|
|
|
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
|
|
20-0094687
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification No.)
|
|
Large accelerated filer
|
¨
|
Accelerated filer
|
ý
|
Non-accelerated filer
|
¨
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
¨
|
|
|
|
PAGE
|
|
||
|
||
|
Condensed Consolidated Balance Sheets
at June 30, 2016 and December 31, 2015
|
|
|
Condensed Consolidated Statements of Operations
- Three and Six Months Ended June 30, 2016 and 2015
|
|
|
Condensed Consolidated Statements of Comprehensive Loss
- Three and Six Months Ended June 30, 2016 and 2015
|
|
|
Condensed Consolidated Statements of Cash Flows
- Six Months Ended June 30, 2016 and 2015
|
|
|
||
|
||
Item 1.
|
Condensed Consolidated Financial Statements
|
|
June 30, 2016
|
|
December 31, 2015
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
19,294
|
|
|
$
|
21,856
|
|
Short-term investments
|
37,846
|
|
|
27,188
|
|
||
Accounts receivable, net
|
25,238
|
|
|
19,725
|
|
||
Inventory
|
12,510
|
|
|
10,138
|
|
||
Prepaid expenses and other
|
3,599
|
|
|
3,886
|
|
||
Total current assets
|
98,487
|
|
|
82,793
|
|
||
Restricted cash
|
143
|
|
|
143
|
|
||
Deferred offering costs
|
178
|
|
|
181
|
|
||
Property and equipment, net
|
10,646
|
|
|
9,414
|
|
||
Other assets
|
420
|
|
|
338
|
|
||
Total assets
|
$
|
109,874
|
|
|
$
|
92,869
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
3,973
|
|
|
$
|
3,243
|
|
Accrued liabilities
|
8,738
|
|
|
12,181
|
|
||
Deferred revenue, current portion
|
16,873
|
|
|
5,261
|
|
||
Deferred rent, current portion
|
172
|
|
|
—
|
|
||
Lease financing obligations, current portion
|
149
|
|
|
226
|
|
||
Total current liabilities
|
29,905
|
|
|
20,911
|
|
||
Deferred revenue, net of current portion
|
27,188
|
|
|
6,486
|
|
||
Deferred rent and other long-term liabilities
|
5,853
|
|
|
4,257
|
|
||
Long-term debt and lease financing obligations, net of current portion and debt issuance costs
|
46,596
|
|
|
41,000
|
|
||
Total liabilities
|
109,542
|
|
|
72,654
|
|
||
Commitment and contingencies
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, $0.0001 par value, 15,000 shares authorized; none issued
|
—
|
|
|
—
|
|
||
Common stock, $0.0001 par value, 150,000 shares authorized; 19,834 and 19,570 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively
|
2
|
|
|
2
|
|
||
Additional paid-in capital
|
248,162
|
|
|
242,693
|
|
||
Accumulated other comprehensive income (loss)
|
27
|
|
|
(29
|
)
|
||
Accumulated deficit
|
(247,859
|
)
|
|
(222,451
|
)
|
||
Total stockholders’ equity
|
332
|
|
|
20,215
|
|
||
Total liabilities and stockholders’ equity
|
$
|
109,874
|
|
|
$
|
92,869
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Revenue:
|
|
|
|
|
|
|
|
||||||||
Product and service
|
$
|
17,488
|
|
|
$
|
12,498
|
|
|
$
|
29,624
|
|
|
$
|
23,330
|
|
Collaboration
|
5,139
|
|
|
568
|
|
|
7,700
|
|
|
1,329
|
|
||||
Total revenue
|
22,627
|
|
|
13,066
|
|
|
37,324
|
|
|
24,659
|
|
||||
Costs and expenses:
|
|
|
|
|
|
|
|
||||||||
Cost of product and service revenue
|
7,871
|
|
|
5,871
|
|
|
13,741
|
|
|
11,211
|
|
||||
Research and development
|
8,799
|
|
|
5,798
|
|
|
16,007
|
|
|
11,714
|
|
||||
Selling, general and administrative
|
15,507
|
|
|
12,823
|
|
|
30,411
|
|
|
26,948
|
|
||||
Total costs and expenses
|
32,177
|
|
|
24,492
|
|
|
60,159
|
|
|
49,873
|
|
||||
Loss from operations
|
(9,550
|
)
|
|
(11,426
|
)
|
|
(22,835
|
)
|
|
(25,214
|
)
|
||||
Other income (expense):
|
|
|
|
|
|
|
|
||||||||
Interest income
|
94
|
|
|
56
|
|
|
162
|
|
|
123
|
|
||||
Interest expense
|
(1,326
|
)
|
|
(1,001
|
)
|
|
(2,641
|
)
|
|
(1,985
|
)
|
||||
Other income (expense), net
|
12
|
|
|
(33
|
)
|
|
(59
|
)
|
|
(222
|
)
|
||||
Total other income (expense), net
|
(1,220
|
)
|
|
(978
|
)
|
|
(2,538
|
)
|
|
(2,084
|
)
|
||||
Net loss before provision for income tax
|
(10,770
|
)
|
|
(12,404
|
)
|
|
(25,373
|
)
|
|
(27,298
|
)
|
||||
Provision for income tax
|
(35
|
)
|
|
—
|
|
|
(35
|
)
|
|
—
|
|
||||
Net loss
|
$
|
(10,805
|
)
|
|
$
|
(12,404
|
)
|
|
(25,408
|
)
|
|
(27,298
|
)
|
||
Net loss per share - basic and diluted
|
$
|
(0.55
|
)
|
|
$
|
(0.66
|
)
|
|
$
|
(1.29
|
)
|
|
$
|
(1.47
|
)
|
Weighted average shares used in computing basic and diluted net loss per share
|
19,803
|
|
|
18,831
|
|
|
19,736
|
|
|
18,572
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Net loss
|
$
|
(10,805
|
)
|
|
$
|
(12,404
|
)
|
|
$
|
(25,408
|
)
|
|
$
|
(27,298
|
)
|
Change in unrealized gain or loss on short-term investments
|
23
|
|
|
(11
|
)
|
|
56
|
|
|
14
|
|
||||
Comprehensive loss
|
$
|
(10,782
|
)
|
|
$
|
(12,415
|
)
|
|
$
|
(25,352
|
)
|
|
$
|
(27,284
|
)
|
|
Six Months Ended
June 30, |
||||||
|
2016
|
|
2015
|
||||
Operating activities
|
|
|
|
||||
Net loss
|
$
|
(25,408
|
)
|
|
$
|
(27,298
|
)
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
|
|
|
|
||||
Depreciation and amortization
|
1,451
|
|
|
1,107
|
|
||
Stock-based compensation expense
|
4,309
|
|
|
2,902
|
|
||
Amortization of premium on short-term investments
|
73
|
|
|
152
|
|
||
Interest accrued on long-term debt
|
74
|
|
|
—
|
|
||
Conversion of accrued interest to long-term debt
|
632
|
|
|
538
|
|
||
Loss on sale of property and equipment
|
—
|
|
|
(2
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable, net
|
(5,516
|
)
|
|
(781
|
)
|
||
Inventory
|
(3,283
|
)
|
|
(4,333
|
)
|
||
Prepaid expenses and other
|
260
|
|
|
(1,091
|
)
|
||
Other assets
|
(89
|
)
|
|
69
|
|
||
Accounts payable
|
660
|
|
|
(989
|
)
|
||
Accrued liabilities
|
(2,832
|
)
|
|
(3,089
|
)
|
||
Deferred revenue
|
32,314
|
|
|
722
|
|
||
Deferred rent
|
1,675
|
|
|
828
|
|
||
Net cash provided by (used in) operating activities
|
4,320
|
|
|
(31,265
|
)
|
||
Investing activities
|
|
|
|
||||
Purchases of property and equipment
|
(2,231
|
)
|
|
(1,564
|
)
|
||
Proceeds from sale of property and equipment
|
—
|
|
|
20
|
|
||
Proceeds from sale of short-term investments
|
1,250
|
|
|
3,000
|
|
||
Proceeds from maturity of short-term investments
|
16,700
|
|
|
34,230
|
|
||
Purchases of short-term investments
|
(28,625
|
)
|
|
(19,150
|
)
|
||
Net cash (used in) provided by investing activities
|
(12,906
|
)
|
|
16,536
|
|
||
Financing activities
|
|
|
|
||||
Borrowings under long-term debt agreement
|
5,000
|
|
|
—
|
|
||
Repayment of lease financing obligations
|
(135
|
)
|
|
(135
|
)
|
||
Proceeds from sale of common stock, net
|
—
|
|
|
12,518
|
|
||
Deferred offering costs
|
—
|
|
|
(137
|
)
|
||
Proceeds from issuance of common stock for employee stock purchase plan
|
767
|
|
|
664
|
|
||
Proceeds from exercise of stock options
|
395
|
|
|
352
|
|
||
Net cash provided by financing activities
|
6,027
|
|
|
13,262
|
|
||
Net decrease in cash and cash equivalents
|
(2,559
|
)
|
|
(1,467
|
)
|
||
Effect of exchange rate changes on cash and cash equivalents
|
(3
|
)
|
|
(19
|
)
|
||
Cash and cash equivalents
|
|
|
|
||||
Beginning of period
|
21,856
|
|
|
17,223
|
|
||
End of period
|
$
|
19,294
|
|
|
$
|
15,737
|
|
1.
|
Description of Business
|
2.
|
Basis of Presentation and Summary of Significant Accounting Policies
|
3.
|
Net Loss Per Share
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||
Options to purchase common stock
|
4,736
|
|
|
4,039
|
|
|
4,623
|
|
|
4,039
|
|
Restricted stock units
|
117
|
|
|
15
|
|
|
100
|
|
|
15
|
|
Common stock warrants
|
516
|
|
|
572
|
|
|
544
|
|
|
572
|
|
4.
|
Concentration of Risks
|
5.
|
Short-term Investments
|
Type of securities as of June 30, 2016
|
Amortized
cost
|
|
Gross
unrealized
gains
|
|
Gross
unrealized
losses
|
|
Fair value
|
||||||||
Corporate debt securities
|
$
|
27,909
|
|
|
$
|
10
|
|
|
$
|
(1
|
)
|
|
$
|
27,918
|
|
U.S. government-related debt securities
|
9,909
|
|
|
19
|
|
|
—
|
|
|
9,928
|
|
||||
Total available-for-sale securities
|
$
|
37,818
|
|
|
$
|
29
|
|
|
$
|
(1
|
)
|
|
$
|
37,846
|
|
Type of securities as of December 31, 2015
|
Amortized
cost
|
|
Gross
unrealized
gains
|
|
Gross
unrealized
losses
|
|
Fair value
|
||||||||
Corporate debt securities
|
$
|
26,116
|
|
|
$
|
—
|
|
|
$
|
(28
|
)
|
|
$
|
26,088
|
|
U.S. government-related debt securities
|
1,101
|
|
|
—
|
|
|
(1
|
)
|
|
1,100
|
|
||||
Total available-for-sale securities
|
$
|
27,217
|
|
|
$
|
—
|
|
|
$
|
(29
|
)
|
|
$
|
27,188
|
|
|
June 30, 2016
|
|
December 31, 2015
|
||||
Maturing in one year or less
|
$
|
34,836
|
|
|
$
|
27,188
|
|
Maturing in one to three years
|
3,010
|
|
|
—
|
|
||
Total available-for-sale securities
|
$
|
37,846
|
|
|
$
|
27,188
|
|
|
Less Than 12 Months
|
|
12 Months or
Greater
|
|
Total
|
||||||||||||||||||
|
Fair
value
|
|
Gross
unrealized
losses
|
|
Fair
value
|
|
Gross
unrealized
losses
|
|
Fair
value
|
|
Gross
unrealized
losses
|
||||||||||||
Corporate debt securities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,505
|
|
|
$
|
(1
|
)
|
|
$
|
1,505
|
|
|
$
|
(1
|
)
|
U.S. government-related debt securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,505
|
|
|
$
|
(1
|
)
|
|
$
|
1,505
|
|
|
$
|
(1
|
)
|
6.
|
Fair Value Measurements
|
Level 1:
|
|
Quoted prices in active markets for identical assets and liabilities.
|
Level 2:
|
|
Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets.
|
Level 3:
|
|
Valuations derived from valuation techniques in which one or more significant inputs and significant value drivers are unobservable.
|
As of June 30, 2016
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Cash equivalents:
|
|
|
|
|
|
|
|
||||||||
Money market fund
|
$
|
12,986
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
12,986
|
|
Short-term investments:
|
|
|
|
|
|
|
|
||||||||
Corporate debt securities
|
—
|
|
|
27,918
|
|
|
—
|
|
|
27,918
|
|
||||
U.S. government-related debt securities
|
—
|
|
|
9,928
|
|
|
—
|
|
|
9,928
|
|
||||
Total
|
$
|
12,986
|
|
|
$
|
37,846
|
|
|
$
|
—
|
|
|
$
|
50,832
|
|
|
|
|
|
|
|
|
|
||||||||
As of December 31, 2015
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Cash equivalents:
|
|
|
|
|
|
|
|
||||||||
Money market fund
|
$
|
5,371
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,371
|
|
Short-term investments:
|
|
|
|
|
|
|
|
||||||||
Corporate debt securities
|
—
|
|
|
26,088
|
|
|
—
|
|
|
26,088
|
|
||||
U.S. government-related debt securities
|
—
|
|
|
1,100
|
|
|
—
|
|
|
1,100
|
|
||||
Total
|
$
|
5,371
|
|
|
$
|
27,188
|
|
|
$
|
—
|
|
|
$
|
32,559
|
|
7.
|
Inventory
|
|
June 30, 2016
|
|
December 31, 2015
|
||||
Raw materials
|
$
|
6,228
|
|
|
$
|
3,575
|
|
Work in process
|
2,970
|
|
|
2,895
|
|
||
Finished goods
|
3,312
|
|
|
3,668
|
|
||
|
$
|
12,510
|
|
|
$
|
10,138
|
|
8.
|
Long-term Debt and Lease Financing Obligations
|
|
June 30, 2016
|
|
December 31, 2015
|
||||
Term loans payable
|
$
|
47,118
|
|
|
$
|
41,487
|
|
Lease financing obligations
|
149
|
|
|
284
|
|
||
Total long-term debt and lease financing obligations
|
47,267
|
|
|
41,771
|
|
||
Unamortized debt issuance costs
|
(522
|
)
|
|
(545
|
)
|
||
Current portion of lease financing obligations
|
(149
|
)
|
|
(226
|
)
|
||
Long-term debt and lease financing obligations, net of debt issuance costs and current portion
|
$
|
46,596
|
|
|
$
|
41,000
|
|
9.
|
Collaboration Agreements
|
10.
|
Commitments and Contingencies
|
11.
|
Information about Geographic Areas
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Americas
|
$
|
16,319
|
|
|
$
|
8,133
|
|
|
$
|
26,404
|
|
|
$
|
15,656
|
|
Europe & Middle East
|
4,880
|
|
|
3,012
|
|
|
7,733
|
|
|
5,955
|
|
||||
Asia Pacific
|
1,428
|
|
|
1,921
|
|
|
3,187
|
|
|
3,048
|
|
||||
Total revenue
|
$
|
22,627
|
|
|
$
|
13,066
|
|
|
$
|
37,324
|
|
|
$
|
24,659
|
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
•
|
our expectations regarding our future operating results and capital needs, including our expectations regarding instrument, consumable and total revenue, operating expenses and operating and net loss;
|
•
|
the implementation of our business model, strategic plans for our business and future product development plans;
|
•
|
the regulatory regime and our ability to secure regulatory clearance or approval or reimbursement for the clinical use of our products, domestically and internationally;
|
•
|
our ability to successfully commercialize Prosigna, our first
in vitro
diagnostic product;
|
•
|
our ability to realize the potential payments set forth in our collaboration agreements;
|
•
|
our strategic relationships, including with patent holders of our technologies, manufacturers and distributors of our products, collaboration partners and third parties who conduct our clinical studies;
|
•
|
our intellectual property position;
|
•
|
our expectations regarding the market size and growth potential for our business; and
|
•
|
our ability to sustain and manage growth, including our ability to expand our customer base, develop new products and enter new markets.
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||||||||
|
2016
|
|
2015
|
|
%
Change
|
|
2016
|
|
2015
|
|
%
Change
|
||||||||||
|
(In thousands)
|
|
|
|
(In thousands)
|
|
|
||||||||||||||
Americas
|
$
|
16,319
|
|
|
$
|
8,133
|
|
|
101
|
%
|
|
$
|
26,404
|
|
|
$
|
15,656
|
|
|
69
|
%
|
Europe & Middle East
|
4,880
|
|
|
3,012
|
|
|
62
|
|
|
7,733
|
|
|
5,955
|
|
|
30
|
|
||||
Asia Pacific
|
1,428
|
|
|
1,921
|
|
|
(26
|
)
|
|
3,187
|
|
|
3,048
|
|
|
5
|
|
||||
Total
|
$
|
22,627
|
|
|
$
|
13,066
|
|
|
73
|
|
|
$
|
37,324
|
|
|
$
|
24,659
|
|
|
51
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||||||||
|
2016
|
|
2015
|
|
%
Change
|
|
2016
|
|
2015
|
|
%
Change
|
||||||||||
|
(In thousands)
|
|
|
|
(In thousands)
|
|
|
||||||||||||||
Product revenue:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Instruments
|
$
|
6,444
|
|
|
$
|
4,401
|
|
|
46
|
%
|
|
$
|
9,846
|
|
|
$
|
8,770
|
|
|
12
|
%
|
Consumables
|
9,068
|
|
|
6,844
|
|
|
32
|
|
|
16,276
|
|
|
12,347
|
|
|
32
|
|
||||
In vitro
diagnostic kits
|
1,241
|
|
|
592
|
|
|
110
|
|
|
1,995
|
|
|
973
|
|
|
105
|
|
||||
Total product revenue
|
16,753
|
|
|
11,837
|
|
|
42
|
|
|
28,117
|
|
|
22,090
|
|
|
27
|
|
||||
Service revenue
|
735
|
|
|
661
|
|
|
11
|
|
|
1,507
|
|
|
1,240
|
|
|
22
|
|
||||
Total product and service revenue
|
17,488
|
|
|
12,498
|
|
|
40
|
|
|
29,624
|
|
|
23,330
|
|
|
27
|
|
||||
Collaboration revenue
|
5,139
|
|
|
568
|
|
|
805
|
|
|
7,700
|
|
|
1,329
|
|
|
479
|
|
||||
Total revenue
|
$
|
22,627
|
|
|
$
|
13,066
|
|
|
73
|
|
|
$
|
37,324
|
|
|
$
|
24,659
|
|
|
51
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||||||||
|
2016
|
|
2015
|
|
%
Change
|
|
2016
|
|
2015
|
|
%
Change
|
||||||||||
|
(Dollars in thousands)
|
|
|
|
(Dollars In thousands)
|
|
|
||||||||||||||
Cost of product and service revenue
|
$
|
7,871
|
|
|
$
|
5,871
|
|
|
34
|
%
|
|
$
|
13,741
|
|
|
$
|
11,211
|
|
|
23
|
%
|
Product and service gross profit
|
$
|
9,617
|
|
|
$
|
6,627
|
|
|
45
|
|
|
$
|
15,883
|
|
|
$
|
12,119
|
|
|
31
|
|
Product and service gross margin
|
55
|
%
|
|
53
|
%
|
|
|
|
54
|
%
|
|
52
|
%
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||||||||
|
2016
|
|
2015
|
|
%
Change
|
|
2016
|
|
2015
|
|
%
Change
|
||||||||||
|
(In thousands)
|
|
|
|
(In thousands)
|
|
|
||||||||||||||
Core nCounter platform technology
|
$
|
2,451
|
|
|
$
|
1,761
|
|
|
39
|
%
|
|
$
|
4,319
|
|
|
$
|
3,398
|
|
|
27
|
%
|
Manufacturing process development
|
652
|
|
|
445
|
|
|
47
|
|
|
1,249
|
|
|
892
|
|
|
40
|
|
||||
Life sciences products and applications
|
1,593
|
|
|
1,228
|
|
|
30
|
|
|
3,119
|
|
|
2,404
|
|
|
30
|
|
||||
Diagnostic product development
|
1,792
|
|
|
627
|
|
|
186
|
|
|
3,015
|
|
|
1,658
|
|
|
82
|
|
||||
Clinical, regulatory and medical affairs
|
1,357
|
|
|
1,168
|
|
|
16
|
|
|
2,467
|
|
|
2,300
|
|
|
7
|
|
||||
Facility allocation
|
954
|
|
|
569
|
|
|
68
|
|
|
1,838
|
|
|
1,062
|
|
|
73
|
|
||||
Total
|
$
|
8,799
|
|
|
$
|
5,798
|
|
|
52
|
|
|
$
|
16,007
|
|
|
$
|
11,714
|
|
|
37
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||||||||
|
2016
|
|
2015
|
|
%
Change
|
|
2016
|
|
2015
|
|
%
Change
|
||||||||||
|
(In thousands)
|
|
|
|
(In thousands)
|
|
|
||||||||||||||
Selling, general and administrative expense
|
$
|
15,507
|
|
|
$
|
12,823
|
|
|
21
|
%
|
|
$
|
30,411
|
|
|
$
|
26,948
|
|
|
13
|
%
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||||||||
|
2016
|
|
2015
|
|
%
Change
|
|
2016
|
|
2015
|
|
%
Change
|
||||||||||
|
(In thousands)
|
|
|
|
(In thousands)
|
|
|
||||||||||||||
Interest income
|
$
|
94
|
|
|
$
|
56
|
|
|
68
|
%
|
|
$
|
162
|
|
|
$
|
123
|
|
|
32
|
%
|
Interest expense
|
(1,326
|
)
|
|
(1,001
|
)
|
|
32
|
|
|
(2,641
|
)
|
|
(1,985
|
)
|
|
33
|
|
||||
Other income (expense), net
|
12
|
|
|
(33
|
)
|
|
(136
|
)
|
|
(59
|
)
|
|
(222
|
)
|
|
(73
|
)
|
||||
Total other income (expense), net
|
$
|
(1,220
|
)
|
|
$
|
(978
|
)
|
|
25
|
|
|
$
|
(2,538
|
)
|
|
$
|
(2,084
|
)
|
|
22
|
|
|
|
Six Months Ended
June 30, |
||||||
|
|
2016
|
|
2015
|
||||
Cash
provided by (used in)
operating activities
|
|
$
|
4,320
|
|
|
$
|
(31,265
|
)
|
Cash (used in) provided by investing activities
|
|
(12,906
|
)
|
|
16,536
|
|
||
Cash provided by financing activities
|
|
6,027
|
|
|
13,262
|
|
•
|
revenue recognition;
|
•
|
stock-based compensation;
|
•
|
inventory valuation;
|
•
|
fair value measurements; and
|
•
|
income taxes.
|
Item 3.
|
Quantitative and Qualitative Disclosures about Market Risk
|
Item 4.
|
Controls and Procedures
|
Item 1.
|
Legal Proceedings
|
Item 1A.
|
Risk Factors
|
•
|
changes in government programs (such as the National Institutes of Health) that provide funding to research institutions and companies;
|
•
|
macroeconomic conditions and the political climate;
|
•
|
changes in the regulatory environment;
|
•
|
differences in budgetary cycles;
|
•
|
market-driven pressures to consolidate operations and reduce costs; and
|
•
|
market acceptance of relatively new technologies, such as ours.
|
•
|
expand the commercialization of our products;
|
•
|
fund our operations; and
|
•
|
further our research and development.
|
•
|
market acceptance of our products;
|
•
|
the cost and timing of establishing additional sales, marketing and distribution capabilities;
|
•
|
revenue and cash flow derived from existing or future collaborations;
|
•
|
the cost of our research and development activities;
|
•
|
the cost and timing of regulatory clearances or approvals;
|
•
|
the effect of competing technological and market developments; and
|
•
|
the extent to which we acquire or invest in businesses, products and technologies, including new licensing arrangements for new products.
|
•
|
greater name and brand recognition, financial and human resources;
|
•
|
broader product lines;
|
•
|
larger sales forces and more established distributor networks;
|
•
|
substantial intellectual property portfolios;
|
•
|
larger and more established customer bases and relationships; and
|
•
|
better established, larger scale, and lower cost manufacturing capabilities.
|
•
|
cost of capital equipment;
|
•
|
cost of consumables and supplies;
|
•
|
reputation among customers;
|
•
|
innovation in product offerings;
|
•
|
flexibility and ease-of-use;
|
•
|
accuracy and reproducibility of results; and
|
•
|
compatibility with existing laboratory processes, tools and methods.
|
•
|
availability of reimbursement for testing services;
|
•
|
breadth of clinical decisions that can be influenced by information generated by tests;
|
•
|
volume, quality, and strength of clinical and analytical validation data;
|
•
|
inclusion in treatment guidelines; and
|
•
|
economic benefit accrued to customers based on testing services enabled by products.
|
•
|
required compliance with existing and changing foreign regulatory requirements and laws;
|
•
|
required compliance with anti-bribery laws, such as the U.S. Foreign Corrupt Practices Act and U.K. Bribery Act, data privacy requirements, labor laws and anti-competition regulations;
|
•
|
export or import restrictions;
|
•
|
various reimbursement and insurance regimes;
|
•
|
laws and business practices favoring local companies;
|
•
|
longer payment cycles and difficulties in enforcing agreements and collecting receivables through certain foreign legal systems;
|
•
|
political and economic instability, such as the anticipated exit of Great Britain from the European Economic Community;
|
•
|
potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements and other trade barriers;
|
•
|
difficulties and costs of staffing and managing foreign operations; and
|
•
|
difficulties protecting or procuring intellectual property rights.
|
•
|
dispose of assets;
|
•
|
complete mergers or acquisitions;
|
•
|
incur indebtedness;
|
•
|
encumber assets;
|
•
|
pay dividends or make other distributions to holders of our capital stock;
|
•
|
make specified investments;
|
•
|
engage in any new line of business; and
|
•
|
engage in certain transactions with our affiliates.
|
•
|
disruption in our relationships with customers, distributors or suppliers as a result of such a transaction;
|
•
|
unanticipated liabilities related to acquired companies;
|
•
|
difficulties integrating acquired personnel, technologies and operations into our existing business;
|
•
|
diversion of management time and focus from operating our business to acquisition integration challenges;
|
•
|
increases in our expenses and reductions in our cash available for operations and other uses; and
|
•
|
possible write-offs or impairment charges relating to acquired businesses.
|
•
|
the federal Anti-kickback Law and state anti-kickback prohibitions;
|
•
|
the federal physician self-referral prohibition, commonly known as the Stark Law, and the state equivalents;
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996, as amended;
|
•
|
the Medicare civil money penalty and exclusion requirements;
|
•
|
the federal False Claims Act civil and criminal penalties and state equivalents; and
|
•
|
state physician gift bans and state and federal marketing expenditure disclosure laws.
|
•
|
We might not have been the first to make the inventions covered by each of our pending patent applications.
|
•
|
We might not have been the first to file patent applications for these inventions.
|
•
|
Others may independently develop similar or alternative products and technologies or duplicate any of our products and technologies.
|
•
|
It is possible that our pending patent applications will not result in issued patents, and even if they issue as patents, they may not provide a basis for commercially viable products, may not provide us with any competitive advantages, or may be challenged and invalidated by third parties.
|
•
|
We may not develop additional proprietary products and technologies that are patentable.
|
•
|
The patents of others may have an adverse effect on our business.
|
•
|
We apply for patents covering our products and technologies and uses thereof, as we deem appropriate. However, we may fail to apply for patents on important products and technologies in a timely fashion or at all.
|
•
|
actual or anticipated quarterly variation in our results of operations or the results of our competitors;
|
•
|
announcements by us or our competitors of new products, significant contracts, commercial relationships or capital commitments;
|
•
|
failure to obtain or delays in obtaining product approvals or clearances from the FDA or foreign regulators;
|
•
|
adverse regulatory or reimbursement announcements;
|
•
|
issuance of new or changed securities analysts’ reports or recommendations for our stock;
|
•
|
developments or disputes concerning our intellectual property or other proprietary rights;
|
•
|
commencement of, or our involvement in, litigation;
|
•
|
market conditions in the research and diagnostics markets;
|
•
|
manufacturing disruptions;
|
•
|
any future sales of our common stock or other securities;
|
•
|
any change to the composition of the board of directors or key personnel;
|
•
|
announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;
|
•
|
general economic conditions and slow or negative growth of our markets; and
|
•
|
the other factors described in this “Risk Factors” section.
|
•
|
permit the board of directors to issue up to 15,000,000 shares of preferred stock, with any rights, preferences and privileges as they may designate;
|
•
|
provide that the authorized number of directors may be changed only by resolution of the board of directors;
|
•
|
provide that all vacancies, including newly-created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;
|
•
|
divide the board of directors into three classes;
|
•
|
provide that a director may only be removed from the board of directors by the stockholders for cause;
|
•
|
require that any action to be taken by our stockholders must be effected at a duly called annual or special meeting of stockholders and may not be taken by written consent;
|
•
|
provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide notice in writing in a timely manner, and meet specific requirements as to the form and content of a stockholder’s notice;
|
•
|
prevent cumulative voting rights (therefore allowing the holders of a plurality of the shares of common stock entitled to vote in any election of directors to elect all of the directors standing for election, if they should so choose);
|
•
|
provide that special meetings of our stockholders may be called only by the chairman of the board, our chief executive officer or by the board of directors; and
|
•
|
provide that stockholders are permitted to amend the bylaws only upon receiving at least two-thirds of the total votes entitled to be cast by holders of all outstanding shares then entitled to vote generally in the election of directors, voting together as a single class.
|
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds.
|
Item 6.
|
Exhibits and Financial Statement Schedules.
|
Exhibit
Number
|
|
Description
|
10.1
|
|
Amendment No. 1 to lease between the Registrant and BMR-500 Fairview Avenue LLC, dated June 27, 2016.
|
10.2
|
|
Amendment No. 2 to Amended and Restated Exclusive License Agreement between the Registrant and Bioclassifer, LLC, dated June 24, 2016.
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a).
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a).
|
32.1*
|
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350.
|
32.2*
|
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 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.
|
*
|
The Certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of NanoString Technologies, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-Q, irrespective of any general incorporation language contained in such filing.
|
|
|
NANOSTRING TECHNOLOGIES, INC.
|
||
|
|
|
|
|
Date:
|
August 4, 2016
|
By:
|
|
/s/ R. Bradley Gray
|
|
|
|
|
R. Bradley Gray
|
|
|
|
|
President and Chief Executive Officer
|
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
Date:
|
August 4, 2016
|
By:
|
|
/s/ James A. Johnson
|
|
|
|
|
James A. Johnson
|
|
|
|
|
Chief Financial Officer
|
|
|
|
|
(Principal Financial and Accounting Officer)
|
Exhibit
Number
|
|
Description
|
10.1
|
|
Amendment No. 1 to lease between the Registrant and BMR-500 Fairview Avenue LLC, dated June 27, 2016.
|
10.2
|
|
Amendment No. 2 to Amended and Restated Exclusive License Agreement between the Registrant and Bioclassifer, LLC, dated June 24, 2016.
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a).
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a).
|
32.1*
|
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350.
|
32.2*
|
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 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.
|
*
|
The Certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of NanoString Technologies, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-Q, irrespective of any general incorporation language contained in such filing.
|
Definition or Provision
|
Means the Following (As of the 7
th
Floor
Premises Term Commencement Date)
|
Approximate Rentable Area of Premises
|
38,928 square feet
|
Approximate Rentable Area of Building
|
122,702 square feet
|
Approximate Rentable Area of Project
|
223,820 square feet
|
Tenant’s Pro Rata Share of Building
|
31.73%
|
Tenant’s Pro Rata Share of Project
|
17.39%
|
1.
|
General Requirements
.
|
a.Commercial General Liability:
Bodily Injury and Property Damage
|
Commercially reasonable amounts, but in any event no less than $1,000,000 per occurrence and $2,000,000 general aggregate, with $2,000,000 products and completed operations aggregate.
|
b.Commercial Automobile Liability:
Bodily Injury and Property Damage
|
$1,000,000 per accident
|
c.Employer’s Liability:
Each Accident
Disease - Policy Limit
Disease - Each Employee
|
$500,000
$500,000
$500,000
|
d.Umbrella Liability:
Bodily Injury and Property Damage
|
Commercially reasonable amounts (excess of coverages a, b and c above), but in any event no less than $5,000,000 per occurrence / aggregate.
|
1.
|
GENERAL INFORMATION
|
a.
|
Occupancy Type: B (Lab/Office)
|
b.
|
Number of Floors: 7+ Mechanical Penthouse + 2 ½ level garage
|
c.
|
Building Area: approximately 122,702 rentable square feet
|
d.
|
Floor Dimension: approximately 170’ x 98
|
e.
|
Floor to Floor: 16’-0” (Level 1); minimum 14’-0” (Levels 2-7)
|
2.
|
SYSTEMS
|
a.
|
Perimeter Interior Wall
: Landlord to provide perimeter window stool trim/sill material for install by Tenant.
|
b.
|
Restrooms
: Men's and women's restrooms at 7th Floor Premises as-is.
|
c.
|
Parking Ratio
: approximately 1.0 / 1,000.
|
3.
|
STRUCTURE
|
a.
|
Construction Type:
Reinforced Concrete
|
b.
|
Bay Size:
approximately 21’ x 31'
|
c.
|
Floor Loads:
100 psf live load.
|
d.
|
Floor Levelness:
Ff35 (25 local) and Fl 25 (15 local)
|
e.
|
Floor Sleeves:
Landlord to provide floor plan which identifies engineered zones for future floor penetrations. All penetrations to be performed by Tenant and must be submitted to Landlord for review and approval.
|
4.
|
MEPFP
|
a.
|
Water:
4” service
|
b.
|
Fire protection and life safety:
Per NFPA 13 and City of Seattle Fire Code. Includes 6” fire service with onsite fire storage tank and fire pump. For the 7
th
Floor Premises, system includes, where applicable, a main loop and secondary distribution installed through or below bottom of floor framing, sized to handle open space plan layout. Routing of piping will be tight to core and shell structure, where possible.
|
c.
|
Switchboards
: One (1) 3000A, three (3) 800A, and one (1) 400A.
|
d.
|
Base-building Switchgear
: included
|
e.
|
Shaft space:
dedicated for tenant use per the attached Proposed Shaft Allocation Plan (see Exhibit D-1). The Proposed Shaft Allocation Plan is subject to change, however Landlord will provide Tenant with substantially the same amount of supply air and exhaust shafts as are shown on the Proposed Shaft Allocation Plan.
|
5.
|
VENTILATION AND AIR DISTRIBUTION SYSTEM
|
a.
|
Air handling units:
The 7
th
Floor Premises will receive up to 20,000 cfm via a system that is shared across multiple floors of the Building. Units are 100% outside-air type, suitable for lab build-out. The system also includes a run-around glycol heat recovery coil, cooling coil, heating coil and final filtration.
|
b.
|
Air distribution:
The system supplies and exhausts air into duct mains installed on the roof. Supply and exhaust ductwork is routed from the duct mains down shafts and extended to the 7th Floor Premises and capped. The system is designed for Tenant Improvement supply and exhaust ductwork to be looped, interconnecting the shafts.
|
c.
|
Dampers:
Fire smoke dampers are included at all supply and return air branch terminations at shafts. Control dampers will be provided by Tenant.
|
d.
|
Fume Exhausts
. See Proposed Shaft Allocation and Proposed Roof Allocation plans, attached as Exhibits D-1 and D-2 respectively. All fume exhaust requirements are Tenant’s responsibility to design, procure, and install as part of Tenant Improvements.
|
6.
|
HEATING SYSTEM
|
a.
|
Boilers:
The 7
th
Floor Premises will receive 50gpm, 140F in, 110F out hot water via a system that is shared across multiple floors of the Building.
|
b.
|
Hot water distribution:
Hot water reheat distribution will be capped and valved at the 7
th
Floor Premises.
|
c.
|
Heating System.
Heating system is designed to a low of ASHRAE 99.6%/24F. 18 ˚F outside design temperature will be accomplished by the backup boiler and control system programming.
|
7.
|
VARIABLE REFRIGERANT FLOW (VRF) SYSTEM
: Space is allocated on the roof and in the shafts for installed VRF units, ducting and piping. Landlord will reimburse Tenant for up to 24 Tons of roof top VRF equipment and piping to the floor. Tenant to provide indoor unit, complete refrigeration piping from shaft to units, controls and electrical during buildout. Tenant shall be responsible for designing and permitting complete VRF system. See Proposed Shaft Allocation and Proposed Roof Allocation plans attached as Exhibits D-1 and D-2 respectively. The Proposed Shaft Allocation Plan and the Proposed Roof Allocation Plan are subject to change, however Landlord will provide Tenant with substantially the same amount of supply air and exhaust shafts as are shown on the Proposed Shaft Allocation Plan and substantially the same amount of roof allocations as are shown on the Proposed Roof Allocation Plan.
|
8.
|
COOLING SYSTEM
: Cooling system is designed to a high of ASHRAE 0.4%/86.1F. 95˚F outside design temperature will be accomplished by the backup chiller and control system programming.
|
9.
|
HVAC CONTROLS
|
a.
|
System:
Includes a head-end DDC system to control the air handling units, boilers, chillers and pumps with dedicated capacity for 40 Tenant devices. Local control panels will be provided by Tenant.
|
b.
|
Integration:
Tenant’s controls are to integrate with the base Building head-end DDC system. Graphics and programming of Tenant Improvement controls are a Tenant cost as a part of the Tenant Improvement work.
|
10.
|
WATER
|
a.
|
Domestic hot water and cold water:
Mains are capped and valved at 7
th
Floor Premises for Tenant use.
|
b.
|
Non-Potable hot and cold water:
Non-Potable Lab Water and Emergency Eyewash/shower to utilize domestic water risers at the 7
th
Floor Premises. All piping, accessory equipment, devices, and heating will be provided by Tenant.
|
11.
|
WASTE NEUTRALIZATION
: Such system will be provided by Tenant. Waste neutralization needs to occur before connecting to base Building piping systems.
|
12.
|
POWER
: The 7th Floor Premises will have one (1) dedicated 277/480V 600amp panel for normal power. The rooftop/mechanical penthouse will have a 277/480V, 1200amp main panel, of which Tenant will have dedicated use of Tenant’s Pro Rata Share, with a sub-panel to be provided by Tenant.
|
13.
|
FIRE ALARM
: The fire alarm panel has dedicated capacity for 150 addressable devices for Tenant’s use.
|
14.
|
TENANT STANDBY GENERATOR
:
The Landlord system includes a 750kW generator located in the basement, basement distribution panels, vertical bus duct, one (1) 150amp, 277/480V distribution panel dedicated for Tenant’s use in the 7th Floor Premises, of which Tenant will have dedicated use of Tenant’s Pro Rata Share, with a sub-panel to be provided by Tenant.
|
15.
|
TELECOM
: A raceway from the base Building main panel to a coordinated tenant IDF location within the 7
th
Floor Premises is dedicated for Tenant’s use.
|
16.
|
SECURITY
: Tenant is responsible for providing, installing, and maintaining security system within the 7
th
Floor Premises.
|
17.
|
WINDOW COVERINGS
: To be provided by Landlord in accordance with Building standard.
|
1.
|
Capitalized terms used but not otherwise defined in this Amendment shall have the meanings provided in the Original Agreement.
|
2.
|
A new row number 6 shall be added to Exhibit A and shall read as follows:
|
|
and the following nationalized applications:
|
|
|
|
AU 2014317843
|
|
CA 2923166
|
|
EP 14781977.5
|
|
IL 244421
|
|
JP (App. No. TBD)
|
3.
|
Except as specifically amended by this Amendment, the Original Agreement shall remain in full force and effect in accordance with its terms. The terms of this Amendment shall form an integral part of the Original Agreement.
|
4.
|
This Amendment may be executed in one or more counterparts, and by the parties hereto in separate counterparts, each of which when executed shall be deemed to be an original and all of which, together with this writing, shall be deemed one and the same instrument. This Amendment may be executed by facsimile or PDF signatures, which signatures shall have the same force and effect as original signatures.
|
5.
|
This Amendment, and all disputes and claims arising under this Amendment, will be interpreted and governed by the laws of the State of New York, without regard to its conflict of laws principles, and the parties hereby consent to venue and to the exercise of personal jurisdiction of a court, federal or state, within the State of New York.
|
NANOSTRING TECHNOLOGIES, INC.
|
BIOCLASSIFIER, LLC
|
|
|
By:
/s/ Kathy Surace-Smith
|
By:
/s/ Matthew Ellis
|
(signature)
|
(signature)
|
|
|
Name:
Kathy Surace-Smith
|
Name:
Matthew Ellis
|
(printed name)
|
(printed name)
|
|
|
Title:
Vice President & General Counsel
|
Title:
CEO
|
|
|
Date:
August 1, 2016
|
Date:
August 1, 2016
|
|
[NOTARY SEAL]
|
|
/s/ Candyce Cummings
|
|
Notary Public, State of Texas
|
|
My Commission Expires August 04, 2018
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of NanoString Technologies, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d–15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ R. Bradley Gray
|
|
R. Bradley Gray
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of NanoString Technologies, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d–15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ James A. Johnson
|
|
James A. Johnson
|
|
Chief Financial Officer
|
|
(Principal Financial and Accounting Officer)
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ R. Bradley Gray
|
|
R. Bradley Gray
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ James A. Johnson
|
James A. Johnson
|
Chief Financial Officer
|
(Principal Financial and Accounting Officer)
|