Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Aug. 04, 2016 | |
Document And Entity Information | ||
Entity Registrant Name | Accelerate Diagnostics, Inc. | |
Entity Central Index Key | 727,207 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 51,228,452 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2,016 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEET - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 37,519 | $ 120,585 |
Investments | 64,919 | 11,839 |
Trade accounts receivable | 169 | 77 |
Prepaid expenses | 1,564 | 1,638 |
Other current assets | 1,232 | 12 |
Total current assets | 105,403 | 134,151 |
Property and equipment, net | 4,960 | 5,016 |
Intellectual property, net | 152 | 157 |
Total assets | 110,515 | 139,324 |
Current liabilities: | ||
Accounts payable | 1,789 | 2,623 |
Accrued liabilities | 2,642 | 2,543 |
Deferred revenue and income | 43 | 127 |
Capital lease obligations | 0 | 13 |
Total current liabilities | 4,474 | 5,306 |
Long-term deferred income | 1,000 | 1,000 |
Total liabilities | 5,474 | 6,306 |
Commitments and contingencies see Note 11, Commitments | 0 | 0 |
Stockholders' equity: | ||
Common stock, $0.001 par value; 75,000,000 common shares authorized with 51,218,417 shares issued and outstanding on June 30, 2016 and 55,000,000 authorized with 51,191,184 shares issued and outstanding on December 31, 2015 | 51 | 51 |
5,000,000 preferred shares authorized and none outstanding as of June 30, 2016 and December 31, 2015 | 0 | 0 |
Contributed capital | 248,776 | 243,894 |
Accumulated deficit | (143,855) | (110,915) |
Accumulated other comprehensive gain (loss) | 69 | (12) |
Total stockholders' equity | 105,041 | 133,018 |
Total liabilities and stockholders' equity | $ 110,515 | $ 139,324 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEET (Parenthetical) - $ / shares | Jun. 30, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Common Stock, par value (usd per share) | $ 0.001 | $ 0.001 |
Common Stock, shares authorized (shares) | 75,000,000 | 55,000,000 |
Common Stock, shares issued (shares) | 51,218,417 | 51,191,184 |
Common Stock, shares outstanding (shares) | 51,218,417 | 51,191,184 |
Preferred Stock, shares authorized (shares) | 5,000,000 | 5,000,000 |
Preferred Stock, shares outstanding (shares) | 0 | 0 |
STATEMENTS OF OPERATIONS AND CO
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Revenues: | ||||
Product sales | $ 0 | $ 0 | $ 143 | $ 0 |
Licensing and royalty revenues | 20 | 19 | 40 | 33 |
Total revenues | 20 | 19 | 183 | 33 |
Costs and expenses: | ||||
Research and development | 8,062 | 7,126 | 15,416 | 12,856 |
Sales, general and administrative | 9,239 | 4,755 | 16,676 | 7,622 |
Amortization | 3 | 3 | 5 | 5 |
Depreciation | 605 | 403 | 1,147 | 729 |
Total costs and expenses | 17,909 | 12,287 | 33,244 | 21,212 |
Loss from operations | (17,889) | (12,268) | (33,061) | (21,179) |
Interest expense and other | 0 | (2) | 0 | (3) |
Foreign currency exchange loss | (117) | 0 | (73) | 0 |
Interest and dividend income | 140 | 18 | 194 | 33 |
Total other income | 23 | 16 | 121 | 30 |
Net loss | $ (17,866) | $ (12,252) | $ (32,940) | $ (21,149) |
Basic and diluted net loss per share (dollars per share) | $ (0.35) | $ (0.27) | $ (0.64) | $ (0.47) |
Weighted average shares outstanding (shares) | 51,213 | 44,678 | 51,205 | 44,664 |
Other comprehensive loss: | ||||
Net loss | $ (17,866) | $ (12,252) | $ (32,940) | $ (21,149) |
Net unrealized gain (loss) on available-for-sale investments | 29 | (8) | 81 | (4) |
Foreign currency translation adjustment | 49 | 0 | 0 | 0 |
Comprehensive loss | $ (17,788) | $ (12,260) | $ (32,859) | $ (21,153) |
CONDENSED CONSOLIDATEDSTATEMENT
CONDENSED CONSOLIDATEDSTATEMENT OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Cash flows from operating activities: | ||
Net loss | $ (32,940) | $ (21,149) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 1,147 | 729 |
Amortization of intangible assets | 5 | 5 |
Amortization of investment discount | 123 | 99 |
Equity-based compensation | 3,921 | 4,185 |
(Increase) decrease in assets: | ||
Accounts receivable | (92) | (65) |
Prepaid expense and other | 272 | (675) |
Other current assets | (1,220) | 0 |
Increase (decrease) in liabilities: | ||
Accounts payable | (394) | (129) |
Accrued liabilities | 1,175 | 657 |
Deferred revenue and income | (84) | (14) |
Net cash used in operating activities | (28,087) | (16,357) |
Cash flows from investing activities: | ||
Purchases of equipment | (2,084) | (2,160) |
Purchases of available-for-sale securities | (63,534) | (8,017) |
Sales of available-for-sale securities | 1,000 | 141 |
Maturity of available-for-sale securities | 9,380 | 7,807 |
Net cash used in investing activities | (55,238) | (2,229) |
Cash flows from financing activities: | ||
Exercise of options | 95 | 327 |
Common stock issuance costs | (814) | 0 |
Payments on capital lease obligations | (13) | (73) |
Recovery of related party short-swing profits | 991 | 0 |
Net cash provided by financing activities | 259 | 254 |
Decrease in cash and cash equivalents | (83,066) | (18,332) |
Cash and cash equivalents, beginning of period | 120,585 | 53,563 |
Cash and cash equivalents, end of period | $ 37,519 | $ 35,231 |
Organization and Nature of Busi
Organization and Nature of Business; Basis of Presentation; Principles of Consolidation; Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2016 | |
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, 2015 , as filed with the SEC on March 9, 2016. The condensed consolidated balance sheet as of December 31, 2015 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, 2016 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. During the three months ended June 30, 2016 new entities were formed based in Europe. Cash and Cash Equivalents All highly liquid investments with an original maturity of three months or less at time of purchase are considered to be cash equivalents. Cash and cash equivalents include overnight repurchase agreement accounts and other investments. As part of our cash management process, excess operating cash is invested in overnight repurchase agreements with our bank. Repurchase agreements and other investments classified as cash and cash equivalents are not deposits and are not insured by the U.S. Government, the FDIC or any other government agency and involve investment risk including possible loss of principal. We believe however, that the market risk arising from holding these financial instruments is minimal. Investments The Company invests excess funds in various investments which are primarily held in the custody of major financial institutions. Investments consist of debt securities in U.S. government and agency securities, corporate debt securities, certificates of deposit, and commercial paper. Management classifies its investments as available-for-sale investments and records these investments in the 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. Inventory The Company currently purchases and produces inventory prior to U.S. Food and Drug Administration (“FDA”) or other regulatory agency approval. We do not believe probable future economic benefit can be asserted prior to the de novo request being granted by the U.S. FDA. Accordingly, the Company does not capitalize pre-launch inventory prior to receipt of marketing authorization, unless the regulatory review process has progressed to a point that objective and persuasive evidence of regulatory approval is sufficiently probable, and future economic benefit can be asserted. Costs associated with the Company’s purchase of inventory are either reported as research and development costs, or if the inventory is used in marketing evaluations, as sales, general and administrative costs on the condensed consolidated statements of operations and comprehensive loss. 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. Deferred revenue represents amounts received but not yet earned under existing agreements. Revenue from operations includes product sales, principally of ACCELERATE PHENO™ systems (formerly referred to as Accelerate ID/AST systems). 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. Warranty A limited warranty of less than a year is covered under selected contracts. Accordingly, a provision for the estimated cost of the limited warranty repair is recorded at the time revenue is recognized. Our estimated warranty provision is based on our estimate of future repair events and the related estimated cost of repairs. 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 sales, general and administrative 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 | 6 Months Ended |
Jun. 30, 2016 | |
New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | |
Recently Issued Accounting Pronouncements | NOTE 2. RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS In June 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2016-13, Financial Instruments-Credit Losses (Topic 326) Measurement of Credit Losses on Financial Instruments, which amends the guidance on measuring credit losses on financial assets (including trade accounts receivable and available for sale debt securities) held at amortized cost. Currently, an "incurred loss" methodology is used for recognizing credit losses which delays recognition until it is probable a loss has been incurred. The amendment requires assets valued at amortized cost to be presented at the net amount expected to be collected using an allowance for credit losses. Reversal of credit losses on available for sale debt securities will be recorded in the current period net income. The amendment will be effective for us on January 1, 2020 with early adoption permitted. We do not anticipate this guidance will have a significant impact on our financial statements and plan to adopt on the effective date. In March 2016, the FASB issued ASU 2016-09, Compensation-Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting. This guidance requires the recognition of the income tax effects of awards in the income statement when the awards vest or are settled, thus eliminating additional paid in capital pools. The guidance also allows for the employer to repurchase more of an employee’s shares for tax withholding purposes without triggering liability accounting. In addition, the guidance allows for a policy election to account for forfeitures as they occur rather than on an estimated basis. The guidance is effective for us on January 1, 2017 with early adoption permitted. We are currently evaluating the impact of this guidance 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 and the timing of adoption. 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. We are carefully evaluating our existing revenue recognition practices to determine whether any contracts in the scope of the guidance will be affected by the new requirements. The effects may include identifying performance obligations in existing arrangements, determining the transaction price and allocating the transaction price to each separate performance obligation. We will also establish practices to determine when a performance obligation has been satisfied, and recognize revenue in accordance with the new requirements. In August 2015, the FASB issued ASU 2015-14, Revenue from Contracts with Customers Deferral of the Effective Date, which deferred the effective date resulting in a new effective date of January 1, 2018 for us. We are permitted to adopt early but not before the original effective date of January 1, 2017. FASB has issued several other ASU's which provide further guidance on Topic 606 and have the same effective date. The standard allows for either “full retrospective” adoption, meaning the standard is applied to all of the periods presented, or “modified retrospective” adoption, meaning the standard is applied only to the most current period presented in the financial statements. We are currently evaluating the transition method and the adoption date that will be elected. We will implement ASU 2014-09 and all relevant subsequently issued ASU's on Topic 606 concurrently. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | NOTE 3. 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 June 30, 2016 and December 31, 2015 . June 30, 2016 (in thousands) Quoted Prices Significant Significant Total Assets: Cash and cash equivalents $ 36,121 $ 1,398 $ — $ 37,519 Investments: Certificates of deposit 6,028 — — 6,028 US Treasury securities 15,822 — — 15,822 US Agency securities — 4,010 — 4,010 Commercial Paper — 499 — 499 Asset-backed securities — 7,095 — 7,095 Corporate notes and bonds — 31,465 — 31,465 Total investments 21,850 43,069 — 64,919 Total assets measured at fair value $ 57,971 $ 44,467 $ — $ 102,438 December 31, 2015 (in thousands) Quoted Prices Significant Other Observable Inputs Significant Unobservable Inputs Total Assets: Cash and cash equivalents $ 120,585 $ — $ — $ 120,585 Investments: Asset-backed securities — 2,507 — 2,507 Corporate notes and bonds — 9,332 — 9,332 Total investments — 11,839 — 11,839 Total assets measured at fair value $ 120,585 $ 11,839 $ — $ 132,424 Level 1 assets are priced using quoted prices in active markets for identical assets which include cash accounts, money market funds, certificates of deposit 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 six month period ended June 30, 2016 . |
Concentration of Credit Risk
Concentration of Credit Risk | 6 Months Ended |
Jun. 30, 2016 | |
Risks and Uncertainties [Abstract] | |
Concentration of Credit Risk | NOTE 4. 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 70% and 100% of the Company’s cash and cash equivalents as of June 30, 2016 and December 31, 2015 , respectively. The Company extends credit to domestic and international clients in various industries. Exposure to losses on accounts receivable is principally dependent on each client's financial position. At June 30, 2016 and December 31, 2015 , $129,000 or 76% and $50,000 or 66% , respectively, of the Company’s outstanding receivable balance was with Denver Health Medical Center (“Denver Health”). See Note 7, License Agreements and Grants for more information. Revenue from product sales purchased from Denver Health represented 100% and 0% for the six months ended June 30, 2016 and 2015 respectively. There were no product sales for the three months ended June 30, 2016 and 2015 . |
Investments
Investments | 6 Months Ended |
Jun. 30, 2016 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | NOTE 5. INVESTMENTS The following tables summarize the Company’s available-for-sale investments at June 30, 2016 and December 31, 2015 : AVAILABLE-FOR-SALE INVESTMENTS June 30, 2016 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Certificates of deposit $ 6,028 $ — $ — $ 6,028 US Treasury securities 15,780 42 — 15,822 US Agency securities 4,009 1 — 4,010 Commercial paper 499 — — 499 Asset-backed securities 7,084 11 — 7,095 Corporate notes and bonds 31,449 27 (11 ) 31,465 Total $ 64,849 $ 81 $ (11 ) $ 64,919 AVAILABLE-FOR-SALE INVESTMENTS December 31, 2015 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Asset-backed securities $ 2,510 $ — $ (3 ) $ 2,507 Corporate notes and bonds 9,341 1 (10 ) 9,332 Total $ 11,851 $ 1 $ (13 ) $ 11,839 The following table summarizes the maturities of the Company’s available-for-sale securities at June 30, 2016 and December 31, 2015 : AVAILABLE-FOR-SALE INVESTMENT MATURITIES (in thousands) June 30, 2016 December 31, 2015 Amortized Fair Value Amortized Fair Value Due in less than 1 year $ 27,517 $ 27,535 $ 11,851 $ 11,839 Due in 1-5 years 37,332 37,384 — — Due in 6-10 years — — — — Total $ 64,849 $ 64,919 $ 11,851 $ 11,839 Proceeds from sales of marketable securities (including principal paydowns), for the three months ended June 30, 2016 and 2015 were $500,000 and $34,000 , respectively, and for the for the six months ended June 30, 2016 and 2015 were $1,000,000 and $141,000 , respectively. The Company determines gains and losses of marketable securities based on specific identification of the securities sold. There were no gross realized gains or losses from sales of marketable securities for the three months ended and six months ended June 30, 2016 and 2015 . No other-than-temporary impairments are recorded as no investments had a fair value that remained less than its cost for more than twelve months as of June 30, 2016 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 3, Fair Value of Financial Instruments . |
Property and Equipment
Property and Equipment | 6 Months Ended |
Jun. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | NOTE 6. PROPERTY AND EQUIPMENT Property and equipment are recorded at cost and consisted of the following at June 30, 2016 and December 31, 2015 . PROPERTY AND EQUIPMENT (in thousands) June 30, December 31, 2016 2015 Computer equipment $ 2,173 $ 1,877 Technical equipment 2,329 1,806 Facilities 3,491 1,772 Capital projects in progress 736 2,183 Total property and equipment $ 8,729 $ 7,638 Accumulated depreciation - other (3,769 ) (2,622 ) Net property and equipment $ 4,960 $ 5,016 Depreciation expense (which includes amortization of capital lease assets) for the three months ended June 30, 2016 and 2015 was $605,000 and $403,000 , respectively, and for the six months ended June 30, 2016 and 2015 was $1,147,000 and $729,000 , respectively. |
License Agreements and Grants
License Agreements and Grants | 6 Months Ended |
Jun. 30, 2016 | |
License Agreements and Grants - Research and Development [Abstract] | |
License Agreements and Grants | NOTE 7. LICENSE AGREEMENTS AND GRANTS Defense Medical Research and Development Program In May 2012, the Company and Denver Health were notified that the Defense Medical Research and Development Program (“DMRDP”) recommended $2.0 million of funding for a proposed 35 -month project. The joint proposal became the sole recipient under the Military Infectious Diseases Applied Research Award program for rapid detection of serious antibiotic-resistant infections. The project will apply the ACCELERATE PHENO™ system to wound infections and other serious infections secondary to trauma. The Company has invoiced a cumulative total of $602,000 under this grant which is recorded as an offset to research and development expenses. The amounts invoiced for the three months ended June 30, 2016 and 2015 were $44,000 and $68,000 , respectively, and for the six months ended June 30, 2016 and 2015 was $44,000 were $136,000 , respectively. The period of performance of this grant was extended through September 2016. National Institute of Health Grant In February 2015, the National Institute of Health awarded Denver Health and the Company a five year, $5.0 million grant to develop a fast and reliable identification and categorical susceptibility test carbepenem-resistant Enterobacteriaceae directly from whole blood. In June 2015, the Company executed a subaward agreement with Denver Health for the services provided as part of this grant which covered the period of February 15, 2015 through January 31, 2016 and totaled $689,000 . The amounts invoiced for the three months ended June 30, 2016 and 2015 were $50,000 and $0 , respectively, and for the six months ended June 30, 2016 and 2015 were $59,000 and $0 , respectively. Amounts invoiced under this grant are recorded as an offset to research and development expenses. 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 June 30, 2016 , the Company has collected all of the $1.0 million in milestones. The full amount is recorded in long-term deferred income until the economic development provisions of the grant have been satisfied in full, as there are “claw-back” provisions which would require repayment of certain amounts received if employment levels are not sustained during the term of the arrangement. Once the “claw-back” provisions expire in January 2018, we will recognize the grant as an offset to expense. Further details are included in Note 8, Deferred Revenue and Income . Arizona R&D Refundable Tax Credit Program The Company has applied for and met the program requirements to receive a “Certificate of Qualification” from the Arizona Commerce Authority (“Authority”), which allows the Company to be eligible for a partial refund of research and development investments ("Arizona R&D Refundable Tax Credit Program"). The amounts incurred under this program are recorded as an offset to research and development expenses, and for the six months ended June 30, 2016 and 2015 were $1.2 million and $647,000 , respectively, and no amounts were incurred for the three months ended June 30, 2016 and 2015 . The refund for the 2014 tax year has been received and the amount for the 2015 tax year remains outstanding and is recorded as other current assets on the Condensed Consolidated Balance Sheets. 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 | 6 Months Ended |
Jun. 30, 2016 | |
Deferred Revenue Disclosure [Abstract] | |
Deferred Revenue and Income | NOTE 8. DEFERRED REVENUE AND INCOME Deferred revenue consists of amounts received for products or services not yet delivered or earned. Deferred income consists of amounts received for commitments not yet fulfilled. If we anticipate that the revenue or income will not be earned within the following twelve months, the amount is reported as long-term deferred income. A summary of the balances as of June 30, 2016 and December 31, 2015 follows: Deferred Revenue and Income (in thousands) June 30, December 31, 2016 2015 Fisher agreement $ — $ 13 Products not yet delivered 43 114 Total current deferred revenue and income $ 43 $ 127 Arizona Commerce Authority grant $ 1,000 $ 1,000 Total long-term deferred income $ 1,000 $ 1,000 We have received $1.0 million in milestone payments from the Arizona Commerce Authority under the Grant Agreement described in Note 7, License Agreements and Grants . As of June 30, 2016 , no such payments have been recognized in income, and we do not anticipate recognizing such payments as income until the “claw-back” provisions under the Grant Agreement expire in January 2018. |
Earnings Per Share
Earnings Per Share | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
Earnings Per Share | NOTE 9. 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 stocks and options to purchase our common stock to be antidilutive. As of June 30, 2016 , and December 31, 2015 , there were common stock options, restricted stock units and warrants exercisable for 7,529,452 and 6,778,580 shares of common stock, respectively, which were not included in diluted loss per share as the effect was antidilutive. |
Employee and Consultant Equity-
Employee and Consultant Equity-Based Compensation | 6 Months Ended |
Jun. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Employee and Consultant Equity-Based Compensation | NOTE 10. EMPLOYEE AND CONSULTANT EQUITY-BASED COMPENSATION The following table summarizes option activity under all plans during the six -month period ending June 30, 2016 : Stock Option Activity Number of Shares Weighted Average Exercise Price per Share Options outstanding January 1, 2016 6,167,170 6.91 Granted 899,600 13.09 Forfeited (119,706 ) 20.06 Exercised (27,233 ) 3.49 Expired (1,789 ) 13.49 Options Outstanding June 30, 2016 6,918,042 7.49 The table below summarizes the resulting weighted average inputs used to calculate the estimated fair value of options awarded for during the periods shown below: Black-Scholes Assumptions for Options Granted Three Months Ended June 30, 2016 June 30, 2015 Expected term (in years) 6.2 6.4 Volatility 85% 92% Expected dividends — — Risk free interest rates 1.45% 1.73% Weighted average fair value $9.66 $17.55 The following table shows summary information for outstanding options, options that are exercisable (vested) and outstanding options that are either vested or expected to vest as of June 30, 2016 : Stock Option Supplemental Information Options Outstanding Options Exercisable Options Vested and Expected to Vest Number of options 6,918,042 4,268,778 6,715,032 Weighted average remaining contractual term (in years) 7.06 6.41 7.00 Weighted average exercise price $ 7.49 $ 5.01 $ 7.28 Weighted average fair value $ 5.80 $ 3.77 $ 5.63 Aggregate intrinsic value (in thousands) $ 37,775 $ 34,813 $ 38,171 The following table summarizes restricted stock unit activity during the six -month period ending June 30, 2016 : Restricted Stock Unit (RSU) Activity Number of Shares Weighted Average Grant Date Fair Value per Share RSUs Outstanding January 1, 2016 40,250 20.91 Granted — — Forfeited — — Vested/released — — RSUs outstanding June 30, 2016 40,250 20.91 The expense recognized on Company’s Statements of Operations and Comprehensive Loss related to options is summarized below: Equity-Based Compensation Expenses (in thousands) Three Months Ended Six Months Ended 6/30/2016 6/30/2015 6/30/2016 6/30/2015 Research and development $ 462 $ 747 $ 664 $ 1,435 Sales, general and administrative 1,773 1,781 3,257 2,750 Equity-based compensation expense $ 2,235 $ 2,528 $ 3,921 $ 4,185 As of June 30, 2016 , unrecognized equity-based compensation cost related to unvested stock options and unvested restricted stock units was $12.4 million and $ 482,000 respectively. This is expected to be recognized over the years 2016 through 2021 . |
Commitments
Commitments | 6 Months Ended |
Jun. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | NOTE 11. COMMITMENTS Leases The Company has entered into lease agreements, lease amendments, and lease extensions ("Lease Agreements") for office, laboratory and manufacturing space located in Tucson, Arizona and Europe, the last of which expires in 2018. Total rent expense, including common area charges was $280,000 and $167,000 for the three months ended June 30, 2016 and 2015 , respectively, and for the six months ended June 30, 2016 and 2015 was $540,000 and $282,000 , respectively. Future minimum lease payments under operating lease agreements are as follows: Operating Lease Obligations (in thousands) Year ending December 31: 2016 $ 498 2017 173 2018 4 2019 — Thereafter — Total operating lease obligations $ 675 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 $760,000 and $178,000 for the three months ended June 30, 2016 and 2015 , respectively, and $1,424,000 and $358,000 for the six months ended June 30, 2016 and 2015 , 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 ID/AST 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). The appeal is pending; Plaintiff filed her Brief on Appeal on June 6, 2016. |
Segments
Segments | 6 Months Ended |
Jun. 30, 2016 | |
Segment Reporting [Abstract] | |
Segments | NOTE 12. 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 | 6 Months Ended |
Jun. 30, 2016 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | NOTE 13. 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. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Events | NOTE 14. SUBSEQUENT EVENTS As Defendants in the securities litigation now pending before the United States Court of Appeals for the Ninth Circuit (Chang v. Accelerate Diagnostics, Inc., et al., No. 2:15-CV-00504-SPL (9th Cir. filed Feb. 26, 2016)), we filed our answering brief with the Court on August 3, 2016. Should Plaintiff choose to file an optional reply brief, that brief will be due on August 22, 2016, unless Plaintiff requests - and the Court grants - an extension of time. Additional information regarding this litigation is included in Note 11, Commitments . |
Organization and Nature of Bu20
Organization and Nature of Business; Basis of Presentation; Principles of Consolidation; Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
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, 2015 , as filed with the SEC on March 9, 2016. The condensed consolidated balance sheet as of December 31, 2015 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, 2016 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. During the three months ended June 30, 2016 new entities were formed based in Europe. |
Cash and Cash Equivalents | Cash and Cash Equivalents All highly liquid investments with an original maturity of three months or less at time of purchase are considered to be cash equivalents. Cash and cash equivalents include overnight repurchase agreement accounts and other investments. As part of our cash management process, excess operating cash is invested in overnight repurchase agreements with our bank. Repurchase agreements and other investments classified as cash and cash equivalents are not deposits and are not insured by the U.S. Government, the FDIC or any other government agency and involve investment risk including possible loss of principal. We believe however, that the market risk arising from holding these financial instruments is minimal. |
Investments | Investments The Company invests excess funds in various investments which are primarily held in the custody of major financial institutions. Investments consist of debt securities in U.S. government and agency securities, corporate debt securities, certificates of deposit, and commercial paper. Management classifies its investments as available-for-sale investments and records these investments in the 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. |
Inventory | Inventory The Company currently purchases and produces inventory prior to U.S. Food and Drug Administration (“FDA”) or other regulatory agency approval. We do not believe probable future economic benefit can be asserted prior to the de novo request being granted by the U.S. FDA. Accordingly, the Company does not capitalize pre-launch inventory prior to receipt of marketing authorization, unless the regulatory review process has progressed to a point that objective and persuasive evidence of regulatory approval is sufficiently probable, and future economic benefit can be asserted. Costs associated with the Company’s purchase of inventory are either reported as research and development costs, or if the inventory is used in marketing evaluations, as sales, general and administrative costs on the condensed consolidated statements of operations and comprehensive loss. |
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. Deferred revenue represents amounts received but not yet earned under existing agreements. Revenue from operations includes product sales, principally of ACCELERATE PHENO™ systems (formerly referred to as Accelerate ID/AST systems). 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. |
Warranty | Warranty A limited warranty of less than a year is covered under selected contracts. Accordingly, a provision for the estimated cost of the limited warranty repair is recorded at the time revenue is recognized. Our estimated warranty provision is based on our estimate of future repair events and the related estimated cost of repairs. 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 sales, general and administrative 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 June 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2016-13, Financial Instruments-Credit Losses (Topic 326) Measurement of Credit Losses on Financial Instruments, which amends the guidance on measuring credit losses on financial assets (including trade accounts receivable and available for sale debt securities) held at amortized cost. Currently, an "incurred loss" methodology is used for recognizing credit losses which delays recognition until it is probable a loss has been incurred. The amendment requires assets valued at amortized cost to be presented at the net amount expected to be collected using an allowance for credit losses. Reversal of credit losses on available for sale debt securities will be recorded in the current period net income. The amendment will be effective for us on January 1, 2020 with early adoption permitted. We do not anticipate this guidance will have a significant impact on our financial statements and plan to adopt on the effective date. In March 2016, the FASB issued ASU 2016-09, Compensation-Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting. This guidance requires the recognition of the income tax effects of awards in the income statement when the awards vest or are settled, thus eliminating additional paid in capital pools. The guidance also allows for the employer to repurchase more of an employee’s shares for tax withholding purposes without triggering liability accounting. In addition, the guidance allows for a policy election to account for forfeitures as they occur rather than on an estimated basis. The guidance is effective for us on January 1, 2017 with early adoption permitted. We are currently evaluating the impact of this guidance 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 and the timing of adoption. 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. We are carefully evaluating our existing revenue recognition practices to determine whether any contracts in the scope of the guidance will be affected by the new requirements. The effects may include identifying performance obligations in existing arrangements, determining the transaction price and allocating the transaction price to each separate performance obligation. We will also establish practices to determine when a performance obligation has been satisfied, and recognize revenue in accordance with the new requirements. In August 2015, the FASB issued ASU 2015-14, Revenue from Contracts with Customers Deferral of the Effective Date, which deferred the effective date resulting in a new effective date of January 1, 2018 for us. We are permitted to adopt early but not before the original effective date of January 1, 2017. FASB has issued several other ASU's which provide further guidance on Topic 606 and have the same effective date. The standard allows for either “full retrospective” adoption, meaning the standard is applied to all of the periods presented, or “modified retrospective” adoption, meaning the standard is applied only to the most current period presented in the financial statements. We are currently evaluating the transition method and the adoption date that will be elected. We will implement ASU 2014-09 and all relevant subsequently issued ASU's on Topic 606 concurrently. |
Fair Value of Financial Instr21
Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | The following tables represent the financial instruments measured at fair value on a recurring basis on the financial statements of the Company and the valuation approach applied to each class of financial instruments at June 30, 2016 and December 31, 2015 . June 30, 2016 (in thousands) Quoted Prices Significant Significant Total Assets: Cash and cash equivalents $ 36,121 $ 1,398 $ — $ 37,519 Investments: Certificates of deposit 6,028 — — 6,028 US Treasury securities 15,822 — — 15,822 US Agency securities — 4,010 — 4,010 Commercial Paper — 499 — 499 Asset-backed securities — 7,095 — 7,095 Corporate notes and bonds — 31,465 — 31,465 Total investments 21,850 43,069 — 64,919 Total assets measured at fair value $ 57,971 $ 44,467 $ — $ 102,438 December 31, 2015 (in thousands) Quoted Prices Significant Other Observable Inputs Significant Unobservable Inputs Total Assets: Cash and cash equivalents $ 120,585 $ — $ — $ 120,585 Investments: Asset-backed securities — 2,507 — 2,507 Corporate notes and bonds — 9,332 — 9,332 Total investments — 11,839 — 11,839 Total assets measured at fair value $ 120,585 $ 11,839 $ — $ 132,424 |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Available-for-Sale Investments | The following tables summarize the Company’s available-for-sale investments at June 30, 2016 and December 31, 2015 : AVAILABLE-FOR-SALE INVESTMENTS June 30, 2016 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Certificates of deposit $ 6,028 $ — $ — $ 6,028 US Treasury securities 15,780 42 — 15,822 US Agency securities 4,009 1 — 4,010 Commercial paper 499 — — 499 Asset-backed securities 7,084 11 — 7,095 Corporate notes and bonds 31,449 27 (11 ) 31,465 Total $ 64,849 $ 81 $ (11 ) $ 64,919 AVAILABLE-FOR-SALE INVESTMENTS December 31, 2015 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Asset-backed securities $ 2,510 $ — $ (3 ) $ 2,507 Corporate notes and bonds 9,341 1 (10 ) 9,332 Total $ 11,851 $ 1 $ (13 ) $ 11,839 |
Schedule of Available-For-Sale Investment Maturities | The following table summarizes the maturities of the Company’s available-for-sale securities at June 30, 2016 and December 31, 2015 : AVAILABLE-FOR-SALE INVESTMENT MATURITIES (in thousands) June 30, 2016 December 31, 2015 Amortized Fair Value Amortized Fair Value Due in less than 1 year $ 27,517 $ 27,535 $ 11,851 $ 11,839 Due in 1-5 years 37,332 37,384 — — Due in 6-10 years — — — — Total $ 64,849 $ 64,919 $ 11,851 $ 11,839 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment are recorded at cost and consisted of the following at June 30, 2016 and December 31, 2015 . PROPERTY AND EQUIPMENT (in thousands) June 30, December 31, 2016 2015 Computer equipment $ 2,173 $ 1,877 Technical equipment 2,329 1,806 Facilities 3,491 1,772 Capital projects in progress 736 2,183 Total property and equipment $ 8,729 $ 7,638 Accumulated depreciation - other (3,769 ) (2,622 ) Net property and equipment $ 4,960 $ 5,016 |
Deferred Revenue and Income (Ta
Deferred Revenue and Income (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Deferred Revenue Disclosure [Abstract] | |
Deferred Revenue and Income Summary | A summary of the balances as of June 30, 2016 and December 31, 2015 follows: Deferred Revenue and Income (in thousands) June 30, December 31, 2016 2015 Fisher agreement $ — $ 13 Products not yet delivered 43 114 Total current deferred revenue and income $ 43 $ 127 Arizona Commerce Authority grant $ 1,000 $ 1,000 Total long-term deferred income $ 1,000 $ 1,000 |
Employee and Consultant Equit25
Employee and Consultant Equity-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Option Activity | The following table summarizes option activity under all plans during the six -month period ending June 30, 2016 : Stock Option Activity Number of Shares Weighted Average Exercise Price per Share Options outstanding January 1, 2016 6,167,170 6.91 Granted 899,600 13.09 Forfeited (119,706 ) 20.06 Exercised (27,233 ) 3.49 Expired (1,789 ) 13.49 Options Outstanding June 30, 2016 6,918,042 7.49 |
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 for during the periods shown below: Black-Scholes Assumptions for Options Granted Three Months Ended June 30, 2016 June 30, 2015 Expected term (in years) 6.2 6.4 Volatility 85% 92% Expected dividends — — Risk free interest rates 1.45% 1.73% Weighted average fair value $9.66 $17.55 |
Stock Option Supplemental Information | The following table shows summary information for outstanding options, options that are exercisable (vested) and outstanding options that are either vested or expected to vest as of June 30, 2016 : Stock Option Supplemental Information Options Outstanding Options Exercisable Options Vested and Expected to Vest Number of options 6,918,042 4,268,778 6,715,032 Weighted average remaining contractual term (in years) 7.06 6.41 7.00 Weighted average exercise price $ 7.49 $ 5.01 $ 7.28 Weighted average fair value $ 5.80 $ 3.77 $ 5.63 Aggregate intrinsic value (in thousands) $ 37,775 $ 34,813 $ 38,171 |
Restricted Stock Unit (RSU) Activity | The following table summarizes restricted stock unit activity during the six -month period ending June 30, 2016 : Restricted Stock Unit (RSU) Activity Number of Shares Weighted Average Grant Date Fair Value per Share RSUs Outstanding January 1, 2016 40,250 20.91 Granted — — Forfeited — — Vested/released — — RSUs outstanding June 30, 2016 40,250 20.91 |
Equity-Based Compensation Expenses | The expense recognized on Company’s Statements of Operations and Comprehensive Loss related to options is summarized below: Equity-Based Compensation Expenses (in thousands) Three Months Ended Six Months Ended 6/30/2016 6/30/2015 6/30/2016 6/30/2015 Research and development $ 462 $ 747 $ 664 $ 1,435 Sales, general and administrative 1,773 1,781 3,257 2,750 Equity-based compensation expense $ 2,235 $ 2,528 $ 3,921 $ 4,185 |
Commitments (Tables)
Commitments (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
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: 2016 $ 498 2017 173 2018 4 2019 — Thereafter — Total operating lease obligations $ 675 |
Fair Value of Financial Instr27
Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | $ 102,438 | $ 132,424 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 57,971 | 120,585 |
Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 44,467 | 11,839 |
Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 0 | 0 |
Cash and cash equivalents | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 37,519 | 120,585 |
Cash and cash equivalents | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 36,121 | 120,585 |
Cash and cash equivalents | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 1,398 | 0 |
Cash and cash equivalents | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 0 | 0 |
Certificates of deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 6,028 | |
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] | ||
Assets measured at fair value | 6,028 | |
Certificates of deposit | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 0 | |
Certificates of deposit | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 0 | |
US Treasury securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 15,822 | |
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] | ||
Assets measured at fair value | 15,822 | |
US Treasury securities | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 0 | |
US Treasury securities | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 0 | |
US Agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 4,010 | |
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] | ||
Assets measured at fair value | 0 | |
US Agency securities | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 4,010 | |
US Agency securities | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 0 | |
Commercial Paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 499 | |
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] | ||
Assets measured at fair value | 0 | |
Commercial Paper | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 499 | |
Commercial Paper | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 0 | |
Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 7,095 | 2,507 |
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] | ||
Assets measured at fair value | 0 | 0 |
Asset-backed securities | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 7,095 | 2,507 |
Asset-backed securities | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 0 | 0 |
Corporate notes and bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 31,465 | 9,332 |
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] | ||
Assets measured at fair value | 0 | 0 |
Corporate notes and bonds | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 31,465 | 9,332 |
Corporate notes and bonds | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 0 | 0 |
Total investments | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 64,919 | 11,839 |
Total investments | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 21,850 | 0 |
Total investments | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 43,069 | 11,839 |
Total investments | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | $ 0 | $ 0 |
Concentration of Credit Risk (D
Concentration of Credit Risk (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | |
Concentration Risk [Line Items] | |||
Trade accounts receivable | $ 169 | $ 77 | |
Cash and cash equivalents | Concentration of Credit Risk | |||
Concentration Risk [Line Items] | |||
Risk concentration (percent) | 70.00% | 100.00% | |
Accounts receivable | Customer Concentration Risk | Denver Health | |||
Concentration Risk [Line Items] | |||
Risk concentration (percent) | 76.00% | 66.00% | |
Trade accounts receivable | $ 129 | $ 50 | |
Revenue from product sales | Customer Concentration Risk | Denver Health | |||
Concentration Risk [Line Items] | |||
Risk concentration (percent) | 100.00% | 0.00% |
Investments - Schedule of Avail
Investments - Schedule of Available-for-sale Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Investment [Line Items] | ||
Amortized Cost | $ 64,849 | $ 11,851 |
Gross Unrealized Gains | 81 | 1 |
Gross Unrealized Losses | (11) | (13) |
Fair Value | 64,919 | 11,839 |
Certificates of deposit | ||
Investment [Line Items] | ||
Amortized Cost | 6,028 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | 6,028 | |
US Treasury securities | ||
Investment [Line Items] | ||
Amortized Cost | 15,780 | |
Gross Unrealized Gains | 42 | |
Gross Unrealized Losses | 0 | |
Fair Value | 15,822 | |
US Agency securities | ||
Investment [Line Items] | ||
Amortized Cost | 4,009 | |
Gross Unrealized Gains | 1 | |
Gross Unrealized Losses | 0 | |
Fair Value | 4,010 | |
Commercial Paper | ||
Investment [Line Items] | ||
Amortized Cost | 499 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | 499 | |
Asset-backed securities | ||
Investment [Line Items] | ||
Amortized Cost | 7,084 | 2,510 |
Gross Unrealized Gains | 11 | 0 |
Gross Unrealized Losses | 0 | (3) |
Fair Value | 7,095 | 2,507 |
Corporate notes and bonds | ||
Investment [Line Items] | ||
Amortized Cost | 31,449 | 9,341 |
Gross Unrealized Gains | 27 | 1 |
Gross Unrealized Losses | (11) | (10) |
Fair Value | $ 31,465 | $ 9,332 |
Investments - Schedule of Ava30
Investments - Schedule of Available-For-Sale Investment Maturities (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Amortized Cost | ||
Due in less than 1 year | $ 27,517 | $ 11,851 |
Due in 1-5 years | 37,332 | 0 |
Due in 6-10 years | 0 | 0 |
Total | 64,849 | 11,851 |
Fair Value | ||
Due in less than 1 year | 27,535 | 11,839 |
Due in 1-5 years | 37,384 | 0 |
Due in 6-10 years | 0 | 0 |
Total | $ 64,919 | $ 11,839 |
Investments - Narrative (Detail
Investments - Narrative (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Investments, Debt and Equity Securities [Abstract] | ||||
Proceeds from sales of marketable securities | $ 500,000 | $ 34,000 | $ 1,000,000 | $ 141,000 |
Gross realized gains or losses from sales of marketable securities | $ 0 | $ 0 | $ 0 | $ 0 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | |
Property, Plant and Equipment [Line Items] | |||||
Property and equipment | $ 8,729 | $ 8,729 | $ 7,638 | ||
Accumulated depreciation - other | (3,769) | (3,769) | (2,622) | ||
Net property and equipment | 4,960 | 4,960 | 5,016 | ||
Depreciation | 605 | $ 403 | 1,147 | $ 729 | |
Computer equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment | 2,173 | 2,173 | 1,877 | ||
Technical equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment | 2,329 | 2,329 | 1,806 | ||
Facilities | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment | 3,491 | 3,491 | 1,772 | ||
Capital projects in progress | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment | $ 736 | $ 736 | $ 2,183 |
License Agreements and Grants -
License Agreements and Grants - Defense Medical Research and Development Program (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 50 Months Ended | ||
May 31, 2012 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Offset to research and development project | $ 0 | $ 0 | $ 1,200,000 | $ 647,000 | ||
Defense medical research and development program | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Total grant funding | $ 2,000,000 | |||||
Length of project (months) | 35 months | |||||
Offset to research and development project | $ 44,000 | $ 68,000 | $ 44,000 | $ 136,000 | $ 602,000 |
License Agreements and Grants34
License Agreements and Grants - National Institute of Health Grant (Details) - National Institute of Health Grant - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Feb. 28, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Jan. 31, 2016 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Length of project (years) | 5 years | |||||
Total grant funding | $ 5,000 | $ 50 | $ 0 | $ 59 | $ 0 | $ 689 |
License Agreements and Grants35
License Agreements and Grants - Arizona Commerce Authority and R&D Refundable Tax Credit Program (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Aug. 31, 2012USD ($)jobmilestone | Jun. 30, 2016USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2016USD ($) | Jun. 30, 2015USD ($) | Dec. 31, 2015USD ($) | |
License Agreements and Grants - Research and Development [Abstract] | ||||||
Arizona Commerce Authority grant | $ | $ 1,000,000 | $ 1,000,000 | $ 1,000,000 | $ 1,000,000 | ||
Number of milestones | milestone | 4 | |||||
Qualified jobs created, milestone one | job | 15 | |||||
Qualified jobs created, milestone two | job | 30 | |||||
Qualified jobs created, milestone three | job | 40 | |||||
Qualified jobs created, milestone four | job | 65 | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Offset to research and development project | $ | $ 0 | $ 0 | $ 1,200,000 | $ 647,000 | ||
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 ($) | Jun. 30, 2016 | Dec. 31, 2015 | Aug. 31, 2012 |
Deferred Revenue Disclosure [Abstract] | |||
Fisher agreement | $ 0 | $ 13,000 | |
Products not yet delivered | 43,000 | 114,000 | |
Total current deferred revenue and income | 43,000 | 127,000 | |
Arizona Commerce Authority grant | 1,000,000 | 1,000,000 | $ 1,000,000 |
Total long-term deferred income | $ 1,000,000 | $ 1,000,000 |
Earnings Per Share (Details)
Earnings Per Share (Details) - shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
Earnings Per Share [Abstract] | ||
Antidilutive common stock instruments outstanding (shares) | 7,529,452 | 6,778,580 |
Employee and Consultant Equit38
Employee and Consultant Equity-Based Compensation - Stock Option Activity (Details) | 6 Months Ended |
Jun. 30, 2016$ / sharesshares | |
Number of Shares | |
Outstanding, beginning balance (shares) | shares | 6,167,170 |
Granted (shares) | shares | 899,600 |
Forfeited (shares) | shares | (119,706) |
Exercised (shares) | shares | (27,233) |
Expired (shares) | shares | (1,789) |
Outstanding, ending balance (shares) | shares | 6,918,042 |
Weighted Average Exercise Price Per Share | |
Outstanding, beginning balance (dollars per share) | $ / shares | $ 6.91 |
Granted (dollars per share) | $ / shares | 13.09 |
Forfeited (dollars per share) | $ / shares | 20.06 |
Exercised (dollars per share) | $ / shares | 3.49 |
Expired (dollars per share) | $ / shares | 13.49 |
Outstanding, ending balance (dollars per share) | $ / shares | $ 7.49 |
Employee and Consultant Equit39
Employee and Consultant Equity-Based Compensation - Black-Scholes Assumptions for Option Granted (Details) - USD ($) | 3 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Expected term (in years) | 6 years 2 months 12 days | 6 years 4 months 24 days |
Volatility (percent) | 85.00% | 92.00% |
Expected dividends | $ 0 | $ 0 |
Risk free interest rates (percent) | 1.45% | 1.73% |
Fair value per share (dollars per share) | $ 9.66 | $ 17.55 |
Employee and Consultant Equit40
Employee and Consultant Equity-Based Compensation - Stock Option Supplemental Information (Details) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2016USD ($)$ / sharesshares | |
Options Outstanding | |
Option Indexed to Issuer's Equity [Line Items] | |
Number of options (shares) | shares | 6,918,042 |
Weighted average remaining contractual term (in years) | 7 years 22 days |
Weighted average exercise price (dollars per share) | $ 7.49 |
Weighted average fair value (dollars per share) | $ 5.80 |
Aggregate intrinsic value (in thousands) | $ | $ 37,775 |
Options Exercisable | |
Option Indexed to Issuer's Equity [Line Items] | |
Number of options (shares) | shares | 4,268,778 |
Weighted average remaining contractual term (in years) | 6 years 4 months 28 days |
Weighted average exercise price (dollars per share) | $ 5.01 |
Weighted average fair value (dollars per share) | $ 3.77 |
Aggregate intrinsic value (in thousands) | $ | $ 34,813 |
Options Vested and Expected to Vest | |
Option Indexed to Issuer's Equity [Line Items] | |
Number of options (shares) | shares | 6,715,032 |
Weighted average remaining contractual term (in years) | 7 years |
Weighted average exercise price (dollars per share) | $ 7.28 |
Weighted average fair value (dollars per share) | $ 5.63 |
Aggregate intrinsic value (in thousands) | $ | $ 38,171 |
Employee and Consultant Equit41
Employee and Consultant Equity-Based Compensation - Restricted Stock Activity (Details) - Restricted Stock Units (RSUs) | 6 Months Ended |
Jun. 30, 2016$ / sharesshares | |
Number of Shares | |
Restricted Stock Outstanding, beginning balance (shares) | shares | 40,250 |
Granted (shares) | shares | 0 |
Forfeited (shares) | shares | 0 |
Vested/Released (shares) | shares | 0 |
Restricted Stock Outstanding, ending balance (shares) | shares | 40,250 |
Weighted Average Grant Date Fair Value per Share | |
Restricted Stock Outstanding, beginning balance (dollars per share) | $ / shares | $ 20.91 |
Granted (dollars per share) | $ / shares | 0 |
Forfeited (dollars per share) | $ / shares | 0 |
Vested/Released (dollars per share) | $ / shares | 0 |
Restricted Stock Outstanding, ending balance (dollars per share) | $ / shares | $ 20.91 |
Employee and Consultant Equit42
Employee and Consultant Equity-Based Compensation - Equity-Based Compensation Expense and Tax Benefit (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Equity-based compensation expense | $ 2,235 | $ 2,528 | $ 3,921 | $ 4,185 |
Unrecognized equity-based compensation cost | 12,400 | 12,400 | ||
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Equity-based compensation expense | 462 | 747 | 664 | 1,435 |
Sales, general and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Equity-based compensation expense | 1,773 | $ 1,781 | 3,257 | $ 2,750 |
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 | $ 482 | $ 482 |
Commitments - Narrative (Detail
Commitments - Narrative (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Rent expense | $ 280,000 | $ 167,000 | $ 540,000 | $ 282,000 |
Research and development | ||||
Product Liability Contingency [Line Items] | ||||
Clinical trial expense | $ 760,000 | $ 178,000 | $ 1,424,000 | $ 358,000 |
Commitments - Operating Lease O
Commitments - Operating Lease Obligations (Details) $ in Thousands | Jun. 30, 2016USD ($) |
Year ending December 31: | |
2,016 | $ 498 |
2,017 | 173 |
2,018 | 4 |
2,019 | 0 |
Thereafter | 0 |
Total operating lease obligations | $ 675 |
Segments (Details)
Segments (Details) | 6 Months Ended |
Jun. 30, 2016segment | |
Segment Reporting [Abstract] | |
Number of operating segments | 1 |
Related Party Transactions (Det
Related Party Transactions (Details) | 1 Months Ended |
Jun. 30, 2016USD ($) | |
Recovery of short-swing profit | |
Related Party Transaction [Line Items] | |
Recovery of related party short-swing profits | $ 866,000 |