2018 Q2 Form 10-Q Financial Statement

#000156459018011871 Filed on May 08, 2018

View on sec.gov

Income Statement

Concept 2018 Q2 2018 Q1 2017 Q1
Revenue $3.931M $2.311M $941.0K
YoY Change 311.19% 145.59% -14.14%
Cost Of Revenue $3.460M $3.273M $1.627M
YoY Change 73.96% 101.17% 58.58%
Gross Profit $470.0K -$962.0K -$686.0K
YoY Change -145.5% 40.23% -1080.0%
Gross Profit Margin 11.96% -41.63% -72.9%
Selling, General & Admin $7.611M $5.755M $5.874M
YoY Change 32.16% -2.03% -5.32%
% of Gross Profit 1619.36%
Research & Development $3.749M $4.718M $6.585M
YoY Change -47.29% -28.35% -0.06%
% of Gross Profit 797.66%
Depreciation & Amortization $600.0K $629.0K $694.0K
YoY Change -18.92% -9.37% 31.19%
% of Gross Profit 127.66%
Operating Expenses $11.36M $10.47M $12.46M
YoY Change -11.74% -15.94% -2.61%
Operating Profit -$10.89M -$11.44M -$13.15M
YoY Change -21.7% -13.01% 3.32%
Interest Expense -$1.510M -$1.568M -$1.637M
YoY Change -8.71% -4.22% 122.72%
% of Operating Profit
Other Income/Expense, Net $69.00K $90.00K $79.00K
YoY Change -32.35% 13.92% 146.88%
Pretax Income -$12.32M -$12.91M -$14.70M
YoY Change -20.31% -12.18% 9.46%
Income Tax
% Of Pretax Income
Net Earnings -$12.32M -$12.91M -$14.70M
YoY Change -20.26% -12.17% 9.51%
Net Earnings / Revenue -313.51% -558.76% -1562.49%
Basic Earnings Per Share
Diluted Earnings Per Share -$322.0K -$358.8K -$481.5K
COMMON SHARES
Basic Shares Outstanding 36.02M 36.02M
Diluted Shares Outstanding

Balance Sheet

Concept 2018 Q2 2018 Q1 2017 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $70.71M $29.73M $58.82M
YoY Change 53.28% -49.46% -1.18%
Cash & Equivalents $70.89M $29.73M $58.82M
Short-Term Investments
Other Short-Term Assets $860.0K $630.0K $930.0K
YoY Change 30.3% -32.26% 4.49%
Inventory $2.160M $2.082M $489.0K
Prepaid Expenses
Receivables $1.590M $582.0K $409.0K
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $75.33M $33.02M $60.65M
YoY Change 54.4% -45.55% -2.22%
LONG-TERM ASSETS
Property, Plant & Equipment $8.500M $8.710M $14.47M
YoY Change -41.42% -39.8% 17.72%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $390.0K $206.0K $280.0K
YoY Change 78.9% -26.43% -54.84%
Total Long-Term Assets $8.880M $9.096M $15.01M
YoY Change -40.75% -39.39% 16.25%
TOTAL ASSETS
Total Short-Term Assets $75.33M $33.02M $60.65M
Total Long-Term Assets $8.880M $9.096M $15.01M
Total Assets $84.21M $42.12M $75.66M
YoY Change 32.04% -44.33% 0.96%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.150M $779.0K $1.161M
YoY Change -30.72% -32.9% -25.1%
Accrued Expenses $4.210M $5.606M $4.060M
YoY Change -10.44% 38.08% -3.79%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $3.770M $41.30M $1.320M
YoY Change 175.18% 3028.79% -80.98%
Total Short-Term Liabilities $10.32M $50.92M $8.913M
YoY Change -1.46% 471.32% -39.45%
LONG-TERM LIABILITIES
Long-Term Debt $38.34M $610.0K $39.75M
YoY Change -3.93% -98.47% 68.65%
Other Long-Term Liabilities $962.0K $680.0K $175.0K
YoY Change 215.41% 288.57% -88.71%
Total Long-Term Liabilities $962.0K $1.290M $175.0K
YoY Change 215.41% 637.14% -99.3%
TOTAL LIABILITIES
Total Short-Term Liabilities $10.32M $50.92M $8.913M
Total Long-Term Liabilities $962.0K $1.290M $175.0K
Total Liabilities $11.28M $52.21M $9.088M
YoY Change 4.68% 474.49% -77.19%
SHAREHOLDERS EQUITY
Retained Earnings -$291.3M -$278.9M -$218.4M
YoY Change 24.55% 27.72%
Common Stock $323.2M $268.8M $244.4M
YoY Change 31.31% 9.99%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $31.98M -$10.09M $26.03M
YoY Change
Total Liabilities & Shareholders Equity $84.21M $42.12M $75.66M
YoY Change 32.04% -44.33% 0.96%

Cashflow Statement

Concept 2018 Q2 2018 Q1 2017 Q1
OPERATING ACTIVITIES
Net Income -$12.32M -$12.91M -$14.70M
YoY Change -20.26% -12.17% 9.51%
Depreciation, Depletion And Amortization $600.0K $629.0K $694.0K
YoY Change -18.92% -9.37% 31.19%
Cash From Operating Activities -$8.620M -$11.74M -$12.76M
YoY Change -29.46% -7.96% 7.79%
INVESTING ACTIVITIES
Capital Expenditures -$540.0K $56.00K $1.594M
YoY Change -38.64% -96.49% -26.14%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities -$540.0K -$56.00K -$1.594M
YoY Change -38.64% -96.49% -26.14%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 50.14M -348.0K -314.0K
YoY Change 12435.0% 10.83% 110.74%
NET CHANGE
Cash From Operating Activities -8.620M -11.74M -12.76M
Cash From Investing Activities -540.0K -56.00K -1.594M
Cash From Financing Activities 50.14M -348.0K -314.0K
Net Change In Cash 40.98M -12.15M -14.67M
YoY Change -422.68% -17.18% 3.7%
FREE CASH FLOW
Cash From Operating Activities -$8.620M -$11.74M -$12.76M
Capital Expenditures -$540.0K $56.00K $1.594M
Free Cash Flow -$8.080M -$11.80M -$14.35M
YoY Change -28.75% -17.8% 2.56%

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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 June&#160;30, 2017 the Company received a CE Mark for its T2Bacteria Panel (&#8220;T2Bacteria&#8221;). On September 8, 2017 the Company filed a 510(k) premarket submission for the T2Bacteria Panel with the FDA.</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 March&#160;31, 2018, the Company had cash and cash equivalents of $29.7 million and an accumulated deficit of $278.9 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 confidentially marketed public offering (&#8220;CMPO&#8221;), its September 2016 private investment in public equity (&#8220;PIPE&#8221;) financing, its September 2017 CMPO, 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 T2Dx and T2Candida, 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 or private equity or debt financings, as well as other sources. However, the Company may be unable to raise additional funds or enter into such other arrangements when needed, on favorable terms, or at all. The Company&#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 and 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 (ASC) 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 March&#160;31, 2018, together with funding available under the Term Loan Agreement (as defined below), will be sufficient to allow the Company to fund its current operating plan through March 31, 2019. However, as certain elements of the Company&#8217;s operating plan are outside of the Company&#8217;s control, including the approval of the Company&#8217;s T2Bacteria Panel and receipt of certain development and regulatory milestone payments under the Company&#8217;s Co-Development agreements, they cannot be considered probable. 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 at this time because none of the plans are entirely within the Company&#8217;s control. In addition, the Company is required to maintain a minimum cash balance under its Term Loan Agreement with CRG Servicing LLC (&#8220;CRG&#8221;) (Note 6).</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;">These conditions raise substantial doubt regarding the Company&#8217;s ability to continue as a going concern for a period of one year after the date that the financial statements are issued. Management&#8217;s plans to alleviate the conditions that raise substantial doubt include raising additional funding, earning milestone payments pursuant to the Company&#8217;s Co-Development agreements, delaying certain research projects and capital expenditures and eliminating certain future operating expenses in order to fund operations at reduced levels for the Company to continue as a going concern for a period of 12 months from the date the financial statements are issued. Management has concluded the likelihood that its plan to obtain sufficient funding from one or more of these sources or adequately reduce expenditures will be successful, while reasonably possible, is less than probable. Accordingly, the Company has concluded that substantial doubt exists about the Company&#8217;s ability to continue as a going concern for a period of at least twelve months from the date of issuance of these consolidated financial statements. </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;">The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.</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;">For more information, refer to the section titled &#8220;Liquidity and Capital Resources&#8221; in Item&#160;2, Management&#8217;s Discussion and Analysis of Financial Condition and Results of Operations and the section entitled &#8220;Risk Factors&#8221; in the Annual Report on Form 10-K for the year ended December&#160;31, 2017, for additional risks associated with our capital needs.</p></div>
CY2018Q1 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 March&#160;31, 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>
CY2018Q1 us-gaap Number Of Operating Segments
NumberOfOperatingSegments
1
CY2018Q1 us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
2311000
CY2018Q1 us-gaap Revenue Remaining Performance Obligation
RevenueRemainingPerformanceObligation
2300000
CY2018Q1 ttoo Revenue Remaining Performance Obligation Percentage Of Revenue Expected To Be Recognized Over Next Nine Months
RevenueRemainingPerformanceObligationPercentageOfRevenueExpectedToBeRecognizedOverNextNineMonths
0.98
CY2018Q1 us-gaap Revenue Remaining Performance Obligation Expected Timing Of Satisfaction Explanation
RevenueRemainingPerformanceObligationExpectedTimingOfSatisfactionExplanation
The Company expects to recognize revenue on approximately 98% of the remaining performance obligations over the next nine months with the remainder recognized thereafter.
CY2018Q1 us-gaap Contract With Customer Liability Revenue Recognized
ContractWithCustomerLiabilityRevenueRecognized
1300000
CY2018Q1 us-gaap Capitalized Contract Cost Gross
CapitalizedContractCostGross
0
CY2018Q1 us-gaap Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
635000
CY2017Q4 us-gaap Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
539000
CY2018Q1 us-gaap Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
1066000
CY2017Q4 us-gaap Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
562000
CY2018Q1 us-gaap Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
381000
CY2017Q4 us-gaap Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
243000
CY2018Q1 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
18462000
CY2017Q4 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
19139000
CY2018Q1 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
9752000
CY2017Q4 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
9124000
CY2018Q1 us-gaap Inventory Work In Process And Raw Materials
InventoryWorkInProcessAndRawMaterials
0
CY2017Q1 us-gaap Inventory Work In Process And Raw Materials
InventoryWorkInProcessAndRawMaterials
800000
CY2018Q1 us-gaap Asset Impairment Charges
AssetImpairmentCharges
0
CY2018Q1 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
2899000
CY2017Q4 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
2793000
CY2018Q1 ttoo Accrued Research And Development Expenses Current
AccruedResearchAndDevelopmentExpensesCurrent
453000
CY2017Q4 ttoo Accrued Research And Development Expenses Current
AccruedResearchAndDevelopmentExpensesCurrent
818000
CY2018Q1 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
698000
CY2017Q4 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
1018000
CY2018Q1 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
1556000
CY2017Q4 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
1589000
CY2018Q1 ttoo Transfer Of Liabilities To Accrued Expenses And Other Current Liabilities
TransferOfLiabilitiesToAccruedExpensesAndOtherCurrentLiabilities
800000
CY2017 ttoo Transfer Of Liabilities To Accrued Expenses And Other Current Liabilities
TransferOfLiabilitiesToAccruedExpensesAndOtherCurrentLiabilities
600000
CY2018Q1 us-gaap Notes Payable
NotesPayable
41912000
CY2017Q4 us-gaap Notes Payable
NotesPayable
41704000
CY2018Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
800000
CY2017Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
1100000
CY2018Q1 us-gaap Employee Service Share Based Compensation Nonvested Awards Total Compensation Cost Not Yet Recognized Stock Options
EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedStockOptions
7800000
CY2018Q1 us-gaap Employee Service Share Based Compensation Nonvested Awards Total Compensation Cost Not Yet Recognized Period For Recognition1
EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedPeriodForRecognition1
P3Y25D
CY2018Q1 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1357000
CY2017Q1 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1128000

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