GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today announced financial results for the second quarter ended June 30, 2017.
Revenue for the second quarter of 2017 was $12.4 million, a decrease of 1% over the prior year period. Annuity per XT-8 analyzer was $69 thousand in the second quarter and in the mid-$70 thousand range over the last 4 quarters.
Gross profit for the second quarter was $4.9 million, or 40% of revenue, compared with $7.8 million, or 62% of revenue in the same period of 2016.
“We are delighted to have accomplished several important goals in the second quarter. Our team achieved FDA 510(k) clearance of the ePlex instrument and Respiratory Pathogen Panel as well as CE Mark for all three of our Blood Culture ID Panels,” said Hany Massarany, President and Chief Executive Officer of GenMark. “In addition, we significantly strengthened our balance sheet, which will enable us to bring even more focus to the global commercialization of our ePlex System and its menu expansion,” added Massarany.
Operating expenses for the second quarter of 2017 were $22.2 million compared to $20.4 million in the same period for 2016. The increase was mainly driven by Marketing and Sales expenses as the Company continues to expand its commercial organization in support of the global ePlex product launch.
Loss per share was $0.37 per share for the second quarter of 2017, compared to a $0.30 loss per share in the second quarter of 2016.
The Company ended the quarter with $106.5 million in cash and cash equivalents.
The Company will be hosting a conference call to discuss second quarter results in further detail on Tuesday, August 1, 2017 starting at 8:30 a.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 48903152 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 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.
GENMARK DIAGNOSTICS, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except par value) | |||||||||
| June 30, 2017 | December 31, 2016 | ||||||||
| Current assets | |||||||||
| Cash and cash equivalents | $ | 88,427 | $ | 15,959 | |||||
| Marketable securities | 18,091 | 25,607 | |||||||
| Accounts receivable, net of allowances of $2,773 and $2,740, respectively | 7,268 | 9,048 | |||||||
| Inventories | 7,105 | 6,633 | |||||||
| Prepaid expenses and other current assets | 1,324 | 1,202 | |||||||
| Total current assets | 122,215 | 58,449 | |||||||
| Property and equipment, net | 19,778 | 18,268 | |||||||
| Intangible assets, net | 2,923 | 2,670 | |||||||
| Restricted cash | 758 | 758 | |||||||
| Other long-term assets | 179 | 179 | |||||||
| Total assets | $ | 145,853 | $ | 80,324 | |||||
| Current liabilities | |||||||||
| Accounts payable | $ | 6,665 | $ | 8,703 | |||||
| Accrued compensation | 4,502 | 5,650 | |||||||
| Loan payable | 19,275 | 7,935 | |||||||
| Other current liabilities | 3,557 | 4,133 | |||||||
| Total current liabilities | 33,999 | 26,421 | |||||||
| Long-term liabilities | |||||||||
| Deferred rent | 3,378 | 3,652 | |||||||
| Long-term debt | 14,901 | 11,880 | |||||||
| Other non-current liabilities | 222 | 220 | |||||||
| Total liabilities | 52,500 | 42,173 | |||||||
| Stockholders’ equity | |||||||||
| Preferred stock, $0.0001 par value; 5,000 authorized, none issued | — | — | |||||||
| Common stock, $0.0001 par value; 100,000 authorized; 54,665 and 46,554 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively | 6 | 4 | |||||||
| Additional paid-in capital | 480,507 | 393,322 | |||||||
| Accumulated deficit | (387,176 | ) | (355,270 | ) | |||||
| Accumulated other comprehensive income | 16 | 95 | |||||||
| Total stockholders’ equity | 93,353 | 38,151 | |||||||
| Total liabilities and stockholders’ equity | $ | 145,853 | $ | 80,324 | |||||
GENMARK DIAGNOSTICS, INC. CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (In thousands, except per share data) | |||||||||||||||||
| Three Months Ended | Six Months Ended | ||||||||||||||||
| June 30, | June 30, | ||||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||||
| Revenue | |||||||||||||||||
| Product revenue | $ | 12,291 | $ | 12,425 | $ | 24,761 | $ | 23,384 | |||||||||
| License and other revenue | 68 | 87 | 133 | 192 | |||||||||||||
| Total revenue | 12,359 | 12,512 | 24,894 | 23,576 | |||||||||||||
| Cost of revenue | 7,475 | 4,720 | 13,827 | 9,095 | |||||||||||||
| Gross profit | 4,884 | 7,792 | 11,067 | 14,481 | |||||||||||||
| Operating expenses | |||||||||||||||||
| Sales and marketing | 5,159 | 3,300 | 9,853 | 7,009 | |||||||||||||
| General and administrative | 3,978 | 3,876 | 7,988 | 7,296 | |||||||||||||
| Research and development | 13,014 | 13,204 | 24,049 | 25,472 | |||||||||||||
| Total operating expenses | 22,151 | 20,380 | 41,890 | 39,777 | |||||||||||||
| Loss from operations | (17,267 | ) | (12,588 | ) | (30,823 | ) | (25,296 | ) | |||||||||
| Other income (expense) | |||||||||||||||||
| Interest income | 54 | 26 | 106 | 55 | |||||||||||||
| Interest expense | (755 | ) | (308 | ) | (1,261 | ) | (585 | ) | |||||||||
| Other income | 56 | (42 | ) | 151 | (9 | ) | |||||||||||
| Total other expense | (645 | ) | (324 | ) | (1,004 | ) | (539 | ) | |||||||||
| Loss before provision for income taxes | (17,912 | ) | (12,912 | ) | (31,827 | ) | (25,835 | ) | |||||||||
| Income tax expense | 77 | (5 | ) | 78 | 31 | ||||||||||||
| Net loss | $ | (17,989 | ) | $ | (12,907 | ) | $ | (31,905 | ) | $ | (25,866 | ) | |||||
| Net loss per share, basic and diluted | $ | (0.37 | ) | $ | (0.30 | ) | $ | (0.67 | ) | $ | (0.60 | ) | |||||
| Weighted average number of shares outstanding, basic and diluted | 48,067 | 42,864 | 47,460 | 42,768 | |||||||||||||
| Other comprehensive loss | |||||||||||||||||
| Net loss | $ | (17,989 | ) | $ | (12,907 | ) | $ | (31,905 | ) | $ | (25,866 | ) | |||||
| Foreign currency translation adjustments | 3 | (34 | ) | 94 | 13 | ||||||||||||
| Net unrealized losses on marketable securities, net of tax | 1 | (5 | ) | (15 | ) | (21 | ) | ||||||||||
| Comprehensive loss | $ | (17,985 | ) | $ | (12,946 | ) | $ | (31,826 | ) | $ | (25,874 | ) | |||||
GENMARK DIAGNOSTICS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) | |||||||||
| Six Months Ended June 30, | |||||||||
| 2017 | 2016 | ||||||||
| Operating activities | |||||||||
| Net loss | $ | (31,905 | ) | $ | (25,866 | ) | |||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||
| Depreciation and amortization | 2,454 | 1,791 | |||||||
| Amortization of premiums on investments | 30 | 35 | |||||||
| Amortization of deferred debt issuance costs | 493 | 169 | |||||||
| Stock-based compensation | 5,602 | 4,540 | |||||||
| Provision for bad debt | 32 | 23 | |||||||
| Non-cash inventory adjustments | 565 | 92 | |||||||
| Other non-cash adjustments | (123 | ) | 19 | ||||||
| Changes in operating assets and liabilities: | |||||||||
| Accounts receivable | 1,795 | 1,406 | |||||||
| Inventories | (2,563 | ) | 306 | ||||||
| Prepaid expenses and other assets | (119 | ) | (721 | ) | |||||
| Accounts payable | (3,134 | ) | 1,289 | ||||||
| Accrued compensation | (1,170 | ) | 1,119 | ||||||
| Other liabilities | (124 | ) | 303 | ||||||
| Net cash used in operating activities | (28,167 | ) | (15,495 | ) | |||||
| Investing activities | |||||||||
| Payments for intellectual property licenses | — | (800 | ) | ||||||
| Purchases of property and equipment | (2,535 | ) | (2,404 | ) | |||||
| Purchases of marketable securities | (10,496 | ) | (2,532 | ) | |||||
| Proceeds from sales of marketable securities | 13,896 | — | |||||||
| Maturities of marketable securities | 4,100 | 4,650 | |||||||
| Net cash provided by (used in) investing activities | 4,965 | (1,086 | ) | ||||||
| Financing activities | |||||||||
| Proceeds from issuance of common stock | 86,835 | 449 | |||||||
| Costs incurred in conjunction with stock issuance | (5,171 | ) | — | ||||||
| Principal repayment of borrowings | (964 | ) | (17 | ) | |||||
| Proceeds from borrowings | 15,000 | 10,000 | |||||||
| Costs associated with debt issuance | (187 | ) | (30 | ) | |||||
| Proceeds from stock option exercises | 170 | 352 | |||||||
Net cash provided by financing activities | 95,683 | 10,754 | |||||||
| Effect of exchange rate changes on cash | (13 | ) | 3 | ||||||
| Net increase (decrease) in cash and cash equivalents | 72,468 | (5,824 | ) | ||||||
| Cash and cash equivalents at beginning of period | 15,959 | 35,385 | |||||||
| Cash and cash equivalents at end of period | $ | 88,427 | $ | 29,561 | |||||
| Non-cash investing and financing activities | |||||||||
| Transfer of instruments from (to) property and equipment into (from) inventory | $ | (1,534 | ) | $ | 42 | ||||
| Property and equipment costs included in accounts payable | 713 | 588 | |||||||
| Intellectual property acquisitions included in other current liabilities | 500 | — | |||||||
| Supplemental cash flow disclosures | |||||||||
| Cash paid for income taxes, net | 54 | 13,000 | |||||||
| Cash received for interest | 187 | 51,000 | |||||||
| Cash paid for interest | 574 | 408,000 | |||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20170801005519/en/
Contacts:
Hany Massarany, 760-448-4325
President/Chief
Executive Officer
