Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | May 07, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | TTOO | |
Entity Registrant Name | T2 Biosystems, Inc. | |
Entity Central Index Key | 0001492674 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-36571 | |
Entity Tax Identification Number | 20-4827488 | |
Entity Address, Address Line One | 101 Hartwell Avenue | |
Entity Address, City or Town | Lexington | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02421 | |
City Area Code | 781 | |
Local Phone Number | 761-4646 | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common Stock, par value $0.001 | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Common Stock, Shares Outstanding | 119,172,630 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 36,323 | $ 11,033 |
Accounts receivable | 2,454 | 2,825 |
Inventories | 3,275 | 3,599 |
Prepaid expenses and other current assets | 1,716 | 1,438 |
Total current assets | 43,768 | 18,895 |
Property and equipment, net | 4,232 | 5,845 |
Operating lease right-of-use assets | 2,966 | 3,360 |
Restricted cash | 180 | 180 |
Other assets | 206 | 206 |
Total assets | 51,352 | 28,486 |
Current liabilities: | ||
Notes payable | 43,400 | 42,902 |
Accounts payable | 1,686 | 3,753 |
Accrued expenses and other current liabilities | 10,029 | 11,207 |
Derivative liability | 2,314 | 2,425 |
Deferred revenue | 238 | 285 |
Total current liabilities | 57,667 | 60,572 |
Operating lease liabilities, net of current portion | 1,350 | 1,873 |
Deferred revenue, net of current portion | 32 | 46 |
Commitments and contingencies (see Note 13) | ||
Stockholders’ deficit: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2020 and December 31, 2019 | ||
Common stock, $0.001 par value; 200,000,000 shares authorized; 119,172,630 and 50,651,535 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 119 | 51 |
Additional paid-in capital | 383,310 | 342,121 |
Accumulated deficit | (391,126) | (376,177) |
Total stockholders’ deficit | (7,697) | (34,005) |
Total liabilities and stockholders’ deficit | $ 51,352 | $ 28,486 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Statement Of Financial Position [Abstract] | ||
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 | 119,172,630 | 50,651,535 |
Common stock, shares outstanding | 119,172,630 | 50,651,535 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Revenue: | ||
Total revenue | $ 2,545 | $ 1,785 |
Costs and expenses: | ||
Research and development | 4,938 | 3,901 |
Selling, general and administrative | 6,497 | 7,055 |
Total costs and expenses | 16,106 | 15,344 |
Loss from operations | (13,561) | (13,559) |
Interest expense, net | (1,417) | (1,782) |
Other income, net | 29 | 194 |
Net loss and comprehensive loss | $ (14,949) | $ (15,147) |
Net loss per share — basic and diluted | $ (0.22) | $ (0.34) |
Weighted-average number of common shares used in computing net loss per share — basic and diluted | 68,637,322 | 44,282,345 |
Product [Member] | ||
Revenue: | ||
Total revenue | $ 1,045 | $ 1,314 |
Costs and expenses: | ||
Cost of product revenue | 4,671 | 4,388 |
Research [Member] | ||
Revenue: | ||
Total revenue | 142 | |
Contribution [Member] | ||
Revenue: | ||
Total revenue | $ 1,500 | $ 329 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements Stockholders' (Deficit) Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2018 | $ 11,387 | $ 44 | $ 328,514 | $ (317,171) |
Balance (in shares) at Dec. 31, 2018 | 44,175,441 | |||
Stock-based compensation expense | 2,033 | 2,033 | ||
Issuance of common stock from vesting of restricted stock, exercise of stock options and employee stock purchase plan (in shares) | 163,802 | |||
Change in fair value of warrants upon modification | 147 | 147 | ||
Net loss | (15,147) | (15,147) | ||
Balance at Mar. 31, 2019 | (1,580) | $ 44 | 330,694 | (332,318) |
Balance (in shares) at Mar. 31, 2019 | 44,339,243 | |||
Balance at Dec. 31, 2019 | $ (34,005) | $ 51 | 342,121 | (376,177) |
Balance (in shares) at Dec. 31, 2019 | 50,651,535 | 50,651,535 | ||
Stock-based compensation expense | $ 1,160 | 1,160 | ||
Issuance of common stock from vesting of restricted stock, exercise of stock options and employee stock purchase plan (in shares) | 370,417 | |||
Issuance of common stock from secondary offering, net | 40,097 | $ 68 | 40,029 | |
Issuance of common stock from secondary offering, net (in shares) | 68,150,678 | |||
Net loss | (14,949) | (14,949) | ||
Balance at Mar. 31, 2020 | $ (7,697) | $ 119 | $ 383,310 | $ (391,126) |
Balance (in shares) at Mar. 31, 2020 | 119,172,630 | 119,172,630 |
Condensed Consolidated Statem_3
Condensed Consolidated Statement of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Cash flows from operating activities | ||
Net loss | $ (14,949) | $ (15,147) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 503 | 557 |
Non-cash lease expense | 394 | 342 |
Stock-based compensation expense | 1,160 | 2,033 |
Change in fair value of derivative instrument | (111) | 83 |
Impairment of property and equipment | 629 | |
Non-cash interest expense | 621 | 568 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 371 | 13 |
Prepaid expenses and other assets | (278) | (401) |
Inventories | 845 | (141) |
Accounts payable | (2,021) | (126) |
Accrued expenses and other liabilities | (1,265) | 118 |
Deferred revenue | (61) | (31) |
Operating lease liabilities | (578) | (735) |
Net cash used in operating activities | (14,740) | (12,867) |
Cash flows from investing activities | ||
Purchases and manufacture of property and equipment | (67) | (194) |
Net cash used in investing activities | (67) | (194) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock in public offering, net of offering costs | 40,097 | |
Principal repayments of finance leases | (344) | |
Net cash provided by (used in) financing activities | 40,097 | (344) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 25,290 | (13,405) |
Cash, cash equivalents and restricted cash at beginning of period | 11,213 | 50,985 |
Cash, cash equivalents and restricted cash at end of period | 36,503 | 37,580 |
Supplemental disclosures of cash flow information | ||
Cash paid for interest | 906 | 1,131 |
Supplemental disclosures of noncash activities | ||
Transfer of T2 owned instruments and components to (from) inventory | 521 | (154) |
Change in fair value of warrants issued and modified | 147 | |
Right-of-use assets obtained in exchange for new operating lease liabilities | 4,805 | |
Purchases of property and equipment included in accounts payable and accrued expenses | $ 50 | $ 56 |
Condensed Consolidated Statem_4
Condensed Consolidated Statement of Cash Flows (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2018 |
Reconciliation of cash, cash equivalents and restricted cash at end of period | ||||
Cash and cash equivalents | $ 36,323 | $ 11,033 | ||
Restricted cash | 180 | 180 | ||
Total cash, cash equivalents and restricted cash | $ 36,503 | $ 11,213 | $ 37,580 | $ 50,985 |
Nature of Business
Nature of Business | 3 Months Ended |
Mar. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of Business | 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 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 and Going Concern At March 31, 2020, the Company had cash and cash equivalents of $36.3 million, an accumulated deficit of $391.1 million, a stockholders’ deficit of $7.7 million, and has experienced cash outflows from operating activities over the past years. 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 public offering, its September 2016 private investment in public equity (“PIPE”) financing, its September 2017 public offering, its June 2018 public offering, its July 2019 establishment of an Equity Distribution Agreement and Equity Purchase Agreement, 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. The COVID-19 pandemic may impact operations. The Company has established protocols for continued manufacturing, distribution and servicing of its products with safe social distancing and personal protective equipment measures and for remote work for employees not essential to on-site operations. To date these measures have been successful but may not continue to function should the pandemic escalate and impact personnel. The Company’s hospital customers have restricted the sales team’s access to their facilities and as a result, the Company significantly reduced its sales and general and administrative staffing levels to reduce expenses. The Company’s customers may reduce their purchases of products. C ustomers may cease to comply with the terms of sales agreements and this may impact the ability to recognize revenue and hinder receivables collections. The Company has a significant development contract with a United States Government agency and should the agency reduce, cancel or not grant additional milestone projects , the Company’s ability to continue its future product development may be impacted. The ability of the Company’s shipping carrier s to deliver products to customers may be disrupted. The Company has reviewed its suppliers and quantities of key materials and believe s that it has sufficient stocks and alternate sources of critical materials including personal protective equipment should the supply chains become disrupted. As further described in Note 5. , the Company believe s the pandemic’s impact on its sales has impacted the recoverability of the value of T2 - owned instruments and components. The COVID-19 pandemic also caused the Company to reassess its build plan and evaluate its inventories accordingly, which resulted in an additional charge to cost of product revenue. Having obtained authorization from the FDA to market the T2Dx, T2Candida, and T2Bacteria, the Company has incurred significant commercialization expenses related to product sales, marketing, manufacturing and distribution. The Company may seek to fund its operations through public equity, 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, financial condition and the Company’s ability to develop and commercialize T2Dx, T2Candida, T2Bacteria and other product candidates. Pursuant to the requirements of Accounting Standards Codification (“ASC”) 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern Management believes that its existing cash and cash equivalents at March 31, 2020, along with additional funding available through the Company’s Equity Distribution Agreement (the “Sales Agreement”) with Canaccord Genuity LLC, as agent (“Canaccord”) (Note 7) in the future, will be sufficient to allow the Company to fund its current operating plan, at least a year from issuance of these financial statements, assuming availability of funds. However, as certain elements of the Company’s operating plan are outside of the Company’s control, including the ability to sell shares under the Sales Agreement, those elements cannot be considered probable. Under ASC 205-40, the future receipt of potential funding from the Company’s Co-Development partners and other resources cannot be considered probable at this time because none of the plans are entirely within the Company’s control. During the three months ended March 31, 2020, management implemented a cost improvement strategy which is focused on reducing operating expenses and improving our cost of goods sold. The Company reduced its total employee headcount by 22% as compared to headcount at December 31, 2019, resulting in severance of $0.4 million, of which $0.3 million is included within other accrued expenses at March 31, 2020. The Term Loan Agreement with CRG Servicing LLC (“CRG”) (Note 6) requires the Company to achieve certain annual revenue targets, whereby the Company is required to pay double the amount of any shortfall as an acceleration of principal payments and maintain a minimum cash balance of $5.0 million. The Term Loan Agreement with CRG is classified as a current liability on the balance sheet at March 31, 2020, based on the Company’s consideration of the probability of violating the 2020 revenue covenant primarily due to the COVID-19 pandemic’s likely impact on our product sales, which in turn would trigger violation of the minimum liquidity covenant. Should the Company fall short of the revenue target, it would seek a waiver of this provision. There can be no assurances that the Company would be successful in obtaining a waiver. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date that the financial statements are issued. Management's plans to alleviate the conditions that raise substantial doubt include raising additional funding, earning payments pursuant to the Company’s Co- Development agreements, delaying certain research projects and capital expenditures and eliminating certain future operating expenses in order to fund operations at reduced levels for the Company to continue as a going concern for a period of twelve months from the date the financial statements are issued. Management has concluded the likelihood that its plan to obtain sufficient funding from one or more of these sources or adequately reduce expenditures will be successful, while reasonably possible, is less than probable. Accordingly, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least twelve months from the date of issuance of these con densed consolidated financial statements . The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States GAAP as defined in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company’s condensed 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. Unaudited Interim Financial Information Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019. The accompanying interim condensed consolidated balance sheet as of March 31, 2020, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2020 and 2019, the condensed consolidated statements of stockholders’ (deficit) equity for the three months ended March 31, 2020 and 2019, the condensed consolidated statements of cash flows for the three months ended March 31, 2020 and 2019 and the related financial data and other information disclosed in these notes are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements, and, in the opinion of management, reflect all adjustments, consisting of normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of March 31, 2020, and the results of its operations for the three months ended March 31, 2020 and 2019 and its cash flows for the three months ended March 31, 2020 and 2019. The results for the three months ended March 31, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020, any other interim periods, or any future year or period. 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, commercializing 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. Geographic Information The Company sells its products domestically and internationally. Total international sales were approximately $0.4 million or 17% of total revenue and $0.6 million or 36% of total revenue for the three months ended March 31, 2020 and 2019, respectively. International customers who represented 10% or more of the Company’s total revenue for the three months ended March 31, 2020 and 2019 were as follows: Three Months Ended March 31, 2020 2019 Customer A * 13 % Customer B * 11 % *Less than 10% for the period indicated As of March 31, 2020 and December 31, 2019, the Company had outstanding receivables of $0.6 million and $1.2 million, respectively, from customers located outside of the U.S. Net Loss Per Share Basic net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock 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, stock options and unvested restricted stock and restricted stock contingently issuable upon achievement of certain market conditions are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders was the same for all periods presented. Guarantees As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while each such officer or director is, or was, serving at the Company’s request in such capacity. The term of the indemnification is 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’ liability insurance coverage that limits its exposure and enables the Company 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 landlords 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 March 31, 2020 and December 31, 2019, 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. Leases Pursuant to Topic 842, Leases In accordance with the guidance in ASC 842, components of a lease should be split into three categories: lease components (e.g. land, building, etc.), non-lease components (e.g. common area maintenance, consumables, etc.), and non-components (e.g. property taxes, insurance, etc.) Then the fixed and in-substance fixed contract consideration (including any related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. The Company made the policy election to not separate lease and non-lease components. Each lease component and the related non-lease components are accounted for together as a single component. Revenue Recognition The Company generates revenue from the sale of instruments, consumable diagnostic tests, related services, reagent rental agreements and research and development agreements with third parties. Pursuant to ASC 606, Revenue from Contracts with Customers Once a contract is determined to be within the scope of ASC 606 at contract inception, the Company reviews the contract to determine which performance obligations the Company must deliver and which of these performance obligations are distinct. The Company recognizes as revenues the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied or as it is satisfied. Generally, the Company's performance obligations are transferred to customers at a point in time, typically upon shipment, or over time, as services are performed. Most of the Company’s contracts with distributors in geographic regions outside the United States contain only a single performance obligation; whereas, most of the Company’s contracts with direct sales customers in the United States contain multiple performance obligations. For these contracts, the Company accounts for individual performance obligations separately if they are distinct. The transaction price is allocated to the separate performance obligations on a relative standalone selling price basis. Excluded from the transaction price are sales tax and other similar taxes which are presented on a net basis. Product revenue is generated by the sale of instruments and consumable diagnostic tests predominantly through the Company’s 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 an instrument is purchased by a customer, the Company recognizes revenue when the related performance obligation is satisfied (i.e. when the control of an instrument has passed to the customer; typically, at shipping point). When the instrument is placed under a reagent rental agreement, the Company’s customers generally agree to fixed term agreements, which can be extended, and incremental charges on each consumable diagnostic test purchased. Revenue from the sale of consumable diagnostic tests (under a reagent rental agreement) is recognized upon shipment. The transaction price from consumables purchases is allocated between the lease of the instrument (under a contingent rent methodology as provided for in ASC 842, Leases Direct sales of instruments include warranty, maintenance and technical support services typically for one year following the installation of the purchased instrument (“Maintenance Services”). Maintenance Services are separate performance obligations as they are service based warranties and are recognized on a straight-line basis over the service delivery period. After the completion of the initial Maintenance Services period, customers have the option to renew or extend the Maintenance Services typically for additional one-year Fees paid to member-owned group purchasing organizations (“GPOs”) are deducted from related product revenues. 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 provides replacement product free of charge. Accordingly, the Company accrues warranty expense associated with the estimated defect rates of the consumable diagnostic tests. Revenue earned from activities performed pursuant to research and development agreements is reported as research revenue in the condensed consolidated statements of operations and comprehensive loss, and is recognized over time using an input method as the work is completed. 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. Milestones are contingent on the occurrence of future events and are considered variable consideration being constrained until the Company believes a significant revenue reversal will not occur. Refer to Note 11 for further details regarding the Company’s research and development arrangements. Grants received, including cost reimbursement agreements, are assessed to determine if the agreement should be accounted for as an exchange transaction or a contribution. An agreement is accounted for as a contribution if the resource provider does not receive commensurate value in return for the assets transferred. Contribution revenue is recognized when all donor-imposed conditions have been met. Our customers may cease to comply with the terms of our sales agreements and this may impact our ability to recognize revenue and hinder receivables collections. We have a significant development contract with a United States Government agency and should the agency reduce, cancel or not grant additional milestone projects our ability to continue our future product development may be impacted. Disaggregation of Revenue The Company disaggregates revenue from contracts with customers by type of products and services, as it best depicts how the nature, amount, timing and uncertainty of revenue and cash flows are affected by economic factors. The following table disaggregates our revenue by major source (in thousands): Three months ended, March 31, 2020 2019 Product Revenue Instruments $ 247 $ 535 Consumables 745 733 Instrument rentals 53 46 Total Product Revenue 1,045 1,314 Research Revenue — 142 Contribution Revenue 1,500 329 Total Revenue $ 2,545 $ 1,785 Remaining Performance Obligations Remaining performance obligations represent the transaction price of firm orders for which work has not been performed or goods and services have not been delivered. As of March 31, 2020, the aggregate amount of transaction price allocated to remaining performance obligations for contracts with an original duration greater than one year was $0.2 million. We do not disclose the value of unsatisfied performance obligations for (i) contracts with an original expected length of one year or less and (ii) contracts for which we recognize revenue at the amount to which we have the right to invoice for services performed. The Company expects to recognize revenue on the remaining performance obligations over the next 21 months. Significant Judgments Our contracts with customers often include promises to transfer multiple products and services to a customer. Determining whether products and services are considered distinct performance obligations that should be accounted for separately versus together may require significant judgment. Once we determine the performance obligations, the Company determines the transaction price, which includes estimating the amount of variable consideration, based on the most likely amount, to be included in the transaction price, if any. We then allocate the transaction price to each performance obligation in the contract based on a relative stand-alone selling price method. The corresponding revenue is recognized as the related performance obligations are satisfied as discussed in the revenue categories above. Judgment is required to determine the standalone selling price for each distinct performance obligation. We determine standalone selling price based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, we estimate the standalone selling price taking into account available information such as market conditions and the expected costs and margin related to the performance obligations. Contract Assets and Liabilities The Company did not record any contract assets at March 31, 2020 and December 31, 2019. The Company’s contract liabilities consist of upfront payments for research and development contracts and Maintenance Services on instrument sales. We classify these contract liabilities in deferred revenue as current or noncurrent based on the timing of when we expect to recognize revenue. Contract liabilities were $0.2 million at March 31, 2020 and December 31, 2019. Revenue recognized in the three months ended March 31, 2020 relating to contract liabilities at December 31, 2019 was $0.1 million, and related to straight-line revenue recognition associated with maintenance agreements. Cost to Obtain and Fulfill a Contract The Company does not meet the recoverability criteria to capitalize costs to obtain or fulfill instrument purchases. Reagent rental agreements do not meet the recoverability criteria to capitalize costs to obtain the contracts and the costs to fulfill the contracts are under the scope of ASC 842. At the end of each reporting period, the Company assesses whether any circumstances have changed to meet the criteria for capitalization. The Company did not incur any expenses to obtain research and development agreements and costs to fulfill those contracts do not generate or enhance resources of the entity. As such, no costs to obtain or fulfill contracts have been capitalized at period end. 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 instruments that have been placed with customers under reagent rental agreements; costs of materials, direct labor and manufacturing overhead costs on the T2Dx instruments sold to customers; and other costs such as customer support costs, royalties and license fees, warranty and repair and maintenance expense on the T2Dx instruments 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 contribution agreements, costs associated with the manufacture of developed products and include salaries and benefits, stock compensation, research‑related facility and overhead costs, laboratory supplies, equipment and contract services. 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 June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (“ASU 2018-18”), which clarifies the interaction between ASC 808, Collaborative Arrangements and ASC 606, Revenue from Contracts with Customers. Certain transactions between participants in a collaborative arrangement should be accounted for under ASC 606 when the counterparty is a customer. In addition, ASU 2018-18 precludes an entity from presenting consideration from a transaction in a collaborative arrangement as revenue if the counterparty is not a customer for that transaction. ASU 2018-18 should be applied retrospectively to the date of initial application of ASC 606. This guidance is effective for interim and fiscal periods beginning after December 15, 2019. We adopted ASU 2018-18 on January 1, 2020. The adoption did not have a material impact on our financial statements. Accounting Standards Issued, Not Adopted In December 2019, the FASB issued ASU No. 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
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 carried at fair value categorized using the lowest level of input applicable to each financial instrument as of March 31, 2020 and December 31, 2019 (in thousands): Balance at March 31, 2020 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Money market funds $ 726 $ 726 $ — $ — Restricted cash 180 180 — — $ 906 $ 906 $ — $ — Liabilities: Derivative liability $ 2,314 $ — $ — $ 2,314 $ 2,314 $ — $ — $ 2,314 Balance at December 31, 2019 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Money market funds $ 4,301 $ 4,301 $ — $ — Restricted cash 180 180 — — $ 4,481 $ 4,481 $ — $ — Liabilities: Derivative liability $ 2,425 $ — $ — $ 2,425 $ 2,425 $ — $ — $ 2,425 The Company maintains certificates of deposit, classified as restricted cash, for $0.2 million (Note 4). The Company’s Term Loan Agreement with CRG (Note 6) contains certain provisions that change the underlying cash flows of the instrument, including acceleration of the obligations under the Term Loan Agreement under an event of default. In addition, under certain circumstances, a default interest rate of an additional 4.0% per annum will apply at the election of CRG on all outstanding obligations during the occurrence and continuance of an event of default. The Company concluded that these features are not clearly and closely related to the host instrument, and represent a single compound derivative that is required to be re-measured at fair value on a quarterly basis. The fair value of the derivative at March 31, 2020 and December 31, 2019 is $2.3 million and $2.4 million, respectively, and is classified as a current liability on the balance sheet at March 31, 2020 and December 31, 2019 to match the classification of the related Term Loan Agreement (Note 6). The estimated fair value of the derivative at March 31, 2020 was determined using a probability-weighted discounted cash flow model that includes contingent interest payments under the following scenarios: Range 4% contingent interest beginning in 2020 90.0 % 4% contingent interest beginning in 2021 10.0 % Should the Company’s assessment of these probabilities change, including amendments of certain revenue targets, there could be a change to the fair value of the derivative liability. The following table provides a roll-forward of the fair value of the derivative liability (in thousands): Balance at December 31, 2019 $ 2,425 Change in fair value of derivative liability, recorded as interest expense (111 ) Balance at March 31, 2020 $ 2,314 |
Restricted Cash
Restricted Cash | 3 Months Ended |
Mar. 31, 2020 | |
Restricted Cash [Abstract] | |
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 March 31, 2020 and December 31, 2019, the Company had certificates of deposit for $0.2 million, which represented collateral as security deposits for its operating lease agreement for its facility and its credit cards. |
Supplemental Balance Sheet Info
Supplemental Balance Sheet Information | 3 Months Ended |
Mar. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Supplemental Balance Sheet Information | 5. Supplemental Balance Sheet Information Inventories Inventories are stated at the lower of cost or net realizable value on a first-in, first-out basis and are comprised of the following (in thousands): March 31, 2020 December 31, 2019 Raw materials $ 1,232 $ 1,617 Work-in-process 1,016 1,227 Finished goods 1,027 755 Total inventories, net $ 3,275 $ 3,599 The COVID-19 pandemic caused the Company to reassess its build plan and evaluate its inventories accordingly, which resulted in an additional $0.6 million charge to cost of product revenue for the three months ended March 31, 2020. Property and Equipment Property and equipment consists of the following (in thousands): March 31, 2020 December 31, 2019 Office and computer equipment $ 538 $ 538 Software 762 762 Laboratory equipment 4,785 4,747 Furniture 194 194 Manufacturing equipment 672 672 Manufacturing tooling and molds 255 255 T2-owned instruments and components 5,575 6,775 Leasehold improvements 3,497 3,497 Construction in progress 1,642 1,641 17,920 19,081 Less accumulated depreciation and amortization (13,688 ) (13,236 ) Property and equipment, net $ 4,232 $ 5,845 Construction in progress is primarily comprised of equipment that has 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 T2-owned instruments, based on our business model and forecast, and completed instruments that will be used for internal research and development, clinical studies or reagent rental agreements with customers. At March 31, 2020 and December 31, 2019, there were $0.1 million and $0.6 million, respectively, of raw materials and work-in-process inventory in T2-owned instruments and components. Completed T2-owned instruments are placed in service once installation procedures are completed and are depreciated over five years. 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 approximately $0.1 million and $0.2 million for the three months ended March 31, 2020 and 2019, respectively. The Company believes the COVID-19 pandemic will reduce product sales and impair the ability to recover the cost of the T2-owned instruments and components. The Company assessed the impact on the related cash flows of the T2-owned instruments and reduced the respective carrying values by $0.6 million as of March 31, 2020, which is recorded as cost of product revenue impairment expense. Depreciation expense for T2-owned instruments used for internal research and development and clinical studies is recorded as a component of research and development expense. Depreciation and amortization expense of $0.5 million and $0.6 million was charged to operations for the three months ended March 31, 2020 and 2019, respectively. Accrued Expenses Accrued expenses consist of the following (in thousands): March 31, 2020 December 31, 2019 Accrued payroll and compensation $ 1,582 $ 3,193 Accrued final fee 2,568 2,445 Accrued research and development expenses 413 267 Accrued professional services 1,174 511 Accrued interest 906 908 Operating lease liabilities 2,033 1,983 Other accrued expenses 1,353 1,900 Total accrued expenses and other current liabilities $ 10,029 $ 11,207 At March 31, 2020 and December 31, 2019, the Company classified $2.6 million and $2.4 million, respectively, related to a fee associated with the Company’s Term Loan Agreement (Note 6), as accrued final fee in the table above to match the current classification of the associated debt. Included within other accrued expenses in the table above, at March 31, 2020 is $0.6 million from the Second Amendment to Employment Agreement with John McDonough (the “Transition Agreement”) (Note 13). Included within other accrued expenses and accrued payroll and compensation in the table above, at December 31, 2019 is $ 1.0 million and $ 0.2 million, respectively related to the Transition Agreement. Included within other accrued expenses in the table above at March 31, 2020 is $ 0.3 million of severance associated with our reduction in headcount as described in Note 1 . |
Notes Payable
Notes Payable | 3 Months Ended |
Mar. 31, 2020 | |
Debt Disclosure [Abstract] | |
Notes Payable | 6. Notes Payable Future principal payments on the notes payable are as follows (in thousands): March 31, 2020 December 31, 2019 Term loan agreement before unamortized PIK interest, discount and issuance costs $ 48,077 $ 48,077 Less: unamortized paid-in-kind interest (2,888 ) (3,284 ) Less: unamortized discount and deferred issuance costs (1,789 ) (1,891 ) Total notes payable $ 43,400 $ 42,902 The Term Loan Agreement with CRG is classified as a current liability on the balance sheet at March 31, 2020 and December 31, 2019 based on the Company’s consideration of the probability of violating the 2020 revenue covenant primarily due to the COVID-19 pandemic’s likely impact on our product sales, which in turn would trigger violation of the minimum liquidity covenant included in the Term Loan Agreement. The Term 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 Term Loan Agreement. The contractual terms of the agreement, as amended, require quarterly principal payments of $12.0 million commencing March 31, 2022 through maturity Term Loan Agreement In December 2016, the Company entered into a Term Loan Agreement (the “Term Loan Agreement”) with CRG. The Company initially borrowed $40.0 million pursuant to the Term Loan Agreement, which has a six-year 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 Term Loan Agreement also contains customary affirmative and negative covenants for a credit facility of this size and type, including a requirement to maintain a minimum cash balance. The Term 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. In March 2019, the Term Loan Agreement was amended to reduce the 2019 minimum revenue target to $9.0 million and eliminate the 2018 revenue covenant. In exchange for the amendment, the Company agreed to reset the strike price of the warrants to purchase a total of 528,958 shares of the Company’s common stock, issued in connection with the Term Loan Agreement, from $8.06 per share to $4.35 per share (Note 9). In September 2019, the Term Loan Agreement was amended to extend the interest-only payment period through December 31, 2021, to extend the initial principal repayment to March 31, 2022, and to reduce the minimum product revenue target for 2019 from $9 million to $4 million, for the twenty-four month period beginning on January 1, 2019 from $95 million to $15 million and for the twenty-four month period beginning on January 1, 2020 from $140 million to $43 million. The Term 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 Term Loan Agreement. Under certain circumstances, a default interest rate of an additional 4.0% per annum will apply at the election of CRG on all outstanding obligations during the occurrence and continuance of an event of default. Equipment Lease Credit Facility In October 2015, the Company signed a $10.0 million Credit Facility (the “Credit Facility”) with Essex Capital Corporation (the “Lessor”) to fund capital equipment needs. As one of the conditions of the Term Loan Agreement, the Credit Facility was capped at a maximum of $5.0 million. Under the Credit Facility, Essex funded capital equipment purchases presented by the Company. The Company repaid 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 had 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 made monthly payments of $67,000 under the first draw and $79,000 under the second draw. The borrowings under the Credit Facility were treated as finance leases and are included in property and equipment on the balance sheet. The amortization of the assets conveyed under the Credit Facility was included as a component of depreciation expense. During the year ended December 31, 2019, the Company repurchased the equipment for $0.3 million in accordance with the terms of the Credit Facility. |
Stockholders' (Deficit) Equity
Stockholders' (Deficit) Equity | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Stockholders' (Deficit) Equity | 7. Stockholders’ (Deficit) Equity Equity Distribution Agreement On July 30, 2019, the Company entered into the Sales Agreement with Canaccord, as agent, pursuant to which the Company may offer and sell shares of common stock, for aggregate gross sale proceeds of up to $30.0 million from time to time through Canaccord. On March 9, 2020, the Company entered into an amendment to the Sales Agreement to increase the aggregate gross sales amount from $30.0 million to $65.0 million. On April 8, 2020, the Company entered into an amendment to the Sales Agreement to increase the aggregate gross sales amount from $65.0 million to $95.0 million. As of March 31, 2020, the Company had sold 73,237,178 shares of common stock with an aggregate gross sales amount of approximately $48.1 million, leaving approximately $46.9 million remaining under the Equity Distribution Agreement. Upon delivery of a placement notice based on the Company’s instructions and subject to the terms and conditions of the Sales Agreement, Canaccord may sell the shares by methods deemed to be an “at the market” offering, subject to shelf limitations if any, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices, or by any other method permitted by law, including negotiated transactions, subject to the prior written consent of the Company. The Company is not obligated to make any sales of shares under the Sales Agreement. The Company or Canaccord may suspend or terminate the offering of shares upon notice to the other party, subject to certain conditions. Canaccord will act as sales agent on a commercially reasonable efforts basis consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of Nasdaq. The Company has agreed to pay Canaccord for its services of acting as agent an amount equal to 3% of the gross proceeds from the sale of the shares pursuant to the Sales Agreement. The Company has also agreed to provide Canaccord with customary indemnification for certain liabilities. Legal and accounting fees are expected to be changed to share capital upon issuance of shares under the Sales Agreement. During the three months ended March 31, 2020, the Company sold 67,750,678 shares for net proceeds of $39.8 million after expenses in connection with the Sales Agreement. Purchase Agreement On July 29, 2019, the Company entered into a $30.0 million Purchase Agreement with Lincoln Park, pursuant to which the Company was able to sell and issue to Lincoln Park, and Lincoln Park was obligated to purchase, up to $30.0 million in value of its shares of common stock from time to time over a 36-month period starting from the effective date of the respective registration statement. On April 7, 2020, the Company terminated the Purchase Agreement, effective April 8, 2020. The Company was able to direct Lincoln Park, at its sole discretion, and subject to certain conditions, to purchase up to 200,000 shares of common stock on any business day, provided that at least one business day had passed since the most recent purchase. The amount of a purchase could be increased under certain circumstances provided, however, that Lincoln Park’s committed obligation under any single purchase would not exceed $2.0 million. The purchase price of shares of common stock related to the future funding was based on the then prevailing market prices of such shares at the time of sales as described in the Purchase Agreement. In consideration for the execution and delivery of the Purchase Agreement, the Company issued 413,349 shares of common stock to Lincoln Park. During the three months ended March 31, 2020, the Company sold 400,000 shares for proceeds of $0.3 million in connection with the Purchase Agreement. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 8. Stock-Based Compensation Stock Incentive Plans 2006 Stock Incentive Plan The Company’s 2006 Stock Option Plan (“2006 Plan”) was established for granting stock incentive awards to directors, officers, employees and consultants of 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 Company’s 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 vested over various periods not exceeding 4 years. 2014 Stock Incentive Plan The Company’s 2014 Incentive Award Plan (“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 units, 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 primarily granted stock options and restricted stock units. 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 shares, (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, 2026, equal to the lesser of (A) 4% of the shares outstanding (on an as-converted basis) on the final day of the immediately preceding calendar year and (B) such smaller number of shares determined by the Company’s board of directors. As of March 31, 2020, there were 1,302,541 shares available for future grant under the Stock Incentive Plans. Inducement Award Plan The Company’s Amended and Restated Inducement Award Plan (“Inducement Plan”), which was adopted in March 2018 and most recently, amended and restated in January 2020, provides for the granting of equity awards to new employees, including options, restricted stock awards, restricted stock units, performance awards, dividend equivalent awards, stock payment awards and stock appreciation rights. The aggregate number of shares of common stock which may be issued or transferred pursuant to awards under the Inducement Plan is 5,625,000 shares. Any awards that forfeit, expire, lapse, or are settled for cash without the delivery of shares to the holder are available for the grant of an award under the Inducement Plan. Any shares repurchased by or surrendered to the Company that are returned shall be available for grant of an award under the Inducement Plan. The payment of dividend equivalents in cash in conjunction with any outstanding award shall not be counted against the shares available for issuance under the Inducement Plan. As of March 31, 2020, there were 2,055,103 shares available for future grant under the Inducement Plan. Stock Options During the three months ended March 31, 2020 and 2019, the Company granted stock options with an aggregate fair value of $3.0 million and $2.0 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 Stock Incentive Plans and Inducement Plan (in thousands, except share and per share amounts): Number of Shares Weighted-Average Exercise Price Per Share Weighted-Average Remaining Contractual Term (In years) Aggregate Intrinsic Value Outstanding at December 31, 2019 6,353,330 $ 4.95 7.29 $ 229 Granted 4,011,500 0.99 Exercised — — Forfeited (528,087 ) 2.09 Cancelled (38,876 ) 10.93 Outstanding at March 31, 2020 9,797,867 $ 3.46 8.00 $ 200 Exercisable at March 31, 2020 3,679,029 $ 6.25 5.57 $ — Vested or expected to vest at March 31, 2020 8,534,515 $ 3.74 7.76 $ 151 There were no options exercised in the three months ended March 31, 2020 and 2019. The weighted-average grant date fair values of stock options granted in the three month periods ended March 31, 2020 and 2019 were $0.74 per share and $2.20 per share, respectively, and were calculated using the following estimated assumptions: Three Months Ended March 31, 2020 2019 Weighted-average risk-free interest rate 1.50 % 2.52 % Expected dividend yield — % — % Expected volatility 91 % 71 % Expected terms 6.0 years 6.0 years The total fair values of options that vested during the three months ended March 31, 2020 and 2019 were $0.8 million and $1.0 million, respectively. As of March 31, 2020, there was $7.3 million of total unrecognized compensation cost related to non-vested stock options granted under the Stock Incentive Plans and Inducement Plan. 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 2.9 years as of March 31, 2020. Restricted Stock Units During the three months ended March 31, 2020, the Company awarded shares of restricted stock units to certain employees and directors at no cost to them, which cannot be sold, assigned, transferred or pledged during the restriction period. The restricted stock units, excluding any restricted stock units with market conditions, vest through the passage of time, assuming continued service. Restricted stock units are not included in issued and outstanding common stock until the shares are vested and released. During the year ended December 31, 2018, an additional 73,172 restricted stock units vested but are not reflected as outstanding shares at December 31, 2019 due to a deferred release date. These restricted stock units are reflected as outstanding shares at March 31, 2020. The fair value of the restricted stock units, at the time of the grant, is expensed on a straight line basis. The granted restricted stock units had an aggregate fair value of $0.5 million, which are being amortized into compensation expense over the vesting period of the restricted stock units as the services are being provided. Included in the nonvested restricted stock units at March 31, 2020 are 399,437 restricted stock units with market conditions, which vest upon the achievement of stock price targets. The compensation cost for restricted stock units with market conditions is being recorded over the derived service period and was immaterial for the three months ended March 31, 2020 and $0.7 million for the three months ended March 31, 2019. The following is a summary of restricted stock unit activity under the 2014 Plan (in thousands, except share and per share amounts): Number of Shares Weighted-Average Grant Date Fair Value Nonvested at December 31, 2019 1,295,508 4.19 Granted 917,064 0.54 Vested (297,245 ) 3.72 Forfeited (438,430 ) 4.10 Cancelled — — Nonvested at March 31, 2020 1,476,897 2.04 As of March 31, 2020, there was $1.1 million of total unrecognized compensation cost related to nonvested restricted stock units granted under the 2014 Plan. 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 2.13 years, as of March 31, 2020. Stock-Based Compensation Expense The following table summarizes the stock-based compensation expense resulting from awards granted under Stock Incentive Plans, including the Inducement Plan and 2014 ESPP, that was recorded in the Company’s results of operations for the periods presented (in thousands): Three Months Ended March 31, 2020 2019 Cost of product revenue $ 42 $ 50 Research and development 299 364 Selling, general and administrative 802 1,506 Total stock-based compensation expense $ 1,143 $ 1,920 For the three months ended March 31, 2020, stock-based compensation expenses capitalized as part of inventory or T2Dx instruments and components was immaterial. For the three months ended March 31, 2019, stock-based compensation expenses capitalized as part of inventory of T2Dx instruments and components was $0.1 million. |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2020 | |
Warrants And Rights Note Disclosure [Abstract] | |
Warrants | 9. Warrants In connection with the Term Loan Agreement entered into in December 2016, the Company issued to CRG 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 $4.35 per share, which was amended in March 2019 from an original 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 amended warrants was $0.9 million. The incremental fair value of the modified instrument of $0.1 million was recorded as debt discount and additional paid-in-capital In connection with the September 2019 amendment of the Term Loan Agreement, the Company issued to CRG warrants to purchase 568,291 shares of the Company’s common stock at an exercise price of $1.55, 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 Company also reduced the exercise price for the warrants previously issued to CRG to $1.55. All of the New Warrants are exercisable any time prior to September 9, 2029. 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 new and amended warrants was determined by the Black-Scholes-Merton option pricing model. The incremental fair value of the amended warrants of $0.1 million and the fair value of the New Warrants of $0.7 million were recorded as debt discount and additional paid-in-capital |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 10. Net Loss Per Share 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: Three Months Ended March 31, 2020 2019 Options to purchase common shares 9,797,867 5,092,470 Restricted stock units 1,476,897 1,656,048 Warrants to purchase common stock 1,097,249 528,958 Total 12,372,013 7,277,476 |
Co-Development Agreements
Co-Development Agreements | 3 Months Ended |
Mar. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Co-Development Agreements | 11. Co-Development Agreements Canon US Life Sciences 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”) to develop a diagnostic test panel to rapidly detect Lyme disease. 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. The Co-Development Agreement was completed in 2019 and the Company did not record any revenue for the three months ended March 31, 2020 and recorded revenue of $0.1 million for the three months ended March 31, 2019. CARB-X In March 2018, the Company was awarded a grant of up to $2.0 million from CARB-X. The collaboration with CARB-X will be used to accelerate the development of new tests to identify bacterial pathogens and resistance markers directly in whole blood more rapidly than is possible using today’s diagnostic tools. The new tests aim to expand the T2Dx instrument product line by detecting 20 additional bacterial species and resistance targets, with a focus on blood borne pathogens on the United States Centers for Disease Control and Prevention (“CDC”) antibiotic resistance threat list. Under this cost-sharing agreement, the Company may be reimbursed up to $1.1 million, with the possibility of up to an additional $0.9 million based on the achievement of certain project milestones. In January 2019, the Company was awarded the $0.9 million reimbursement option. The Company did not record any revenue for the three months ended March 31, 2020. The Company recognized the $0.9 million that was awarded under the reimbursement option in 2019, and recorded revenue of $0.3 million for the three months ended March 31, 2019, under the CARB-X Agreement. The Company will not recognize any additional revenue under the CARB-X agreement. US Government Contract In September 2019, the Biomedical Advanced Research and Development Authority (“BARDA”) awarded the Company a milestone-based contract, with an initial value of $6.0 million, and a potential value of up to $69.0 million, if BARDA awards all contract options. BARDA operates within the Office of the Assistant Secretary for Preparedness and Response (“ASPR”) at the U.S. Department of Health and Human Services’ (“HHS”). If BARDA awards and the Company completes all options, the Company’s management believes it will enable a significant expansion of the Company’s current portfolio of diagnostics for sepsis-causing pathogen and anti-biotic resistance genes. The Company recorded revenue of $1.5 million for the three months ended March 31, 2020. The contract began in September 2019 and the Company did not record any revenue under the US Government Contract for the three months ended March 31, 2019. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
Leases | 12. Leases Operating Leases The Company leases certain office space, laboratory space, and equipment. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. The Company does not recognize right-of-use assets or lease liabilities for leases determined to have a term of 12 months or less. For new and amended leases beginning in 2019 and after, the Company has elected to account for the lease and non-lease components as a combined lease component. In August 2010, the Company entered into an operating lease for office and laboratory space at its headquarters in Lexington, Massachusetts. The lease commenced in January 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 $160,000 in January 2018, which is recorded as restricted cash in the condensed consolidated balance sheets. In March 2017, the Company entered into an amendment to extend the term to December 2021 In May 2013, the Company entered into an operating lease for additional office, laboratory and manufacturing space in Wilmington, Massachusetts. In August 2018, the Company entered into an amendment to extend the term to December 2020 In November 2014, the Company entered into an agreement to rent additional office space in Lexington, Massachusetts. In April 2015, the Company entered into an amendment to extend the term to December 31, 2017. In connection with this agreement, the Company paid a security deposit of $50,000, which is recorded as a component of other assets in the condensed consolidated balance sheets. In May 2015, the Company entered into an amendment to expand existing manufacturing facilities in Lexington, Massachusetts. In September 2017, the Company entered into an amendment to extend the term to December 31, 2021. In May 2020, the Company provided written notice of its intent to vacate this space on June 30, 2020; however, at this time, we cannot estimate the impact that this may or may not have. In November 2014, the Company entered into a lease for additional laboratory space in Lexington, Massachusetts. The lease term commenced in April 2015 and extended 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. Prior to the adoption of ASC 842, the incentive was recorded as a component of lease incentives on the condensed consolidated balance sheets and was amortized as a reduction in rent expense on a straight-line basis over the term of the lease. Upon adoption of the new standard the unamortized balance of the lease incentive as of January 1, 2019 was reclassified as a reduction to the initial recognition of the right-of-use asset related to this lease. In connection with this lease agreement, the Company paid a security deposit of $281,000, which is recorded as a component of both prepaid expenses and other current assets and other assets in the condensed consolidated balance sheets. Operating leases are amortized over the lease term and included in costs and expenses in the condensed consolidated statement of operations and comprehensive loss. Variable lease costs are recognized in costs and expenses in the condensed consolidated statement of operations and comprehensive loss as incurred. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 13. Commitments and Contingencies Leases Refer to Note 12, Leases, for discussion of the commitments associated with the Company’s leases. 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. 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. 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 between 0.5% - 3.5%, subject to reductions and offsets in certain circumstances, as well as a royalty on net sales of products that the Company sublicenses at 10% of specified gross revenue. Royalties for the three months ended March 31, 2020 and 2019 were immaterial. Worldwide Licensing Agreement In March 2020, the Company entered into a worldwide licensing agreement for a rapid COVID-19, novel coronavirus test developed by the Center of Discovery and Innovation at Hackensack Meridian Health Health Health Transition Agreement On July 30, 2019, the Company announced that founding CEO John McDonough was named Executive Chairman of the Board until a successor is named at which time Mr. McDonough will become non-executive Chairman of the Board. John Sperzel was named CEO in January 2020. In connection with John McDonough’s transition to Non-Executive Chairman of the Board from CEO, the Company agreed to transition payments and health benefits to be paid over the 15 month period following Mr. Sperzel’s start date. At December 31, 2019, included within other accrued expenses is $1.0 million related to Mr. McDonough’s transition payments and health benefits and included within accrued payroll and compensation is $0.2 million related to Mr. McDonough’s bonus. At March 31, 2020, included within other accrued expenses is $0.6 million related to Mr. McDonough’s transition payments and health benefits. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States GAAP as defined in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company’s condensed 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. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019. The accompanying interim condensed consolidated balance sheet as of March 31, 2020, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2020 and 2019, the condensed consolidated statements of stockholders’ (deficit) equity for the three months ended March 31, 2020 and 2019, the condensed consolidated statements of cash flows for the three months ended March 31, 2020 and 2019 and the related financial data and other information disclosed in these notes are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements, and, in the opinion of management, reflect all adjustments, consisting of normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of March 31, 2020, and the results of its operations for the three months ended March 31, 2020 and 2019 and its cash flows for the three months ended March 31, 2020 and 2019. The results for the three months ended March 31, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020, any other interim periods, or any future year or period. |
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, commercializing 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. |
Geographic Information | Geographic Information The Company sells its products domestically and internationally. Total international sales were approximately $0.4 million or 17% of total revenue and $0.6 million or 36% of total revenue for the three months ended March 31, 2020 and 2019, respectively. International customers who represented 10% or more of the Company’s total revenue for the three months ended March 31, 2020 and 2019 were as follows: Three Months Ended March 31, 2020 2019 Customer A * 13 % Customer B * 11 % *Less than 10% for the period indicated As of March 31, 2020 and December 31, 2019, the Company had outstanding receivables of $0.6 million and $1.2 million, respectively, from customers located outside of the U.S. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock 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, stock options and unvested restricted stock and restricted stock contingently issuable upon achievement of certain market conditions are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders was the same for all periods presented. |
Guarantees | Guarantees As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while each such officer or director is, or was, serving at the Company’s request in such capacity. The term of the indemnification is 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’ liability insurance coverage that limits its exposure and enables the Company 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 landlords 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 March 31, 2020 and December 31, 2019, 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. |
Leases | Leases Pursuant to Topic 842, Leases In accordance with the guidance in ASC 842, components of a lease should be split into three categories: lease components (e.g. land, building, etc.), non-lease components (e.g. common area maintenance, consumables, etc.), and non-components (e.g. property taxes, insurance, etc.) Then the fixed and in-substance fixed contract consideration (including any related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. The Company made the policy election to not separate lease and non-lease components. Each lease component and the related non-lease components are accounted for together as a single component. |
Revenue Recognition | Revenue Recognition The Company generates revenue from the sale of instruments, consumable diagnostic tests, related services, reagent rental agreements and research and development agreements with third parties. Pursuant to ASC 606, Revenue from Contracts with Customers Once a contract is determined to be within the scope of ASC 606 at contract inception, the Company reviews the contract to determine which performance obligations the Company must deliver and which of these performance obligations are distinct. The Company recognizes as revenues the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied or as it is satisfied. Generally, the Company's performance obligations are transferred to customers at a point in time, typically upon shipment, or over time, as services are performed. Most of the Company’s contracts with distributors in geographic regions outside the United States contain only a single performance obligation; whereas, most of the Company’s contracts with direct sales customers in the United States contain multiple performance obligations. For these contracts, the Company accounts for individual performance obligations separately if they are distinct. The transaction price is allocated to the separate performance obligations on a relative standalone selling price basis. Excluded from the transaction price are sales tax and other similar taxes which are presented on a net basis. Product revenue is generated by the sale of instruments and consumable diagnostic tests predominantly through the Company’s 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 an instrument is purchased by a customer, the Company recognizes revenue when the related performance obligation is satisfied (i.e. when the control of an instrument has passed to the customer; typically, at shipping point). When the instrument is placed under a reagent rental agreement, the Company’s customers generally agree to fixed term agreements, which can be extended, and incremental charges on each consumable diagnostic test purchased. Revenue from the sale of consumable diagnostic tests (under a reagent rental agreement) is recognized upon shipment. The transaction price from consumables purchases is allocated between the lease of the instrument (under a contingent rent methodology as provided for in ASC 842, Leases Direct sales of instruments include warranty, maintenance and technical support services typically for one year following the installation of the purchased instrument (“Maintenance Services”). Maintenance Services are separate performance obligations as they are service based warranties and are recognized on a straight-line basis over the service delivery period. After the completion of the initial Maintenance Services period, customers have the option to renew or extend the Maintenance Services typically for additional one-year Fees paid to member-owned group purchasing organizations (“GPOs”) are deducted from related product revenues. 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 provides replacement product free of charge. Accordingly, the Company accrues warranty expense associated with the estimated defect rates of the consumable diagnostic tests. Revenue earned from activities performed pursuant to research and development agreements is reported as research revenue in the condensed consolidated statements of operations and comprehensive loss, and is recognized over time using an input method as the work is completed. 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. Milestones are contingent on the occurrence of future events and are considered variable consideration being constrained until the Company believes a significant revenue reversal will not occur. Refer to Note 11 for further details regarding the Company’s research and development arrangements. Grants received, including cost reimbursement agreements, are assessed to determine if the agreement should be accounted for as an exchange transaction or a contribution. An agreement is accounted for as a contribution if the resource provider does not receive commensurate value in return for the assets transferred. Contribution revenue is recognized when all donor-imposed conditions have been met. Our customers may cease to comply with the terms of our sales agreements and this may impact our ability to recognize revenue and hinder receivables collections. We have a significant development contract with a United States Government agency and should the agency reduce, cancel or not grant additional milestone projects our ability to continue our future product development may be impacted. Disaggregation of Revenue The Company disaggregates revenue from contracts with customers by type of products and services, as it best depicts how the nature, amount, timing and uncertainty of revenue and cash flows are affected by economic factors. The following table disaggregates our revenue by major source (in thousands): Three months ended, March 31, 2020 2019 Product Revenue Instruments $ 247 $ 535 Consumables 745 733 Instrument rentals 53 46 Total Product Revenue 1,045 1,314 Research Revenue — 142 Contribution Revenue 1,500 329 Total Revenue $ 2,545 $ 1,785 Remaining Performance Obligations Remaining performance obligations represent the transaction price of firm orders for which work has not been performed or goods and services have not been delivered. As of March 31, 2020, the aggregate amount of transaction price allocated to remaining performance obligations for contracts with an original duration greater than one year was $0.2 million. We do not disclose the value of unsatisfied performance obligations for (i) contracts with an original expected length of one year or less and (ii) contracts for which we recognize revenue at the amount to which we have the right to invoice for services performed. The Company expects to recognize revenue on the remaining performance obligations over the next 21 months. Significant Judgments Our contracts with customers often include promises to transfer multiple products and services to a customer. Determining whether products and services are considered distinct performance obligations that should be accounted for separately versus together may require significant judgment. Once we determine the performance obligations, the Company determines the transaction price, which includes estimating the amount of variable consideration, based on the most likely amount, to be included in the transaction price, if any. We then allocate the transaction price to each performance obligation in the contract based on a relative stand-alone selling price method. The corresponding revenue is recognized as the related performance obligations are satisfied as discussed in the revenue categories above. Judgment is required to determine the standalone selling price for each distinct performance obligation. We determine standalone selling price based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, we estimate the standalone selling price taking into account available information such as market conditions and the expected costs and margin related to the performance obligations. Contract Assets and Liabilities The Company did not record any contract assets at March 31, 2020 and December 31, 2019. The Company’s contract liabilities consist of upfront payments for research and development contracts and Maintenance Services on instrument sales. We classify these contract liabilities in deferred revenue as current or noncurrent based on the timing of when we expect to recognize revenue. Contract liabilities were $0.2 million at March 31, 2020 and December 31, 2019. Revenue recognized in the three months ended March 31, 2020 relating to contract liabilities at December 31, 2019 was $0.1 million, and related to straight-line revenue recognition associated with maintenance agreements. Cost to Obtain and Fulfill a Contract The Company does not meet the recoverability criteria to capitalize costs to obtain or fulfill instrument purchases. Reagent rental agreements do not meet the recoverability criteria to capitalize costs to obtain the contracts and the costs to fulfill the contracts are under the scope of ASC 842. At the end of each reporting period, the Company assesses whether any circumstances have changed to meet the criteria for capitalization. The Company did not incur any expenses to obtain research and development agreements and costs to fulfill those contracts do not generate or enhance resources of the entity. As such, no costs to obtain or fulfill contracts have been capitalized at period end. |
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 instruments that have been placed with customers under reagent rental agreements; costs of materials, direct labor and manufacturing overhead costs on the T2Dx instruments sold to customers; and other costs such as customer support costs, royalties and license fees, warranty and repair and maintenance expense on the T2Dx instruments 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 contribution agreements, costs associated with the manufacture of developed products and include salaries and benefits, stock compensation, research‑related facility and overhead costs, laboratory supplies, equipment and contract services. |
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 June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (“ASU 2018-18”), which clarifies the interaction between ASC 808, Collaborative Arrangements and ASC 606, Revenue from Contracts with Customers. Certain transactions between participants in a collaborative arrangement should be accounted for under ASC 606 when the counterparty is a customer. In addition, ASU 2018-18 precludes an entity from presenting consideration from a transaction in a collaborative arrangement as revenue if the counterparty is not a customer for that transaction. ASU 2018-18 should be applied retrospectively to the date of initial application of ASC 606. This guidance is effective for interim and fiscal periods beginning after December 15, 2019. We adopted ASU 2018-18 on January 1, 2020. The adoption did not have a material impact on our financial statements. Accounting Standards Issued, Not Adopted In December 2019, the FASB issued ASU No. 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Disaggregation of Revenue by Major Source | The following table disaggregates our revenue by major source (in thousands): Three months ended, March 31, 2020 2019 Product Revenue Instruments $ 247 $ 535 Consumables 745 733 Instrument rentals 53 46 Total Product Revenue 1,045 1,314 Research Revenue — 142 Contribution Revenue 1,500 329 Total Revenue $ 2,545 $ 1,785 |
Non-US [Member] | Revenue [Member] | Customer Concentration Risk [Member] | |
Schedule of Concentration of Risk, by Risk Factor | International customers who represented 10% or more of the Company’s total revenue for the three months ended March 31, 2020 and 2019 were as follows: Three Months Ended March 31, 2020 2019 Customer A * 13 % Customer B * 11 % *Less than 10% for the period indicated |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Liabilities at Fair value on a Recurring Basis | 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 carried at fair value categorized using the lowest level of input applicable to each financial instrument as of March 31, 2020 and December 31, 2019 (in thousands): Balance at March 31, 2020 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Money market funds $ 726 $ 726 $ — $ — Restricted cash 180 180 — — $ 906 $ 906 $ — $ — Liabilities: Derivative liability $ 2,314 $ — $ — $ 2,314 $ 2,314 $ — $ — $ 2,314 Balance at December 31, 2019 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Money market funds $ 4,301 $ 4,301 $ — $ — Restricted cash 180 180 — — $ 4,481 $ 4,481 $ — $ — Liabilities: Derivative liability $ 2,425 $ — $ — $ 2,425 $ 2,425 $ — $ — $ 2,425 |
Summary of Contingent Interest Payments | The estimated fair value of the derivative at March 31, 2020 was determined using a probability-weighted discounted cash flow model that includes contingent interest payments under the following scenarios: Range 4% contingent interest beginning in 2020 90.0 % 4% contingent interest beginning in 2021 10.0 % |
Roll-Forward of Fair Value of Derivative Liability | The following table provides a roll-forward of the fair value of the derivative liability (in thousands): Balance at December 31, 2019 $ 2,425 Change in fair value of derivative liability, recorded as interest expense (111 ) Balance at March 31, 2020 $ 2,314 |
Supplemental Balance Sheet In_2
Supplemental Balance Sheet Information (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Inventory | Inventories are stated at the lower of cost or net realizable value on a first-in, first-out basis and are comprised of the following (in thousands): March 31, 2020 December 31, 2019 Raw materials $ 1,232 $ 1,617 Work-in-process 1,016 1,227 Finished goods 1,027 755 Total inventories, net $ 3,275 $ 3,599 |
Schedule of Property and Equipment | Property and equipment consists of the following (in thousands): March 31, 2020 December 31, 2019 Office and computer equipment $ 538 $ 538 Software 762 762 Laboratory equipment 4,785 4,747 Furniture 194 194 Manufacturing equipment 672 672 Manufacturing tooling and molds 255 255 T2-owned instruments and components 5,575 6,775 Leasehold improvements 3,497 3,497 Construction in progress 1,642 1,641 17,920 19,081 Less accumulated depreciation and amortization (13,688 ) (13,236 ) Property and equipment, net $ 4,232 $ 5,845 |
Components of Accrued Expenses | Accrued expenses consist of the following (in thousands): March 31, 2020 December 31, 2019 Accrued payroll and compensation $ 1,582 $ 3,193 Accrued final fee 2,568 2,445 Accrued research and development expenses 413 267 Accrued professional services 1,174 511 Accrued interest 906 908 Operating lease liabilities 2,033 1,983 Other accrued expenses 1,353 1,900 Total accrued expenses and other current liabilities $ 10,029 $ 11,207 |
Notes Payable (Tables)
Notes Payable (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | Future principal payments on the notes payable are as follows (in thousands): March 31, 2020 December 31, 2019 Term loan agreement before unamortized PIK interest, discount and issuance costs $ 48,077 $ 48,077 Less: unamortized paid-in-kind interest (2,888 ) (3,284 ) Less: unamortized discount and deferred issuance costs (1,789 ) (1,891 ) Total notes payable $ 43,400 $ 42,902 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock Option Activity | The following is a summary of option activity under the Stock Incentive Plans and Inducement Plan (in thousands, except share and per share amounts): Number of Shares Weighted-Average Exercise Price Per Share Weighted-Average Remaining Contractual Term (In years) Aggregate Intrinsic Value Outstanding at December 31, 2019 6,353,330 $ 4.95 7.29 $ 229 Granted 4,011,500 0.99 Exercised — — Forfeited (528,087 ) 2.09 Cancelled (38,876 ) 10.93 Outstanding at March 31, 2020 9,797,867 $ 3.46 8.00 $ 200 Exercisable at March 31, 2020 3,679,029 $ 6.25 5.57 $ — Vested or expected to vest at March 31, 2020 8,534,515 $ 3.74 7.76 $ 151 |
Schedule of Estimated Assumptions Used to Calculate Weighted-Average Grant Date Fair Value of Options Granted | There were no options exercised in the three months ended March 31, 2020 and 2019. The weighted-average grant date fair values of stock options granted in the three month periods ended March 31, 2020 and 2019 were $0.74 per share and $2.20 per share, respectively, and were calculated using the following estimated assumptions: Three Months Ended March 31, 2020 2019 Weighted-average risk-free interest rate 1.50 % 2.52 % Expected dividend yield — % — % Expected volatility 91 % 71 % Expected terms 6.0 years 6.0 years |
Schedule of Nonvested Restricted Stock Units Activity | The following is a summary of restricted stock unit activity under the 2014 Plan (in thousands, except share and per share amounts): Number of Shares Weighted-Average Grant Date Fair Value Nonvested at December 31, 2019 1,295,508 4.19 Granted 917,064 0.54 Vested (297,245 ) 3.72 Forfeited (438,430 ) 4.10 Cancelled — — Nonvested at March 31, 2020 1,476,897 2.04 |
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 resulting from awards granted under Stock Incentive Plans, including the Inducement Plan and 2014 ESPP, that was recorded in the Company’s results of operations for the periods presented (in thousands): Three Months Ended March 31, 2020 2019 Cost of product revenue $ 42 $ 50 Research and development 299 364 Selling, general and administrative 802 1,506 Total stock-based compensation expense $ 1,143 $ 1,920 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | 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: Three Months Ended March 31, 2020 2019 Options to purchase common shares 9,797,867 5,092,470 Restricted stock units 1,476,897 1,656,048 Warrants to purchase common stock 1,097,249 528,958 Total 12,372,013 7,277,476 |
Nature of Business - Additional
Nature of Business - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | ||||
Mar. 31, 2020 | Apr. 07, 2020 | Dec. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | |
Nature of Business | |||||
Cash and cash equivalents | $ 36,323 | $ 11,033 | |||
Accumulated deficit | (391,126) | (376,177) | |||
Stockholders’ deficit | $ (7,697) | (34,005) | $ (1,580) | $ 11,387 | |
Reduction in employee headcount | 22.00% | ||||
Severance costs | $ 400 | ||||
Other accrued expenses | 1,353 | $ 1,900 | |||
Subsequent Event [Member] | |||||
Nature of Business | |||||
Minimum bid price of common stock for continued listing | $ 1 | ||||
Term Loan Agreement [Member] | CRG [Member] | |||||
Nature of Business | |||||
Minimum cash balance | 5,000 | ||||
Severance [Member] | |||||
Nature of Business | |||||
Other accrued expenses | $ 300 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | ||
Mar. 31, 2020USD ($)Segment | Mar. 31, 2019USD ($) | Dec. 31, 2019USD ($) | |
Product Information [Line Items] | |||
Number of operating segments | Segment | 1 | ||
Total revenue | $ 2,545,000 | $ 1,785,000 | |
Outstanding receivable | 2,454,000 | $ 2,825,000 | |
Aggregate amount of transaction price allocated to remaining performance obligations for contracts with original duration greater than one year | $ 200,000 | ||
Remaining performance obligation, expected timing of satisfaction | The Company expects to recognize revenue on the remaining performance obligations over the next 21 months. | ||
Contract assets | $ 0 | 0 | |
Contract liabilities | 200,000 | 200,000 | |
Revenue recognized relating to contract liabilities | 100,000 | ||
Costs to obtain or fulfill contract capitalized | $ 0 | ||
Minimum [Member] | |||
Product Information [Line Items] | |||
Aggregate amount of transaction price allocated to remaining performance obligations, original duration | 1 year | ||
Maximum [Member] | |||
Product Information [Line Items] | |||
Original expected period of contracts for which value of unsatisfied performance obligations not to be disclosed | 1 year | ||
T2 Dx [Member] | |||
Product Information [Line Items] | |||
Maintenance Services period (in years) | 1 year | ||
Additional period for Maintenance Service option (in years) | 1 year | ||
Non-US [Member] | |||
Product Information [Line Items] | |||
Total revenue | $ 400,000 | $ 600,000 | |
Outstanding receivable | $ 600,000 | $ 1,200,000 | |
Revenue [Member] | Geographic Concentration Risk [Member] | Non-US [Member] | |||
Product Information [Line Items] | |||
Total revenue (as a percent) | 17.00% | 36.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Concentration of Risk, by Risk Factor (Detail) - Non-US [Member] - Revenue [Member] - Customer Concentration Risk [Member] | 3 Months Ended |
Mar. 31, 2019 | |
Customer A [Member] | |
Concentration Risk [Line Items] | |
Concentration risk percentage | 13.00% |
Customer B [Member] | |
Concentration Risk [Line Items] | |
Concentration risk percentage | 11.00% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Disaggregation of Revenue by Major Resource (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Disaggregation Of Revenue [Line Items] | ||
Total revenue | $ 2,545 | $ 1,785 |
Product Instruments [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 247 | 535 |
Product Consumables [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 745 | 733 |
Instrument Rentals [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 53 | 46 |
Total Product Revenue [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 1,045 | 1,314 |
Research [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 142 | |
Contribution Revenue [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | $ 1,500 | $ 329 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Assets and Liabilities at Fair value on a Recurring Basis (Detail) - Estimate of Fair Value Measurement [Member] - Recurring [Member] - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Assets: | ||
Restricted cash | $ 180 | $ 180 |
Total assets | 906 | 4,481 |
Liabilities: | ||
Derivative liability | 2,314 | 2,425 |
Total Liabilities | 2,314 | 2,425 |
Money Market Funds [Member] | ||
Assets: | ||
Cash | 726 | 4,301 |
Level 1 [Member] | ||
Assets: | ||
Restricted cash | 180 | 180 |
Total assets | 906 | 4,481 |
Level 1 [Member] | Money Market Funds [Member] | ||
Assets: | ||
Cash | 726 | 4,301 |
Level 3 [Member] | ||
Liabilities: | ||
Derivative liability | 2,314 | 2,425 |
Total Liabilities | $ 2,314 | $ 2,425 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2020 | Dec. 31, 2019 | |
Certificates of deposit [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Certificates of deposit classified as restricted cash | $ 0.2 | $ 0.2 |
CRG [Member] | Term Loan Agreement [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Additional interest rate, event of default (as a percent) | 4.00% | |
Derivative liability | $ 2.3 | $ 2.4 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Contingent Interest Payments (Detail) - CRG [Member] - Term Loan Agreement [Member] - Measurement Input, Discount Rate [Member] | 3 Months Ended |
Mar. 31, 2020 | |
Contingent Interest Beginning in 2020 [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
4% contingent interest beginning in 2020 | 90.00% |
Contingent Interest Beginning in 2021 [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
4% contingent interest beginning in 2020 | 10.00% |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of Contingent Interest Payments (Parenthetical) (Detail) - CRG [Member] - Term Loan Agreement [Member] | 3 Months Ended |
Mar. 31, 2020 | |
Contingent Interest Beginning in 2020 [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Contingent payment of interest rate | 4.00% |
Contingent Interest Beginning in 2021 [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Contingent payment of interest rate | 4.00% |
Fair Value Measurements - Roll-
Fair Value Measurements - Roll-Forward of Fair Value of Derivative Liability (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Change in fair value of derivative liability, recorded as interest expense | $ (111) | $ 83 |
Probability-Weighted Discounted Cash Flow Model [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Balance at December 31, 2019 | 2,425 | |
Change in fair value of derivative liability, recorded as interest expense | (111) | |
Balance at March 31, 2020 | $ 2,314 |
Restricted Cash - Additional In
Restricted Cash - Additional Information (Detail) - USD ($) $ in Millions | Mar. 31, 2020 | Dec. 31, 2019 |
Certificates of deposit [Member] | ||
Restricted Cash And Cash Equivalents Items [Line Items] | ||
Security deposit | $ 0.2 | $ 0.2 |
Supplemental Balance Sheet In_3
Supplemental Balance Sheet Information - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Balance Sheet Related Disclosures [Abstract] | ||
Raw materials | $ 1,232 | $ 1,617 |
Work-in-process | 1,016 | 1,227 |
Finished goods | 1,027 | 755 |
Total inventories, net | $ 3,275 | $ 3,599 |
Supplemental Balance Sheet In_4
Supplemental Balance Sheet Information - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 17,920 | $ 19,081 |
Less accumulated depreciation and amortization | (13,688) | (13,236) |
Property and equipment, net | 4,232 | 5,845 |
Office and Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 538 | 538 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 762 | 762 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 4,785 | 4,747 |
Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 194 | 194 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 672 | 672 |
Manufacturing Tooling and Molds [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 255 | 255 |
T2-Owned Instruments and Components [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 5,575 | 6,775 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,497 | 3,497 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,642 | $ 1,641 |
Supplemental Balance Sheet In_5
Supplemental Balance Sheet Information - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
Supplemental Balance Sheet Information [Line Items] | |||
Raw materials and work-in-process inventory | $ 100 | $ 600 | |
Impairment of property and equipment | 629 | ||
Depreciation and amortization | 503 | $ 557 | |
Transfer from other liabilities to accrued expenses and other current liabilities related to fee from debt | 2,600 | 2,400 | |
Other accrued expenses | 1,353 | 1,900 | |
Accrued payroll and compensation | 1,582 | 3,193 | |
Transition Agreement [Member] | |||
Supplemental Balance Sheet Information [Line Items] | |||
Other accrued expenses | 600 | 1,000 | |
Accrued payroll and compensation | $ 200 | ||
Severance [Member] | |||
Supplemental Balance Sheet Information [Line Items] | |||
Other accrued expenses | $ 300 | ||
T2 Owned Instruments in Service [Member] | |||
Supplemental Balance Sheet Information [Line Items] | |||
Estimated useful lives (in years) | 5 years | ||
T2 Owned Instruments in Service [Member] | Product [Member] | |||
Supplemental Balance Sheet Information [Line Items] | |||
Depreciation expense recorded as a component of cost of product revenue | $ 100 | $ 200 | |
T2-Owned Instruments and Components [Member] | COVID-19 [Member] | |||
Supplemental Balance Sheet Information [Line Items] | |||
Decrease in carrying value of property and equipment | 600 | ||
Impairment of property and equipment | $ 600 |
Supplemental Balance Sheet In_6
Supplemental Balance Sheet Information - Components of Accrued Expenses (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Accrued Liabilities Current [Abstract] | ||
Accrued payroll and compensation | $ 1,582 | $ 3,193 |
Accrued final fee | 2,568 | 2,445 |
Accrued research and development expenses | 413 | 267 |
Accrued professional services | 1,174 | 511 |
Accrued interest | 906 | 908 |
Operating lease liabilities | 2,033 | 1,983 |
Other accrued expenses | 1,353 | 1,900 |
Total accrued expenses and other current liabilities | $ 10,029 | $ 11,207 |
Notes Payable - Schedule of Deb
Notes Payable - Schedule of Debt (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Debt Disclosure [Abstract] | ||
Term loan agreement before unamortized PIK interest, discount and issuance costs | $ 48,077 | $ 48,077 |
Less: unamortized paid-in-kind interest | (2,888) | (3,284) |
Less: unamortized discount and deferred issuance costs | (1,789) | (1,891) |
Total notes payable | $ 43,400 | $ 42,902 |
Notes Payable - Term Loan Agree
Notes Payable - Term Loan Agreement - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 24 Months Ended | |||
Sep. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2016 | Mar. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Common Stock [Member] | |||||||
Debt Instrument | |||||||
Number of shares issuable for warrants outstanding (in shares) | 568,291 | 528,958 | |||||
Exercise price of warrants | $ 1.55 | $ 4.35 | $ 8.06 | ||||
CRG [Member] | Term Loan Agreement [Member] | |||||||
Debt Instrument | |||||||
Proceeds from issuance of long-term debt | $ 40,000,000 | ||||||
Debt term (in years) | 6 years | ||||||
Debt instrument, term of interest-only payments (in years) | 4 years | ||||||
Final fee as a percentage of the principal outstanding (as a percent) | 10.00% | 8.00% | |||||
Annual fixed rate (as a percent) | 11.50% | ||||||
Deferred interest rate (as a percent) | 3.50% | ||||||
Debt instrument, prepayment fee term (in years) | 5 years | ||||||
Debt instrument covenant compliance revenue target | $ 4,000,000 | $ 9,000,000 | |||||
Additional interest rate, event of default (as a percent) | 4.00% | ||||||
CRG [Member] | Term Loan Agreement [Member] | Scenario Forecast [Member] | |||||||
Debt Instrument | |||||||
Debt instrument, quarterly principal payment | $ 12,000,000 | ||||||
Debt instrument covenant compliance revenue target | $ 140,000,000 | $ 95,000,000 | |||||
CRG [Member] | Term Loan Agreement, Amended [Member] | Scenario Forecast [Member] | |||||||
Debt Instrument | |||||||
Debt instrument covenant compliance revenue target | $ 43,000,000 | $ 15,000,000 |
Notes Payable - Equipment Lease
Notes Payable - Equipment Lease Credit Facility - Additional Information (Detail) - Finance Lease Obligations [Member] | 1 Months Ended | 12 Months Ended | ||
Jun. 30, 2016USD ($)Draw | Apr. 30, 2016USD ($) | Oct. 31, 2015USD ($) | Dec. 31, 2019USD ($) | |
Debt Instrument | ||||
Initial borrowing capacity | $ 10,000,000 | |||
Maximum borrowings available (up to) | $ 5,000,000 | |||
Debt term (in months) | 36 months | |||
Repurchase price as percentage of original equipment value that the equipment under lease may be repurchased by lessee | 10.00% | |||
Minimum lease period to extend lease (in years) | 1 year | |||
Amount of draw | $ 2,500,000 | $ 2,100,000 | ||
Amount of monthly payment | $ 79,000 | $ 67,000 | ||
Number of draws | Draw | 2 | |||
Repurchase of equipment | $ 300,000 |
Stockholders' (Deficit) Equity
Stockholders' (Deficit) Equity - Additional Information (Detail) - USD ($) | Apr. 08, 2020 | Apr. 07, 2020 | Mar. 09, 2020 | Jul. 30, 2019 | Jul. 29, 2019 | Mar. 31, 2020 |
Subsequent Event [Member] | Lincoln Park [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Purchase agreement termination effective date | Apr. 8, 2020 | |||||
Equity Distribution Agreement [Member] | Canaccord [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Number of shares issued/sold | 73,237,178 | |||||
Aggregate gross sales amount of common stock | $ 48,100,000 | |||||
Sale of common stock authorized remaining amount | $ 46,900,000 | |||||
Sales Agreement [Member] | Canaccord [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Sale of common stock authorized, amount | $ 65,000,000 | $ 30,000,000 | ||||
Number of shares issued/sold | 67,750,678 | |||||
Percentage of agent service fee | 3.00% | |||||
Proceeds from issuance of common stock | $ 39,800,000 | |||||
Sales Agreement [Member] | Subsequent Event [Member] | Canaccord [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Sale of common stock authorized, amount | $ 95,000,000 | |||||
Purchase Agreement | Lincoln Park [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Sale of common stock authorized, amount | $ 30,000,000 | |||||
Number of shares issued/sold | 413,349 | 400,000 | ||||
Proceeds from issuance of common stock | $ 300,000 | |||||
Effective period for sale of common stock | 36 months | |||||
Maximum number of shares issue per business day | 200,000 | |||||
Maximum amount of shares to be issue per business day | $ 2,000,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | |
Share-Based Compensation | ||||
Fair value of vested stock options | $ 800 | $ 1,000 | ||
Stock-based compensation expense | $ 1,143 | 1,920 | ||
T2Dx Instruments and Components [Member] | ||||
Share-Based Compensation | ||||
Stock-based compensation expense | 100 | |||
Restricted Stock Units [Member] | ||||
Share-Based Compensation | ||||
Weighted-average period | 2 years 1 month 17 days | |||
Unrecognized compensation cost related to unvested stock options | $ 1,100 | |||
2014 Stock Option Plan [Member] | Stock Options [Member] | ||||
Share-Based Compensation | ||||
Shares available for future issuance under stock incentive plan | 823,529 | |||
Percentage of common shares outstanding | 4.00% | |||
Shares available for grant | 1,302,541 | |||
2014 Stock Option Plan [Member] | Restricted Stock Units [Member] | ||||
Share-Based Compensation | ||||
Restricted stock units vested | 297,245 | |||
Restricted stock units granted | 917,064 | |||
Inducement Award Plan [Member] | ||||
Share-Based Compensation | ||||
Shares available for grant | 2,055,103 | |||
Shares available for authorization | 5,625,000 | |||
2006 and 2014 Stock Option Plans [Member] | Stock Options [Member] | ||||
Share-Based Compensation | ||||
Aggregate fair value of options granted | $ 3,000 | $ 2,000 | ||
Unrecognized compensation cost related to non-vested stock options | $ 7,300 | |||
Weighted-average period | 2 years 10 months 24 days | |||
2006 and 2014 Stock Option Plans and Inducement Plan [Member] | Stock Options [Member] | ||||
Share-Based Compensation | ||||
Options exercised | 0 | 0 | ||
Weighted average fair value of options granted | $ 0.74 | $ 2.20 | ||
2006 and 2014 Stock Option Plans and Inducement Plan [Member] | Restricted Stock Units [Member] | ||||
Share-Based Compensation | ||||
Aggregate fair value of restricted stock units granted | $ 500 | |||
2006 and 2014 Stock Option Plans and Inducement Plan [Member] | Restricted Stock Units [Member] | Restricted Stock Units Vested, Not Reflected As Outstanding Shares [Member] | ||||
Share-Based Compensation | ||||
Restricted stock units vested | 73,172 | |||
2006 and 2014 Stock Option Plans and Inducement Plan [Member] | Restricted Stock Units with Market Condition [Member] | ||||
Share-Based Compensation | ||||
Restricted stock units granted | 399,437 | |||
Compensation Cost | $ 700 | |||
Maximum [Member] | 2006 Stock Option Plan [Member] | Stock Options [Member] | ||||
Share-Based Compensation | ||||
Expiration period | 10 years | |||
Vesting period | 4 years | |||
Maximum [Member] | 2014 Stock Option Plan [Member] | Stock Options [Member] | ||||
Share-Based Compensation | ||||
Expiration period | 10 years | |||
Vesting period | 4 years |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - 2006 and 2014 Stock Option Plans and Inducement Plan [Member] - Stock Options [Member] - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
Share-Based Compensation | |||
Number of Shares Outstanding, beginning of the period | 6,353,330 | ||
Number of Shares, Granted | 4,011,500 | ||
Number of Shares, Exercised | 0 | 0 | |
Number of Shares, Forfeited | (528,087) | ||
Number of Shares, Cancelled | (38,876) | ||
Number of Shares Outstanding, end of the period | 9,797,867 | 6,353,330 | |
Number of Shares, Exercisable | 3,679,029 | ||
Number of Shares, Vested or expected to vest | 8,534,515 | ||
Weighted-Average Exercise Price Per Share Outstanding, beginning of the period | $ 4.95 | ||
Weighted-Average Exercise Price Per Share, Granted | 0.99 | ||
Weighted-Average Exercise Price Per Share, Forfeited | 2.09 | ||
Weighted-Average Exercise Price Per Share, Cancelled | 10.93 | ||
Weighted-Average Exercise Price Per Share Outstanding, end of the period | 3.46 | $ 4.95 | |
Weighted-Average Exercise Price Per Share, Exercisable | 6.25 | ||
Weighted-Average Exercise Price Per Share, Vested or expected to vest | $ 3.74 | ||
Weighted-Average Remaining Contractual Term, Outstanding | 8 years | 7 years 3 months 14 days | |
Weighted-Average Remaining Contractual Term, Exercisable | 5 years 6 months 25 days | ||
Weighted-Average Remaining Contractual Term, Vested or expected to vest | 7 years 9 months 3 days | ||
Aggregate Intrinsic Value, Outstanding, beginning of the period | $ 229 | ||
Aggregate Intrinsic Value Outstanding, end of the period | 200 | $ 229 | |
Aggregate Intrinsic Value, Vested or expected to vest | $ 151 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Estimated Assumptions Used to Calculate Weighted-Average Grant Date Fair Value of Options Granted (Detail) - Stock Options [Member] - 2006 and 2014 Stock Option Plans and Inducement Plan [Member] | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share-Based Compensation | ||
Weighted-average risk-free interest rate | 1.50% | 2.52% |
Expected volatility | 91.00% | 71.00% |
Expected terms | 6 years | 6 years |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Nonvested Restricted Stock Units Activity (Detail) - 2014 Stock Option Plan [Member] - Restricted Stock Units [Member] | 3 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Share-Based Compensation | |
Number of Shares, Nonvested restricted shares at the beginning of the period | shares | 1,295,508 |
Number of Shares, Restricted shares granted | shares | 917,064 |
Number of Shares, Restricted shares vested | shares | (297,245) |
Number of Shares, Restricted shares forfeited | shares | (438,430) |
Number of Shares, Cancelled | shares | 0 |
Number of Shares, Nonvested restricted shares at the end of the period | shares | 1,476,897 |
Weighted-Average Grant Date Fair Value, Nonvested restricted shares at the beginning of the period | $ / shares | $ 4.19 |
Weighted-Average Grant Date Fair Value, Granted | $ / shares | 0.54 |
Weighted-Average Grant Date Fair Value, Vested | $ / shares | 3.72 |
Weighted-Average Grant Date Fair Value, Forfeited | $ / shares | 4.10 |
Weighted-Average Grant Date Fair Value, Cancelled | $ / shares | 0 |
Weighted-Average Grant Date Fair Value, Nonvested restricted shares at the end of the period | $ / shares | $ 2.04 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock-Based Compensation Expense for Stock Options Granted that was Recorded in the Company's Results of Operations (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Stock-based compensation expense | ||
Stock-based compensation expense | $ 1,143 | $ 1,920 |
Cost of Product Revenue [Member] | ||
Stock-based compensation expense | ||
Stock-based compensation expense | 42 | 50 |
Research and Development [Member] | ||
Stock-based compensation expense | ||
Stock-based compensation expense | 299 | 364 |
Selling, General and Administrative [Member] | ||
Stock-based compensation expense | ||
Stock-based compensation expense | $ 802 | $ 1,506 |
Warrants - Additional Informati
Warrants - Additional Information (Detail) - Common Stock [Member] - USD ($) $ / shares in Units, $ in Millions | Aug. 31, 2019 | Sep. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2016 |
Class of Warrant or Right [Line Items] | ||||
Number of shares issuable for warrants outstanding | 568,291 | 528,958 | ||
Exercise price of warrants | $ 1.55 | $ 4.35 | $ 8.06 | |
Fair market value of amended warrants | $ 0.9 | $ 0.7 | ||
Incremental fair value of warrants adjustment | $ 0.1 | $ 0.1 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the computation of diluted net loss per share | 12,372,013 | 7,277,476 |
Options to Purchase Common Shares [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the computation of diluted net loss per share | 9,797,867 | 5,092,470 |
Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the computation of diluted net loss per share | 1,476,897 | 1,656,048 |
Warrants to Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the computation of diluted net loss per share | 1,097,249 | 528,958 |
Co-Development Agreements - Add
Co-Development Agreements - Additional Information (Detail) | Sep. 21, 2016USD ($) | Jan. 31, 2019USD ($) | Mar. 31, 2018USD ($)specie | Mar. 31, 2020USD ($) | Mar. 31, 2019USD ($) | Sep. 30, 2019USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Revenue | $ 2,545,000 | $ 1,785,000 | ||||
Co Development Partnership Agreement [Member] | Canon U.S. Life Sciences Inc [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Revenue | 0 | 100,000 | ||||
Co Development Partnership Agreement [Member] | CARB-X [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Revenue | 0 | 300,000 | ||||
Number of additional bacteria species added to existing product candidate | specie | 20 | |||||
Co Development Partnership Agreement [Member] | CARB-X [Member] | Maximum [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Aggregate consideration receivable | $ 2,000,000 | |||||
Collaborative arrangement reimbursement amount | $ 900,000 | 1,100,000 | 900,000 | |||
Milestone payment | $ 900,000 | |||||
Co Development Partnership Agreement [Member] | Biomedical Advanced Research and Development Authority [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Revenue | $ 1,500,000 | $ 0 | ||||
Initial value of consideration receivable | $ 6,000,000 | |||||
Co Development Partnership Agreement [Member] | Biomedical Advanced Research and Development Authority [Member] | Maximum [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Aggregate consideration receivable | $ 69,000,000 | |||||
Private Placement [Member] | Canon U S A Inc [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Proceeds from sale of shares in related party | $ 39,700,000 | |||||
Percentage of outstanding shares at date of sale | 19.90% |
Leases - Additional Information
Leases - Additional Information (Detail) - USD ($) | Sep. 30, 2017 | Aug. 31, 2018 | Mar. 31, 2017 | Apr. 30, 2015 | Nov. 30, 2014 | Mar. 31, 2020 | Dec. 31, 2019 | Jan. 31, 2018 | Jan. 11, 2011 |
Leases [Line Items] | |||||||||
Right-of-use assets | $ 2,966,000 | $ 3,360,000 | |||||||
Operating Lease Entered into November 2014 [Member] | License Agreement [Member] | Office Space [Member] | |||||||||
Leases [Line Items] | |||||||||
Lease expiration date | Dec. 31, 2021 | Dec. 31, 2017 | |||||||
Security deposit | $ 50,000 | ||||||||
Office Space, Laboratory Space, and Equipment [Member] | |||||||||
Leases [Line Items] | |||||||||
Right-of-use assets | 0 | ||||||||
Lease liabilities | $ 0 | ||||||||
Maximum lease period to not recognize right of use assets or lease liabilities | 12 months | ||||||||
Office and Laboratory Space [Member] | Operating Lease Entered into August 2010 [Member] | |||||||||
Leases [Line Items] | |||||||||
Lease expiration date | Dec. 31, 2021 | ||||||||
Security deposit | $ 160,000 | $ 400,000 | |||||||
Office, Laboratory and Manufacturing Space [Member] | Operating Lease Entered into May 2013 [Member] | |||||||||
Leases [Line Items] | |||||||||
Lease expiration date | Dec. 31, 2020 | ||||||||
Laboratory Space [Member] | Operating Lease Entered into November 2014 [Member] | |||||||||
Leases [Line Items] | |||||||||
Security deposit | $ 281,000 | ||||||||
Term of lease | 6 years | ||||||||
Space build-out costs paid | $ 1,400,000 | ||||||||
Space build-out costs | $ 2,200,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 3 Months Ended | 24 Months Ended | ||
Mar. 31, 2020 | Dec. 31, 2007 | Dec. 31, 2019 | Dec. 31, 2006 | |
Commitments and Contingencies [Line Items] | ||||
Accrued payroll and compensation | $ 1,582,000 | $ 3,193,000 | ||
License Agreement [Member] | ||||
Commitments and Contingencies [Line Items] | ||||
Shares issued | 84,678 | |||
Royalty on net sales sublicensing gross revenue | 10.00% | |||
Transition Agreement [Member] | ||||
Commitments and Contingencies [Line Items] | ||||
Payment period on transition and health benefits | 15 months | |||
Transition Agreement [Member] | Bonus [Member] | ||||
Commitments and Contingencies [Line Items] | ||||
Accrued payroll and compensation | 200,000 | |||
Transition Agreement [Member] | Other Accrued Expenses [Member] | ||||
Commitments and Contingencies [Line Items] | ||||
Transition payments and health benefits | $ 600,000 | $ 1,000,000 | ||
Minimum [Member] | License Agreement [Member] | ||||
Commitments and Contingencies [Line Items] | ||||
Annual license fee payable | $ 5,000 | |||
Percentage of royalty on net sales | 0.50% | |||
Maximum [Member] | License Agreement [Member] | ||||
Commitments and Contingencies [Line Items] | ||||
Annual license fee payable | $ 25,000 | |||
Percentage of royalty on net sales | 3.50% |