$TTOO
T2 Biosystems, Inc.

2019 Q4 Form 10-Q Financial Statement

#000156459019043775 Filed on November 18, 2019

View on sec.gov

Income Statement

Concept 2019 Q4 2019 Q3 2018 Q4
Revenue $3.069M $1.677M $1.792M
YoY Change 71.26% -32.0% 7.89%
Cost Of Revenue $3.610M $3.940M $5.630M
YoY Change -35.88% 29.61% -10.72%
Gross Profit -$540.0K -$2.270M -$3.840M
YoY Change -85.94% 291.38% -17.33%
Gross Profit Margin -17.6% -135.36% -214.29%
Selling, General & Admin $7.546M $5.981M $6.458M
YoY Change 16.85% 1.84% 16.05%
% of Gross Profit
Research & Development $4.279M $4.098M $3.297M
YoY Change 29.78% 50.39% -20.67%
% of Gross Profit
Depreciation & Amortization $510.0K $500.0K $590.0K
YoY Change -13.56% -16.67% -21.33%
% of Gross Profit
Operating Expenses $11.83M $10.08M $9.755M
YoY Change 21.22% 17.22% 0.35%
Operating Profit -$12.37M -$12.35M -$13.59M
YoY Change -9.03% 34.58% -5.37%
Interest Expense -$1.690M -$1.876M -$1.770M
YoY Change -4.52% 2.18% -54.62%
% of Operating Profit
Other Income/Expense, Net $20.00K $51.00K $220.0K
YoY Change -90.91% -79.01% 214.29%
Pretax Income -$14.04M -$14.17M -$15.15M
YoY Change -7.33% 31.57% -16.71%
Income Tax
% Of Pretax Income
Net Earnings -$14.04M -$14.17M -$15.15M
YoY Change -7.31% 31.62% -16.73%
Net Earnings / Revenue -457.51% -845.02% -845.37%
Basic Earnings Per Share
Diluted Earnings Per Share -$293.1K -$312.0K -$343.1K
COMMON SHARES
Basic Shares Outstanding 46.68M 44.54M
Diluted Shares Outstanding

Balance Sheet

Concept 2019 Q4 2019 Q3 2018 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $11.03M $16.21M $50.81M
YoY Change -78.29% -73.09% 21.56%
Cash & Equivalents $11.03M $16.39M $50.81M
Short-Term Investments
Other Short-Term Assets $1.440M $1.920M $1.340M
YoY Change 7.46% -4.95% 88.73%
Inventory $3.599M $4.110M $2.677M
Prepaid Expenses
Receivables $2.825M $1.570M $1.786M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $18.90M $23.81M $56.61M
YoY Change -66.62% -64.63% 27.73%
LONG-TERM ASSETS
Property, Plant & Equipment $5.845M $10.05M $7.315M
YoY Change -20.1% 22.71% -26.96%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $206.0K $206.0K $206.0K
YoY Change 0.0% 0.0% -23.13%
Total Long-Term Assets $9.591M $10.44M $7.701M
YoY Change 24.54% 21.77% -26.96%
TOTAL ASSETS
Total Short-Term Assets $18.90M $23.81M $56.61M
Total Long-Term Assets $9.591M $10.44M $7.701M
Total Assets $28.49M $34.25M $64.31M
YoY Change -55.7% -54.87% 17.22%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $3.753M $3.430M $744.0K
YoY Change 404.44% 522.5% 14.81%
Accrued Expenses $11.21M $8.800M $6.073M
YoY Change 84.54% 98.78% -2.33%
Deferred Revenue $285.0K $610.0K $697.0K
YoY Change -59.11% -19.95% -59.85%
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $42.90M $42.26M $42.37M
YoY Change 1.25% 1142.94% 4.1%
Total Short-Term Liabilities $60.57M $57.70M $52.30M
YoY Change 15.82% 513.74% 0.99%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change -100.0% -100.0%
Other Long-Term Liabilities $1.920M $2.470M $630.0K
YoY Change 204.76% 113.48% -13.7%
Total Long-Term Liabilities $1.920M $2.470M $630.0K
YoY Change 204.76% 113.48% -63.79%
TOTAL LIABILITIES
Total Short-Term Liabilities $60.57M $57.70M $52.30M
Total Long-Term Liabilities $1.920M $2.470M $630.0K
Total Liabilities $62.49M $60.17M $52.92M
YoY Change 18.08% 469.9% -1.12%
SHAREHOLDERS EQUITY
Retained Earnings -$376.2M -$362.1M -$317.2M
YoY Change 18.6% 19.18%
Common Stock $342.2M $336.2M $328.6M
YoY Change 4.14% 22.85%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity -$34.01M -$25.91M $11.39M
YoY Change
Total Liabilities & Shareholders Equity $28.49M $34.25M $64.31M
YoY Change -55.7% -54.87% 17.22%

Cashflow Statement

Concept 2019 Q4 2019 Q3 2018 Q4
OPERATING ACTIVITIES
Net Income -$14.04M -$14.17M -$15.15M
YoY Change -7.31% 31.62% -16.73%
Depreciation, Depletion And Amortization $510.0K $500.0K $590.0K
YoY Change -13.56% -16.67% -21.33%
Cash From Operating Activities -$10.12M -$13.53M -$9.690M
YoY Change 4.44% 34.09% -12.55%
INVESTING ACTIVITIES
Capital Expenditures -$20.00K -$300.0K $360.0K
YoY Change -105.56% -14.29% 200.0%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities -$20.00K -$300.0K $360.0K
YoY Change -105.56% -14.29% 200.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 4.960M 1.620M -90.00K
YoY Change -5611.11% -4150.0% -35.71%
NET CHANGE
Cash From Operating Activities -10.12M -13.53M -9.690M
Cash From Investing Activities -20.00K -300.0K 360.0K
Cash From Financing Activities 4.960M 1.620M -90.00K
Net Change In Cash -5.180M -12.21M -9.420M
YoY Change -45.01% 16.51% -15.14%
FREE CASH FLOW
Cash From Operating Activities -$10.12M -$13.53M -$9.690M
Capital Expenditures -$20.00K -$300.0K $360.0K
Free Cash Flow -$10.10M -$13.23M -$10.05M
YoY Change 0.5% 35.83% -10.27%

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<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 &#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, cerebral spinal fluid 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;). On February 6, 2019, the FDA granted the Company&#8217;s T2Resistance Panel designation as a Breakthrough Device. On August 2, 2019, the Center for Medicare &amp; Medicaid Services (CMS) granted approval for a New Technology Add-on Payment for the T2Bacteria Panel for fiscal year 2020.</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, 2019, the Company had cash and cash equivalents of $16.2 million and an accumulated deficit of $362.1 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, its July 2019 establishment of an Equity Distribution Agreement and Equity Purchase Agreement, private placements of redeemable convertible preferred stock and 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, 2019, along with funding available through our Equity Distribution Agreement (the &#8220;Sales Agreement&#8221;) with Canaccord Genuity LLC, as agent (&#8220;Canaccord&#8221;) and our Purchase Agreement (the &#8220;Purchase Agreement&#8221;) with Lincoln Park Capital Fund, LLC (&#8220;Lincoln Park&#8221;) (Note 7), will be sufficient to allow us to fund our current operating plan at least a year from issuance of these financial statements. <font style="color:#000000;">However, because certain elements of our operating plan are outside of our control, including our ability to sell shares under the Sales Agreement and the Purchase Agreement,</font> 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).<font style="color:#000000;"> </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;">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'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 twelve months from the date the financial statements are issued.&nbsp;&nbsp;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.&nbsp;&nbsp;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 condensed consolidated financial statements.</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;">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.<font style="color:#000000;"> </font></p>
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