EX-99.1 2 d390103dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

August 7, 2012

GenMark Diagnostics Reports Second Quarter 2012 Results

 

   

Quarterly Reagent Revenue Grows Over 300%

 

   

Installed Base Grows to 220 Analyzers

 

   

Quarterly Gross Margin Reaches 40%

 

   

Annuity Per Analyzer $73,000

CARLSBAD, Calif.—(BUSINESS WIRE)—GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today reported financial results for the second quarter ended June 30, 2012.

Revenues for the quarter ending June 30, 2012 were $3.6 million compared with $901,000 during the second quarter of 2011. The 301% year-over-year increase in total revenue reflects an increase in the number of systems placed at customer sites, growth in test menus and a significant increase in the number of tests sold. Reagent revenues for the second quarter grew 321% year-over-year to $3.5 million from $825,000. Instrument and other revenues increased by 86% year-over-year to $141,000 from $76,000 due mainly to capital sales of instruments.

The Company placed a net 31 analyzers during the quarter, bringing the total installed base to 220, all in end-user laboratories within the U.S. market.

Gross profit for the quarter ending June 30, 2012 was $1.4 million, or 40% of revenue, compared with a gross loss of $393,000, or (44%) of revenue for the same period in 2011. The continued improvement in gross profit is the result of significant volume increases and manufacturing efficiencies.

Operating expenses increased $1.7 million to $7.0 million during the second quarter of 2012 compared with the second quarter of 2011. Selling, General and Administrative expenses increased $978,000 year-over-year due to the increase in revenue, headcount growth and other corporate expenses. Research and Development expenses increased $728,000 due to an expansion of the R&D team, menu development for the XT-8 and initial development work on the NexGen platform.

Loss per share was $0.26 for the second quarter of 2012, compared with a loss per share of $0.39 in the second quarter of 2011.


“Our Company continues to meet expectations for business growth and product development,” stated GenMark’s President & CEO Hany Massarany. “We significantly grew our reagents business in the second quarter by adding new customers, as well as expanding menu utilization and revenue with existing customers. We also increased the number of net new analyzers by 31 to a cumulative net 220 analyzers. Furthermore, our NexGen development efforts are on schedule and we plan to show a prototype system at the Association for Molecular Pathology (AMP) meeting in October.”

The Company ended the second quarter of 2012 with $64.2 million in cash and cash equivalents. The Company intends to continue utilizing its cash balances to invest in new product and menu development, including the development of its NexGen platform, and for infrastructure improvements and general corporate purposes.

“We significantly strengthened our balance sheet this quarter with a successful raise of $45 million net in a public offering of our common stock,” Massarany further stated.

YEAR-TO-DATE 2012

Revenue for the first six months of 2012 was $5.8 million, compared to $1.7 million for the prior year period, an increase of 248%. Reagent revenue for the first six months of 2012 was $5.4 million, compared to $1.4 million for the prior year period, and instrument and other revenue for the first six months of 2012 was $381,000 compared to $226,000 for the prior year period.

Net loss for the first six months of 2012 was $11.2 million, or $0.54 loss per share, compared to net loss of $12.2 million, or $0.93 loss per share, for the prior year period.

INVESTOR CONFERENCE CALL

GenMark will hold a conference call to discuss second quarter 2012 results and the outlook for 2012 at 4:30PM EST today. The conference call and webcast can be accessed live through the Company’s website under the Investor Relations section and will be archived for future reference. To listen to the conference call, please dial (877) 312-5847 (US/Canada) or (253) 237-1154 (International) and use the conference ID number 17509226 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. Utilizing GenMark’s proprietary eSensor® detection technology, GenMark’s eSensor® XT-8 system is designed to support a broad range of molecular diagnostic tests with a compact, easy-to-use workstation and self-contained, disposable test cartridges. GenMark currently markets three tests that are FDA cleared for IVD use: Cystic Fibrosis Genotyping Test, Warfarin Sensitivity Test, and Thrombophilia Risk Test. A Respiratory Viral Panel (RVP) has been submitted to the FDA for 510(k) clearance. A number of other tests, including HCV Genotyping and 2C19, versions of which are available for research use only, and KRAS, are in development for IVD use. 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, the development and functionality of our products and the continued development of our technology, are all subject to risks and uncertainties that could cause our actual performance, operating 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, our ability to successfully commercialize our products, inherent risk and uncertainty in the protection of intellectual property rights, ability to maintain gross margins, 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.

SOURCE: GenMark Diagnostics, Inc.

GenMark Diagnostics, Inc.

Hany Massarany

Chief Executive Officer

760-448-4300


GenMark Diagnostics, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except par value)

 

     As of
June 30, 2012
    As of
December 31, 2011
 

Current assets

    

Cash and cash equivalents

   $ 64,219      $ 25,320   

Short-term investments

     —          5,000   

Accounts receivable—net of allowance of $80 and $98

     1,286        1,098   

Inventories

     1,879        2,168   

Other current assets

     192        322   
  

 

 

   

 

 

 

Total current assets

     67,576        33,908   

Property and equipment—net

     4,185        2,836   

Intangible assets—net

     1,672        1,362   

Other long-term assets

     102        80   
  

 

 

   

 

 

 

Total assets

   $ 73,535      $ 38,186   
  

 

 

   

 

 

 

Current liabilities

    

Accounts payable

   $ 1,570      $ 1,201   

Accrued compensation

     1,594        1,521   

Current portion of long-term debt

     1,016        1,000   

Other current liabilities

     2,551        2,659   
  

 

 

   

 

 

 

Total current liabilities

     6,731        6,381   

Long-term liabilities

    

Long-term debt, net of current portion

     155        583   

Other non-current liabilities

     805        588   
  

 

 

   

 

 

 

Total liabilities

     7,691        7,552   
  

 

 

   

 

 

 

Stockholders’ equity

    

Common stock, $0.0001 par value; 100,000 authorized; 32,724 and 20,478 issued and outstanding as of June 30, 2012 and December 31, 2011, respectively

     3        2   

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

     —          —     

Additional paid-in capital

     245,897        199,531   

Accumulated deficit

     (179,620     (168,463

Accumulated other comprehensive loss

     (436     (436
  

 

 

   

 

 

 

Total stockholders’ equity

     65,844        30,634   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 73,535      $ 38,186   
  

 

 

   

 

 

 


GenMark Diagnostics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except per share amounts)

 

     Three Months ended June 30,     Six months ended June 30,  
           2012                 2011                 2012                 2011        

Revenue

        

Product revenue

   $ 3,562      $ 866      $ 5,682      $ 1,559   

License and other revenue

     50        35        89        100   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     3,612        901        5,771        1,659   

Cost of sales

     2,165        1,294        3,853        2,795   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit (loss)

     1,447        (393     1,918        (1,136
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses

        

Research and development

     3,020        2,292        4,969        4,856   

Sales and marketing

     1,360        1,220        2,779        2,439   

General and administrative

     2,648        1,810        5,233        3,933   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     7,028        5,322        12,981        11,228   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (5,581     (5,715     (11,063     (12,364

Other (expense) income, net

     (9     147        (53     165   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (5,590     (5,568     (11,116     (12,199

Provision for income taxes

     (10     (12     (41     (23
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (5,600   $ (5,580   $ (11,157   $ (12,222
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, basic and diluted

   $ (0.26   $ (0.39   $ (0.54   $ (0.93

Weighted average number of shares outstanding

     21,163        14,366        20,623        13,076   
Consolidated Statements of Comprehensive Loss For the Three and Six Months ended June 30, 2012 and 2011  

Net loss

   $ (5,600   $ (5,580   $ (11,157   $ (12,222

Foreign currency translation adjustment

     —          (64     —          (64
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss

   $ (5,600   $ (5,644   $ (11,157   $ (12,286
  

 

 

   

 

 

   

 

 

   

 

 

 


GenMark Diagnostics, Inc.

Condensed Consolidated Statements of Cash Flows

(In thousands)

 

     Six Months ended June 30,  
           2012                 2011        

Cash flows from operating activities

    

Net loss

   $ (11,157   $ (12,222

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

    

Depreciation and amortization

     576        622   

Share-based compensation

     1,033        1,227   

Change in allowance for doubtful accounts

     (18     72   

Non-cash inventory adjustments

     (740     123   

Changes in operating assets and liabilities:

    

Accounts receivable

     (170     (34

Inventories

     1,139        (398

Other current and long-term assets

     108        1,673   

Accounts payable

     369        1,443   

Accrued compensation

     277        92   

Other current and long-term liabilities

     (162     (591
  

 

 

   

 

 

 

Net cash used in operating activities

     (8,745     (7,993
  

 

 

   

 

 

 

Cash flows from investing activities

    

Proceeds from maturity of investments

     5,000        —     

Payments for intellectual property licenses

     (739     (365

Purchases of property and equipment

     (1,529     (609
  

 

 

   

 

 

 

Net cash used in investing activities

     2,732        (974
  

 

 

   

 

 

 

Cash flows from financing activities

    

Proceeds from the issuance of common stock

     48,300        34,532   

Costs incurred in conjunction with public offerings

     (2,919     (2,377

Proceeds of borrowings

     —          2,000   

Proceeds from stock option exercises

     52        —     

Principal repayments of borrowings

     (521     —     
  

 

 

   

 

 

 

Net cash provided by financing activities

     44,912        34,155   
  

 

 

   

 

 

 

Net increase (decrease) in cash and cash equivalents

     38,899        25,188   

Cash and cash equivalents—Beginning of period

     25,320        18,329   
  

 

 

   

 

 

 

Cash and cash equivalents—End of period

   $ 64,219      $ 43,517   
  

 

 

   

 

 

 

Supplementary schedule of non-cash transactions:

    

Property and equipment purchased with capital lease

   $ 109      $ —     

Transfer of systems from property and equipment into inventory

     110        34   

Property and equipment costs incurred but not paid incl. in accounts payable and accrued liabilities

     307        482   

Offering costs incurred but not paid incl. in other current liabilities

     303        416