Document


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 1, 2018
 
GENMARK DIAGNOSTICS, INC.
(Exact name of registrant as specified in its charter)

Commission File Number: 001-34753
 
Delaware
 
27-2053069
(State or other jurisdiction
of incorporation)
 
(I.R.S. Employer
Identification No.)
 
5964 La Place Court
Carlsbad, California 92008
(Address of principal executive offices, including zip code)
 
760-448-4300
(Registrant’s telephone number, including area code)
 
(Former Name or Former Address, if Changed Since Last Report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2).
Emerging Growth Company o
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Selection 13(a) of the Exchange Act. o
 





Item 2.02. Results of Operations and Financial Condition.

On May 1, 2018, GenMark Diagnostics, Inc. (the "Company") issued a press release announcing its financial results for the fiscal quarter ended March 31, 2018. A copy of the press release is attached hereto as Exhibit 99.1.

The information contained under this Item 2.02, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing, unless the Company expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.
Item 9.01. Financial Statements and Exhibits.
 
(d)
The following exhibit is furnished with this Current Report:
 
 
99.1
Press release dated May 1, 2018.
 





SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
 
GENMARK DIAGNOSTICS, INC.
 
 
 
 
 
 
Date:
May 1, 2018
/s/ Scott Mendel
 
 
Scott Mendel
 
 
Chief Financial Officer
 
 
 
 
 
 
 
 
 





EXHIBITS
 
 
 
 
Exhibit
Number
 
Description
 



Exhibit


Exhibit 99.1
May 1, 2018


GenMark Diagnostics Reports First Quarter 2018 Results

CARLSBAD, Calif - 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 fourth 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.
UNAUDITED CONDENSED 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.
UNAUDITED CONDENSED 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.
UNAUDITED CONDENSED 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 included in accounts payable
$
147

 
$
183

Supplemental cash flow information:
 
 
 
Cash paid for income taxes, net
$
33

 
$
5

Cash paid for interest
$
508

 
$
347