the Financial Accounting Standards Board (“FASB”) issued ASU 2017-09, Compensation—Stock Compensation (Topic 718) Scope of Modification Accounting. This amendment clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. It is effective prospectively for the annual period ending December 31, 2018 and interim periods within that annual period. Early adoption is permitted. Historically, modifications to our share-based awards is rare. As such, we do not expect the application of this standard to have a significant impact on our consolidated financial statements . In March 2017, the FASB issued ASU 2017-08, Receivable-Nonrefundable Fees and Other Costs (Topic 310-20) Premium Amortization on Purchased Callable Debt Securities. This amendment shortens the amortization period for certain callable debt securities held at a premium. Specifically, the amendment requires premiums to be amortized to the earliest call date. The amendments do not require an accounting change for securities held at a discount; the discount continues to be amortized to maturity. The guidance is effective for public business entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. Early adoption is permitted, including adoption in an interim period. If an entity early adopts in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. The amendments should be applied on a modified retrospective basis, with a cumulative-effect adjustment directly to retained earnings as of the beginning of the period of adoption. We are currently assessing the impact this will have on our consolidated financial statements and the timing of adoption. In October 2016, the FASB issued ASU 2016-16, Income Taxes (Topic 740) Intra-Entity Transfers of Assets Other Than Inventory. The update amends accounting guidance for intra-entity transfers of assets other than inventory to require the recognition of income tax consequences when the transfer occurs. The update is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017, with early adoption permitted. A modified retrospective approach should be applied. We are currently assessing the impact this will have on our consolidated financial statements and the timing of adoption. In June 2016, the FASB issued 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 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. 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 for us of January 1, 2018. Early adoption is permitted. 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 transition method. We are carefully evaluating our existing revenue recognition practices to determine the extent to which our 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. Given limited revenues have been recognized to date, we have not yet determined the effect of the standard on our future consolidated financial statements. |
Fair Value of Financial Instr25
Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
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 September 30, 2017 , and December 31, 2016 . September 30, 2017 (in thousands) Quoted Prices Significant Significant Total Assets: Cash and cash equivalents Money market funds $ 19,610 $ — $ — $ 19,610 Commercial paper — 1,800 — 1,800 Total cash and cash equivalents 19,610 1,800 — 21,410 Investments: Certificates of deposit — 14,367 — 14,367 US Treasury securities 12,009 — — 12,009 US Agency securities — 7,485 — 7,485 Commercial paper — 10,456 — 10,456 Asset-backed securities — 5,024 — 5,024 Corporate notes and bonds — 37,548 — 37,548 Total investments 12,009 74,880 — 86,889 Total assets measured at fair value $ 31,619 $ 76,680 $ — $ 108,299 December 31, 2016 (in thousands) Quoted Prices Significant Significant 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 |
Investments (Tables)
Investments (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Available-for-Sale Investments | The following tables summarize the Company’s available-for-sale investments at September 30, 2017 , and December 31, 2016 : AVAILABLE-FOR-SALE INVESTMENTS September 30, 2017 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Certificates of deposit $ 14,367 $ — $ — $ 14,367 US Treasury securities 12,035 — (26 ) 12,009 US Agency securities 7,511 — (26 ) 7,485 Commercial paper 10,456 — — 10,456 Asset-backed securities 5,023 1 — 5,024 Corporate notes and bonds 37,577 — (29 ) 37,548 Total $ 86,969 $ 1 $ (81 ) $ 86,889 AVAILABLE-FOR-SALE INVESTMENTS December 31, 2016 (in thousands) Amortized Gross Gross 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 |
Schedule of Available-For-Sale Investment Maturities | The following table summarizes the maturities of the Company’s available-for-sale securities at September 30, 2017 , and December 31, 2016 : AVAILABLE-FOR-SALE INVESTMENT MATURITIES (in thousands) September 30, 2017 December 31, 2016 Amortized Fair Value Amortized Fair Value Due in less than 1 year $ 60,999 $ 60,974 $ 45,391 $ 45,344 Due in 1-5 years 25,970 25,915 13,204 13,175 Total $ 86,969 $ 86,889 $ 58,595 $ 58,519 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Inventory Disclosure [Abstract] | |
Components of Inventories | The components of inventories were as follows (in thousands): September 30, December 31, 2017 2016 Raw materials $ 4,607 $ — Work in process 429 — Finished goods 2,305 — Inventory, net $ 7,341 $ — |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment are recorded at cost and consisted of the following at September 30, 2017 , and December 31, 2016 . PROPERTY AND EQUIPMENT (in thousands) September 30, December 31, 2017 2016 Computer equipment $ 2,865 $ 2,270 Technical equipment 3,267 2,427 Facilities 3,512 3,387 Instruments 1,015 — Capital projects in progress 464 1,010 Total property and equipment $ 11,123 $ 9,094 Accumulated depreciation - other (6,433 ) (4,836 ) Net property and equipment $ 4,690 $ 4,258 |
Deferred Revenue and Income (Ta
Deferred Revenue and Income (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Deferred Revenue Disclosure [Abstract] | |
Deferred Revenue and Income Summary | A summary of the balances as of September 30, 2017 , and December 31, 2016 , follows: Deferred Revenue and Income (in thousands) September 30, December 31, 2017 2016 Products and services not yet delivered $ 81 $ 35 Arizona Commerce Authority grant 1,000 — Total current deferred revenue and income $ 1,081 $ 35 Arizona Commerce Authority grant — 1,000 Total long-term deferred income $ — $ 1,000 |
Employee Equity-Based Compens30
Employee Equity-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Option Activity | The following table summarizes option activity under all plans during the nine -month period ending September 30, 2017 : Stock Option Activity Number of Shares Weighted Average Exercise Price per Share Options outstanding December 31, 2016 6,857,124 $ 7.72 Granted 1,113,861 24.49 Forfeited (131,167 ) 21.41 Exercised (384,812 ) 9.93 Expired (6,422 ) 24.45 Options Outstanding September 30, 2017 7,448,584 9.86 |
Black-Scholes Assumptions for Options Granted | The table below summarizes the resulting weighted average inputs used to calculate the estimated fair value of options awarded during the periods shown below: Black-Scholes Assumptions for Options Granted Three Months Ended September 30, 2017 September 30, 2016 Expected term (in years) 6.46 6.46 Volatility 74 % 89 % Expected dividends — — Risk free interest rates 2.02 % 1.30 % Weighted average fair value $ 15.74 $ 15.40 |
Stock Option Supplemental Information | The following table shows summary information for outstanding options and options that are exercisable (vested) as of September 30, 2017 : Stock Option Supplemental Information Options Outstanding Options Exercisable Number of options 7,448,584 5,214,464 Weighted average remaining contractual term (in years) 6.32 5.40 Weighted average exercise price $ 9.86 $ 6.02 Weighted average fair value $ 7.31 $ 4.51 Aggregate intrinsic value (in thousands) $ 96,074 $ 86,005 |
Restricted Stock Unit (RSU) Activity | The following table summarizes restricted stock unit and restricted stock award activity during the nine -month period ending September 30, 2017 : Restricted Stock Unit (RSU) and Restricted Stock Award (RSA) Activity Number of Shares Weighted Average Grant Date Fair Value per Share RSUs & RSAs Outstanding December 31, 2016 40,250 $ 20.91 Granted 1,911 22.40 Forfeited — — Vested/released (18,011 ) 21.07 RSUs & RSAs outstanding September 30, 2017 24,150 20.91 |
Equity-Based Compensation Expenses | The expense recognized on the Company’s condensed consolidated statements of operations and comprehensive loss related to options is summarized below: Equity-Based Compensation Expenses (in thousands) Three Months Ended Nine Months Ended September 30, 2017 September 30, 2016 September 30, 2017 September 30, 2016 Cost of sales $ 22 $ — $ 44 $ — Research and development 994 504 2,886 1,168 Sales, general and administrative 2,504 2,166 8,040 5,423 Equity-based compensation expense $ 3,520 $ 2,670 $ 10,970 $ 6,591 |
Commitments (Tables)
Commitments (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Operating Leases Obligations | Future minimum lease payments under operating lease agreements are as follows: Operating Lease Obligations (in thousands) Year ending December 31: 2017 $ 264 2018 1,022 2019 180 2020 65 2021 30 Thereafter 4 Total operating lease obligations $ 1,565 |
Organization and Nature of Bu32
Organization and Nature of Business; Basis of Presentation; Principles of Consolidation; Significant Accounting Policies (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Depreciation and amortization expense | $ 550 | $ 598 | $ 1,600 | $ 1,700 |
Bundled rental agreement, term | 7 years | |||
Dividend yield | 0.00% | 0.00% | 0.00% | |
Instrument warranty term | 1 year | |||
Kits and accessories warranty term | 60 days | |||
Minimum | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Estimated useful life of assets | 1 year | |||
Maximum | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Estimated useful life of assets | 7 years | |||
Research and development | Reclassification | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Depreciation and amortization expense | $ 303 | $ 342 | $ 1,086 | 1,026 |
Sales, general and administrative | Reclassification | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Depreciation and amortization expense | $ 168 | $ 259 | $ 435 | $ 727 |
Fair Value of Financial Instr33
Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | $ 86,889 | $ 58,519 |
Fair value on a recurring basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 21,410 | |
Investments | 86,889 | 58,519 |
Total assets measured at fair value | 108,299 | 69,489 |
Fair value on a recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 19,610 | |
Investments | 12,009 | 8,544 |
Total assets measured at fair value | 31,619 | 19,514 |
Fair value on a recurring basis | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 1,800 | |
Investments | 74,880 | 49,975 |
Total assets measured at fair value | 76,680 | 49,975 |
Fair value on a recurring basis | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 0 | |
Investments | 0 | 0 |
Total assets measured at fair value | 0 | 0 |
Fair value on a recurring basis | Certificates of deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 14,367 | 7,257 |
Fair value on a recurring basis | Certificates of deposit | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair value on a recurring basis | Certificates of deposit | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 14,367 | 7,257 |
Fair value on a recurring basis | Certificates of deposit | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair value on a recurring basis | US Treasury securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 12,009 | 8,544 |
Fair value on a recurring basis | US Treasury securities | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 12,009 | 8,544 |
Fair value on a recurring basis | US Treasury securities | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair value on a recurring basis | US Treasury securities | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair value on a recurring basis | US Agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 7,485 | 4,501 |
Fair value on a recurring basis | US Agency securities | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair value on a recurring basis | US Agency securities | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 7,485 | 4,501 |
Fair value on a recurring basis | US Agency securities | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair value on a recurring basis | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 10,456 | |
Fair value on a recurring basis | Commercial paper | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair value on a recurring basis | Commercial paper | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 10,456 | |
Fair value on a recurring basis | Commercial paper | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | |
Fair value on a recurring basis | Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 5,024 | 5,557 |
Fair value on a recurring basis | Asset-backed securities | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair value on a recurring basis | Asset-backed securities | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 5,024 | 5,557 |
Fair value on a recurring basis | Asset-backed securities | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair value on a recurring basis | Corporate notes and bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 37,548 | 32,660 |
Fair value on a recurring basis | Corporate notes and bonds | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair value on a recurring basis | Corporate notes and bonds | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 37,548 | 32,660 |
Fair value on a recurring basis | Corporate notes and bonds | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Fair value on a recurring basis | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 19,610 | 10,970 |
Fair value on a recurring basis | Money market funds | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 19,610 | 10,970 |
Fair value on a recurring basis | Money market funds | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 0 | 0 |
Fair value on a recurring basis | Money market funds | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 0 | $ 0 |
Fair value on a recurring basis | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 1,800 | |
Fair value on a recurring basis | Commercial paper | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 0 | |
Fair value on a recurring basis | Commercial paper | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 1,800 | |
Fair value on a recurring basis | Commercial paper | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 0 |
Concentration of Credit Risk (D
Concentration of Credit Risk (Details) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2017 | Dec. 31, 2016 | |
Cash and cash equivalents | Concentration of credit risk | ||
Concentration Risk [Line Items] | ||
Risk concentration | 76.00% | 57.00% |
Investments - Schedule of Avail
Investments - Schedule of Available-for-sale Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Investment [Line Items] | ||
Amortized Cost | $ 86,969 | $ 58,595 |
Gross Unrealized Gains | 1 | 7 |
Gross Unrealized Losses | (81) | (83) |
Fair Value | 86,889 | 58,519 |
Certificates of deposit | ||
Investment [Line Items] | ||
Amortized Cost | 14,367 | 7,257 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 14,367 | 7,257 |
US Treasury securities | ||
Investment [Line Items] | ||
Amortized Cost | 12,035 | 8,553 |
Gross Unrealized Gains | 0 | 1 |
Gross Unrealized Losses | (26) | (10) |
Fair Value | 12,009 | 8,544 |
US Agency securities | ||
Investment [Line Items] | ||
Amortized Cost | 7,511 | 4,514 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (26) | (13) |
Fair Value | 7,485 | 4,501 |
Commercial paper | ||
Investment [Line Items] | ||
Amortized Cost | 10,456 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | 10,456 | |
Asset-backed securities | ||
Investment [Line Items] | ||
Amortized Cost | 5,023 | 5,554 |
Gross Unrealized Gains | 1 | 3 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 5,024 | 5,557 |
Corporate notes and bonds | ||
Investment [Line Items] | ||
Amortized Cost | 37,577 | 32,717 |
Gross Unrealized Gains | 0 | 3 |
Gross Unrealized Losses | (29) | (60) |
Fair Value | $ 37,548 | $ 32,660 |
Investments - Schedule of Ava36
Investments - Schedule of Available-for-Sale Investment Maturities (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Amortized Cost | ||
Due in less than 1 year | $ 60,999 | $ 45,391 |
Due in 1-5 years | 25,970 | 13,204 |
Total | 86,969 | 58,595 |
Fair Value | ||
Due in less than 1 year | 60,974 | 45,344 |
Due in 1-5 years | 25,915 | 13,175 |
Total | $ 86,889 | $ 58,519 |
Investments - Narrative (Detail
Investments - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Investments, Debt and Equity Securities [Abstract] | ||||
Proceeds from sales of marketable securities | $ 3,000,000 | $ 7,700,000 | $ 9,522,000 | $ 8,716,000 |
Gross realized gains or losses from sales of marketable securities | $ 0 | (6,000) | $ 0 | (6,000) |
Gross proceeds | $ 7,200,000 | $ 7,200,000 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 4,607 | $ 0 |
Work in process | 429 | 0 |
Finished goods | 2,305 | 0 |
Inventory, net | $ 7,341 | $ 0 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Property, Plant and Equipment [Line Items] | |||||
Total property and equipment | $ 11,123 | $ 11,123 | $ 9,094 | ||
Accumulated depreciation - other | (6,433) | (6,433) | (4,836) | ||
Net property and equipment | 4,690 | 4,690 | 4,258 | ||
Depreciation | 550 | $ 598 | 1,600 | $ 1,700 | |
Computer equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Total property and equipment | 2,865 | 2,865 | 2,270 | ||
Technical equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Total property and equipment | 3,267 | 3,267 | 2,427 | ||
Facilities | |||||
Property, Plant and Equipment [Line Items] | |||||
Total property and equipment | 3,512 | 3,512 | 3,387 | ||
Instruments | |||||
Property, Plant and Equipment [Line Items] | |||||
Total property and equipment | 1,015 | 1,015 | 0 | ||
Capital projects in progress | |||||
Property, Plant and Equipment [Line Items] | |||||
Total property and equipment | $ 464 | $ 464 | $ 1,010 |
License Agreements and Grants -
License Agreements and Grants - National Institute of Health Grant (Details) - National Institute of Health Grant - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 32 Months Ended | ||
Feb. 28, 2015 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Length of project | 5 years | |||||
Total grant funding | $ 5,000 | $ 180 | $ 8 | $ 183 | $ 67 | $ 740 |
Research and Development Arrangement, Contract to Perform for Others, Invoiced | $ 885 |
License Agreements and Grants41
License Agreements and Grants - Arizona Commerce Authority and R&D Refundable Tax Credit Program (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Aug. 31, 2012USD ($)jobmilestone | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | |
Research and Development [Abstract] | |||||
Arizona Commerce Authority grant | $ | $ 1,000,000 | $ 1,000,000 | $ 1,000,000 | ||
Number of installments | 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 | $ | $ 0 | $ 0 | $ 0 | $ 1,200,000 | |
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 ($) | Sep. 30, 2017 | Dec. 31, 2016 | Aug. 31, 2012 |
Deferred Revenue Disclosure [Abstract] | |||
Products and services not yet delivered | $ 81,000 | $ 35,000 | |
Arizona Commerce Authority grant | 1,000,000 | 0 | |
Total current deferred revenue and income | 1,081,000 | 35,000 | |
Arizona Commerce Authority grant | 0 | 1,000,000 | |
Total long-term deferred income | 0 | $ 1,000,000 | |
Milestone payments from the Arizona Commerce Authority | $ 1,000,000 | $ 1,000,000 |
Stock Purchase (Details)
Stock Purchase (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Dec. 31, 2016 | |
Equity [Abstract] | ||
Unexercised warrants (shares) | 45,564 | 415,871 |
Additional exercised warrant per purchase agreement (shares) | 370,307 | |
Price per warrant (usd per share) | $ 2 | |
Proceeds from warrants | $ 741 |
Public Offering (Details)
Public Offering (Details) - USD ($) $ / shares in Units, $ in Millions | May 15, 2017 | May 09, 2017 |
Shares to the public | Pro-forma | ||
Subsidiary, Sale of Stock [Line Items] | ||
Sale of stock (shares) | 2,800,000 | |
Over-allotment option | ||
Subsidiary, Sale of Stock [Line Items] | ||
Sale of stock (shares) | 335,000 | |
Over-allotment option | Pro-forma | ||
Subsidiary, Sale of Stock [Line Items] | ||
Sale of stock (shares) | 413,000 | |
Public offering | ||
Subsidiary, Sale of Stock [Line Items] | ||
Sale of stock (shares) | 2,800,000 | |
Public offering price (usd per share) | $ 28.850 | |
Underwriting discounts and commissions (usd per share) | 1.731 | |
Net proceeds (usd per share) | $ 27.119 | |
Total proceeds from sale | $ 89 | |
Underwriting discounts, commissions and other costs | 5.8 | |
Net proceeds | $ 83.2 | |
Public offering | Pro-forma | ||
Subsidiary, Sale of Stock [Line Items] | ||
Sale of stock (shares) | 3,200,000 |
Earnings Per Share (Details)
Earnings Per Share (Details) - shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2017 | Dec. 31, 2016 | |
Earnings Per Share [Abstract] | ||
Antidilutive common stock instruments outstanding (shares) | 7,472,734 | 7,313,245 |
Employee Equity-Based Compens46
Employee Equity-Based Compensation - Stock Option Activity (Details) | 9 Months Ended |
Sep. 30, 2017$ / sharesshares | |
Number of Shares | |
Outstanding, beginning balance (shares) | shares | 6,857,124 |
Granted (shares) | shares | 1,113,861 |
Forfeited (shares) | shares | (131,167) |
Exercised (shares) | shares | (384,812) |
Expired (shares) | shares | (6,422) |
Outstanding, ending balance (shares) | shares | 7,448,584 |
Weighted Average Exercise Price per Share | |
Outstanding, beginning balance (dollars per share) | $ / shares | $ 7.72 |
Granted (dollars per share) | $ / shares | 24.49 |
Forfeited (dollars per share) | $ / shares | 21.41 |
Exercised (dollars per share) | $ / shares | 9.93 |
Expired (dollars per share) | $ / shares | 24.45 |
Outstanding, ending balance (dollars per share) | $ / shares | $ 9.86 |
Employee Equity-Based Compens47
Employee Equity-Based Compensation - Black-Scholes Assumptions for Option Granted (Details) - $ / shares | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Expected term (in years) | 6 years 5 months 16 days | 6 years 5 months 16 days | |
Volatility | 74.00% | 89.00% | |
Expected dividends | 0.00% | 0.00% | 0.00% |
Risk free interest rates | 2.02% | 1.30% | |
Weighted average fair value (dollars per share) | $ 15.74 | $ 15.40 |
Employee Equity-Based Compens48
Employee Equity-Based Compensation - Stock Option Supplemental Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Dec. 31, 2016 | |
Options Outstanding | ||
Number of options (shares) | 7,448,584 | 6,857,124 |
Weighted average remaining contractual term (in years) | 6 years 3 months 26 days | |
Weighted average exercise price (dollars per share) | $ 9.86 | $ 7.72 |
Weighted average fair value (dollars per share) | $ 7.31 | |
Aggregate intrinsic value (in thousands) | $ 96,074 | |
Options Exercisable | ||
Number of options (shares) | 5,214,464 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 5 years 4 months 24 days | |
Weighted average exercise price (dollars per share) | $ 6.02 | |
Weighted average fair value (dollars per share) | $ 4.51 | |
Aggregate intrinsic value (in thousands) | $ 86,005 |
Employee Equity-Based Compens49
Employee Equity-Based Compensation - Restricted Stock Activity (Details) - RSUs and RSAs | 9 Months Ended |
Sep. 30, 2017$ / sharesshares | |
Number of Shares | |
Beginning balance (shares) | shares | 40,250 |
Granted (shares) | shares | 1,911 |
Forfeited (shares) | shares | 0 |
Vested/Released (shares) | shares | (18,011) |
Ending balance (shares) | shares | 24,150 |
Weighted Average Grant Date Fair Value per Share | |
Beginning balance (dollars per share) | $ / shares | $ 20.91 |
Granted (dollars per share) | $ / shares | 22.40 |
Forfeited (dollars per share) | $ / shares | 0 |
Vested/Released (dollars per share) | $ / shares | 21.07 |
Ending balance (dollars per share) | $ / shares | $ 20.91 |
Employee Equity-Based Compens50
Employee Equity-Based Compensation - Equity-Based Compensation Expense and Tax Benefit (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Jan. 01, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Equity-based compensation expense | $ 3,520 | $ 2,670 | $ 10,970 | $ 6,591 | |
Unrecognized equity-based compensation cost | 16,700 | 16,700 | |||
ASU 2016-09 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Additional deferred tax assets | $ 1,500 | ||||
ASU 2016-09 | Retained earnings | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Cumulative-effect adjustment | 655 | ||||
ASU 2016-09 | Additional paid-in capital | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Cumulative-effect adjustment | $ 655 | ||||
Restricted Stock Units (RSUs) | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Unrecognized equity-based compensation cost, restricted stock units | 216 | 216 | |||
Cost of sales | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Equity-based compensation expense | 22 | 0 | 44 | 0 | |
Research and development | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Equity-based compensation expense | 994 | 504 | 2,886 | 1,168 | |
Sales, general and administrative | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Equity-based compensation expense | 2,504 | $ 2,166 | $ 8,040 | $ 5,423 | |
Capitalized inventory | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Equity-based compensation expense | 262 | ||||
Property and equipment | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Equity-based compensation expense | $ 33 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Income Tax Disclosure [Abstract] | ||||
Provision from income taxes | $ 45 | $ 0 | $ 220 | $ 0 |
Pre-tax loss | (17,030) | $ (17,299) | (47,513) | $ (50,239) |
Gross unrecognized tax benefits | $ 1,100 | $ 1,100 |
Commitments - Narrative (Detail
Commitments - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Rent expense | $ 308,000 | $ 286,000 | $ 933,000 | $ 826,000 |
Research and development | ||||
Product Liability Contingency [Line Items] | ||||
Clinical trial expense | $ 0 | $ 354,000 | $ 27,000 | $ 1,800,000 |
Commitments - Operating Lease O
Commitments - Operating Lease Obligations (Details) $ in Thousands | Sep. 30, 2017USD ($) |
Year ending December 31: | |
2,017 | $ 264 |
2,018 | 1,022 |
2,019 | 180 |
2,020 | 65 |
2,021 | 30 |
Thereafter | 4 |
Total operating lease obligations | $ 1,565 |
Segments (Details)
Segments (Details) | 9 Months Ended |
Sep. 30, 2017segment | |
Segment Reporting [Abstract] | |
Number of operating segments | 1 |
Related Party Transaction (Deta
Related Party Transaction (Details) $ in Thousands | 1 Months Ended |
Jun. 30, 2016USD ($) | |
Recovery of short swing profits | |
Related Party Transaction [Line Items] | |
Recovery of short-swing profits | $ 866 |