Delaware | 84-1072256 |
(State or other jurisdiction | (I.R.S. Employer Identification No.) |
of incorporation or organization) | |
3950 South Country Club, Suite 470 | |
Tucson, Arizona | 85714 |
(Address of principal executive offices) | (Zip Code) |
Title of each class | Name of each exchange on which registered |
Common Stock, $0.001 par value per share | The NASDAQ Stock Market LLC (NASDAQ Capital Market) |
Large accelerated filer | o | |
Accelerated filer | þ | |
Non-accelerated file | ☐ (Do not check if a smaller reporting company) | |
Smaller reporting company | o |
• | Automated specimen preparation. The initial step in the process is the automated purification of samples through an on-board and proprietary process to separate live organisms from sample debris. |
• | Live-cell immobilization. Following preparation, the purified sample is moved to the imaging cassette where pathogens are immobilized onto the cassette surface such that they can be imaged and analyzed in a stationary position during the identification and antibiotic susceptibility testing. |
• | Identification testing via fluorescent in situ hybridization (FISH). The now immobilized cells are tested with our proprietary FISH probes to enable identification. Because the genetic sequences of bacteria are distinctive, the binding of fluorescently labeled probes indicates the presence of a specific target sequence of RNA associated with a single or group of bacterial species or yeasts. When the probe finds a targeted sequence, it binds to it—generating a fluorescent signal—which is visible by the imaging system on the Accelerate Pheno™ system. Positive fluorescent signals from more than one target probe indicate |
• | Susceptibility testing via live-cell optical analysis. With the identification of the pathogen known, the system’s software determines the antibiotic panel to be used for susceptibility testing. These antibiotics, growth media, and additional patient sample are introduced to additional channels on the optical cassette. Finally, our proprietary imaging platform and algorithms determine the minimum inhibitory concentration of the bacteria through the observation of which antibiotics arrested live cell growth and lead to cell death and which antibiotics were ineffective in ceasing live cell growth. The susceptibility test result is presented approximately five hours after the conclusion of the identification test. |
• | design, development, manufacturing, and storage; |
• | testing, content, and language of instructions for use and storage; |
• | labeling; |
• | pre-clinical testing and clinical trials; |
• | product safety; |
• | advertising, promotion, marketing, sales, and distribution; |
• | pre-market clearance and approval; |
• | record-keeping procedures; |
• | advertising and promotion; |
• | recalls and corrective field actions; |
• | post-market reporting, including reporting of deaths, serious injuries, and malfunctions that, if they were to recur, could lead to death or serious injury; |
• | post-market studies and surveillance; and |
• | product import and export. |
• | the QSR, which imposes elaborate development, testing, control, documentation, and other quality assurance requirements on the design and manufacturing process; |
• | establishment registration, which requires establishments involved in the production and distribution of medical devices, intended for commercial distribution in the United States, to register with the FDA; |
• | medical device listing, which requires manufacturers to list the devices they have in commercial distribution with the FDA; |
• | labeling regulations and various statutory provisions, which prohibit false or misleading labeling, as well as the promotion of products for unapproved or "off-label" uses, and impose other restrictions on labeling; and |
• | post-market reporting requirements, which require that manufacturers report to the FDA deaths, serious injuries, and malfunctions that, if they were to recur, could lead to death or serious injury, recalls, and corrective field actions. |
• | untitled letters or warning letters; |
• | fines, injunctions, and civil penalties; |
• | mandatory recall or seizure of our products; |
• | administrative detention or banning of our products; |
• | operating restrictions, partial suspension, or total shutdown of production; |
• | import holds; |
• | refusing to approve pending 510(k) notifications or PMAs; |
• | revocation of 510(k) clearance or pre-market approvals previously granted; and |
• | criminal prosecution and penalties. |
• | the expenses we incur for research and development required to maintain and improve our technology, including the final development of the Accelerate Pheno™ system; |
• | the expenses we incur in connection with the development, marketing authorization and regulatory clearance of the use of the Accelerate Pheno™ system to test on additional specimen types; |
• | the costs of preparing, filing, prosecuting, defending and enforcing patent claims and other intellectual property related costs, including litigation costs and the results of such litigation; |
• | the expenses we incur in connection with commercialization activities, including product marketing, sales and distribution expenses; |
• | the costs incurred to build manufacturing capabilities; |
• | the expenses to implement our sales strategy; |
• | the costs to attract and retain personnel with the skills required for effective operations; and |
• | the costs associated with being a public company. |
• | required compliance with existing and changing foreign healthcare and other regulatory requirements and laws, such as those relating to patient privacy or handling of bio-hazardous waste; |
• | required compliance with anti-bribery laws, such as the U.S. Foreign Corrupt Practices Act and the U.K. Bribery Act, data privacy requirements, labor laws and anti-competition regulations; |
• | export and import restrictions; |
• | various reimbursement and insurance regimes; |
• | laws and business practices favoring local companies; |
• | longer payment cycles and difficulties in enforcing agreements and collecting receivables through certain foreign legal systems; |
• | political and economic instability; |
• | potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements and other trade barriers; |
• | foreign exchange controls; |
• | fluctuations due to changes in foreign currency exchange rates; |
• | difficulties and costs of staffing and managing foreign operations; and |
• | impediments with protecting or procuring intellectual property rights. |
• | reliance on third parties for regulatory compliance and quality assurance; |
• | possible breaches of manufacturing agreements by the third parties because of factors beyond our control; |
• | possible regulatory violations or manufacturing problems experienced by our suppliers; |
• | possible termination or non-renewal of agreements by third parties, based on their own business priorities, at times that are costly or inconvenient for us; |
• | the potential obsolescence and/or inability of our suppliers to obtain required components; |
• | the potential delays and expenses of seeking alternate sources of supply or manufacturing services; |
• | the inability to qualify alternate sources without impacting performance claims of our products; |
• | reduced control over pricing, quality and timely delivery due to the difficulties in switching to alternate suppliers or assemblers; and |
• | increases in prices of raw materials and key components. |
• | The federal Anti-Kickback Statute, which prohibits persons from knowingly and willfully offering, providing, soliciting, or receiving any remuneration, directly or indirectly, in exchange for or to induce the referral of an individual, or the purchasing, leasing, ordering, recommending, furnishing or arranging for a good or service, for which payment may be made under a federal health care program, such as Medicare or Medicaid. |
• | The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which prohibits knowingly and willfully (i) executing a scheme to defraud any health care benefit program, including private payers, or (ii) falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for items or services under a health care benefit program. |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, which also restricts the use and disclosure of protected health information, mandates the adoption of standards relating to the privacy and security of protected health information, and requires us to report certain security breaches to health care provider customers with respect to such information where we are acting as a HIPAA business associate to that customer. |
• | The federal Physician Payment Sunshine Act, which requires manufacturers of certain medical devices to track payments or other transfers of value given to U.S. licensed physicians or teaching hospitals and to report this data to CMS annually for subsequent public disclosure. |
• | The federal False Claims Act, which imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal health care program. The qui tam provisions of the False Claims Act allow a private individual to bring actions on behalf of the federal government alleging that the defendant has submitted a false claim to the federal government and to share in any monetary recovery. |
• | administrative or judicially imposed sanctions; |
• | injunctions or the imposition of civil penalties; |
• | recall or seizure of our products; |
• | total or partial suspension of production or distribution; |
• | withdrawal or suspension of marketing clearances or approvals; |
• | clinical holds; |
• | warning letters; |
• | refusal to permit the import or export of our products; |
• | criminal prosecution; and |
• | exclusion or debarment from participation in federal health care programs such as Medicare and Medicaid. |
• | we may not be able to demonstrate to the FDA’s satisfaction that our product candidates are safe and effective, sensitive and specific diagnostic tests, for their intended users; |
• | the data from our pre-clinical studies and clinical trials may be insufficient to support clearance or approval, where required; and |
• | the manufacturing process or facilities we or our contract manufacturers use may not meet applicable requirements. |
• | our ability to obtain marketing authorization from the FDA or clearance from the FDA to market our product candidates; |
• | market acceptance of our product candidates, if cleared; |
• | the cost and timing of establishing sales, marketing and distribution capabilities; |
• | the cost of our research and development activities; |
• | the ability of healthcare providers to obtain coverage and adequate reimbursement by third-party payers for procedures using our products; |
• | the cost and timing of marketing authorization or regulatory clearances; |
• | the cost of goods associated with our product candidates; |
• | the cost of customer disruptions due to supply disruptions; |
• | the effect of competing technological and market developments; and |
• | the extent to which we acquire or invest in businesses, products and technologies, including entering into licensing or collaboration arrangements for product candidates, although we currently have no commitments or agreements to complete any such transactions. |
Common Stock Closing Price | ||
Quarter Ended | High | Low |
March 31, 2015 | $26.66 | $16.50 |
June 30, 2015 | 28.97 | 21.29 |
September 30, 2015 | 31.29 | 14.77 |
December 31, 2015 | 23.80 | 15.45 |
March 31, 2016 | 22.97 | 10.29 |
June 30, 2016 | 17.17 | 10.87 |
September 30, 2016 | 28.50 | 14.39 |
December 31, 2016 | 27.95 | 19.50 |
Dec-11 | Dec-12 | Dec-13 | Dec-14 | Dec-15 | Dec-16 | |
Accelerate Diagnostics, Inc. | 100.00 | 333.06 | 1,008.26 | 1,585.95 | 1,776.03 | 1,714.88 |
NASDAQ Composite | 100.00 | 117.45 | 164.57 | 188.84 | 201.98 | 219.89 |
NASDAQ Biotechnology | 100.00 | 132.29 | 219.56 | 295.10 | 329.83 | 259.41 |
Equity Compensation Plan | |||||||
Plan category | Number of securities to be issued upon exercise of outstanding options, restricted stock, warrants and rights | Weighted average exercise price of available outstanding options, restricted stock, warrants and rights | Number of securities remaining for future issuance under equity compensation plans (excluding securities reflected in the 1st column) | ||||
Equity compensation plans approved by security holders | 6,897,374 | $ | 7.67 | 2,585,669 | |||
Equity compensation plans not approved by security holders | — | — | — | ||||
Total | 6,897,374 | $ | 7.67 | 2,585,669 |
Selected Consolidated Financial Data (in thousands except per share data) | |||||||||||||||
12 months | 12 months | 12 months | 12 months | 12 months | |||||||||||
12/31/2016 | 12/31/2015 | 12/31/2014 | 12/31/2013 | 12/31/2012 | |||||||||||
Operating revenues | $ | 246 | $ | 147 | $ | 122 | $ | 48 | $ | 52 | |||||
Net loss | (66,374 | ) | (45,498 | ) | (30,933 | ) | (15,282 | ) | (8,124 | ) | |||||
Basic and diluted loss per share (1) | (1.29 | ) | (1.01 | ) | (0.71 | ) | (0.41 | ) | (0.44 | ) | |||||
Cash dividends | — | — | — | — | — |
12/31/2016 | 12/31/2015 | 12/31/2014 | 12/31/2013 | 12/31/2012 | |||||||||||
Total assets | $ | 82,852 | $ | 139,324 | $ | 69,801 | $ | 43,431 | $ | 13,316 | |||||
Long-term obligations | — | — | 13 | — | — |
Cash Flow Summary (in thousands) | |||||||||
12/31/2016 | 12/31/2015 | 12/31/2014 | |||||||
Net cash used in operating activities | $ | (53,408 | ) | $ | (35,126 | ) | $ | (18,785 | ) |
Net cash used in investing activities | (49,568 | ) | (2,675 | ) | (3,372 | ) | |||
Net cash provided by financing activities | 1,762 | 104,823 | 45,691 |
Contractual Obligations (in thousands) | ||||||||||||||||||
Total | 2017 | 2018 | 2019 | 2020 | 2021 | |||||||||||||
Operating Lease Obligations | $ | 1,083 | $ | 1,004 | $ | 79 | $ | — | $ | — | $ | — | ||||||
Total | $ | 1,083 | $ | 1,004 | $ | 79 | $ | — | $ | — | $ | — |
12/31/2016 | 12/31/2015 | |||||
ASSETS | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 19,244 | $ | 120,585 | ||
Investments | 58,519 | 11,839 | ||||
Trade accounts receivable | 34 | 77 | ||||
Prepaid expenses | 468 | 1,638 | ||||
Other current assets | 183 | 12 | ||||
Total current assets | 78,448 | 134,151 | ||||
Property and equipment, net | 4,258 | 5,016 | ||||
Intellectual property, net | 146 | 157 | ||||
Total assets | $ | 82,852 | $ | 139,324 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
Current liabilities: | ||||||
Accounts payable | $ | 992 | $ | 2,623 | ||
Accrued liabilities | 3,009 | 2,543 | ||||
Deferred revenue and income | 35 | 127 | ||||
Capital lease obligations | — | 13 | ||||
Total current liabilities | 4,036 | 5,306 | ||||
Long-term deferred income | 1,000 | 1,000 | ||||
Total liabilities | 5,036 | 6,306 | ||||
Commitments and contingencies see Note 16, Commitments | — | — | ||||
Stockholders' equity: | ||||||
Common stock, $0.001 par value; | ||||||
75,000,000 common shares authorized with 51,516,309 shares issued and outstanding on December 31, 2016 and 55,000,000 authorized with 51,191,184 shares issued and outstanding on December 31, 2015 | 52 | 51 | ||||
Preferred shares, $0.001 par value; | ||||||
5,000,000 preferred shares authorized and none outstanding as of December 31, 2016 and December 31, 2015 | — | — | ||||
Contributed capital | 255,257 | 243,894 | ||||
Accumulated deficit | (177,289 | ) | (110,915 | ) | ||
Accumulated other comprehensive loss | (204 | ) | (12 | ) | ||
Total stockholders' equity | 77,816 | 133,018 | ||||
Total liabilities and stockholders' equity | $ | 82,852 | $ | 139,324 |
Years Ended December 31, | |||||||||
2016 | 2015 | 2014 | |||||||
Revenues: | |||||||||
Product revenue | $ | 163 | $ | 76 | $ | — | |||
Licensing and royalty revenues | 83 | 71 | 122 | ||||||
Total revenues | 246 | 147 | 122 | ||||||
Costs and expenses: | |||||||||
Research and development | 28,196 | 26,022 | 19,526 | ||||||
Sales, general and administrative | 36,200 | 17,882 | 10,695 | ||||||
Amortization | 11 | 10 | 71 | ||||||
Depreciation | 2,340 | 1,782 | 817 | ||||||
Impairment of intangibles | — | 3 | |||||||
Total costs and expenses | 66,747 | 45,696 | 31,112 | ||||||
Loss from operations | (66,501 | ) | (45,549 | ) | (30,990 | ) | |||
Interest expense and other | (23 | ) | (4 | ) | (7 | ) | |||
Interest and dividend income | 494 | 74 | 64 | ||||||
Foreign currency exchange loss | (77 | ) | (19 | ) | — | ||||
Total other income | 394 | 51 | 57 | ||||||
Net loss before income taxes | (66,107 | ) | (45,498 | ) | (30,933 | ) | |||
Provision from income taxes | (267 | ) | — | — | |||||
Net loss | $ | (66,374 | ) | $ | (45,498 | ) | $ | (30,933 | ) |
Basic and diluted net loss per share | $ | (1.29 | ) | $ | (1.01 | ) | $ | (0.71 | ) |
Weighted average shares outstanding | 51,276 | 44,998 | 43,626 | ||||||
Other comprehensive loss: | |||||||||
Net loss | $ | (66,374 | ) | $ | (45,498 | ) | $ | (30,933 | ) |
Net unrealized loss on available-for-sale investments | (64 | ) | (20 | ) | (15 | ) | |||
Foreign currency translation adjustment | (128 | ) | 1 | — | |||||
Comprehensive loss | $ | (66,566 | ) | $ | (45,517 | ) | $ | (30,948 | ) |
Shares | Common Stock Amount | Contributed Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total Stockholders’ Equity | ||||||||||||
Balances, January 1, 2014 | 41,650 | $ | 42 | $ | 75,937 | $ | (34,484 | ) | $ | 22 | $ | 41,517 | |||||
Net loss | — | — | — | (30,933 | ) | — | (30,933 | ) | |||||||||
Issuance of common stock | 2,678 | 3 | 44,872 | — | — | 44,875 | |||||||||||
Exercise of options | 312 | — | 923 | — | — | 923 | |||||||||||
Unrealized loss on available-for-sale securities | — | — | — | — | (15 | ) | (15 | ) | |||||||||
Equity-based compensation | — | — | 9,624 | — | — | 9,624 | |||||||||||
Balances, December 31, 2014 | 44,640 | 45 | 131,356 | (65,417 | ) | 7 | 65,991 | ||||||||||
Net loss | — | — | — | (45,498 | ) | — | (45,498 | ) | |||||||||
Issuance of common stock | 6,426 | 6 | 103,345 | — | — | 103,351 | |||||||||||
Exercise of options | 125 | — | 805 | — | — | 805 | |||||||||||
Unrealized loss on available-for-sale securities | — | — | — | — | (20 | ) | (20 | ) | |||||||||
Foreign currency translation adjustment | — | — | — | — | 1 | 1 | |||||||||||
Equity-based compensation | — | — | 8,388 | — | — | 8,388 | |||||||||||
Balances, December 31, 2015 | 51,191 | 51 | 243,894 | (110,915 | ) | (12 | ) | 133,018 | |||||||||
Net loss | — | (66,374 | ) | — | (66,374 | ) | |||||||||||
Exercise of options and warrants | 314 | 1 | 1,496 | — | — | 1,497 | |||||||||||
Issuance of common stock under employee purchase plan | 11 | — | 226 | — | — | 226 | |||||||||||
Short swing profits (net of costs) | — | — | 866 | — | — | 866 | |||||||||||
Unrealized loss on available-for-sale securities | — | — | — | — | (64 | ) | (64 | ) | |||||||||
Foreign currency translation adjustment | — | — | — | — | (128 | ) | (128 | ) | |||||||||
Equity-based compensation | — | — | 8,775 | — | — | 8,775 | |||||||||||
Balances, December 31, 2016 | 51,516 | 52 | 255,257 | (177,289 | ) | (204 | ) | 77,816 |
Years Ended December 31, | |||||||||
2016 | 2015 | 2014 | |||||||
Cash flows from operating activities: | |||||||||
Net loss | $ | (66,374 | ) | $ | (45,498 | ) | $ | (30,933 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||
Depreciation | 2,340 | 1,782 | 817 | ||||||
Amortization of intangible assets | 11 | 10 | 71 | ||||||
Amortization of investment discount | 374 | 188 | 269 | ||||||
Equity-based compensation | 8,775 | 8,388 | 9,624 | ||||||
Impairment loss | — | — | 3 | ||||||
Realized gain on available-for-sale securities | (6 | ) | — | — | |||||
Loss on disposal of property & equipment | 23 | — | — | ||||||
(Increase) decrease in assets: | |||||||||
Accounts receivable | 43 | 1 | (54 | ) | |||||
Prepaid expense and other | 1,292 | (1,241 | ) | (166 | ) | ||||
Other current assets | (171 | ) | (12 | ) | — | ||||
Increase (decrease) in liabilities: | |||||||||
Accounts payable | (1,242 | ) | 329 | 1,336 | |||||
Accrued liabilities | 1,619 | 827 | 80 | ||||||
Deferred revenue and income | (92 | ) | 100 | 168 | |||||
Net cash used in operating activities | (53,408 | ) | (35,126 | ) | (18,785 | ) | |||
Cash flows from investing activities: | |||||||||
Purchases of equipment | (2,409 | ) | (3,656 | ) | (1,933 | ) | |||
Purchase of available-for-sale securities | (74,075 | ) | (12,418 | ) | (7,657 | ) | |||
Sales of available-for-sale securities | 9,716 | 141 | 861 | ||||||
Maturity of available-for-sale securities | 17,200 | 13,258 | 5,357 | ||||||
Net cash used in investing activities | (49,568 | ) | (2,675 | ) | (3,372 | ) | |||
Cash flows from financing activities: | |||||||||
Exercise of warrants and options | 1,497 | 805 | 923 | ||||||
Common stock issuance cost | (814 | ) | — | — | |||||
Issuance of common stock and warrants | 226 | 104,165 | 44,875 | ||||||
Recovery of related party short-swing profits | 866 | — | — | ||||||
Payments on capital lease obligations | (13 | ) | (147 | ) | (107 | ) | |||
Net cash provided by financing activities | 1,762 | 104,823 | 45,691 | ||||||
Effect of exchange rate on cash | (127 | ) | — | — | |||||
Increase (decrease) in cash and cash equivalents | (101,341 | ) | 67,022 | 23,534 | |||||
Cash and cash equivalents, beginning of period | 120,585 | 53,563 | 30,029 | ||||||
Cash and cash equivalents, end of period | $ | 19,244 | $ | 120,585 | $ | 53,563 |
• | Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; |
• | Level 2: Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs that are observable, either directly or indirectly, for substantially the full term of the asset or liability; |
• | Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e. supported by little or no market activity). |
• | 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. |
December 31, 2016 | ||||||||||||
(in thousands) | ||||||||||||
Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | Total | |||||||||
Assets: | ||||||||||||
Cash and cash equivalents: | ||||||||||||
Money market funds | $ | 10,970 | $ | — | $ | — | $ | 10,970 | ||||
Investments: | ||||||||||||
Certificates of deposit | — | 7,257 | — | 7,257 | ||||||||
US Treasury securities | 8,544 | — | — | 8,544 | ||||||||
US Agency securities | — | 4,501 | — | 4,501 | ||||||||
Asset-backed securities | — | 5,557 | — | 5,557 | ||||||||
Corporate notes and bonds | — | 32,660 | — | 32,660 | ||||||||
Total investments | 8,544 | 49,975 | — | 58,519 | ||||||||
Total assets measured at fair value | $ | 19,514 | $ | 49,975 | $ | — | $ | 69,489 |
December 31, 2015 | ||||||||||||
(in thousands) | ||||||||||||
Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | Total | |||||||||
Assets: | ||||||||||||
Cash and cash equivalents: | ||||||||||||
Money market funds | $ | 5,221 | $ | — | $ | — | $ | 5,221 | ||||
Investments: | ||||||||||||
Asset-backed securities | — | 2,507 | — | 2,507 | ||||||||
Corporate notes and bonds | — | 9,332 | — | 9,332 | ||||||||
Total investments | — | 11,839 | — | 11,839 | ||||||||
Total assets measured at fair value | $ | 5,221 | $ | 11,839 | $ | — | $ | 17,060 |
AVAILABLE-FOR-SALE INVESTMENTS | ||||||||||||
December 31, 2016 | ||||||||||||
(in thousands) | ||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | |||||||||
Certificates of deposit | $ | 7,257 | $ | — | $ | — | $ | 7,257 | ||||
US Treasury securities | 8,553 | 1 | (10 | ) | 8,544 | |||||||
US Agency securities | 4,514 | — | (13 | ) | 4,501 | |||||||
Asset-backed securities | 5,554 | 3 | — | 5,557 | ||||||||
Corporate notes and bonds | 32,717 | 3 | (60 | ) | 32,660 | |||||||
Total | $ | 58,595 | $ | 7 | $ | (83 | ) | $ | 58,519 |
AVAILABLE-FOR-SALE INVESTMENTS | ||||||||||||
December 31, 2015 | ||||||||||||
(in thousands) | ||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | |||||||||
Asset-backed securities | $ | 2,510 | $ | — | $ | (3 | ) | $ | 2,507 | |||
Corporate notes and bonds | 9,341 | 1 | (10 | ) | 9,332 | |||||||
Total | $ | 11,851 | $ | 1 | $ | (13 | ) | $ | 11,839 |
AVAILABLE-FOR-SALE INVESTMENT MATURITIES | ||||||||||||
(in thousands) | ||||||||||||
At December 31, 2016 | At December 31, 2015 | |||||||||||
Amortized Cost | Fair Value | Amortized Cost | Fair Value | |||||||||
Due in less than 1 year | $ | 45,391 | $ | 45,344 | $ | 11,851 | $ | 11,839 | ||||
Due in 1-5 years | 13,204 | 13,175 | — | — | ||||||||
Total | $ | 58,595 | $ | 58,519 | $ | 11,851 | $ | 11,839 |
PROPERTY AND EQUIPMENT | ||||||
(in thousands) | ||||||
12/31/2016 | 12/31/2015 | |||||
Computer equipment | $ | 2,270 | $ | 1,877 | ||
Technical equipment | 2,427 | 1,806 | ||||
Facilities | 3,387 | 1,772 | ||||
Capital projects in progress | 1,010 | 2,183 | ||||
Total property and equipment | $ | 9,094 | $ | 7,638 | ||
Accumulated depreciation - other | (4,836 | ) | (2,622 | ) | ||
Net property and equipment | $ | 4,258 | $ | 5,016 |
• | 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. |
Deferred Revenue and Income | ||||||
(in thousands) | ||||||
12/31/2016 | 12/31/2015 | |||||
Fisher agreement | $ | — | $ | 13 | ||
Products not yet delivered | 35 | 114 | ||||
Total current deferred revenue and income | $ | 35 | $ | 127 | ||
Arizona Commerce Authority grant | $ | 1,000 | $ | 1,000 | ||
Total long-term deferred income | $ | 1,000 | $ | 1,000 |
• | the warrants provide for partial exercises, but they do not provide for a “cashless” exercise feature (i.e., they may only be exercised for cash); |
• | the warrants do not contain anti-dilution provisions that would trigger exercise price or other adjustments as a result of subsequent issuances of the Company’s equity securities, but they do contain customary provisions for equitable adjustments in connection with stock dividends, stock splits or reclassifications of Common Stock; |
• | following certain types of fundamental transactions involving the Company (e.g., a transaction resulting in a change in control of the Company), the holder of the warrants would continue to be entitled to exercise the warrants in exchange for the equity securities or alternate consideration receivable by a holder of Common Stock as a result of the fundamental transaction; and |
• | the holder of the warrants is entitled to certain demand and piggy-back registration rights, including for shelf registrations, with respect to the shares of Common Stock issuable upon its exercise of the warrants. |
Stock Option Activity | |||||
Number of Shares | Weighted Average Exercise Price per Share | ||||
Options Outstanding January 1, 2015 | 5,628,726 | $ | 5.20 | ||
Granted | 717,833 | 20.59 | |||
Forfeited | (54,505 | ) | 11.71 | ||
Exercised | (124,884 | ) | 6.44 | ||
Expired | — | — | |||
Options Outstanding December 31, 2015 | 6,167,170 | 6.91 | |||
Granted | 1,024,050 | 14.05 | |||
Forfeited | (147,663 | ) | 18.43 | ||
Exercised | (158,743 | ) | 7.47 | ||
Expired | (27,690 | ) | 4.87 | ||
Options Outstanding December 31, 2016 | 6,857,124 | 7.72 | |||
Exercisable December 31, 2016 | 4,566,005 | 4.94 |
Black-Scholes Assumptions for Option Granted | |||||||||
12 months | 12 months | 12 months | |||||||
12/31/2016 | 12/31/2015 | 12/31/2014 | |||||||
Expected term (in years) | 6.43 | 6.26 | 6.25 | ||||||
Volatility | 86 | % | 91 | % | 96 | % | |||
Expected dividends | — | — | — | ||||||
Risk free interest rates | 1.6 | % | 1.7 | % | 1.9 | % | |||
Estimated forfeitures | 8.5 | % | 5.6 | % | 0.4 | % | |||
Weighted average fair value | $ | 10.35 | $ | 16.69 | $ | 12.63 |
Stock Option Supplemental Information | |||||||||
Options Outstanding | Options Exercisable | Options Vested and Expected to Vest | |||||||
Number of options | 6,857,124 | 4,566,005 | 6,711,021 | ||||||
Weighted average remaining contractual term (in years) | 6.57 | 5.83 | 6.52 | ||||||
Weighted average exercise price | $ | 7.72 | $ | 4.94 | $ | 7.55 | |||
Weighted average fair value | $ | 5.95 | $ | 3.72 | $ | 5.82 | |||
Aggregate intrinsic value (in millions) | $ | 82.0 | $ | 70.4 | $ | 81.6 |
Restricted Stock Unit (RSU) Activity | ||||
Number of Shares | Weighted Average Grant Date Fair Value per Share | |||
RSU's outstanding January 1, 2015 | — | — | ||
Granted | 40,250 | 20.91 | ||
Forfeited | — | — | ||
Vested/released | — | — | ||
RSU's outstanding December 31, 2015 | 40,250 | 20.91 | ||
Granted | — | — | ||
Forfeited | — | — | ||
Vested/released | — | — | ||
RSU's outstanding December 31, 2016 | 40,250 | 20.91 |
Equity-Based Compensation Expenses and Tax Benefit (in thousands) | |||||||||
12 months | 12 months | 12 months | |||||||
12/31/2016 | 12/31/2015 | 12/31/2014 | |||||||
Research and development | $ | 1,585 | $ | 2,479 | $ | 4,334 | |||
Sales, general and administrative | 7,190 | 5,909 | 5,290 | ||||||
Equity-based compensation expense | 8,775 | 8,388 | 9,624 | ||||||
Recognized tax benefit | $ | — | $ | — | $ | — |
Shares issued | 11,093 | |
Weighted average fair value | 20.40 | |
Employee purchases (in thousands) | 226 |
Components of the Pretax Loss From Operations | |||||||||
(in thousands) | |||||||||
12/31/2016 | 12/31/2015 | 12/31/2014 | |||||||
U.S. Domestic | $ | (48,539 | ) | $ | (44,415 | ) | $ | (30,933 | ) |
Foreign | (17,568 | ) | (1,083 | ) | — | ||||
Pretax loss from operations | $ | (66,107 | ) | $ | (45,498 | ) | $ | (30,933 | ) |
Provision for Income Taxes | |||||||||
(in thousands) | |||||||||
12/31/2016 | 12/31/2015 | 12/31/2014 | |||||||
Current: | |||||||||
Federal | $ | — | $ | — | $ | — | |||
State | — | — | — | ||||||
Foreign | 267 | — | — | ||||||
Total current provision | 267 | — | — | ||||||
Deferred: | |||||||||
Federal | — | — | — | ||||||
State | — | — | — | ||||||
Foreign | — | — | — | ||||||
Total deferred provision | — | — | — | ||||||
Total provision | $ | 267 | $ | — | $ | — |
Deferred Income Tax Components | ||||||
(in thousands) | ||||||
12/31/2016 | 12/31/2015 | |||||
Deferred tax assets: | ||||||
Net operating loss carryforward | $ | 42,013 | $ | 28,584 | ||
Property & equipment | 690 | 339 | ||||
Inventory | 1,735 | 864 | ||||
Stock options | 7,208 | 5,208 | ||||
Intangible assets, definite-lived | 220 | 333 | ||||
General business credit | 3,984 | 1,915 | ||||
Deferred revenue | 370 | 372 | ||||
Other | 121 | 205 | ||||
Valuation allowance | (56,341 | ) | (37,820 | ) | ||
Deferred tax assets | $ | — | $ | — |
Effective Tax Rate | ||||||
12/31/2016 | 12/31/2015 | 12/31/2014 | ||||
U.S. federal statutory income tax rate | (34.00 | )% | (34.00 | )% | (34.00 | )% |
State taxes, net of federal tax benefit | (1.69 | ) | (2.93 | ) | (3.20 | ) |
Permanent and other differences | (0.17 | ) | 0.11 | — | ||
Change in tax rates | 0.67 | — | — | |||
Tax rate differential | 8.62 | 0.42 | — | |||
Unrecognized tax benefits | 1.09 | 0.40 | — | |||
Nondeductible equity and other compensation | 1.17 | 2.86 | 3.70 | |||
Limitation on net operating losses due to §382 | — | — | 0.50 | |||
Credit for increased research activities | (3.31 | ) | (2.67 | ) | (0.80 | ) |
Change in Valuation allowance | 28.02 | 35.81 | 33.80 | |||
0.40 | % | — | % | — | % |
Uncertain Tax Positions | |||||||||
(in thousands) | |||||||||
12/31/2016 | 12/31/2015 | 12/31/2014 | |||||||
Balance at beginning of year | $ | 343 | $ | 161 | $ | — | |||
Increases for prior positions | 37 | — | 78 | ||||||
Increases for current year positions | 721 | 182 | 83 | ||||||
Other Increases | — | — | — | ||||||
Decreases due to settlements | — | — | — | ||||||
Expiration of the statute of limitations for the assessment of taxes | — | — | — | ||||||
Other Decreases | — | — | — | ||||||
Balance at end of year | $ | 1,101 | $ | 343 | $ | 161 |
Operating Lease Obligations (in thousands) | |||
Year ending December 31: | |||
2017 | $ | 1,004 | |
2018 | 79 | ||
2019 | — | ||
2020 | — | ||
Thereafter | — | ||
Total operating lease obligations | $ | 1,083 |
QUARTERLY FINANCIAL INFORMATION | ||||||||||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||||||||||
Unaudited | ||||||||||||||||||||||||
For the quarters ending: | ||||||||||||||||||||||||
12/31/2016 | 9/30/2016 | 6/30/2016 | 3/31/2016 | 12/31/2015 | 9/30/2015 | 6/30/2015 | 3/31/2015 | |||||||||||||||||
Revenue | $ | 39 | $ | 24 | $ | 20 | $ | 163 | $ | 22 | $ | 92 | $ | 19 | $ | 14 | ||||||||
Net loss | (16,135 | ) | (17,299 | ) | (17,866 | ) | (15,074 | ) | (13,163 | ) | (11,186 | ) | (12,252 | ) | (8,897 | ) | ||||||||
Basic and diluted net loss per share | (0.31 | ) | (0.34 | ) | (0.35 | ) | (0.29 | ) | (0.29 | ) | (0.25 | ) | (0.27 | ) | (0.20 | ) |
• | pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets; |
• | provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S. GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and our directors; and |
• | provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements. |
Page | |
ACCELERATE DIAGNOSTICS, INC. | ||
February 27, 2017 | By: /s/ Lawrence Mehren | |
Lawrence Mehren President and Chief Executive Officer |
Signature | Title | Date | ||
/s/ Lawrence Mehren Lawrence Mehren | President, Chief Executive Officer and Director | February 27, 2017 | ||
/s/ Steve Reichling Steve Reichling | Corporate Secretary, Chief Financial Officer and Chief Accounting Officer | February 27, 2017 | ||
/s/ John Patience John Patience | Chairman of the Board of Directors | February 27, 2017 | ||
/s/ Jack Schuler Jack Schuler | Director | February 27, 2017 | ||
/s/ Matthew W. Strobeck, Ph.D. Matthew W. Strobeck, Ph.D. | Director | February 27, 2017 | ||
/s/ Frank ten Brink Frank ten Brink | Director | February 27, 2017 | ||
/s/ Mark Miller Mark Miller | Director | February 27, 2017 |
Exhibit No. | Description | Filing Information | |
3.1 | Certificate of Incorporation of Registrant | Incorporated by reference to Appendix B of the Registrant’s Definitive Proxy Statement on Schedule 14A filed on November 13, 2012 |
3.1.1 | Certificate of Amendment to Certificate of Incorporation of Registrant | Incorporated by reference to Exhibit A to the Registrant’s Definitive Information Statement on Schedule 14C filed on July 12, 2013 | |
3.1.2 | Certificate of Amendment to Certificate of Incorporation of Registrant | Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on March 15, 2016 | |
3.2 | Bylaws of Registrant | Incorporated by reference to Exhibit 3.2 filed with the Registrant’s Annual Report on Form 10-K for the fiscal year ended July 31, 2012. | |
4.1 | Warrant No. 2 issued by Registrant to Abeja Ventures, LLC on June 26, 2012 | Incorporated by reference to Exhibit 4.2 filed with the Registrant’s Annual Report on Form 10-K for the fiscal year ended July 31, 2012 | |
10.1 | Registrant’s 2004 Omnibus Stock Option Plan | Incorporated by reference to Appendix A of the Registrant’s Definitive Proxy Statement on Schedule 14A filed on November 15, 2004 | |
10.2 | Amendment to Registrant’s 2004 Omnibus Stock Option Plan | Incorporated by reference to Annex C of the Registrant’s Definitive Proxy Statement on Schedule 14A filed on May 17, 2012 | |
10.3 | Form of Stock Option Award Agreement under Registrant’s 2004 Omnibus Stock Option Plan | Incorporated by reference to Exhibit 4.4 filed with the Registrant’s Form S-8 Registration Statement (No. 333-182930) on July 30, 2012 | |
10.4 | Registration Rights Agreement between Registrant and Abeja Ventures, LLC, dated as of June 26, 2012 | Incorporated by reference to Exhibit 10.5 filed with the Registrant’s Annual Report on Form 10-K for the fiscal year ended July 31, 2012 | |
10.5 | Offer Letter between Registrant and Lawrence Mehren, dated as of June 24, 2012 | Incorporated by reference to Exhibit 10.9 filed with the Registrant’s Annual Report on Form 10-K for the fiscal year ended July 31, 2012 | |
10.6 | CFO Offer Letter between Registrant and Steve Reichling, dated as of August 8, 2012 | Incorporated by reference to Exhibit 10.10 filed with the Registrant’s Annual Report on Form 10-K for the fiscal year ended July 31, 2012 | |
10.7 | Lease Agreement between Registrant and Pima County, dated as of August 20, 2012 | Incorporated by reference to Exhibit 10.11 filed with the Registrant’s Annual Report on Form 10-K for the fiscal year ended July 31, 2012 | |
10.8 | Grant Agreement between Registrant and the Arizona Commerce Authority, dated as of August 22, 2012 | Incorporated by reference to Exhibit 10.12 filed with the Registrant’s Annual Report on Form 10-K for the fiscal year ended July 31, 2012 | |
10.9 | Registrant’s 2012 Omnibus Equity Incentive Plan | Incorporated by reference to Appendix C of the Registrant’s Definitive Proxy Statement on Schedule 14A filed on November 13, 2012 | |
10.9.1 | First Amendment to Registrant’s 2012 Omnibus Equity Incentive Plan | Incorporated by reference to Exhibit 99.2 to the Form S-8 Registration Statement (No. 333-187439) filed by the Registrant on March 22, 2013 | |
10.9.2 | Form of Nonqualified Stock Option Award Agreement under Registrant’s 2012 Omnibus Equity Incentive Plan | Incorporated by reference to Exhibit 99.3 to the Form S-8 Registration Statement (No. 333-187439) filed by the Registrant on March 22, 2013 |
10.9.3 | Form of Incentive Stock Option Award Agreement under Registrant’s 2012 Omnibus Equity Incentive Plan | Incorporated by reference to Exhibit 99.4 to the Form S-8 Registration Statement (No. 333-187439) filed by the Registrant on March 22, 2013 | |
10.9.4 | Second Amendment to Registrant’s 2012 Omnibus Equity Incentive Plan | Incorporated by reference to Appendix A of the Registrant’s Definitive Proxy Statement on Schedule 14A filed on April 15, 2014 | |
21 | List of Subsidiaries | Filed herewith | |
23.1 | Consent of Independent Registered Public Accounting Firm (Ernst & Young LLP) | Filed herewith | |
31.1 | Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | Filed herewith | |
31.2 | Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | Filed herewith | |
32 | Certificate of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | Filed herewith | |
101 | XBRL Instance Document | ||
101 | XBRL Taxonomy Extension Schema Document | ||
101 | XBRL Taxonomy Calculation Linkbase Document | ||
101 | XBRL Taxonomy Extension Definition Linkbase Document | ||
101 | XBRL Taxonomy Label Linkbase Document | ||
101 | XBRL Taxonomy Presentation Linkbase Document |
Legal Entity | Jurisdiction/Domicile |
Accelerate Diagnostics UK Limited | England |
Accelerate Diagnostics S.L. | Spain |
Accelerate Diagnostics GmbH | Germany |
Accelerate Diagnostics SARL | France |
Accelerate Diagnostics S.r.l | Italy |
Accelerate Diagnostics B.V. | Netherlands |
AX Diagnostics C.V. | Netherlands |
Accelerate Diagnostics Holdings, LLC | United States |
(1) | Registration Statement (Form S-8 No. 333-187439) pertaining to the Accelerate Diagnostics, Inc. 2012 Omnibus Equity Incentive Plan, |
(2) | Registration Statement (Form S-8 No. 333-199992) pertaining to the Accelerate Diagnostics, Inc. 2012 Omnibus Equity Incentive Plan, and |
(3) | Registration Statement (Form S-8 No. 333-213072) pertaining to the Accelerate Diagnostics, Inc. 2016 Employee Stock Purchase Plan; |
1. | I have reviewed this annual report on Form 10-K of Accelerate Diagnostics, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchanged Act Rules 13a-15(f) and 15d-15(f) for the registrant and have: |
a. | designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b. | designed such internal control over financial reporting, caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c. | evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d. | disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
a. | all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b. | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
February 27, 2017 | /s/ Lawrence Mehren |
Lawrence Mehren President and Chief Executive Officer | |
(Principal Executive Officer) |
1. | I have reviewed this annual report on Form 10-K of Accelerate Diagnostics, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchanged Act Rules 13a-15(f) and 15d-15(f) for the registrant and have: |
a. | designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b. | designed such internal control over financial reporting, caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c. | evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d. | disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
a. | all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b. | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
February 27, 2017 | /s/ Steve Reichling |
Steve Reichling Chief Financial Officer | |
(Principal Financial and Accounting Officer) |
February 27, 2017 | /s/ Lawrence Mehren |
Lawrence Mehren President and Chief Executive Officer | |
(Principal Executive Officer) | |
February 27, 2017 | /s/ Steve Reichling |
Steve Reichling Chief Financial Officer | |
(Principal Financial and Accounting Officer) |
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Document and Entity Information - USD ($) $ in Millions |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Feb. 25, 2017 |
Jun. 30, 2016 |
|
Document And Entity Information | |||
Entity Registrant Name | Accelerate Diagnostics, Inc. | ||
Entity Central Index Key | 0000727207 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2016 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 383.1 | ||
Entity Common Stock, Shares Outstanding | 51,895,049 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2016 |
Consolidated Balance Sheets (Parenthetical) - $ / shares |
Dec. 31, 2016 |
Dec. 31, 2015 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Common stock, par value (dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 75,000,000 | 55,000,000 |
Common stock, shares issued | 51,516,309 | 51,191,184 |
Common stock, shares outstanding | 51,516,309 | 51,191,184 |
Preferred shares, par value (dollars per share) | $ 0 | $ 0 |
Preferred shares, shares authorized | 5,000,000 | 5,000,000 |
Preferred shares, shares issued | 0 | 0 |
Preferred shares, shares outstanding | 0 | 0 |
Organization and Nature of Business; Basis of Presentation; Principles of Consolidation |
12 Months Ended |
---|---|
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Organization and Nature of Business; Basis of Presentation; Principles of Consolidation | NOTE 1. ORGANIZATION AND NATURE OF BUSINESS; BASIS OF PRESENTATION; PRINCIPLES OF CONSOLIDATION Accelerate Diagnostics, Inc. (“we” or “us” or “our” or “Accelerate” or “the Company”) is an in vitro diagnostics company dedicated to providing solutions which improve patient outcomes and lower healthcare costs through the rapid diagnosis of serious infections. Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, (“U.S. GAAP”), and applicable rules and regulations of the United States Securities and Exchange Commission (“SEC”), regarding annual financial reporting. All amounts are rounded to the nearest thousand dollars unless otherwise indicated. Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries after elimination of intercompany transactions and balances. During the fiscal year ending December 31, 2016, new entities were formed based in Europe. Reclassification Certain prior year amounts have been reclassified for consistency with the current year presentation and had no effect on our net income, stockholders' equity or cash flows. |
Summary of Significant Accounting Policies |
12 Months Ended | ||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2016 | |||||||||||||||||||||||||||||
Accounting Policies [Abstract] | |||||||||||||||||||||||||||||
Summary of Significant Accounting Policies | NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Estimated Fair Value of Financial Instruments The Company follows ASC Topic 820, Fair Value Measurements and Disclosures which has defined fair value and requires the Company to establish a framework for measuring fair value and disclose fair value measurements. The framework requires the valuation of assets and liabilities subject to fair value measurements using a three tiered approach and fair value measurement be classified and disclosed in one of the following three categories:
The carrying amounts of financial instruments such as cash and cash equivalents, trade accounts receivable, prepaid expenses, accounts payable, accrued liabilities, and other current liabilities approximate the related fair values due to the short-term maturities of these instruments. See Note 4, Fair Value of Financial Instruments for further information and related disclosures regarding the Company’s fair value measurements. Cash and Cash Equivalents All highly liquid investments with an original maturity of three months or less at time of purchase are considered to be cash equivalents. Cash and cash equivalents include overnight repurchase agreement accounts and other investments. As part of our cash management process, excess operating cash is invested in overnight repurchase agreements with our bank. Repurchase agreements and other investments classified as cash and cash equivalents are not deposits and are not insured by the U.S. Government, the FDIC or any other government agency and involve investment risk including possible loss of principal. We believe however, that the market risk arising from holding these financial instruments is minimal. Investments The Company invests excess funds in various investments which are primarily held in the custody of major financial institutions. Investments consist of debt securities in U.S. government and agency securities, corporate debt securities, certificates of deposit, and commercial paper. Management classifies its investments as available-for-sale investments and records these investments in the consolidated balance sheet at fair value. The Company considers all available-for-sale securities, including those with maturity dates beyond 12 months, as available to support current operational liquidity needs. Unrealized gains or losses for available-for-sale securities are included in accumulated other comprehensive income or loss, a component of stockholders’ equity. The Company classifies its investments as current based on the nature of the investments and their availability for use in current operations. The Company assesses whether an other-than-temporary impairment loss has occurred due to declines in fair value or other market conditions when an investment’s fair value remains less than its cost for more than twelve months. This assessment includes a determination of whether the investment is expected to recover in value and whether the Company has the intent and ability to hold the investment until the anticipated recovery in value occurs. When an investment is identified as having an other-than-temporary impairment loss, we adjust the cost basis of the investment down to fair value resulting in a realized loss. The new cost basis is not changed for subsequent recoveries in fair value and temporary future increases or decreases in fair value are included in other comprehensive income. Inventory The Company currently purchases and produces inventory prior to U.S. Food and Drug Administration (“FDA”) or other regulatory agency approval. We do not believe probable future economic benefit can be asserted prior to the de novo request being granted by the U.S. FDA unless the regulatory review process has progressed to a point that objective and persuasive evidence of regulatory approval is sufficiently probable ("Regulatory Approval"). Accordingly, the Company does not capitalize pre-launch inventory prior to Regulatory Approval and future economic benefit can be asserted. Costs associated with the Company’s purchase of inventory are either reported as research and development costs, or if the inventory is used in marketing evaluations, as sales, general and administrative costs on the consolidated statements of operations and comprehensive loss. Accounts Receivable Allowances Allowances on accounts receivable are recorded when circumstances indicate collection is doubtful for a particular accounts receivable. Receivables are written off if reasonable collection efforts prove unsuccessful. The Company provides for allowances on a specific account basis. Property and Equipment Property and equipment are recorded at cost. Maintenance and repairs are charged to expense as incurred and expenditures for major improvements are capitalized. Gains and losses from retirement or replacement are included in costs and expenses. Depreciation of property and equipment is computed using the straight-line method over the estimated useful life of the assets, ranging from one to seven years. Leasehold improvements are depreciated over the remaining life of the lease or the life of the asset, whichever is less. See Note 6, Property and Equipment below. Long-lived Assets Long-lived assets and certain identifiable intangibles to be held and used by the Company are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company continuously evaluates the recoverability of its long-lived assets based on estimated future cash flows from and the estimated fair value of such long-lived assets, and provides for impairment if such undiscounted cash flows or the estimated fair value are insufficient to recover the carrying amount of the long-lived asset. Warranty Reserve A limited warranty of a year or less is covered under selected contracts. Accordingly, a provision for the estimated cost of the limited warranty repair is recorded at the time revenue is recognized. Our estimated warranty provision is based on our estimate of future repair events and the related estimated cost of repairs. We periodically assess the adequacy of the warranty reserve and adjust the amount as necessary. The expense incurred for these provisions is included in sales, general and administrative on the consolidated statements of operations and comprehensive loss. Revenue Recognition The Company recognizes revenue in accordance with ASC 605, “Revenue Recognition,” when persuasive evidence of an arrangement exists, the price is fixed or determinable, collection is reasonably assured and delivery of products has occurred or services have been rendered. Additional considerations include whether the applicable fee arrangement contains future delivery or performance obligations that should be divided into separate accounting units, whether the arrangement requires the Company to retain risks consistent with a collaborative arrangement, and/or whether any of the fees are contingent on the achievement of future milestones. Product revenue is derived from the sale or rental of our instruments and sales of related consumable products. When an instrument is sold, revenue is generally recognized upon installation of the unit consistent with contract terms, which do not include a right of return. When a consumable product is sold, revenue is generally recognized upon shipment. We also provide instruments to customers under bundled rental agreements. Under these agreements, we install the instrument in the customer's facility and provide service and training without a fee. The customer agrees to purchase consumable products at a stated price over the term of the agreement which varies but is under seven years. Contracts sometimes have renewal clauses but such clauses do not provide for a bargain renewal option or penalize the customer if they don't renew. The instrument remains our property throughout the term of the agreement and there is no transfer of title upon expiration. Revenue is recognized as consumable products are shipped or delivered, depending on contract terms. Deferred revenue represents amounts received but not yet earned under existing agreements. Leases The Company accounts for leases in accordance with ASC 840, Leases, which requires leases to be classified as either operating or capital leases. In general, the Company classifies leases as capital leases when there is either a transfer of ownership at the end of the lease term, the lease contains a bargain purchase option, the lease term is seventy-five percent or more of the estimated economic life of the leased property or the minimum lease payments are ninety percent or more of the fair value at lease inception. Other leases are classified as operating leases. Operating lease rent is recorded as an operating expense monthly. For capital leases, both an asset and liability are recorded at the inception of the lease based on the present value of lease payments. The asset is included with property and equipment on the Balance Sheet and amortization is recorded on a straight-line basis over the term of the lease with the amortization expense included with depreciation on the Statements of Operations and Comprehensive Loss. For the liability, the amount due within the next year is recorded as capital lease obligations and the amount due in more than a year is recorded as long-term capital lease obligation on the Balance Sheet. Interest expense is recorded based on the implicit or explicit interest rate used in the lease and is included as non-operating interest expense on the Statements of Operations and Comprehensive Loss. Equity-Based Compensation The Company awards stock options and other equity-based instruments to its employees, directors and consultants. Compensation cost related to equity-based instruments is based on the fair value of the instrument on the grant date, and is recognized over the requisite service period on a straight-line basis over the vesting period for each tranche (an accelerated attribution method). For unvested consultant grants, the assumptions are updated at the end of each reporting period until the grant is vested. The Company estimates the fair value of stock option awards, including modifications of stock option awards, using the Black-Scholes option pricing model. This model derives the fair value of stock options based on certain assumptions related to expected stock price volatility, expected option life, risk-free interest rate and dividend yield.
The Company estimates the forfeiture rate of unvested awards based on the forfeitures in the previous twelve-month period. The rate is calculated separately for awards to the board of directors/executives and all other awards. The Company also has an employee stock purchase program whereby eligible employees can elect payroll deductions that are subsequently used to purchase common stock at a discounted price. There is no compensation recorded for this program as (i) the purchase discount does not exceed the issuance costs that would have been incurred to raise a significant amount of capital by a public offering, (ii) substantially all employees that meet limited employment qualifications may participate on an equitable basis, and (iii) the plan doesn't incorporate option features that would require compensation to be recorded. See Note 14, Employee and Consultant Equity-Based Compensation for further information. Income Taxes and Deferred Tax Assets Deferred tax assets and liabilities are recorded for the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the accompanying balance sheets. The change in deferred tax assets and liabilities for the period represents the deferred tax provision or benefit for the period. Effects of changes in enacted tax laws in deferred tax assets and liabilities are reflected as an adjustment to the tax provision or benefit in the period of enactment. The Company follows the provisions of ASC 740, Income Taxes, to account for any uncertainty in income taxes with respect to the accounting for all tax positions taken (or expected to be taken) on any income tax return. This guidance applies to all open tax periods in all tax jurisdictions in which the Company is required to file an income tax return. Under U.S. GAAP, in order to recognize an uncertain tax benefit the taxpayer must be more likely than not certain of sustaining the position, and the measurement of the benefit is calculated as the largest amount that is more than 50% likely to be realized upon resolution of the position. Interest and penalties, if any, would be recorded as tax expense in general and administrative expenses. Foreign Currency Translation and Foreign Currency Transactions The Company follows ASC 830 Foreign Currency Matters, which provides guidance on foreign currency transactions and translation of financial statements. Adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars are included in the foreign currency translation adjustment, a component of accumulated other comprehensive income (loss) in the consolidated statements of stockholder's equity. The Company has assets and liabilities, including receivables and payables, which are denominated in currencies other than their functional currency. These balance sheet items are subject to re-measurement, the impact of which is recorded in interest expense and other, within the consolidated statement of operations and comprehensive loss. Earnings Per Share The Company follows ASC 260, Earnings Per Share, which requires companies to present basic earnings per share and diluted earnings per share. Basic earnings (loss) per share includes no dilution and is computed by dividing income (loss) available to common stockholders by the weighted average number of common shares outstanding for the period. Diluted earnings per share are computed similarly to basic earnings (loss) per share except the denominator includes additional common shares that would have been outstanding if warrants and share-based payments had been issued. Diluted earnings are not presented when the effect of adding such additional common shares is antidilutive. Earnings per share are restated when certain transactions or events, including rights offerings determined to have bonus elements have occurred. See Note 13, Earnings Per Share for further information. Comprehensive Loss The Company follows ASC 220, Reporting Comprehensive Income, which establishes standards for reporting and displaying comprehensive income (loss) and its components (revenues, expenses, gains and losses) in a full set of general-purpose financial statements. The Company holds investments classified as available-for-sale securities and records the change in fair market value as a component of comprehensive income (loss). The Company also has adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars which is included as a component of comprehensive income (loss). Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments-Credit Losses (Topic 326) Measurement of Credit Losses on Financial Instruments, which amends the guidance on measuring credit losses on financial assets (including trade accounts receivable and available for sale debt securities) held at amortized cost. Currently, an “incurred loss” methodology is used for recognizing credit losses which delays recognition until it is probable a loss has been incurred. The amendment requires assets valued at amortized cost to be presented at the net amount expected to be collected using an allowance for credit losses. Reversal of credit losses on available for sale debt securities will be recorded in the current period net income. The amendment will be effective for us on January 1, 2020, with early adoption permitted. We do not anticipate this guidance will have a significant impact on our financial statements and plan to adopt on the effective date. In March 2016, the FASB issued ASU 2016-09, Compensation-Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting. This guidance requires the recognition of the income tax effects of awards in the income statement when the awards vest or are settled, thus eliminating additional paid in capital pools. The guidance also allows for the employer to repurchase more of an employee’s shares for tax withholding purposes without triggering liability accounting. In addition, the guidance allows for a policy election to account for forfeitures as they occur rather than on an estimated basis. We will implement this guidance on January 1, 2017, effective date and have elected to account for forfeitures as they occur. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). This replaces the existing standards relating to leases for both lessees and lessors. For lessees, the new standard requires most leases to be recorded on the balance sheet with expenses recognized much like the existing standard. For lessors, the new standard modifies the classification criteria and accounting for sales-type and direct financing leases and eliminates leveraged leases. For both lessees and lessors, the standard eliminates real estate-specific provisions, changes some of the presentation and disclosure requirements, and changes sale and leaseback criteria. The ASU is required for us on January 1, 2019, with early adoption permitted. We are currently assessing the impact this will have on our consolidated financial statements and the timing of adoption. In January, 2016, the FASB issued ASU 2016-01, Financial Instruments - Overall. This standard requires equity investments, with some exceptions, be measured at fair value with valuation changes recognized in net income, simplifies the impairment assessment of some equity investments, eliminates the requirement to disclose the methods and significant assumptions used to estimate the fair value for financial instruments measured at amortized cost, requires the use of the exit price notion when measuring the fair value of financial instruments, requires separate presentation of some changes in other comprehensive income, requires separate presentation of financial assets and financial liabilities by measurement category and form of financial assets, and clarifies the need for a valuation allowance on some deferred tax assets. The ASU is required for us on January 1, 2018. We do not expect the adoption of ASU 2016-01 to have a significant impact on our consolidated financial statements. In November 2015, the FASB issued ASU 2015-17, Income Taxes-Balance Sheet Classification of Deferred Taxes. The new standard required that deferred income tax liabilities and assets be classified as noncurrent in a classified statement of financial position rather than separating these amounts between current and noncurrent amounts. The deferred tax liabilities and assets continue to be offset and presented as a single amount. The ASU was required for us on January 1, 2017, and we adopted this standard retrospectively for the period ended December 31, 2015. There was no significant impact on our consolidated financial statements as a result of adopting this ASU. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements - Going Concern. The new standard required management of public and private companies to evaluate whether there is substantial doubt about the entity’s ability to continue as a going concern and, if so, disclose that fact. Management is also required to evaluate and disclose whether its plans alleviate that doubt. The new standard became effective for us on January 1, 2016 and the adoption did not have an impact on our consolidated financial statements. In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606), which will supersede nearly all existing revenue recognition guidance under U.S. GAAP. The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In August 2015, the FASB issued ASU 2015-14, Revenue from Contracts with Customers Deferral of the Effective Date, which deferred the effective date resulting in a new effective date of January 1, 2018, for us. We are permitted to adopt early but not before the original effective date of January 1, 2017. FASB has issued several other ASU's which provide further guidance on Topic 606 and have the same effective date. The standard allows for either “full retrospective” adoption, meaning the standard is applied to all of the periods presented, or “modified retrospective” adoption, meaning the standard is applied only to the most current period presented in the financial statements. We will implement ASU 2014-09 and all relevant subsequently issued ASU's on Topic 606 concurrently on January 1, 2018, and are currently evaluating the transitions method. We are carefully evaluating our existing revenue recognition practices to determine whether any contracts in the scope of the guidance will be affected by the new requirements. The effects may include identifying performance obligations in existing arrangements, determining the transaction price and allocating the transaction price to each separate performance obligation. We will also establish practices to determine when a performance obligation has been satisfied, and recognize revenue in accordance with the new requirements. As no material revenues have been recognized to date, we do not anticipate the adoption of this standard to have a material effect. |
Concentration of Credit Risk |
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Risks and Uncertainties [Abstract] | |
Concentration of Credit Risk | NOTE 3. CONCENTRATION OF CREDIT RISK Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, short-term investments and accounts receivable, including receivables from major customers. The Company’s main financial institution for banking operations held 57% and 100% of the Company’s cash and cash equivalents as of December 31, 2016, and December 31, 2015, respectively. The Company grants credit to domestic and international clients in various industries. Exposure to losses on accounts receivable is principally dependent on each client's financial position. At December 31, 2016, and 2015, 29% and 66%, respectively, of the outstanding receivable balance was with one customer. |
Fair Value of Financial Instruments |
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Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value of Financial Instruments | NOTE 4. FAIR VALUE OF FINANCIAL INSTRUMENTS The following tables represent the financial instruments measured at fair value on a recurring basis on the financial statements of the Company and the valuation approach applied to each class of financial instruments at December 31, 2016, and 2015 (see Note 2, Summary of Significant Accounting Policies for further information):
Money market funds are included in cash and cash equivalents on the consolidated balance sheet. Level 1 assets are priced using quoted prices in active markets for identical assets which include money market funds and U.S. Treasury securities as these specific assets are liquid. Level 2 available-for-sale securities are priced using quoted market prices for similar instruments or nonbinding market prices that are corroborated by observable market data. The Company uses inputs such as actual trade data, benchmark yields, broker/dealer quotes, and other similar data, which are obtained from quoted market prices, independent pricing vendors, or other sources, to determine the ultimate fair value of these assets and liabilities. The Company uses such pricing data as the primary input to make its assessments and determinations as to the ultimate valuation of its investment portfolio and has not made, during the periods presented, any material adjustments to such inputs. There were no transfers between levels during the year ended December 31, 2016. |
Investments |
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Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments | NOTE 5. INVESTMENTS The following tables summarize the Company’s available-for-sale investments at December 31, 2016, and 2015 (in thousands):
The following table summarizes the maturities of the Company’s available-for-sale securities at December 31, 2016, and 2015 (in thousands):
Proceeds from sales of marketable securities (including principal paydowns) for the years ended December 31, 2016, and 2015, were $9.7 million and $141,000, respectively. The Company determines gains and losses of marketable securities based on specific identification of the securities sold. There were $6,000 of realized gains from sales of marketable securities the year ended December 31, 2016, and no gross realized gains or losses from sales of marketable securities for year ended December 31, 2015. The gross proceeds associated with the realized gains for the year ended December 31, 2016 were $7.2 million. No material balances were reclassified out of accumulated other comprehensive income for the years ended December 31, 2016, and 2015. No other-than-temporary impairments are recorded as no investments had a fair value that remained less than its cost for more than twelve months as of December 31, 2016, and 2015. The Company does not intend to sell investments and it is more likely than not that we will not be required to sell investments before recovering the amortized cost. Additional information regarding the fair value of our financial instruments is included in Item 8, Note 4, Fair Value of Financial Instruments. |
Property and Equipment |
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Property and Equipment | NOTE 6. PROPERTY AND EQUIPMENT Property and equipment are recorded at cost and consisted of the following at December 31, 2016, and 2015 (in thousands).
Depreciation expense (which includes amortization of capital lease assets) for the years ended December 31, 2016, 2015 and 2014, was $2.3 million, $1.8 million and $817,000, respectively. |
License Agreements and Grants |
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License Agreements and Grants | NOTE 7. LICENSE AGREEMENTS AND GRANTS Defense Medical Research and Development Program In May 2012, the Company and Denver Health were notified that the Defense Medical Research and Development Program (“DMRDP”) recommended $2.0 million of funding for a proposed 35-month project. The joint proposal became the sole recipient under the Military Infectious Diseases Applied Research Award program for rapid detection of serious antibiotic-resistant infections. The project applied the Accelerate Pheno™ system to wound infections and other serious infections secondary to trauma. The Company has invoiced a cumulative total of $612,000 under this grant which is recorded as an offset to research and development expenses. The amount invoiced for the years ended December 31, 2016, 2015, 2014 was $54,000, $179,000, $221,000, respectively. The period of performance for this grant was complete as of September 30, 2016. National Institute of Health Grant In February 2015, the National Institute of Health awarded Denver Health and the Company a five year, $5.0 million grant to develop a fast and reliable identification and categorical susceptibility test for carbepenem-resistant Enterobacteriaceae directly from whole blood. The Company completed the first subaward agreement with Denver Health for services provided as part of this grant on January 31, 2016. A second subaward was obtained which continued the period of performance through January 31, 2017. The cumulative award amount under these subawards is $818,000. The amounts invoiced for the years ended December 31, 2016, 2015 and 2014, were $74,000, $483,000 and $0, respectively. Arizona Commerce Authority In August 2012, the Company entered into a Grant Agreement (the “Grant Agreement”) with the Arizona Commerce Authority, an agency of the State of Arizona (the “Authority”), pursuant to which the Authority provided certain state and county sponsored incentives for the Company to relocate its corporate headquarters to, and expand its business within, the State of Arizona (the “Project”). Pursuant to the Grant Agreement, the Authority agreed to provide a total grant in the amount of $1.0 million (the “Grant”) for the use by the Company in the advancement of the Project. The Grant is payable out of an escrow account in four installments, upon the achievement of the following milestones:
For purposes of the Grant Agreement, a “Qualified Job” is a job that is permanent, full-time, new to Arizona, and for which the Company pays average (across all Qualified Jobs identified by the Company in its discretion) annual wages of at least $63,000 and offers health insurance benefits and pays at least 65% of the premiums associated with such benefits. The amount of each installment payment will be determined in accordance with a formula specified in the Grant Agreement. The Grant Agreement also contains other customary provisions, including representations, warranties and covenants of both parties. As of December 31, 2016, the Company has collected all of the $1.0 million in milestones. The full amount is recorded in long-term deferred income until the economic development provisions of the grant have been satisfied in full, as there are “claw-back” provisions which would require repayment of certain amounts received if employment levels are not sustained during the term of the arrangement. Once the “claw-back” provisions expire in January 2018, we will recognize the grant as an offset to expense. Further details are included in Note 8, Deferred Revenue and Income. Arizona R&D Refundable Tax Credit Program The Company has applied for and met the program requirements to receive a “Certificate of Qualification” from the Arizona Commerce Authority (“Authority”) which allows the Company to be eligible for a partial refund of research and development investments ("Arizona R&D Refundable Tax Credit Program"). The amounts collected under this program are recorded as an offset to research and development expenses, and for the years ended December 31, 2016, 2015 and 2014, were $1.2 million, $647,000 and $527,000, respectively. If the amount received for this program is later determined to be incorrect or invalid, the excess may need to be repaid. |
Deferred Revenue and Income |
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Deferred Revenue and Income | NOTE 8. DEFERRED REVENUE AND INCOME Deferred revenue consists of amounts received for products or services not yet delivered or earned. Deferred income consists of amounts received for commitments not yet fulfilled. If we anticipate that the revenue or income will not be earned within the following twelve months, the amount is reported as long-term deferred income. A summary of the balances as of December 31, 2016, and 2015 follows (in thousands):
Through December 31, 2016, we received $1.0 million in milestone payments from the Arizona Commerce Authority under the Grant Agreement described in Note 7, License Agreements and Grants. As of December 31, 2016, no such payments have been recognized in income, and we do not anticipate recognizing such payments as income until the “claw-back” provisions under the Grant Agreement expire in January 2018. The deferred income of $114,000 for products not yet delivered as of December 31, 2015, was recognized as product revenue for the year ended December 31, 2016. |
Stock Purchase |
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Dec. 31, 2016 | |||||||||||||||||
Securities Financing Transactions Disclosures [Abstract] | |||||||||||||||||
Stock Purchase | NOTE 9. STOCK PURCHASE In April 2012, we entered into a Securities Purchase Agreement with Abeja Ventures, LLC (“Abeja”), pursuant to which the Company agreed to sell and issue to Abeja at a purchase price of $1.03 per share for an aggregate purchase price of $14.4 million; (i) 14.0 million shares of the Company’s common stock (“Common Stock”); (ii) a warrant to purchase 7.0 million shares of Common Stock at an exercise price of $1.03 per share (the “$1.03 " Warrant”); and (iii) another warrant to purchase 7.0 million shares of Common Stock at an exercise price of $2.00 per share (the “$2.00" Warrant”), with each warrant exercisable prior to the fifth anniversary of the closing of the transactions contemplated by the Securities Purchase Agreement (collectively, the “Investment”). The purchase of Common Stock and warrants pursuant to the Investment, which was consummated in June, 2012, qualified for equity treatment under U.S. GAAP. The respective values of the warrants and Common Stock were calculated using their relative fair values and both are classified under Contributed Capital. The value therefore recorded for the warrants was $5.9 million and for the Common Stock was $8.5 million. Both warrants are exercisable until June 26, 2017, which was the fifth anniversary of the date on which the warrants were issued. Other significant terms and conditions of the warrants are as follows:
In March 2013, Abeja exercised in full its warrant to purchase 7.0 million shares of Common Stock at an exercise price of $1.03 per share. On the same date, Abeja also exercised the 92% of its warrant to purchase an additional 7.0 million shares of Common Stock at an exercise price of $2.00 per share (Abeja exercised such warrant for 6.4 million shares, leaving 571,160 shares unexercised on that date). The Company received aggregate funds of $20.1 million in connection with such exercises. Shares issued by the Company in connection with the warrant exercises were issued directly to the members of Abeja on a pro rata basis in accordance with their membership interests and written exercise instructions provided to the Company by Abeja. Immediately after giving effect to the warrant exercises, Abeja also distributed in kind to its members (on a pro rata basis in accordance with their membership interests) the remaining shares of Common Stock held by that entity. In September and October 2016, warrants to purchase 155,289 shares were exercised at an exercise price of $2.00 leaving 415,871 warrants for shares unexercised at December 31, 2016. The Company received funds totaling $311,000 in connection with these exercises which are recorded as common stock and contributed capital in the Consolidated Balance Sheet. |
Public Offering |
12 Months Ended |
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Dec. 31, 2016 | |
Equity [Abstract] | |
Public Offering | NOTE 10. PUBLIC OFFERING On December 9, 2015, the Company published a prospectus supplement underwritten by J.P. Morgan and Piper Jaffray ("Underwriters") offering 5.6 million shares of common stock with an option for the Underwriters to purchase up to 838,000 additional shares of common stock for a total of 6.4 million shares. The public offering price was $17.00 per share and underwriting discounts and commissions were $1.19 per share. Affiliates, including entities affiliated with one of Company's directors, Jack Schuler, and which together are our largest stockholders, purchased 2.9 million of the offered shares at the public offering price of $17.00 per share. These shares were subject to lock-up agreements for a period of 90 days starting December 9, 2015. In general, the lock-up agreement, with limited exceptions, requires J.P. Morgan Securities LLC's prior written approval for the sale (directly or indirectly) of AXDX common stock. This includes various types of sales or offers to sell. The underwriters did not receive any underwriting discount or commissions on the sale of 2.4 million shares to such affiliates. The public offering was finalized and 6.4 million shares of common stock were delivered to the purchasers on or around December 15, 2015. Proceeds from the sale totaled $109.3 million less underwriting and other expenses of $5.9 million for net proceeds of $103.4 million. The net proceeds will be used for general corporate purposes. We may also use a portion of the net proceeds to acquire or invest in complementary businesses, technologies, product candidates or other intellectual property, although we have no present commitments or agreements to do so. Accordingly, we will retain broad discretion over the use of these proceeds. NOTE 11. RIGHTS OFFERING April 2014 Offering On April 7, 2014, the Company commenced a rights offering to raise $45.0 million to fund continued operations, clinical trials, and product commercialization efforts. Under the terms of the rights offering, the Company distributed, at no charge to the holders of its Common Stock as of March 14, 2014, which was established as the record date for the rights offering, 0.063921 non-transferable subscription rights for each share of Common Stock owned on the record date. Each whole subscription right allowed the holder to subscribe to purchase one share of Common Stock at a subscription price of $16.80 per share which was lower than the market price of $17.64 per share on the date of the rights offering commencement and the $17.54 per share on the date the rights offering period expired. In the aggregate, the Company intended to issue 2.7 million shares of Common Stock in connection with the rights offering. The purpose of the rights offering was to raise equity capital in a cost-effective manner that gives all of the Company’s existing stockholders the opportunity to participate on a pro rata basis. In connection with the rights offering, the Company received standby commitments from the Jack W. Schuler Living Trust and the Schuler Family Foundation. The standby purchasers agreed to purchase any and all shares of Common Stock that were not subscribed for by stockholders in connection with the rights offering. On May 1, 2014, the Company entered into an Assignment and Assumption Agreement with the standby purchasers, Oracle Institutional Partners, L.P. and Oracle Partners, L.P., pursuant to which each standby purchaser assigned and transferred its respective rights, responsibilities, liabilities and obligations under the Standby Purchase Agreement to purchase 297,619 shares of Common Stock not subscribed for by the Company’s stockholders in connection with the rights offering to (i) Oracle Institutional Partners, L.P., with respect to 119,047 shares of such Common Stock, and (ii) Oracle Partners, L.P., with respect to the remaining 178,572 shares of such Common Stock. The rights offering period expired on April 28, 2014, and the transactions contemplated by the rights offering and the Standby Purchase Agreement described above (including the Company’s issuance of an aggregate of 2.7 million shares of its Common Stock to the rights offering participants and standby purchasers) were completed on May 19, 2014. The Company received gross proceeds of $45.0 million before costs associated with the transactions which totaled $125,000 and are treated as a reduction of contributed capital in the Stockholders’ Equity section of the Balance Sheets. Because the exercise price of the rights offering of $16.80 was less than the fair value of the Company’s shares of Common Stock at the expiration of the offering, there is a bonus element that is treated similar to a stock dividend. The weighted average shares outstanding, as well as the basic and diluted loss per share for the year ended December 31, 2013, has been revised for those effects. |
Rights Offering |
12 Months Ended |
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Dec. 31, 2016 | |
Warrants and Rights Note Disclosure [Abstract] | |
Rights Offering | NOTE 10. PUBLIC OFFERING On December 9, 2015, the Company published a prospectus supplement underwritten by J.P. Morgan and Piper Jaffray ("Underwriters") offering 5.6 million shares of common stock with an option for the Underwriters to purchase up to 838,000 additional shares of common stock for a total of 6.4 million shares. The public offering price was $17.00 per share and underwriting discounts and commissions were $1.19 per share. Affiliates, including entities affiliated with one of Company's directors, Jack Schuler, and which together are our largest stockholders, purchased 2.9 million of the offered shares at the public offering price of $17.00 per share. These shares were subject to lock-up agreements for a period of 90 days starting December 9, 2015. In general, the lock-up agreement, with limited exceptions, requires J.P. Morgan Securities LLC's prior written approval for the sale (directly or indirectly) of AXDX common stock. This includes various types of sales or offers to sell. The underwriters did not receive any underwriting discount or commissions on the sale of 2.4 million shares to such affiliates. The public offering was finalized and 6.4 million shares of common stock were delivered to the purchasers on or around December 15, 2015. Proceeds from the sale totaled $109.3 million less underwriting and other expenses of $5.9 million for net proceeds of $103.4 million. The net proceeds will be used for general corporate purposes. We may also use a portion of the net proceeds to acquire or invest in complementary businesses, technologies, product candidates or other intellectual property, although we have no present commitments or agreements to do so. Accordingly, we will retain broad discretion over the use of these proceeds. NOTE 11. RIGHTS OFFERING April 2014 Offering On April 7, 2014, the Company commenced a rights offering to raise $45.0 million to fund continued operations, clinical trials, and product commercialization efforts. Under the terms of the rights offering, the Company distributed, at no charge to the holders of its Common Stock as of March 14, 2014, which was established as the record date for the rights offering, 0.063921 non-transferable subscription rights for each share of Common Stock owned on the record date. Each whole subscription right allowed the holder to subscribe to purchase one share of Common Stock at a subscription price of $16.80 per share which was lower than the market price of $17.64 per share on the date of the rights offering commencement and the $17.54 per share on the date the rights offering period expired. In the aggregate, the Company intended to issue 2.7 million shares of Common Stock in connection with the rights offering. The purpose of the rights offering was to raise equity capital in a cost-effective manner that gives all of the Company’s existing stockholders the opportunity to participate on a pro rata basis. In connection with the rights offering, the Company received standby commitments from the Jack W. Schuler Living Trust and the Schuler Family Foundation. The standby purchasers agreed to purchase any and all shares of Common Stock that were not subscribed for by stockholders in connection with the rights offering. On May 1, 2014, the Company entered into an Assignment and Assumption Agreement with the standby purchasers, Oracle Institutional Partners, L.P. and Oracle Partners, L.P., pursuant to which each standby purchaser assigned and transferred its respective rights, responsibilities, liabilities and obligations under the Standby Purchase Agreement to purchase 297,619 shares of Common Stock not subscribed for by the Company’s stockholders in connection with the rights offering to (i) Oracle Institutional Partners, L.P., with respect to 119,047 shares of such Common Stock, and (ii) Oracle Partners, L.P., with respect to the remaining 178,572 shares of such Common Stock. The rights offering period expired on April 28, 2014, and the transactions contemplated by the rights offering and the Standby Purchase Agreement described above (including the Company’s issuance of an aggregate of 2.7 million shares of its Common Stock to the rights offering participants and standby purchasers) were completed on May 19, 2014. The Company received gross proceeds of $45.0 million before costs associated with the transactions which totaled $125,000 and are treated as a reduction of contributed capital in the Stockholders’ Equity section of the Balance Sheets. Because the exercise price of the rights offering of $16.80 was less than the fair value of the Company’s shares of Common Stock at the expiration of the offering, there is a bonus element that is treated similar to a stock dividend. The weighted average shares outstanding, as well as the basic and diluted loss per share for the year ended December 31, 2013, has been revised for those effects. |
Related Party Transaction |
12 Months Ended |
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Dec. 31, 2016 | |
Related Party Transactions [Abstract] | |
Related Party Transaction | NOTE 12. RELATED PARTY TRANSACTION In June 2016, the Company recorded a net amount of $866,000 related to the recovery of short-swing profits under Section 16(b) of the Securities Exchange Act of 1934, as amended. The Company recognized these related party proceeds as an increase to contributed capital on the consolidated balance sheet. |
Earnings Per Share |
12 Months Ended |
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Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |
Earnings Per Share | NOTE 13. EARNINGS PER SHARE The financial statements show basic earnings (loss) per share. The Company’s net loss for the periods presented caused the inclusion of all outstanding warrants, restricted stocks and options to purchase our Common Stock to be antidilutive. As of December 31, 2016, 2015 and 2014, there were Common Stock options, restricted stocks and warrants exercisable for 7,313,245, 6,778,580 and 6,174,886 shares of Common Stock, respectively, which were not included in diluted loss per share as the effect was antidilutive. |
Employee and Consultant Equity-Based Compensation |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Employee and Consultant Equity-Based Compensation | NOTE 14. EMPLOYEE AND CONSULTANT EQUITY-BASED COMPENSATION The Company has three stock option equity-based compensation plans, which are discussed below: Non-Qualified Stock Option Plan The Non-Qualified Stock Option Plan (the “Non-Qualified Plan”) was a stockholder-approved plan that provided for stock option grants to independent contractors, technical advisors and directors of the Company. The exercise price of each option, which has a maximum 10 year life, was established by the Company's Compensation Committee on the date of grant. As of December 31, 2016, there were 273,900 options exercised under the Non-Qualified Plan and 6,100 that remain outstanding. The Non-Qualified Plan has been replaced by the 2012 Omnibus Equity Incentive Plan, so no further options are available for grant. 2004 Omnibus Stock Option Plan In December 2004, the Company’s stockholders approved the Omnibus Stock Option Plan and reserved 500,000 shares of its authorized but unissued Common Stock for stock options to be granted to employees, independent contractors, technical advisors and directors of the Company. The authorized shares in this plan were increased by 5,000,000 shares to an aggregate amount of 5,500,000 upon stockholder approval during the fiscal year ended July 31, 2012. As of December 31, 2016, there were 428,907 options exercised under the 2004 Omnibus Stock Option Plan and 3,511,093 that remain outstanding. The 2004 Omnibus Stock Option Plan has been replaced by the 2012 Omnibus Equity Incentive Plan, so no further options are available for grant. 2012 Omnibus Equity Incentive Plan In December 2012, the Company’s stockholders approved the Company’s 2012 Omnibus Equity Incentive Plan to replace all prior plans ("Prior Plans"). The Prior Plans remain in effect until all awards granted under those plans have been exercised, forfeited, canceled, expired or otherwise terminated. In connection with the approval of such plan, all stock options, totaling 1,677,500 formerly available for new awards under the Prior Plans were transferred to the 2012 Omnibus Equity Incentive Plan. At the Company’s 2014 Annual Meeting of Stockholders held in May 2014, stockholders approved an amendment to the Company’s 2012 Omnibus Equity Incentive Plan increasing the number of stock options of Common Stock reserved and available for grant by 4,000,000 to 5,677,500 shares. Stock options granted under this plan typically vest either (i) one year after grant date, (ii) monthly over a one year period, (iii) annually over a five year period, or (iv) 40% two years after grant date and the remaining 60% monthly over the next three years. The maximum term is ten years. As of December 31, 2016, there were 200,557 options exercised under the 2012 Omnibus Equity Incentive Plan and 3,380,181 that remain outstanding, leaving 2,096,762 available for grant. In December 2015, the Board of Directors voted to restrict new grants under the 2012 Omnibus Equity Incentive Plan to 200,000 shares until such time as the Company’s total available shares are increased. The Company's total available shares were increased in March 2016 terminating the restriction of new grants. Combined Stock Option Plans The following table summarizes option activity under all plans during the years ending December 31, 2016, and December 31, 2015 and shows the exercisable shares as of December 31, 2016:
The cash received from the exercise of options during the year ending December 31, 2016, was $1.2 million and the tax benefit realized was $0 for the same period. Upon exercise, shares are issued from shares authorized and held in reserve. The intrinsic value of options exercised was $2.2 million, $2.0 million and $3.8 million for the years ending December 31, 2016, 2015 and 2014, respectively. The total fair value of shares vesting during the period was $6.6 million, $7.3 million, and $3.8 million for the years ending December 31, 2016, 2015 and 2014, respectively. As discussed in Note 2, Summary of Significant Accounting Policies, the Company accounts for all option grants using the Black-Scholes option pricing model in accordance with ASC 718 for options granted or extended. Note 2 also describes the significant assumptions utilized for estimating the various inputs required this pricing model. The table below summarizes the resulting weighted average inputs used to calculate the estimated fair value of options awarded for during the periods shown below:
In general, option awards have a requisite service period and unvested options are forfeited upon employee or consultant termination. The Company estimates a forfeiture rate which is applied to outstanding options to determine options expected to be forfeited with the remaining outstanding options being those expected to vest. Further information regarding the forfeiture rate calculation is included in Note 2, Summary of Significant Accounting Policies. The following table shows summary information for outstanding options, options that are exercisable (vested) and outstanding options that are either vested or expected to vest as of December 31, 2016:
The aggregate intrinsic value in the table above represents the total pretax intrinsic value that would have been received by the option holders had all option holders exercised their options on that date. It is calculated as the difference between the Company’s closing stock price of $20.75 on the last trading day of 2016 and the exercise price multiplied by the number of shares for options where the exercise price is below the closing stock price. This amount changes based on the fair market value of the Company’s stock. In December 2015, in connection with the Company's public offering, we modified the stock options of three of our executive officers to restrict the ability to exercise until such time as additional available unissued shares have been authorized. Such authorization was obtained from a majority of our shareholders as of December 31, 2015, and was filed with the State of Delaware in March 2016. There was an immaterial amount of incremental compensation associated with this modification. The following table summarizes restricted stock unit activity during the years ending December 31, 2016, and December 31, 2015:
The expense and tax benefits recognized on Company’s Statements of Operations and Comprehensive Loss related to options is summarized below (in thousands):
As of December 31, 2016, unrecognized equity-based compensation cost related to unvested stock options and unvested restricted stock was $10.3 million. This is expected to be recognized over the years 2017 through 2021. Employee Stock Purchase Plan In May 2016, the Company's stockholders approved the Company's 2016 Employee Stock Purchase Plan ("ESPP") which permits eligible employees to purchase common stock at a discount through payroll deductions. Eligible employees include employees of the Company and subsidiaries as designated by the Compensation Committee of the Board ("Committee") who (i) are employed more than twenty hours per week and (ii) are not owners of 5% or more of the total combined voting power or value of Company stock including the ESPP stock. In addition, the Committee has the discretion to exclude highly compensated employees. Eligible employees enroll in the ESPP and can contribute between 2% and 15% of compensation up to a maximum of $25,000 of the fair market value of shares for each calendar year. The payroll deductions are accumulated during each offering period. Generally, each offering period will be for a period of three months as determined by the Committee provided that no offering period may extend more than 27 months. On the last trading day of the offering period, the accumulated payroll deductions for each employee are used to purchase as many shares of stock as possible up to a maximum of 100,000 shares or as otherwise determined by the Committee. The price at which stock is purchased is equal to 90% of closing price for the common stock on the date of the purchase. A total of 500,000 shares of the Company’s common stock are reserved for issuance under the ESPP. As of December 31, 2016, 11,093 shares were issued and 488,907 shares of common stock are available for issuance. As the ESPP is not a compensatory plan as defined by the authoritative guidance for stock compensation, there is no stock-based compensation expense recorded related to the ESPP. See Note 2, Summary of Significant Accounting Policies for further information. A summary of ESPP activity for the year ended December 31, 2016 is as follows:
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Income Taxes |
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Income Tax Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Taxes | NOTE 15. INCOME TAXES The components of the pretax loss from operations for the years ended December 31, 2016, 2015 and 2014, are as follows (in thousands):
The components of the provision for income taxes is presented in the following table:
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s net deferred income taxes for the years ended December 31, 2016, and 2015, are as follows (in thousands):
As of December 31, 2016, the Company has generated regular tax federal net operating losses of approximately $125.1 million. The Company's ability to realize tax benefit from the net operating loss is subject to annual limitation under Internal Revenue Code Section 382. Due to the change in control which occurred as a result of Abeja Ventures, LLC’s investment in the Company on June 26, 2012, the Company estimates that the annual Section 382 limitation on utilization of net operating losses generated prior to the transaction will be $420,000. As such, the Company will never get the benefit of $4.2 million of the net operating losses generated prior to June 26, 2012. The deferred tax asset has been adjusted to reflect the Section 382 limitation. Section 382 also applies to built-in losses at the time of the transaction. The amounts of any unrealized built-in losses or gains were not calculated at the date of the transaction. The net operating losses available for future use are approximately $120.9 million. For federal purposes, net operating losses can be carried forward for up to 20 years. The Company’s federal net operating losses will begin to expire in 2023. The Company relocated its headquarters to Arizona in January 2013. As of December 31, 2016, the Company has generated Arizona net operating losses of approximately $102.5 million. The Company's Arizona net operating losses will begin to expire in 2033. The net deferred tax asset valuation allowance is $56.3 million as of December 31, 2016, compared to $37.8 million as of December 31, 2015. The valuation allowance is based on management’s assessment that it is more likely than not that the Company will not have taxable income in the foreseeable future. Under current GAAP, in a classified statement of financial position, deferred tax assets and liabilities are separated into current amounts and a non-current amounts on the basis of the classification of the related assets or liabilities for financial reporting. Deferred tax assets and liabilities that are not related to an asset or liability for financial reporting are classified according to the expected reversal date of the temporary difference. On November 20, 2015, the FASB issued Accounting Standards Update 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes which requires noncurrent classification of all deferred tax assets and liabilities for all public entities for annual periods beginning after December 15, 2016. Accounting Standards Update 2015-17 also provides for early adoption for all entities as of the beginning of an annual period. For the year ended December 31, 2015, the Company elected to early adopt Accounting Standards Update 2015-17 and presents all of its deferred tax assets and liabilities as non-current for the periods ended December 31, 2016, and 2015. The Company has applied the Standard on a prospective basis. Therefore, the classification of deferred tax assets and liabilities in periods prior to the period ended December 31, 2015 have not been changed from the original presentation. The Company began commercialization of its products in Europe in 2016 and has subsidiaries in the Netherlands, France, Germany, Italy, Spain and the United Kingdom. The Company intends to treat earnings from its foreign subsidiaries as permanently reinvested. As of December 31, 2016, there would be no US tax effect of a repatriation of the earnings of its foreign subsidiaries, due to the Company’s loss position. The difference between the U.S. federal statutory income tax rate and the Company’s effective tax rate for years ending December 31, 2016, 2015 and 2014, is as follows:
At December 31, 2016, the Company had uncertain tax positions of $1.1 million, determined as follows (in thousands):
These uncertain positions are not expected to change within the next twelve months. Of the $1.1 million of uncertain tax positions, $57,000 would impact the effective tax rate, if reversed. The Company accounts for interest on uncertain tax positions within tax expense. The Company's foreign subsidiaries are subject to applicable jurisdiction examination for all years of operations. The Company did not accrue interest or penalties for these uncertain tax positions as of December 31, 2016. The Company has incurred federal net operating losses dating to the tax year ended July 31, 2004. As such, all loss carryovers are subject to adjustment under IRS and state examination, depending on the jurisdiction in which they were incurred. In 2016, the IRS began an examination of the Company’s 2014 income tax return. Management does not believe the examination will result in a material change to its tax position. |
Commitments |
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Commitments | NOTE 16. COMMITMENTS Leases The Company has entered into lease agreements, lease amendments, and lease extensions ("Lease Agreements") for office, laboratory and manufacturing space located in Tucson, Arizona and Europe, the last of which expires in 2018. Total rent expense including common area charges was $1.1 million, $685,000 and $293,000 for the years ended December 31, 2016, 2015 and 2014, respectively. Future minimum lease payments under this agreement are as follows (in thousands):
Clinical Trial Agreements The Company has entered into master agreements with clinical trial sites in which we typically pay a set amount for start-up costs and then pay for work performed. These agreements typically indemnify the clinical trial sites from any and all losses arising from third party claims as a result of the Company's negligence, willful misconduct or misrepresentation. Clinical trial master agreement expense was $2.1 million and $1.6 million for years ended December 31, 2016, and 2015, respectively. No amounts were incurred for these arrangements through December 31, 2014. The expense incurred as part of the clinical trial is included in research and development on the consolidated statements of operations and comprehensive loss. Marketing Study Agreements The Company has entered into marketing study agreements with research institutions and hospitals in which we typically pay a set amount for start-up costs and then pay for work performed. These agreements typically indemnify the sites from any and all losses arising from third party claims as a result of the Company's negligence, willful misconduct or misrepresentation. Marketing study agreement expense was $233,000 and $66,000 for years ended December 31, 2016, and 2015, respectively. No amounts were incurred for these arrangements through December 31, 2014. The expense incurred as part of these studies is included in sales, general and administrative on the consolidated statements of operations and comprehensive loss. Legal Matters On March 19, 2015, a putative securities class action lawsuit was filed against Accelerate Diagnostics, Inc., Lawrence Mehren, and Steve Reichling, and is captioned as Rapp v. Accelerate Diagnostics, Inc., et al., U.S. District Court, District of Arizona, 2:2015-cv-00504. The complaint alleges that we violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and SEC Rule 10b-5, by making false or misleading statements about our Accelerate Pheno™ system, formerly called the BACcel System. Plaintiff purports to bring the action on behalf of a class of persons who purchased or otherwise acquired our stock between March 7, 2014, and February 17, 2015. On June 9, 2015, Julia Chang was appointed Lead Plaintiff of the purported class. On June 23, 2015, Plaintiff filed an amended complaint alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5, by making false or misleading statements or omissions about our Accelerate Pheno™ system and by allegedly employing schemes to defraud. Plaintiff sought certification of the action as a class action, compensatory damages for the class in an unspecified amount, legal fees and costs, and such other relief as the court may order. Defendants moved to dismiss the amended complaint on July 21, 2015. The Court granted the motion and dismissed the case with prejudice on January 28, 2016. On February 26, 2016, Plaintiff filed a notice of appeal with the United States Court of Appeals for the Ninth Circuit, which challenges the dismissal of the amended complaint. See Chang v. Accelerate Diagnostics, Inc., et al., No. 2:15-CV-00504-SPL (9th Cir. filed Feb. 26, 2016). The appeal has been fully briefed and is pending. See Item 8, Note 18, Subsequent Events for an update on this lawsuit. We do not anticipate this will have a material impact on our financial statements. |
Segments |
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Segment Reporting [Abstract] | |
Segments | NOTE 17. SEGMENTS The Company operates as one operating segment. Operating segments are defined as components of an enterprise for which separate financial information is evaluated regularly by the chief operating decision maker, who is the chief executive officer, in deciding how to allocate resources and assessing performance. The Company’s business operates in one operating segment because the Company’s chief operating decision maker evaluates the Company’s financial information and resources and assesses the performance of these resources on a consolidated basis. Since the Company operates in one operating segment, all required financial segment information can be found in the consolidated financial statements. |
Subsequent Events |
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Subsequent Events [Abstract] | |
Subsequent Events | NOTE 18. SUBSEQUENT EVENTS FDA Clearance On February 23, 2017, the U.S. Food and Drug Administration granted Accelerate's de novo request to market the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit for identification and antibiotic susceptibility testing of pathogens directly from positive blood culture samples. Legal Matters As described in Item 8, Note 16, Commitments, Legal Matters, on February 26, 2016, Plaintiff filed a notice of appeal with the United States Court of Appeals for the Ninth Circuit, which challenges the dismissal of the amended complaint. See Chang v. Accelerate Diagnostics, Inc., et al., No. 2:15-CV-00504-SPL (9th Cir. filed Feb. 26, 2016). The appeal has been fully briefed and is pending. On January 27, 2017, the appellate Court informed the Company that this case is being considered for oral argument, possibly as early as May 2017, although the exact date has not yet been set. We do not anticipate this will have a material impact on our financial statements. |
Supplemental Data Quarterly Financial Information |
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Supplemental Quarterly Financial Information | NOTE 19. SUPPLEMENTAL DATA QUARTERLY FINANCIAL INFORMATION (UNAUDITED)
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Summary of Significant Accounting Policies (Policies) |
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Accounting Policies [Abstract] | |||||||||||||||||
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, (“U.S. GAAP”), and applicable rules and regulations of the United States Securities and Exchange Commission (“SEC”), regarding annual financial reporting. All amounts are rounded to the nearest thousand dollars unless otherwise indicated. |
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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. |
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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. |
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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. |
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Estimated Fair Value of Financial Instruments | Estimated Fair Value of Financial Instruments The Company follows ASC Topic 820, Fair Value Measurements and Disclosures which has defined fair value and requires the Company to establish a framework for measuring fair value and disclose fair value measurements. The framework requires the valuation of assets and liabilities subject to fair value measurements using a three tiered approach and fair value measurement be classified and disclosed in one of the following three categories:
The carrying amounts of financial instruments such as cash and cash equivalents, trade accounts receivable, prepaid expenses, accounts payable, accrued liabilities, and other current liabilities approximate the related fair values due to the short-term maturities of these instruments. |
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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. |
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Investments | Investments The Company invests excess funds in various investments which are primarily held in the custody of major financial institutions. Investments consist of debt securities in U.S. government and agency securities, corporate debt securities, certificates of deposit, and commercial paper. Management classifies its investments as available-for-sale investments and records these investments in the consolidated balance sheet at fair value. The Company considers all available-for-sale securities, including those with maturity dates beyond 12 months, as available to support current operational liquidity needs. Unrealized gains or losses for available-for-sale securities are included in accumulated other comprehensive income or loss, a component of stockholders’ equity. The Company classifies its investments as current based on the nature of the investments and their availability for use in current operations. The Company assesses whether an other-than-temporary impairment loss has occurred due to declines in fair value or other market conditions when an investment’s fair value remains less than its cost for more than twelve months. This assessment includes a determination of whether the investment is expected to recover in value and whether the Company has the intent and ability to hold the investment until the anticipated recovery in value occurs. When an investment is identified as having an other-than-temporary impairment loss, we adjust the cost basis of the investment down to fair value resulting in a realized loss. The new cost basis is not changed for subsequent recoveries in fair value and temporary future increases or decreases in fair value are included in other comprehensive income. |
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Inventory | Inventory The Company currently purchases and produces inventory prior to U.S. Food and Drug Administration (“FDA”) or other regulatory agency approval. We do not believe probable future economic benefit can be asserted prior to the de novo request being granted by the U.S. FDA unless the regulatory review process has progressed to a point that objective and persuasive evidence of regulatory approval is sufficiently probable ("Regulatory Approval"). Accordingly, the Company does not capitalize pre-launch inventory prior to Regulatory Approval and future economic benefit can be asserted. Costs associated with the Company’s purchase of inventory are either reported as research and development costs, or if the inventory is used in marketing evaluations, as sales, general and administrative costs on the consolidated statements of operations and comprehensive loss. |
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Accounts Receivable Allowances | Accounts Receivable Allowances Allowances on accounts receivable are recorded when circumstances indicate collection is doubtful for a particular accounts receivable. Receivables are written off if reasonable collection efforts prove unsuccessful. The Company provides for allowances on a specific account basis. |
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Property and Equipment | Property and Equipment Property and equipment are recorded at cost. Maintenance and repairs are charged to expense as incurred and expenditures for major improvements are capitalized. Gains and losses from retirement or replacement are included in costs and expenses. Depreciation of property and equipment is computed using the straight-line method over the estimated useful life of the assets, ranging from one to seven years. Leasehold improvements are depreciated over the remaining life of the lease or the life of the asset, whichever is less. |
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Long-lived Assets | Long-lived Assets Long-lived assets and certain identifiable intangibles to be held and used by the Company are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company continuously evaluates the recoverability of its long-lived assets based on estimated future cash flows from and the estimated fair value of such long-lived assets, and provides for impairment if such undiscounted cash flows or the estimated fair value are insufficient to recover the carrying amount of the long-lived asset. |
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Warranty Reserve | Warranty Reserve A limited warranty of a year or less is covered under selected contracts. Accordingly, a provision for the estimated cost of the limited warranty repair is recorded at the time revenue is recognized. Our estimated warranty provision is based on our estimate of future repair events and the related estimated cost of repairs. We periodically assess the adequacy of the warranty reserve and adjust the amount as necessary. The expense incurred for these provisions is included in sales, general and administrative on the consolidated statements of operations and comprehensive loss. |
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Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with ASC 605, “Revenue Recognition,” when persuasive evidence of an arrangement exists, the price is fixed or determinable, collection is reasonably assured and delivery of products has occurred or services have been rendered. Additional considerations include whether the applicable fee arrangement contains future delivery or performance obligations that should be divided into separate accounting units, whether the arrangement requires the Company to retain risks consistent with a collaborative arrangement, and/or whether any of the fees are contingent on the achievement of future milestones. Product revenue is derived from the sale or rental of our instruments and sales of related consumable products. When an instrument is sold, revenue is generally recognized upon installation of the unit consistent with contract terms, which do not include a right of return. When a consumable product is sold, revenue is generally recognized upon shipment. We also provide instruments to customers under bundled rental agreements. Under these agreements, we install the instrument in the customer's facility and provide service and training without a fee. The customer agrees to purchase consumable products at a stated price over the term of the agreement which varies but is under seven years. Contracts sometimes have renewal clauses but such clauses do not provide for a bargain renewal option or penalize the customer if they don't renew. The instrument remains our property throughout the term of the agreement and there is no transfer of title upon expiration. Revenue is recognized as consumable products are shipped or delivered, depending on contract terms. Deferred revenue represents amounts received but not yet earned under existing agreements. |
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Leases | Leases The Company accounts for leases in accordance with ASC 840, Leases, which requires leases to be classified as either operating or capital leases. In general, the Company classifies leases as capital leases when there is either a transfer of ownership at the end of the lease term, the lease contains a bargain purchase option, the lease term is seventy-five percent or more of the estimated economic life of the leased property or the minimum lease payments are ninety percent or more of the fair value at lease inception. Other leases are classified as operating leases. Operating lease rent is recorded as an operating expense monthly. For capital leases, both an asset and liability are recorded at the inception of the lease based on the present value of lease payments. The asset is included with property and equipment on the Balance Sheet and amortization is recorded on a straight-line basis over the term of the lease with the amortization expense included with depreciation on the Statements of Operations and Comprehensive Loss. For the liability, the amount due within the next year is recorded as capital lease obligations and the amount due in more than a year is recorded as long-term capital lease obligation on the Balance Sheet. Interest expense is recorded based on the implicit or explicit interest rate used in the lease and is included as non-operating interest expense on the Statements of Operations and Comprehensive Loss. |
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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.
The Company estimates the forfeiture rate of unvested awards based on the forfeitures in the previous twelve-month period. The rate is calculated separately for awards to the board of directors/executives and all other awards. The Company also has an employee stock purchase program whereby eligible employees can elect payroll deductions that are subsequently used to purchase common stock at a discounted price. There is no compensation recorded for this program as (i) the purchase discount does not exceed the issuance costs that would have been incurred to raise a significant amount of capital by a public offering, (ii) substantially all employees that meet limited employment qualifications may participate on an equitable basis, and (iii) the plan doesn't incorporate option features that would require compensation to be recorded. |
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Income Taxes and Deferred Tax Assets | Income Taxes and Deferred Tax Assets Deferred tax assets and liabilities are recorded for the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the accompanying balance sheets. The change in deferred tax assets and liabilities for the period represents the deferred tax provision or benefit for the period. Effects of changes in enacted tax laws in deferred tax assets and liabilities are reflected as an adjustment to the tax provision or benefit in the period of enactment. The Company follows the provisions of ASC 740, Income Taxes, to account for any uncertainty in income taxes with respect to the accounting for all tax positions taken (or expected to be taken) on any income tax return. This guidance applies to all open tax periods in all tax jurisdictions in which the Company is required to file an income tax return. Under U.S. GAAP, in order to recognize an uncertain tax benefit the taxpayer must be more likely than not certain of sustaining the position, and the measurement of the benefit is calculated as the largest amount that is more than 50% likely to be realized upon resolution of the position. Interest and penalties, if any, would be recorded as tax expense in general and administrative expenses. |
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Foreign Currency Translation and Foreign Currency Transactions | Foreign Currency Translation and Foreign Currency Transactions The Company follows ASC 830 Foreign Currency Matters, which provides guidance on foreign currency transactions and translation of financial statements. Adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars are included in the foreign currency translation adjustment, a component of accumulated other comprehensive income (loss) in the consolidated statements of stockholder's equity. The Company has assets and liabilities, including receivables and payables, which are denominated in currencies other than their functional currency. These balance sheet items are subject to re-measurement, the impact of which is recorded in interest expense and other, within the consolidated statement of operations and comprehensive loss. |
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Earnings Per Share | Earnings Per Share The Company follows ASC 260, Earnings Per Share, which requires companies to present basic earnings per share and diluted earnings per share. Basic earnings (loss) per share includes no dilution and is computed by dividing income (loss) available to common stockholders by the weighted average number of common shares outstanding for the period. Diluted earnings per share are computed similarly to basic earnings (loss) per share except the denominator includes additional common shares that would have been outstanding if warrants and share-based payments had been issued. Diluted earnings are not presented when the effect of adding such additional common shares is antidilutive. Earnings per share are restated when certain transactions or events, including rights offerings determined to have bonus elements have occurred. |
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Comprehensive loss | Comprehensive Loss The Company follows ASC 220, Reporting Comprehensive Income, which establishes standards for reporting and displaying comprehensive income (loss) and its components (revenues, expenses, gains and losses) in a full set of general-purpose financial statements. The Company holds investments classified as available-for-sale securities and records the change in fair market value as a component of comprehensive income (loss). The Company also has adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars which is included as a component of comprehensive income (loss). |
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Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments-Credit Losses (Topic 326) Measurement of Credit Losses on Financial Instruments, which amends the guidance on measuring credit losses on financial assets (including trade accounts receivable and available for sale debt securities) held at amortized cost. Currently, an “incurred loss” methodology is used for recognizing credit losses which delays recognition until it is probable a loss has been incurred. The amendment requires assets valued at amortized cost to be presented at the net amount expected to be collected using an allowance for credit losses. Reversal of credit losses on available for sale debt securities will be recorded in the current period net income. The amendment will be effective for us on January 1, 2020, with early adoption permitted. We do not anticipate this guidance will have a significant impact on our financial statements and plan to adopt on the effective date. In March 2016, the FASB issued ASU 2016-09, Compensation-Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting. This guidance requires the recognition of the income tax effects of awards in the income statement when the awards vest or are settled, thus eliminating additional paid in capital pools. The guidance also allows for the employer to repurchase more of an employee’s shares for tax withholding purposes without triggering liability accounting. In addition, the guidance allows for a policy election to account for forfeitures as they occur rather than on an estimated basis. We will implement this guidance on January 1, 2017, effective date and have elected to account for forfeitures as they occur. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). This replaces the existing standards relating to leases for both lessees and lessors. For lessees, the new standard requires most leases to be recorded on the balance sheet with expenses recognized much like the existing standard. For lessors, the new standard modifies the classification criteria and accounting for sales-type and direct financing leases and eliminates leveraged leases. For both lessees and lessors, the standard eliminates real estate-specific provisions, changes some of the presentation and disclosure requirements, and changes sale and leaseback criteria. The ASU is required for us on January 1, 2019, with early adoption permitted. We are currently assessing the impact this will have on our consolidated financial statements and the timing of adoption. In January, 2016, the FASB issued ASU 2016-01, Financial Instruments - Overall. This standard requires equity investments, with some exceptions, be measured at fair value with valuation changes recognized in net income, simplifies the impairment assessment of some equity investments, eliminates the requirement to disclose the methods and significant assumptions used to estimate the fair value for financial instruments measured at amortized cost, requires the use of the exit price notion when measuring the fair value of financial instruments, requires separate presentation of some changes in other comprehensive income, requires separate presentation of financial assets and financial liabilities by measurement category and form of financial assets, and clarifies the need for a valuation allowance on some deferred tax assets. The ASU is required for us on January 1, 2018. We do not expect the adoption of ASU 2016-01 to have a significant impact on our consolidated financial statements. In November 2015, the FASB issued ASU 2015-17, Income Taxes-Balance Sheet Classification of Deferred Taxes. The new standard required that deferred income tax liabilities and assets be classified as noncurrent in a classified statement of financial position rather than separating these amounts between current and noncurrent amounts. The deferred tax liabilities and assets continue to be offset and presented as a single amount. The ASU was required for us on January 1, 2017, and we adopted this standard retrospectively for the period ended December 31, 2015. There was no significant impact on our consolidated financial statements as a result of adopting this ASU. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements - Going Concern. The new standard required management of public and private companies to evaluate whether there is substantial doubt about the entity’s ability to continue as a going concern and, if so, disclose that fact. Management is also required to evaluate and disclose whether its plans alleviate that doubt. The new standard became effective for us on January 1, 2016 and the adoption did not have an impact on our consolidated financial statements. In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606), which will supersede nearly all existing revenue recognition guidance under U.S. GAAP. The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In August 2015, the FASB issued ASU 2015-14, Revenue from Contracts with Customers Deferral of the Effective Date, which deferred the effective date resulting in a new effective date of January 1, 2018, for us. We are permitted to adopt early but not before the original effective date of January 1, 2017. FASB has issued several other ASU's which provide further guidance on Topic 606 and have the same effective date. The standard allows for either “full retrospective” adoption, meaning the standard is applied to all of the periods presented, or “modified retrospective” adoption, meaning the standard is applied only to the most current period presented in the financial statements. We will implement ASU 2014-09 and all relevant subsequently issued ASU's on Topic 606 concurrently on January 1, 2018, and are currently evaluating the transitions method. We are carefully evaluating our existing revenue recognition practices to determine whether any contracts in the scope of the guidance will be affected by the new requirements. The effects may include identifying performance obligations in existing arrangements, determining the transaction price and allocating the transaction price to each separate performance obligation. We will also establish practices to determine when a performance obligation has been satisfied, and recognize revenue in accordance with the new requirements. As no material revenues have been recognized to date, we do not anticipate the adoption of this standard to have a material effect. |
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Concentration of Credit Risk | Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, short-term investments and accounts receivable, including receivables from major customers. The Company’s main financial institution for banking operations held 57% and 100% of the Company’s cash and cash equivalents as of December 31, 2016, and December 31, 2015, respectively. The Company grants credit to domestic and international clients in various industries. Exposure to losses on accounts receivable is principally dependent on each client's financial position. |
Fair Value of Financial Instruments (Tables) |
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Dec. 31, 2016 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurement | The following tables represent the financial instruments measured at fair value on a recurring basis on the financial statements of the Company and the valuation approach applied to each class of financial instruments at December 31, 2016, and 2015 (see Note 2, Summary of Significant Accounting Policies for further information):
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Investments (Tables) |
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Dec. 31, 2016 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments, Debt and Equity Securities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Available-for-sale Investments | The following tables summarize the Company’s available-for-sale investments at December 31, 2016, and 2015 (in thousands):
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Summary of Maturities of Available-for-sale Investments | The following table summarizes the maturities of the Company’s available-for-sale securities at December 31, 2016, and 2015 (in thousands):
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Property and Equipment (Tables) |
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Dec. 31, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property and Equipment | Property and equipment are recorded at cost and consisted of the following at December 31, 2016, and 2015 (in thousands).
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Deferred Revenue and Income (Tables) |
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Dec. 31, 2016 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deferred Revenue Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deferred Revenue and Income Summary | A summary of the balances as of December 31, 2016, and 2015 follows (in thousands):
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Employee and Consultant Equity-Based Compensation (Tables) |
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Dec. 31, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock Option Activity | The following table summarizes option activity under all plans during the years ending December 31, 2016, and December 31, 2015 and shows the exercisable shares as of December 31, 2016:
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Black-Scholes Assumptions for Option Granted | The table below summarizes the resulting weighted average inputs used to calculate the estimated fair value of options awarded for during the periods shown below:
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Stock Option Supplemental Information | The following table shows summary information for outstanding options, options that are exercisable (vested) and outstanding options that are either vested or expected to vest as of December 31, 2016:
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Restricted Stock Activity | The following table summarizes restricted stock unit activity during the years ending December 31, 2016, and December 31, 2015:
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Equity-Based Compensation Expense and Tax Benefit | The expense and tax benefits recognized on Company’s Statements of Operations and Comprehensive Loss related to options is summarized below (in thousands):
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Summary of ESPP Activity | A summary of ESPP activity for the year ended December 31, 2016 is as follows:
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Income Taxes (Tables) |
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Dec. 31, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Components of Pretax Loss from Operations | The components of the pretax loss from operations for the years ended December 31, 2016, 2015 and 2014, are as follows (in thousands):
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Schedule of Provision for Income Taxes | The components of the provision for income taxes is presented in the following table:
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Deferred Income Tax Components | Significant components of the Company’s net deferred income taxes for the years ended December 31, 2016, and 2015, are as follows (in thousands):
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Effective Tax Rate | The difference between the U.S. federal statutory income tax rate and the Company’s effective tax rate for years ending December 31, 2016, 2015 and 2014, is as follows:
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Uncertain Tax Positions | At December 31, 2016, the Company had uncertain tax positions of $1.1 million, determined as follows (in thousands):
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Commitments (Tables) |
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Dec. 31, 2016 | |||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||
Operating Leases Obligations | Future minimum lease payments under this agreement are as follows (in thousands):
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Supplemental Data Quarterly Financial Information (Tables) |
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Dec. 31, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Quarterly Financial Information Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Unaudited Quarterly Financial Information |
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Summary of Significant Accounting Policies (Details) |
12 Months Ended |
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Dec. 31, 2016 | |
Property, Plant and Equipment [Line Items] | |
Bundled rental agreement, term (under) | 7 years |
Dividend yield (percent) | 0.00% |
Minimum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 1 year |
Maximum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 7 years |
Concentration of Credit Risk (Details) - Concentration of Credit Risk |
12 Months Ended | |
---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
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Cash and Cash Equivalents | ||
Concentration Risk [Line Items] | ||
Risk concentration | 57.00% | 100.00% |
Accounts Receivable | One Customer | ||
Concentration Risk [Line Items] | ||
Risk concentration | 29.00% | 66.00% |
Investments - Schedule of Available-for-sale Securities (Details) - USD ($) $ in Thousands |
Dec. 31, 2016 |
Dec. 31, 2015 |
---|---|---|
Investment [Line Items] | ||
Amortized Cost | $ 58,595 | $ 11,851 |
Gross Unrealized Gains | 7 | 1 |
Gross Unrealized Losses | (83) | (13) |
Fair Value | 58,519 | 11,839 |
Certificates of deposit | ||
Investment [Line Items] | ||
Amortized Cost | 7,257 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | 7,257 | |
US Treasury securities | ||
Investment [Line Items] | ||
Amortized Cost | 8,553 | |
Gross Unrealized Gains | 1 | |
Gross Unrealized Losses | (10) | |
Fair Value | 8,544 | |
US Agency securities | ||
Investment [Line Items] | ||
Amortized Cost | 4,514 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (13) | |
Fair Value | 4,501 | |
Asset-backed securities | ||
Investment [Line Items] | ||
Amortized Cost | 5,554 | 2,510 |
Gross Unrealized Gains | 3 | 0 |
Gross Unrealized Losses | 0 | (3) |
Fair Value | 5,557 | 2,507 |
Corporate notes and bonds | ||
Investment [Line Items] | ||
Amortized Cost | 32,717 | 9,341 |
Gross Unrealized Gains | 3 | 1 |
Gross Unrealized Losses | (60) | (10) |
Fair Value | $ 32,660 | $ 9,332 |
Investments - Schedule of Available-For-Sale Investment Maturities (Details) - USD ($) $ in Thousands |
Dec. 31, 2016 |
Dec. 31, 2015 |
---|---|---|
Amortized Cost | ||
Due in less than 1 year | $ 45,391 | $ 11,851 |
Due in 1-5 years | 13,204 | 0 |
Total | 58,595 | 11,851 |
Fair Value | ||
Due in less than 1 year | 45,344 | 11,839 |
Due in 1-5 years | 13,175 | 0 |
Total | $ 58,519 | $ 11,839 |
Investments - Narrative (Details) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
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Investments, Debt and Equity Securities [Abstract] | |||
Proceeds from sales of marketable securities | $ 9,716,000 | $ 141,000 | $ 861,000 |
Realized gain on available-for-sale securities | 6,000 | 0 | $ 0 |
Gross realized gains or losses from sales of marketable securities | $ 0 | ||
Gross proceeds associated with realized gains | $ 7,200,000 |
Property and Equipment (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 9,094 | $ 7,638 | |
Accumulated depreciation - other | (4,836) | (2,622) | |
Net property and equipment | 4,258 | 5,016 | |
Depreciation expense | 2,340 | 1,782 | $ 817 |
Computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 2,270 | 1,877 | |
Technical equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 2,427 | 1,806 | |
Facilities | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 3,387 | 1,772 | |
Capital projects in progress | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 1,010 | $ 2,183 |
License Agreements and Grants - Defense Medical Research and Development Program (Details) - USD ($) $ in Thousands |
1 Months Ended | 12 Months Ended | 56 Months Ended | ||
---|---|---|---|---|---|
May 31, 2012 |
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
Dec. 31, 2016 |
|
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Offset to research and development project | $ 1,200 | $ 647 | $ 527 | ||
Defense Medical Research and Development Program | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Total grant funding | $ 2,000 | ||||
Length of project (months) | 35 years | ||||
Offset to research and development project | $ 54 | $ 179 | $ 221 | $ 612 |
License Agreements and Grants - National Institute of Health Grant (Details) - National Institute of Health Grant - USD ($) |
1 Months Ended | 12 Months Ended | |||
---|---|---|---|---|---|
Feb. 28, 2015 |
Dec. 31, 2016 |
Jan. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
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Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Length of project (years) | 5 years | ||||
Total grant funding | $ 5,000,000 | $ 74,000 | $ 818,000 | $ 483,000 | $ 0 |
License Agreements and Grants - Arizona Commerce Authority and R&D Refundable Tax Credit Program (Details) |
1 Months Ended | 12 Months Ended | ||
---|---|---|---|---|
Aug. 31, 2012
USD ($)
job
milestone
|
Dec. 31, 2016
USD ($)
|
Dec. 31, 2015
USD ($)
|
Dec. 31, 2014
USD ($)
|
|
Research and Development [Abstract] | ||||
Arizona Commerce Authority grant | $ | $ 1,000,000 | $ 1,000,000 | $ 1,000,000 | |
Number of milestones | milestone | 4 | |||
Qualified jobs created, milestone 1 | job | 15 | |||
Qualified jobs created, milestone 2 | job | 30 | |||
Qualified jobs created, milestone 3 | job | 40 | |||
Qualified jobs created, milestone 4 | job | 65 | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Offset to research and development project | $ | $ 1,200,000 | $ 647,000 | $ 527,000 | |
Minimum | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Capital investment milestone | $ | $ 4,500,000 | |||
Grant related minimum annual wages | $ | $ 63,000 | |||
Percent of company paid premiums | 65.00% |
Deferred Revenue and Income (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Aug. 31, 2012 |
|
Deferred Revenue Disclosure [Abstract] | |||
Fisher agreement | $ 0 | $ 13 | |
Products not yet delivered | 35 | 114 | |
Total current deferred revenue and income | 35 | 127 | |
Arizona Commerce Authority grant | 1,000 | 1,000 | $ 1,000 |
Total long-term deferred income | 1,000 | $ 1,000 | |
Deferred revenue recognized | $ 114 |
Related Party Transaction (Details) $ in Thousands |
1 Months Ended |
---|---|
Jun. 30, 2016
USD ($)
| |
Recovery of short-swing profit | |
Related Party Transaction [Line Items] | |
Recovery of related party short-swing profits | $ 866 |
Earnings Per Share (Details) - shares |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Earnings Per Share [Abstract] | |||
Antidilutive common stock instruments outstanding (shares) | 7,313,245 | 6,778,580 | 6,174,886 |
Employee and Consultant Equity-Based Compensation - Non-Qualified Stock Option Plan (Details) - shares |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise of options (shares) | 158,743 | 124,884 | |
Outstanding (shares) | 6,857,124 | 6,167,170 | 5,628,726 |
Non-Qualified Stock Option Plan | Stock Option | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expiration period | 10 years | ||
Exercise of options (shares) | 273,900 | ||
Outstanding (shares) | 6,100 | ||
Options available (shares) | 0 |
Employee and Consultant Equity-Based Compensation - 2004 Omnibus Stock Option Plan (Details) - shares |
12 Months Ended | ||||
---|---|---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Jul. 31, 2012 |
Dec. 31, 2014 |
Dec. 31, 2004 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise of options (shares) | 158,743 | 124,884 | |||
Outstanding (shares) | 6,857,124 | 6,167,170 | 5,628,726 | ||
2004 Omnibus Stock Option Plan | Stock Option | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares authorized (shares) | 5,500,000 | 500,000 | |||
Additional shares authorized (shares) | 5,000,000 | ||||
Exercise of options (shares) | 428,907 | ||||
Outstanding (shares) | 3,511,093 | ||||
Options available (shares) | 0 |
Employee and Consultant Equity-Based Compensation - Black-Scholes Assumptions for Option Granted (Details) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016
USD ($)
yr
$ / shares
|
Dec. 31, 2015
USD ($)
yr
$ / shares
|
Dec. 31, 2014
USD ($)
yr
$ / shares
|
|
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Expected term (in years) | yr | 6.43 | 6.26 | 6.25 |
Volatility | 86.00% | 91.00% | 96.00% |
Expected dividends | $ | $ 0 | $ 0 | $ 0 |
Risk free interest rates | 1.60% | 1.70% | 1.90% |
Estimated forfeitures | 8.50% | 5.60% | 0.40% |
Weighted average fair value (dollars per share) | $ / shares | $ 10.35 | $ 16.69 | $ 12.63 |
Employee and Consultant Equity-Based Compensation - Restricted Stock Activity (Details) - $ / shares |
12 Months Ended | |
---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Number of Shares | ||
Beginning balance (shares) | 40,250 | 0 |
Granted (shares) | 0 | 40,250 |
Forfeited (shares) | 0 | 0 |
Vested/Released (shares) | 0 | 0 |
Ending balance (shares) | 40,250 | 40,250 |
Weighted Average Grant Date Fair Value per Share | ||
Beginning balance (dollars per share) | $ 20.91 | $ 0.00 |
Granted (dollars per share) | 0.00 | 20.91 |
Forfeited (dollars per share) | 0.00 | 0.00 |
Vested/Released (dollars per share) | 0.00 | 0.00 |
Ending balance (dollars per share) | $ 20.91 | $ 20.91 |
Employee and Consultant Equity-Based Compensation - Equity-Based Compensation Expense and Tax Benefit (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Equity-based compensation expense | $ 8,775 | $ 8,388 | $ 9,624 |
Recognized tax benefit | 0 | 0 | 0 |
Unrecognized equity-based compensation cos | 10,300 | ||
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Equity-based compensation expense | 1,585 | 2,479 | 4,334 |
Sales, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Equity-based compensation expense | $ 7,190 | $ 5,909 | $ 5,290 |
Employee and Consultant Equity-Based Compensation - Employee Stock Purchase Plan (Details) - 2016 ESPP - Employee Stock |
1 Months Ended | 12 Months Ended |
---|---|---|
May 31, 2016
USD ($)
hour
shares
|
Dec. 31, 2016
shares
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Offering period | 3 months | |
Maximum number of shares per employee | 100,000 | |
Purchase price of common stock (percent) | 90.00% | |
Shares authorized (shares) | 500,000 | |
Shares issued (shares) | 11,093 | |
Options available (shares) | 488,907 | |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Employee contribution (percent) | 2.00% | |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Hours worked per week | hour | 20 | |
Threshold of percentage of voting interests | 5.00% | |
Employee contribution (percent) | 15.00% | |
Employee contribution | $ | $ 25,000 | |
Offering period | 27 months |
Employee and Consultant Equity-Based Compensation - Summary of ESPP Activity (Details) - 2016 ESPP - Employee Stock $ / shares in Units, $ in Thousands |
12 Months Ended |
---|---|
Dec. 31, 2016
USD ($)
$ / shares
shares
| |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Shares issued (shares) | shares | 11,093 |
Weighted average fair value (dollars per share) | $ / shares | $ 20.40 |
Employee purchases (in thousands) | $ | $ 226 |
Income Taxes - Components of the Pretax Loss From Operations (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Income Tax Disclosure [Abstract] | |||
U.S. Domestic | $ (48,539) | $ (44,415) | $ (30,933) |
Foreign | (17,568) | (1,083) | 0 |
Net loss before income taxes | $ (66,107) | $ (45,498) | $ (30,933) |
Income Taxes - Provision for Income Taxes (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Current: | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 0 | 0 | 0 |
Foreign | 267 | 0 | 0 |
Total current provision | 267 | 0 | 0 |
Deferred: | |||
Federal | 0 | 0 | 0 |
State | 0 | 0 | 0 |
Foreign | 0 | 0 | 0 |
Total deferred provision | 0 | 0 | 0 |
Total provision | $ 267 | $ 0 | $ 0 |
Income Taxes - Deferred Income Taxes Components (Details) - USD ($) $ in Thousands |
Dec. 31, 2016 |
Dec. 31, 2015 |
---|---|---|
Deferred tax assets: | ||
Net operating loss carryforward | $ 42,013 | $ 28,584 |
Property & equipment | 690 | 339 |
Inventory | 1,735 | 864 |
Stock options | 7,208 | 5,208 |
Intangible assets, definite-lived | 220 | 333 |
General business credit | 3,984 | 1,915 |
Deferred revenue | 370 | 372 |
Other | 121 | 205 |
Valuation allowance | (56,341) | (37,820) |
Deferred tax assets | $ 0 | $ 0 |
Income Taxes - Narrative (Details) - USD ($) $ in Thousands |
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
Dec. 31, 2013 |
---|---|---|---|---|
Operating Loss Carryforwards [Line Items] | ||||
Valuation allowance | $ 56,341 | $ 37,820 | ||
Unrecognized tax benefits | 1,101 | $ 343 | $ 161 | $ 0 |
Uncertain tax positions that would impact the effective tax rate | 57 | |||
Domestic Tax Authority | Internal Revenue Service (IRS) | ||||
Operating Loss Carryforwards [Line Items] | ||||
Operating loss carryforwards, Sec. 382 limitation | 125,100 | |||
Operating loss carryforwards, expected to be unrealized | 420 | |||
Gross operating loss carryforwards | 4,200 | |||
Operating loss carryforwards | 120,900 | |||
State and Local Jurisdiction | Arizona Department of Revenue | ||||
Operating Loss Carryforwards [Line Items] | ||||
Operating loss carryforwards | $ 102,500 |
Income Taxes - Effective Tax Rate (Details) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Income Tax Disclosure [Abstract] | |||
U.S. federal statutory income tax rate | (34.00%) | (34.00%) | (34.00%) |
State taxes, net of federal tax benefit | (1.69%) | (2.93%) | (3.20%) |
Permanent and other differences | (0.17%) | 0.11% | (0.00%) |
Change in tax rates | 0.67% | (0.00%) | (0.00%) |
Tax rate differential | 8.62% | 0.42% | (0.00%) |
Unrecognized tax benefits | 1.09% | 0.40% | (0.00%) |
Nondeductible equity and other compensation | 1.17% | 2.86% | 3.70% |
Limitation on net operating losses due to §382 | (0.00%) | (0.00%) | 0.50% |
Credit for increased research activities | (3.31%) | (2.67%) | (0.80%) |
Change in Valuation allowance | 28.02% | 35.81% | 33.80% |
Effective tax rate | 0.40% | (0.00%) | (0.00%) |
Income Taxes - Uncertain Tax Positions (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Uncertain Tax Positions | |||
Balance at beginning of year | $ 343 | $ 161 | $ 0 |
Increases for prior positions | 37 | 0 | 78 |
Increases for current year positions | 721 | 182 | 83 |
Other Increases | 0 | 0 | 0 |
Decreases due to settlements | 0 | 0 | 0 |
Expiration of the statute of limitations for the assessment of taxes | 0 | 0 | 0 |
Other Decreases | 0 | 0 | 0 |
Balance at end of year | $ 1,101 | $ 343 | $ 161 |
Commitments - (Details Narrative) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Commitments and Contingencies Disclosure [Abstract] | |||
Rent expense | $ 1,100,000 | $ 685,000 | $ 293,000 |
Clinical trial master agreement expense | 2,100,000 | 1,600,000 | 0 |
Marketing study agreement expense | $ 233,000 | $ 66,000 | $ 0 |
Commitments - Operating Lease Obligations (Details) $ in Thousands |
Dec. 31, 2016
USD ($)
|
---|---|
Commitments and Contingencies Disclosure [Abstract] | |
2017 | $ 1,004 |
2018 | 79 |
2019 | 0 |
2020 | 0 |
Thereafter | 0 |
Total operating lease obligations | $ 1,083 |
Segments (Details) |
12 Months Ended |
---|---|
Dec. 31, 2016
segment
| |
Segment Reporting [Abstract] | |
Number of operating segments | 1 |
Supplemental Data Quarterly Financial Information (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 12 Months Ended | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2016 |
Sep. 30, 2016 |
Jun. 30, 2016 |
Mar. 31, 2016 |
Dec. 31, 2015 |
Sep. 30, 2015 |
Jun. 30, 2015 |
Mar. 31, 2015 |
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenue | $ 39 | $ 24 | $ 20 | $ 163 | $ 22 | $ 92 | $ 19 | $ 14 | $ 246 | $ 147 | $ 122 |
Net loss | $ (16,135) | $ (17,299) | $ (17,866) | $ (15,074) | $ (13,163) | $ (11,186) | $ (12,252) | $ (8,897) | $ (66,374) | $ (45,498) | $ (30,933) |
Basic and diluted net loss per share (dollars per share) | $ (0.31) | $ (0.34) | $ (0.35) | $ (0.29) | $ (0.29) | $ (0.25) | $ (0.27) | $ (0.20) |
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