|
|
|
|
|
|
x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
Delaware
|
|
20-0028718
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification No.)
|
|
Large accelerated filer
|
o
|
|
Accelerated filer
|
o
|
|
|
|
|
|
Non-accelerated filer
|
o
|
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
x
|
|
|
|
|
|
|
|
|
Emerging growth company
|
o
|
|
|
|
|
|
|
|
See the Exhibit Index immediately following the signature page of this Quarterly Report on Form 10-Q, which is incorporated herein by reference.
|
|
•
|
uncertainty as to our ability to achieve profitability and positive cash flow through the commercialization of ILUVIEN
®
in the European Economic Area (EEA), the United States (U.S.) and other regions of the world where we sell ILUVIEN;
|
•
|
our ability to operate our business in compliance with the covenants and restrictions that we are subject to under our credit facility;
|
•
|
dependence on third-party manufacturers to manufacture ILUVIEN or any future products or product candidates in sufficient quantities and quality.
|
•
|
our ability to raise sufficient additional funding and our need to raise such funds;
|
•
|
uncertainty as to the pricing and reimbursement guidelines for ILUVIEN or any future products or product candidates, including ILUVIEN;
|
•
|
our ability to successfully commercialize ILUVIEN following regulatory approval in additional markets;
|
•
|
delay in or failure to obtain regulatory approval of ILUVIEN in additional countries or any future products or product candidates; and
|
•
|
the extent of government regulations.
|
|
June 30,
2017
|
|
December 31,
2016
|
||||
|
(In thousands, except share and per share data)
|
||||||
CURRENT ASSETS:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
26,882
|
|
|
$
|
30,979
|
|
Restricted cash
|
33
|
|
|
31
|
|
||
Accounts receivable, net
|
13,648
|
|
|
13,839
|
|
||
Prepaid expenses and other current assets
|
2,574
|
|
|
2,107
|
|
||
Inventory, net (Note 5)
|
1,143
|
|
|
446
|
|
||
Total current assets
|
44,280
|
|
|
47,402
|
|
||
NON-CURRENT ASSETS:
|
|
|
|
||||
Property and equipment, net
|
1,477
|
|
|
1,787
|
|
||
Intangible asset, net (Note 6)
|
19,642
|
|
|
20,604
|
|
||
Deferred tax asset
|
474
|
|
|
436
|
|
||
TOTAL ASSETS
|
$
|
65,873
|
|
|
$
|
70,229
|
|
CURRENT LIABILITIES:
|
|
|
|
||||
Accounts payable
|
$
|
5,711
|
|
|
$
|
4,986
|
|
Accrued expenses (Note 7)
|
3,729
|
|
|
3,758
|
|
||
Derivative warrant liability
|
—
|
|
|
188
|
|
||
Capital lease obligations
|
137
|
|
|
191
|
|
||
Total current liabilities
|
9,577
|
|
|
9,123
|
|
||
NON-CURRENT LIABILITIES:
|
|
|
|
||||
Note payable (Note 9)
|
33,689
|
|
|
33,084
|
|
||
Capital lease obligations — less current portion
|
132
|
|
|
274
|
|
||
Other non-current liabilities
|
773
|
|
|
2,162
|
|
||
COMMITMENTS AND CONTINGENCIES
|
|
|
|
|
|
||
STOCKHOLDERS’ EQUITY:
|
|
|
|
||||
Preferred stock, $.01 par value — 10,000,000 shares authorized at June 30, 2017 and December 31, 2016:
|
|
|
|
|
|
||
Series A Convertible Preferred Stock, 1,300,000 authorized and 600,000 issued and outstanding at June 30, 2017 and December 31, 2016; liquidation preference of $24,000 at June 30, 2017 and December 31, 2016
|
19,227
|
|
|
19,227
|
|
||
Series B Convertible Preferred Stock, 8,417 authorized and 8,416.251 issued and outstanding at June 30, 2017 and December 31, 2016; liquidation preference of $50,750 at June 30, 2017 and December 31, 2016
|
49,568
|
|
|
49,568
|
|
||
Common stock, $.01 par value — 150,000,000 shares authorized, 67,042,349 shares issued and outstanding at June 30, 2017 and 64,862,904 shares issued and outstanding at December 31, 2016
|
670
|
|
|
649
|
|
||
Additional paid-in capital
|
336,093
|
|
|
330,781
|
|
||
Common stock warrants
|
3,707
|
|
|
3,707
|
|
||
Accumulated deficit
|
(386,566
|
)
|
|
(377,074
|
)
|
||
Accumulated other comprehensive loss
|
(997
|
)
|
|
(1,272
|
)
|
||
TOTAL STOCKHOLDERS’ EQUITY
|
21,702
|
|
|
25,586
|
|
||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
65,873
|
|
|
$
|
70,229
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
(In thousands, except share and per share data)
|
||||||||||||||
NET REVENUE
|
$
|
10,368
|
|
|
$
|
9,557
|
|
|
$
|
16,986
|
|
|
$
|
15,358
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(769
|
)
|
|
(556
|
)
|
|
(1,356
|
)
|
|
(934
|
)
|
||||
GROSS PROFIT
|
9,599
|
|
|
9,001
|
|
|
15,630
|
|
|
14,424
|
|
||||
|
|
|
|
|
|
|
|
||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
2,238
|
|
|
3,205
|
|
|
4,348
|
|
|
6,225
|
|
||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
3,012
|
|
|
4,039
|
|
|
6,276
|
|
|
7,434
|
|
||||
SALES AND MARKETING EXPENSES
|
5,060
|
|
|
7,510
|
|
|
10,562
|
|
|
14,619
|
|
||||
DEPRECIATION AND AMORTIZATION
|
667
|
|
|
696
|
|
|
1,333
|
|
|
1,385
|
|
||||
OPERATING EXPENSES
|
10,977
|
|
|
15,450
|
|
|
22,519
|
|
|
29,663
|
|
||||
NET LOSS FROM OPERATIONS
|
(1,378
|
)
|
|
(6,449
|
)
|
|
(6,889
|
)
|
|
(15,239
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
INTEREST EXPENSE, NET AND OTHER
|
(1,384
|
)
|
|
(1,177
|
)
|
|
(2,721
|
)
|
|
(2,512
|
)
|
||||
UNREALIZED FOREIGN CURRENCY GAIN (LOSS), NET
|
28
|
|
|
(14
|
)
|
|
—
|
|
|
20
|
|
||||
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY
|
21
|
|
|
824
|
|
|
188
|
|
|
2,343
|
|
||||
LOSS ON EARLY EXTINGUISHMENT OF DEBT
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,564
|
)
|
||||
NET LOSS BEFORE TAXES
|
(2,713
|
)
|
|
(6,816
|
)
|
|
(9,422
|
)
|
|
(17,952
|
)
|
||||
PROVISION FOR TAXES
|
(44
|
)
|
|
(42
|
)
|
|
(70
|
)
|
|
(51
|
)
|
||||
NET LOSS
|
$
|
(2,757
|
)
|
|
$
|
(6,858
|
)
|
|
$
|
(9,492
|
)
|
|
$
|
(18,003
|
)
|
NET LOSS PER SHARE — Basic and diluted
|
$
|
(0.04
|
)
|
|
$
|
(0.15
|
)
|
|
$
|
(0.15
|
)
|
|
$
|
(0.40
|
)
|
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted
|
65,485,106
|
|
|
45,088,072
|
|
|
65,175,724
|
|
|
45,046,952
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
(In thousands)
|
||||||||||||||
NET LOSS
|
$
|
(2,757
|
)
|
|
$
|
(6,858
|
)
|
|
$
|
(9,492
|
)
|
|
$
|
(18,003
|
)
|
|
|
|
|
|
|
|
|
||||||||
OTHER COMPREHENSIVE INCOME (LOSS)
|
|
|
|
|
|
|
|
||||||||
Foreign currency translation adjustments
|
226
|
|
|
(70
|
)
|
|
275
|
|
|
(288
|
)
|
||||
TOTAL OTHER COMPREHENSIVE INCOME (LOSS)
|
226
|
|
|
(70
|
)
|
|
275
|
|
|
(288
|
)
|
||||
COMPREHENSIVE LOSS
|
$
|
(2,531
|
)
|
|
$
|
(6,928
|
)
|
|
$
|
(9,217
|
)
|
|
$
|
(18,291
|
)
|
|
Six Months Ended
June 30, |
||||||
|
2017
|
|
2016
|
||||
|
(In thousands)
|
||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
||||
Net loss
|
$
|
(9,492
|
)
|
|
$
|
(18,003
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
1,333
|
|
|
1,385
|
|
||
Inventory reserve
|
34
|
|
|
50
|
|
||
Unrealized foreign currency transaction gain
|
—
|
|
|
(20
|
)
|
||
Loss on early extinguishment of debt
|
—
|
|
|
2,564
|
|
||
Amortization of debt discount
|
693
|
|
|
517
|
|
||
Stock-based compensation expense
|
2,400
|
|
|
2,619
|
|
||
Change in fair value of derivative warrant liability
|
(188
|
)
|
|
(2,343
|
)
|
||
Changes in assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
337
|
|
|
(3,456
|
)
|
||
Prepaid expenses and other current assets
|
(390
|
)
|
|
(652
|
)
|
||
Inventory
|
(719
|
)
|
|
301
|
|
||
Accounts payable
|
572
|
|
|
264
|
|
||
Accrued expenses and other current liabilities
|
(216
|
)
|
|
2,604
|
|
||
Other long-term liabilities
|
(1,357
|
)
|
|
(26
|
)
|
||
Net cash used in operating activities
|
(6,993
|
)
|
|
(14,196
|
)
|
||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
||||
Purchases of property and equipment
|
(167
|
)
|
|
(116
|
)
|
||
Net cash used in investing activities
|
(167
|
)
|
|
(116
|
)
|
||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
||||
Proceeds from exercise of stock options
|
—
|
|
|
88
|
|
||
Proceeds from sale of common stock
|
3,042
|
|
|
287
|
|
||
Payment of issuance cost of common stock
|
(108
|
)
|
|
(52
|
)
|
||
Payment of debt costs
|
—
|
|
|
(357
|
)
|
||
Changes in restricted cash
|
2
|
|
|
—
|
|
||
Payment of capital lease obligations
|
(73
|
)
|
|
(124
|
)
|
||
Net cash provided by (used in) financing activities
|
2,863
|
|
|
(158
|
)
|
||
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS
|
200
|
|
|
22
|
|
||
NET DECREASE IN CASH AND CASH EQUIVALENTS
|
(4,097
|
)
|
|
(14,448
|
)
|
||
CASH AND CASH EQUIVALENTS — Beginning of period
|
30,979
|
|
|
31,075
|
|
||
CASH AND CASH EQUIVALENTS — End of period
|
$
|
26,882
|
|
|
$
|
16,627
|
|
SUPPLEMENTAL DISCLOSURES:
|
|
|
|
||||
Cash paid for interest
|
$
|
2,013
|
|
|
$
|
2,006
|
|
Cash paid for income taxes
|
$
|
55
|
|
|
$
|
263
|
|
Supplemental schedule of non-cash investing and financing activities:
|
|
|
|
||||
Property and equipment acquired under capital leases
|
$
|
—
|
|
|
$
|
56
|
|
Proceeds receivable from sale of common stock
|
$
|
—
|
|
|
$
|
172
|
|
Common stock issuance costs accrued but unpaid
|
$
|
—
|
|
|
$
|
32
|
|
Note payable end of term payment accrued but unpaid
|
$
|
1,400
|
|
|
$
|
1,400
|
|
1.
|
NATURE OF OPERATIONS
|
|
June 30,
2017
|
|
December 31,
2016
|
||||
|
(In thousands)
|
||||||
Component parts (1)
|
$
|
455
|
|
|
$
|
115
|
|
Work-in-process (2)
|
480
|
|
|
18
|
|
||
Finished goods
|
208
|
|
|
353
|
|
||
Total inventory
|
1,143
|
|
|
486
|
|
||
Inventory reserve
|
—
|
|
|
(40
|
)
|
||
Inventory — net
|
$
|
1,143
|
|
|
$
|
446
|
|
|
June 30,
2017
|
|
December 31,
2016
|
||||
|
(In thousands)
|
||||||
Accrued clinical investigator expenses
|
$
|
765
|
|
|
$
|
1,122
|
|
Accrued compensation expenses
|
494
|
|
|
1,020
|
|
||
Accrued rebate, chargeback and other revenue reserves
|
374
|
|
|
809
|
|
||
Accrued End of Term Payment (Note 9)
|
1,400
|
|
|
—
|
|
||
Other accrued expenses
|
696
|
|
|
807
|
|
||
Total accrued expenses
|
$
|
3,729
|
|
|
$
|
3,758
|
|
•
|
In the first two years following the increase in royalty amount to
6%
, the royalty will be reduced to
4%
for net revenues and other related consideration up to
$75,000,000
annually and
5%
for net revenues and other related consideration in excess of
$75,000,000
on an annual basis; and
|
•
|
Beginning with the third year following the increase in royalty amount to
6%
, the royalty will be reduced to
5.2%
for net revenues and other related consideration up to
$75,000,000
annually and to
6.8%
for net revenues and other related consideration in excess of
$75,000,000
on an annual basis.
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30, |
||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||
Series A convertible preferred stock
|
9,022,556
|
|
|
9,022,556
|
|
|
9,022,556
|
|
|
9,022,556
|
|
Series B convertible preferred stock
|
8,416,251
|
|
|
8,416,251
|
|
|
8,416,251
|
|
|
8,416,251
|
|
Series A convertible preferred stock warrants
|
4,511,279
|
|
|
4,511,279
|
|
|
4,511,279
|
|
|
4,511,279
|
|
Common stock warrants
|
1,795,663
|
|
|
940,023
|
|
|
1,795,663
|
|
|
940,023
|
|
Stock options
|
11,496,801
|
|
|
10,648,702
|
|
|
11,496,801
|
|
|
10,648,702
|
|
Restricted stock units
|
861,430
|
|
|
—
|
|
|
861,430
|
|
|
—
|
|
Total
|
36,103,980
|
|
|
33,538,811
|
|
|
36,103,980
|
|
|
33,538,811
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||||||||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||||||||||||||||||
|
Options
|
|
Weighted
Average
Exercise
Price
|
|
Options
|
|
Weighted
Average
Exercise
Price
|
|
Options
|
|
Weighted
Average
Exercise
Price
|
|
Options
|
|
Weighted
Average
Exercise
Price
|
||||||||||||||||
Options outstanding at beginning of period
|
11,696,269
|
|
|
$
|
3.00
|
|
|
10,626,077
|
|
|
$
|
3.32
|
|
|
10,804,412
|
|
|
$
|
3.22
|
|
|
9,475,890
|
|
|
$
|
3.43
|
|
||||
Grants
|
336,300
|
|
|
1.39
|
|
|
192,500
|
|
|
1.59
|
|
|
1,648,800
|
|
|
1.23
|
|
|
1,420,500
|
|
|
2.34
|
|
||||||||
Forfeitures
|
(535,768
|
)
|
|
3.04
|
|
|
(120,647
|
)
|
|
2.81
|
|
|
(956,411
|
)
|
|
2.93
|
|
|
(198,460
|
)
|
|
3.10
|
|
||||||||
Exercises
|
—
|
|
|
—
|
|
|
(49,228
|
)
|
|
1.80
|
|
|
—
|
|
|
—
|
|
|
(49,228
|
)
|
|
1.80
|
|
||||||||
Options outstanding at period end
|
11,496,801
|
|
|
2.96
|
|
|
10,648,702
|
|
|
3.30
|
|
|
11,496,801
|
|
|
2.96
|
|
|
10,648,702
|
|
|
3.30
|
|
||||||||
Options exercisable at period end
|
7,599,761
|
|
|
3.25
|
|
|
6,739,491
|
|
|
3.28
|
|
|
7,599,761
|
|
|
3.25
|
|
|
6,739,491
|
|
|
3.28
|
|
||||||||
Weighted average per share fair value of options granted during the period
|
$
|
1.07
|
|
|
|
|
$
|
1.19
|
|
|
|
|
$
|
0.95
|
|
|
|
|
$
|
1.77
|
|
|
|
|
Shares
|
|
Weighted
Average
Exercise
Price
|
|
Weighted
Average
Remaining Contractual
Term
|
|
Aggregate
Intrinsic
Value
|
|||||
|
|
|
|
|
|
|
(In thousands)
|
|||||
Outstanding
|
11,496,801
|
|
|
$
|
2.96
|
|
|
6.69 years
|
|
$
|
282
|
|
Exercisable
|
7,599,761
|
|
|
3.25
|
|
|
5.61 years
|
|
28
|
|
||
Outstanding, vested and expected to vest
|
11,028,468
|
|
|
2.99
|
|
|
6.59 years
|
|
240
|
|
|
Shares
|
|
Weighted
Average
Exercise
Price
|
|
Weighted
Average
Remaining Contractual
Term
|
|
Aggregate
Intrinsic
Value
|
|||||
|
|
|
|
|
|
|
(In thousands)
|
|||||
Outstanding
|
10,804,412
|
|
|
$
|
3.22
|
|
|
6.45 years
|
|
$
|
—
|
|
Exercisable
|
7,363,400
|
|
|
3.29
|
|
|
5.42 years
|
|
—
|
|
||
Outstanding, vested and expected to vest
|
10,374,846
|
|
|
3.23
|
|
|
6.35 years
|
|
—
|
|
|
June 30, 2017
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
|
(In thousands)
|
||||||||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents (1)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Assets measured at fair value
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Derivative warrant liability (2)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities measured at fair value
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
December 31, 2016
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
|
(In thousands)
|
||||||||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents (1)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Assets measured at fair value
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Derivative warrant liability (2)
|
$
|
—
|
|
|
$
|
188
|
|
|
$
|
—
|
|
|
$
|
188
|
|
Liabilities measured at fair value
|
$
|
—
|
|
|
$
|
188
|
|
|
$
|
—
|
|
|
$
|
188
|
|
(1)
|
The carrying amounts approximate fair value due to the short-term maturities of the cash equivalents.
|
(2)
|
The Company uses the Black-Scholes option pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments.
|
|
Three Months Ended
June 30, 2017 |
|
Three Months Ended
June 30, 2016 |
||||||||||||||||||||||||||||
|
U.S.
|
|
International
|
|
Other
|
|
Consolidated
|
|
U.S.
|
|
International
|
|
Other
|
|
Consolidated
|
||||||||||||||||
|
(In thousands)
|
||||||||||||||||||||||||||||||
NET REVENUE
|
$
|
8,056
|
|
|
$
|
2,312
|
|
|
$
|
—
|
|
|
$
|
10,368
|
|
|
$
|
7,208
|
|
|
$
|
2,349
|
|
|
$
|
—
|
|
|
$
|
9,557
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(503
|
)
|
|
(266
|
)
|
|
—
|
|
|
(769
|
)
|
|
(368
|
)
|
|
(188
|
)
|
|
—
|
|
|
(556
|
)
|
||||||||
GROSS PROFIT
|
7,553
|
|
|
2,046
|
|
|
—
|
|
|
9,599
|
|
|
6,840
|
|
|
2,161
|
|
|
—
|
|
|
9,001
|
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
1,498
|
|
|
518
|
|
|
222
|
|
|
2,238
|
|
|
1,869
|
|
|
1,048
|
|
|
288
|
|
|
3,205
|
|
||||||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
1,828
|
|
|
476
|
|
|
708
|
|
|
3,012
|
|
|
2,126
|
|
|
1,164
|
|
|
749
|
|
|
4,039
|
|
||||||||
SALES AND MARKETING EXPENSES
|
3,521
|
|
|
1,236
|
|
|
303
|
|
|
5,060
|
|
|
5,185
|
|
|
2,039
|
|
|
286
|
|
|
7,510
|
|
||||||||
DEPRECIATION AND AMORTIZATION
|
—
|
|
|
—
|
|
|
667
|
|
|
667
|
|
|
—
|
|
|
—
|
|
|
696
|
|
|
696
|
|
||||||||
OPERATING EXPENSES
|
6,847
|
|
|
2,230
|
|
|
1,900
|
|
|
10,977
|
|
|
9,180
|
|
|
4,251
|
|
|
2,019
|
|
|
15,450
|
|
||||||||
SEGMENT INCOME (LOSS) FROM OPERATIONS
|
706
|
|
|
(184
|
)
|
|
(1,900
|
)
|
|
(1,378
|
)
|
|
(2,340
|
)
|
|
(2,090
|
)
|
|
(2,019
|
)
|
|
(6,449
|
)
|
||||||||
OTHER INCOME AND EXPENSES, NET
|
—
|
|
|
—
|
|
|
(1,335
|
)
|
|
(1,335
|
)
|
|
—
|
|
|
—
|
|
|
(367
|
)
|
|
(367
|
)
|
||||||||
NET LOSS BEFORE TAXES
|
|
|
|
|
|
|
$
|
(2,713
|
)
|
|
|
|
|
|
|
|
$
|
(6,816
|
)
|
|
Six Months Ended
June 30, 2017 |
|
Six Months Ended
June 30, 2016 |
||||||||||||||||||||||||||||
|
U.S.
|
|
International
|
|
Other
|
|
Consolidated
|
|
U.S.
|
|
International
|
|
Other
|
|
Consolidated
|
||||||||||||||||
|
(In thousands)
|
||||||||||||||||||||||||||||||
NET REVENUE
|
$
|
12,501
|
|
|
$
|
4,485
|
|
|
$
|
—
|
|
|
$
|
16,986
|
|
|
$
|
11,327
|
|
|
$
|
4,031
|
|
|
$
|
—
|
|
|
$
|
15,358
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(951
|
)
|
|
(405
|
)
|
|
—
|
|
|
(1,356
|
)
|
|
(590
|
)
|
|
(344
|
)
|
|
—
|
|
|
(934
|
)
|
||||||||
GROSS PROFIT
|
11,550
|
|
|
4,080
|
|
|
—
|
|
|
15,630
|
|
|
10,737
|
|
|
3,687
|
|
|
—
|
|
|
14,424
|
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
2,656
|
|
|
1,259
|
|
|
433
|
|
|
4,348
|
|
|
3,576
|
|
|
2,134
|
|
|
515
|
|
|
6,225
|
|
||||||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
3,531
|
|
|
1,395
|
|
|
1,350
|
|
|
6,276
|
|
|
4,047
|
|
|
1,878
|
|
|
1,509
|
|
|
7,434
|
|
||||||||
SALES AND MARKETING EXPENSES
|
7,567
|
|
|
2,378
|
|
|
617
|
|
|
10,562
|
|
|
10,495
|
|
|
3,529
|
|
|
595
|
|
|
14,619
|
|
||||||||
DEPRECIATION AND AMORTIZATION
|
—
|
|
|
—
|
|
|
1,333
|
|
|
1,333
|
|
|
—
|
|
|
—
|
|
|
1,385
|
|
|
1,385
|
|
||||||||
OPERATING EXPENSES
|
13,754
|
|
|
5,032
|
|
|
3,733
|
|
|
22,519
|
|
|
18,118
|
|
|
7,541
|
|
|
4,004
|
|
|
29,663
|
|
||||||||
SEGMENT LOSS FROM OPERATIONS
|
(2,204
|
)
|
|
(952
|
)
|
|
(3,733
|
)
|
|
(6,889
|
)
|
|
(7,381
|
)
|
|
(3,854
|
)
|
|
(4,004
|
)
|
|
(15,239
|
)
|
||||||||
OTHER INCOME AND EXPENSES, NET
|
—
|
|
|
—
|
|
|
(2,533
|
)
|
|
(2,533
|
)
|
|
—
|
|
|
—
|
|
|
(2,713
|
)
|
|
(2,713
|
)
|
||||||||
NET LOSS BEFORE TAXES
|
|
|
|
|
|
|
$
|
(9,422
|
)
|
|
|
|
|
|
|
|
$
|
(17,952
|
)
|
•
|
continue the commercialization of ILUVIEN in the U.S. and the EEA;
|
•
|
seek the regulatory approval of ILUVIEN for NIPU in Europe, the Middle East and Africa;
|
•
|
continue to seek regulatory approval of ILUVIEN for DME in other jurisdictions
|
•
|
evaluate the use of ILUVIEN for the treatment of other diseases; and
|
•
|
advance the clinical development of any future products or product candidates either currently in our pipeline, or that we may license or acquire in the future.
|
•
|
In the first two years following the increase in royalty amount to 6%, the royalty will be reduced to 4% for net revenues and other related consideration up to $75.0 million annually and 5% for net revenues and other related consideration in excess of $75.0 million on an annual basis; and
|
•
|
Beginning with the third year following the increase in royalty amount to 6%, the royalty will be reduced to 5.2% for net revenues and other related consideration up to $75.0 million annually and to 6.8% for net revenues and other related consideration in excess of $75.0 million on an annual basis.
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
(In thousands)
|
|
|
|
|
||||||||||
NET REVENUE
|
$
|
10,368
|
|
|
$
|
9,557
|
|
|
$
|
16,986
|
|
|
$
|
15,358
|
|
GROSS PROFIT
|
9,599
|
|
|
9,001
|
|
|
15,630
|
|
|
14,424
|
|
||||
OPERATING EXPENSES
|
10,977
|
|
|
15,450
|
|
|
22,519
|
|
|
29,663
|
|
||||
NET LOSS FROM OPERATIONS
|
(1,378
|
)
|
|
(6,449
|
)
|
|
(6,889
|
)
|
|
(15,239
|
)
|
||||
NET LOSS
|
(2,757
|
)
|
|
(6,858
|
)
|
|
(9,492
|
)
|
|
(18,003
|
)
|
•
|
salaries and related expenses for personnel, including medical science liaisons;
|
•
|
costs related to the provision of medical affairs support, including symposia development for physician education;
|
•
|
costs related to compliance with FDA, EEA or other regulatory requirements;
|
•
|
costs related to seeking the regulatory approval of ILUVIEN for NIPU in Europe, the Middle East and Africa;
|
•
|
fees paid to consultants and contract research organizations (CRO) in conjunction with independently monitoring clinical trials and acquiring and evaluating data in conjunction with clinical trials, including all related fees such as investigator grants, patient screening, lab work and data compilation and statistical analysis;
|
•
|
costs incurred with third parties related to the establishment of a commercially viable manufacturing process for products or product candidates;
|
•
|
costs related to production of clinical materials;
|
•
|
costs related to post marketing authorization studies;
|
•
|
consulting fees paid to third-parties involved in research, development and medical affairs activities; and
|
•
|
costs related to stock options or other stock-based compensation granted to personnel in research, development and medical affairs functions.
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
(In thousands)
|
|
|
|
|
||||||||||
NET REVENUE
|
$
|
8,056
|
|
|
$
|
7,208
|
|
|
$
|
12,501
|
|
|
$
|
11,327
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(503
|
)
|
|
(368
|
)
|
|
(951
|
)
|
|
(590
|
)
|
||||
GROSS PROFIT
|
7,553
|
|
|
6,840
|
|
|
11,550
|
|
|
10,737
|
|
||||
|
|
|
|
|
|
|
|
||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
1,498
|
|
|
1,869
|
|
|
2,656
|
|
|
3,576
|
|
||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
1,828
|
|
|
2,126
|
|
|
3,531
|
|
|
4,047
|
|
||||
SALES AND MARKETING EXPENSES
|
3,521
|
|
|
5,185
|
|
|
7,567
|
|
|
10,495
|
|
||||
OPERATING EXPENSES
|
6,847
|
|
|
9,180
|
|
|
13,754
|
|
|
18,118
|
|
||||
SEGMENT INCOME (LOSS) FROM OPERATIONS
|
$
|
706
|
|
|
$
|
(2,340
|
)
|
|
$
|
(2,204
|
)
|
|
$
|
(7,381
|
)
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
(In thousands)
|
||||||||||||||
NET REVENUE
|
$
|
2,312
|
|
|
$
|
2,349
|
|
|
$
|
4,485
|
|
|
$
|
4,031
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(266
|
)
|
|
(188
|
)
|
|
(405
|
)
|
|
(344
|
)
|
||||
GROSS PROFIT
|
2,046
|
|
|
2,161
|
|
|
4,080
|
|
|
3,687
|
|
||||
|
|
|
|
|
|
|
|
||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
518
|
|
|
1,048
|
|
|
1,259
|
|
|
2,134
|
|
||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
476
|
|
|
1,164
|
|
|
1,395
|
|
|
1,878
|
|
||||
SALES AND MARKETING EXPENSES
|
1,236
|
|
|
2,039
|
|
|
2,378
|
|
|
3,529
|
|
||||
OPERATING EXPENSES
|
2,230
|
|
|
4,251
|
|
|
5,032
|
|
|
7,541
|
|
||||
SEGMENT LOSS FROM OPERATIONS
|
$
|
(184
|
)
|
|
$
|
(2,090
|
)
|
|
$
|
(952
|
)
|
|
$
|
(3,854
|
)
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
(In thousands)
|
|
|
|
|
||||||||||
NET LOSS FROM OPERATIONS
|
$
|
(1,378
|
)
|
|
$
|
(6,449
|
)
|
|
$
|
(6,889
|
)
|
|
$
|
(15,239
|
)
|
|
|
|
|
|
|
|
|
||||||||
INTEREST EXPENSE, NET AND OTHER
|
(1,384
|
)
|
|
(1,177
|
)
|
|
(2,721
|
)
|
|
(2,512
|
)
|
||||
UNREALIZED FOREIGN CURRENCY GAIN (LOSS), NET
|
28
|
|
|
(14
|
)
|
|
—
|
|
|
20
|
|
||||
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY
|
21
|
|
|
824
|
|
|
188
|
|
|
2,343
|
|
||||
LOSS ON EARLY EXTINGUISHMENT OF DEBT
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,564
|
)
|
||||
NET LOSS BEFORE TAXES
|
(2,713
|
)
|
|
(6,816
|
)
|
|
(9,422
|
)
|
|
(17,952
|
)
|
||||
PROVISION FOR TAXES
|
(44
|
)
|
|
(42
|
)
|
|
(70
|
)
|
|
(51
|
)
|
||||
NET LOSS
|
$
|
(2,757
|
)
|
|
$
|
(6,858
|
)
|
|
$
|
(9,492
|
)
|
|
$
|
(18,003
|
)
|
Exhibit
Number
|
|
Description
|
|
|
|
3.1
|
|
Restated Certificate of Incorporation of Registrant, as amended on various dates (filed as Exhibit 3.2 to Amendment No. 4 to the Registrant’s Registration Statement on Form S-1 (SEC File No. 333-162782), as filed on April 6, 2010 and incorporated herein by reference).
|
|
|
|
3.2
|
|
Amended and Restated Bylaws of the Registrant, as amended (filed as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, as filed on November 5, 2015 and incorporated herein by reference).
|
|
|
|
3.3
|
|
Certificate of Designation of Series A Convertible Preferred Stock (filed as Exhibit 3.5 to the Registrant’s Current Report on Form 8-K, as filed on October 2, 2012 and incorporated herein by reference).
|
|
|
|
3.4
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (filed as Exhibit 3.6 to the Registrant’s Current Report on Form 8-K, as filed on December 15, 2014 and incorporated herein by reference).
|
|
|
|
3.5
|
|
Certificate of Amendment to the Restated Certificate of Incorporation of the Registrant (filed as Exhibit 3.5 to the Registrant’s Annual Report on Form 10-K, as filed on March 3, 2017 and incorporated herein by reference).
|
|
|
|
10.48
|
|
2017 Amendment to Amended and Restated Collaboration Agreement dated May 3, 2017 by and between Alimera Sciences Inc. and pSivida US, Inc. (f/k/a pSivida, Inc.).
|
|
|
|
10.49
|
|
Fifth Amendment to Loan and Security Agreement dated May 5, 2017 by and among Alimera Sciences Limited, Hercules Capital Funding Trust and Hercules Capital, Inc. f/k/a Hercules Technology Growth Capital, Inc.
|
|
|
|
31.1
|
|
Certification of the Principal Executive Officer, as required by Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
31.2
|
|
Certification of the Principal Financial Officer, as required by Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1
|
|
Certification of the Chief Executive Officer and Chief Financial Officer, as required by Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
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 Link Document.
|
|
|
|
101.PRE+
|
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
|
|
|
+
|
Users of this data are advised pursuant to Rule 406T of Regulation S-T that this interactive data file is deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended and otherwise is not subject to liability under these sections.
|
|
ALIMERA SCIENCES, INC.
|
|
|
|
|
August 10, 2017
|
By:
|
/s/ C. Daniel Myers
|
|
|
C. Daniel Myers
|
|
|
Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
August 10, 2017
|
By:
|
/s/ Richard S. Eiswirth, Jr.
|
|
|
Richard S. Eiswirth, Jr.
|
|
|
President and Chief Financial Officer
|
|
|
(Principal Financial and Accounting Officer)
|
Exhibit
Number
|
|
Description
|
|
|
|
3.1
|
|
Restated Certificate of Incorporation of Registrant, as amended on various dates (filed as Exhibit 3.2 to Amendment No. 4 to the Registrant’s Registration Statement on Form S-1 (SEC File No. 333-162782), as filed on April 6, 2010 and incorporated herein by reference).
|
|
|
|
3.2
|
|
Amended and Restated Bylaws of the Registrant, as amended (filed as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, as filed on November 5, 2015 and incorporated herein by reference).
|
|
|
|
3.3
|
|
Certificate of Designation of Series A Convertible Preferred Stock (filed as Exhibit 3.5 to the Registrant’s Current Report on Form 8-K, as filed on October 2, 2012 and incorporated herein by reference).
|
|
|
|
3.4
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (filed as Exhibit 3.6 to the Registrant’s Current Report on Form 8-K, as filed on December 15, 2014 and incorporated herein by reference).
|
|
|
|
3.5
|
|
Certificate of Amendment to the Restated Certificate of Incorporation of the Registrant (filed as Exhibit 3.5 to the Registrant’s Annual Report on Form 10-K, as filed on March 3, 2017 and incorporated herein by reference).
|
|
|
|
10.48
|
|
2017 Amendment to Amended and Restated Collaboration Agreement dated May 3, 2017 by and between Alimera Sciences Inc. and pSivida US, Inc. (f/k/a pSivida, Inc.).
|
|
|
|
10.49
|
|
Fifth Amendment to Loan and Security Agreement dated May 5, 2017 by and among Alimera Sciences Limited, Hercules Capital Funding Trust and Hercules Capital, Inc. f/k/a Hercules Technology Growth Capital, Inc.
|
|
|
|
31.1
|
|
Certification of the Principal Executive Officer, as required by Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
31.2
|
|
Certification of the Principal Financial Officer, as required by Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1
|
|
Certification of the Chief Executive Officer and Chief Financial Officer, as required by Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
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 Link Document.
|
|
|
|
101.PRE+
|
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
|
|
|
+
|
Users of this data are advised pursuant to Rule 406T of Regulation S-T that this interactive data file is deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended and otherwise is not subject to liability under these sections.
|
c.
|
Section 1.36(o) is added with the following language:
|
d.
|
Section 1.36(p) is added with the following language:
|
e.
|
Section 1.36(q) is added with the following language:
|
i.
|
One hundred percent (100%) of the costs associated with the Majority Time Individual who has managing responsibility for European Operations shall be allocated as Direct Commercialization Costs rather than Direct Development Costs, for so long as no product other than a Product is being Commercialized by Alimera in Europe.
|
a.
|
At the end of Section 6.5.1(a) insert the words “and documents”.
|
b.
|
Section 6.5.1(a)(vi) is hereby added as follows:
|
“Alimera”
|
|
“pSivida”
|
||
|
|
|
|
|
Alimera Sciences, Inc.
|
|
pSivida
US, Inc.
|
||
|
|
|
|
|
By:
|
/s/ Richard S. Eiswirth, Jr.
|
|
By:
|
/s/ Nancy Lurker
|
|
|
|
|
|
Name:
|
Richard S. Eiswirth, Jr.
|
|
Name:
|
Nancy Lurker
|
|
|
|
|
|
Title:
|
President and Chief Financial Officer
|
|
Title:
|
President and CEO
|
|
|
|
|
|
Date:
|
5/3/2017
|
|
Date:
|
May 3, 2017
|
Signature:
|
/s/ Richard S. Eiswirth, Jr.
|
|
|
Print Name:
|
Richard S. Eiswirth, Jr.
|
|
|
Title:
|
President and Chief Financial Officer
|
Signature:
|
/s/ Zhuo Huang
|
|
|
Print Name:
|
Zhuo Huang
|
Title:
|
Assistant General Counsel
|
Signature:
|
/s/ Zhuo Huang
|
|
|
Print Name:
|
Zhuo Huang
|
Title:
|
Assistant General Counsel
|
Signature:
|
/s/ Zhuo Huang
|
|
|
Print Name:
|
Zhuo Huang
|
Title:
|
Assistant General Counsel
|
|
1
|
|
|
|
|
|
2
|
|
|
|
|
|
|
3
|
|
|
|
|
|
|
4
|
|
|
|
|
|
|
5
|
|
|
|
|
|
|
6
|
|
|
|
|
|
|
7
|
|
|
|
|
|
|
|
||||||
SUBSIDIARY / AFFILIATE COMPANY Name/Address
|
|
|||||
|
1
|
|
|
|
|
|
2
|
|
|
|
|
|
|
3
|
|
|
|
|
|
|
4
|
|
|
|
|
|
|
5
|
|
|
|
|
|
|
6
|
|
|
|
|
|
|
7
|
|
|
|
|
|
|
|
1.
|
|
I have reviewed this Quarterly Report on Form 10-Q of Alimera Sciences, 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, 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.
|
||||
|
|
|
|
|
|||
Date: August 10, 2017
|
/s/ C. Daniel Myers
|
||||||
|
C. Daniel Myers
|
|
|||||
|
Chief Executive Officer
(Principal Executive Officer) |
|
1.
|
|
I have reviewed this Quarterly Report on Form 10-Q of Alimera Sciences, 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, 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.
|
|||
|
|
|
|
|||
Date: August 10, 2017
|
/s/ Richard S. Eiswirth, Jr.
|
|||||
|
Richard S. Eiswirth, Jr.
|
|||||
|
President and Chief Financial Officer
(Principal Financial and Accounting Officer) |
Date: August 10, 2017
|
/s/ C. Daniel Myers
|
||
|
C. Daniel Myers
|
||
|
Chief Executive Officer
(Principal Executive Officer) |
||
|
|||
Date: August 10, 2017
|
/s/ Richard S. Eiswirth, Jr.
|
||
|
Richard S. Eiswirth, Jr.
|
||
|
President and Chief Financial Officer
(Principal Financial and Accounting Officer) |