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8-K - 8-K - Great Basin Scientific, Inc.v462396_8k.htm

 

Exhibit 99.1

 

 

 

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 – 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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