2020 Q2 Form 10-Q Financial Statement
#000156459020039633 Filed on August 12, 2020
Income Statement
Concept | 2020 Q2 | 2019 Q2 |
---|---|---|
Revenue | $2.552M | $1.804M |
YoY Change | 41.46% | -54.11% |
Cost Of Revenue | $2.300M | $4.820M |
YoY Change | -52.28% | 39.31% |
Gross Profit | $250.0K | -$3.020M |
YoY Change | -108.28% | -742.55% |
Gross Profit Margin | 9.8% | -167.41% |
Selling, General & Admin | $4.610M | $6.722M |
YoY Change | -31.42% | -11.68% |
% of Gross Profit | 1844.0% | |
Research & Development | $3.580M | $4.048M |
YoY Change | -11.56% | 7.98% |
% of Gross Profit | 1432.0% | |
Depreciation & Amortization | $400.0K | $600.0K |
YoY Change | -33.33% | 0.0% |
% of Gross Profit | 160.0% | |
Operating Expenses | $8.590M | $10.77M |
YoY Change | -20.24% | -5.19% |
Operating Profit | -$8.340M | -$13.79M |
YoY Change | -39.5% | 26.63% |
Interest Expense | -$1.840M | -$2.000M |
YoY Change | -8.0% | 32.45% |
% of Operating Profit | ||
Other Income/Expense, Net | $0.00 | $140.0K |
YoY Change | -100.0% | 102.9% |
Pretax Income | -$10.69M | -$15.65M |
YoY Change | -31.69% | 27.03% |
Income Tax | ||
% Of Pretax Income | ||
Net Earnings | -$10.69M | -$15.65M |
YoY Change | -31.71% | 26.96% |
Net Earnings / Revenue | -418.69% | -867.35% |
Basic Earnings Per Share | ||
Diluted Earnings Per Share | -$88.87K | -$352.2K |
COMMON SHARES | ||
Basic Shares Outstanding | 44.34M | |
Diluted Shares Outstanding |
Balance Sheet
Concept | 2020 Q2 | 2019 Q2 |
---|---|---|
SHORT-TERM ASSETS | ||
Cash & Short-Term Investments | $35.80M | $28.42M |
YoY Change | 25.97% | -59.81% |
Cash & Equivalents | $26.50M | $28.42M |
Short-Term Investments | $9.250M | |
Other Short-Term Assets | $6.170M | $710.0K |
YoY Change | 769.01% | -17.44% |
Inventory | $4.111M | $3.100M |
Prepaid Expenses | ||
Receivables | $1.300M | $1.179M |
Other Receivables | $0.00 | $0.00 |
Total Short-Term Assets | $47.37M | $33.41M |
YoY Change | 41.77% | -55.64% |
LONG-TERM ASSETS | ||
Property, Plant & Equipment | $3.900M | $7.262M |
YoY Change | -46.3% | -14.56% |
Goodwill | ||
YoY Change | ||
Intangibles | ||
YoY Change | ||
Long-Term Investments | ||
YoY Change | ||
Other Assets | $370.0K | $206.0K |
YoY Change | 79.61% | -47.18% |
Total Long-Term Assets | $6.340M | $11.76M |
YoY Change | -46.07% | 32.39% |
TOTAL ASSETS | ||
Total Short-Term Assets | $47.37M | $33.41M |
Total Long-Term Assets | $6.340M | $11.76M |
Total Assets | $53.71M | $45.17M |
YoY Change | 18.91% | -46.36% |
SHORT-TERM LIABILITIES | ||
YoY Change | ||
Accounts Payable | $1.780M | $2.911M |
YoY Change | -38.85% | 153.13% |
Accrued Expenses | $5.971M | $8.823M |
YoY Change | -32.32% | 109.57% |
Deferred Revenue | $677.0K | |
YoY Change | ||
Short-Term Debt | $0.00 | $0.00 |
YoY Change | ||
Long-Term Debt Due | $0.00 | $42.89M |
YoY Change | -100.0% | 1037.67% |
Total Short-Term Liabilities | $7.950M | $57.80M |
YoY Change | -86.25% | 460.34% |
LONG-TERM LIABILITIES | ||
Long-Term Debt | $44.00M | $0.00 |
YoY Change | -100.0% | |
Other Long-Term Liabilities | $6.150M | $2.990M |
YoY Change | 105.69% | 210.81% |
Total Long-Term Liabilities | $50.15M | $2.990M |
YoY Change | 1577.26% | 210.81% |
TOTAL LIABILITIES | ||
Total Short-Term Liabilities | $7.950M | $57.80M |
Total Long-Term Liabilities | $50.15M | $2.990M |
Total Liabilities | $58.10M | $60.79M |
YoY Change | -4.43% | 439.06% |
SHAREHOLDERS EQUITY | ||
Retained Earnings | -$401.8M | -$348.0M |
YoY Change | 15.47% | 19.47% |
Common Stock | $332.3M | |
YoY Change | 2.82% | |
Preferred Stock | ||
YoY Change | ||
Treasury Stock (at cost) | ||
YoY Change | ||
Treasury Stock Shares | ||
Shareholders Equity | -$4.388M | -$15.62M |
YoY Change | ||
Total Liabilities & Shareholders Equity | $53.71M | $45.17M |
YoY Change | 18.91% | -46.36% |
Cashflow Statement
Concept | 2020 Q2 | 2019 Q2 |
---|---|---|
OPERATING ACTIVITIES | ||
Net Income | -$10.69M | -$15.65M |
YoY Change | -31.71% | 26.96% |
Depreciation, Depletion And Amortization | $400.0K | $600.0K |
YoY Change | -33.33% | 0.0% |
Cash From Operating Activities | -$13.49M | -$8.840M |
YoY Change | 52.6% | 2.55% |
INVESTING ACTIVITIES | ||
Capital Expenditures | -$60.00K | -$250.0K |
YoY Change | -76.0% | -53.7% |
Acquisitions | ||
YoY Change | ||
Other Investing Activities | -$9.240M | |
YoY Change | ||
Cash From Investing Activities | -$9.300M | -$250.0K |
YoY Change | 3620.0% | -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 | 13.00M | 110.0K |
YoY Change | 11718.18% | -99.78% |
NET CHANGE | ||
Cash From Operating Activities | -13.49M | -8.840M |
Cash From Investing Activities | -9.300M | -250.0K |
Cash From Financing Activities | 13.00M | 110.0K |
Net Change In Cash | -9.790M | -8.980M |
YoY Change | 9.02% | -121.91% |
FREE CASH FLOW | ||
Cash From Operating Activities | -$13.49M | -$8.840M |
Capital Expenditures | -$60.00K | -$250.0K |
Free Cash Flow | -$13.43M | -$8.590M |
YoY Change | 56.34% | 6.31% |
Facts In Submission
Frame | Concept Type | Concept / XBRL Key | Value | Unit |
---|---|---|---|---|
CY2018Q4 | us-gaap |
Stockholders Equity
StockholdersEquity
|
11387000 | |
CY2019Q1 | us-gaap |
Adjustments To Additional Paid In Capital Warrant Issued
AdjustmentsToAdditionalPaidInCapitalWarrantIssued
|
147000 | |
CY2019Q1 | us-gaap |
Stockholders Equity
StockholdersEquity
|
-1580000 | |
CY2019Q2 | us-gaap |
Adjustments To Additional Paid In Capital Sharebased Compensation Requisite Service Period Recognition Value
AdjustmentsToAdditionalPaidInCapitalSharebasedCompensationRequisiteServicePeriodRecognitionValue
|
1277000 | |
CY2019Q2 | us-gaap |
Stock Issued During Period Value Share Based Compensation
StockIssuedDuringPeriodValueShareBasedCompensation
|
330000 | |
CY2019Q2 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-15647000 | |
CY2019Q2 | us-gaap |
Stockholders Equity
StockholdersEquity
|
-15620000 | |
CY2019Q4 | us-gaap |
Stockholders Equity
StockholdersEquity
|
-34005000 | |
CY2020Q1 | us-gaap |
Adjustments To Additional Paid In Capital Sharebased Compensation Requisite Service Period Recognition Value
AdjustmentsToAdditionalPaidInCapitalSharebasedCompensationRequisiteServicePeriodRecognitionValue
|
1160000 | |
CY2020Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-14949000 | |
us-gaap |
Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
|
-9370000 | ||
us-gaap |
Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
|
-444000 | ||
ttoo |
Proceeds From Issuance Of Shares From Employee Stock Purchase Plan And Stock Option Exercises Net
ProceedsFromIssuanceOfSharesFromEmployeeStockPurchasePlanAndStockOptionExercisesNet
|
180000 | ||
ttoo |
Proceeds From Issuance Of Shares From Employee Stock Purchase Plan And Stock Option Exercises Net
ProceedsFromIssuanceOfSharesFromEmployeeStockPurchasePlanAndStockOptionExercisesNet
|
330000 | ||
ttoo |
Proceeds From Issuance Initial Public Offering Net Of Offering Costs
ProceedsFromIssuanceInitialPublicOfferingNetOfOfferingCosts
|
52917000 | ||
us-gaap |
Finance Lease Principal Payments
FinanceLeasePrincipalPayments
|
562000 | ||
CY2019Q4 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
11213000 | |
CY2020Q1 | us-gaap |
Stockholders Equity
StockholdersEquity
|
-7697000 | |
CY2020Q2 | us-gaap |
Adjustments To Additional Paid In Capital Sharebased Compensation Requisite Service Period Recognition Value
AdjustmentsToAdditionalPaidInCapitalSharebasedCompensationRequisiteServicePeriodRecognitionValue
|
994000 | |
CY2020Q2 | us-gaap |
Stock Issued During Period Value Share Based Compensation
StockIssuedDuringPeriodValueShareBasedCompensation
|
180000 | |
CY2020Q2 | us-gaap |
Stock Issued During Period Value New Issues
StockIssuedDuringPeriodValueNewIssues
|
12820000 | |
CY2020Q2 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-10685000 | |
us-gaap |
Profit Loss
ProfitLoss
|
-25634000 | ||
us-gaap |
Profit Loss
ProfitLoss
|
-30794000 | ||
us-gaap |
Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
|
905000 | ||
us-gaap |
Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
|
1172000 | ||
ttoo |
Noncash Lease Expense
NoncashLeaseExpense
|
802000 | ||
ttoo |
Noncash Lease Expense
NoncashLeaseExpense
|
697000 | ||
us-gaap |
Share Based Compensation
ShareBasedCompensation
|
2154000 | ||
us-gaap |
Share Based Compensation
ShareBasedCompensation
|
3310000 | ||
us-gaap |
Derivative Gain Loss On Derivative Net
DerivativeGainLossOnDerivativeNet
|
34000 | ||
us-gaap |
Derivative Gain Loss On Derivative Net
DerivativeGainLossOnDerivativeNet
|
-361000 | ||
us-gaap |
Gain Loss On Disposition Of Assets
GainLossOnDispositionOfAssets
|
2000 | ||
us-gaap |
Gain Loss On Disposition Of Assets
GainLossOnDispositionOfAssets
|
3000 | ||
us-gaap |
Operating Lease Impairment Loss
OperatingLeaseImpairmentLoss
|
523000 | ||
us-gaap |
Production Related Impairments Or Charges
ProductionRelatedImpairmentsOrCharges
|
636000 | ||
us-gaap |
Paid In Kind Interest
PaidInKindInterest
|
1474000 | ||
us-gaap |
Paid In Kind Interest
PaidInKindInterest
|
1154000 | ||
us-gaap |
Increase Decrease In Accounts Receivable
IncreaseDecreaseInAccountsReceivable
|
-1525000 | ||
us-gaap |
Increase Decrease In Accounts Receivable
IncreaseDecreaseInAccountsReceivable
|
-607000 | ||
us-gaap |
Increase Decrease In Prepaid Deferred Expense And Other Assets
IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets
|
4727000 | ||
us-gaap |
Increase Decrease In Prepaid Deferred Expense And Other Assets
IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets
|
-627000 | ||
us-gaap |
Increase Decrease In Inventories
IncreaseDecreaseInInventories
|
-19000 | ||
us-gaap |
Increase Decrease In Inventories
IncreaseDecreaseInInventories
|
882000 | ||
us-gaap |
Increase Decrease In Accounts Payable
IncreaseDecreaseInAccountsPayable
|
-1983000 | ||
us-gaap |
Increase Decrease In Accounts Payable
IncreaseDecreaseInAccountsPayable
|
2017000 | ||
us-gaap |
Increase Decrease In Accrued Liabilities And Other Operating Liabilities
IncreaseDecreaseInAccruedLiabilitiesAndOtherOperatingLiabilities
|
-2811000 | ||
us-gaap |
Increase Decrease In Accrued Liabilities And Other Operating Liabilities
IncreaseDecreaseInAccruedLiabilitiesAndOtherOperatingLiabilities
|
1211000 | ||
us-gaap |
Increase Decrease In Contract With Customer Liability
IncreaseDecreaseInContractWithCustomerLiability
|
-115000 | ||
us-gaap |
Increase Decrease In Contract With Customer Liability
IncreaseDecreaseInContractWithCustomerLiability
|
-55000 | ||
ttoo |
Increase Decrease In Operating Lease Liabilities
IncreaseDecreaseInOperatingLeaseLiabilities
|
-963000 | ||
ttoo |
Increase Decrease In Operating Lease Liabilities
IncreaseDecreaseInOperatingLeaseLiabilities
|
-1129000 | ||
us-gaap |
Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-28231000 | ||
us-gaap |
Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-21707000 | ||
us-gaap |
Payments To Acquire Marketable Securities
PaymentsToAcquireMarketableSecurities
|
9247000 | ||
us-gaap |
Proceeds From Sale Of Property Plant And Equipment
ProceedsFromSaleOfPropertyPlantAndEquipment
|
4000 | ||
us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
127000 | ||
us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
444000 | ||
us-gaap |
Interest Paid Net
InterestPaidNet
|
1820000 | ||
us-gaap |
Interest Paid Net
InterestPaidNet
|
2267000 | ||
ttoo |
Transfer Of T2 Owned Instruments And Components To From Inventory
TransferOfT2OwnedInstrumentsAndComponentsToFromInventory
|
531000 | ||
ttoo |
Transfer Of T2 Owned Instruments And Components To From Inventory
TransferOfT2OwnedInstrumentsAndComponentsToFromInventory
|
-459000 | ||
ttoo |
Change In Fair Value Of Warrants Issued And Modified
ChangeInFairValueOfWarrantsIssuedAndModified
|
147000 | ||
us-gaap |
Right Of Use Asset Obtained In Exchange For Operating Lease Liability
RightOfUseAssetObtainedInExchangeForOperatingLeaseLiability
|
4805000 | ||
us-gaap |
Capital Expenditures Incurred But Not Yet Paid
CapitalExpendituresIncurredButNotYetPaid
|
94000 | ||
us-gaap |
Capital Expenditures Incurred But Not Yet Paid
CapitalExpendituresIncurredButNotYetPaid
|
193000 | ||
CY2020Q2 | us-gaap |
Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
|
26549000 | |
CY2019Q4 | us-gaap |
Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
|
11033000 | |
CY2020Q2 | us-gaap |
Restricted Cash And Cash Equivalents Noncurrent
RestrictedCashAndCashEquivalentsNoncurrent
|
160000 | |
CY2019Q4 | us-gaap |
Restricted Cash And Cash Equivalents Noncurrent
RestrictedCashAndCashEquivalentsNoncurrent
|
180000 | |
CY2020Q2 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
26709000 | |
CY2019Q4 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
11213000 | |
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 & Medicaid Services (CMS) granted approval for a New Technology Add-on Payment for the T2Bacteria Panel for fiscal year 2020. 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 US 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). On July 1, 2020, the Company submitted an EUA request to the FDA for the 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 June 30, 2020, the Company had cash and cash equivalents of $26.5 million, marketable securities of $9.2 million, an accumulated deficit of $401.8 million, a stockholders’ deficit of $4.4 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 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.</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 COVID-19 pandemic has impacted and may continue to 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. Customers 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 carriers to deliver products to customers may be disrupted. The Company has reviewed its suppliers and quantities of key materials and believes 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 believes 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. </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;">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.</span></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 June 30, 2020, <span style="color:#000000;">along with the $33.4 million of additional funding available through the Company’s Equity Distribution Agreement (the “Sales Agreement”) with Canaccord Genuity LLC, as agent (“Canaccord”) (Note 7) which was raised in July 2020, 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 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, all of which was paid by June 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 the Company will not achieve the revenue target of $15.0 million for the twenty-four month period ended December 31, 2020, and 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> | ||
CY2020Q2 | us-gaap |
Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
|
26500000 | |
CY2020Q2 | us-gaap |
Marketable Securities Current
MarketableSecuritiesCurrent
|
9200000 | |
CY2020Q2 | us-gaap |
Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
|
-401800000 | |
CY2020Q2 | us-gaap |
Stockholders Equity
StockholdersEquity
|
-4400000 | |
ttoo |
Percentage Of Reduction In Employee Headcount
PercentageOfReductionInEmployeeHeadcount
|
0.22 | ||
us-gaap |
Severance Costs1
SeveranceCosts1
|
400000 | ||
CY2020Q2 | ttoo |
Minimum Bid Price Of Common Stock
MinimumBidPriceOfCommonStock
|
1.00 | |
CY2019Q4 | us-gaap |
Contract With Customer Asset Net
ContractWithCustomerAssetNet
|
0 | |
CY2020Q2 | us-gaap |
Contract With Customer Liability
ContractWithCustomerLiability
|
100000 | |
CY2019Q4 | us-gaap |
Contract With Customer Liability
ContractWithCustomerLiability
|
200000 | |
us-gaap |
Contract With Customer Liability Revenue Recognized
ContractWithCustomerLiabilityRevenueRecognized
|
100000 | ||
CY2020Q2 | us-gaap |
Capitalized Contract Cost Gross
CapitalizedContractCostGross
|
0 | |
us-gaap |
Other Than Temporary Impairment Loss Debt Securities Available For Sale Recognized In Earnings
OtherThanTemporaryImpairmentLossDebtSecuritiesAvailableForSaleRecognizedInEarnings
|
0 | ||
CY2020Q2 | us-gaap |
Marketable Securities Current
MarketableSecuritiesCurrent
|
9247000 | |
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 June 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> | ||
CY2020Q2 | us-gaap |
Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
|
2552000 | |
CY2019Q2 | us-gaap |
Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
|
1804000 | |
us-gaap |
Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
|
5097000 | ||
us-gaap |
Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
|
3589000 | ||
CY2020Q2 | us-gaap |
Revenue Remaining Performance Obligation
RevenueRemainingPerformanceObligation
|
100000 | |
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 18 months. | ||
CY2020Q2 | us-gaap |
Contract With Customer Asset Net
ContractWithCustomerAssetNet
|
0 | |
CY2020Q2 | us-gaap |
Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
|
1388000 | |
CY2019Q4 | us-gaap |
Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
|
3193000 | |
CY2019Q4 | ttoo |
Accrued Final Fee Related To Debt
AccruedFinalFeeRelatedToDebt
|
2445000 | |
CY2020Q2 | ttoo |
Accrued Research And Development Expenses Current
AccruedResearchAndDevelopmentExpensesCurrent
|
199000 | |
CY2019Q4 | ttoo |
Accrued Research And Development Expenses Current
AccruedResearchAndDevelopmentExpensesCurrent
|
267000 | |
CY2020Q2 | us-gaap |
Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
|
578000 | |
CY2019Q4 | us-gaap |
Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
|
511000 | |
CY2020Q2 | us-gaap |
Interest Payable Current
InterestPayableCurrent
|
914000 | |
CY2019Q4 | us-gaap |
Interest Payable Current
InterestPayableCurrent
|
908000 | |
CY2020Q2 | us-gaap |
Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
|
2010000 | |
CY2019Q4 | us-gaap |
Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
|
1983000 | |
CY2020Q2 | us-gaap |
Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
|
882000 | |
CY2019Q4 | us-gaap |
Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
|
1900000 | |
CY2020Q2 | us-gaap |
Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
|
3900000 | |
CY2019Q4 | us-gaap |
Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
|
5845000 | |
CY2020Q2 | us-gaap |
Accrued Liabilities Current
AccruedLiabilitiesCurrent
|
5971000 | |
CY2019Q4 | us-gaap |
Accrued Liabilities Current
AccruedLiabilitiesCurrent
|
11207000 | |
CY2019Q4 | ttoo |
Accrued Final Fee Related To Debt
AccruedFinalFeeRelatedToDebt
|
2400000 | |
CY2020Q2 | ttoo |
Accrued Final Fee Noncurrent Related To Debt
AccruedFinalFeeNoncurrentRelatedToDebt
|
2800000 | |
CY2020Q2 | us-gaap |
Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
|
1203000 | |
CY2019Q4 | us-gaap |
Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
|
1617000 | |
CY2020Q2 | us-gaap |
Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
|
1368000 | |
CY2019Q4 | us-gaap |
Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
|
1227000 | |
CY2020Q2 | us-gaap |
Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
|
1540000 | |
CY2019Q4 | us-gaap |
Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
|
755000 | |
CY2020Q2 | us-gaap |
Inventory Net
InventoryNet
|
4111000 | |
CY2019Q4 | us-gaap |
Inventory Net
InventoryNet
|
3599000 | |
CY2020Q2 | us-gaap |
Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
|
17928000 | |
CY2019Q4 | us-gaap |
Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
|
19081000 | |
CY2020Q2 | us-gaap |
Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
|
14028000 | |
CY2019Q4 | us-gaap |
Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
|
13236000 | |
CY2020Q2 | us-gaap |
Inventory Work In Process And Raw Materials
InventoryWorkInProcessAndRawMaterials
|
100000 | |
CY2019Q4 | us-gaap |
Inventory Work In Process And Raw Materials
InventoryWorkInProcessAndRawMaterials
|
600000 | |
CY2020Q2 | us-gaap |
Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
|
400000 | |
CY2019Q2 | us-gaap |
Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
|
600000 | |
us-gaap |
Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
|
900000 | ||
us-gaap |
Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
|
1200000 | ||
CY2020Q2 | 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 | |
CY2020Q2 | ttoo |
Debt Instrument Unamortized Paid In Kind Interest Relating To Future Payments
DebtInstrumentUnamortizedPaidInKindInterestRelatingToFuturePayments
|
2488000 | |
CY2019Q4 | ttoo |
Debt Instrument Unamortized Paid In Kind Interest Relating To Future Payments
DebtInstrumentUnamortizedPaidInKindInterestRelatingToFuturePayments
|
3284000 | |
CY2020Q2 | us-gaap |
Debt Instrument Unamortized Discount Premium And Debt Issuance Costs Net
DebtInstrumentUnamortizedDiscountPremiumAndDebtIssuanceCostsNet
|
1589000 | |
CY2019Q4 | us-gaap |
Debt Instrument Unamortized Discount Premium And Debt Issuance Costs Net
DebtInstrumentUnamortizedDiscountPremiumAndDebtIssuanceCostsNet
|
1891000 | |
CY2020Q2 | us-gaap |
Notes Payable
NotesPayable
|
44000000 | |
CY2019Q4 | us-gaap |
Notes Payable
NotesPayable
|
42902000 | |
us-gaap |
Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
|
2300000 | ||
us-gaap |
Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
|
1700000 | ||
CY2020Q2 | us-gaap |
Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
|
944000 | |
CY2019Q2 | us-gaap |
Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
|
1284000 | |
us-gaap |
Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
|
2135000 | ||
us-gaap |
Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
|
3233000 | ||
us-gaap |
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
|
12207818 | ||
CY2020Q2 | us-gaap |
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
|
12207818 | |
us-gaap |
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
|
7232641 | ||
CY2019Q2 | us-gaap |
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
|
7232641 |