$TTOO
T2 Biosystems, Inc.

2020 Q3 Form 10-Q Financial Statement

#000156459020051270 Filed on November 05, 2020

View on sec.gov

Income Statement

Concept 2020 Q3 2019 Q3 2019 Q2
Revenue $5.245M $1.677M $1.804M
YoY Change 212.76% -32.0% -54.11%
Cost Of Revenue $6.830M $3.940M $4.820M
YoY Change 73.35% 29.61% 39.31%
Gross Profit -$1.590M -$2.270M -$3.020M
YoY Change -29.96% 291.38% -742.55%
Gross Profit Margin -30.31% -135.36% -167.41%
Selling, General & Admin $5.083M $5.981M $6.722M
YoY Change -15.01% 1.84% -11.68%
% of Gross Profit
Research & Development $3.965M $4.098M $4.048M
YoY Change -3.25% 50.39% 7.98%
% of Gross Profit
Depreciation & Amortization $400.0K $500.0K $600.0K
YoY Change -20.0% -16.67% 0.0%
% of Gross Profit
Operating Expenses $9.048M $10.08M $10.77M
YoY Change -10.23% 17.22% -5.19%
Operating Profit -$10.64M -$12.35M -$13.79M
YoY Change -13.85% 34.58% 26.63%
Interest Expense -$646.0K -$1.876M -$2.000M
YoY Change -65.57% 2.18% 32.45%
% of Operating Profit
Other Income/Expense, Net $27.00K $51.00K $140.0K
YoY Change -47.06% -79.01% 102.9%
Pretax Income -$11.26M -$14.17M -$15.65M
YoY Change -20.54% 31.57% 27.03%
Income Tax
% Of Pretax Income
Net Earnings -$11.26M -$14.17M -$15.65M
YoY Change -20.58% 31.62% 26.96%
Net Earnings / Revenue -214.59% -845.02% -867.35%
Basic Earnings Per Share
Diluted Earnings Per Share -$76.19K -$312.0K -$352.2K
COMMON SHARES
Basic Shares Outstanding 44.54M 44.34M
Diluted Shares Outstanding

Balance Sheet

Concept 2020 Q3 2019 Q3 2019 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $61.26M $16.21M $28.42M
YoY Change 277.91% -73.09% -59.81%
Cash & Equivalents $19.06M $16.39M $28.42M
Short-Term Investments $42.20M
Other Short-Term Assets $2.970M $1.920M $710.0K
YoY Change 54.69% -4.95% -17.44%
Inventory $3.569M $4.110M $3.100M
Prepaid Expenses
Receivables $3.860M $1.570M $1.179M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $51.45M $23.81M $33.41M
YoY Change 116.09% -64.63% -55.64%
LONG-TERM ASSETS
Property, Plant & Equipment $3.585M $10.05M $7.262M
YoY Change -64.33% 22.71% -14.56%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments $20.19M
YoY Change
Other Assets $680.0K $206.0K $206.0K
YoY Change 230.1% 0.0% -47.18%
Total Long-Term Assets $26.18M $10.44M $11.76M
YoY Change 150.69% 21.77% 32.39%
TOTAL ASSETS
Total Short-Term Assets $51.45M $23.81M $33.41M
Total Long-Term Assets $26.18M $10.44M $11.76M
Total Assets $77.63M $34.25M $45.17M
YoY Change 126.64% -54.87% -46.36%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $2.410M $3.430M $2.911M
YoY Change -29.74% 522.5% 153.13%
Accrued Expenses $7.654M $8.800M $8.823M
YoY Change -13.02% 98.78% 109.57%
Deferred Revenue $610.0K $677.0K
YoY Change -19.95%
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $0.00 $42.26M $42.89M
YoY Change -100.0% 1142.94% 1037.67%
Total Short-Term Liabilities $10.35M $57.70M $57.80M
YoY Change -82.06% 513.74% 460.34%
LONG-TERM LIABILITIES
Long-Term Debt $44.61M $0.00 $0.00
YoY Change -100.0% -100.0%
Other Long-Term Liabilities $3.080M $2.470M $2.990M
YoY Change 24.7% 113.48% 210.81%
Total Long-Term Liabilities $3.080M $2.470M $2.990M
YoY Change 24.7% 113.48% 210.81%
TOTAL LIABILITIES
Total Short-Term Liabilities $10.35M $57.70M $57.80M
Total Long-Term Liabilities $3.080M $2.470M $2.990M
Total Liabilities $13.43M $60.17M $60.79M
YoY Change -77.68% 469.9% 439.06%
SHAREHOLDERS EQUITY
Retained Earnings -$413.1M -$362.1M -$348.0M
YoY Change 14.07% 19.47%
Common Stock $336.2M $332.3M
YoY Change 2.82%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $17.60M -$25.91M -$15.62M
YoY Change
Total Liabilities & Shareholders Equity $77.63M $34.25M $45.17M
YoY Change 126.64% -54.87% -46.36%

Cashflow Statement

Concept 2020 Q3 2019 Q3 2019 Q2
OPERATING ACTIVITIES
Net Income -$11.26M -$14.17M -$15.65M
YoY Change -20.58% 31.62% 26.96%
Depreciation, Depletion And Amortization $400.0K $500.0K $600.0K
YoY Change -20.0% -16.67% 0.0%
Cash From Operating Activities -$6.240M -$13.53M -$8.840M
YoY Change -53.88% 34.09% 2.55%
INVESTING ACTIVITIES
Capital Expenditures -$300.0K -$300.0K -$250.0K
YoY Change 0.0% -14.29% -53.7%
Acquisitions
YoY Change
Other Investing Activities -$32.97M
YoY Change
Cash From Investing Activities -$33.26M -$300.0K -$250.0K
YoY Change 10986.67% -14.29% -53.7%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 32.40M 1.620M 110.0K
YoY Change 1900.0% -4150.0% -99.78%
NET CHANGE
Cash From Operating Activities -6.240M -13.53M -8.840M
Cash From Investing Activities -33.26M -300.0K -250.0K
Cash From Financing Activities 32.40M 1.620M 110.0K
Net Change In Cash -7.100M -12.21M -8.980M
YoY Change -41.85% 16.51% -121.91%
FREE CASH FLOW
Cash From Operating Activities -$6.240M -$13.53M -$8.840M
Capital Expenditures -$300.0K -$300.0K -$250.0K
Free Cash Flow -$5.940M -$13.23M -$8.590M
YoY Change -55.1% 35.83% 6.31%

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us-gaap Nature Of Operations
NatureOfOperations
<p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">1. Nature of Business </p> <p style="margin-top:6pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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 <span style="font-style:italic;">in vitro</span> diagnostics company that has developed an innovative and proprietary technology platform that offers a rapid, sensitive and simple alternative to existing diagnostic methodologies. The Company is using its T2 Magnetic Resonance technology (“T2MR”) to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables rapid detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, plasma, serum, saliva, sputum, cerebral spinal fluid and urine, and can detect cellular targets at limits of detection as low as one colony forming unit per milliliter (“CFU/mL”). The Company’s initial development efforts target sepsis and Lyme disease, which are areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics. On September 22, 2014, the Company received market clearance from the U.S. Food and Drug Administration (“FDA”) for its first two products, the T2Dx<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup> Instrument (the “T2Dx”) and T2Candida<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup> Panel (“T2Candida”). On May 24, 2018, the Company received market clearance from the FDA for its T2Bacteria<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup> Panel (“T2Bacteria”). On February 6, 2019, the FDA granted the Company’s T2Resistance<sup style="font-size:85%;line-height:120%;vertical-align:top">TM</sup> Panel (“T2Resistance”) designation as a Breakthrough Device. On August 2, 2019, the Center for Medicare &amp; Medicaid Services (CMS) granted approval for a New Technology Add-on Payment (NTAP) for the T2Bacteria Panel for fiscal year 2020 and in September 2020, CMS extended the approval for 2021. On November 20, 2019, the Company’s T2Resistance Panel was granted a CE-Mark. <span style="color:#000000;">On June 30, 2020, the Company announced the U.S. launch of its COVID-19 molecular diagnostic test, the T2SARS-CoV-2 Panel, after validation of the test meeting the FDA’s requirements for an Emergency Use Authorization (EUA). In August 2020, the FDA issued EUA for the Company’s T2SARS-CoV-2 Panel.</span> The test is designed to detect the presence of the SARS-CoV-2 virus in a nasopharyngeal swab sample.<span style="color:#000000;">  </span></p> <p style="margin-bottom:0pt;margin-top:18pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Liquidity and Going Concern </p> <p style="margin-bottom:0pt;margin-top:6pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">At September 30, 2020, the Company had cash and cash equivalents of $19.1 million, marketable securities of $42.2 million, an accumulated deficit of $413.1 million, a stockholders’ equity of $17.6 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.</p> <p style="margin-top:12pt;margin-bottom:0pt;text-indent:5.15%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company is subject to a number of risks similar to other early commercial stage 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.</p> <p style="margin-top:12pt;margin-bottom:0pt;text-indent:5.15%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The COVID-19 pandemic </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">has impacted and may continue to</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> impact operations. </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company has</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> established protocols for continued manufacturing, distribution and servicing of </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">its</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> products with safe social distancing and personal protective equipment measures and for remote work for </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">certain </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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. </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company’s</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> hospital customers have restricted </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">the</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> sales team’s access to their facilities and </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">as a result, </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">the Company</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> significantly reduced </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">its</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> sales and general and administrative staffing levels to reduce expenses. </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company’s</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> customers may reduce their purchases of products. </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">C</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">ustomers may cease to comply with the terms of sales agreements and this may impact </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">the </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">ability to recognize revenue and hinder receivables collections. </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company has</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> a significant development</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> contract with a United States g</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">overnment agency and should the agency reduce, cancel or not grant additional milestone projects</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">, the Company’s</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> ability to continue </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">its</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> future product development may be impacted. </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The ability of the Company’s</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> shipping carrier</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">s</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> to deliver products to customers may be disrupted. </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> Company has</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> reviewed </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">its</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> suppliers and </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">quantities</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> of key materials and believe</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">s that it has</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> sufficient stocks and alternate sources of critical materials including personal protective equipment should </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">the</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> supply chains become disrupted</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">, although raw materials for the manufacturing of reagents is in high demand, and interruptions in supply are difficult to predict</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">. As further described in Note </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">5</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">, the Company</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> believe</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">s</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> the pandemic’s impact on </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">its</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> sales has impacted the recoverability of the value of T2</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">-</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">owned instruments and components.</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> 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.</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> </span></p> <p style="margin-top:12pt;margin-bottom:0pt;text-indent:5.15%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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.</p> <p style="margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Pursuant to the requirements of Accounting Standards Codification (“ASC”) 205-40, <span style="font-style:italic;">Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern</span>, management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued.</p> <p style="margin-top:12pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Management believes that its existing cash and cash equivalents and marketable securities at September 30, 2020 <span style="color:#000000;">will be sufficient to allow the Company to fund its current operating plan, at least a year from issuance of these financial statements. Certain elements of the Company’s operating plan are outside of the Company’s control, 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 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, all of which was paid by September 30, 2020. The Term Loan Agreement with CRG Servicing LLC (“CRG”) (Note 6) has certain covenants which require 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. As of the date of these financial statements, it is probable that the Company will achieve the revenue target of $15.0 million for the twenty-four month period ended December 31, 2020, however there are no assurances that the Company will achieve the revenue target of $43.0 million for the twenty-four month period ended December 31, 2021. Should the Company fail to meet 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. If the Company is unsuccessful in obtaining a waiver, it would pay the cure amount set forth under the Term Loan Agreement. While the Company believes it can continue as a going concern for at least a year from issuance of these financial statements, there can be no assurances the Company will continue to be in compliance with the cash covenant in future periods without additional funding.</span></p> <p style="margin-top:12pt;margin-bottom:0pt;text-indent:4.54%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On April 7, 2020, the Company received a letter from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last thirty consecutive business days, the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq Global Market under Nasdaq Listing Rule 5450(a)(1). On June 16, 2020, the Company received a letter from the Nasdaq stating that the Company had regained compliance. <span style="color:#000000;"> </span></p>
CY2020Q3 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
19100000
CY2020Q3 us-gaap Marketable Securities
MarketableSecurities
42200000
CY2020Q3 us-gaap Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
-413100000
CY2020Q3 us-gaap Stockholders Equity
StockholdersEquity
17600000
us-gaap Number Of Operating Segments
NumberOfOperatingSegments
1
CY2019Q3 us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
1677000
us-gaap Other Than Temporary Impairment Loss Debt Securities Available For Sale Recognized In Earnings
OtherThanTemporaryImpairmentLossDebtSecuritiesAvailableForSaleRecognizedInEarnings
0
us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
10342000
CY2020Q3 us-gaap Available For Sale Debt Securities Amortized Cost Basis
AvailableForSaleDebtSecuritiesAmortizedCostBasis
42212000
CY2020Q3 us-gaap Available For Sale Debt Securities Accumulated Gross Unrealized Gain Before Tax
AvailableForSaleDebtSecuritiesAccumulatedGrossUnrealizedGainBeforeTax
1000
CY2020Q3 us-gaap Available For Sale Debt Securities Accumulated Gross Unrealized Loss Before Tax
AvailableForSaleDebtSecuritiesAccumulatedGrossUnrealizedLossBeforeTax
37000
CY2020Q3 us-gaap Available For Sale Securities Debt Securities
AvailableForSaleSecuritiesDebtSecurities
42176000
CY2020Q3 us-gaap Available For Sale Securities Debt Maturities Within One Year Amortized Cost
AvailableForSaleSecuritiesDebtMaturitiesWithinOneYearAmortizedCost
21983000
CY2020Q3 us-gaap Available For Sale Securities Debt Maturities Within One Year Fair Value
AvailableForSaleSecuritiesDebtMaturitiesWithinOneYearFairValue
21990000
CY2020Q3 ttoo Available For Sale Securities Debt Maturities After One Through Two Years Amortized Cost
AvailableForSaleSecuritiesDebtMaturitiesAfterOneThroughTwoYearsAmortizedCost
20229000
CY2020Q3 ttoo Available For Sale Securities Debt Maturities After One Through Two Years Fair Value
AvailableForSaleSecuritiesDebtMaturitiesAfterOneThroughTwoYearsFairValue
20186000
CY2020Q3 us-gaap Available For Sale Debt Securities Amortized Cost Basis
AvailableForSaleDebtSecuritiesAmortizedCostBasis
42212000
CY2020Q3 us-gaap Available For Sale Securities Debt Securities
AvailableForSaleSecuritiesDebtSecurities
42176000
us-gaap Guarantees Indemnifications And Warranties Policies
GuaranteesIndemnificationsAndWarrantiesPolicies
<p style="margin-bottom:0pt;margin-top:18pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Guarantees </p> <p style="margin-bottom:0pt;margin-top:6pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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. </p> <p style="margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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. </p> <p style="margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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. </p> <p style="margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">As of September 30, 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. </p>
CY2020Q3 us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
5245000
us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
5266000
us-gaap Revenue Remaining Performance Obligation Expected Timing Of Satisfaction Explanation
RevenueRemainingPerformanceObligationExpectedTimingOfSatisfactionExplanation
The Company expects to recognize revenue on the remaining performance obligations over the next 23 months.
CY2019Q4 us-gaap Contract With Customer Asset Net
ContractWithCustomerAssetNet
0
CY2019Q4 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
200000
us-gaap Contract With Customer Liability Revenue Recognized
ContractWithCustomerLiabilityRevenueRecognized
200000
CY2020Q3 us-gaap Capitalized Contract Cost Gross
CapitalizedContractCostGross
0
CY2020Q3 us-gaap Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
1717000
CY2019Q4 us-gaap Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
1617000
CY2020Q3 us-gaap Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
1430000
CY2019Q4 us-gaap Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
1227000
CY2020Q3 us-gaap Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
422000
CY2019Q4 us-gaap Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
755000
CY2020Q3 us-gaap Inventory Net
InventoryNet
3569000
CY2019Q4 us-gaap Inventory Net
InventoryNet
3599000
CY2020Q3 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
17938000
CY2019Q4 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
19081000
CY2020Q3 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
14353000
CY2019Q4 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
13236000
CY2020Q3 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
3585000
CY2019Q4 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
5845000
CY2020Q3 us-gaap Inventory Work In Process And Raw Materials
InventoryWorkInProcessAndRawMaterials
0
CY2019Q4 us-gaap Inventory Work In Process And Raw Materials
InventoryWorkInProcessAndRawMaterials
600000
CY2020Q3 us-gaap Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
400000
CY2019Q3 us-gaap Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
500000
us-gaap Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
1300000
us-gaap Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
1700000
CY2020Q3 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
2954000
CY2019Q4 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
3193000
CY2019Q4 ttoo Accrued Final Fee Related To Debt
AccruedFinalFeeRelatedToDebt
2445000
CY2020Q3 ttoo Accrued Research And Development Expenses Current
AccruedResearchAndDevelopmentExpensesCurrent
474000
CY2019Q4 ttoo Accrued Research And Development Expenses Current
AccruedResearchAndDevelopmentExpensesCurrent
267000
CY2020Q3 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
569000
CY2019Q4 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
511000
CY2020Q3 us-gaap Interest Payable Current
InterestPayableCurrent
932000
CY2019Q4 us-gaap Interest Payable Current
InterestPayableCurrent
908000
CY2020Q3 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
1941000
CY2019Q4 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
1983000
CY2020Q3 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
784000
CY2019Q4 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
1900000
CY2020Q3 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
7654000
CY2019Q4 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
11207000
CY2019Q4 ttoo Accrued Final Fee Related To Debt
AccruedFinalFeeRelatedToDebt
2400000
CY2020Q3 ttoo Accrued Final Fee Noncurrent Related To Debt
AccruedFinalFeeNoncurrentRelatedToDebt
3100000
CY2020Q3 ttoo Debt Instrument Carrying Amount Including Unamortized Paid In Kind Interest Discount And Issuance Costs
DebtInstrumentCarryingAmountIncludingUnamortizedPaidInKindInterestDiscountAndIssuanceCosts
48077000
CY2019Q4 ttoo Debt Instrument Carrying Amount Including Unamortized Paid In Kind Interest Discount And Issuance Costs
DebtInstrumentCarryingAmountIncludingUnamortizedPaidInKindInterestDiscountAndIssuanceCosts
48077000
CY2020Q3 ttoo Debt Instrument Unamortized Paid In Kind Interest Relating To Future Payments
DebtInstrumentUnamortizedPaidInKindInterestRelatingToFuturePayments
2080000
CY2019Q4 ttoo Debt Instrument Unamortized Paid In Kind Interest Relating To Future Payments
DebtInstrumentUnamortizedPaidInKindInterestRelatingToFuturePayments
3284000
CY2020Q3 us-gaap Debt Instrument Unamortized Discount Premium And Debt Issuance Costs Net
DebtInstrumentUnamortizedDiscountPremiumAndDebtIssuanceCostsNet
1385000
CY2019Q4 us-gaap Debt Instrument Unamortized Discount Premium And Debt Issuance Costs Net
DebtInstrumentUnamortizedDiscountPremiumAndDebtIssuanceCostsNet
1891000
CY2020Q3 us-gaap Notes Payable
NotesPayable
44612000
CY2019Q4 us-gaap Notes Payable
NotesPayable
42902000
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
2900000
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
2400000
CY2020Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
835000
CY2019Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1152000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
2990000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
4486000
CY2020Q3 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
11889511
CY2019Q3 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
8840444

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