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CST: 23/09/2019 07:06:08   

GenMark Diagnostics Reports Fourth Quarter and Full Year 2018 Results

213 Days ago

CARLSBAD, Calif., Feb. 21, 2019 (GLOBE NEWSWIRE) -- GenMark Diagnostics, Inc. (Nasdaq: GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today announced financial results for the fourth quarter and year ended December 31, 2018.

Financial Highlights

  • Revenues for the full year 2018 were $70.8 million, an increase of 35% over 2017
    • ePlex® revenue for the full year 2018 of $37.9 million, an increase of more than 270% over 2017
  • Revenues for the fourth quarter of 2018 were $19.4 million, an increase of 21% over the prior year period
    • ePlex revenue for the fourth quarter of 2018 of $12.1 million, an increase of approximately 110% over the prior year

Operational Highlights

  • Placed 42 net new ePlex analyzers in the fourth quarter of 2018, exiting the year with a global installed base of 354 ePlex analyzers
  • Received FDA 510(k) market clearance for the company’s ePlex Blood Culture Identification Gram-Positive Panel (BCID-GP) and Fungal Pathogen Panel (BCID-FP)
  • Announced Executive Leadership Changes
    • Former CFO Scott Mendel to assume newly created position as Chief Operating Officer
    • Former Vice President of Finance and Corporate Controller Johnny Ek promoted to Chief Financial Officer
  • Expanded and restructured term loan agreement adding $11 million to the balance sheet on February 1, 2019 with potential to increase by an additional $15 million upon meeting certain revenue milestones

“I'm proud of our many accomplishments in 2018, including driving global commercial ePlex adoption, expanding our ePlex test menu, and improving manufacturing cost and yield efficiencies,” said Hany Massarany, President and Chief Executive Officer. “With a highly experienced commercial team and expanded ePlex menu, this year we will remain focused on growing our market share and installed base of ePlex systems. We will also continue to implement additional manufacturing improvements which further drive cost efficiencies and help achieve our ePlex gross margin target of 60%-plus over the next two to three years.”

Fourth Quarter Financial Results
Revenue was $19.4 million in the fourth quarter of 2018, an increase of 21% versus $16.0 million in the fourth quarter of 2017.  Gross profit was $5.3 million, or 27% of revenue, compared with $4.7 million, or 30% of revenue in the same period of 2017.

Operating expenses for the fourth quarter of 2018 were $15.9 million compared to $18.7 million in the same period of 2017.  The decrease was largely due to reduced ePlex development expenses.

Loss per share was $0.21 for the fourth quarter of 2018, compared to a $0.26 loss per share in the fourth quarter of 2017.

Full Year 2018 Financial Results
Revenue was $70.8 million in 2018, an increase of 35% versus $52.5 million in 2017.  Gross profit was $19.5 million, or 28% of revenue, compared with $20.0 million, or 38% of revenue in the prior year.

Operating expenses for 2018 were $67.3 million compared to $79.5 million in 2017.  The decrease was largely due to reduced ePlex development expenses.

Loss per share was $0.91 for 2018, compared to a $1.21 loss per share in 2017.

Cash and investments were $45.2 million as of December 31, 2018.

Guidance for Full Year 2019
GenMark expects total revenue for the full year 2019 to be in the range of $85 million to $90 million.

Global ePlex placements are expected to range from 170 to 190 net new analyzers with an annuity per analyzer of $135,000 to $145,000.  The ePlex platform is expected to reach 75% of total 2019 revenue, representing 70% year-over-year growth in ePlex revenues.

Gross margin is expected to be in the 28% to 30% range and operating expenses are expected to be approximately $65 million to $70 million.

Cash usage is projected to decline year-over-year to $25 million to $30 million.

Webcast and Conference Call Information
GenMark will be hosting a conference call to discuss fourth quarter results in further detail on Thursday, February 21, 2019 starting at 4:30 p.m. ET. The conference call will be concurrently webcast. The link to the webcast will be available on the GenMark Diagnostics, Inc. website at www.genmarkdx.com 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 8163576 approximately five minutes prior to the start time.

About GenMark Diagnostics
GenMark Diagnostics (NASDAQ: GNMK) is a leading provider of multiplex molecular diagnostic solutions designed to enhance patient care, improve key quality metrics, and reduce the total cost-of-care. Utilizing GenMark's proprietary eSensor® detection technology, GenMark's eSensor XT-8® and ePlex® systems are designed to support a broad range of molecular diagnostic tests with compact, easy-to-use workstations and self-contained, disposable test cartridges. GenMark’s ePlex: The True Sample-to-Answer Solution™ is designed to optimize laboratory efficiency and address a broad range of infectious disease testing needs, including respiratory, bloodstream, and gastrointestinal infections.  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 our future financial performance, regulatory submissions and approvals, plans and objectives of management, and the timely and effective commercialization and clinical impact of our ePlex system, 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, our ability to successfully commercialize our ePlex system and its related test menu in a timely manner, constraints or inefficiencies caused by unanticipated acceleration and deceleration of customer demand, our ability to successfully expand sales of our product offerings outside the United States, and third-party payor reimbursement to our customers, 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.

Investor Relations Contact                                                             
Lynn Pieper Lewis or Leigh Salvo                                  
(415) 937-5404   
ir@genmarkdx.com


GENMARK DIAGNOSTICS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except par value)

  As of December 31,
  2018   2017
ASSETS:
Current Assets:      
Cash and cash equivalents $ 36,286     $ 26,754  
Short-term marketable securities 8,882     45,236  
Accounts receivable, net of allowances of $75 and $2,754, respectively 11,534     10,676  
Inventories 10,244     10,949  
Prepaid expenses and other current assets 1,483     2,216  
      Total current assets 68,429     95,831  
       
Property and equipment, net 21,070     22,581  
Intangible assets, net 2,023     2,624  
Restricted cash 758     758  
Other long-term assets 701     505  
     Total assets $ 92,981     $ 122,299  
       
LIABILITIES AND STOCKHOLDERS' EQUITY:
Current liabilities:      
Accounts payable $ 9,886     $ 11,171  
Accrued compensation 7,358     5,419  
Current portion of long-term debt     7,927  
Other current liabilities 3,043     3,226  
     Total current liabilities 20,287     27,743  
       
Deferred rent 2,996     3,059  
Long-term debt 36,042     20,099  
Other noncurrent liabilities 109     241  
     Total liabilities 59,434     51,142  
       
Commitments and contingencies - See Note 7      
       
Stockholders' equity      
Preferred stock, $0.0001 par value; 5,000 authorized, none issued      
Common stock, $0.0001 par value; 100,000 authorized; 56,240 and 55,066 shares issued and outstanding, respectively 6     6  
Additional paid-in capital 500,344     487,525  
Accumulated deficit (466,883 )   (416,383 )
Accumulated other comprehensive income 80     9  
     Total stockholders’ equity 33,547     71,157  
     Total liabilities and stockholders’ equity $ 92,981     $ 122,299  
               


GENMARK DIAGNOSTICS, INC. 
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS 
(In thousands, except per share data)   

    Three months ended December 31,
  Twelve Months Ended December 31,
 
    2018     2017     2018     2017  
Revenue                        
Product revenue   $ 19,325     $ 15,947     $ 70,481     $ 52,260  
License and other revenue   53     75     278     259  
Total revenue   19,378     16,022     70,759     52,519  
Cost of revenue   14,106     11,287     51,278     32,514  
Gross profit   5,272     4,735     19,481     20,005  
Operating expenses:                        
Sales and marketing   5,813     5,584     21,777     20,557  
General and administrative   4,147     4,651     17,545     16,205  
Research and development   5,924     8,463     27,931     42,760  
Total operating expenses   15,884     18,698     67,253     79,522  
Loss from operations   (10,612 )   (13,963 )   (47,772 )   (59,517 )
Other income (expense):                        
Interest income   134     208     711     561  
Interest expense   (862 )   (771 )   (3,108 )   (3,042 )
Other income (expense)   (143 )   22     (192 )   249  
Total other income (expense)   (871 )   (541 )   (2,589 )   (2,232 )
Loss before provision for income taxes   (11,483 )   (14,504 )   (50,361 )   (61,749 )
Income tax expense   80     32     139     101  
Net loss   $   (11,563 )   $   (14,536 )   $   (50,500 )   $   (61,850 )
Net loss per share, basic and diluted   $   (0.21 )   $   (0.26 )   $   (0.91 )   $   (1.21 )
Weighted average number of shares outstanding basic and diluted   56,065     54,910     55,669     51,169  
                         
Other comprehensive loss                        
Net loss   $   (11,563 )   $   (14,536 )   $   (50,500 )   $   (61,850 )
Other comprehensive income/(loss):                        
Foreign currency translation  adjustments, net of tax   15     (229 )   44     (84 )
Net unrealized gains (losses) on marketable securities, net of tax   1     22     27     (2 )
Total other comprehensive income/(loss)   16     (207 )   71     (86 )
Total comprehensive loss   $   (11,547 )   $   (14,743 )   $   (50,429 )   $   (61,936 )
                         


GENMARK DIAGNOSTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)

  Years ended December 31,
  2018   2017   2016
Operating activities:          
Net loss $ (50,500 )   $ (61,850 )   $ (50,601 )
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation and amortization 7,088     5,317     3,916  
Net amortization/(accretion) of premiums/discounts on investments (142 )   (39 )   89  
Gain on sale of investment in preferred stock         (9 )
Amortization of deferred debt issuance costs 938     1,132     388  
Stock-based compensation 11,697     12,170     9,236  
Provision for bad debt 23     14     13  
Non-cash inventory adjustments 1,426     1,323     134  
Other non-cash adjustments 15     (224 )   145  
Changes in operating assets and liabilities:          
Accounts receivable (878 )   (1,555 )   (2,250 )
Inventories (2,414 )   (10,512 )   (3,450 )
Prepaid expenses and other assets 854     (599 )   (613 )
Accounts payable (1,389 )   2,557     4,105  
Accrued compensation 1,059     (263 )   2,172  
Other current and non-current liabilities (289 )   (893 )   1,088  
Net cash used in operating activities (32,512 )   (53,422 )   (35,637 )
Investing activities:          
Payments for intellectual property licenses     (500 )   (1,500 )
Purchases of property and equipment (2,575 )   (4,815 )   (7,000 )
Purchases of marketable securities (29,778 )   (70,989 )   (33,688 )
Proceeds from sales of marketable securities     13,896     8,015  
Maturities of marketable securities 66,300     37,500     10,050  
Net cash provided by (used in) investing activities 33,947     (24,908 )   (24,123 )
Financing activities:          
Proceeds from issuance of common stock 1,061     87,267     30,920  
Costs incurred in conjunction with public offering     (5,469 )   (1,143 )
Principal repayment of borrowings (92 )   (7,848 )   (40 )
Proceeds from borrowings 7,098     15,000     10,000  
Costs associated with debt issuance (20 )   (187 )   (90 )
Proceeds from stock option exercises 22     287     712  
Net cash provided by financing activities 8,069     89,050     40,359  
Effect of exchange rate changes on cash 28     75     (25 )
Net increase (decrease) in cash and cash equivalents 9,532     10,795     (19,426 )
Cash and cash equivalents at beginning of year 27,512     16,717     36,143  
Cash and cash equivalents at end of year $ 37,044     $ 27,512     $ 16,717  
Non-cash investing and financing activities:          
Transfer of systems from property and equipment into inventory $ 1,689     $ 4,885     $ 263  
Property and equipment costs incurred but not paid included in accounts payable $ 372     $ 227     $ 1,159  
Supplemental cash flow information:          
Cash paid for interest $ 2,028     $ 1,643     $ 1,130  
Cash paid for income taxes, net $ 165     $ 61     $ 65  

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