GenMark Diagnostics Reports Second Quarter 2013 Results

GenMark Diagnostics Reports Second Quarter 2013 Results

Revenue grows by 44%, Installed Base increases by 45 analyzers, Gross Margin of 39%

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, 2013.


Revenues for the quarter ended June 30, 2013 were $5.2 million compared with $3.6 million during the second quarter of 2012. The 44% year-over-year increase in total revenue reflects an increase in the number of systems placed at customer sites, growth in test menus and an increase in the number of tests sold. Reagent revenues for the second quarter grew 33% year-over-year to $4.6 million from $3.5 million. Instrument and other revenues increased by 313% year-over-year to $583,000 from $141,000 due mainly to sales of instruments.

The Company placed a net 45 analyzers during the quarter, bringing the total installed base to 384, all in end-user laboratories within the U.S. market.

Gross profit for the quarter ended June 30, 2013 was $2.0 million, or 39% of revenue, compared with a gross profit of $1.4 million, or 40% of revenue for the same period in 2012.

Operating expenses increased $3.1 million to $10.1 million during the second quarter of 2013 compared with the second quarter of 2012. Selling, General and Administrative expenses increased $1.1 million year-over-year mainly due to increases in sales headcount and certain marketing commitments. Research and Development expenses increased $2.0 million due to an expansion of our R&D team and our continued commitment to develop our NexGen platform and its assay menu.

Loss per share was $0.25 for the second quarter of 2013, compared with a loss per share of $0.26 in the second quarter of 2012.

"Excluding our largest pharmacogenetics customer, we grew our reagents business by 128% and increased our annuity per analyzer by 41% compared with the second quarter of 2012. In addition, strong performance by our sales team saw our installed base of analyzers increase by 45 in the quarter," stated GenMark's President & CEO Hany Massarany. "Furthermore, our NexGen development efforts remain on schedule with assay integration expected to be completed in the third quarter of this year. Our initial menu will target infectious disease testing and includes RVP, Sepsis, Gastrointestinal Infection panel and HCV genotyping. These multiplex assays are being designed to deliver broad pathogen coverage with higher sensitivity, specificity, and overall clinical performance compared to culture and competitive molecular systems. We remain confident that we will bring to market the most competitively differentiated sample-to-answer system and we're on track to complete its development in the second quarter of 2014," added Massarany.

The Company ended the second quarter of 2013 with $36.5 million in cash and investments. The Company intends to continue utilizing its cash balances to invest in new product and menu development, mainly the development of its NexGen platform and related test menu, and for infrastructure improvements and general corporate purposes.

YEAR-TO-DATE 2013

Revenue for the first six months of 2013 was $16.3 million, compared to $5.8 million for the prior year period, an increase of 183%. Reagent revenue for the first six months of 2013 was $15.4 million, compared to $5.4 million for the prior year period, and instrument and other revenue for the first six months of 2013 was $878,000 compared to $381,000 for the prior year period.

Net loss for the first six months of 2013 was $12.2 million, or $0.38 loss per share, compared to net loss of $11.2 million, or $0.54 loss per share, for the prior year period.

INVESTOR CONFERENCE CALL

GenMark will hold a conference call to discuss second quarter 2013 results and the outlook for 2013 at 4:30PM EDT 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 26104659 approximately five minutes prior to the start time.

About GenMark Diagnostics

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 four tests that are FDA cleared for IVD use: Cystic Fibrosis Genotyping Test, Respiratory Viral Panel, Thrombophilia Risk Test, and Warfarin Sensitivity Test. A number of other tests, including HCV Genotyping, 2C19 Genotyping, and 3A4/3A5 Genotyping are available for research use only. 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 expected 2013 financial performance and the timely completion of our research and development projects, 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, third-party payor reimbursement to our customers, the loss of a significant customer, 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, 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.

GenMark Diagnostics, Inc.

Unaudited Condensed Consolidated Balance Sheets

(In thousands, except par value)

As of

As of

June 30, 2013

December 31, 2012

Current assets

Cash and cash equivalents

$

18,836

$

51,250

Investments

16,826

-

Restricted cash

843

1,343

Accounts receivable - net of allowance of $318 and $30

4,426

3,190

Inventories

3,425

1,993

Other current assets

772

226

Total current assets

45,128

58,002

Property and equipment, net

8,051

7,074

Intangible assets, net

2,590

1,832

Other long-term assets

1,104

1,108

Total assets

$

56,873

$

68,016

Current liabilities

Accounts payable

$

2,063

$

2,445

Accrued compensation

2,268

3,076

Current portion of loan payable

251

638

Other current liabilities

3,120

3,015

Total current liabilities

7,702

9,174

Long-term liabilities

Loan payable, net of current portion

54

63

Other noncurrent liabilities

2,281

2,329

Total liabilities

10,037

11,566

Stockholders' equity

Common stock, $0.0001 par value; 100,000 authorized; 32,722 and 32,753 shares issued

3

3

and outstanding as of June 30, 2013 and December 31, 2012, respectively

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

-

-

Additional paid-in capital

250,039

247,449

Accumulated deficit

(202,761

)

(190,566

)

Accumulated other comprehensive loss

(445

)

(436

)

Total stockholders' equity

46,836

56,450

Total liabilities and stockholders' equity

$

56,873

$

68,016

GENMARK DIAGNOSTICS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In thousands, except per share data)

Three Months Ended

Six Months Ended

June 30,

June 30,

2013

2012

2013

2012

Revenue

Product revenue

$

5,138

$

3,562

$

16,106

$

5,682

License and other revenue

77

50

210

89

Total revenue

5,215

3,612

16,316

5,771

Cost of sales

3,201

2,165

8,235

3,853

Gross profit

2,014

1,447

8,081

1,918

Operating expenses

Sales and marketing

2,556

1,360

4,915

2,779

General and administrative

2,539

2,648

5,096

5,233

Research and development

5,006

3,020

10,388

4,969

Total operating expenses

10,101

7,028

20,399

12,981

Loss from operations

(8,087

)

(5,581

)

(12,318

)

(11,063

)

Other income (expense)

Interest income

136

6

211

43

Interest expense

(7

)

(25

)

(14

)

(82

)

Other income (expense)

(60

)

10

(65

)

(14

)

Total other income (expense)

69

(9

)

132

(53

)

Loss before income taxes

(8,018

)

(5,590

)

(12,186

)

(11,116

)

Provision for income taxes

(1

)

(10

)

(8

)

(41

)

Net loss

$

(8,019

)

$

(5,600

)

$

(12,194

)

$

(11,157

)

Net loss per share, basic and diluted

$

(0.25

)

$

(0.26

)

$

(0.38

)

$

(0.54

)

Weighted average number of shares outstanding

31,891

21,163

31,920

20,623

Other comprehensive loss

Net loss

$

(8,019

)

$

(5,600

)

$

(12,194

)

$

(11,157

)

Net unrealized loss on available-for-sale investments

(5

)

(9

)

Comprehensive loss

$

(8,024

)

$

(5,600

)

$

(12,203

)

$

(11,157

)

GenMark Diagnostics, Inc.

Unaudited Condensed Consolidated Statements of Cash flows

(In thousands)

Six Months Ended June 30,

2013

2012

Operating activities:

Net loss

$

(12,194

)

$

(11,157

)

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

Depreciation and amortization

1,036

576

Amortization of premiums on investments

63

-

Share-based compensation

1,657

1,033

Provision for bad debt

309

(18

)

Non-cash inventory adjustments

546

(740

)

Changes in operating assets and liabilities:

Accounts receivable

(1,545

)

(170

)

Inventories

(1,752

)

1,139

Other current assets

(485

)

108

Accounts payable

(310

)

369

Accrued compensation

(155

)

277

Other liabilities

(498

)

(162

)

Net cash used in operating activities

(13,328

)

(8,745

)

Investing activities

Restricted cash

500

-

Purchase of available-for-sale securities

(20,206

)

-

Payments for intellectual property licenses

(345

)

(739

)

Purchases of property and equipment

(2,168

)

(1,529

)

Proceeds from sales of marketable securities

3,250

-

Maturity of short-term investment

-

5,000

Net cash (used in) provided by investing activities

(18,969

)

2,732

Financing activities

Proceeds from iss