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8-K - FORM 8-K - GenMark Diagnostics, Inc.d8k.htm

Exhibit 99.1

GenMark Diagnostics Reports

Second Quarter 2011 Results

Reagent Revenues Grow 104% and Placements Increase by 17 to 119

CARLSBAD, Calif., August 5, 2011 (BUSINESS WIRE) — GenMark Diagnostics, Inc. (Nasdaq:GNMK) today reported financial results for the second quarter ended June 30, 2011.

Revenues for the three months ended June 30, 2011 were $901,000 and net loss per share was $0.39 per share compared with $665,000 and a net loss of $0.60 per share during the second quarter of 2010. The 35% year-over-year increase in total revenue reflects an increase in the number of systems in the field, growth in the company’s test menu and a significant increase in the number of tests sold. Reagent revenues for the second quarter grew 104% year over year to $825,000 from $404,000, while instrument and other revenues decreased $185,000 due mainly to lower partnering contract revenue. The Company placed net 17 analyzers during the quarter.

The gross margin loss of $393,000 for the three months ended June 30, 2011 as compared to a loss of $84,000 for the same period in 2010, and a loss of $743,000 in the first quarter of 2011 was driven by the transfer and expansion of manufacturing operations to the company’s new facility in Carlsbad. The gross loss improvement compared with the first quarter of 2011 was primarily due to the now completed closure of duplicative manufacturing facilities in Pasadena. All operations are now consolidated in Carlsbad, CA.

Operating expenses increased $265,000 to $5.3 million during the second quarter of 2011, due primarily to increased clinical trial costs and spending for new product development, specifically our Hepatits C genotyping and Respiratory Viral Panel tests.

The Company ended the second quarter with $43.5 million in cash compared with $18.3 million at year-end. The Company raised net proceeds of $31.7 million through a follow-on equity offering in June 2011 and used $8.0 million in cash flow from operations during the first six months of 2011 compared with $9.1 million in the first six months of 2010. The Company intends to use a portion of the offering proceeds to invest more heavily in its sales force, research and development, and other infrastructure improvements during the second half of 2011 compared with spending levels in the first half of the year.

During the first six months of 2011, depreciation and amortization expense was $622,000; capital expenditures and other investing activities were $974,000; and the Company drew $2.0 million on its loan facility.

“The second quarter of 2011 was another strong quarter for GenMark Diagnostics” commented Hany Massarany, GenMark’s President and CEO. “During the quarter, we significantly grew revenue, particularly in our core reagents, expanded our installed base,

 

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as well as advanced key product development programs. Our successful follow-on fundraising will allow us to accelerate product development and commercial activities during the remainder of 2011 and then next year as we look to execute our high growth strategy” Massarany further stated.

INVESTOR CONFERENCE CALL

GenMark will hold a conference call to discuss second quarter 2011 results and the outlook for the current year at 9:00AM EST today. The conference call and webcast can be accessed live through the company’s website under the Investor Relations section and will be available for replay through August 25, 2011. To listen to the conference call, please dial (877) 312-5847 (US/Canada) or (253) 237-1154 (International) and use the conference ID number “83859663” approximately five minutes prior to the start time.

ABOUT GENMARK

GenMark Diagnostics is a leading provider of automated, multiplex molecular diagnostic testing systems that detect and measure DNA and RNA targets to diagnose disease and optimize patient treatment. GenMark’s eSensor® XT-8 system supports a broad range of molecular diagnostic tests with a compact, easy-to-use workstation and self-contained, disposable test cartridges. GenMark tests that are FDA cleared for IVD use include the Cystic Fibrosis Genotyping Test, Warfarin Sensitivity Test, and Thrombophilia Risk Test. A Respiratory Viral Panel (RVP) is currently undergoing a clinical trial and tests for HCV Genotyping, 2C19, and KRAS are in development. For more information, visit www.genmarkdx.com.

SAFE HARBOR STATEMENT

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding continued growth in sales of our diagnostic tests, the expansion of our diagnostic test menu, and the continued development of our technology, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, risks related to our history of operating losses, the need for further financing and our ability to access the necessary additional capital for our business, inherent risk and uncertainty in the protection intellectual property rights, regulatory uncertainties regarding approval or clearance for our products, as well as other risks and uncertainties described under the “Risk Factors” in our public filings with the Securities and Exchange Commission. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.

 

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SOURCE: GenMark Diagnostics, Inc.

GenMark Diagnostics, Inc.

Paul Ross

Chief Financial Officer

760 - 448 - 4318

 

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GENMARK DIAGNOSTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except par value)

(Unaudited)

 

     As of
June 30, 2011
    As of
December 31, 2010
(A)
 

Current assets

    

Cash and cash equivalents

   $ 43,517      $ 18,329   

Accounts receivable, net of allowance of $87 and $39 at June 30, 2011 and December 31, 2010, respectively

     640        678   

Inventories, net

     1,206        897   

Other current assets

     495        2,193   
  

 

 

   

 

 

 

Total current assets

     45,858        22,097   

Property and equipment, net

     3,195        2,702   

Intangible assets, net

     1,403        1,460   

Other long-term assets

     80        55   
  

 

 

   

 

 

 

Total assets

   $ 50,536      $ 26,314   
  

 

 

   

 

 

 

Current liabilities

    

Accounts payable

   $ 2,866      $ 823   

Accrued compensation

     1,288        1,172   

Other current liabilities

     1,575        1,945   
  

 

 

   

 

 

 

Total current liabilities

     5,729        3,940   

Long-term liabilities

    

Loan payable

     2,000        —     

Other non-current liabilities

     1,083        1,307   
  

 

 

   

 

 

 

Total liabilities

   $ 8,812      $ 5,247   
  

 

 

   

 

 

 

Stockholders’ equity

    

Common stock, $.0001 par value; 100,000,000 authorized; 20,474,570 and 11,723,512 issued and outstanding as of June 30, 2011 and December 31, 2010, respectively

     2        1   

Preferred stock, $0.0001 par value; 5,000,000 authorized, none issued

     —          —     

Additional paid-in capital

     198,951        166,009   

Accumulated deficit

     (156,715     (144,493

Accumulated other comprehensive loss

     (514     (450
  

 

 

   

 

 

 

Total stockholders’ equity

     41,724        21,067   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 50,536      $ 26,314   
  

 

 

   

 

 

 

 

(A) Includes adjustment to 12/31/10 balance sheet-see accompanying tables and footnote 1

 

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GENMARK DIAGNOSTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share data)

(Unaudited)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2011     2010 (B)     2011 (B)     2010 (B)  

Product Revenue

   $ 866      $ 523      $ 1,559      $ 907   

License and other revenue

     35        142        100        168   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     901        665        1,659        1,075   

Cost of sales

     1,294        749        2,795        1,189   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross loss

     (393     (84     (1,136     (114
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses

        

Sales and marketing

     1,220        1,285        2,439        2,454   

General and administrative

     1,810        2,015        3,933        4,195   

Research and development

     2,292        1,757        4,856        3,226   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     5,322        5,057        11,228        9,875   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (5,715     (5,141     (12,364     (9,989
  

 

 

   

 

 

   

 

 

   

 

 

 

Other income

        

Other income (expense)

     174        —          186        (1

Interest income (expense)

     (27     4        (21     9   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income

     147        4        165        8   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (5,568     (5,137     (12,199     (9,981

Provision for income taxes

     (12     —          (23     (5
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (5,580   $ (5,137   $ (12,222   $ (9,986
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, basic and diluted

   $ (0.39   $ (0.60   $ (0.93   $ (1.28

Weighted average number of shares outstanding

     14,366        8,539        13,076        7,830   

Condensed consolidated statements of comprehensive loss three and six months ended June 30, 2011 and 2010

        

Net loss

   $ (5,580   $ (5,137   $ (12,222   $ (9,986

Foreign currency translation adjustment

     (64     —          (64     (35
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss

   $ (5,644   $ (5,137   $ (12,286   $ (10,021
  

 

 

   

 

 

   

 

 

   

 

 

 

 

(B) Includes reclassifications between certain cost pools-see accompanying tables and footnote 2

 

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GENMARK DIAGNOSTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

     Six Months Ended
June 30,
 
     2011     2010  

Cash flows from operating activities:

    

Net loss

   $ (12,222   $ (9,986

Adjustments to reconcile net loss to net cash used in operating activities:

    

Depreciation and amortization

     622        468   

Share-based compensation

     1,227        812   

Changes in operating assets and liabilities:

    

Trade accounts receivable

     38        (268

Inventories

     (275     (128

Other current assets

     1,673        (224

Accounts payable

     1,443        (802

Accrued compensation

     92        455   

Accrued and other liabilities

     (591     564   
  

 

 

   

 

 

 

Net cash used in operating activities

     (7,993     (9,109
  

 

 

   

 

 

 

Investing activities:

    

Payments for intellectual property licenses

     (365     —     

Purchases of property and equipment

     (609     (575
  

 

 

   

 

 

 

Net cash used in investing activities

     (974     (575
  

 

 

   

 

 

 

Financing activities:

    

Proceeds from issuance of ordinary shares and common stock

     34,532        27,600   

Costs incurred in conjunction with public offering

     (2,377     (4,752

Proceeds from borrowings

     2,000        —     

Proceeds from stock option exercises

     —          4   
  

 

 

   

 

 

 

Net cash provided by financing activities

     34,155        22,852   
  

 

 

   

 

 

 

Effect of foreign exchange rate changes

     —          (47
  

 

 

   

 

 

 

Net increase in cash and cash equivalents

     25,188        13,121   

Cash and cash equivalents at beginning of period

     18,329        16,483   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 43,517      $ 29,604   
  

 

 

   

 

 

 

 

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GENMARK DIAGNOSTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS-See Footnote 1

(In thousands, except par value)

(Unaudited)

 

     As Reported
December 31, 2010
    (1)
Adjustment
     As Corrected
December 31, 2010
 

Current assets

       

Cash and cash equivalents

   $ 18,329        —         $ 18,329   

Accounts receivable, net of allowance of $87 and $39 at June 30, 2011 and December 31, 2010, respectively

     678        —           678   

Inventories, net

     897        —           897   

Other current assets

     2,193        —           2,193   
  

 

 

   

 

 

    

 

 

 

Total current assets

     22,097        —           22,097   

Property and equipment, net

     2,702        —           2,702   

Intangible assets, net

     71        1,389         1,460   

Other long-term assets

     55        —           55   
  

 

 

   

 

 

    

 

 

 

Total assets

   $ 24,925      $ 1,389       $ 26,314   
  

 

 

   

 

 

    

 

 

 

Current liabilities

       

Accounts payable

   $ 823        —         $ 823   

Accrued compensation

     1,172        —           1,172   

Other current liabilities

     1,250        695         1,945   
  

 

 

   

 

 

    

 

 

 

Total current liabilities

     3,245        695         3,940   

Long-term liabilities

       

Loan payable

     —          —           0   

Other non-current liabilities

     613        694         1,226   
  

 

 

   

 

 

    

 

 

 

Total liabilities

   $ 3,858      $ 1,389       $ 5,247   
  

 

 

   

 

 

    

 

 

 

Stockholders’ equity

       

Common stock, $.0001 par value; 100,000,000 authorized; 20,474,570 and 11,723,512 issued and outstanding as of June 30, 2011 and December 31, 2010, respectively

     1        —           1   

Preferred stock, $0.0001 par value; 5,000,000 authorized, none issued

          0   

Additional paid-in capital

     166,009        —           166,009   

Accumulated deficit

     (144,493     —           (144,493

Accumulated other comprehensive loss

     (450     —           (450
  

 

 

   

 

 

    

 

 

 

Total stockholders’ equity

     21,067        0         21,067   
  

 

 

   

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 24,925      $ 1,389       $ 26,314   
  

 

 

   

 

 

    

 

 

 

 

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TABLES AND FOOTNOTES

GENMARK DIAGNOSTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS -See Footnote 2

(In thousands, except per share data)

(Unaudited)

 

     As Reported     Adjustments     As Corrected  
     Three Months Ended
June 30,
    Three Months
Ended
June  30,
    Three Months Ended
June 30,
 
     2011     2010     2010     2011     2010  

Product Revenue

   $ 866      $ 523      $ —        $ 866      $ 523   

License and other revenue

     35        128        14        35        142   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     901        651        14        901        665   

Cost of sales

     1,294        862        (113     1,294        749   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross loss

     (393     (211     127        (393     (84
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses

          

Sales and marketing

     1,220        1,204        81        1,220        1,285   

General and administrative

     1,810        2,002        13        1,810        2,015   

Research and development

     2,292        1,724        33        2,292        1,757   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     5,322        4,930        127        5,322        5,057   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (5,715     (5,141     —          (5,715     (5,141
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other income

          

Other income (expense)

     174        —          —          174        0   

Interest income (expense)

     (27     4        —          (27     4   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total other income

     147        4        0        147        4   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (5,568     (5,137     —          (5,568     (5,137

Provision for income taxes

     (12     —          —          (12     0   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   ($ 5,580   ($ 5,137   $ 0      ($ 5,580   ($ 5,137
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, basic and diluted

   ($ 0.39   ($ 0.60     ($ 0.39   ($ 0.60

Weighted average number of shares outstanding

     14,366        8,539          14,366        8,539   

Condensed consolidated statements of comprehensive loss three and six months ended June 30, 2011 and 2010

          

Net loss

   ($ 5,580   ($ 5,137     ($ 5,580   ($ 5,137

Foreign currency translation adjustment

     (64     —            (64     —     
  

 

 

   

 

 

     

 

 

   

 

 

 

Comprehensive loss

   ($ 5,644   ($ 5,137     ($ 5,644   ($ 5,137
  

 

 

   

 

 

     

 

 

   

 

 

 

 

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GENMARK DIAGNOSTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS-See Footnote 2

(In thousands, except per share data)

(Unaudited)

 

     As Reported     Adjustments (2)     As Corrected  
     Six Months Ended
June  30,
    Six Months Ended
June 30,
    Six Months Ended
June 30,
 
     2011     2010     2011     2010     2011     2010  

Product Revenue

   $ 1,559      $ 907      $ —        $ —        $ 1,559      $ 907   

License and other revenue

     106        143        (6     25        100        168   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     1,665        1,050        (6     25        1,659        1,075   

Cost of sales

     2,937        1,430        (142     (241     2,795        1,189   
     0        0        0        0        0        0   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross loss

     (1,272     (380     136        266        (1,136     (114
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses

            

Sales and marketing

     2,350        2,262        89        192        2,439        2,454   

General and administrative

     3,921        4,169        12        26        3,933        4,195   

Research and development

     4,821        3,178        35        48        4,856        3,226   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     11,092        9,609        136        266        11,228        9,875   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (12,364     (9,989     0        0        (12,364     (9,989
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other income

            

Other income (expense)

     186        (1     —          —          186        (1

Interest income (expense)

     (21     9        —          —          (21     9   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total other income

     165        8        0        0        165        8   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (12,199     (9,981     —          —          (12,199     (9,981

Provision for income taxes

     (23     (5     —          —          (23     (5
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   ($ 12,222   ($ 9,986   $ 0      $ 0      ($ 12,222   ($ 9,986
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, basic and diluted

   ($ 0.93   ($ 1.28   $ 0.00      $ 0.00      ($ 0.93   ($ 1.28

Weighted average number of shares outstanding

     13,076        7,830        13,076        7,830        13,076        7,830   

Condensed consolidated statements of comprehensive loss three and six months ended June 30, 2011 and 2010

            

Net loss

   ($ 12,222   ($ 9,986   $ 0      $ 0      ($ 12,222   ($ 9,986

Foreign currency translation adjustment

     (64     (35     (64     (35     (64     (35
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss

   ($ 12,286   ($ 10,021   ($ 64   ($ 35   ($ 12,286   ($ 10,021
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

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(1) Subsequent to the issuance of the 2010 audited financial statements, the Company concluded that a contract for the purchase of certain intellectual property rights should have been recorded as both an asset and a liability in the financial statements for the periods ended December 31, 2010 and March 31, 2011. The Company has recorded this contract which results in an increase of Intangible Assets and corresponding increase in current and long-term liabilities of $1,389,000 for the year ended December 31, 2010.
(2) Subsequent to the issuance of the 2010 audited financial statements, the Company further concluded that certain expenses were classified incorrectly in its Consolidated Statements of Operations for the periods presented herein, with no net impact to operating income, net income, statements of cash flows or balance sheets. The Company has corrected these immaterial misstatements. These corrections result in reductions to cost of goods sold of $113,000 and $241,000 in the quarter and six-month period ended June 30, 2010 and $142,000 in the six-month period ended June 30, 2011 and corresponding increases to sales and marketing and research and development expenses.

 

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