Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Mar. 03, 2017 | Jun. 30, 2016 | |
Document and Entity Information | |||
Entity Registrant Name | T2 Biosystems, Inc. | ||
Entity Central Index Key | 1,492,674 | ||
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 | $ 154.2 | ||
Entity Common Stock, Shares Outstanding | 30,576,110 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 73,488 | $ 73,662 |
Accounts receivable | 327 | 369 |
Prepaid expenses and other current assets | 820 | 838 |
Inventories, net | 803 | 683 |
Total current assets | 75,438 | 75,552 |
Property and equipment, net | 13,589 | 10,655 |
Restricted cash | 260 | 260 |
Other assets | 281 | 358 |
Total assets | 89,568 | 86,825 |
Current liabilities: | ||
Accounts payable | 962 | 1,228 |
Accrued expenses and other current liabilities | 4,908 | 4,162 |
Current portion of notes payable | 1,269 | 4,449 |
Deferred revenue | 2,445 | 2,146 |
Current portion of lease incentives | 301 | 268 |
Total current liabilities | 9,885 | 12,253 |
Notes payable, net of current portion | 39,504 | 26,121 |
Lease incentives, net of current portion | 792 | 1,076 |
Other liabilities | 49 | 436 |
Commitments and contingencies (see Note 13) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding at December 31, 2016 and December 31, 2015 | ||
Common stock, $0.001 par value; 200,000,000 shares authorized; 30,482,712 and 24,175,381 shares issued and outstanding at December 31, 2016 | 30 | 24 |
Additional paid-in capital | 242,997 | 195,800 |
Accumulated deficit | (203,689) | (148,885) |
Total stockholders' equity | 39,338 | 46,939 |
Total liabilities and stockholders' equity | $ 89,568 | $ 86,825 |
Consolidated Balance Sheet (Par
Consolidated Balance Sheet (Parentheticals) - $ / shares | Dec. 31, 2016 | Dec. 31, 2015 |
Consolidated Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 30,482,712 | 24,175,381 |
Common stock, shares outstanding | 30,482,712 | 24,175,381 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Revenue: | |||
Product revenue | $ 1,747 | $ 599 | |
Research revenue | 2,333 | 2,214 | $ 119 |
Total revenue | 4,080 | 2,813 | 119 |
Costs and expenses: | |||
Cost of product revenue | 6,872 | 1,740 | |
Research and development | 24,009 | 25,362 | 19,782 |
Selling, general and administrative | 24,077 | 19,094 | 11,018 |
Total costs and expenses | 54,958 | 46,196 | 30,800 |
Loss from operations | (50,878) | (43,383) | (30,681) |
Interest expense, net | (4,098) | (1,967) | (721) |
Other income, net | 172 | 60 | 12 |
Net loss and comprehensive loss | (54,804) | (45,290) | (31,390) |
Comprehensive loss | (54,804) | (45,290) | (31,390) |
Accretion of redeemable convertible preferred stock to redemption value | (4,570) | ||
Net loss applicable to common stockholders | $ (54,804) | $ (45,290) | $ (35,960) |
Net loss per share applicable to common stockholders — basic and diluted | $ (2.11) | $ (2.21) | $ (4.15) |
Weighted-average number of common shares used in computing net loss per share — basic and diluted | 26,015,751 | 20,501,748 | 8,674,931 |
Consolidated Statements of Rede
Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders Equity (Deficit) - USD ($) $ in Thousands | Series A-1 | Series A-2 | Series B | Series C | Series D | Series E | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2013 | $ 874 | $ 7,724 | $ 15,464 | $ 19,100 | $ 27,357 | $ 42,294 | ||||
Balance (in shares) at Dec. 31, 2013 | 282,849 | 1,703,959 | 3,249,877 | 4,055,125 | 5,054,945 | 6,930,967 | ||||
Increase (Decrease) in Redeemable Convertible Preferred Stock | ||||||||||
Accretion of redeemable convertible preferred stock to redemption value | $ 26 | $ 240 | $ 520 | $ 722 | $ 1,115 | $ 1,947 | ||||
Conversion of redeemable convertible preferred stock into common stock | $ (900) | $ (7,964) | $ (15,984) | $ (19,822) | $ (28,472) | $ (44,241) | ||||
Conversion of redeemable convertible preferred stock into common stock (in shares) | (282,849) | (1,703,959) | (3,249,877) | (4,055,125) | (5,054,945) | (6,930,967) | ||||
Balance at Dec. 31, 2013 | $ 1 | $ (89,544) | $ (89,543) | |||||||
Balance (in shares) at Dec. 31, 2013 | 1,411,986 | |||||||||
Increase (Decrease) in Stockholders' Equity | ||||||||||
Accretion of redeemable convertible preferred stock to redemption value | $ (880) | (3,690) | (4,570) | |||||||
Stock-based compensation expense | 1,653 | 1,653 | ||||||||
Conversion of redeemable convertible preferred stock into common stock | $ 13 | 96,341 | 21,029 | 117,383 | ||||||
Conversion of redeemable convertible preferred stock into common stock (in shares) | 12,516,298 | |||||||||
Issuance of common stock upon net settlement of warrants to purchase redeemable convertible preferred stock | 1,226 | 1,226 | ||||||||
Issuance of common stock upon net settlement of warrants to purchase redeemable convertible preferred stock (in shares) | 68,700 | |||||||||
Exercise of stock options | 153 | 153 | ||||||||
Exercise of stock options (in shares) | 64,661 | |||||||||
Issuance of common stock | $ 6 | 58,083 | 58,089 | |||||||
Issuance of common stock (in shares) | 5,980,000 | |||||||||
Net loss | (31,390) | (31,390) | ||||||||
Balance at Dec. 31, 2014 | $ 20 | 156,576 | (103,595) | 53,001 | ||||||
Balance (in shares) at Dec. 31, 2014 | 20,041,645 | |||||||||
Increase (Decrease) in Stockholders' Equity | ||||||||||
Stock-based compensation expense | 4,168 | 4,168 | ||||||||
Issuance of common stock from exercise of stock options and employee stock purchase plan | 1,804 | 1,804 | ||||||||
Issuance of common stock from exercises of stock options and employee stock purchase plan (in shares) | 442,687 | |||||||||
Issuance of common stock | $ 4 | 33,252 | 33,256 | |||||||
Issuance of common stock (in shares) | 3,691,049 | |||||||||
Net loss | (45,290) | (45,290) | ||||||||
Balance at Dec. 31, 2015 | $ 24 | 195,800 | (148,885) | $ 46,939 | ||||||
Balance (in shares) at Dec. 31, 2015 | 24,175,381 | 24,175,381 | ||||||||
Increase (Decrease) in Stockholders' Equity | ||||||||||
Stock-based compensation expense | 4,848 | $ 4,848 | ||||||||
Offering costs on issuance of common stock from secondary public offering | (215) | (215) | ||||||||
Issuance of common stock from exercise of stock options and employee stock purchase plan | 1,018 | 1,018 | ||||||||
Issuance of common stock from exercises of stock options and employee stock purchase plan (in shares) | 251,990 | |||||||||
Issuance of common stock | $ 6 | 39,717 | 39,723 | |||||||
Issuance of common stock (in shares) | 6,055,341 | |||||||||
Issuance of warrants | 1,829 | 1,829 | ||||||||
Net loss | (54,804) | (54,804) | ||||||||
Balance at Dec. 31, 2016 | $ 30 | $ 242,997 | $ (203,689) | $ 39,338 | ||||||
Balance (in shares) at Dec. 31, 2016 | 30,482,712 | 30,482,712 |
Consolidated Statements of Red6
Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders Equity (Deficit) (Parentheticals) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Common Stock | ||
Issuance costs | $ 2,732 | $ 7,700 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Operating activities | |||
Net loss | $ (54,804) | $ (45,290) | $ (31,390) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 2,280 | 1,465 | 691 |
Stock-based compensation expense | 4,848 | 4,168 | 1,653 |
Noncash interest expense | 564 | 354 | 112 |
Loss on extinguishment of debt | 112 | ||
Change in fair value of warrants | 1 | ||
Deferred rent | (250) | (119) | 5 |
Changes in operating assets and liabilities: | |||
Accounts receivable | 42 | (168) | (201) |
Prepaid expenses and other assets | 68 | 190 | (1,217) |
Inventories, net | (120) | (568) | (115) |
Accounts payable | (61) | 177 | (208) |
Accrued expenses and other liabilities | 580 | 260 | 2,405 |
Deferred revenue | 299 | 2,066 | 80 |
Net cash used in operating activities | (46,442) | (37,465) | (28,184) |
Investing activities | |||
Purchases and manufacture of property and equipment | (5,487) | (7,974) | (2,084) |
Decrease in restricted cash | 80 | ||
Net cash used in investing activities | (5,487) | (7,894) | (2,084) |
Financing activities | |||
Proceeds from issuance of common stock in public offering, net of offering costs | (385) | 33,677 | 58,089 |
Proceeds from issuance of common stock and stock options exercises, net | 1,018 | 1,804 | 153 |
Proceeds from private investment in public equity | 39,723 | ||
Proceeds from notes payable, net of issuance costs | 43,803 | 10,000 | 19,714 |
Repayments of notes payable | (32,404) | (309) | (4,037) |
Net cash provided by financing activities | 51,755 | 45,172 | 73,919 |
Net (decrease) increase in cash and cash equivalents | (174) | (187) | 43,651 |
Cash and cash equivalents at beginning of period | 73,662 | 73,849 | 30,198 |
Cash and cash equivalents at end of period | 73,488 | 73,662 | 73,849 |
Supplemental disclosures of cash flow information | |||
Cash paid for interest | 2,732 | 1,506 | 515 |
Supplemental disclosures of noncash investing and financing activities | |||
Accrued property and equipment | $ 82 | 247 | 128 |
Leasehold improvements paid by landlord | 1,268 | 121 | |
Public offering costs unpaid at year end | $ 420 | ||
Accretion of Series A-1, A-2, B, C, D and E redeemable convertible preferred stock to redemption value | 4,570 | ||
Conversion of redeemable and convertible preferred stock to common stock | 117,383 | ||
Conversion of preferred warrants to common stock | $ 1,226 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2016 | |
Nature of Business | |
Nature of Business | T2 Biosystems, Inc. Notes to Consolidated Financial Statements 1. Nature of Business T2 Biosystems, Inc. (the “Company”) was incorporated on April 27, 2006 as a Delaware corporation with operations based in Lexington, Massachusetts. The Company is an in vitro diagnostics company that has developed an innovative and proprietary technology platform that offers a rapid, sensitive and simple alternative to existing diagnostic methodologies. The Company is using its T2 Magnetic Resonance technology, or T2MR, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables rapid detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, plasma, serum, saliva, sputum and urine, and can detect cellular targets at limits of detection as low as one colony forming unit per milliliter, or CFU/mL. The Company’s initial development efforts target sepsis and Lyme disease, which are areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics. On September 22, 2014, the Company received market clearance from the U.S. Food and Drug Administration (“FDA”) for its first two products, the T2Dx Instrument (the “T2Dx”) and T2Candida Panel (“T2Candida”). The Company has devoted substantially all of its efforts to research and development, business planning, recruiting management and technical staff, acquiring operating assets, raising capital, and, most recently, the commercialization and improvement of its existing products. Liquidity At December 31, 2016, the Company has cash and cash equivalents of $73.5 million and an accumulated deficit of $203.7 million. The future success of the Company is dependent on its ability to successfully commercialize its products, obtain regulatory clearance for and successfully launch its future product candidates, obtain additional capital and ultimately attain profitable operations. Historically, the Company has funded its operations primarily through its August 2014 initial public offering, its December 2015 secondary public offering, its September 2016 private investment in public equity (“PIPE”) financing, private placements of redeemable convertible preferred stock, and through debt financing arrangements. The Company is subject to a number of risks similar to other newly commercial life science companies, including, but not limited to commercially launching the Company’s products, development and market acceptance of the Company’s product candidates, development by its competitors of new technological innovations, protection of proprietary technology, and raising additional capital. Having obtained clearance from the FDA and a CE mark in Europe to market the T2Dx and T2Candida, the Company has incurred significant commercialization expenses related to product sales, marketing, manufacturing and distribution. In addition, the Company anticipates costs and expenses to increase as the Company continues to develop other product candidates, improve existing products and maintain, expand and protect its intellectual property portfolio. The Company may seek to fund its operations through public equity or private equity or debt financings, as well as other sources. However, the Company may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. The Company’s failure to raise capital or enter into such other arrangements if and when needed would have a negative impact on the Company’s business, results of operations and financial condition and the Company’s ability to develop, commercialize and drive adoption of the T2Dx, T2Candida, its product candidate, T2Bacteria, and future T2MR-based diagnostics.. Management believes that its existing cash and cash equivalents at December 31, 2016, together with the additional remaining liquidity of up to $1.3 million available under an Equipment Lease Credit Facility (the “Credit Facility”) entered into in October 2015 to help the Company meet its capital equipment needs (Note 6), will be sufficient to allow the Company to fund its current operating plan for at least the next 12 months from the date of issuance of these consolidated financial statements. For more information, refer to the section titled “Liquidity and Capital Resources” in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, and in Item 1a, Risk Factors, for additional risks associated with our capital needs. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2016 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation and Consolidation The Company’s financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company’s consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, T2 Biosystems Securities Corporation. All intercompany balances and transactions have been eliminated. Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company utilizes certain estimates in the determination of the fair value of its stock options, deferred tax valuation allowances, revenue recognition, to record expenses relating to research and development contracts, accrued expenses, and to classify the value of instrument raw material and work-in-process inventory between inventory and property and equipment. The Company bases its estimates on historical experience and other market‑specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results could differ from such estimates. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision‑making group, in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker is the Chief Executive Officer. The Company views its operations and manages its business in one operating segment, which is the business of developing and, upon regulatory clearance, launching commercially its diagnostic products aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. Off‑Balance Sheet Risk and Concentrations of Credit Risk The Company has no significant off-balance sheet risks, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Cash and cash equivalents are financial instruments that potentially subject the Company to concentrations of credit risk. At December 31, 2016 and 2015, substantially all of the Company’s cash was deposited in accounts at one financial institution, with a significant amount invested in money market funds that are invested in short-term U.S. government agency securities. The Company maintains its cash deposits, which at times may exceed the federally insured limits, with a large financial institution and, accordingly, the Company believes such funds are subject to minimal credit risk. For the year ended December 31, 2016, the Company derived approximately 45% of its total revenue from one customer and 10% of its total revenue from a second customer. For the year ended December 31, 2015, the Company derived approximately 50% of its total revenue from one customer and 25% of its total revenue from a second customer. For the year ended December 31, 2014, the Company derived all of its revenue from a single customer. Cash Equivalents Cash equivalents include all highly liquid investments maturing within 90 days from the date of purchase. Cash equivalents consist of money market funds invested in short-term U.S. government agency securities as of December 31, 2016 and 2015. Accounts Receivable The Company’s accounts receivable consists of amounts due from commercial customers and from research and development arrangements with partners. At each reporting period, management reviews all outstanding balances to determine if the facts and circumstances of each customer relationship indicate the need for a reserve. The Company does not require collateral and did not have an allowance for doubtful accounts at December 31, 2016 or 2015. Inventories Inventories are stated at the lower of cost or market. The Company determines the cost of its inventories, which includes amounts related to materials, direct labor, and manufacturing overhead, on a first-in, first-out basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and writes down any excess and obsolete inventories to their realizable value in the period in which the impairment is first identified. Shipping and handling costs incurred for inventory purchases are capitalized and recorded upon sale in cost of product revenues in the consolidated statements of operations and comprehensive loss or are included in the value of T2-owned instruments and components, a component of property and equipment, net, and depreciated. The Company capitalizes inventories in preparation for sales of products when the related product candidates are considered to have a high likelihood of regulatory clearance, which for the T2Dx Instrument and T2Candida Panel was upon the achievement of regulatory clearance, and the related costs are expected to be recoverable through sales of the inventories. In addition, the Company capitalizes inventories related to the manufacture of instruments that have a high likelihood of regulatory clearance, which for the T2Dx Instrument was upon the achievement of regulatory clearance, and will be retained as the Company’s assets, upon determination that the instrument has alternative future uses. In determining whether or not to capitalize such inventories, the Company evaluates, among other factors, information regarding the product candidate’s status of regulatory submissions and communications with regulatory authorities, the outlook for commercial sales and alternative future uses of the product candidate. Costs associated with development products prior to satisfying the inventory capitalization criteria are charged to research and development expense as incurred. The Company classifies inventories related to instruments that are Company-owned, as a component of property and equipment. Raw material and work-in-process inventories that are expected to be used to produce Company-owned instruments, based on our business model and forecast, are also classified as property and equipment. Company-owned instruments are instruments that are manufactured and placed with customers in connection with reagent rental agreements, or are used for internal purposes. The components of inventory consist of the following (in thousands): December 31, December 31, 2016 2015 Raw materials $ $ Work-in-process Finished goods Total inventories, net $ $ Fair Value Measurements The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. ASC 820, Fair Value Measurements and Disclosures (“ASC 820”), establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability, and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs: Level 1 — Quoted unadjusted prices for identical instruments in active markets. Level 2 — Quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model‑derived valuations in which all observable inputs and significant value drivers are observable in active markets. Level 3 — Model derived valuations in which one or more significant inputs or significant value drivers are unobservable, including assumptions developed by the Company. The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability (See Note 3). Financial instruments measured at fair value on a recurring basis include cash, money market funds and restricted cash (See Note 3). For certain financial instruments, including accounts payable and accrued expenses, the carrying amounts approximate their fair values as of December 31, 2016 and 2015 because of their short-term nature. At December 31, 2016 and 2015, the carrying value of the Company’s debt approximated fair value, which was determined using Level 3 inputs, using market quotes from brokers and is based on current rates offered for similar debt (Note 6). Property and Equipment Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight‑line method. Property and equipment includes raw materials, work-in-process and finished instruments that are Company-owned or expected to remain Company-owned when placed in service. Company-owned instruments are instruments that are manufactured and placed with customers in connection with reagent rental agreements, or are used for internal purposes. Repairs and maintenance costs are expensed as incurred, whereas major improvements are capitalized as additions to property and equipment. Revenue Recognition The Company generates revenue from product sales, which includes the sale of instruments, consumable diagnostic tests and related services, and research and development agreements with third parties. The Company recognizes revenue in accordance with FASB ASC Topic 605, Revenue Recognition (“ASC 605”). Accordingly, the Company recognizes revenue when all of the following criteria have been met: i. ii. iii. iv. If any of the above criteria have not been met, the Company defers revenue until such time each of the criteria have been satisfied. Product revenue is generated by the sale of instruments and consumable diagnostic tests predominantly through its direct sales force in the United States, and distributors in geographic regions outside the United States. The Company does not offer product return or exchange rights (other than those relating to defective goods under warranty) or price protection allowances to its customers, including its distributors. Payment terms granted to distributors are the same as those granted to end-user customers and payments are not dependent upon the distributors’ receipt of payment from their end-user customers. The Company either sells instruments to customers and international distributors, or retains title and places the instrument at the customer site pursuant to a reagent rental agreement. When the instrument is directly purchased by a customer, the Company recognizes revenue when all applicable revenue recognition criteria are met. When the instrument is placed under a reagent rental agreement, the Company’s customers generally agree to fixed term agreements, which can be extended, certain of which may include minimum purchase commitments and/or incremental charges on each consumable diagnostic test purchased, which varies based on the volume of test cartridges purchased. Revenue from the sale of consumable diagnostic tests, which includes the incremental charge, is recognized upon delivery as a component of product revenue in the Company’s consolidated statements of operations and comprehensive loss. Direct sales of instruments include warranty, maintenance and technical support services for one year following the installation of the purchased instrument (“Maintenance Services”). After the completion of the initial Maintenance Services period, customers have the option to renew the Maintenance Services for additional one year periods in exchange for additional consideration. In addition, the Company may provide training to customers. The Company defers revenue from the initial sale of the instrument equal to the relative fair value of the other deliverables, including one year of Maintenance Services, and recognizes the amounts ratably over the service delivery period. The Company warrants that consumable diagnostic tests will be free from defects, when handled according to product specifications, for the stated life of the product. To fulfill valid warranty claims, the Company either provides a credit to its customers on future orders or provides replacement product. Accordingly, the Company defers revenue associated with the estimated defect rates of the consumable diagnostic tests. The Company does not offer rights of return for instruments or consumable diagnostic tests. Shipping and handling costs incurred associated with products sold to customers are recorded as a cost of product revenue in the consolidated statement of operations and comprehensive loss. Shipping and handling costs billed to customers in connection with a product sale are recorded as a component of product revenue in the consolidated statements of operations and comprehensive loss. For multiple-element arrangements, the Company identifies the deliverables included within each agreement and evaluates which deliverables represent separate units of accounting. The determination that multiple elements in an arrangement meet the criteria for separate units of accounting requires the Company’s management to exercise judgment. The Company accounts for those components as separate elements when the following criteria are met: (1) the delivered items have value to the customer on a stand-alone basis; and, (2) if there is a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and within its control. The consideration received is allocated among the separate units of accounting based on a selling price hierarchy. The selling price hierarchy is based on: (1) vendor specific objective evidence (“VSOE”), if available; (2) third party evidence of selling price if VSOE is not available; or (3) best estimated selling price (“BESP”) if neither VSOE nor third party evidence is available. The Company generally expects that it will not be able to establish selling price using third-party evidence due to the nature of our products and the markets in which the Company competes, and, as such, the Company typically will determine selling price using VSOE or BESP. When the Company establishes selling price using BESP, consideration is given to both market and Company-specific factors, including the cost to produce the deliverable and the anticipated margin on that deliverable, as well as the characteristics of markets in which the deliverable is sold. Revenue earned from activities performed pursuant to research and development agreements is reported as research revenue in the consolidated statements of operations and comprehensive loss, using the proportional performance method as the work is completed, limited to payments earned, and the related costs are expensed as incurred as research and development expense. The timing of receipt of cash from the Company’s research and development agreements generally differs from when revenue is recognized. Product Recall In July 2016, the Company initiated a voluntary recall and replacement of its T2Candida cartridges at certain customer sites because T2Candida was experiencing higher than normal invalid test rates as the T2Candida cartridges aged. As of June 30, 2016, as a result of this voluntary recall, the Company deferred revenue totaling $149,000 and recorded additional costs of product revenue of $41,000 related to returned products, which are no longer usable. As of December 31, 2016, the Company had approximately $37,000 of deferred revenue and $3,000 of warranty reserve remaining, both related to this voluntary recall. The impact of the voluntary recall on T2Candida cartridges in inventory was not material to the consolidated financial statements. Cost of Product Revenue Cost of product revenue includes the cost of materials, direct labor and manufacturing overhead costs used in the manufacture of consumable diagnostic tests sold to customers and related license and royalty fees. Cost of product revenue also includes depreciation on revenue generating T2Dx that have been placed with customers under reagent rental agreements; costs of materials, direct labor and manufacturing overhead costs on the T2Dx sold to customers; and other costs such as customer support costs, royalties and license fees, warranty and repair and maintenance expense on the T2Dx that have been placed with customers under reagent rental agreements. Research and Development Costs Costs incurred in the research and development of the Company’s product candidates are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including activities associated with performing services under research revenue arrangements, and include salaries and benefits, stock compensation, research‑related facility and overhead costs, laboratory supplies, equipment and contract services. Impairment of Long Lived Assets The Company reviews long‑lived assets, including capitalized T2 owned instruments and components, for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. During this review, the Company reevaluates the significant assumptions used in determining the original cost and estimated lives of long‑lived assets. Although the assumptions may vary from asset to asset, they generally include operating results, changes in the use of the asset, cash flows and other indicators of value. Management then determines whether the remaining useful life continues to be appropriate or whether there has been an impairment of long‑lived assets based primarily upon whether expected future undiscounted cash flows are sufficient to support the assets’ recovery. If impairment exists, the Company would adjust the carrying value of the asset to fair value, generally determined by a discounted cash flow analysis. No impairment charges have been recorded in any of the periods presented. Comprehensive Loss Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non‑owner sources. Comprehensive loss consists of net loss and other comprehensive loss, which includes certain changes in equity that are excluded from net loss. The Company’s comprehensive loss equals reported net loss for all periods presented. Stock-Based Compensation The Company has a stock‑based compensation plan which is more fully described in Note 9. The Company records stock‑based compensation for options granted to employees and to members of the board of directors for their services on the board of directors, based on the grant date fair value of awards issued, and the expense is recorded on a straight‑line basis over the applicable service period, which is generally four years. The Company accounts for non‑employee stock‑based compensation arrangements based upon the fair value of the consideration received or the equity instruments issued, whichever is more reliably measurable. The measurement date for non‑employee awards is generally the date that the performance of services required for the non‑employee award is complete. Stock‑based compensation costs for non‑employee awards is recognized as services are provided, which is generally the vesting period, on a straight‑line basis. The Company records the expense for stock option grants to performance-based milestone vesting using the accelerated attribution method over the remaining service period when management determines that achievement of the milestone is probable. Management evaluates when the achievement of a performance-based milestone is probable based on the relative satisfaction of the performance conditions as of the reporting date. The Company expenses restricted stock awards based on the fair value of the award on the date of issuance, on a straight‑line basis over the associated service period of the award. The Company uses the Black‑Scholes‑Merton option pricing model to determine the fair value of stock options. The use of the Black‑Scholes‑Merton option‑pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, risk‑free interest rates and expected dividend yields of the common stock. The expected term was determined according to the simplified method, which is the average of the vesting tranche dates and the contractual term. Due to the lack of company specific historical and implied volatility data resulting from our limited public market trading history, we have based our estimate of expected volatility primarily on the historical volatility of a group of similar companies that are publicly traded. For these analyses, companies with comparable characteristics are selected, including enterprise value and position within the industry, and with historical share price information sufficient to meet the expected life of the stock‑based awards. The Company computes the historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of its stock‑based awards. The risk‑free interest rate is determined by reference to U.S. Treasury zero‑coupon issues with remaining maturities similar to the expected term of the options. The Company has not paid, and does not anticipate paying, cash dividends on shares of common stock; therefore, the expected dividend yield is assumed to be zero. The Company is required to estimate forfeitures at the time of grant and revise those estimates in subsequent periods if actual forfeitures differ from those estimates. Income Taxes The Company provides for income taxes using the liability method. The Company provides deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. A valuation allowance is provided to reduce the deferred tax assets to the amount that will more likely than not be realized. The Company applies ASC 740 Income Taxes (“ASC 740”) in accounting for uncertainty in income taxes. The Company does not have any material uncertain tax positions for which reserves would be required. The Company will recognize interest and penalties related to uncertain tax positions, if any, in income tax expense. Guarantees As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Company’s request in such capacity. The term of the indemnification is for the officer’s or director’s lifetime. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ and officers’ insurance coverage that limits its exposure and enables it to recover a portion of any future amounts paid. The Company leases office, laboratory and manufacturing space under noncancelable operating leases. The Company has standard indemnification arrangements under the leases that require it to indemnify the landlord against all costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from any breach, violation or nonperformance of any covenant or condition of the Company’s leases. In the ordinary course of business, the Company enters into indemnification agreements with certain suppliers and business partners where the Company has certain indemnification obligations limited to the costs, expenses, fines, suits, claims, demands, liabilities and actions directly resulting from the Company’s gross negligence or willful misconduct, and in certain instances, breaches, violations or nonperformance of covenants or conditions under the agreements. As of December 31, 2016 and 2015, the Company had not experienced any material losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. Net Loss Per Share Basic net loss per share is calculated by dividing net loss applicable to common stockholders by the weighted‑average number of shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted‑average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury‑stock method. For purposes of the diluted net loss per share calculation, redeemable convertible preferred stock, and warrants to purchase redeemable convertible preferred stock, which were outstanding prior to the Company’s IPO, and stock options and unvested restricted stock are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect, including the related impact to the numerator of the fair value adjustment of the warrants and the impact to the denominator of the warrant shares, would be anti‑dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented. Recent Accounting Standards From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. Accounting Standards Adopted In 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements – Going Concern (“ASU 2014-15”). ASU 2014-15 provides new guidance on (1) management’s responsibility in evaluating whether or not there is substantial doubt about a company’s ability to continue as a going concern within one year from the date the financial statements are issued each reporting period and (2) related financial statement disclosures. The Company adopted the guidance prescribed by ASU 2014-15 as of December 31, 2016 and the Company concluded that there was not a substantial doubt about its ability to continue as a going concern. The Company faces certain risks and uncertainties, as described in Note 1, “Nature of Business,” that could affect this analysis in the future. In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs (“ASU 2015-03”). This standard amends existing guidance to require the presentation of debt issuance costs in the balance sheet as a deduction from the carrying amount of the related debt liability instead of a deferred charge. It is effective for annual reporting periods beginning after December 15, 2015, but early adoption is permitted. Adoption of ASU 2015-03 is applied retrospectively. The Company adopted ASU 2015-03 as of January 1, 2016, which resulted in a balance sheet reclassification of issuance costs of $22,000 recorded in prepaid expenses and other current assets and $102,000 in other assets to a reduction in the current portion of notes payable and notes payable, net of current portion as of December 31, 2015, respectively. The Company’s adoption of this standard did not have an impact on its consolidated results of operations or cash flows for the calendar year ended December 31, 2016. Accounting Standards Issued, Not Adopted In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments ("ASC 2016-15"), which provides guidance on the classification of certain specific cash flow issues including debt prepayment or extinguishment costs, settlement of certain debt instruments, contingent consideration payments made after a business combination, proceeds from the settlement of certain insurance claims and distributions received from equity method investees. The standard requires the use of a retrospective approach to all periods presented, but may be applied prospectively if retrospective application would be impracticable. The guidance is effective for public entities for fiscal years beginning after December 15, 2017, and interim periods within those years, and early application is permitted. The Company is currently evaluating the impact of its pending adoption of ASU 2016-15 on the Company’s consolidated financial statements. In March 2016, the FASB released ASU No. 2016-09 Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”) which is intended to simplify income tax accounting for excess tax benefits, accounting for forfeitures, and employer statutory withholding. Under the current guidance, excess tax benefits that result from an award vesting or settling are recognized in additional paid-in capital in the period that they reduce cash taxes payable. This requires the provision to be computed on a with and without option basis and may result in net operating loss and credit carryforwards on the balance sheet being less than what is available on the tax return. Under the new guidance, the income tax effects of awards will be recognized as a component of income tax expense when the awards vest or are settled (regardless if cash taxes are reduced). For interim reporting purposes, companies will account for excess tax benefits and tax deficiencies as discrete items in the period during which they occurred. The guidance is effective for public entities for fiscal years beginning after December 15, 2016, and interim periods within those years. Early adoption is permitted, however all of the guidance included in the update must be applied when adopted. The Company must use a modified retrospective transition method for adopting and record the cumulative effect of all unrecognized benefits and any change in valuation allowances at the end of the prior tax period as an adjustment to retained earnings. The Company has not elected to early adopt ASU 2016-09 and is evaluating the new guidance and the expected effect on the Company’s consolidated financial statements. In March 2016, the FASB issued ASU No. 2016-06, Derivatives and Hedging (Topic 815): Contingent Put and Call Options in Debt Instruments (“ASU 2016-06”), which applies to all issuers of or investors in debt instruments with embedded call or put options. ASU 2016-06 clarifies the requirements for assessing whether contingent call or put options that can accelerate the payment of principal on debt instruments are clearly and closely related to their debt hosts. Entities performing the assessment under the guidance of ASU 2016-06 are required to assess the embedded call or put options solely in accordance with the four-step decision process. In addition, ASU 2016-06 clarifies what steps are required when assessing whether the economic characteristics and risks of call or put options are clearly and closely related to the economic characteristics and risks of their debt hosts. ASU 2016-06 is effective for financial statements issued for |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Measurements | |
Fair Value Measurements | 3. Fair Value Measurements The Company measures the following financial assets at fair value on a recurring basis. There were no transfers between levels of the fair value hierarchy during any of the periods presented. The following tables set forth the Company’s financial assets and liabilities carried at fair value categorized using the lowest level of input applicable to each financial instrument as of December 31, 2016 and 2015 (in thousands): Quoted Prices in Active Significant Markets for Other Significant Balance at Identical Observable Unobservable December 31, Assets Inputs Inputs 2016 (Level 1) (Level 2) (Level 3) Assets: Cash $ $ $ — $ — Money market funds — — Restricted cash — — $ $ $ — $ — Quoted Prices in Active Significant Markets for Other Significant Balance at Identical Observable Unobservable December 31, Assets Inputs Inputs 2015 (Level 1) (Level 2) (Level 3) Assets: Cash $ $ $ — $ — Money market funds — — Restricted cash — — $ $ $ — $ — For certain financial instruments, including accounts payable and accrued expenses, the carrying amounts approximate their fair values as of December 31, 2016 and 2015 because of their short-term nature. |
Restricted Cash
Restricted Cash | 12 Months Ended |
Dec. 31, 2016 | |
Restricted Cash | |
Restricted cash | 4. Restricted Cash The Company is required to maintain a security deposit for its operating lease agreement for the duration of the lease agreement and for its credit cards as long as they are in place. At both December 31, 2016 and 2015, the Company had certificates of deposit for $260,000, which represented collateral as security deposits for its operating lease agreement for its facility and its credit card. |
Supplemental Balance Sheet Info
Supplemental Balance Sheet Information | 12 Months Ended |
Dec. 31, 2016 | |
Supplemental Balance Sheet Information | |
Supplemental Balance Sheet Information | 5. Supplemental Balance Sheet Information Property and Equipment Property and equipment consists of the following (in thousands) Estimated Useful December 31, December 31, Life (Years) 2016 2015 Office and computer equipment 3 $ $ Software 3 Laboratory equipment 5 Furniture 5-7 Manufacturing equipment 5 Manufacturing tooling and molds 0.5 T2-owned instruments and components 5 Leasehold improvements Lesser of useful life or lease term Construction in progress n/a Less accumulated depreciation and amortization Property and equipment, net $ $ Construction in progress is primarily comprised of equipment and leasehold improvement construction projects that have not been placed in service. T2-owned instruments and components is comprised of raw materials and work-in-process inventory that are expected to be used or used to produce Company-owned instruments, based on our business model and forecast, and completed instruments that will be used for internal research and development or reagent rental agreements with customers. Completed T2-owned instruments are placed in service once installation procedures are completed and are depreciated over five years. The Company has approximately $5.7 million of T2-owned instruments at customer and clinical locations as of December 31, 2016. Depreciation expense for T2-owned instruments placed at customer sites pursuant to reagent rental agreements is recorded as a component of cost of product revenue and totaled $599,000 and $105,000 for the years ended December 31, 2016 and December 31, 2015, respectively. Depreciation expense for T2-owned instruments used for internal research and development is recorded as a component of research and development expense. Depreciation and amortization expense of $2.3 million, $1.5 million and $691,000 was charged to operations for the years ended December 31, 2016, 2015 and 2014, respectively. Accrued Expenses Accrued expenses consist of the following (in thousands): December 31, December 31, 2016 2015 Accrued payroll and compensation $ $ Accrued research and development expenses Accrued professional services Other accrued expenses Total accrued expenses $ $ |
Notes Payable
Notes Payable | 12 Months Ended |
Dec. 31, 2016 | |
Debt | |
Notes Payable | 6. Notes Payable Future principal payments on the notes payable as of December 31, 2016 are as follows (in thousands): Year ended December 31, 2017 $ 2018 2019 2020 2021 Thereafter Total before unamortized discount and issuance costs Less: paid-in-kind interest Less: unamortized discount and issuance costs Total notes payable $ In 2016, the Company adopted, and retroactively implemented ASU No. 2015-03, "Simplifying the Presentation of Debt Issuance Costs." Under this new guidance, the Company is required to present debt issuance costs as a direct deduction from the related debt liability on our consolidated balance sheet. The cumulative effect of the change as of December 31, 2015 was $22,000 recorded in prepaid expenses and other current assets and $102,000 in other assets to a reduction in the current portion of notes payable and notes payable, net of current portion. Term Loan Agreement In December 2016, the Company entered into a Term Loan Agreement (the “Term Loan Agreement”) with CRG Servicing LLC (“CRG”). The Company initially borrowed $40.0 million pursuant to the Term Loan Agreement and may borrow up to an additional $10.0 million at any time through and including July 27, 2018, provided that, among other conditions, the Company receives 510(k) clearance for the marketing of T2BacteriaTM by the U.S. Food and Drug Administration (“FDA”) on or before April 30, 2018 (the “Approval Milestone”). The Term Loan Agreement has a six-year term with three years (through December 30, 2019) of interest-only payments, which period shall be extended to four years (through December 30, 2020) if the Company achieves the Approval Milestone, after which quarterly principal and interest payments will be due through the December 30, 2022 maturity date. Interest on the amounts borrowed under the Term Loan Agreement accrues at an annual fixed rate of (a) prior to the Approval Milestone, 12.50%, 4.0% of which may be deferred during the interest-only period by adding such amount to the aggregate principal loan amount and (b) following the Approval Milestone, 11.50%, 3.5% of which may be deferred during the interest-only period by adding such amount to the aggregate principal loan amount. In addition, if the Company achieves certain financial performance metrics, the loan will convert to interest-only until the December 30, 2022 maturity, at which time all unpaid principal and accrued unpaid interest will be due and payable. The Company is required to pay CRG a financing fee based on the loan principal amount drawn. The Company is also required to pay a final payment fee of 8% of the principal outstanding upon repayment. The Company may prepay all or a portion of the outstanding principal and accrued unpaid interest under the Term Loan Agreement at any time upon prior notice subject to a certain prepayment fee during the first five years of the term and no prepayment fee thereafter. As security for its obligations under the Term Loan Agreement the Company entered into a security agreement with CRG whereby the Company granted a lien on substantially all of its assets, including intellectual property. The Loan Agreement also contains customary affirmative and negative covenants for a credit facility of this size and type. The Loan Agreement also requires the Company to achieve certain revenue targets, whereby the Company is required to pay double the amount of any shortfall as an acceleration of principal payments. The Loan Agreement includes a subjective acceleration clause whereby an event of default, including a material adverse change in the business, operations, or conditions (financial or otherwise), could result in the acceleration of the obligations under the Loan Agreement. Under certain circumstances, a default interest rate of an additional 4.00% per annum will apply at the election of CRG on all outstanding obligations during the occurrence and continuance of an event of default. CRG has not exercised its right under this clause, as there have been no such events. The Company believes the likelihood of CRG exercising this right is remote. The Company assessed the terms and features of the Term Loan Agreement in order to identify any potential embedded features that would require bifurcation or any beneficial conversion features. As part of this analysis, the Company assessed the economic characteristics and risks of the Term Loan Agreement , including put and call features. The Company determined that the features of the Term Loan Agreement are either clearly and closely associated with a debt host and do not require bifurcation as a derivative liability, or the fair value of the feature is immaterial. Included in these features are principal payment acceleration clauses triggered by a developmental milestone. Should the Company’s assessment of this milestone change, there could be a non-cash charge in operations. The Company will continue to reassess the features to determine if they require separate accounting on a quarterly basis. In December 2016, pursuant to the Term Loan Agreement, the Company made an initial draw of $39.2 million, net of financing fees. The Company used approximately $28.0 million of the initial proceeds to repay approximately $27.5 million of outstanding debt pursuant to the Loan and Security Agreement and to repay approximately $479,000 of outstanding debt pursuant to the Promissory Note. Upon the repayment of all amounts owed by the Company under these agreements, all commitments were terminated and all security interests granted by the Company were released. In connection with the Term Loan Agreement entered into in December 2016, the Company issued to CRG four separate warrants to purchase a total of 528,958 shares of the Company’s common stock. The warrants are exercisable any time prior to December 30, 2026 at a price of $8.06 per share, with typical provisions for termination upon a change of control or a sale of all or substantially all of the assets of the Company. The warrants are classified within shareholders’ equity, and the proceeds were allocated between the debt and warrants based on their relative fair value. The fair value of the warrants was determined by the Black Scholes Merton option pricing model. The fair value of the warrants at December 30, 2016 was $1.8 million. Equipment Lease Credit Facility In October 2015, the Company signed the $10.0 million Credit Facility (the “Credit Facility”) with Essex Capital Corporation (“Essex”) to fund capital equipment needs. As one of the conditions of the Term Loan Agreement, the Credit Facility is capped at a maximum of $5.0 million. Under the Credit Facility, Essex will fund capital equipment purchases presented by the Company. The Company will repay the amounts borrowed in 36 equal monthly installments from the date of the amount funded. At the end of the 36 month lease term, the Company has the option to (a) repurchase the leased equipment at the lesser of fair market value or 10% of the original equipment value, (b) extend the applicable lease for a specified period of time, which will not be less than one year, or (c) return the leased equipment to the Lessor. In April 2016 and June 2016, the Company completed the first two draws under the Credit Facility of $2.1 million and $2.5 million, respectively. The Company will make monthly payments of $67,000 under the first draw and $79,000 under the second draw. The borrowings under the Credit Facility are treated as capital leases. The amortization of the assets conveyed under the Credit Facility is included as a component of depreciation expense. Loan and Security Agreement On July 11, 2014, the Company entered into a loan and security agreement (“Loan and Security Agreement”) with two lenders to borrow up to $30.0 million for operations. The Loan and Security Agreement allows the Company to borrow amounts in two tranches, up to $20.0 million (drawn in amounts not less than $10.0 million upon closing and the remainder drawn in amounts not less than $5.0 million draws) for tranche A and up to $10.0 million for tranche B. The Company borrowed a total of $29.7 million under the Loan and Security Agreement, net of issuance costs. In December 2016, the Company used approximately $27.5 million of the proceeds from the Term Loan agreement to repay the outstanding debt pursuant to the Loan and Security Agreement . Upon the repayment of all amounts owed by the Company under the Loan and Security Agreement , all commitments were terminated and all security interests granted by the Company were released. The amounts borrowed under the Loan and Security Agreement were collateralized by substantially all of the assets of the Company and bear interest at the one-month LIBOR plus 7.05%. The Company was required to pay interest only payments on the amounts borrowed under the Loan and Security Agreement through July 31, 2016. After the interest-only period, the Company was repaying the amounts borrowed in equal monthly installments until the maturity date. The Loan and Security Agreement required payment of a final fee of 4.75% of the aggregate original principal of amounts borrowed, which the Company accrued over the term of the Loan and Security Agreement. In addition, amounts borrowed could have been prepaid at the option of the Company in denominations of not less than $1.0 million, and any amounts prepaid were subject to a prepayment premium of 1.0% if prepaid prior to the second anniversary of the borrowing date and 0.5% if prepaid prior to the maturity date and after the second anniversary of the borrowing date. The effective interest rate for the Loan and Security Agreement, including final fee interest and non-cash interest, was 9.7%. The Loan and Security Agreement did not include any financial covenants, but did contain a subjective acceleration clause whereby upon an event of default, which includes a material adverse change in the business, operations, or conditions of the Company or a material impairment of the prospect of repayment of any portion of the obligations, the lender could accelerate the Company’s repayment obligations. In the event of default, the lender had first priority to substantially all of the Company’s assets. The Company assessed the terms and features of the Loan and Security Agreement in order to identify any potential embedded features that would require bifurcation or any beneficial conversion features. As part of this analysis, the Company assessed the economic characteristics and risks of the Loan and Security Agreement, including put and call features. The Company determined that all features of the Loan and Security Agreement were clearly and closely associated with a debt host and do not require bifurcation as a derivative liability, or the fair value of the feature is immaterial. The Company borrowed the full $20.0 million available under tranche A by December 31, 2014. In May 2015, the Company entered into an amendment to the Loan and Security Agreement whereby the availability to draw up to $10.0 million for tranche B was extended from June 30, 2015 to December 31, 2015. Commencing July 1, 2015, the Company incurred a fee equal to 1.0% per annum of any undrawn amounts under tranche B. This fee was payable on the date tranche B was drawn or upon the expiration of the draw period. The Company paid the $50,000 fee upon drawing the remaining $10.0 million under tranche B on December 28, 2015. Promissory Note In May 2011, the Company entered into a promissory agreement (the “Promissory Note”) with a separate lender to borrow up to $1.7 million for the purchase of laboratory equipment and office equipment through December 2013. The Company borrowed a total of $1.4 million under the Promissory Note. The Company paid interest only on the borrowings through December 2013 and was required to make equal monthly payments of principal and interest through the maturity date. In December 2016, the Company used approximately $479,000 of the proceeds from the Term Loan agreement to repay the outstanding debt pursuant to the Promissory Note. Upon the repayment of all amounts owed by the Company under the Promissory Note, all commitments were terminated and all security interests granted by the Company were released. The amounts borrowed were collateralized by the associated equipment and bear interest at 6.5%. The Promissory Note included financial covenants that required the Company to maintain a minimum cash balance of $300,000. In addition, the Promissory Note contained a subjective acceleration clause whereby an event of default and immediate acceleration of the borrowing occurs if there was a material adverse change in the business, operations, or condition of the Company or a material impairment of the prospect of repayment of any portion of the obligations. In the event of default, the lender had first priority on the laboratory equipment and office equipment purchased with the proceeds. Interest Expense, Net Interest expense for the years ended December 31, 2016, 2015 and 2014 was $4.1 million, $2.0 million, and $741,000, respectively. Interest expense for the years ended December 31, 2016, 2015, and 2014 included non-cash interest of $564,000, $354,000, and $112,000, respectively, related to the amortization of debt discounts and deferred financing costs under each of the above agreements. Interest expense for the year ended December 31, 2016 also included a non-cash charge for the extinguishment of debt of $112,000. |
Redeemable Convertible Preferre
Redeemable Convertible Preferred Stock | 12 Months Ended |
Dec. 31, 2016 | |
Redeemable Convertible Preferred Stock. | |
Redeemable Convertible Preferred Stock | 7. Redeemable Convertible Preferred Stock Upon closing of the IPO on August 12, 2014, all of the outstanding shares of the Company’s redeemable convertible preferred stock were converted into 12,516,298 shares of its common stock. As the preferred stock was redeemable, the Company accreted the shares to the redemption values over the period from issuance to the redemption date. The accretion amounts are recorded as an increase to the carrying value of the preferred stock with a corresponding charge to additional paid in capital or accumulated deficit. On the conversion date, the redeemable convertible preferred stock had a balance of $117.4 million, which was recorded in temporary equity. Upon conversion into common stock, this balance was reclassified as stockholders’ equity (deficit), reducing accumulated deficit by $21.0 million, with the residual amount of $96.3 million recorded as common stock (par value) and additional paid-in capital. The amount recorded as a reduction in accumulated deficit reflects the value of redeemable convertible preferred stock dividends and issuance costs accreted through the conversion date. As of August 12, 2014, the Company does not have any redeemable convertible preferred stock issued or outstanding. Prior to the IPO, the holders of the Company’s redeemable convertible preferred stock had certain voting, dividend, and redemption rights, as well as liquidation preferences and conversion privileges. All rights, preferences, and privileges associated with the redeemable convertible preferred stock were terminated at the time of the Company’s IPO in conjunction with the conversion of all outstanding shares of redeemable convertible preferred stock into shares of common stock. |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 12 Months Ended |
Dec. 31, 2016 | |
Stockholders' Equity | |
Stockholders' Equity | 8. Stockholders’ Equity Common Stock Each share of common stock is entitled to one vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors, subject to the prior rights of holders of all classes of stock outstanding. As of December 31, 2016, a total of 4,042,627 shares and 357,798 shares of common stock were reserved for issuance upon (i) the exercise of outstanding stock options and (ii) the issuance of stock awards under the Company’s 2014 Incentive Award Plan and 2014 Employee Stock Purchase Plan, respectively. Private Investment in Public Equity Financing On September 21, 2016, Canon U.S.A., Inc. (“Canon”) became a related party when the Company sold 6,055,341 shares of its common stock (the “Canon Shares”) to Canon at $6.56 per share, the closing price on this date, for an aggregate cash purchase price of $39.7 million. As of September 21, 2016, the Canon Shares represented 19.9% of the outstanding shares of common stock of the Company. In connection with the sale of the Canon Shares, the Company agreed to grant Canon certain board designation rights, including the right to initially appoint a Class I director to the Company’s board of directors. On or before March 21, 2017, the Company has agreed to use its best efforts to prepare and file with the Securities and Exchange Commission (the “SEC”) a registration statement on Form S-3 for purposes of registering the resale of the Canon Shares, or if the Company is not eligible for the use of Form S-3 at that time, on or before June 21, 2017, the Company has agreed to prepare and file a registration statement on Form S-1, or on an alternative form that permits the resale of the Canon Shares, with the SEC. |
Stock Based Compensation
Stock Based Compensation | 12 Months Ended |
Dec. 31, 2016 | |
Stock Based Compensation | |
Stock-Based Compensation | 9. Stock-Based Compensation Stock Incentive Plans 2006 Stock Incentive Plan The Company’s 2006 Stock Option Plan (the “2006 Plan”) was established for granting stock incentive awards to directors, officers, employees and consultants to the Company. Upon closing of the Company’s IPO in August 2014, the Company ceased granting stock incentive awards under the 2006 Plan. The 2006 Plan provided for the grant of incentive and non-qualified stock options and restricted stock grants as determined by the Board of Directors. Under the 2006 Plan, stock options were generally granted with exercise prices equal to or greater than the fair value of the common stock as determined by the board of directors, expired no later than 10 years from the date of grant, and vest over various periods not exceeding 4 years. 2014 Stock Incentive Plan The Company’s 2014 Plan (the “2014 Plan” and, together with the 2006 Plan, the “Stock Incentive Plans”) provides for the issuance of shares of common stock in the form of stock options, awards of restricted stock, awards of restricted stock unit awards, performance awards, dividend equivalent awards, stock payment awards and stock appreciation rights to directors, officers, employees and consultants of the Company. Since the establishment of the 2014 Plan, the Company has only granted stock options. Generally, stock options are granted with exercise prices equal to or greater than the fair value of the common stock on the date of grant, expire no later than 10 years from the date of grant, and vest over various periods not exceeding 4 years. The number of shares reserved for future issuance under the 2014 Plan is the sum of (1) 823,529, (2) any shares that were granted under the 2006 Plan which are forfeited, lapse unexercised or are settled in cash subsequent to the effective date of the 2014 Plan and (3) an annual increase on the first day of each calendar year beginning January 1, 2015 and ending on January 1, 2024, equal to the lesser of (A) 4% of the shares outstanding on the final day of the immediately preceding calendar year and (B) such smaller number of shares determined by the Board of Directors. As of December 31, 2016 there were 223,397 shares available for future grant under the Plan. Stock Options During the years ended December 31, 2016, 2015, and 2014, the Company granted options with an aggregate fair value of $7.0 million and $10.1 million, and $6.0 million, respectively, which are being amortized into compensation expense over the vesting period of the options as the services are being provided. The following is a summary of option activity under the Plan (in thousands, except share and per share amounts): Weighted-Average Weighted-Average Remaining Number of Exercise Price Per Contractual Term Aggregate Intrinsic Shares Share (In years) Value Outstanding at December 31, 2015 $ $ Granted Exercised Forfeited Canceled Outstanding at December 31, 2016 Exercisable at December 31, 2016 Vested or expected to vest at December 31, 2016 Included in the stock options granted during the year ended December 31, 2016 are 166,066 options to purchase common stock granted to certain executive officers of the Company that vest upon the achievement of certain performance conditions, which include the attainment of specified operating result and regulatory targets, by December 31, 2017. Included in the stock options forfeited during the year ended December 31, 2016 are 20,000 options to purchase common stock upon the achievement of certain performance conditions. There are 146,066 performance based options included in the outstanding balance at December 31, 2016. The Company will continually evaluate the probability of achievement of each performance condition and will commence recognition of stock-based compensation expense on these awards in the period the achievement of each performance condition is deemed probable, including a catch-up adjustment from the grant date. The weighted‑average fair values of options granted in the years ended December 31, 2016, 2015, and 2014 were $4.68, $8.42, and $7.59 per share, respectively, and were calculated using the following estimated assumptions: Year ended December 31, 2016 2015 Weighted-average risk-free interest rate % % Expected dividend yield % % Expected volatility % % Expected terms years years The total fair values of stock options that vested during the years ended December 31, 2016, 2015, and 2014 were $4.9 million, $4.0 million, and $1.2 million, respectively. As of December 31, 2016, there was $8.8 million of total unrecognized compensation cost related to non‑vested stock options granted under the Stock Incentive Plans. Total unrecognized compensation cost will be adjusted for future changes in the estimated forfeiture rate. The Company expects to recognize that cost over a remaining weighted‑average period of 2.54 years as of December 31, 2016. Restricted Stock Units During the year ended December 31, 2016 the Company awarded shares of restricted stock units to certain employees at no cost to them, which cannot be sold, assigned, transferred or pledged during the restriction period. The restricted stock and restricted stock units vest through the passage of time, assuming continued employment. Restricted stock units are not included in issued and outstanding common stock until the shares are vested and released. The fair value of the award at the time of the grant is expensed on a straight line basis. The granted restricted stock units had an aggregate fair value of $1.4 million, which are being amortized into compensation expense over the vesting period of the options as the services are being provided. The following is a summary of restricted stock unit activity under the Plan (in thousands, except share and per share amounts): Weighted-Average Number of Grant Date Fair Shares Value Nonvested at December 31, 2015 — $ — Granted Exercised — — Forfeited — — Canceled — — Nonvested at December 31, 2016 There was no vesting of restricted stock units during the year ended December 31, 2016. As of December 31, 2016, there was $1.4 million of total unrecognized compensation cost related to non‑vested stock options granted under the Stock Incentive Plans. Total unrecognized compensation cost will be adjusted for future changes in the estimated forfeiture rate. The Company expects to recognize that cost over a remaining weighted‑average period of 1.92 years as of December 31, 2016. Employee Stock Purchase Plan The 2014 Employee Stock Purchase Plan (the “2014 ESPP”) period is semi-annual and allows participants to purchase the Company’s common stock at 85% of the lower of (i) the market value per share of common stock on the first day of the offering period or (ii) the market value per share of the common stock on the purchase date. Each participant can purchase up to a maximum of $25,000 per calendar year in fair market value. The first plan period began on August 7, 2014. Stock-based compensation expense from the 2014 ESPP for the years ended December 31, 2016, 2015 and 2014 was approximately $253,000, $233,000 and $103,000, respectively. The fair value of the purchase rights granted under this plan was estimated on the date of grant that uses the following weighted-average assumptions, which were derived in a manner similar to those discussed in Note 2 relative to stock options: Year ended December 31, 2016 2015 Weighted-average risk-free interest rate % % Expected dividend yield % % Expected volatility % % Expected terms years years The 2014 ESPP provides initially for the granting of up to 220,588 shares of the Company’s common stock to eligible employees. In addition, on the first day of each calendar year beginning January 1, 2015 and ending on January 1, 2024, the number of common shares available under the Plan shall be increased by the number of shares equal to the lesser of (1) 1% of the common shares outstanding on the final day of the immediately preceding calendar year and (2) such smaller number of common shares as determined by the Board of Directors. At December 31, 2016, there were 134,401 shares available under the 2014 ESPP. Stock‑Based Compensation Expense The following table summarizes the stock-based compensation expense for stock options granted to employees and non-employees, as well as stock-compensation expense for the 2014 ESPP that was recorded in the Company’s results of operations for the years presented (in thousands): Year ended December 31, 2016 2015 2014 Cost of product revenue $ $ — $ — Research and development Selling, general and administrative Total stock-based compensation expense $ $ $ For the years ended December 31, 2016 and December 31, 2015, $118,000 and $115,000 of stock-based compensation expense was capitalized, respectively, as part of inventory or T2 instruments and components. |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2016 | |
Warrants. | |
Warrants | 10. Warrants In connection with the Term Loan Agreement entered into in December 2016, the Company issued to CRG four separate warrants to purchase a total of 528,958 shares of the Company’s common stock. The warrants are exercisable any time prior to December 30, 2026 at a price of $8.06 per share, with typical provisions for termination upon a change of control or a sale of all or substantially all of the assets of the Company. The warrants are classified within shareholders’ equity, and the proceeds were allocated between the debt and warrants based on their relative fair value. The fair value of the warrants was determined by the Black‑Scholes‑Merton option pricing model . The fair value of the warrants at date of issuance was $1.8 million. Prior to the completion of the IPO, the Company had outstanding warrants to purchase 250,727 shares of various classes of redeemable convertible preferred stock. The warrants were recorded as a liability and changes in the fair value of the warrants were recorded as a component of other income (expense), net. In connection with the closing of the Company’s IPO, all of the Company’s outstanding warrants to purchase convertible preferred stock automatically converted into 68,700 shares of common stock, resulting in the net settlement of the liability to purchase redeemable securities to common stock (par value) and additional paid-in capital as of August 12, 2014. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2016 | |
Net Loss Per Share | |
Net Loss Per Share | 11. Net Loss Per Share The following table presents the calculation of basic and diluted net loss per share applicable to common stockholders (in thousands, except share and per share data): Year ended December 31, 2016 2015 2014 Numerator: Net loss $ $ $ Accretion of redeemable convertible preferred stock to redemption value — — Net loss applicable to common stockholders $ $ $ Denominator: Weighted-average number of common shares outstanding — basic and diluted Net loss per share applicable to common stockholders — basic and diluted $ $ $ The following shares were excluded from the calculation of diluted net loss per share applicable to common stockholders, prior to the application of the treasury stock method, because their effect would have been anti‑dilutive for the periods presented: Year ended December 31, 2016 2015 2014 Options to purchase common shares Restricted stock units — — Warrants to purchase common stock — — Total |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2016 | |
Income Taxes | |
Income Taxes | 12. Income Taxes The reconciliation of the U.S. federal statutory rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2016 2015 2014 Tax at statutory rates % % % State income taxes Permanent differences Research and development credits Change in valuation allowance Effective tax rate % % % The significant components of the Company’s deferred tax asset consist of the following at December 31, 2016 and 2015 (in thousands): December 31, 2016 2015 Deferred tax assets: Net operating loss carryforwards $ $ Tax credits Other temporary differences Start-up expenditures Stock option expenses Total deferred tax assets Deferred tax asset valuation allowance Net deferred tax assets Deferred tax liabilities: Prepaid expenses Net deferred taxes $ — $ — In 2016 and 2015, the Company did not record a benefit for income taxes related to its operating losses incurred. ASC 740 requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Based upon the level of historical U.S. losses and future projections over the period in which the net deferred tax assets are deductible, at this time, management believes it is more likely than not that the Company will not realize the benefits of these deductible differences, and as a result the Company continues to maintain a valuation allowance for the full amount of the 2016 deferred tax assets. The valuation allowance increased $22.1 million, $18.9 million and $12.7 million for the years ended December 31, 2016, 2015 and 2014, respectively, primarily related to each year’s taxable loss. As of December 31, 2016, the Company had federal and state net operating losses of $174.9 million and $162.1 million, respectively, which are available to offset future taxable income, if any, through 2036. Included in the federal and state net operating losses are deductions attributable to excess tax benefits from the exercise of stock options of $626,000 and $2.9 million, respectively. The tax benefits attributable to these deductions are credited directly to additional paid-in capital when realized. The Company also had federal and state research and development tax credits of $3.5 million and $2.8 million, respectively, which expire at various dates through 2036. Under the provisions of the Internal Revenue Code, the net operating loss and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. Net operating loss and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code, respectively, as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The Company has completed several financings since its inception which may have resulted in a change in control as defined by Sections 382 and 383 of the Internal Revenue Code, or could result in a change in control in the future. The Company has not conducted an assessment to determine whether there may have been a Section 382 or 383 ownership change. The Company has no unrecognized tax benefits. Interest and penalty charges, if any, related to uncertain tax positions would be classified as income tax expenses in the accompanying consolidated statements of operations. At December 31, 2016 and 2015, the Company had no accrued interest or penalties related to uncertain tax positions. The Company files income tax returns in the U.S. federal tax jurisdiction and various state jurisdictions. Since the Company is in a loss carryforward position, the Company is generally subject to examination by the U.S. federal, state and local income tax authorities for all tax years in which a loss carryforward is available. The Company does not have any international operations as of December 31, 2016. The statute of limitations for assessment by federal and state tax jurisdictions in which the Company has business operations is open for tax years ending December 31, 2013, 2014, and 2015. The tax years under examination vary by jurisdiction. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 13. Commitments and Contingencies Operating Leases In August 2010, the Company entered into a five-year, non-cancelable operating lease for office and laboratory space at its headquarters in Lexington, MA. The lease commenced on January 1, 2011, with the Company providing a security deposit of $400,000. In accordance with the operating lease agreement, the Company reduced its security deposit to $240,000 in May 2015, which is recorded as restricted cash in the consolidated balance sheets. In July 2014, the Company amendment the lease to expand the office and laboratory space leased. In May 2015, the Company entered into an amendment to this lease to extend the term from December 31, 2015 to December 31, 2017. In March 2017, the Company entered into an amendment to extend the term from December 31, 2017 to December 31, 2021. The rent expense, inclusive of the escalating rent payments, is recognized on a straight-line basis over the lease term. In May, 2013, the Company entered into a two-year operating lease for additional office, laboratory and manufacturing space in Wilmington, MA. The Company entered into an amendment in September 2015 to extend this lease term through December 31, 2017. In November, 2014 the Company entered into an agreement to rent additional office space in Lexington, MA. The term of the agreement is two years, commencing December 2014. In April 2015, the Company entered into an amendment to extend the term of this agreement. The amendment extends the agreement term from December 31, 2016 to December 31, 2017. In connection with this agreement, the Company paid a security deposit totaling $50,000, which is recorded as a component of prepaid assets in the consolidated balance sheets. In May 2015, the Company entered into an amendment to a lease to expand existing manufacturing facilities in Lexington, MA. The lease amendment term is June 1, 2015 to December 31, 2017. In November, 2014, the Company entered into a lease for additional laboratory space in Lexington, MA. The lease term commenced April 1, 2015 and extends for six years. The rent expense, inclusive of the escalating rent payments, is recognized on a straight-line basis over the lease term. As an incentive to enter into the lease, the landlord paid approximately $1.4 million of the $2.2 million space build-out costs. The incentive is recorded as a component of lease incentives on the consolidated balance sheets and is amortized as a reduction in rent expense on a straight-line basis over the term of the lease. In connection with this lease agreement, the Company paid a security deposit of $281,000, which is recorded as a component of other assets in the consolidated balance sheets. Future minimum non-cancelable lease payments under the Company’s operating leases as of December 31, 2016 are as follows (in thousands): Year ending December 31, 2017 $ 2018 2019 2020 2021 Thereafter — $ The future minimum noncancelable lease payments will increase to $2.1 million in 2017, $1.7 million in 2018, $1.8 million in 2019, $1.9 million in 2020 and $1.6 million in 2021 as a result of the lease amendment entered into on March 7, 2017 for office and laboratory space at the Company’s headquarters in Lexington, MA. Rent expense for the years ended December 31, 2016, 2015, and 2014 was $1.8 million, $1.6 million, and $950,000, respectively. License Agreement In 2006, the Company entered into a license agreement with a third party, pursuant to which the third party granted the Company an exclusive, worldwide, sublicenseable license under certain patent rights to make, use, import and commercialize products and processes for diagnostic, industrial and research and development purposes. The Company agreed to pay an annual license fee ranging from $5,000 to $25,000 for the royalty‑bearing license to certain patents. For the years ended December 31, 2016, 2015 and 2014, the Company incurred $31,000, $34,000 and $345,000, respectively, for regulatory milestones, license fees and reimbursed patent costs under the agreement. The Company also issued a total of 84,678 shares of common stock pursuant to the agreement in 2006 and 2007, which were recorded at fair value at the date of issuance. Regulatory milestones totaling $300,000 became due during the year ended December 31, 2014, as the Company received FDA marketing clearance and European CE Mark for the T2Dx and T2Candida. The Company is required to pay royalties on net sales of products and processes that are covered by patent rights licensed under the agreement at a percentage ranging in the low single digits, subject to reductions and offsets in certain circumstances, as well as a royalty on net sales of products that the Company sublicenses at a low double‑digit percentage of specified gross revenue. Royalties that became due under this agreement for the years ended December 31, 2016 and 2015 were immaterial. |
401(k) Savings Plan
401(k) Savings Plan | 12 Months Ended |
Dec. 31, 2016 | |
401(k) Savings Plan | |
401(k) Savings Plan | 14. 401(k) Savings Plan In March, 2008, the Company established a retirement savings plan under Section 401(k) of the Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan covers substantially all employees of the Company who meet minimum age and service requirements, and allows participants to defer a portion of their annual compensation on a pretax basis. Company contributions to the 401(k) Plan may be made at the discretion of the board of directors. Company contributions to the 401(k) Plan were $237,000 for the year ended December 31, 2016. No contributions were made in the years ended December 31, 2015 and 2014. |
Co-Development Agreements
Co-Development Agreements | 12 Months Ended |
Dec. 31, 2016 | |
Co-Development Agreements | |
Co-Development Agreements | 15. Co-Development Agreements Canon US Life Sciences On September 21, 2016, Canon became a related party when the Company sold the Canon Shares for an aggregate cash purchase price of $39.7 million, which represented 19.9% of the outstanding shares of common stock of the Company. On February 3, 2015, the Company entered into a Co-Development Partnership Agreement (the “Co-Development Agreement”) with Canon U.S. Life Sciences, Inc. (“Canon US Life Sciences”) to develop a diagnostic test panel to rapidly detect Lyme disease. Under the terms of the Co-Development Agreement, the Company received an upfront payment of $2.0 million from Canon US Life Sciences and the agreement includes an additional $6.5 million of consideration upon achieving certain development and regulatory milestones for total aggregate payments of up to $8.5 million. In October 2015, the Company achieved a specified technical requirement and received $1.5 million related to the achievement of the milestone. The Company is eligible to receive an additional $5.0 million under the arrangement, in two milestone payments of $2.0 million and $3.0 million, related to the achievement of additional development and regulatory milestones. All payments under the Co-Development Agreement are non-refundable once received. The Company will retain exclusive worldwide commercialization rights of any products developed under the Co-Development Agreement, including sales, marketing and distribution and Canon US Life Sciences will not receive any commercial right and will be entitled to only receive royalty payments on the sales of all products developed under the Co-Development Agreement. Either party may terminate the Co-Development Agreement upon the occurrence of a material breach by the other party (subject to a cure period). The Company evaluated the deliverables under the Co-Development Agreement and determined that the Co-Development Agreement included one unit of accounting, the research and development services, as the joint research and development committee deliverable was deemed to be de minimus . The Company is recognizing revenue for research and development services as a component of research revenue in the consolidated financial statements as the services are delivered using the proportional performance method of accounting, limited to payments earned. Costs incurred to deliver the services under the Co-Development Agreement are recorded as research and development expense in the consolidated financial statements. The Company recorded revenue of $1.8 million and $1.4 million for the years ended December 31, 2016 and 2015, respectively, under the Co-Development Agreement, and expects to record revenue over the next two years, provided development and regulatory milestones are achieved. Allergan Sales, LLC On November 1, 2016, the Company entered into a Co-Development, Collaboration and Co-Marketing Agreement (the “Allergan Agreement”) with Allergan Sales, LLC (“Allergan Sales”) to develop (1) a direct detection diagnostic test panel that adds one additional bacteria species to the existing T2Bacteria product candidate (the “T2Bacteria II Panel”), and (2) a direct detection diagnostic test panel for testing drug resistance directly in whole blood (the “T2GNR Panel” and, together with the T2Bacteria II Panel, the “Developed Products”). In addition, both the Company and Allergan Sales will participate in a joint research and development committee and Allergan Sales will receive the right to cooperatively market the T2Candida, T2Bacteria, and the Developed Products under the Allergan Agreement to certain agreed-upon customers. Under the terms of the Allergan Agreement, the Company received an upfront payment of $2.0 million from Allergan Sales and will receive additional milestone payments upon achieving certain developmental milestones for total aggregate payments of up to $4.0 million. All payments under the Allergan Agreement are non-refundable once received. The Company will retain exclusive worldwide commercialization rights of any products developed under the Allergan Agreement, including distribution, subject to Allergan Sales’ right to co-market the Developed Products. Allergan Sales, at its election, may co-market T2Candida, T2Bacteria and the Developed Products worldwide to certain agreed-upon customers and will receive royalty based on its sales for a period of time. The Company evaluated the deliverables under the Allergan Agreement and determined that the Allergan Agreement included two units of accounting, the research and development services for the T2Bacteria II Panel and the research and development services for the T2GNR Panel , as the joint research and development committee and right to cooperatively market deliverables were deemed to be de minimus . The Company is recognizing revenue for research and development services as a component of research revenue in the consolidated financial statements as the services are delivered using the proportional performance method of accounting, limited to payments earned. Costs incurred to deliver the services under the Allergan Agreement are recorded as research and development expense in the consolidated financial statements. The Company did not record any revenue for the year ended December 31, 2016 under the Allergan Agreement and expects to record revenue over the next two years, provided development and regulatory milestones are achieved. |
Quarterly Financial Data (unaud
Quarterly Financial Data (unaudited) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Data (unaudited) | |
Quarterly Financial Data (unaudited) | 16. Quarterly Financial Data (unaudited) Year ended December 31, 2016 (In thousands, except per share data) First Quarter Second Quarter Third Quarter Fourth Quarter Revenue: Product revenue $ $ $ $ Research revenue Total revenue $ $ $ $ Costs and expenses: Cost of product revenue Research and development Selling, general and administrative Total costs and expenses Loss from operations $ $ $ $ Net loss $ $ $ $ Net loss applicable to common shareholders $ $ $ $ Per share data: Net loss per common share—basic and diluted $ $ $ $ Year ended December 31, 2015 (In thousands, except per share data) First Quarter Second Quarter Third Quarter Fourth Quarter Revenue: Product revenue $ $ — $ $ Research revenue Total revenue $ $ $ $ Costs and expenses: Cost of product revenue — Research and development Selling, general and administrative Total costs and expenses Loss from operations $ $ $ $ Net loss $ $ $ $ Net loss applicable to common shareholders $ $ $ $ Per share data: Net loss per common share—basic and diluted $ $ $ $ |
Summary of Significant Accoun24
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Summary of Significant Accounting Policies | |
Basis of Presentation and Consolidation | Basis of Presentation and Consolidation The Company’s financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company’s consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, T2 Biosystems Securities Corporation. All intercompany balances and transactions have been eliminated. |
Use of Estimates | Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company utilizes certain estimates in the determination of the fair value of its stock options, deferred tax valuation allowances, revenue recognition, to record expenses relating to research and development contracts, accrued expenses, and to classify the value of instrument raw material and work-in-process inventory between inventory and property and equipment. The Company bases its estimates on historical experience and other market‑specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results could differ from such estimates. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision‑making group, in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker is the Chief Executive Officer. The Company views its operations and manages its business in one operating segment, which is the business of developing and, upon regulatory clearance, launching commercially its diagnostic products aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. |
Off Balance Sheet Risk and Concentrations of Credit Risk | Off‑Balance Sheet Risk and Concentrations of Credit Risk The Company has no significant off-balance sheet risks, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Cash and cash equivalents are financial instruments that potentially subject the Company to concentrations of credit risk. At December 31, 2016 and 2015, substantially all of the Company’s cash was deposited in accounts at one financial institution, with a significant amount invested in money market funds that are invested in short-term U.S. government agency securities. The Company maintains its cash deposits, which at times may exceed the federally insured limits, with a large financial institution and, accordingly, the Company believes such funds are subject to minimal credit risk. For the year ended December 31, 2016, the Company derived approximately 45% of its total revenue from one customer and 10% of its total revenue from a second customer. For the year ended December 31, 2015, the Company derived approximately 50% of its total revenue from one customer and 25% of its total revenue from a second customer. For the year ended December 31, 2014, the Company derived all of its revenue from a single customer. |
Cash Equivalents | Cash Equivalents Cash equivalents include all highly liquid investments maturing within 90 days from the date of purchase. Cash equivalents consist of money market funds invested in short-term U.S. government agency securities as of December 31, 2016 and 2015. |
Accounts Receivable | Accounts Receivable The Company’s accounts receivable consists of amounts due from commercial customers and from research and development arrangements with partners. At each reporting period, management reviews all outstanding balances to determine if the facts and circumstances of each customer relationship indicate the need for a reserve. The Company does not require collateral and did not have an allowance for doubtful accounts at December 31, 2016 or 2015. |
Inventories | Inventories Inventories are stated at the lower of cost or market. The Company determines the cost of its inventories, which includes amounts related to materials, direct labor, and manufacturing overhead, on a first-in, first-out basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and writes down any excess and obsolete inventories to their realizable value in the period in which the impairment is first identified. Shipping and handling costs incurred for inventory purchases are capitalized and recorded upon sale in cost of product revenues in the consolidated statements of operations and comprehensive loss or are included in the value of T2-owned instruments and components, a component of property and equipment, net, and depreciated. The Company capitalizes inventories in preparation for sales of products when the related product candidates are considered to have a high likelihood of regulatory clearance, which for the T2Dx Instrument and T2Candida Panel was upon the achievement of regulatory clearance, and the related costs are expected to be recoverable through sales of the inventories. In addition, the Company capitalizes inventories related to the manufacture of instruments that have a high likelihood of regulatory clearance, which for the T2Dx Instrument was upon the achievement of regulatory clearance, and will be retained as the Company’s assets, upon determination that the instrument has alternative future uses. In determining whether or not to capitalize such inventories, the Company evaluates, among other factors, information regarding the product candidate’s status of regulatory submissions and communications with regulatory authorities, the outlook for commercial sales and alternative future uses of the product candidate. Costs associated with development products prior to satisfying the inventory capitalization criteria are charged to research and development expense as incurred. The Company classifies inventories related to instruments that are Company-owned, as a component of property and equipment. Raw material and work-in-process inventories that are expected to be used to produce Company-owned instruments, based on our business model and forecast, are also classified as property and equipment. Company-owned instruments are instruments that are manufactured and placed with customers in connection with reagent rental agreements, or are used for internal purposes. The components of inventory consist of the following (in thousands): December 31, December 31, 2016 2015 Raw materials $ $ Work-in-process Finished goods Total inventories, net $ $ |
Fair Value Measurements | Fair Value Measurements The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. ASC 820, Fair Value Measurements and Disclosures (“ASC 820”), establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability, and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs: Level 1 — Quoted unadjusted prices for identical instruments in active markets. Level 2 — Quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model‑derived valuations in which all observable inputs and significant value drivers are observable in active markets. Level 3 — Model derived valuations in which one or more significant inputs or significant value drivers are unobservable, including assumptions developed by the Company. The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability (See Note 3). Financial instruments measured at fair value on a recurring basis include cash, money market funds and restricted cash (See Note 3). For certain financial instruments, including accounts payable and accrued expenses, the carrying amounts approximate their fair values as of December 31, 2016 and 2015 because of their short-term nature. At December 31, 2016 and 2015, the carrying value of the Company’s debt approximated fair value, which was determined using Level 3 inputs, using market quotes from brokers and is based on current rates offered for similar debt (Note 6). |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight‑line method. Property and equipment includes raw materials, work-in-process and finished instruments that are Company-owned or expected to remain Company-owned when placed in service. Company-owned instruments are instruments that are manufactured and placed with customers in connection with reagent rental agreements, or are used for internal purposes. Repairs and maintenance costs are expensed as incurred, whereas major improvements are capitalized as additions to property and equipment. |
Revenue Recognition | Revenue Recognition The Company generates revenue from product sales, which includes the sale of instruments, consumable diagnostic tests and related services, and research and development agreements with third parties. The Company recognizes revenue in accordance with FASB ASC Topic 605, Revenue Recognition (“ASC 605”). Accordingly, the Company recognizes revenue when all of the following criteria have been met: i. ii. iii. iv. If any of the above criteria have not been met, the Company defers revenue until such time each of the criteria have been satisfied. Product revenue is generated by the sale of instruments and consumable diagnostic tests predominantly through its direct sales force in the United States, and distributors in geographic regions outside the United States. The Company does not offer product return or exchange rights (other than those relating to defective goods under warranty) or price protection allowances to its customers, including its distributors. Payment terms granted to distributors are the same as those granted to end-user customers and payments are not dependent upon the distributors’ receipt of payment from their end-user customers. The Company either sells instruments to customers and international distributors, or retains title and places the instrument at the customer site pursuant to a reagent rental agreement. When the instrument is directly purchased by a customer, the Company recognizes revenue when all applicable revenue recognition criteria are met. When the instrument is placed under a reagent rental agreement, the Company’s customers generally agree to fixed term agreements, which can be extended, certain of which may include minimum purchase commitments and/or incremental charges on each consumable diagnostic test purchased, which varies based on the volume of test cartridges purchased. Revenue from the sale of consumable diagnostic tests, which includes the incremental charge, is recognized upon delivery as a component of product revenue in the Company’s consolidated statements of operations and comprehensive loss. Direct sales of instruments include warranty, maintenance and technical support services for one year following the installation of the purchased instrument (“Maintenance Services”). After the completion of the initial Maintenance Services period, customers have the option to renew the Maintenance Services for additional one year periods in exchange for additional consideration. In addition, the Company may provide training to customers. The Company defers revenue from the initial sale of the instrument equal to the relative fair value of the other deliverables, including one year of Maintenance Services, and recognizes the amounts ratably over the service delivery period. The Company warrants that consumable diagnostic tests will be free from defects, when handled according to product specifications, for the stated life of the product. To fulfill valid warranty claims, the Company either provides a credit to its customers on future orders or provides replacement product. Accordingly, the Company defers revenue associated with the estimated defect rates of the consumable diagnostic tests. The Company does not offer rights of return for instruments or consumable diagnostic tests. Shipping and handling costs incurred associated with products sold to customers are recorded as a cost of product revenue in the consolidated statement of operations and comprehensive loss. Shipping and handling costs billed to customers in connection with a product sale are recorded as a component of product revenue in the consolidated statements of operations and comprehensive loss. For multiple-element arrangements, the Company identifies the deliverables included within each agreement and evaluates which deliverables represent separate units of accounting. The determination that multiple elements in an arrangement meet the criteria for separate units of accounting requires the Company’s management to exercise judgment. The Company accounts for those components as separate elements when the following criteria are met: (1) the delivered items have value to the customer on a stand-alone basis; and, (2) if there is a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and within its control. The consideration received is allocated among the separate units of accounting based on a selling price hierarchy. The selling price hierarchy is based on: (1) vendor specific objective evidence (“VSOE”), if available; (2) third party evidence of selling price if VSOE is not available; or (3) best estimated selling price (“BESP”) if neither VSOE nor third party evidence is available. The Company generally expects that it will not be able to establish selling price using third-party evidence due to the nature of our products and the markets in which the Company competes, and, as such, the Company typically will determine selling price using VSOE or BESP. When the Company establishes selling price using BESP, consideration is given to both market and Company-specific factors, including the cost to produce the deliverable and the anticipated margin on that deliverable, as well as the characteristics of markets in which the deliverable is sold. Revenue earned from activities performed pursuant to research and development agreements is reported as research revenue in the consolidated statements of operations and comprehensive loss, using the proportional performance method as the work is completed, limited to payments earned, and the related costs are expensed as incurred as research and development expense. The timing of receipt of cash from the Company’s research and development agreements generally differs from when revenue is recognized. Product Recall In July 2016, the Company initiated a voluntary recall and replacement of its T2Candida cartridges at certain customer sites because T2Candida was experiencing higher than normal invalid test rates as the T2Candida cartridges aged. As of June 30, 2016, as a result of this voluntary recall, the Company deferred revenue totaling $149,000 and recorded additional costs of product revenue of $41,000 related to returned products, which are no longer usable. As of December 31, 2016, the Company had approximately $37,000 of deferred revenue and $3,000 of warranty reserve remaining, both related to this voluntary recall. The impact of the voluntary recall on T2Candida cartridges in inventory was not material to the consolidated financial statements. |
Cost of Product Revenue | Cost of Product Revenue Cost of product revenue includes the cost of materials, direct labor and manufacturing overhead costs used in the manufacture of consumable diagnostic tests sold to customers and related license and royalty fees. Cost of product revenue also includes depreciation on revenue generating T2Dx that have been placed with customers under reagent rental agreements; costs of materials, direct labor and manufacturing overhead costs on the T2Dx sold to customers; and other costs such as customer support costs, royalties and license fees, warranty and repair and maintenance expense on the T2Dx that have been placed with customers under reagent rental agreements. |
Research and Development Costs | Research and Development Costs Costs incurred in the research and development of the Company’s product candidates are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including activities associated with performing services under research revenue arrangements, and include salaries and benefits, stock compensation, research‑related facility and overhead costs, laboratory supplies, equipment and contract services. |
Impairment of Long Lived Assets | Impairment of Long Lived Assets The Company reviews long‑lived assets, including capitalized T2 owned instruments and components, for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. During this review, the Company reevaluates the significant assumptions used in determining the original cost and estimated lives of long‑lived assets. Although the assumptions may vary from asset to asset, they generally include operating results, changes in the use of the asset, cash flows and other indicators of value. Management then determines whether the remaining useful life continues to be appropriate or whether there has been an impairment of long‑lived assets based primarily upon whether expected future undiscounted cash flows are sufficient to support the assets’ recovery. If impairment exists, the Company would adjust the carrying value of the asset to fair value, generally determined by a discounted cash flow analysis. No impairment charges have been recorded in any of the periods presented. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non‑owner sources. Comprehensive loss consists of net loss and other comprehensive loss, which includes certain changes in equity that are excluded from net loss. The Company’s comprehensive loss equals reported net loss for all periods presented. |
Stock Based Compensation | Stock-Based Compensation The Company has a stock‑based compensation plan which is more fully described in Note 9. The Company records stock‑based compensation for options granted to employees and to members of the board of directors for their services on the board of directors, based on the grant date fair value of awards issued, and the expense is recorded on a straight‑line basis over the applicable service period, which is generally four years. The Company accounts for non‑employee stock‑based compensation arrangements based upon the fair value of the consideration received or the equity instruments issued, whichever is more reliably measurable. The measurement date for non‑employee awards is generally the date that the performance of services required for the non‑employee award is complete. Stock‑based compensation costs for non‑employee awards is recognized as services are provided, which is generally the vesting period, on a straight‑line basis. The Company records the expense for stock option grants to performance-based milestone vesting using the accelerated attribution method over the remaining service period when management determines that achievement of the milestone is probable. Management evaluates when the achievement of a performance-based milestone is probable based on the relative satisfaction of the performance conditions as of the reporting date. The Company expenses restricted stock awards based on the fair value of the award on the date of issuance, on a straight‑line basis over the associated service period of the award. The Company uses the Black‑Scholes‑Merton option pricing model to determine the fair value of stock options. The use of the Black‑Scholes‑Merton option‑pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, risk‑free interest rates and expected dividend yields of the common stock. The expected term was determined according to the simplified method, which is the average of the vesting tranche dates and the contractual term. Due to the lack of company specific historical and implied volatility data resulting from our limited public market trading history, we have based our estimate of expected volatility primarily on the historical volatility of a group of similar companies that are publicly traded. For these analyses, companies with comparable characteristics are selected, including enterprise value and position within the industry, and with historical share price information sufficient to meet the expected life of the stock‑based awards. The Company computes the historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of its stock‑based awards. The risk‑free interest rate is determined by reference to U.S. Treasury zero‑coupon issues with remaining maturities similar to the expected term of the options. The Company has not paid, and does not anticipate paying, cash dividends on shares of common stock; therefore, the expected dividend yield is assumed to be zero. The Company is required to estimate forfeitures at the time of grant and revise those estimates in subsequent periods if actual forfeitures differ from those estimates. |
Income Taxes | Income Taxes The Company provides for income taxes using the liability method. The Company provides deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. A valuation allowance is provided to reduce the deferred tax assets to the amount that will more likely than not be realized. The Company applies ASC 740 Income Taxes (“ASC 740”) in accounting for uncertainty in income taxes. The Company does not have any material uncertain tax positions for which reserves would be required. The Company will recognize interest and penalties related to uncertain tax positions, if any, in income tax expense. |
Guarantees | Guarantees As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Company’s request in such capacity. The term of the indemnification is for the officer’s or director’s lifetime. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ and officers’ insurance coverage that limits its exposure and enables it to recover a portion of any future amounts paid. The Company leases office, laboratory and manufacturing space under noncancelable operating leases. The Company has standard indemnification arrangements under the leases that require it to indemnify the landlord against all costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from any breach, violation or nonperformance of any covenant or condition of the Company’s leases. In the ordinary course of business, the Company enters into indemnification agreements with certain suppliers and business partners where the Company has certain indemnification obligations limited to the costs, expenses, fines, suits, claims, demands, liabilities and actions directly resulting from the Company’s gross negligence or willful misconduct, and in certain instances, breaches, violations or nonperformance of covenants or conditions under the agreements. As of December 31, 2016 and 2015, the Company had not experienced any material losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing net loss applicable to common stockholders by the weighted‑average number of shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted‑average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury‑stock method. For purposes of the diluted net loss per share calculation, redeemable convertible preferred stock, and warrants to purchase redeemable convertible preferred stock, which were outstanding prior to the Company’s IPO, and stock options and unvested restricted stock are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect, including the related impact to the numerator of the fair value adjustment of the warrants and the impact to the denominator of the warrant shares, would be anti‑dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented. |
Recent Accounting Standards | Recent Accounting Standards From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. Accounting Standards Adopted In 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements – Going Concern (“ASU 2014-15”). ASU 2014-15 provides new guidance on (1) management’s responsibility in evaluating whether or not there is substantial doubt about a company’s ability to continue as a going concern within one year from the date the financial statements are issued each reporting period and (2) related financial statement disclosures. The Company adopted the guidance prescribed by ASU 2014-15 as of December 31, 2016 and the Company concluded that there was not a substantial doubt about its ability to continue as a going concern. The Company faces certain risks and uncertainties, as described in Note 1, “Nature of Business,” that could affect this analysis in the future. In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs (“ASU 2015-03”). This standard amends existing guidance to require the presentation of debt issuance costs in the balance sheet as a deduction from the carrying amount of the related debt liability instead of a deferred charge. It is effective for annual reporting periods beginning after December 15, 2015, but early adoption is permitted. Adoption of ASU 2015-03 is applied retrospectively. The Company adopted ASU 2015-03 as of January 1, 2016, which resulted in a balance sheet reclassification of issuance costs of $22,000 recorded in prepaid expenses and other current assets and $102,000 in other assets to a reduction in the current portion of notes payable and notes payable, net of current portion as of December 31, 2015, respectively. The Company’s adoption of this standard did not have an impact on its consolidated results of operations or cash flows for the calendar year ended December 31, 2016. Accounting Standards Issued, Not Adopted In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments ("ASC 2016-15"), which provides guidance on the classification of certain specific cash flow issues including debt prepayment or extinguishment costs, settlement of certain debt instruments, contingent consideration payments made after a business combination, proceeds from the settlement of certain insurance claims and distributions received from equity method investees. The standard requires the use of a retrospective approach to all periods presented, but may be applied prospectively if retrospective application would be impracticable. The guidance is effective for public entities for fiscal years beginning after December 15, 2017, and interim periods within those years, and early application is permitted. The Company is currently evaluating the impact of its pending adoption of ASU 2016-15 on the Company’s consolidated financial statements. In March 2016, the FASB released ASU No. 2016-09 Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”) which is intended to simplify income tax accounting for excess tax benefits, accounting for forfeitures, and employer statutory withholding. Under the current guidance, excess tax benefits that result from an award vesting or settling are recognized in additional paid-in capital in the period that they reduce cash taxes payable. This requires the provision to be computed on a with and without option basis and may result in net operating loss and credit carryforwards on the balance sheet being less than what is available on the tax return. Under the new guidance, the income tax effects of awards will be recognized as a component of income tax expense when the awards vest or are settled (regardless if cash taxes are reduced). For interim reporting purposes, companies will account for excess tax benefits and tax deficiencies as discrete items in the period during which they occurred. The guidance is effective for public entities for fiscal years beginning after December 15, 2016, and interim periods within those years. Early adoption is permitted, however all of the guidance included in the update must be applied when adopted. The Company must use a modified retrospective transition method for adopting and record the cumulative effect of all unrecognized benefits and any change in valuation allowances at the end of the prior tax period as an adjustment to retained earnings. The Company has not elected to early adopt ASU 2016-09 and is evaluating the new guidance and the expected effect on the Company’s consolidated financial statements. In March 2016, the FASB issued ASU No. 2016-06, Derivatives and Hedging (Topic 815): Contingent Put and Call Options in Debt Instruments (“ASU 2016-06”), which applies to all issuers of or investors in debt instruments with embedded call or put options. ASU 2016-06 clarifies the requirements for assessing whether contingent call or put options that can accelerate the payment of principal on debt instruments are clearly and closely related to their debt hosts. Entities performing the assessment under the guidance of ASU 2016-06 are required to assess the embedded call or put options solely in accordance with the four-step decision process. In addition, ASU 2016-06 clarifies what steps are required when assessing whether the economic characteristics and risks of call or put options are clearly and closely related to the economic characteristics and risks of their debt hosts. ASU 2016-06 is effective for financial statements issued for fiscal years beginning after December 15, 2016 and interim periods within those fiscal years using the modified retrospective method for existing debt instruments. The Company is evaluating the new guidance and the expected effect on the Company’s consolidated financial statements. In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASU 2016-02”), which applies to all leases. Under ASU 2016-02, a right-of-use asset and lease obligation will be recorded for all leases, whether operating or financing leases, while the statement of operations will reflect lease expense for operating leases and amortization and interest expense for financing leases. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018 and interim periods within those years, which is the year ended December 31, 2019 for the Company. Entities are required to use a modified retrospective approach of adoption for leases that exist or are entered into after the beginning of the earliest comparative period in the financial statements. Full retrospective application is prohibited. The Company is evaluating the new guidance and the expected effect on the Company’s consolidated financial statements. In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory (“ASU 2015-11”). The standard simplifies the subsequent measurement of inventory by requiring inventory to be measured at the lower of cost and net realizable value for entities using the first-in-first out method of valuing inventory. ASU 2015-11 eliminates other measures required by current guidance to determine net realizable value. ASU 2015-11 is effective for fiscal years beginning after December 15, 2016 and interim periods within those fiscal years and early adoption is permitted. The Company has not adopted ASU 2015-11 and does not expect the new guidance to have a material effect on its consolidated financial statements. In June 2014, the FASB issued amended guidance, ASU No. 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”), which is applicable to revenue recognition that will now be effective for the Company for the year ending December 31, 2018, as a result of the deferral of the effective date adopted by the FASB in July 2015. The new guidance must be adopted using either a full retrospective approach for all periods presented or a modified retrospective approach. Early adoption prior to the original adoption date of ASU 2014-09 is not permitted. The new guidance applies a more principles-based approach to revenue recognition. The Company currently anticipates adoption of the new standard effective January 1, 2018 under the full retrospective method. The Company’s revenue is primarily comprised of product sales and research services, and the Company is in the process of determining the impact of the new standard on its financial statements. |
Summary of Significant Accoun25
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Summary of Significant Accounting Policies | |
Schedule of inventory | The components of inventory consist of the following (in thousands): December 31, December 31, 2016 2015 Raw materials $ $ Work-in-process Finished goods Total inventories, net $ $ |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Measurements | |
Schedule of financial assets and liabilities at fair value on a recurring basis | The following tables set forth the Company’s financial assets and liabilities carried at fair value categorized using the lowest level of input applicable to each financial instrument as of December 31, 2016 and 2015 (in thousands): Quoted Prices in Active Significant Markets for Other Significant Balance at Identical Observable Unobservable December 31, Assets Inputs Inputs 2016 (Level 1) (Level 2) (Level 3) Assets: Cash $ $ $ — $ — Money market funds — — Restricted cash — — $ $ $ — $ — Quoted Prices in Active Significant Markets for Other Significant Balance at Identical Observable Unobservable December 31, Assets Inputs Inputs 2015 (Level 1) (Level 2) (Level 3) Assets: Cash $ $ $ — $ — Money market funds — — Restricted cash — — $ $ $ — $ — |
Supplemental Balance Sheet In27
Supplemental Balance Sheet Information (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Supplemental Balance Sheet Information. | |
Schedule of property and equipment | Property and equipment consists of the following (in thousands) Estimated Useful December 31, December 31, Life (Years) 2016 2015 Office and computer equipment 3 $ $ Software 3 Laboratory equipment 5 Furniture 5-7 Manufacturing equipment 5 Manufacturing tooling and molds 0.5 T2-owned instruments and components 5 Leasehold improvements Lesser of useful life or lease term Construction in progress n/a Less accumulated depreciation and amortization Property and equipment, net $ $ |
Components of accrued expenses | Accrued expenses consist of the following (in thousands): December 31, December 31, 2016 2015 Accrued payroll and compensation $ $ Accrued research and development expenses Accrued professional services Other accrued expenses Total accrued expenses $ $ |
Notes Payable (Tables)
Notes Payable (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Debt | |
Summary of future principal payments on the notes payable | Future principal payments on the notes payable as of December 31, 2016 are as follows (in thousands): Year ended December 31, 2017 $ 2018 2019 2020 2021 Thereafter Total before unamortized discount and issuance costs Less: paid-in-kind interest Less: unamortized discount and issuance costs Total notes payable $ |
Share Based Compensation (Table
Share Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Stock Based Compensation | |
Summary of stock option activity | The following is a summary of option activity under the Plan (in thousands, except share and per share amounts): Weighted-Average Weighted-Average Remaining Number of Exercise Price Per Contractual Term Aggregate Intrinsic Shares Share (In years) Value Outstanding at December 31, 2015 $ $ Granted Exercised Forfeited Canceled Outstanding at December 31, 2016 Exercisable at December 31, 2016 Vested or expected to vest at December 31, 2016 |
Schedule of estimated assumptions used to calculate weighted-average fair value of options granted | Year ended December 31, 2016 2015 Weighted-average risk-free interest rate % % Expected dividend yield % % Expected volatility % % Expected terms years years |
Summary of restricted stock unit activity | The following is a summary of restricted stock unit activity under the Plan (in thousands, except share and per share amounts): Weighted-Average Number of Grant Date Fair Shares Value Nonvested at December 31, 2015 — $ — Granted Exercised — — Forfeited — — Canceled — — Nonvested at December 31, 2016 |
Schedule of estimated assumptions used to calculate weighted-average fair value of the purchase rights granted | Year ended December 31, 2016 2015 Weighted-average risk-free interest rate % % Expected dividend yield % % Expected volatility % % Expected terms years years |
Summary of stock-based compensation expense for stock options granted that was recorded in the Company's results of operations | The following table summarizes the stock-based compensation expense for stock options granted to employees and non-employees, as well as stock-compensation expense for the 2014 ESPP that was recorded in the Company’s results of operations for the years presented (in thousands): Year ended December 31, 2016 2015 2014 Cost of product revenue $ $ — $ — Research and development Selling, general and administrative Total stock-based compensation expense $ $ $ |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Net Loss Per Share | |
Schedule of basic and diluted net loss per share applicable to common stockholders | The following table presents the calculation of basic and diluted net loss per share applicable to common stockholders (in thousands, except share and per share data): Year ended December 31, 2016 2015 2014 Numerator: Net loss $ $ $ Accretion of redeemable convertible preferred stock to redemption value — — Net loss applicable to common stockholders $ $ $ Denominator: Weighted-average number of common shares outstanding — basic and diluted Net loss per share applicable to common stockholders — basic and diluted $ $ $ |
Schedule of shares excluded from the calculation where the inclusion would be anti-dilutive | Year ended December 31, 2016 2015 2014 Options to purchase common shares Restricted stock units — — Warrants to purchase common stock — — Total |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income Taxes | |
Schedule of reconciliation of the U.S. federal statutory rate to the Company?s effective tax rate | Year Ended December 31, 2016 2015 2014 Tax at statutory rates % % % State income taxes Permanent differences Research and development credits Change in valuation allowance Effective tax rate % % % |
Schedule of Deferred Tax Assets | The significant components of the Company’s deferred tax asset consist of the following at December 31, 2016 and 2015 (in thousands): December 31, 2016 2015 Deferred tax assets: Net operating loss carryforwards $ $ Tax credits Other temporary differences Start-up expenditures Stock option expenses Total deferred tax assets Deferred tax asset valuation allowance Net deferred tax assets Deferred tax liabilities: Prepaid expenses Net deferred taxes $ — $ — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies. | |
Schedule of future minimum lease payments under the Company?s operating leases | Future minimum non-cancelable lease payments under the Company’s operating leases as of December 31, 2016 are as follows (in thousands): Year ending December 31, 2017 $ 2018 2019 2020 2021 Thereafter — $ |
Quarterly Financial Data (una33
Quarterly Financial Data (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Data (unaudited) | |
Schedule of quarterly financial information | Year ended December 31, 2016 (In thousands, except per share data) First Quarter Second Quarter Third Quarter Fourth Quarter Revenue: Product revenue $ $ $ $ Research revenue Total revenue $ $ $ $ Costs and expenses: Cost of product revenue Research and development Selling, general and administrative Total costs and expenses Loss from operations $ $ $ $ Net loss $ $ $ $ Net loss applicable to common shareholders $ $ $ $ Per share data: Net loss per common share—basic and diluted $ $ $ $ Year ended December 31, 2015 (In thousands, except per share data) First Quarter Second Quarter Third Quarter Fourth Quarter Revenue: Product revenue $ $ — $ $ Research revenue Total revenue $ $ $ $ Costs and expenses: Cost of product revenue — Research and development Selling, general and administrative Total costs and expenses Loss from operations $ $ $ $ Net loss $ $ $ $ Net loss applicable to common shareholders $ $ $ $ Per share data: Net loss per common share—basic and diluted $ $ $ $ |
Nature of Business (Details)
Nature of Business (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Cash and cash equivalents | $ 73,488 | $ 73,662 | $ 73,849 | $ 30,198 |
Accumulated deficit | $ (203,689) | $ (148,885) | ||
Period over which cash resources will be sufficient to allow Company to fund current operating plan | 12 months | |||
Equipment Lease Credit Facility | ||||
Remaining borrowing capacity | $ 1,300 |
Summary of Significant Accoun35
Summary of Significant Accounting Policies (Details) | 12 Months Ended | ||
Dec. 31, 2016segment | Dec. 31, 2015item | Dec. 31, 2014item | |
Segment Information | |||
Number of operating segments | segment | 1 | ||
Off Balance Sheet Risk and Concentrations of Credit Risk | |||
Number of financial institutions in which cash was deposited | item | 1 | 1 |
Summary of Significant Accoun36
Summary of Significant Accounting Policies (Credit Risk) (Details) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Customer One | ||
Off Balance Sheet Risk and Concentrations of Credit Risk | ||
Total revenue (as a percent) | 45.00% | 50.00% |
Customer Two | ||
Off Balance Sheet Risk and Concentrations of Credit Risk | ||
Total revenue (as a percent) | 10.00% | 25.00% |
Summary of Significant Accoun37
Summary of Significant Accounting Policies (Inventory) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Inventory | ||
Raw materials | $ 389 | $ 203 |
Work-in-process | 351 | 287 |
Finished goods | 63 | 193 |
Total inventories, net | $ 803 | $ 683 |
Summary of Significant Accoun38
Summary of Significant Accounting Policies Product Service (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Mar. 31, 2015 | Jun. 30, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | |
Product information | ||||||||||
Deferred revenue | $ 2,445,000 | $ 2,146,000 | $ 2,445,000 | $ 2,146,000 | ||||||
Cost of product revenue | 2,171,000 | $ 1,894,000 | $ 1,781,000 | $ 1,026,000 | $ 910,000 | $ 829,000 | $ 1,000 | $ 6,872,000 | $ 1,740,000 | |
Instruments | ||||||||||
Product information | ||||||||||
Maintenance Services period (in years) | 1 year | |||||||||
Additional period for Maintenance Service option (in years) | 1 year | |||||||||
T2Candida | ||||||||||
Product information | ||||||||||
Deferred revenue | 37,000 | $ 149,000 | $ 149,000 | $ 37,000 | ||||||
Cost of product revenue | $ 41,000 | |||||||||
Remaining warranty reserve | $ 3,000 | $ 3,000 |
Summary of Significant Accoun39
Summary of Significant Accounting Policies (Impairment, Stock Based Comp) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Impairment of Long Lived Assets | |||
Impairment charges | $ 0 | $ 0 | $ 0 |
Stock Based Compensation | |||
Vesting period | 4 years | ||
Expected dividend yield | 0.00% |
Summary of Significant Accoun40
Summary of Significant Accounting Policies Recent Accounting Pronouncements (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
New Accounting Pronouncements or Change in Accounting Principle | ||
Prepaid expenses and other current assets | $ 820,000 | $ 838,000 |
Other assets | 281,000 | 358,000 |
Current portion of notes payable | 1,269,000 | 4,449,000 |
Notes payable, net of current portion | 39,504,000 | 26,121,000 |
ASU 2015-03 | Scenario, Adjustment | ||
New Accounting Pronouncements or Change in Accounting Principle | ||
Prepaid expenses and other current assets | (22,000) | |
Current portion of notes payable | $ (22,000) | |
New Accounting Pronouncement, Early Adoption, Effect | ASU 2015-03 | ||
New Accounting Pronouncements or Change in Accounting Principle | ||
Other assets | (102,000) | |
Notes payable, net of current portion | $ (102,000) |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Fair Value Measurements | ||
Transfers of assets from level 1 to 2 | $ 0 | $ 0 |
Fair Value Measurements (Table)
Fair Value Measurements (Table) (Details) - Recurring - Total - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Assets: | ||
Restricted cash | $ 260 | $ 260 |
Total assets | 73,748 | 73,922 |
Cash | ||
Assets: | ||
Cash and cash equivalents | 16,887 | 1,520 |
Money market funds | ||
Assets: | ||
Cash and cash equivalents | 56,601 | 72,142 |
Level I | ||
Assets: | ||
Restricted cash | 260 | 260 |
Total assets | 73,748 | 73,922 |
Level I | Cash | ||
Assets: | ||
Cash and cash equivalents | 16,887 | 1,520 |
Level I | Money market funds | ||
Assets: | ||
Cash and cash equivalents | $ 56,601 | $ 72,142 |
Restricted Cash (Details)
Restricted Cash (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Certificates of deposit | ||
Restricted cash | ||
Security deposit | $ 260,000 | $ 260,000 |
Supplemental Balance Sheet In44
Supplemental Balance Sheet Information - Property and Equipment - (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Property and Equipment | ||
Property and equipment, gross | $ 20,655,000 | $ 15,462,000 |
Accumulated depreciation and amortization | (7,066,000) | (4,807,000) |
Property and equipment, net | 13,589,000 | 10,655,000 |
Office and computer equipment | ||
Property and Equipment | ||
Property and equipment, gross | $ 409,000 | 395,000 |
Estimated useful lives (Years) | 3 years | |
Software | ||
Property and Equipment | ||
Property and equipment, gross | $ 708,000 | 632,000 |
Estimated useful lives (Years) | 3 years | |
Laboratory equipment | ||
Property and Equipment | ||
Property and equipment, gross | $ 4,516,000 | 4,112,000 |
Estimated useful lives (Years) | 5 years | |
Furniture | ||
Property and Equipment | ||
Property and equipment, gross | $ 200,000 | 187,000 |
Furniture | Minimum | ||
Property and Equipment | ||
Estimated useful lives (Years) | 5 years | |
Furniture | Maximum | ||
Property and Equipment | ||
Estimated useful lives (Years) | 7 years | |
Manufacturing equipment | ||
Property and Equipment | ||
Property and equipment, gross | $ 897,000 | 577,000 |
Estimated useful lives (Years) | 5 years | |
Manufacturing tooling and molds | ||
Property and Equipment | ||
Property and equipment, gross | $ 154,000 | 71,000 |
Estimated useful lives (Years) | 6 months | |
T2-owned instruments and components | ||
Property and Equipment | ||
Property and equipment, gross | $ 9,119,000 | 4,960,000 |
Estimated useful lives (Years) | 5 years | |
Leasehold improvements | ||
Property and Equipment | ||
Property and equipment, gross | $ 3,353,000 | 3,332,000 |
Construction in progress | ||
Property and Equipment | ||
Property and equipment, gross | 1,299,000 | 1,196,000 |
T2 Owned Instruments in Service | ||
Property and Equipment | ||
Property and equipment, gross | $ 5,700,000 | |
Estimated useful lives (Years) | 5 years | |
Depreciation expense recorded as a component of cost of product revenue | $ 599,000 | $ 105,000 |
Supplemental Balance Sheet In45
Supplemental Balance Sheet Information - Depreciation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Supplemental Balance Sheet Information | |||
Depreciation and amortization | $ 2,280 | $ 1,465 | $ 691 |
Supplemental Balance Sheet In46
Supplemental Balance Sheet Information - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Accrued expenses | ||
Accrued payroll and compensation | $ 2,479 | $ 2,418 |
Accrued research and development expenses | 846 | 458 |
Accrued professional services | 884 | 542 |
Other accrued expenses | 699 | 744 |
Total accrued expenses | $ 4,908 | $ 4,162 |
Notes Payable - Future principa
Notes Payable - Future principal payments on notes payable (Details) $ in Thousands | Dec. 31, 2016USD ($) |
Future principal payments on the notes payable | |
2,017 | $ 1,286 |
2,018 | 1,485 |
2,019 | 1,015 |
2,020 | 5,723 |
2,021 | 22,893 |
Thereafter | 17,171 |
Total before unamortized discount and issuance costs | 49,573 |
Less: paid-in-kind interest | (5,782) |
Less: unamortized discount and issuance costs | (3,018) |
Total notes payable | $ 40,773 |
Notes Payable (ASU 2015-03) (De
Notes Payable (ASU 2015-03) (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Debt Instrument | ||
Prepaid expenses and other current assets | $ 820,000 | $ 838,000 |
Other assets | 281,000 | 358,000 |
Current portion of notes payable | 1,269,000 | 4,449,000 |
Notes payable, net of current portion | 39,504,000 | 26,121,000 |
New Accounting Pronouncement, Early Adoption, Effect | ASU 2015-03 | ||
Debt Instrument | ||
Other assets | (102,000) | |
Notes payable, net of current portion | $ (102,000) | |
Scenario, Adjustment | ASU 2015-03 | ||
Debt Instrument | ||
Prepaid expenses and other current assets | (22,000) | |
Current portion of notes payable | $ (22,000) |
Notes Payable - Term Loan (Deta
Notes Payable - Term Loan (Details) | 1 Months Ended | 12 Months Ended | 30 Months Ended | |||||
Dec. 31, 2016USD ($)item$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 30, 2016USD ($) | Jul. 11, 2014USD ($) | May 31, 2011USD ($) | |
Debt Instrument | ||||||||
Proceeds from notes payable, net of issuance costs | $ 43,803,000 | $ 10,000,000 | $ 19,714,000 | |||||
Repayments of notes payable | $ 32,404,000 | $ 309,000 | $ 4,037,000 | |||||
Term Loan Agreement | ||||||||
Debt Instrument | ||||||||
Proceeds from issuance of debt | $ 40,000,000 | |||||||
Increase in additional borrowing capacity | $ 10,000,000 | |||||||
Debt term | 6 years | |||||||
Debt term of interest only payments | 3 years | |||||||
Debt extended term of interest only payments | 4 years | |||||||
Final fee as a percentage of the principal outstanding | 8.00% | 8.00% | 8.00% | |||||
Prepayment fee term | 5 years | |||||||
Prepayment fee after first five years of the term | $ 0 | $ 0 | $ 0 | |||||
Additional interest rate, event of default (as a percent) | 4.00% | 4.00% | 4.00% | |||||
Proceeds from notes payable, net of issuance costs | $ 39,200,000 | |||||||
Portion of proceeds used for debt repayment | $ 28,000,000 | |||||||
Term Loan Agreement | Prior to Approval Milestone | ||||||||
Debt Instrument | ||||||||
Annual fixed rate (as a percent) | 12.50% | 12.50% | 12.50% | |||||
Deferred interest rate (as a percent) | 4.00% | |||||||
Term Loan Agreement | Following Approval Milestone | ||||||||
Debt Instrument | ||||||||
Annual fixed rate (as a percent) | 11.50% | 11.50% | 11.50% | |||||
Deferred interest rate (as a percent) | 3.50% | |||||||
Term Loan Agreement | Common Stock Warrant | ||||||||
Debt Instrument | ||||||||
Number of separate warrants | item | 4 | |||||||
Number of shares issuable for warrants outstanding | shares | 528,958 | 528,958 | 528,958 | |||||
Exercise price (in dollars per share) | $ / shares | $ 8.06 | $ 8.06 | $ 8.06 | |||||
Fair market value of warrants | $ 1,800,000 | $ 1,800,000 | $ 1,800,000 | $ 1,800,000 | ||||
Loan and Security Agreement | ||||||||
Debt Instrument | ||||||||
Maximum borrowings available | $ 30,000,000 | |||||||
Proceeds from notes payable, net of issuance costs | $ 29,700,000 | |||||||
Repayments of notes payable | 27,500,000 | |||||||
Promissory Note | ||||||||
Debt Instrument | ||||||||
Maximum borrowings available | $ 1,700,000 | |||||||
Annual fixed rate (as a percent) | 6.50% | |||||||
Repayments of notes payable | $ 479,000 |
Notes Payable (Equipment Lease)
Notes Payable (Equipment Lease) (Details) - Equipment Lease Credit Facility | 1 Months Ended | ||
Jun. 30, 2016USD ($)item | Apr. 30, 2016USD ($) | Oct. 31, 2015USD ($) | |
Capital lease obligation | |||
Maximum borrowings available | $ 10,000,000 | ||
Maximum capped amount | $ 5,000,000 | ||
Debt term | 36 months | ||
Repurchase price as percentage of original equipment value that the equipment under lease may be repurchased by lessee | 10.00% | ||
Number of draws | item | 2 | ||
Minimum | |||
Capital lease obligation | |||
Renewal term (in years) | 1 year | ||
First Draw | |||
Capital lease obligation | |||
Amount of draw | $ 2,100,000 | ||
Amount of monthly payment | $ 67,000 | ||
Second Draw | |||
Capital lease obligation | |||
Amount of draw | $ 2,500,000 | ||
Amount of monthly payment | $ 79,000 |
Notes Payable - Loan and Securi
Notes Payable - Loan and Security Agreement (Details) | Dec. 28, 2015USD ($) | Jul. 11, 2014USD ($)trancheLender | Dec. 31, 2016USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2016 | Dec. 31, 2016USD ($) | May 31, 2015USD ($) |
Debt Instrument | |||||||||
Proceeds from notes payable, net of issuance costs | $ 43,803,000 | $ 10,000,000 | $ 19,714,000 | ||||||
Repayments of notes payable | $ 32,404,000 | $ 309,000 | 4,037,000 | ||||||
Loan and Security Agreement | |||||||||
Debt Instrument | |||||||||
Number of lenders | Lender | 2 | ||||||||
Maximum borrowings available | $ 30,000,000 | ||||||||
Number of tranches | tranche | 2 | ||||||||
Final fee as a percentage of original principal amount of amounts borrowed | 4.75% | ||||||||
Minimum amount of denomination for prepayment of borrowings | $ 1,000,000 | ||||||||
Effective interest rate (as a percent) | 9.70% | 9.70% | 9.70% | 9.70% | |||||
Proceeds from notes payable, net of issuance costs | $ 29,700,000 | ||||||||
Repayments of notes payable | $ 27,500,000 | ||||||||
Loan and Security Agreement | Prior to second anniversary and after first anniversary of borrowing date | |||||||||
Debt Instrument | |||||||||
Prepayment premium (as a percent) | 1.00% | ||||||||
Loan and Security Agreement | Prior to maturity date and after second anniversary of borrowing date | |||||||||
Debt Instrument | |||||||||
Prepayment premium (as a percent) | 0.50% | ||||||||
Loan and Security Agreement | One-month LIBOR | |||||||||
Debt Instrument | |||||||||
Basis spread (as a percent) | 7.05% | ||||||||
Loan and Security Agreement | Tranche A | |||||||||
Debt Instrument | |||||||||
Maximum borrowings available | $ 20,000,000 | ||||||||
Minimum amount of draw upon closing | 10,000,000 | ||||||||
Minimum amount of draw after closing | 5,000,000 | ||||||||
Proceeds from issuance of debt | $ 20,000,000 | ||||||||
Loan and Security Agreement | Tranche B | |||||||||
Debt Instrument | |||||||||
Maximum borrowings available | $ 10,000,000 | $ 10,000,000 | |||||||
Proceeds from issuance of debt | $ 10,000,000 | ||||||||
Commitment fee on undrawn principal (as a percent) | 1.00% | ||||||||
Fee Amount | $ 50,000 |
Notes Payable - Promissory Note
Notes Payable - Promissory Note (Details) - USD ($) | 1 Months Ended | 12 Months Ended | 68 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2016 | May 31, 2011 | |
Debt Instrument | ||||||
Repayments of notes payable | $ 32,404,000 | $ 309,000 | $ 4,037,000 | |||
Promissory Note | ||||||
Debt Instrument | ||||||
Maximum borrowings available | $ 1,700,000 | |||||
Stated interest rate (as a percent) | 6.50% | |||||
Minimum cash balance | $ 300,000 | |||||
Proceeds received on borrowings | $ 1,400,000 | |||||
Repayments of notes payable | $ 479,000 |
Notes Payable (Interest Expense
Notes Payable (Interest Expense) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Interest expense | |||
Interest expense | $ 4,100,000 | $ 2,000,000 | $ 741,000 |
Non-cash interest | 564,000 | $ 354,000 | $ 112,000 |
Extinguishment of debt | $ 112,000 |
Redeemable Convertible Prefer54
Redeemable Convertible Preferred Stock (Details) - USD ($) $ in Thousands | Aug. 12, 2014 | Dec. 31, 2014 |
Conversion of convertible preferred stock into common stock | $ 117,400 | |
Conversion of redeemable convertible preferred stock into common stock | $ 117,383 | |
Common Stock | ||
Conversion of redeemable convertible preferred stock into common stock (in shares) | 12,516,298 | 12,516,298 |
Conversion of redeemable convertible preferred stock into common stock | $ 13 | |
Accumulated Deficit | ||
Conversion of redeemable convertible preferred stock into common stock | $ 21,000 | 21,029 |
Additional Paid-in Capital | ||
Conversion of redeemable convertible preferred stock into common stock | $ 96,300 | $ 96,341 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | 12 Months Ended |
Dec. 31, 2016itemshares | |
IPO | |
Number of voting rights per share of common stock | item | 1 |
2014 Incentive Award Plan | |
IPO | |
Common stock were reserved for issuance | 4,042,627 |
2014 Employee Stock Purchase Plan | |
IPO | |
Common stock were reserved for issuance | 357,798 |
Stockholders' Equity - Private
Stockholders' Equity - Private Investment (Details) - USD ($) $ / shares in Units, $ in Thousands | Sep. 21, 2016 | Dec. 31, 2016 |
Stock Purchase Agreement | ||
Proceeds from private investment in public equity | $ 39,723 | |
Stock sale agreement | Private Placement | ||
Stock Purchase Agreement | ||
Number of shares sold | 6,055,341 | |
Sale price of stock (in dollars per share) | $ 6.56 | |
Proceeds from private investment in public equity | $ 39,700 | |
Ownership percentage (as a percent) | 19.90% |
Stock Based Compensation (Stock
Stock Based Compensation (Stock Options) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Share-Based Compensation | |||
Vesting period | 4 years | ||
Stock Options | |||
Share-Based Compensation | |||
Aggregate fair value of options granted | $ 7,000 | $ 10,100 | $ 6,000 |
Number of Shares | |||
Outstanding, beginning of the period (in shares) | 3,484,298 | ||
Granted (in shares) | 1,489,384 | ||
Exercised (in shares) | (165,803) | ||
Forfeited (in shares) | (664,303) | ||
Canceled (in shares) | (100,949) | ||
Outstanding, end of the period (in shares) | 4,042,627 | 3,484,298 | |
Exercisable (in shares) | 2,251,925 | ||
Vested or expected to vest (in shares) | 3,845,455 | ||
Weighted Average Exercise Price Per Share | |||
Outstanding, beginning of the period (in dollars per share) | $ 8.79 | ||
Granted (in dollars per share) | 8.35 | ||
Exercised (in dollars per share) | 2.84 | ||
Forfeited (in dollars per share) | 11.55 | ||
Cancelled (in dollars per share) | 17.38 | ||
Outstanding, end of the period (in dollars per share) | 8.20 | $ 8.79 | |
Exercisable (in dollars per share) | 6.77 | ||
Vested or expected to vest (in dollars per share) | $ 8.12 | ||
Weighted-Average Remaining Contractual Term (in years) | |||
Outstanding (in years) | 7 years 18 days | 7 years 7 months 21 days | |
Exercisable (in years) | 5 years 7 months 10 days | ||
Vested or expected to vest (in years) | 6 years 11 months 12 days | ||
Aggregate Intrinsic Value | |||
Outstanding, beginning of the period | $ 14,620 | ||
Exercised | 930 | ||
Outstanding, end of the period | 4,091 | $ 14,620 | |
Exercisable | 3,922 | ||
Vested or expected to vest | $ 4,084 | ||
Weighted-average fair values of options | |||
Weighted average fair value of options granted (in dollars per share) | $ 4.68 | $ 8.42 | $ 7.59 |
Fair value assumptions | |||
Weighted-average risk-free interest rate | 1.42% | 1.69% | |
Expected dividend yield | 0.00% | 0.00% | |
Expected volatility | 61.00% | 56.00% | |
Expected terms | 6 years | 6 years | |
Stock options | |||
Fair value of stock options vested | $ 4,900 | $ 4,000 | $ 1,200 |
Unrecognized compensation cost | |||
Total unrecognized compensation costs related to non-vested stock options | $ 8,800 | ||
Remaining weighted-average period that unrecognized compensation costs are expected to be recognized | 2 years 6 months 15 days | ||
Performance-based awards | |||
Number of Shares | |||
Granted (in shares) | 166,066 | ||
Forfeited (in shares) | (20,000) | ||
Outstanding, end of the period (in shares) | 146,066 | ||
2006 Stock Incentive Plan | Maximum | Stock Options | |||
Share-Based Compensation | |||
Expiration Period | 10 years | ||
Vesting period | 4 years | ||
2014 Stock Incentive Plan | Stock Options | |||
Share-Based Compensation | |||
Common stock were reserved for issuance | 823,529 | ||
Percentage of common shares outstanding | 4.00% | ||
Shares available for grant | 223,397 | ||
2014 Stock Incentive Plan | Maximum | Stock Options | |||
Share-Based Compensation | |||
Expiration Period | 10 years | ||
Vesting period | 4 years |
Stock Based Compensation (Restr
Stock Based Compensation (Restricted Stock) (Details) - Restricted Stock Units $ / shares in Units, $ in Millions | 12 Months Ended |
Dec. 31, 2016USD ($)$ / sharesshares | |
Share-Based Compensation | |
Aggregate fair value of restricted stock units granted (in dollars) | $ | $ 1.4 |
Number of Shares | |
Nonvested at beginning of period (in shares) | |
Granted (in shares) | 272,195 |
Nonvested at end of period (in shares) | 272,195 |
Weighted-Average Grant Date Fair Value | |
Nonvested at beginning of period (in dollars per share) | $ / shares | |
Granted (in dollars per share) | $ / shares | 5.83 |
Nonvested at end of period (in dollars per share) | $ / shares | $ 5.83 |
Restricted Stock Units | |
Vested (in shares) | 0 |
Unrecognized compensation cost | |
Unrecognized compensation cost (in dollars) | $ | $ 1.4 |
Remaining weighted-average period that unrecognized compensation costs are expected to be recognized | 1 year 11 months 1 day |
Stock Based Compensation (Emplo
Stock Based Compensation (Employee Stock Purchase Plan) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Share-Based Compensation | |||
Stock-based compensation expense | $ 4,730,000 | $ 4,053,000 | $ 1,653,000 |
Employee Stock Purchase Plan | |||
Share-Based Compensation | |||
Percentage of full share price paid in purchase of common stock | 85.00% | ||
Maximum amount of annual employee common stock purchases | $ 25,000 | ||
Stock-based compensation expense | $ 253,000 | $ 233,000 | $ 103,000 |
Fair value assumptions | |||
Weighted-average risk-free interest rate | 0.50% | 0.19% | |
Expected dividend yield | 0.00% | 0.00% | |
Expected volatility | 67.00% | 57.00% | |
Expected terms | 6 months | 6 months | |
Employee Stock Purchase Plan | |||
Shares available for authorization | 220,588 | ||
Percentage of common shares outstanding | 1.00% | ||
Shares available for grant | 134,401 |
Stock Based Compensation (Sto60
Stock Based Compensation (Stock Based Compensation Expense) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Stock-based compensation expense | |||
Stock-based compensation expense | $ 4,730,000 | $ 4,053,000 | $ 1,653,000 |
T2 Owned Instruments in Service | |||
Stock-based compensation expense | |||
Stock-based compensation expense | 118,000 | 115,000 | |
Cost of product revenue | |||
Stock-based compensation expense | |||
Stock-based compensation expense | 123,000 | ||
Research and development | |||
Stock-based compensation expense | |||
Stock-based compensation expense | 1,127,000 | 1,213,000 | 501,000 |
Selling, general and administrative | |||
Stock-based compensation expense | |||
Stock-based compensation expense | $ 3,480,000 | $ 2,840,000 | $ 1,152,000 |
Warrants (Details)
Warrants (Details) $ / shares in Units, $ in Millions | Aug. 12, 2014shares | Dec. 31, 2016USD ($)item$ / sharesshares | Dec. 31, 2014shares | Dec. 30, 2016USD ($) | Aug. 11, 2014shares |
Common Stock | |||||
Warrants | |||||
Issuance of common stock upon net settlement of warrants to purchase redeemable convertible preferred stock (in shares) | 68,700 | ||||
Common Stock | IPO | |||||
Warrants | |||||
Issuance of common stock upon net settlement of warrants to purchase redeemable convertible preferred stock (in shares) | 68,700 | ||||
Common Stock Warrant | Term Loan Agreement | |||||
Warrants | |||||
Number of separate warrants | item | 4 | ||||
Number of shares issuable for warrants outstanding | 528,958 | ||||
Exercise price (in dollars per share) | $ / shares | $ 8.06 | ||||
Fair market value of warrants | $ | $ 1.8 | $ 1.8 | |||
Preferred Stock Warrant | |||||
Warrants | |||||
Number of shares issuable for warrants outstanding | 250,727 |
Net Loss Per Share (Calc of Bas
Net Loss Per Share (Calc of Basic and Diluted) (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 | |
Numerator: | |||||||||||
Net loss | $ (14,549) | $ (12,783) | $ (14,046) | $ (13,426) | $ (12,032) | $ (11,644) | $ (10,995) | $ (10,619) | $ (54,804) | $ (45,290) | $ (31,390) |
Accretion of redeemable convertible preferred stock to redemption value | (4,570) | ||||||||||
Net loss applicable to common stockholders | $ (14,549) | $ (12,783) | $ (14,046) | $ (13,426) | $ (12,032) | $ (11,644) | $ (10,995) | $ (10,619) | $ (54,804) | $ (45,290) | $ (35,960) |
Denominator: | |||||||||||
Weighted-average number of common shares outstanding - basic and diluted | 26,015,751 | 20,501,748 | 8,674,931 | ||||||||
Net loss per common share - basic and diluted (in dollars per share) | $ (0.48) | $ (0.51) | $ (0.58) | $ (0.55) | $ (0.56) | $ (0.57) | $ (0.54) | $ (0.53) | $ (2.11) | $ (2.21) | $ (4.15) |
Net Loss Per Share (Antidiluted
Net Loss Per Share (Antidiluted) (Details) - shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Stock Options | |||
Antidilutive Securities | |||
Anti-dilutive securities excluded from the computation of diluted net loss per share (in shares) | 4,042,627 | 3,484,298 | 2,911,146 |
Restricted Stock Units | |||
Antidilutive Securities | |||
Anti-dilutive securities excluded from the computation of diluted net loss per share (in shares) | 272,195 | ||
Warrants | |||
Antidilutive Securities | |||
Anti-dilutive securities excluded from the computation of diluted net loss per share (in shares) | 528,958 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Effective Income Tax Rate Reconciliation, Percent. | |||
Tax at statutory rates | 35.00% | 35.00% | 35.00% |
State income taxes | 5.20% | 6.60% | 5.10% |
Permanent differences | (1.20%) | (1.30%) | (0.80%) |
Research and development credits | 1.30% | 1.50% | 1.90% |
Change in valuation allowance | (40.30%) | (41.80%) | (41.20%) |
Effective tax rate | 0.00% | 0.00% | 0.00% |
Deferred tax assets: | |||
Net operating loss carryforwards | $ 69,411 | $ 49,417 | |
Tax credits | 5,269 | 4,107 | |
Other temporary differences | 1,636 | 1,623 | |
Startup expenditures | 5,088 | 5,288 | |
Stock option expenses | 2,779 | 1,649 | |
Total deferred tax assets | 84,183 | 62,084 | |
Deferred tax asset valuation allowance | (83,924) | (61,813) | |
Net deferred tax assets | 259 | 271 | |
Deferred tax liabilities: | |||
Prepaid expenses | $ (259) | $ (271) |
Income Taxes (Valuation Allowan
Income Taxes (Valuation Allowance) (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Taxes | |||
Increase in valuation allowance | $ 22.1 | $ 18.9 | $ 12.7 |
Income Taxes (NOL and Credit) (
Income Taxes (NOL and Credit) (Details) | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Federal | |
Net operating losses | $ 174,900,000 |
Tax benefits from the exercise of stock options | 626,000 |
State | |
Net operating losses | 162,100,000 |
Tax benefits from the exercise of stock options | 2,900,000 |
Research and Development. | Federal | |
Credit carryforward | 3,500,000 |
Research and Development. | State | |
Credit carryforward | $ 2,800,000 |
Income Taxes (Unrecognized) (De
Income Taxes (Unrecognized) (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Income Taxes | ||
Unrecognized tax benefits | $ 0 | |
Accrued interest or penalties related to uncertain tax positions | $ 0 | $ 0 |
Commitments and Contingencies68
Commitments and Contingencies (Details) - USD ($) | 1 Months Ended | ||||
Nov. 30, 2014 | May 31, 2013 | Aug. 31, 2010 | May 31, 2015 | Jan. 01, 2011 | |
Operating lease entered into August 2010 | Office and laboratory space | |||||
Leases | |||||
Term of lease | 5 years | ||||
Security deposit | $ 240,000 | $ 400,000 | |||
Operating lease entered into May 2013 | Office, laboratory and manufacturing space | |||||
Leases | |||||
Term of lease | 2 years | ||||
Operating lease entered into November 2014 | Laboratory Space | |||||
Leases | |||||
Term of lease | 6 years | ||||
Security deposit | $ 281,000 | ||||
Space build-out costs paid | 1,400,000 | ||||
Space build-out costs to be paid by landlord | $ 2,200,000 | ||||
License Agreement | Operating lease entered into November 2014 | Office Space | |||||
Leases | |||||
Term of lease | 2 years | ||||
Security deposit | $ 50,000 |
Commitments and Contingencies69
Commitments and Contingencies (Future Minimum Lease Payments) (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Mar. 07, 2017 | |
Future minimum lease payments | ||||
2,017 | $ 2,079,000 | $ 2,100,000 | ||
2,018 | 404,000 | 1,700,000 | ||
2,019 | 414,000 | 1,800,000 | ||
2,020 | 425,000 | 1,900,000 | ||
2,021 | 107,000 | $ 1,600,000 | ||
Total | 3,429,000 | |||
Rent | ||||
Rent expenses | $ 1,800,000 | $ 1,600,000 | $ 950,000 |
Commitments and Contingencies70
Commitments and Contingencies (License Agreement) (Details) - License Agreement - USD ($) | 12 Months Ended | 24 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2007 | Dec. 31, 2006 | |
License Agreement | |||||
Payment of license fees and reimbursed patent costs | $ 31,000 | $ 34,000 | $ 345,000 | ||
Shares issued | 84,678 | ||||
Amount receivable for achievement of regulatory milestones | $ 300,000 | ||||
Minimum | |||||
License Agreement | |||||
Annual license fee payable | $ 5,000 | ||||
Maximum | |||||
License Agreement | |||||
Annual license fee payable | $ 25,000 |
401(k) Savings Plan (Details)
401(k) Savings Plan (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
401(k) Savings Plan | |||
Contributions to 401 (k) plan at the discretion of the board | $ 237,000 | $ 0 | $ 0 |
Co-Development Agreements (Deta
Co-Development Agreements (Details) $ in Thousands | Nov. 01, 2016USD ($)item | Sep. 21, 2016USD ($) | Oct. 31, 2015USD ($) | Feb. 03, 2015USD ($)item | Dec. 31, 2016USD ($)item | Sep. 30, 2016USD ($) | Jun. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Sep. 30, 2015USD ($) | Jun. 30, 2015USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2016USD ($)item | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) |
Co-Development Agreements | |||||||||||||||
Proceeds from private investment in public equity | $ 39,723 | ||||||||||||||
Revenues | $ 910 | $ 1,084 | $ 990 | $ 1,096 | $ 1,011 | $ 1,049 | $ 564 | $ 189 | 4,080 | $ 2,813 | $ 119 | ||||
Investor | Stock sale agreement | Canon U.S. Life Sciences Inc. | |||||||||||||||
Co-Development Agreements | |||||||||||||||
Proceeds from private investment in public equity | $ 39,700 | ||||||||||||||
Ownership percentage (as a percent) | 19.90% | ||||||||||||||
Co Development Partnership Agreement | Canon U.S. Life Sciences Inc. | |||||||||||||||
Co-Development Agreements | |||||||||||||||
Upfront payment | $ 2,000 | ||||||||||||||
Additional consideration receivable upon achievement of certain development and regulatory milestones | 6,500 | ||||||||||||||
Aggregate consideration receivable | $ 8,500 | ||||||||||||||
Proceeds received for achievement of milestone | $ 1,500 | ||||||||||||||
Consideration eligible to receive upon achievement of specified technical requirement related to the achievement of the milestone | $ 5,000 | $ 5,000 | |||||||||||||
Number of milestone payments | item | 2 | 2 | |||||||||||||
Additional consideration receivable upon achievement of development and regulatory milestones, payment one | $ 2,000 | $ 2,000 | |||||||||||||
Additional consideration receivable upon achievement of development and regulatory milestones, payment two | $ 3,000 | 3,000 | |||||||||||||
Number of units | item | 1 | ||||||||||||||
Revenues | $ 1,800 | $ 1,400 | |||||||||||||
Co-Development, Collaboration and Co-Marketing Agreement | Allergan Sales, LLC | |||||||||||||||
Co-Development Agreements | |||||||||||||||
Upfront payment | $ 2,000 | ||||||||||||||
Number of units | item | 2 | ||||||||||||||
Number of additional bacteria species added to existing product candidate | item | 1 | ||||||||||||||
Period entity expects to record revenue | 2 years | ||||||||||||||
Maximum | Co-Development, Collaboration and Co-Marketing Agreement | Allergan Sales, LLC | |||||||||||||||
Co-Development Agreements | |||||||||||||||
Additional consideration receivable upon achievement of certain development and regulatory milestones | $ 4,000 |
Quarterly Financial Data (una73
Quarterly Financial Data (unaudited) (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 | |
Revenue: | |||||||||||
Product revenue | $ 579 | $ 580 | $ 151 | $ 437 | $ 343 | $ 245 | $ 11 | $ 1,747 | $ 599 | ||
Research revenue | 331 | 504 | 839 | 659 | 668 | 804 | $ 564 | 178 | 2,333 | 2,214 | $ 119 |
Total revenue | 910 | 1,084 | 990 | 1,096 | 1,011 | 1,049 | 564 | 189 | 4,080 | 2,813 | 119 |
Costs and expenses: | |||||||||||
Cost of product revenue | 2,171 | 1,894 | 1,781 | 1,026 | 910 | 829 | 1 | 6,872 | 1,740 | ||
Research and development | 5,851 | 5,200 | 6,369 | 6,589 | 6,638 | 6,204 | 6,651 | 5,869 | 24,009 | 25,362 | 19,782 |
Selling, general and administrative | 5,795 | 5,935 | 6,143 | 6,204 | 5,008 | 5,181 | 4,437 | 4,468 | 24,077 | 19,094 | 11,018 |
Total costs and expenses | 13,817 | 13,029 | 14,293 | 13,819 | 12,556 | 12,214 | 11,088 | 10,338 | 54,958 | 46,196 | 30,800 |
Loss from operations | (12,907) | (11,945) | (13,303) | (12,723) | (11,545) | (11,165) | (10,524) | (10,149) | (50,878) | (43,383) | (30,681) |
Net loss | (14,549) | (12,783) | (14,046) | (13,426) | (12,032) | (11,644) | (10,995) | (10,619) | (54,804) | (45,290) | (31,390) |
Net loss applicable to common shareholders | $ (14,549) | $ (12,783) | $ (14,046) | $ (13,426) | $ (12,032) | $ (11,644) | $ (10,995) | $ (10,619) | $ (54,804) | $ (45,290) | $ (35,960) |
Per share data: | |||||||||||
Net loss per common share - basic and diluted (in dollars per share) | $ (0.48) | $ (0.51) | $ (0.58) | $ (0.55) | $ (0.56) | $ (0.57) | $ (0.54) | $ (0.53) | $ (2.11) | $ (2.21) | $ (4.15) |