We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
GenMark Diagnostics Inc | NASDAQ:GNMK | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 24.05 | 23.92 | 24.39 | 0 | 01:00:00 |
|
|
|
x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
¨
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
|
Delaware
|
27-2053069
|
(State or other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer
Identification No.)
|
|
|
5964 La Place Court
Carlsbad, California
|
92008-8829
|
(Address of principal executive offices)
|
(Zip code)
|
|
Large accelerated filer
|
¨
|
Accelerated filer
|
x
|
|
|
|
|
Non-accelerated filer
|
¨
|
Smaller reporting company
|
¨
|
|
|
|
Page
|
PART I. FINANCIAL INFORMATION
|
|
|
Item 1.
|
||
Item 2.
|
||
Item 3.
|
||
Item 4.
|
||
PART II. OTHER INFORMATION
|
|
|
Item 1.
|
||
Item 1A.
|
||
Item 2.
|
||
Item 3.
|
||
Item 4.
|
||
Item 5.
|
||
Item 6.
|
|
June 30,
2016 |
|
December 31,
2015 |
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
29,561
|
|
|
$
|
35,385
|
|
Marketable securities
|
7,939
|
|
|
10,080
|
|
||
Accounts receivable, net of allowances of $2,751 and $2,727, respectively
|
5,417
|
|
|
6,847
|
|
||
Inventories
|
2,614
|
|
|
3,054
|
|
||
Prepaid expenses and other current assets
|
1,315
|
|
|
591
|
|
||
Total current assets
|
46,846
|
|
|
55,957
|
|
||
Property and equipment, net
|
12,654
|
|
|
11,396
|
|
||
Intangible assets, net
|
2,188
|
|
|
2,376
|
|
||
Restricted cash
|
758
|
|
|
758
|
|
||
Other long-term assets
|
177
|
|
|
180
|
|
||
Total assets
|
$
|
62,623
|
|
|
$
|
70,667
|
|
Current liabilities
|
|
|
|
||||
Accounts payable
|
$
|
6,106
|
|
|
$
|
4,376
|
|
Accrued compensation
|
4,616
|
|
|
3,861
|
|
||
Current portion of long-term debt
|
2,920
|
|
|
(373)
|
|
||
Other current liabilities
|
2,238
|
|
|
2,725
|
|
||
Total current liabilities
|
15,880
|
|
|
10,589
|
|
||
Long-term liabilities
|
|
|
|
||||
Deferred rent
|
1,378
|
|
|
1,257
|
|
||
Long-term debt
|
16,737
|
|
|
9,890
|
|
||
Other non-current liabilities
|
183
|
|
|
334
|
|
||
Total liabilities
|
34,178
|
|
|
22,070
|
|
||
Stockholders’ equity
|
|
|
|
||||
Preferred stock, $0.0001 par value; 5,000 authorized, none issued
|
—
|
|
|
—
|
|
||
Common stock, $0.0001 par value; 100,000 authorized; 42,994 and 42,551 shares issued and outstanding as of June 30, 2016 and December 31, 2015, respectively
|
4
|
|
|
4
|
|
||
Additional paid-in capital
|
358,938
|
|
|
353,233
|
|
||
Accumulated deficit
|
(330,535)
|
|
|
(304,669)
|
|
||
Accumulated other comprehensive income
|
38
|
|
|
29
|
|
||
Total stockholders’ equity
|
28,445
|
|
|
48,597
|
|
||
Total liabilities and stockholders’ equity
|
$
|
62,623
|
|
|
$
|
70,667
|
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
June 30,
|
|
June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Revenue
|
|
|
|
|
|
|
|
||||||||
Product revenue
|
$
|
12,425
|
|
|
$
|
7,550
|
|
|
$
|
23,384
|
|
|
$
|
17,562
|
|
License and other revenue
|
87
|
|
|
96
|
|
|
192
|
|
|
191
|
|
||||
Total revenue
|
12,512
|
|
|
7,646
|
|
|
23,576
|
|
|
17,753
|
|
||||
Cost of revenue
|
4,720
|
|
|
3,286
|
|
|
9,095
|
|
|
7,278
|
|
||||
Gross profit
|
7,792
|
|
|
4,360
|
|
|
14,481
|
|
|
10,475
|
|
||||
Operating expenses
|
|
|
|
|
|
|
|
||||||||
Sales and marketing
|
3,300
|
|
|
3,704
|
|
|
7,009
|
|
|
7,397
|
|
||||
General and administrative
|
3,876
|
|
|
3,662
|
|
|
7,296
|
|
|
7,332
|
|
||||
Research and development
|
13,204
|
|
|
8,924
|
|
|
25,472
|
|
|
17,703
|
|
||||
Total operating expenses
|
20,380
|
|
|
16,290
|
|
|
39,777
|
|
|
32,432
|
|
||||
Loss from operations
|
(12,588)
|
|
|
(11,930)
|
|
|
(25,296)
|
|
|
(21,957)
|
|
||||
Other income (expense)
|
|
|
|
|
|
|
|
||||||||
Interest income
|
26
|
|
|
33
|
|
|
55
|
|
|
69
|
|
||||
Interest expense
|
(308
|
)
|
|
(245
|
)
|
|
(585
|
)
|
|
(317
|
)
|
||||
Other income
|
(42)
|
|
|
(11
|
)
|
|
(9)
|
|
|
206
|
|
||||
Total other income (expense)
|
(324)
|
|
|
(223)
|
|
|
(539)
|
|
|
(42)
|
|
||||
Loss before provision for income taxes
|
(12,912)
|
|
|
(12,153)
|
|
|
(25,835)
|
|
|
(21,999)
|
|
||||
Income tax (benefit) expense
|
(5
|
)
|
|
(1
|
)
|
|
31
|
|
|
22
|
|
||||
Net loss
|
$
|
(12,907
|
)
|
|
$
|
(12,152
|
)
|
|
$
|
(25,866
|
)
|
|
$
|
(22,021
|
)
|
Net loss per share, basic and diluted
|
$
|
(0.30
|
)
|
|
$
|
(0.29
|
)
|
|
$
|
(0.60
|
)
|
|
$
|
(0.53
|
)
|
Weighted average number of shares outstanding, basic and diluted
|
42,864
|
|
|
42,091
|
|
|
42,768
|
|
|
41,934
|
|
||||
Other comprehensive loss
|
|
|
|
|
|
|
|
||||||||
Net loss
|
$
|
(12,907
|
)
|
|
$
|
(12,152
|
)
|
|
$
|
(25,866
|
)
|
|
$
|
(22,021
|
)
|
Foreign currency translation adjustments
|
(34
|
)
|
|
—
|
|
|
13
|
|
|
9
|
|
||||
Net unrealized losses on marketable securities, net of tax
|
(5
|
)
|
|
1
|
|
|
(21
|
)
|
|
(16
|
)
|
||||
Comprehensive loss
|
$
|
(12,946
|
)
|
|
$
|
(12,151
|
)
|
|
$
|
(25,874
|
)
|
|
$
|
(22,028
|
)
|
|
Six Months Ended June 30,
|
||||||
|
2016
|
|
2015
|
||||
Operating activities
|
|
|
|
||||
Net loss
|
$
|
(25,866
|
)
|
|
$
|
(22,021
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
1,791
|
|
|
1,632
|
|
||
Amortization of premiums on investments
|
35
|
|
|
126
|
|
||
Amortization of deferred debt issuance costs
|
169
|
|
|
116
|
|
||
Gain on sale of investment in preferred stock
|
—
|
|
|
(223
|
)
|
||
Stock-based compensation
|
4,540
|
|
|
4,823
|
|
||
Provision for bad debt
|
23
|
|
|
—
|
|
||
Non-cash inventory adjustments
|
92
|
|
|
543
|
|
||
Other non-cash adjustments
|
19
|
|
|
15
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
1,406
|
|
|
1,331
|
|
||
Inventories
|
306
|
|
|
(246
|
)
|
||
Prepaid expenses and other assets
|
(721
|
)
|
|
(472
|
)
|
||
Accounts payable
|
1,289
|
|
|
(1,212
|
)
|
||
Accrued compensation
|
1,119
|
|
|
(231
|
)
|
||
Other liabilities
|
303
|
|
|
(39
|
)
|
||
Net cash used in operating activities
|
(15,495
|
)
|
|
(15,858
|
)
|
||
Investing activities
|
|
|
|
||||
Payments for intellectual property licenses
|
(800
|
)
|
|
(550
|
)
|
||
Purchases of property and equipment
|
(2,404
|
)
|
|
(2,243
|
)
|
||
Purchases of marketable securities
|
(2,532
|
)
|
|
(14,797
|
)
|
||
Proceeds from sales of marketable securities
|
—
|
|
|
223
|
|
||
Maturities of marketable securities
|
4,650
|
|
|
17,850
|
|
||
Net cash provided by (used in) investing activities
|
(1,086
|
)
|
|
483
|
|
||
Financing activities
|
|
|
|
||||
Proceeds from issuance of common stock
|
449
|
|
|
427
|
|
||
Principal repayment of borrowings
|
(17
|
)
|
|
(10
|
)
|
||
Proceeds from borrowings
|
10,000
|
|
|
10,000
|
|
||
Costs associated with debt issuance
|
(30
|
)
|
|
(718
|
)
|
||
Proceeds from stock option exercises
|
352
|
|
|
894
|
|
||
Net cash provided by financing activities
|
10,754
|
|
|
10,593
|
|
||
Effect of exchange rate changes on cash
|
3
|
|
|
2
|
|
||
Net decrease in cash and cash equivalents
|
(5,824
|
)
|
|
(4,780
|
)
|
||
Cash and cash equivalents at beginning of period
|
35,385
|
|
|
36,855
|
|
||
Cash and cash equivalents at end of period
|
$
|
29,561
|
|
|
$
|
32,075
|
|
Non-cash investing and financing activities
|
|
|
|
||||
Transfer of instruments from property and equipment to inventory
|
$
|
42
|
|
|
$
|
127
|
|
Property and equipment costs included in accounts payable
|
$
|
588
|
|
|
$
|
303
|
|
Supplemental cash flow disclosures
|
|
|
|
||||
Cash paid for income taxes, net
|
$
|
13
|
|
|
$
|
15
|
|
Cash received for interest
|
$
|
51
|
|
|
$
|
196
|
|
Cash paid for interest
|
$
|
408
|
|
|
$
|
317
|
|
Machinery and laboratory equipment
|
3 - 5 years
|
Instruments
|
4 - 5 years
|
Office equipment
|
5 years
|
Leasehold improvements
|
over the shorter of the remaining life of the lease or the useful economic life of the asset
|
|
Number of
Shares
|
|
Weighted Average Exercise Price
|
|||
Outstanding at December 31, 2015
|
3,004,011
|
|
|
$
|
9.74
|
|
Granted
|
5,000
|
|
|
4.70
|
|
|
Exercised
|
(56,747)
|
|
|
6.21
|
|
|
Cancelled
|
(204,841)
|
|
|
11.56
|
|
|
Outstanding at June 30, 2016
|
2,747,423
|
|
|
9.67
|
|
|
Vested and expected to vest at June 30, 2016
|
2,604,691
|
|
|
9.55
|
|
|
Exercisable at June 30, 2016
|
1,822,545
|
|
|
$
|
8.57
|
|
|
Six Months Ended
|
||||
|
June 30,
|
||||
|
2016
|
|
2015
|
||
Expected volatility
|
51
|
%
|
|
50
|
%
|
Expected life (years)
|
5.90
|
|
|
6.08
|
|
Risk-free interest rate
|
1.35
|
%
|
|
1.69
|
%
|
Expected dividend
|
—
|
%
|
|
—
|
%
|
Weighted average fair value
|
$2.27
|
|
$6.42
|
|
Restricted Stock Awards
|
|
Restricted Stock Units
|
||||||||||
|
Number of
Shares
|
|
Weighted
Average
Grant Date
Fair Value
|
|
Number of
Shares
|
|
Weighted
Average
Grant Date
Fair Value
|
||||||
Unvested at December 31, 2015
|
32,837
|
|
|
$
|
5.00
|
|
|
934,977
|
|
|
$
|
12.66
|
|
Granted
|
—
|
|
|
—
|
|
|
1,334,023
|
|
|
4.90
|
|
||
Vested
|
(29,774)
|
|
|
4.64
|
|
|
(311,162)
|
|
|
11.93
|
|
||
Cancelled
|
—
|
|
|
—
|
|
|
(225,874)
|
|
|
7.47
|
|
||
Unvested at June 30, 2016
|
3,063
|
|
|
$
|
8.50
|
|
|
1,731,964
|
|
|
$
|
7.06
|
|
|
Market-Based Stock Units
|
|||||
|
Number of
Shares
|
|
Weighted
Average
Grant Date
Fair Value
|
|||
Unvested at December 31, 2015
|
136,730
|
|
|
$
|
18.07
|
|
Target units granted
|
263,351
|
|
|
4.94
|
|
|
Vested
|
—
|
|
|
—
|
|
|
Cancelled
|
(56,269)
|
|
|
9.81
|
|
|
Unvested at June 30, 2016
|
343,812
|
|
|
$
|
9.43
|
|
|
Six Months Ended
|
||||||
|
June 30,
|
||||||
|
2016
|
|
2015
|
||||
Expected volatility
|
49
|
%
|
|
45
|
%
|
||
Risk-free interest rate
|
0.90
|
%
|
|
1.10
|
%
|
||
Expected dividend
|
—
|
%
|
|
—
|
%
|
||
Weighted average fair value
|
$
|
4.94
|
|
|
$
|
18.07
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Options outstanding to purchase common stock
|
2,747
|
|
3,047
|
|
2,747
|
|
3,047
|
Other unvested equity awards
|
2,101
|
|
1,308
|
|
2,101
|
|
1,308
|
Total
|
4,848
|
|
4,355
|
|
4,848
|
|
4,355
|
|
June 30, 2016
|
|
December 31, 2015
|
||||
Raw materials
|
$
|
886
|
|
|
$
|
1,147
|
|
Work-in-process
|
775
|
|
|
693
|
|
||
Finished goods
|
953
|
|
|
1,214
|
|
||
Total inventories
|
$
|
2,614
|
|
|
$
|
3,054
|
|
|
June 30, 2016
|
|
December 31, 2015
|
||||
Property and equipment — at cost:
|
|
|
|
||||
Machinery and laboratory equipment
|
$
|
9,064
|
|
|
$
|
7,728
|
|
Instruments
|
9,698
|
|
|
8,195
|
|
||
Office equipment
|
1,521
|
|
|
1,526
|
|
||
Leasehold improvements
|
4,311
|
|
|
4,311
|
|
||
Total property and equipment — at cost
|
24,594
|
|
|
21,760
|
|
||
Less: accumulated depreciation
|
(11,940
|
)
|
|
(10,364
|
)
|
||
Property and equipment, net
|
$
|
12,654
|
|
|
$
|
11,396
|
|
|
June 30, 2016
|
|
December 31, 2015
|
||||||||||||||||||||
|
Gross Carrying Amount
|
|
Accumulated Amortization
|
|
Net Carrying Amount
|
|
Gross Carrying Amount
|
|
Accumulated Amortization
|
|
Net Carrying Amount
|
||||||||||||
Intellectual property licenses
|
$
|
3,550
|
|
|
$
|
(1,362
|
)
|
|
$
|
2,188
|
|
|
$
|
3,550
|
|
|
$
|
(1,174
|
)
|
|
$
|
2,376
|
|
Fiscal Years Ending
|
|
Future Amortization Expense
|
||
Remaining in 2016
|
|
$
|
187
|
|
2017
|
|
375
|
|
|
2018
|
|
375
|
|
|
2019
|
|
375
|
|
|
2020
|
|
375
|
|
|
Thereafter
|
|
501
|
|
|
Total
|
|
$
|
2,188
|
|
|
|
June 30, 2016
|
|
December 31, 2015
|
||||
Term Loans
|
|
|
|
|
||||
Term Loan A - 6.9% principal
|
|
$
|
10,000
|
|
|
$
|
10,000
|
|
Term Loan B - 6.9% principal
|
|
10,000
|
|
|
—
|
|
||
Unamortized issuance premium
|
|
(343
|
)
|
|
(483
|
)
|
||
Total debt, net
|
|
19,657
|
|
|
9,517
|
|
||
Current portion of long-term debt
|
|
(2,920
|
)
|
|
373
|
|
||
Long-term debt
|
|
$
|
16,737
|
|
|
$
|
9,890
|
|
|
June 30, 2016
|
||||||||||||||
|
Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Total
|
||||||||
Money market funds (cash equivalents)
|
$
|
7,192
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
7,192
|
|
Corporate notes and bonds
|
—
|
|
|
7,939
|
|
|
—
|
|
|
7,939
|
|
||||
Total
|
$
|
7,192
|
|
|
$
|
7,939
|
|
|
$
|
—
|
|
|
$
|
15,131
|
|
|
|
|
|
|
|
|
|
||||||||
|
December 31, 2015
|
||||||||||||||
|
Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Total
|
||||||||
Money market funds (cash equivalents)
|
$
|
22,128
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
22,128
|
|
Corporate notes and bonds
|
—
|
|
|
8,483
|
|
|
—
|
|
|
8,483
|
|
||||
U.S. government and agency securities
|
—
|
|
|
799
|
|
|
—
|
|
|
799
|
|
||||
Commercial paper
|
—
|
|
|
798
|
|
|
—
|
|
|
798
|
|
||||
Total
|
$
|
22,128
|
|
|
$
|
10,080
|
|
|
$
|
—
|
|
|
$
|
32,208
|
|
June 30, 2016
|
|
Amortized Cost
|
|
Gross Unrealized Gains
|
|
Gross Unrealized Losses
|
|
Estimated Fair Value
|
||||||||
Corporate notes and bonds
|
|
$
|
7,938
|
|
|
$
|
2
|
|
|
$
|
(1
|
)
|
|
$
|
7,939
|
|
|
|
|
|
|
|
|
|
|
||||||||
December 31, 2015
|
|
Amortized Cost
|
|
Gross Unrealized Gains
|
|
Gross Unrealized Losses
|
|
Estimated Fair Value
|
||||||||
Corporate notes and bonds
|
|
$
|
8,495
|
|
|
$
|
1
|
|
|
$
|
(13
|
)
|
|
$
|
8,483
|
|
U.S. government and agency securities
|
|
799
|
|
|
—
|
|
|
—
|
|
|
799
|
|
||||
Commercial paper
|
|
798
|
|
|
—
|
|
|
—
|
|
|
798
|
|
||||
Total
|
|
$
|
10,092
|
|
|
$
|
1
|
|
|
$
|
(13
|
)
|
|
$
|
10,080
|
|
|
Amortized Cost
|
|
Estimated Fair Value
|
||||
Due in one year or less
|
$
|
7,938
|
|
|
$
|
7,939
|
|
Due after one year through two years
|
—
|
|
|
—
|
|
||
Total
|
$
|
7,938
|
|
|
$
|
7,939
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||||||||||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
||||||||||||||
|
(dollars in thousands)
|
|
|
|
|
|
(dollars in thousands)
|
|
|
|
|
||||||||||||||||||
Revenue
|
$
|
12,512
|
|
|
$
|
7,646
|
|
|
$
|
4,866
|
|
|
64
|
%
|
|
$
|
23,576
|
|
|
$
|
17,753
|
|
|
$
|
5,823
|
|
|
33
|
%
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||||||||||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
||||||||||||||
|
(dollars in thousands)
|
|
|
|
|
|
(dollars in thousands)
|
|
|
|
|
||||||||||||||||||
Cost of Revenue
|
$
|
4,720
|
|
|
$
|
3,286
|
|
|
$
|
1,434
|
|
|
44
|
%
|
|
$
|
9,095
|
|
|
$
|
7,278
|
|
|
$
|
1,817
|
|
|
25
|
%
|
Gross Profit
|
$
|
7,792
|
|
|
$
|
4,360
|
|
|
$
|
3,432
|
|
|
79
|
%
|
|
14,481
|
|
|
10,475
|
|
|
$
|
4,006
|
|
|
38
|
%
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||||||||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
||||||||||||
|
(dollars in thousands)
|
|
|
|
|
|
(dollars in thousands)
|
|
|
|
|
||||||||||||||||
Sales and Marketing
|
$
|
3,300
|
|
|
$
|
3,704
|
|
|
$
|
(404
|
)
|
|
(11
|
)%
|
|
7,009
|
|
|
7,397
|
|
|
$
|
(388
|
)
|
|
(5
|
)%
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||||||||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
||||||||||||
|
(dollars in thousands)
|
|
|
|
|
|
(dollars in thousands)
|
|
|
|
|
||||||||||||||||
General and Administrative
|
$
|
3,876
|
|
|
$
|
3,662
|
|
|
$
|
214
|
|
|
6
|
%
|
|
7,296
|
|
|
7,332
|
|
|
$
|
(36
|
)
|
|
—
|
%
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||||||||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
||||||||||||
|
(dollars in thousands)
|
|
|
|
|
|
(dollars in thousands)
|
|
|
|
|
||||||||||||||||
Research and Development
|
$
|
13,204
|
|
|
$
|
8,924
|
|
|
$
|
4,280
|
|
|
48
|
%
|
|
25,472
|
|
|
17,703
|
|
|
$
|
7,769
|
|
|
44
|
%
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||||||||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
||||||||||||
|
(dollars in thousands)
|
|
|
|
|
|
(dollars in thousands)
|
|
|
|
|
||||||||||||||||
Other Income (Expense)
|
$
|
(324
|
)
|
|
$
|
(223
|
)
|
|
$
|
(101
|
)
|
|
45
|
%
|
|
(539
|
)
|
|
(42
|
)
|
|
$
|
(497
|
)
|
|
1,183
|
%
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||||||||||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
||||||||||||||
|
(dollars in thousands)
|
|
|
|
|
|
(dollars in thousands)
|
|
|
|
|
||||||||||||||||||
Income tax expense (benefit)
|
$
|
(5
|
)
|
|
$
|
(1
|
)
|
|
$
|
(4
|
)
|
|
400
|
%
|
|
$
|
31
|
|
|
$
|
22
|
|
|
$
|
9
|
|
|
41
|
%
|
|
June 30,
|
||||||
Six months ended (in thousands):
|
2016
|
|
2015
|
||||
Net cash used in operating activities
|
(15,495
|
)
|
|
(15,858
|
)
|
||
Net cash provided by (used in) investing activities
|
(1,086
|
)
|
|
483
|
|
||
Net cash provided by financing activities
|
10,754
|
|
|
10,593
|
|
||
Effect of exchange rate on cash
|
3
|
|
|
2
|
|
||
Net decrease in cash and cash equivalents
|
$
|
(5,824
|
)
|
|
$
|
(4,780
|
)
|
•
|
our ability to manage the risks associated with manufacturing variability;
|
•
|
scaling-up for new product production;
|
•
|
our and our supplier's ability to consistently manufacture highly complex products that deliver valid and accurate results at the level required for FDA clearance and overall market adoption;
|
•
|
timely market introduction;
|
•
|
product reliability;
|
•
|
overall market acceptance;
|
•
|
our ability to offer a broad test menu at a competitive price;
|
•
|
the effective management of purchase and supply commitments and inventory levels in line with anticipated product demand;
|
•
|
the availability of products in appropriate quantities and at expected costs to meet anticipated demand and drive market adoption;
|
•
|
increased repair or re-engineering costs due to product returns or design adjustments; and
|
•
|
the risk that new products may not have the level of quality in the early stages of introduction that our customers expect.
|
•
|
the relative convenience, ease of use, accuracy, reliability, scalability, cost, and time-to-result of our diagnostic products over competing products;
|
•
|
the introduction of new technologies and competing products that may make our technologies and products a less attractive solution for our target customers;
|
•
|
the breadth and relevance of our menu of available diagnostic tests relative to our competitors;
|
•
|
our success in training our customers in the proper use of our products;
|
•
|
the acceptance in the medical community and key opinion leaders of our molecular diagnostic technology and products;
|
•
|
the extent and success of our marketing and sales efforts; and
|
•
|
general economic conditions.
|
•
|
companies developing and marketing multiplex molecular diagnostics systems, including: Luminex; Nanosphere, Inc.; bioMerieux, which acquired BioFire Diagnostics, Inc.; Qiagen NV; Abbott Molecular Diagnostics, a division of Abbott Laboratories; Hologic, Inc. and Cepheid;
|
•
|
large hospital-based laboratories and reference laboratories who provide large-scale testing using their own proprietary testing methods, including Quest Diagnostics Incorporated and Laboratory Corporation of America; and
|
•
|
companies that manufacture laboratory-based tests and analyzers, including: Cepheid; Siemens; Hologic, Inc.; Qiagen NV; bioMérieux; Roche Diagnostics, a division of F. Hoffmann-La Roche Ltd.; and Abbott Molecular Diagnostics.
|
•
|
reliance on third parties for regulatory compliance and quality assurance;
|
•
|
possible breaches of manufacturing agreements by the third parties because of factors beyond our control;
|
•
|
possible regulatory violations or manufacturing problems experienced by our suppliers;
|
•
|
possible termination or non-renewal of agreements by third parties, based on their own business priorities, at times that are costly or inconvenient for us;
|
•
|
the potential obsolescence and/or inability of our suppliers to obtain required components;
|
•
|
the potential delays and expenses of seeking alternate sources of supply or manufacturing services;
|
•
|
the inability to qualify alternate sources without impacting performance claims of our products;
|
•
|
reduced control over pricing, quality and timely delivery due to the difficulties in switching to alternate suppliers or assemblers;
|
•
|
the potential for financial hardship or other detrimental circumstances at key suppliers that may impact our ability to source key materials or services required for the manufacturing of our products; and
|
•
|
increases in prices of raw materials and key components.
|
•
|
the time and resources required to develop, and conduct clinical studies and obtain regulatory clearances for, our diagnostic tests;
|
•
|
the expenses we incur for research and development required to maintain and improve our technology, including developing our ePlex system;
|
•
|
the costs of preparing, filing, prosecuting, defending and enforcing patent claims and other patent related costs, including litigation costs and the results of such litigation;
|
•
|
the expenses we incur in connection with commercialization activities, including product marketing, sales, and distribution expenses;
|
•
|
the expenses we incur in licensing technologies from third parties to expand the menu of diagnostics tests we plan to offer;
|
•
|
our sales strategy and whether the revenues from sales of our test cartridges or systems will be sufficient to offset our expenses;
|
•
|
the costs to attract and retain personnel with the skills required for effective operations; and
|
•
|
the costs associated with being a public company.
|
•
|
incur additional indebtedness or issue certain preferred shares;
|
•
|
pay dividends on, repurchase or make distributions in respect of, our capital stock or make other restricted payments;
|
•
|
make certain investments or acquisitions;
|
•
|
sell certain assets;
|
•
|
create liens; or
|
•
|
enter into certain transactions with our affiliates.
|
•
|
administrative or judicially imposed sanctions;
|
•
|
injunctions or the imposition of civil penalties;
|
•
|
recall or seizure of our products;
|
•
|
total or partial suspension of production or distribution;
|
•
|
withdrawal or suspension of marketing clearances or approvals;
|
•
|
clinical holds;
|
•
|
warning letters;
|
•
|
refusal to permit the import or export of our products; and
|
•
|
criminal prosecution.
|
•
|
our ability to attract and retain the skilled support team, marketing staff and sales force necessary to commercialize and gain market acceptance for our technology and our products;
|
•
|
the ability of our sales and marketing team to identify and penetrate the potential customer base, including hospitals and national and regional reference laboratories; and
|
•
|
the difficulty of establishing brand recognition and loyalty for our products.
|
•
|
allow the authorized number of directors to be changed only by resolution of our Board of Directors;
|
•
|
provide that our stockholders may remove our directors only for cause;
|
•
|
establish a classified board of directors, such that not all members of the Board of Directors may be elected at one time;
|
•
|
authorize our Board of Directors to issue without stockholder approval up to 100,000,000 shares of common stock, that, if issued, would dilute our stock ownership and could operate as a “poison pill” to dilute the stock ownership of a potential hostile acquirer to prevent an acquisition that is not approved by our Board of Directors;
|
•
|
authorize our Board of Directors to issue without stockholder approval up to 5,000,000 shares of preferred stock, the rights of which will be determined at the discretion of the Board of Directors that, if issued, could operate as a “poison pill” to dilute the stock ownership of a potential hostile acquirer to prevent an acquisition that is not approved by our Board of Directors;
|
•
|
require that stockholder actions must be effected at a duly called stockholder meeting or by unanimous written consent;
|
•
|
establish advance notice requirements for stockholder nominations to our Board of Directors or for stockholder proposals that can be acted on at stockholder meetings;
|
•
|
limit who may call stockholder meetings; and
|
•
|
require the approval of the holders of 80% of the outstanding shares of our capital stock entitled to vote in order to amend certain provisions of our certificate of incorporation and bylaws.
|
|
|
|
GENMARK DIAGNOSTICS, INC.
|
|
|
|
|
|
|
|
|
Date:
|
July 28, 2016
|
By:
|
/s/ HANY MASSARANY
|
|
|
|
Hany Massarany
|
|
|
|
President and Chief Executive Officer
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
|
|
|
|
|
Date:
|
July 28, 2016
|
By:
|
/s/ SCOTT MENDEL
|
|
|
|
Scott Mendel
|
|
|
|
Chief Financial Officer
|
|
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
|
Exhibit
|
Description
|
3.1
|
Certificate of Incorporation (incorporated by reference to our Registration Statement on Form S-1 (File No. 333-165562) filed with the Commission on March 19, 2010).
|
3.2
|
Amended and Restated Bylaws (incorporated by reference to our Current Report on Form 8-K filed with the SEC on October 31, 2014).
|
10.1
|
Equity Distribution Agreement dated June 14, 2016 by and between GenMark Diagnostics, Inc. and Canaccord Genuity Inc.
|
31.1
|
Certification of Principal Executive Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended.
|
31.2
|
Certification of Principal Financial Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended.
|
32.1
|
Certification of Principal Executive Officer and Principal Financial Officer Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. §1350.
|
101.INS
|
XBRL Instance Document.
|
101.SCH
|
XBRL Taxonomy Extension Schema Document.
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document.
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
1 Year GenMark Diagnostics Chart |
1 Month GenMark Diagnostics Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions