|
|
|
|
|
|
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
|
x
|
|
|
|
|
|
Non-accelerated filer
|
o
|
|
Smaller reporting company
|
x
|
|
|
|
|
|
|
|
|
Emerging growth company
|
o
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock, $0.01 par value per share
|
ALIM
|
The Nasdaq Stock Market LLC
(Nasdaq Global Market)
|
|
|
|
|
|
|
|
See the Exhibit Index immediately following the signature page of this Quarterly Report on Form 10-Q, which is incorporated herein by reference.
|
|
•
|
a slowdown or reduction in our sales in due to a reduction in end user demand, unanticipated competition, regulatory issues, or other unexpected circumstances;
|
•
|
uncertainty regarding our ability to achieve profitability and positive cash flow through the commercialization of ILUVIEN
®
in the U.S., the European Economic Area (EEA) and other regions of the world where we sell ILUVIEN;
|
•
|
dependence on third-party manufacturers to manufacture ILUVIEN or any future products or product candidates in sufficient quantities and quality;
|
•
|
uncertainty associated with our need to replace our key third-party manufacturer of certain component parts of the ILUVIEN injector before our manufacturing contact with the manufacturer expires on September 30, 2020;
|
•
|
uncertainty regarding the pricing and reimbursement guidelines for ILUVIEN or any future products or product candidates, including ILUVIEN in new markets;
|
•
|
uncertainty associated with our pursuit of reimbursement with local health authorities in countries including the U.K., Ireland, Germany, Austria, Portugal, Italy, Spain and France for the recently obtained additional indication for ILUVIEN for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU);
|
•
|
uncertainty associated with our ability to meet any post-market requirements for NIPU in the EEA;
|
•
|
our ability to successfully commercialize ILUVIEN following regulatory approval in additional markets;
|
•
|
delay in or failure to obtain regulatory approval of ILUVIEN or any future products or product candidates in additional countries;
|
•
|
the possibility that we may again fail to comply with the continuing listing standards of the Nasdaq Global Market because the closing bid price of our common stock on the Nasdaq Global Market is below $1.00 for 30 consecutive business days;
|
•
|
our ability to operate our business in compliance with the covenants and restrictions in our credit facility;
|
•
|
current and future laws and regulations; and
|
•
|
our possible need to raise additional financing.
|
|
March 31, 2019
|
|
December 31, 2018
|
||||
|
(In thousands, except share and per share data)
|
||||||
CURRENT ASSETS:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
13,094
|
|
|
$
|
13,043
|
|
Restricted cash
|
33
|
|
|
32
|
|
||
Accounts receivable, net
|
15,417
|
|
|
17,259
|
|
||
Prepaid expenses and other current assets
|
2,469
|
|
|
2,109
|
|
||
Inventory (Note 7)
|
1,860
|
|
|
2,405
|
|
||
Total current assets
|
32,873
|
|
|
34,848
|
|
||
NON-CURRENT ASSETS:
|
|
|
|
||||
Property and equipment, net
|
1,259
|
|
|
1,355
|
|
||
Right of use assets, net
|
775
|
|
|
—
|
|
||
Intangible asset, net (Note 8)
|
16,245
|
|
|
16,723
|
|
||
Deferred tax asset
|
1,158
|
|
|
1,182
|
|
||
TOTAL ASSETS
|
$
|
52,310
|
|
|
$
|
54,108
|
|
CURRENT LIABILITIES:
|
|
|
|
||||
Accounts payable
|
$
|
6,602
|
|
|
$
|
6,355
|
|
Accrued expenses (Note 9)
|
3,118
|
|
|
3,643
|
|
||
Finance lease obligations
|
253
|
|
|
236
|
|
||
Total current liabilities
|
9,973
|
|
|
10,234
|
|
||
NON-CURRENT LIABILITIES:
|
|
|
|
||||
Note payable (Note 11)
|
38,080
|
|
|
37,873
|
|
||
Finance lease obligations — less current portion
|
241
|
|
|
305
|
|
||
Other non-current liabilities
|
3,370
|
|
|
2,974
|
|
||
COMMITMENTS AND CONTINGENCIES
|
|
|
|
|
|
||
STOCKHOLDERS’ EQUITY:
|
|
|
|
||||
Preferred stock, $.01 par value — 10,000,000 shares authorized at March 31, 2019 and December 31, 2018:
|
|
|
|
|
|
||
Series A Convertible Preferred Stock, 1,300,000 authorized and 600,000 issued and outstanding at March 31, 2019 and December 31, 2018; liquidation preference of $24,000 at March 31, 2019 and December 31, 2018
|
19,227
|
|
|
19,227
|
|
||
Series C Convertible Preferred Stock, 10,150 authorized issued and outstanding at March 31, 2019 and December 31, 2018; liquidation preference of $10,150 at March 31, 2019 and December 31, 2018
|
11,117
|
|
|
11,117
|
|
||
Common stock, $.01 par value — 150,000,000 shares authorized, 70,968,630 shares issued and outstanding at March 31, 2019 and 70,078,878 shares issued and outstanding at December 31, 2018
|
710
|
|
|
701
|
|
||
Additional paid-in capital
|
346,869
|
|
|
346,108
|
|
||
Common stock warrants
|
3,707
|
|
|
3,707
|
|
||
Accumulated deficit
|
(379,890
|
)
|
|
(377,127
|
)
|
||
Accumulated other comprehensive loss
|
(1,094
|
)
|
|
(1,011
|
)
|
||
TOTAL STOCKHOLDERS’ EQUITY
|
646
|
|
|
2,722
|
|
||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
52,310
|
|
|
$
|
54,108
|
|
|
Three months ended March 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands, except share and per share data)
|
||||||
NET REVENUE
|
$
|
12,890
|
|
|
$
|
9,630
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(1,600
|
)
|
|
(1,104
|
)
|
||
GROSS PROFIT
|
11,290
|
|
|
8,526
|
|
||
|
|
|
|
||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
2,727
|
|
|
2,822
|
|
||
GENERAL AND ADMINISTRATIVE EXPENSES
|
3,393
|
|
|
3,855
|
|
||
SALES AND MARKETING EXPENSES
|
5,913
|
|
|
5,969
|
|
||
DEPRECIATION AND AMORTIZATION
|
652
|
|
|
649
|
|
||
OPERATING EXPENSES
|
12,685
|
|
|
13,295
|
|
||
NET LOSS FROM OPERATIONS
|
(1,395
|
)
|
|
(4,769
|
)
|
||
|
|
|
|
||||
INTEREST EXPENSE AND OTHER
|
(1,228
|
)
|
|
(1,151
|
)
|
||
UNREALIZED FOREIGN CURRENCY (LOSS) GAIN, NET
|
(69
|
)
|
|
2
|
|
||
LOSS ON EARLY EXTINGUISHMENT OF DEBT
|
—
|
|
|
(1,766
|
)
|
||
NET LOSS BEFORE TAXES
|
(2,692
|
)
|
|
(7,684
|
)
|
||
PROVISION FOR TAXES
|
(71
|
)
|
|
—
|
|
||
NET LOSS
|
(2,763
|
)
|
|
(7,684
|
)
|
||
NET LOSS PER SHARE — Basic and diluted
|
$
|
(0.04
|
)
|
|
$
|
(0.11
|
)
|
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted
|
70,740,851
|
|
|
69,883,012
|
|
|
Three Months Ended
March 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
NET LOSS
|
$
|
(2,763
|
)
|
|
$
|
(7,684
|
)
|
|
|
|
|
||||
OTHER COMPREHENSIVE INCOME
|
|
|
|
||||
Foreign currency translation adjustments
|
(83
|
)
|
|
106
|
|
||
TOTAL OTHER COMPREHENSIVE INCOME
|
(83
|
)
|
|
106
|
|
||
COMPREHENSIVE LOSS
|
$
|
(2,846
|
)
|
|
$
|
(7,578
|
)
|
|
Three Months Ended
March 31, |
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
||||
Net loss
|
$
|
(2,763
|
)
|
|
$
|
(7,684
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
652
|
|
|
649
|
|
||
Unrealized foreign currency transaction loss (gain)
|
69
|
|
|
(2
|
)
|
||
Loss on early extinguishment of debt
|
—
|
|
|
1,766
|
|
||
Amortization of debt discount
|
206
|
|
|
214
|
|
||
Stock-based compensation expense
|
770
|
|
|
1,207
|
|
||
Changes in assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
1,755
|
|
|
(867
|
)
|
||
Prepaid expenses and other current assets
|
(381
|
)
|
|
309
|
|
||
Inventory
|
532
|
|
|
299
|
|
||
Accounts payable
|
301
|
|
|
(992
|
)
|
||
Accrued expenses and other current liabilities
|
(857
|
)
|
|
70
|
|
||
Other long-term liabilities
|
—
|
|
|
(17
|
)
|
||
Net cash provided by (used in) operating activities
|
284
|
|
|
(5,048
|
)
|
||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
||||
Purchases of property and equipment
|
(15
|
)
|
|
(91
|
)
|
||
Net cash used in investing activities
|
(15
|
)
|
|
(91
|
)
|
||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
||||
Proceeds from exercise of stock options
|
—
|
|
|
2
|
|
||
Issuance of debt
|
—
|
|
|
40,000
|
|
||
Payment of principal on notes payable
|
—
|
|
|
(35,000
|
)
|
||
Payment of extinguishment of debt costs
|
—
|
|
|
(2,544
|
)
|
||
Payment of deferred financing costs
|
—
|
|
|
(1,142
|
)
|
||
Payment of finance lease obligations
|
(110
|
)
|
|
(83
|
)
|
||
Net cash (used in) provided by financing activities
|
(110
|
)
|
|
1,233
|
|
||
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH
|
(107
|
)
|
|
93
|
|
||
NET CHANGE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH
|
52
|
|
|
(3,813
|
)
|
||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — Beginning of period
|
13,075
|
|
|
24,101
|
|
||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — End of period
|
$
|
13,127
|
|
|
$
|
20,288
|
|
SUPPLEMENTAL DISCLOSURES:
|
|
|
|
||||
Cash paid for interest
|
$
|
1,012
|
|
|
$
|
932
|
|
Cash paid for income taxes
|
$
|
4
|
|
|
$
|
—
|
|
Supplemental schedule of non-cash investing and financing activities:
|
|
|
|
||||
Property and equipment acquired under capital leases
|
$
|
64
|
|
|
$
|
252
|
|
Note payable end of term payment accrued but unpaid
|
$
|
—
|
|
|
$
|
1,800
|
|
|
Common Stock
|
|
Series A
Convertible
Preferred Stock
|
|
Series B
Convertible
Preferred Stock
|
|
Series C
Convertible
Preferred Stock
|
|
Additional
Paid-In
Capital
|
|
Common
Stock
Warrants
|
|
Accumulated
Deficit
|
|
Accumulated
Other
Comprehensive
Loss
|
|
Total
|
||||||||||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|||||||||||||||||||||||||||
2019
|
(In thousands, except share data)
|
||||||||||||||||||||||||||||||||||||||||||||||
Balance, December 31, 2018
|
70,078,878
|
|
|
$
|
701
|
|
|
600,000
|
|
|
$
|
19,227
|
|
|
—
|
|
|
$
|
—
|
|
|
10,150
|
|
|
$
|
11,117
|
|
|
$
|
346,108
|
|
|
$
|
3,707
|
|
|
$
|
(377,127
|
)
|
|
$
|
(1,011
|
)
|
|
$
|
2,722
|
|
Issuance of common stock, net of issuance costs
|
889,752
|
|
|
9
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(9
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
770
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
770
|
|
|||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,763
|
)
|
|
—
|
|
|
(2,763
|
)
|
|||||||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(83
|
)
|
|
(83
|
)
|
|||||||||
Balance, March 31, 2019
|
70,968,630
|
|
|
$
|
710
|
|
|
600,000
|
|
|
$
|
19,227
|
|
|
—
|
|
|
$
|
—
|
|
|
10,150
|
|
|
$
|
11,117
|
|
|
$
|
346,869
|
|
|
$
|
3,707
|
|
|
$
|
(379,890
|
)
|
|
$
|
(1,094
|
)
|
|
$
|
646
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||
Balance, December 31, 2017
|
69,146,381
|
|
|
$
|
691
|
|
|
600,000
|
|
|
$
|
19,227
|
|
|
8,416
|
|
|
$
|
49,568
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
341,622
|
|
|
$
|
3,707
|
|
|
$
|
(399,074
|
)
|
|
$
|
(821
|
)
|
|
$
|
14,920
|
|
Issuance of common stock, net of issuance costs
|
839,285
|
|
|
9
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(9
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||||
Exercise of stock options
|
729
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2
|
|
|||||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,207
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,207
|
|
|||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(7,684
|
)
|
|
—
|
|
|
(7,684
|
)
|
|||||||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
106
|
|
|
106
|
|
|||||||||
Balance, March 31, 2018
|
69,986,395
|
|
|
$
|
700
|
|
|
600,000
|
|
|
$
|
19,227
|
|
|
8,416
|
|
|
$
|
49,568
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
342,822
|
|
|
$
|
3,707
|
|
|
$
|
(406,758
|
)
|
|
$
|
(715
|
)
|
|
$
|
8,551
|
|
1.
|
NATURE OF OPERATIONS
|
Years Ending December 31
|
|
(In thousands)
|
||
2019 (remaining)
|
|
$
|
394
|
|
2020
|
|
412
|
|
|
2021
|
|
299
|
|
|
Total
|
|
1,105
|
|
|
Less amount representing interest
|
|
(112
|
)
|
|
Present value of minimum lease payments
|
|
993
|
|
|
Less current portion
|
|
(433
|
)
|
|
Non-current portion
|
|
$
|
560
|
|
|
March 31, 2019
|
|
December 31, 2018
|
||||
|
(In thousands)
|
||||||
NON-CURRENT ASSETS:
|
|
|
|
||||
Property and equipment, net
|
$
|
602
|
|
|
$
|
615
|
|
Total lease assets
|
$
|
602
|
|
|
$
|
615
|
|
|
|
|
|
||||
CURRENT LIABILITIES:
|
|
|
|
||||
Finance lease obligations
|
$
|
253
|
|
|
$
|
236
|
|
NON-CURRENT LIABILITIES:
|
|
|
|
||||
Finance lease obligations — less current portion
|
241
|
|
|
305
|
|
||
Total lease liabilities
|
$
|
494
|
|
|
$
|
541
|
|
Years Ending December 31
|
(In thousands)
|
||
2019 (remaining)
|
$
|
211
|
|
2020
|
253
|
|
|
2021
|
65
|
|
|
2022
|
3
|
|
|
Total
|
532
|
|
|
Less amount representing interest
|
(38
|
)
|
|
Present value of minimum lease payments
|
494
|
|
|
Less current portion
|
(253
|
)
|
|
Non-current portion
|
$
|
241
|
|
|
March 31,
2019
|
|
December 31,
2018
|
||||
|
(In thousands)
|
||||||
Component parts (1)
|
$
|
413
|
|
|
$
|
129
|
|
Work-in-process (2)
|
111
|
|
|
924
|
|
||
Finished goods
|
1,336
|
|
|
1,352
|
|
||
Total Inventory
|
$
|
1,860
|
|
|
$
|
2,405
|
|
|
March 31, 2019
|
|
December 31, 2018
|
||||
|
(In thousands)
|
||||||
Accrued clinical investigator expenses
|
$
|
840
|
|
|
$
|
781
|
|
Accrued compensation expenses
|
1,212
|
|
|
1,427
|
|
||
Accrued rebate, chargeback and other revenue reserves
|
385
|
|
|
346
|
|
||
Accrued lease liabilities (Note 5)
|
433
|
|
|
—
|
|
||
Other accrued expenses
|
248
|
|
|
1,089
|
|
||
Total accrued expenses
|
$
|
3,118
|
|
|
$
|
3,643
|
|
•
|
In the first two years following the December 12, 2018 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%
, rather than
8%
, 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 December 12, 2018 increase in royalty amount to
6%
, the royalty will be reduced to approximately
5.2%
for net revenues and other related consideration up to
$75,000,000
annually and to approximately
6.8%
, rather than
8%
, for net revenues and other related consideration in excess of
$75,000,000
on an annual basis.
|
(i)
|
fail twice to cure its breach of an obligation to make certain payments to EyePoint following receipt of written notice thereof;
|
(ii)
|
fail to cure other breaches of material terms of the New Collaboration Agreement within
30
days after notice of such breaches or such longer period (up to
90 days
) as may be reasonably necessary if the breach cannot be cured within such
30
-day period;
|
(iii)
|
file for protection under the bankruptcy laws, make an assignment for the benefit of creditors, appoint or suffer appointment of a receiver or trustee over its property, file a petition under any bankruptcy or insolvency act or have any such petition filed against it and such proceeding remains undismissed or unstayed for a period of more than
60 days
; or
|
(iv)
|
notify EyePoint in writing of its decision to abandon its license with respect to a certain product using EyePoint’s proprietary delivery device.
|
a.
|
2.00%
of the principal amount prepaid for a prepayment made on or after January 5, 2018 through and including January 5, 2019;
|
b.
|
1.00%
of the principal amount prepaid for a prepayment made after January 5, 2019 through and including January 5, 2020; and
|
c.
|
0.50%
of the principal amount prepaid for a prepayment made after January 5, 2020 and greater than
30
days before the maturity date.
|
a.
|
first, if the Company achieves revenues of
$80,000,000
or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured on a trailing 12-month basis during the term of the agreement, tested at the end of each month; and
|
b.
|
second, if the Company achieves revenues of
$100,000,000
or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured in the same manner.
|
|
Three Months Ended
March 31, |
||||
|
2019
|
|
2018
|
||
Series A convertible preferred stock
|
9,022,556
|
|
|
9,022,556
|
|
Series B convertible preferred stock
|
—
|
|
|
8,416,251
|
|
Series C convertible preferred stock
|
10,150,000
|
|
|
—
|
|
Common stock warrants
|
1,795,663
|
|
|
1,795,663
|
|
Stock options
|
13,407,536
|
|
|
12,343,820
|
|
Restricted stock units
|
480,400
|
|
|
1,039,370
|
|
Total
|
34,856,155
|
|
|
32,617,660
|
|
|
Three Months Ended March 31,
|
||||||||||||||
|
2019
|
|
2018
|
||||||||||||
|
Options
|
|
Weighted
Average
Exercise
Price
|
|
Options
|
|
Weighted
Average
Exercise
Price
|
||||||||
Options outstanding at beginning of period
|
12,447,355
|
|
|
$
|
2.63
|
|
|
11,595,510
|
|
|
$
|
2.90
|
|
||
Grants
|
1,174,750
|
|
|
0.87
|
|
|
1,233,000
|
|
|
1.16
|
|
||||
Forfeitures
|
(214,569
|
)
|
|
1.99
|
|
|
(483,127
|
)
|
|
2.34
|
|
||||
Exercises
|
—
|
|
|
—
|
|
|
(1,563
|
)
|
|
1.06
|
|
||||
Options outstanding at period end
|
13,407,536
|
|
|
2.48
|
|
|
12,343,820
|
|
|
2.75
|
|
||||
Options exercisable at period end
|
9,536,065
|
|
|
3.02
|
|
|
8,168,883
|
|
|
3.24
|
|
||||
Weighted average per share fair value of options granted during the period
|
$
|
0.55
|
|
|
|
|
$
|
0.78
|
|
|
|
|
Shares
|
|
Weighted
Average
Exercise
Price
|
|
Weighted
Average
Remaining Contractual
Term
|
|
Aggregate
Intrinsic
Value
|
|||||
|
|
|
|
|
|
|
(In thousands)
|
|||||
Outstanding
|
13,407,536
|
|
|
$
|
2.48
|
|
|
6.29 years
|
|
$
|
321
|
|
Exercisable
|
9,536,065
|
|
|
3.02
|
|
|
5.24 years
|
|
53
|
|
||
Outstanding, vested and expected to vest
|
12,885,031
|
|
|
2.54
|
|
|
6.17 years
|
|
276
|
|
|
Shares
|
|
Weighted
Average
Exercise
Price
|
|
Weighted
Average
Remaining Contractual
Term
|
|
Aggregate
Intrinsic
Value
|
|||||
|
|
|
|
|
|
|
(In thousands)
|
|||||
Outstanding
|
12,447,355
|
|
|
$
|
2.63
|
|
|
6.25 years
|
|
$
|
—
|
|
Exercisable
|
9,138,544
|
|
|
3.09
|
|
|
5.37 years
|
|
—
|
|
||
Outstanding, vested and expected to vest
|
12,044,311
|
|
|
2.67
|
|
|
6.16 years
|
|
—
|
|
|
Three Months Ended March 31,
|
||||||||||||
|
2019
|
|
2018
|
||||||||||
|
RSUs
|
|
Weighted Average Grant Date Fair Value
|
|
RSUs
|
|
Weighted Average Grant Date Fair Value
|
||||||
Restricted stock units outstanding at beginning of period
|
900,252
|
|
|
$
|
1.15
|
|
|
839,285
|
|
|
$
|
1.21
|
|
Grants
|
480,400
|
|
|
0.86
|
|
|
1,061,170
|
|
|
1.16
|
|
||
Vested units
|
(889,752
|
)
|
|
1.15
|
|
|
(839,285
|
)
|
|
1.21
|
|
||
Forfeitures
|
(10,500
|
)
|
|
1.16
|
|
|
(21,800
|
)
|
|
1.16
|
|
||
Restricted stock units outstanding at year end
|
480,400
|
|
|
0.86
|
|
|
1,039,370
|
|
|
1.16
|
|
|
Three Months Ended
March 31, 2019 |
|
Three Months Ended
March 31, 2018 |
||||||||||||||||||||||||||||
|
U.S.
|
|
International
|
|
Other
|
|
Consolidated
|
|
U.S.
|
|
International
|
|
Other
|
|
Consolidated
|
||||||||||||||||
|
(In thousands)
|
||||||||||||||||||||||||||||||
NET REVENUE
|
$
|
6,766
|
|
|
$
|
6,124
|
|
|
$
|
—
|
|
|
$
|
12,890
|
|
|
$
|
6,805
|
|
|
$
|
2,825
|
|
|
$
|
—
|
|
|
$
|
9,630
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(685
|
)
|
|
(915
|
)
|
|
—
|
|
|
(1,600
|
)
|
|
(713
|
)
|
|
(391
|
)
|
|
—
|
|
|
(1,104
|
)
|
||||||||
GROSS PROFIT
|
6,081
|
|
|
5,209
|
|
|
—
|
|
|
11,290
|
|
|
6,092
|
|
|
2,434
|
|
|
—
|
|
|
8,526
|
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
1,427
|
|
|
1,170
|
|
|
130
|
|
|
2,727
|
|
|
1,640
|
|
|
950
|
|
|
232
|
|
|
2,822
|
|
||||||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
1,933
|
|
|
988
|
|
|
472
|
|
|
3,393
|
|
|
2,293
|
|
|
907
|
|
|
655
|
|
|
3,855
|
|
||||||||
SALES AND MARKETING EXPENSES
|
4,041
|
|
|
1,705
|
|
|
167
|
|
|
5,913
|
|
|
4,371
|
|
|
1,278
|
|
|
320
|
|
|
5,969
|
|
||||||||
DEPRECIATION AND AMORTIZATION
|
—
|
|
|
—
|
|
|
652
|
|
|
652
|
|
|
—
|
|
|
—
|
|
|
649
|
|
|
649
|
|
||||||||
OPERATING EXPENSES
|
7,401
|
|
|
3,863
|
|
|
1,421
|
|
|
12,685
|
|
|
8,304
|
|
|
3,135
|
|
|
1,856
|
|
|
13,295
|
|
||||||||
SEGMENT (LOSS) INCOME FROM OPERATIONS
|
(1,320
|
)
|
|
1,346
|
|
|
(1,421
|
)
|
|
(1,395
|
)
|
|
(2,212
|
)
|
|
(701
|
)
|
|
(1,856
|
)
|
|
(4,769
|
)
|
||||||||
OTHER INCOME AND EXPENSES, NET
|
—
|
|
|
—
|
|
|
(1,297
|
)
|
|
(1,297
|
)
|
|
—
|
|
|
—
|
|
|
(2,915
|
)
|
|
(2,915
|
)
|
||||||||
NET LOSS BEFORE TAXES
|
|
|
|
|
|
|
$
|
(2,692
|
)
|
|
|
|
|
|
|
|
$
|
(7,684
|
)
|
•
|
continue the commercialization of ILUVIEN in the U.S. and EEA, where we sell direct;
|
•
|
continue to seek regulatory approval of ILUVIEN for other indications and 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.
|
|
Three months ended March 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands, except share and per share data)
|
||||||
NET REVENUE
|
$
|
12,890
|
|
|
$
|
9,630
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(1,600
|
)
|
|
(1,104
|
)
|
||
GROSS PROFIT
|
11,290
|
|
|
8,526
|
|
||
|
|
|
|
||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
2,727
|
|
|
2,822
|
|
||
GENERAL AND ADMINISTRATIVE EXPENSES
|
3,393
|
|
|
3,855
|
|
||
SALES AND MARKETING EXPENSES
|
5,913
|
|
|
5,969
|
|
||
DEPRECIATION AND AMORTIZATION
|
652
|
|
|
649
|
|
||
OPERATING EXPENSES
|
12,685
|
|
|
13,295
|
|
||
NET LOSS FROM OPERATIONS
|
(1,395
|
)
|
|
(4,769
|
)
|
||
|
|
|
|
||||
INTEREST EXPENSE AND OTHER
|
(1,228
|
)
|
|
(1,151
|
)
|
||
UNREALIZED FOREIGN CURRENCY (LOSS) GAIN, NET
|
(69
|
)
|
|
2
|
|
||
LOSS ON EARLY EXTINGUISHMENT OF DEBT
|
—
|
|
|
(1,766
|
)
|
||
NET LOSS BEFORE TAXES
|
(2,692
|
)
|
|
(7,684
|
)
|
||
PROVISION FOR TAXES
|
(71
|
)
|
|
—
|
|
||
NET LOSS
|
(2,763
|
)
|
|
(7,684
|
)
|
||
NET INCOME (LOSS) AVAILABLE TO STOCKHOLDERS
|
$
|
(2,763
|
)
|
|
$
|
(7,684
|
)
|
NET LOSS PER SHARE — Basic and diluted
|
$
|
(0.04
|
)
|
|
$
|
(0.11
|
)
|
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted
|
70,740,851
|
|
|
69,883,012
|
|
|
Three Months Ended
March 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
NET REVENUE
|
$
|
6,766
|
|
|
$
|
6,805
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(685
|
)
|
|
(713
|
)
|
||
GROSS PROFIT
|
6,081
|
|
|
6,092
|
|
||
|
|
|
|
||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
1,427
|
|
|
1,640
|
|
||
GENERAL AND ADMINISTRATIVE EXPENSES
|
1,933
|
|
|
2,293
|
|
||
SALES AND MARKETING EXPENSES
|
4,041
|
|
|
4,371
|
|
||
OPERATING EXPENSES
|
7,401
|
|
|
8,304
|
|
||
SEGMENT LOSS FROM OPERATIONS
|
$
|
(1,320
|
)
|
|
$
|
(2,212
|
)
|
|
Three Months Ended
March 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
NET REVENUE
|
$
|
6,124
|
|
|
$
|
2,825
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(915
|
)
|
|
(391
|
)
|
||
GROSS PROFIT
|
5,209
|
|
|
2,434
|
|
||
|
|
|
|
||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
1,170
|
|
|
950
|
|
||
GENERAL AND ADMINISTRATIVE EXPENSES
|
988
|
|
|
907
|
|
||
SALES AND MARKETING EXPENSES
|
1,705
|
|
|
1,278
|
|
||
OPERATING EXPENSES
|
3,863
|
|
|
3,135
|
|
||
SEGMENT INCOME (LOSS) FROM OPERATIONS
|
$
|
1,346
|
|
|
$
|
(701
|
)
|
|
Three Months Ended
March 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
NET REVENUE
|
$
|
—
|
|
|
$
|
—
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
—
|
|
|
—
|
|
||
GROSS PROFIT
|
—
|
|
|
—
|
|
||
|
|
|
|
||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
130
|
|
|
232
|
|
||
GENERAL AND ADMINISTRATIVE EXPENSES
|
472
|
|
|
655
|
|
||
SALES AND MARKETING EXPENSES
|
167
|
|
|
320
|
|
||
DEPRECIATION AND AMORTIZATION
|
652
|
|
|
649
|
|
||
OPERATING EXPENSES
|
1,421
|
|
|
1,856
|
|
||
SEGMENT LOSS FROM OPERATIONS
|
$
|
(1,421
|
)
|
|
$
|
(1,856
|
)
|
|
ALIMERA SCIENCES, INC.
|
|
|
|
|
May 7, 2019
|
By:
|
/s/ Richard S. Eiswirth, Jr.
|
|
|
Richard S. Eiswirth, Jr.
|
|
|
President and Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
May 7, 2019
|
By:
|
/s/ J. Philip Jones
|
|
|
J. Philip Jones
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial and Accounting Officer)
|
By:
|
/s/ Richard S. Eiswirth, Jr.
|
By:
|
/s/ Kenneth Green, Ph.D.
|
|
Richard S. Eiswirth, Jr., President and CEO
|
|
Kenneth Green, Ph.D.
|
|
|
|
|
Date:
|
March 27, 2019
|
Date:
|
March 27, 2019
|
|
|
|
|
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: May 7, 2019
|
/s/ Richard S. Eiswirth, Jr.
|
||||||
|
Richard S. Eiswirth, Jr.
|
|
|||||
|
President and 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: May 7, 2019
|
/s/ J. Philip Jones
|
|||||
|
J. Philip Jones
|
|||||
|
Chief Financial Officer
(Principal Financial and Accounting Officer) |
Date: May 7, 2019
|
/s/ Richard S. Eiswirth, Jr.
|
||
|
Richard S. Eiswirth, Jr.
|
||
|
President and Chief Executive Officer
(Principal Executive Officer) |
||
|
|||
Date: May 7, 2019
|
/s/ J. Philip Jones
|
||
|
J. Philip Jones
|
||
|
President and Chief Financial Officer
(Principal Financial and Accounting Officer) |