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Great Basin Scientific Reports Fourth Quarter and Full Year 2016 Results

Company reduces operating costs, improves gross margin and cash burn rate quarter-over-quarter

  • Fourth quarter revenue increased 39% year-over-year; 2016 revenues increased 42%
  • 14% reduction in net cash used in operating activities from the third quarter to the fourth quarter of 2016
  • 34% reduction in fourth quarter G&A expenses leads to 4% reduction in total operating expenses compared to third quarter
  • Quarterly gross margin improved 42 basis points over third quarter to best level of the year
  • Percentage of customers using more than one assay increased 17% quarter-over-quarter and 81% year-over-year

SALT LAKE CITY, March 22, 2017 (GLOBE NEWSWIRE) -- Great Basin Scientific, Inc. (OTCQB:GBSN), a molecular diagnostic company, today reported operating results for the fourth quarter and full year ended December 31, 2016.

“The fourth quarter of 2016 was a period of significant progress and change for Great Basin,” said Ryan Ashton, co-founder and chief executive officer of Great Basin. “During the third quarter, research and development spending and gross margin inefficiency peaked as we invested in significant menu expansion, which included concurrently running two clinical trials and preparing for the commercial launch of two products that the U.S. Food and Drug Administration (FDA) cleared in early 2016. With those efforts either behind us or winding down, we turned our focus to improving operational efficiencies and implementing cost management programs in preparation for 2017. These efforts resulted in a reduction in sequential quarterly operating expenses and our strongest gross margins of the fiscal year. Furthermore, we expect that the changes we made in the fourth quarter—along with the January completion of the clinical trial for our Bordetella Direct Test and the restructuring and reduction plan we announced in early February—will result in further improvements to our operating expenses, burn rate and gross margins in the first half of 2017.”

“Beyond the sequential improvements in gross margins and reduced operating expenses, 2016, overall, was a year of noteworthy progress for the Company. For the first time, we launched two new products and successfully completed two clinical trials in a single year. The doubling of our menu to four assays will promote our objective of continually expanding our customer footprint and increasing our revenue per customer.”

Quarterly/Full Year Performance

  • Gross margin improved 42 basis points in the fourth quarter compared with the third quarter of 2016, marking the greatest improvement in gross margin during 2016. The Company anticipates gross margins will improve throughout 2017 as cost of goods sold declines, the higher-value Staph ID/R Blood Culture Panel becomes more widely adopted, and the Stool Bacterial Pathogens Panel receives FDA 510(k) clearance and is commercialized.
  • Net cash used in operating activities decreased 14% in the fourth quarter to $7,516,300 compared with $8,708,100 in the third quarter. The decrease was due primarily to reduced R&D spending as the Company completed the first of two clinical trials during the quarter. The second clinical trial was completed in the first quarter of 2017. The completion of these trials, along with cost-reduction measures taken in late 2016 and early 2017, should result in further reductions to cash burn in the first half of 2017.
  • Revenue for the fourth quarter was $852,000, a 39% increase from a year ago, and a 16% increase from the third quarter of 2016. Over 94% of fourth quarter revenue was from sales of C. diff and Group B Strep assays. C. diff sales increased 14% and Group B Strep sales grew 274% as compared to the fourth quarter of 2015.
  • 34% of customer sites were using multiple assays in the fourth quarter, an increase of 81% from a year ago and a 17% increase over the third quarter.
  • Revenue for 2016 was $3,048,000 compared with $2,142,000 in 2015 – an increase of 42%. C. diff sales increased 25% in 2016 compared with 2015, while Group B Strep sales grew 515% compared with a year ago. Sales of Shiga toxin-producing E. coli test (STEC) and Staph ID/R Blood Culture Panel, which became commercially available in late 2016, totaled approximately $53,000.
  • Annualized revenue per active instrument (RPAI) was $6,761 in the fourth quarter of 2016 compared with $6,407 a year ago, representing a 6% improvement. The Company reported 498 analyzers placed at the end of 2016 – a 16% increase from a year ago. The Company expects a greater focus on RPAI into 2017 coinciding with the expansion of its product menu.

Table 1: GAAP Net Loss and Non-GAAP Net Loss

  4Q 2016 3Q 2016 FY 2016 FY 2015
GAAP Net Loss $ (6,171,000 ) $ (29,047,800 ) $ (89,148,300 ) $ (57,899,200 )
Non-GAAP Net Loss $ (8,040,000 ) $ (8,597,400 ) $ (31,446,600 ) $ (20,793,700 )

Table 1: The table above includes net loss as shown in or derived from quarterly and annual financial statements presented in accordance with generally accepted accounting principles (GAAP). We also show Non-GAAP net loss, which excludes certain non-cash expenses and all items related to our convertible note financial structure such as interest, extinguishments of debt, and fair value liability gains and losses caused by fluctuations in our stock price. Management believes Non-GAAP net loss is a better indicator of the Company’s core operating performance.  See table below for an explanation and reconciliation between GAAP net loss and Non-GAAP net loss.

Outlook

“With the anticipated FDA clearances and subsequent commercial launches of Bordetella Direct Test and Stool Bacterial Pathogens Panel in 2017, we believe that Great Basin has a compelling menu of assays that, along with our no-cost instrumentation model and exceptional ease-of-use, should make us a convincing molecular diagnostics option for a wide variety of hospitals and labs in the U.S.,” said Ashton. “We expect to recognize revenue growth from six commercially-available assays beginning in the second half of 2017. We remain focused on cost management efforts which we expect will result in lower cash burn and improved gross and operating margins.”

“Looking at the first half of 2017, we expect revenues to be driven primarily by sales of C. diff and Group B Strep assays. The customers’ evaluation process for our Staph ID/R Blood Culture Panel is more complex than it is for our two older products, and consequently, we expect it will be 6-9 months from the launch, which occurred last fall, before meaningful revenue from the product is recognized. We expect the evaluation timeline for our Stool Bacterial Pathogens Panel will be closer to the historical 60-90 days seen with C. diff and Group B Strep products, and therefore, expect meaningful revenue from that product within 90-120 days of FDA clearance.”

Non-GAAP Financial Measure

This press release includes a “Non-GAAP Financial Measure” as defined by the Securities and Exchange Commission. The presentation of this financial information, which is not prepared under any comprehensive set of accounting rules or principles, is not intended to be considered in isolation of, or as a substitute for, the financial information prepared and presented in accordance with generally accepted accounting principles (GAAP). For a reconciliation of this Non-GAAP Financial Measure to the nearest comparable GAAP measure, see “Reconciliation of Non-GAAP Financial Measure” below.

Reconciliation of Non-GAAP Financial Measure

The Company excludes certain non-cash and other financing-related income and expense items in calculating non-GAAP net loss because the Company believes this non-GAAP financial measure provides meaningful supplemental information regarding performance of the Company’s core operations. The Company further believes that this measure is useful to investors in that it allows for greater transparency to certain line items in its financial statements and may facilitate comparisons to the operating results of peer companies.

The following table presents a reconciliation between net loss as shown or derived from the Company’s financial statements for the periods presented in accordance with GAAP net loss and non-GAAP net loss. The table specifically reflects the elimination of certain non-cash amounts, income taxes, and other financing-related items:

    Three months ended        
    December 31,    September 30,   Years Ended December 31,
     2016    2016    2016    2015
GAAP Net loss   $   (6,170,970 )   $   (29,047,775 )   $   (89,148,268 )   $   (57,899,169 )
Adjustment for depreciation and amortization       776,015         674,402         2,634,372         1,612,086  
Adjustment for interest expense       16,780,691         138,214,061         167,466,170         11,757,445  
Adjustment for interest income       (3,216 )       (2,884 )       (7,399 )       (18,193 )
Adjustment for (gain) loss on exchange of warrants       —         —         (3,374,752 )       4,038,063  
Adjustment for loss on extinguishment of debt       6,880,273         17,292,463         24,172,736         —  
Adjustment for change in fair value liabilities       (26,302,821 )       (135,727,676 )       (133,191,183 )       19,714,808  
Adjustment for provision for income taxes       —         —         1,750         1,250  
Non-GAAP Net loss   $   (8,040,028 )   $   (8,597,409 )   $   (31,446,574 )   $   (20,793,710 )
Non-GAAP Net loss per common share - basic and diluted   $   (18.25 )   $   (4,470.83 )   $   (281.55 )   $   (43,684.26 )
Weighted average common shares - basic and diluted       440,652         1,923         111,691         476  
 

The following table presents cash flows used in operations as shown in or derived from our Statements of Cash Flows for the periods presented. However, the table begins with Non-GAAP Net loss as calculated above, then excludes reconciling amounts related to Other income (expense) (except for such items paid or received in cash), and also reflects resultant modications to changes in operating assets and liabilities:

    Three months ended        
    December 31,    September 30,   Years Ended December 31,
     2016    2016    2016    2015
Cash flows from operating activities                
(presented using Non-GAAP Net loss):                
Non-GAAP Net loss   $   (8,040,028 )   $   (8,597,409 )   $   (31,446,574 )   $   (20,793,710 )
Adjustments to reconcile Non-GAAP Net loss to cash used by operating activities:                
Bad debt expense (recoveries)       (72,480 )       667         12,702         —  
Employee stock option amortization       24,927         37,044         136,060         110,124  
Warrant issuance and modifications       —         —         —         612,006  
Interest income received in cash       3,216         2,884         7,399         18,193  
Interest expense paid in cash       (678,225 )       (508,217 )       (1,778,831 )       (1,055,255 )
Income taxes paid in cash       —         —         (1,750 )       (1,250 )
Changes in operating assets and liabilities:                
Decrease in accounts receivable, net       (7,857 )       (38,770 )       (80,706 )       (143,905 )
(Increase) decrease in inventory       105,299         (406,974 )       (288,430 )       (676,048 )
(Increase) decrease in prepaid and other assets       326,671         286,919         (385,784 )       (56,797 )
Increase in accounts payable       306,537         745,679         879,404         602,056  
Increase (decrease) in accrued liabilities       515,668         (229,888 )       1,292,120         714,832  
Net cash used in operating activities   $   (7,516,272 )   $   (8,708,065 )   $   (31,654,390 )   $   (20,669,754 )
 

Net Gain (Loss) on Exchange and Issuance of Warrants

For the fourth quarter ended December 31, 2016, the exchange and issuance of warrants resulted in a net loss of $4.0 million. The exchange and issuance of warrants during the year ended December 31, 2016 resulted in a net gain of $3.4 million, which comprised a gain on the exchange of Series E Warrants in the amount of $4.1 million, partially offset by a loss on the issuance of our Series G Warrants in the amount of $0.7 million.

The loss on extinguishment of warrants in the amount of $4.0 million for the year ended December 31, 2015 was due to the extinguishment of 1.05 million Series C Warrants for $2.1 million in convertible notes payable and associated Series D Warrants. The fair value of the convertible note and warrants issued as consideration in the exchange was $6.4 million, which was offset by $2.3 million, the fair value of the Series C Warrants.

Loss on Extinguishment of Debt

The Company’s senior secured convertible notes issued in 2015 contained a conversion feature whereby installment payments could be made if the Company issued shares of common stock to the noteholders. Because this feature was separate from the note itself, when such conversions occurred, they were deemed extinguishments of debt for accounting purposes.  During 2016, the Company issued shares of common stock in various installments to pay down the note. In November 2016, the noteholders agreed to extinguish the remaining balance of the 2015 notes in exchange for a new class of Series F Convertible Preferred Stock. A total loss on the extinguishment of debt in the amount of $24.2 million was recorded to account for all these transactions for the 2016 year. The loss amounts were equal to the fair market values of the shares of common stock and preferred stock issued, offset by the principal amounts of the notes either paid down or extinguished, the related remaining debt discount associated with the principal amounts, the related derivative liability amounts also reduced, and the fair value of an embedded conversion feature inherent in the shares of preferred stock.

Change in Fair Value Liability

The change in the fair value liability resulted in a fourth quarter 2016 net gain of $26.3 million compared to a net gain of $2.9 million in the fourth quarter of 2015. For the year ended December 31, 2016, the change in the fair value liability resulted in a net gain in earnings of $133.2 million, compared to a net loss in earnings of $19.7 million for the year ended December 31, 2015. During 2016, the Company had a decrease in the fair value of the conversion feature and warrants associated with the 2015 and 2016 notes in the amount of $125.9 million and a net decrease in the fair value of all other fair value liabilities in the amount of $21.8 million. These decreases were the result of the decrease in the value of common stock during 2016.

About Great Basin Scientific

Great Basin Scientific is a molecular diagnostics company that commercializes breakthrough chip-based technologies. The Company is dedicated to the development of simple, yet powerful, sample-to-result technology and products that provide fast, multiple-pathogen diagnoses of infectious diseases. The Company’s vision is to make molecular diagnostic testing so simple and cost-effective that every patient will be tested for every serious infection, reducing misdiagnoses and significantly limiting the spread of infectious disease. More information can be found on the Company’s website at www.gbscience.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding events, trends and business prospects, which may affect future operating results and financial position, including but not limited to statements regarding the potential future commercial success of the Company’s assays, the Company’s continued revenue growth, adding the Company’s systems to larger hospitals and labs, expanding assays at existing customers, investments yielding higher revenue per customer, expanded customer base and new assays in the future, building the Company’s total revenue base, increasing sales per instrument, and reducing seasonality in the Company’s revenue stream. Forward-looking statements involve risk and uncertainties, which could cause actual results to differ materially, and reported results should not be considered an indication of future performance. These risks and uncertainties include, but are not limited to: (i) our limited operating history and history of losses; (ii) our ability to develop and commercialize new products and the timing of commercialization; (iii) our ability to obtain capital when needed; and (iv) other risks set forth in the Company’s filings with the Securities and Exchange Commission, including the risks set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. These forward-looking statements speak only as of the date hereof and Great Basin Scientific specifically disclaims any obligation to update these forward-looking statements, except as required by law.

FINANCIAL TABLES FOLLOW

   
Great Basin Scientific, Inc.  
Balance Sheets  
  December 31,     December 31,  
  2016     2015  
Assets              
Current assets:              
Cash $ 1,014,255     $ 4,787,759  
Restricted cash   47,066,313       13,800,000  
Accounts receivable, net   479,394       411,390  
Inventory   1,421,572       1,133,142  
Prepaid and other current assets   950,694       564,910  
Total current assets   50,932,228       20,697,201  
Restricted cash, net of current portion   12,344,039        
Intangible assets, net   42,586       119,171  
Property and equipment, net   10,078,484       7,741,991  
Total assets $ 73,397,337     $ 28,558,363  
Liabilities and Stockholders' Deficit              
Current liabilities:              
Accounts payable $ 3,855,997     $ 2,432,459  
Accrued expenses   6,275,808       1,313,149  
Current portion of notes payable         5,693  
Current portion of convertible notes payable   60,000,000       16,575,000  
Notes payable - related party   500,000       500,000  
Current portion of capital lease obligations   865,049       1,305,426  
Total current liabilities   71,496,854       22,131,727  
Convertible notes payable, net of current portion and debt discount   15,000,000       2,177,657  
Capital lease obligations, net of current portion   55,912       851,410  
Derivative liability, net of current portion   36,344,180       26,592,532  
Series F convertible preferred stock   5,655,006        
Other long term liabilities   831,678        
Total liabilities   129,383,630       51,753,326  
Commitments and contingencies              
Stockholders' deficit:              
Preferred stock, $.001 par value, 5,000,000 shares authorized; Series E convertible preferred stock; 74,380 and 2,860,200 shares authorized, respectively; 74,380 and 88,347 shares issued and outstanding, respectively   74       88  
Common stock, $.0001 par value: 1,500,000,000 and 200,000,000 shares authorized; 764,690 and 489 shares issued and outstanding, respectively   76        
Additional paid-in capital   155,065,690       98,708,814  
Accumulated deficit   (211,052,133 )     (121,903,865 )
Total stockholders' deficit   (55,986,293 )     (23,194,963 )
Total liabilities and stockholders' deficit $ 73,397,337     $ 28,558,363  
               


Great Basin Scientific, Inc.
Statements of Operations
 
    Three Months Ended
December 31,
    Years Ended
December 31,
 
    2016     2015     2016     2015  
Revenues   $ 851,930     $ 611,870     $ 3,048,126     $ 2,142,040  
Cost of sales     2,149,287       1,444,147       8,061,382       4,813,415  
Gross loss     (1,297,357 )     (832,277 )     (5,013,256 )     (2,671,375 )
Operating expenses:                                
Research and development     3,913,483       2,201,498       13,406,370       8,485,668  
Selling and marketing     1,966,420       1,800,363       6,859,323       5,007,320  
General and administrative     1,638,783       2,108,460       8,801,997       6,241,433  
Total operating expenses     7,518,686       6,110,321       29,067,690       19,734,421  
Loss from operations     (8,816,043 )     (6,942,598 )     (34,080,946 )     (22,405,796 )
Other income (expense):                                
Interest expense     (16,780,691 )     (10,888,858 )     (167,466,170 )     (11,757,445 )
Interest income     3,216       115       7,399       18,193  
Gain (loss) on exchange and issuance of warrants           (4,038,063 )     3,374,752       (4,038,063 )
Loss on extinguishment of debt     (6,880,273 )           (24,172,736 )      
Change in fair value liabilities     26,302,821       2,926,817       133,191,183       (19,714,808 )
Total other income (expense)     2,645,073       (11,999,989 )     (55,065,572 )     (35,492,123 )
Loss before provision for income taxes     (6,170,970 )     (18,942,587 )     (89,146,518 )     (57,897,919 )
Provision for income taxes                 (1,750 )     (1,250 )
Net loss   $ (6,170,970 )   $ (18,942,587 )   $ (89,148,268 )   $ (57,899,169 )
Net loss per common share - basic and diluted   $ (14.00   $ (39,963.26 )   $ (798.17 )   $ (121,636.91 )
Weighted average common shares - basic and diluted     440,652       474       111,691       476  
                                 


Great Basin Scientific, Inc.
Statements of Cash Flows
 
  Years Ended December 31,  
  2016     2015  
Cash flows from operating activities:              
Net loss $ (89,148,268 )   $ (57,899,169 )
Adjustments to reconcile net loss to net cash used in operating activities:              
Depreciation and amortization   2,634,372       1,612,086  
Bad debt expense   12,702        
Change in fair value liabilities   (133,191,183 )     19,714,808  
Loss on issuance on convertible note as interest   119,185,886       10,594,182  
Loss on extinguishment of debt   24,172,736        
Net gain on exchange and issuance of warrants   (3,374,752 )     4,038,063  
Employee stock compensation   136,060       110,124  
Warrant issuance and modifications         612,006  
Debt discount amortization   46,529,237       122,050  
Changes in operating assets and liabilities:              
Increase in accounts receivable   (80,706 )     (143,905 )
Increase in inventory   (288,430 )     (676,048 )
Increase in prepaid and other assets   (385,784 )     (56,797 )
Increase in accounts payable   879,403       602,056  
Increase in accrued liabilities   1,264,337       700,790  
Net cash used in operating activities   (31,654,390 )     (20,669,754 )
Cash flows from investing activities:              
Acquisition of property and equipment   (1,161,125 )     (1,566,044 )
Construction of analyzer instruments   (3,211,755 )     (3,226,943 )
Net cash used in investing activities   (4,372,880 )     (4,792,987 )
Cash flows from financing activities:              
Proceeds from exercise of warrants   1,449,850       3,161,220  
Proceeds from issuance of convertible notes payable   5,407,772       4,135,000  
Proceeds from follow-on offering   10,631,377       21,933,874  
Proceeds from issuance of notes payable - related party         250,000  
Proceeds from release of restricted cash   16,396,214        
Payment of cash settlement for warrant exercises   (314,879 )      
Principal payments of capital leases   (1,310,875 )     (947,423 )
Principal payments of notes payable   (5,693 )     (49,994 )
Principal payments of notes payable -related party         (250,000 )
Net cash provided by financing activities   32,253,766       28,232,677  
Net increase (decrease) in cash   (3,773,504 )     2,769,936  
Cash, beginning of the period   4,787,759       2,017,823  
Cash, end of the period $ 1,014,255     $ 4,787,759  
Supplemental disclosures of cash flow information:              
Interest paid $ 1,778,831     $ 1,055,255  
Income taxes paid $ 1,750     $ 1,250  
Supplemental schedule of non-cash investing and financing activities:              
Conversion of preferred stock to common stock $ 36     $ 2,651  
Conversion of note payable to preferred stock $ 3,144,000     $  
Assets acquired through capital leases $ 80,138     $  
Offering costs incurred but unpaid $ 281,188     $ 235,020  
Property and equipment included in accounts payable $ 446,400     $ 226,214  
Cashless exercise of warrants $     $ 1,011  
Change in derivative liability from exercised and issued warrants and convertible notes $ 12,503,276     $ 54,883,264  


Contact:
Betsy Hartman, Great Basin Scientific
(385) 215-3372
ir@gbscience.com

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