2017 Q3 Form 10-Q Financial Statement

#000156459017021350 Filed on November 03, 2017

View on sec.gov

Income Statement

Concept 2017 Q3 2016 Q3
Revenue $1.108M $1.084M
YoY Change 2.21% 3.24%
Cost Of Revenue $2.106M $1.894M
YoY Change 11.19% 128.19%
Gross Profit -$998.0K -$810.0K
YoY Change 23.21% -468.18%
Gross Profit Margin -90.07% -74.72%
Selling, General & Admin $5.559M $5.935M
YoY Change -6.34% 14.58%
% of Gross Profit
Research & Development $5.880M $5.200M
YoY Change 13.08% -16.13%
% of Gross Profit
Depreciation & Amortization $760.0K $560.0K
YoY Change 35.71% 47.37%
% of Gross Profit
Operating Expenses $11.44M $11.14M
YoY Change 2.73% -2.15%
Operating Profit -$12.44M -$11.95M
YoY Change 4.12% 7.03%
Interest Expense -$1.718M -$880.0K
YoY Change 95.23% 76.0%
% of Operating Profit
Other Income/Expense, Net $79.00K $40.00K
YoY Change 97.5% 100.0%
Pretax Income -$14.08M -$12.78M
YoY Change 10.17% 9.79%
Income Tax
% Of Pretax Income
Net Earnings -$14.08M -$12.78M
YoY Change 10.11% 9.82%
Net Earnings / Revenue -1270.4% -1179.24%
Basic Earnings Per Share
Diluted Earnings Per Share -$448.1K -$510.6K
COMMON SHARES
Basic Shares Outstanding 30.76M shares
Diluted Shares Outstanding

Balance Sheet

Concept 2017 Q3 2016 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $52.90M $75.11M
YoY Change -29.57% 87.21%
Cash & Equivalents $52.90M $75.11M
Short-Term Investments
Other Short-Term Assets $750.0K $960.0K
YoY Change -21.88% -12.73%
Inventory $1.250M $1.340M
Prepaid Expenses
Receivables $440.0K $380.0K
Other Receivables $0.00 $0.00
Total Short-Term Assets $55.35M $77.78M
YoY Change -28.84% 82.33%
LONG-TERM ASSETS
Property, Plant & Equipment $13.85M $13.63M
YoY Change 1.61% 44.23%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $480.0K $590.0K
YoY Change -18.64% -42.16%
Total Long-Term Assets $14.33M $14.22M
YoY Change 0.77% 35.95%
TOTAL ASSETS
Total Short-Term Assets $55.35M $77.78M
Total Long-Term Assets $14.33M $14.22M
Total Assets $69.68M $92.00M
YoY Change -24.26% 73.19%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $990.0K $900.0K
YoY Change 10.0% -9.09%
Accrued Expenses $5.510M $5.040M
YoY Change 9.33% 17.48%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due $1.420M $11.50M
YoY Change -87.65% 709.86%
Total Short-Term Liabilities $10.25M $18.54M
YoY Change -44.74% 119.41%
LONG-TERM LIABILITIES
Long-Term Debt $40.09M $21.25M
YoY Change 88.66% 9.88%
Other Long-Term Liabilities $467.0K $1.640M
YoY Change -71.52% 7.89%
Total Long-Term Liabilities $467.0K $22.89M
YoY Change -97.96% 9.73%
TOTAL LIABILITIES
Total Short-Term Liabilities $10.25M $18.54M
Total Long-Term Liabilities $467.0K $22.89M
Total Liabilities $10.71M $41.42M
YoY Change -74.14% 41.32%
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 $18.13M $50.58M
YoY Change
Total Liabilities & Shareholders Equity $69.68M $92.00M
YoY Change -24.26% 73.19%

Cashflow Statement

Concept 2017 Q3 2016 Q3
OPERATING ACTIVITIES
Net Income -$14.08M -$12.78M
YoY Change 10.11% 9.82%
Depreciation, Depletion And Amortization $760.0K $560.0K
YoY Change 35.71% 47.37%
Cash From Operating Activities -$11.66M -$11.35M
YoY Change 2.73% 0.8%
INVESTING ACTIVITIES
Capital Expenditures -$130.0K -$1.420M
YoY Change -90.85% -26.04%
Acquisitions
YoY Change
Other Investing Activities $0.00
YoY Change
Cash From Investing Activities -$130.0K -$1.420M
YoY Change -90.85% -26.04%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 18.56M 37.67M
YoY Change -50.73% -376800.0%
NET CHANGE
Cash From Operating Activities -11.66M -11.35M
Cash From Investing Activities -130.0K -1.420M
Cash From Financing Activities 18.56M 37.67M
Net Change In Cash 6.770M 24.90M
YoY Change -72.81% -288.78%
FREE CASH FLOW
Cash From Operating Activities -$11.66M -$11.35M
Capital Expenditures -$130.0K -$1.420M
Free Cash Flow -$11.53M -$9.930M
YoY Change 16.11% 6.32%

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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 U.S. Food and Drug Administration (FDA).</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 </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, 2017, the Company had cash and cash equivalents of $52.9 million and an accumulated deficit of $247.9 million. The future success of the Company is dependent on its ability to successfully commercialize its FDA approved products, obtain regulatory clearance for and successfully launch its future product candidates, including T2Bacteria, 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 will continue the research and development of other product candidates and maintain, expand and protect its intellectual property portfolio. 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%;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 30, 2017, together with the additional remaining liquidity on the Company&#8217;s Term Loan Agreement of up to an additional $10.0 million, will be sufficient to allow the Company to fund its current operating plan through early 2019. <font style="font-size:12pt;">&#160;</font>The borrowing on the Term Loan Agreement is available at any time through July 27, 2018, and is subject to certain conditions including that the Company receive 510(k) clearance for the marketing of T2Bacteria by the FDA by April 30, 2018 (see Note 5). Should the Company&#8217;s current operating plan not materialize as expected, including the Company&#8217;s ability to draw additional borrowings on the Term Loan Agreement on a timely basis, the Company would delay certain research projects and capital expenditures and reduce or eliminate 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. </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, 2016, for additional risks associated with our capital needs.</p></div>
us-gaap Guarantees Indemnifications And Warranties Policies
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<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, 2017 and December&#160;31, 2016, 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>
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Files In Submission

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