2018 Q3 Form 10-Q Financial Statement

#000156459018026265 Filed on November 01, 2018

View on sec.gov

Income Statement

Concept 2018 Q3 2017 Q3
Revenue $2.466M $1.108M
YoY Change 122.56% 2.21%
Cost Of Revenue $3.040M $2.106M
YoY Change 44.35% 11.19%
Gross Profit -$580.0K -$998.0K
YoY Change -41.88% 23.21%
Gross Profit Margin -23.52% -90.07%
Selling, General & Admin $5.873M $5.559M
YoY Change 5.65% -6.34%
% of Gross Profit
Research & Development $2.725M $5.880M
YoY Change -53.66% 13.08%
% of Gross Profit
Depreciation & Amortization $600.0K $760.0K
YoY Change -21.05% 35.71%
% of Gross Profit
Operating Expenses $8.598M $11.44M
YoY Change -24.84% 2.73%
Operating Profit -$9.174M -$12.44M
YoY Change -26.24% 4.12%
Interest Expense -$1.836M -$1.718M
YoY Change 6.87% 95.23%
% of Operating Profit
Other Income/Expense, Net $243.0K $79.00K
YoY Change 207.59% 97.5%
Pretax Income -$10.77M -$14.08M
YoY Change -23.51% 10.17%
Income Tax
% Of Pretax Income
Net Earnings -$10.77M -$14.08M
YoY Change -23.51% 10.11%
Net Earnings / Revenue -436.62% -1270.4%
Basic Earnings Per Share
Diluted Earnings Per Share -$246.1K -$448.1K
COMMON SHARES
Basic Shares Outstanding 30.76M shares
Diluted Shares Outstanding

Balance Sheet

Concept 2018 Q3 2017 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $60.23M $52.90M
YoY Change 13.86% -29.57%
Cash & Equivalents $60.41M $52.90M
Short-Term Investments
Other Short-Term Assets $2.020M $750.0K
YoY Change 169.33% -21.88%
Inventory $3.337M $1.250M
Prepaid Expenses
Receivables $1.730M $440.0K
Other Receivables $0.00 $0.00
Total Short-Term Assets $67.32M $55.35M
YoY Change 21.63% -28.84%
LONG-TERM ASSETS
Property, Plant & Equipment $8.190M $13.85M
YoY Change -40.87% 1.61%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $206.0K $480.0K
YoY Change -57.08% -18.64%
Total Long-Term Assets $8.576M $14.33M
YoY Change -40.15% 0.77%
TOTAL ASSETS
Total Short-Term Assets $67.32M $55.35M
Total Long-Term Assets $8.576M $14.33M
Total Assets $75.90M $69.68M
YoY Change 8.92% -24.26%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $551.0K $990.0K
YoY Change -44.34% 10.0%
Accrued Expenses $4.427M $5.510M
YoY Change -19.66% 9.33%
Deferred Revenue $762.0K
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due $3.400M $1.420M
YoY Change 139.44% -87.65%
Total Short-Term Liabilities $9.401M $10.25M
YoY Change -8.24% -44.74%
LONG-TERM LIABILITIES
Long-Term Debt $38.87M $40.09M
YoY Change -3.04% 88.66%
Other Long-Term Liabilities $1.157M $467.0K
YoY Change 147.75% -71.52%
Total Long-Term Liabilities $1.157M $467.0K
YoY Change 147.75% -97.96%
TOTAL LIABILITIES
Total Short-Term Liabilities $9.401M $10.25M
Total Long-Term Liabilities $1.157M $467.0K
Total Liabilities $10.56M $10.71M
YoY Change -1.44% -74.14%
SHAREHOLDERS EQUITY
Retained Earnings
YoY Change
Common Stock
YoY Change
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $23.77M $18.13M
YoY Change
Total Liabilities & Shareholders Equity $75.90M $69.68M
YoY Change 8.93% -24.26%

Cashflow Statement

Concept 2018 Q3 2017 Q3
OPERATING ACTIVITIES
Net Income -$10.77M -$14.08M
YoY Change -23.51% 10.11%
Depreciation, Depletion And Amortization $600.0K $760.0K
YoY Change -21.05% 35.71%
Cash From Operating Activities -$10.09M -$11.66M
YoY Change -13.46% 2.73%
INVESTING ACTIVITIES
Capital Expenditures -$350.0K -$130.0K
YoY Change 169.23% -90.85%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities -$350.0K -$130.0K
YoY Change 169.23% -90.85%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -40.00K 18.56M
YoY Change -100.22% -50.73%
NET CHANGE
Cash From Operating Activities -10.09M -11.66M
Cash From Investing Activities -350.0K -130.0K
Cash From Financing Activities -40.00K 18.56M
Net Change In Cash -10.48M 6.770M
YoY Change -254.8% -72.81%
FREE CASH FLOW
Cash From Operating Activities -$10.09M -$11.66M
Capital Expenditures -$350.0K -$130.0K
Free Cash Flow -$9.740M -$11.53M
YoY Change -15.52% 16.11%

Facts In Submission

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ttoo Proceeds From Issuance Of Common Stock And Stock Options Exercised
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<div> <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-bottom:0pt;margin-top:6pt;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;text-indent:4.54%;">T2 Biosystems, Inc. (the &#8220;Company&#8221;) was incorporated on April&#160;27, 2006 as a Delaware corporation with operations based in Lexington, Massachusetts. The Company is an&#160;<font style="font-style:italic;">in vitro</font>&#160;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 (&#8220;T2MR&#8221;) to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables rapid detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, plasma, serum, saliva, sputum and urine, and can detect cellular targets at limits of detection as low as one colony forming unit per milliliter (&#8220;CFU/mL&#8221;). The Company&#8217;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&#160;22, 2014, the Company received market clearance from the U.S. Food and Drug Administration (&#8220;FDA&#8221;) for its first two products, the T2Dx Instrument (the &#8220;T2Dx&#8221;) and T2Candida Panel (&#8220;T2Candida&#8221;). On May 24, 2018, the Company received market clearance from the FDA for its T2Bacteria Panel (&#8220;T2Bacteria&#8221;). </p> <p style="margin-bottom:0pt;margin-top:6pt;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;">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.</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&#160;30, 2018, the Company had cash and cash equivalents of $60.2 million and an accumulated deficit of $302.0 million. The future success of the Company is dependent on its ability to successfully commercialize its products, obtain regulatory clearance for and successfully launch its future product candidates, obtain additional capital and ultimately attain profitable operations. Historically, the Company has funded its operations primarily through its August 2014 initial public offering, its December 2015 public offering, its September 2016 private investment in public equity (&#8220;PIPE&#8221;) financing, its September 2017 public offering, its June 2018 public offering, private placements of redeemable convertible preferred stock and through debt financing arrangements.</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 is subject to a number of risks similar to other newly commercial life science companies, including, but not limited to commercially launching the Company&#8217;s products, development and market acceptance of the Company&#8217;s product candidates, development by its competitors of new technological innovations, protection of proprietary technology, and raising additional capital. </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;">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&#8217;s failure to raise capital or enter into such other arrangements if and when needed would have a negative impact on the Company&#8217;s business, results of operations, financial condition and the Company&#8217;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%;color:#000000;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 (&#8220;ASC&#8221;) 205-40,&#160;<font style="font-style:italic;">Disclosure of Uncertainties about an Entity&#8217;s Ability to Continue as a Going Concern</font>, management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company&#8217;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&#8217;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&#8217;s ability to continue as a going concern. The mitigating effect of management&#8217;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&#8217;s ability to continue as a going concern within one year after the date that the financial statements are issued.</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;">Management believes that its existing cash and cash equivalents at September&#160;30, 2018 will be sufficient to allow the Company to fund its current operating plan through November 30, 2019. <font style="color:#000000;">At December 31, 2017, management had concluded that substantial doubt existed about the Company&#8217;s ability to continue as a going concern for a period of at least twelve months from the date of issuance of those consolidated financial statements. However, management alleviated the substantial doubt during the nine months ended September 30, 2018. On June 4, 2018, the Company raised net proceeds of $49.2 million through its June 2018 public offering. During the nine months ended September 30, 2018, the Company also received a $2.0 million milestone payment from a co-development partner and received 510(k) clearance for the marketing of T2Bacteria. </font></p> <p style="margin-top:12pt;margin-bottom:0pt;text-indent:5.15%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">At December 31, 2017, the conditions that raised substantial doubt regarding the Company&#8217;s ability to continue as a going concern resulted from certain elements of the Company&#8217;s operating plan being outside of the Company&#8217;s control, including the approval of T2Bacteria and receipt&#160;of certain development and regulatory milestone payments under the Company&#8217;s co-development agreements. Under ASC 205-40, the future receipt of potential funding from the Company&#8217;s co-development partners and other resources cannot be considered probable if the plans are not entirely within the Company&#8217;s control. T<font style="color:#000000;">he Term Loan Agreement with CRG requires us to achieve certain annual revenue targets, whereby we are required to pay double the amount of any shortfall as an acceleration of principal payments, and maintain a minimum liquidity amount (Note 6). Should we have fallen short of the revenue target we would have sought a waiver of this provision. There can be no assurances that we would have been successful in obtaining a waiver</font>.<font style="color:#000000;"> </font></p></div>
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us-gaap Guarantees Indemnifications And Warranties Policies
GuaranteesIndemnificationsAndWarrantiesPolicies
<div> <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;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;text-indent:4.54%;">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&#8217;s request in such capacity. The term of the indemnification is the officer&#8217;s or director&#8217;s lifetime. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors&#8217; and officers&#8217; 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&#8217;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&#8217;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&#160;30, 2018 and December&#160;31, 2017, 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></div>
us-gaap Number Of Operating Segments
NumberOfOperatingSegments
1
CY2018Q3 us-gaap Revenue Remaining Performance Obligation
RevenueRemainingPerformanceObligation
3800000
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 2 years.
CY2018Q3 us-gaap Contract With Customer Asset Net
ContractWithCustomerAssetNet
900000
CY2017Q4 us-gaap Contract With Customer Asset Net
ContractWithCustomerAssetNet
0
CY2018Q3 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
700000
CY2017Q4 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
1700000
CY2018Q3 us-gaap Contract With Customer Liability Revenue Recognized
ContractWithCustomerLiabilityRevenueRecognized
0
us-gaap Contract With Customer Liability Revenue Recognized
ContractWithCustomerLiabilityRevenueRecognized
1700000
CY2018Q3 us-gaap Capitalized Contract Cost Gross
CapitalizedContractCostGross
0
CY2018Q3 us-gaap Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
715000
CY2017Q4 us-gaap Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
539000
CY2018Q3 us-gaap Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
2069000
CY2017Q4 us-gaap Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
562000
CY2018Q3 us-gaap Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
553000
CY2017Q4 us-gaap Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
243000
CY2018Q3 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
18917000
CY2017Q4 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
19139000
CY2018Q3 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
10727000
CY2017Q4 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
9124000
CY2018Q3 us-gaap Inventory Work In Process And Raw Materials
InventoryWorkInProcessAndRawMaterials
0
CY2017Q4 us-gaap Inventory Work In Process And Raw Materials
InventoryWorkInProcessAndRawMaterials
800000
CY2018Q3 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
3077000
CY2017Q4 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
2793000
CY2018Q3 ttoo Accrued Research And Development Expenses Current
AccruedResearchAndDevelopmentExpensesCurrent
189000
CY2017Q4 ttoo Accrued Research And Development Expenses Current
AccruedResearchAndDevelopmentExpensesCurrent
818000
CY2018Q3 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
566000
CY2017Q4 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
1018000
CY2018Q3 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
595000
CY2017Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1220000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
7240000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
3689000
CY2018Q3 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
5967676
CY2017Q3 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
5112578
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
5967676
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
5112578

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