GenMark Diagnostics Reports First Quarter 2018 Results

May 1, 2018

CARLSBAD, Calif., May 01, 2018 (GLOBE NEWSWIRE) -- GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today announced financial results for the first quarter ended March 31, 2018.

Highlights

  • Revenues of $20.6 million, an increase of 65% over the prior year period
  • ePlex net new placements of 32 analyzers, expanding the global installed base to 228 placements
  • Five abstracts and posters on the benefits of ePlex BCID panels presented at ECCMID, the largest microbiology meeting in Europe

“We’re off to a solid start in 2018, with revenue growth in the first quarter driven by high respiratory testing volumes in an exceptionally strong flu season, as well as a growing number of customers utilizing ePlex for routine clinical testing.  As a result, ePlex contributed meaningfully to first quarter sales and for the first time, surpassed revenues from our XT-8 products,” said Hany Massarany, President and Chief Executive Officer. “We’re encouraged by the steady positive customer feedback we receive on the performance, ease of use and processing capacity of ePlex, and we’re very pleased with its strong market acceptance across all segments. We’re also excited about the potential for our uniquely differentiated BCID panels and look forward to accelerating future placements and revenue as we launch them in the U.S. market.”

First Quarter Financial Results
Revenue was $20.6 million in the first quarter of 2018, an increase of 65% versus $12.5 million in the first quarter of 2017.  Gross profit was $4.2 million, or 20% of revenue, compared with $6.2 million, or 49% of revenue in the same period of 2017, reflecting the increased proportion of ePlex revenues in the quarter, driven by extraordinary flu season demand.

Operating expenses for the first quarter of 2018 were $15.0 million compared to $19.7 million in the same period for 2017.  The decrease was largely due to reduced ePlex development expenses, partially offset by an increase in Sales and Marketing expenses.

Loss per share was $0.21 per share for the first quarter of 2018, compared to a $0.30 loss per share in the first quarter of 2017.

The Company ended the quarter with $65.5 million in cash and investments, reflecting the impact of reductions in operating expenses and the focus on minimizing working capital needs.

Guidance for Full Year 2018
GenMark is reconfirming prior 2018 revenue guidance of $68 to $72 million. Gross margin is expected to be in the 30% range. The Company continues to expect ePlex placements of 140-170 net new analyzers, and an annuity per ePlex placement in the $100,000 to $120,000 range.

Webcast and Conference Call Information
The Company will be hosting a conference call to discuss first quarter results in further detail on Tuesday, May 1, 2018 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 9384229 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, 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)

  March 31,
 2018
  December 31,
 2017
ASSETS:
Current Assets:      
Cash and cash equivalents $ 30,278     $ 26,754  
Short-term marketable securities 35,185     45,236  
Accounts receivable, net of allowances of $52 and $2,754, respectively 8,081     10,676  
Inventories 10,452     10,949  
Prepaid expenses and other current assets 1,490     2,216  
Total current assets 85,486     95,831  
       
Property and equipment, net 21,881     22,581  
Intangible assets, net 2,475     2,624  
Restricted cash 758     758  
Other long-term assets 507     505  
Total assets $ 111,107     $ 122,299  
       
LIABILITIES AND STOCKHOLDERS' EQUITY:
Current liabilities:      
Accounts payable $ 9,688     $ 11,171  
Accrued compensation 4,577     5,419  
Current portion of long-term debt 13,428     7,927  
Other current liabilities 2,912     3,226  
Total current liabilities 30,605     27,743  
       
Deferred rent 2,893     3,059  
Long-term debt 14,868     20,099  
Other noncurrent liabilities 187     241  
Total liabilities 48,553     51,142  
       
Stockholders' equity:      
Preferred stock, $0.0001 par value; 5,000 authorized, none issued      
Common stock, $0.0001 par value; 100,000 authorized; 55,412 and 55,066 shares issued and outstanding, respectively 6     6  
Additional paid-in capital 490,306     487,525  
Accumulated deficit (427,808 )   (416,383 )
Accumulated other comprehensive income 50     9  
Total stockholders’ equity 62,554     71,157  
Total liabilities and stockholders’ equity $ 111,107     $ 122,299  



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

  Three months ended
  March 31,
  2018   2017
Revenue      
Product revenue $ 20,576   $ 12,470
License and other revenue 69
  65
Total revenue 20,645
  12,535
Cost of revenue 16,480
  6,352
Gross profit 4,165
  6,183
Operating expenses:      
Sales and marketing 5,402
  4,693
General and administrative 4,133
  4,011
Research and development 5,420
  11,035
Total operating expenses 14,955
  19,739
Loss from operations (10,790)   (13,556)
Other income (expense):      
Interest income 187
  52
Interest expense (788)   (507)
Other income (expense) (12)   95
Total other income (expense) (613)   (360)
Loss before provision for income taxes (11,403)   (13,916)
Income tax expense 20   1
Net loss $ (11,423)   $ (13,917)
Net loss per share, basic and diluted $ (0.21)   $ (0.30)
Weighted average number of shares outstanding basic and diluted 55,205
  46,846
       
Other comprehensive loss:      
Net loss $ (11,423)   $ (13,917)
Other comprehensive income/(loss):      
Foreign currency translation adjustments, net of tax (34)   91
Net unrealized losses on marketable securities, net of tax 8   (16)
Total other comprehensive income/(loss) (26)   75
Total comprehensive loss $ (11,449)   $ (13,842)

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

  Three months ended March 31,
  2018   2017
       
Operating activities:      
Net loss $ (11,423 )   $ (13,917 )
Adjustments to reconcile net loss to net cash used in operating activities:      
Depreciation and amortization 1,740     1,217  
Net amortization/(accretion) of premiums/discounts on investments (42 )   19  
Amortization of deferred debt issuance costs 290     151  
Stock-based compensation 2,724     2,808  
Provision for bad debt     9  
Non-cash inventory adjustments 449     317  
Other non-cash adjustments 84     (85 )
Changes in operating assets and liabilities:      
Accounts receivable 2,566     1,558  
Inventories (526 )   (3,118 )
Prepaid expenses and other assets 760     (216 )
Accounts payable (1,361 )   (2,821 )
Accrued compensation (992 )   (1,144 )
Other current and non-current liabilities (321 )   (343 )
Net cash used in operating activities (6,052 )   (15,565 )
Investing activities:      
Purchases of property and equipment (465 )   (1,888 )
Purchases of marketable securities (7,900 )    
Proceeds from sales of marketable securities     13,896  
Maturities of marketable securities 18,000     700  
Net cash provided by investing activities 9,635     12,708  
Financing activities:      
Principal repayment of borrowings (22 )   (6 )
Payments associated with debt issuance (20 )   (20 )
Proceeds from stock option exercises 17     88  
Net cash provided by (used in) financing activities (25 )   62  
Effect of exchange rate changes on cash, cash equivalents, and restricted cash (34 )   14  
Net increase (decrease) in cash, cash equivalents, and restricted cash 3,524     (2,781 )
Cash, cash equivalents, and restricted cash at beginning of year 27,512     16,717  
Cash, cash equivalents, and restricted cash at end of period $ 31,036     $ 13,936  
Non-cash investing and financing activities:      
Transfer of systems to property and equipment from inventory $ 569     $ 415  
Property and equipment costs incurred but not paid included in accounts payable $ 147     $ 183  
Supplemental cash flow information:      
Cash paid for income taxes, net $ 33     $ 5  
Cash paid for interest $ 508     $ 347  

 

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Source: GenMark Diagnostics, Inc.