Delaware
|
|
001-34703
|
|
20-0028718
|
||
(State or other Jurisdiction of Incorporation)
|
|
(Commission File Number)
|
|
(IRS Employer Identification No.)
|
||
|
|
|
||||
6120 Windward Parkway
Suite 290 Alpharetta, Georgia |
|
30005
|
||||
(Address of Principal Executive Offices)
|
|
(Zip Code)
|
Not Applicable
|
(Former name or former address if changed since last report.)
|
Exhibit
No.
|
|
Description
|
3.1
|
|
Amended and Restated Bylaws of Alimera Sciences, Inc.
|
99.1
|
|
Press Release of Alimera Sciences, Inc. dated November 5, 2015
|
|
ALIMERA SCIENCES, INC.
|
|
|
|
|
Dated: November 5, 2015
|
By:
|
/s/ RICHARD S. EISWIRTH, JR.
|
|
Name:
|
Richard S. Eiswirth, Jr.
|
|
Title:
|
Chief Operating Officer and
Chief Financial Officer
|
Exhibit
No.
|
|
Description
|
3.1
|
|
Amended and Restated Bylaws of Alimera Sciences, Inc.
|
99.1
|
|
Press Release of Alimera Sciences, Inc. dated November 5, 2015
|
TABLE OF CONTENTS
|
||
|
Page
|
|
|
|
|
ARTICLE I OFFICE AND RECORDS
|
1
|
|
Section 1.1 Delaware Office
|
1
|
|
Section 1.2 Other Offices
|
1
|
|
Section 1.3 Books and Records
|
1
|
|
|
|
|
ARTICLE II STOCKHOLDERS
|
1
|
|
Section 2.1 Annual Meeting
|
1
|
|
Section 2.2 Special Meeting
|
1
|
|
Section 2.3 Place of Meeting
|
1
|
|
Section 2.4 Notice of Meeting
|
1
|
|
Section 2.5 Quorum and Adjournment
|
2
|
|
Section 2.6 Proxies
|
2
|
|
Section 2.7 Notice of Stockholder Business and Nominations
|
2
|
|
Section 2.8 Procedure for Election of Directors
|
4
|
|
Section 2.9 Inspectors of Elections
|
5
|
|
Section 2.10 Conduct of Meetings
|
5
|
|
Section 2.11 No Consent of Stockholders in Lieu of Meeting
|
6
|
|
|
|
|
ARTICLE III BOARD OF DIRECTORS
|
6
|
|
Section 3.1 General Powers
|
6
|
|
Section 3.2 Number, Tenure and Qualifications
|
6
|
|
Section 3.3 Regular Meetings
|
6
|
|
Section 3.4 Special Meetings
|
6
|
|
Section 3.5 Action by Unanimous Consent of Directors
|
6
|
|
Section 3.6 Notice
|
7
|
|
Section 3.7 Conference Telephone Meetings
|
7
|
|
Section 3.8 Quorum
|
7
|
|
Section 3.9 Vacancies
|
7
|
|
Section 3.10 Committee
|
8
|
|
Section 3.11 Removal
|
8
|
|
|
|
|
ARTICLE IV OFFICERS
|
8
|
|
Section 4.1 Elected Officers
|
8
|
|
Section 4.2 Election and Term of Office
|
8
|
|
Section 4.3 Chairman of the Board
|
9
|
|
Section 4.4 Chief Executive Officer
|
9
|
|
Section 4.5 President
|
9
|
|
Section 4.6 Secretary
|
9
|
|
Section 4.7 Treasurer
|
9
|
|
Section 4.8 Removal
|
9
|
|
Section 4.9 Vacancies
|
10
|
|
ARTICLE V STOCK CERTIFICATES AND TRANSFERS
|
10
|
|
Section 5.1 Stock Certificates and Transfers
|
10
|
|
|
|
|
ARTICLE VI INDEMNIFICATION
|
10
|
|
Section 6.1 Right to Indemnification
|
10
|
|
Section 6.2 Right to Advancement of Expenses
|
11
|
|
Section 6.3 Right of Indemnitee to Bring Suit
|
11
|
|
Section 6.4 Non-Exclusivity of Rights
|
12
|
|
Section 6.5 Insurance
|
12
|
|
Section 6.6 Amendment of Rights
|
12
|
|
Section 6.7 Indemnification of Employees and Agents of the Corporation
|
12
|
|
|
|
|
ARTICLE VII MISCELLANEOUS PROVISIONS
|
12
|
|
Section 7.1 Fiscal Year
|
12
|
|
Section 7.2 Dividends
|
12
|
|
Section 7.3 Seal
|
12
|
|
Section 7.4 Waiver of Notice
|
13
|
|
Section 7.5 Audits
|
13
|
|
Section 7.6 Resignations
|
13
|
|
Section 7.7 Contracts
|
14
|
|
Section 7.8 Proxies
|
14
|
|
|
|
|
ARTICLE VIII AMENDMENTS
|
14
|
|
Section 8.1 Amendments
|
14
|
|
|
|
|
ARTICLE IX FORUM SELECTION
|
14
|
|
Section 9.1 Forum Selection
|
14
|
|
Section 9.2 Personal Jurisdiction
|
14
|
|
•
|
ILUVIEN is contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases.
|
•
|
ILUVIEN is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8.
|
•
|
ILUVIEN is contraindicated in patients with known hypersensitivity to any components of this product.
|
•
|
Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the injection.
|
•
|
Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.
|
•
|
Patients in whom the posterior capsule of the lens is absent or has a tear are at risk of implant migration into the anterior chamber.
|
•
|
In controlled studies, the most common adverse reactions reported were cataract development (ILUVIEN 82%; sham 50%) and intraocular pressure elevation of greater than 10 mmHg (ILUVIEN 34%; sham 10%).
|
|
Three Months Ended,
September 30,
|
|
Nine Months Ended,
September 30,
|
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
|
(unaudited)
|
||||||||||||||
NET REVENUE
|
$
|
6,901
|
|
|
$
|
2,408
|
|
|
$
|
16,615
|
|
|
$
|
6,682
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(634
|
)
|
|
(372
|
)
|
|
(1,293
|
)
|
|
(1,312
|
)
|
||||
GROSS PROFIT
|
6,267
|
|
|
2,036
|
|
|
15,322
|
|
|
5,370
|
|
||||
|
|
|
|
|
|
|
|
||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
4,078
|
|
|
4,145
|
|
|
11,222
|
|
|
8,840
|
|
||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
3,031
|
|
|
2,958
|
|
|
10,471
|
|
|
8,643
|
|
||||
SALES AND MARKETING EXPENSES
|
6,949
|
|
|
3,476
|
|
|
21,003
|
|
|
9,763
|
|
||||
DEPRECIATION AND AMORTIZATION
|
653
|
|
|
82
|
|
|
1,864
|
|
|
151
|
|
||||
OPERATING EXPENSES
|
14,711
|
|
|
10,661
|
|
|
44,560
|
|
|
27,397
|
|
||||
NET LOSS FROM OPERATIONS
|
(8,444
|
)
|
|
(8,625
|
)
|
|
(29,238
|
)
|
|
(22,027
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
INTEREST EXPENSE, NET AND OTHER
|
(1,317
|
)
|
|
(408
|
)
|
|
(3,590
|
)
|
|
(862
|
)
|
||||
UNREALIZED FOREIGN CURRENCY LOSS, NET
|
(63
|
)
|
|
(255
|
)
|
|
(34
|
)
|
|
(457
|
)
|
||||
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY
|
8,363
|
|
|
2,324
|
|
|
13,085
|
|
|
(2,752
|
)
|
||||
LOSS ON EARLY EXTINGUISHMENT OF DEBT
|
—
|
|
|
—
|
|
|
—
|
|
|
(440
|
)
|
||||
NET LOSS BEFORE TAXES
|
(1,461
|
)
|
|
(6,964
|
)
|
|
(19,777
|
)
|
|
(26,538
|
)
|
||||
PROVISION FOR TAXES
|
(82
|
)
|
|
(45
|
)
|
|
(155
|
)
|
|
(114
|
)
|
||||
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS
|
$
|
(1,543
|
)
|
|
$
|
(7,009
|
)
|
|
$
|
(19,932
|
)
|
|
$
|
(26,652
|
)
|
NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS - Basic and diluted
|
$
|
(0.03)
|
|
|
$
|
(0.17)
|
|
|
$
|
(0.45)
|
|
|
$
|
(0.68)
|
|
WEIGHTED AVERAGE SHARES OUTSTANDING - Basic and diluted
|
44,436,224
|
|
|
41,062,814
|
|
|
44,393,831
|
|
|
39,083,187
|
|
|
September 30,
2015
|
|
December 31,
2014
|
|||
|
(unaudited)
|
|
|
|||
CURRENT ASSETS:
|
|
|
|
|
|
|
Cash and cash equivalents
|
$
|
39,340
|
|
|
$
|
76,697
|
Accounts receivable, net
|
9,377
|
|
|
850
|
||
Prepaid expenses and other current assets
|
2,497
|
|
|
3,234
|
||
Inventory, net
|
1,716
|
|
|
1,734
|
||
Deferred financing costs
|
458
|
|
|
754
|
||
Total current assets
|
53,388
|
|
|
83,269
|
||
PROPERTY AND EQUIPMENT, net
|
2,587
|
|
|
1,653
|
||
INTANGIBLE ASSET, net
|
23,038
|
|
|
24,490
|
||
TOTAL ASSETS
|
$
|
79,013
|
|
|
$
|
109,412
|
|
|
|
|
|
|
|
CURRENT LIABILITIES:
|
|
|
|
|
|
|
Accounts payable
|
$
|
3,068
|
|
|
$
|
5,021
|
Accrued expenses
|
3,238
|
|
|
954
|
||
Accrued milestone payments
|
—
|
|
|
2,000
|
||
Outsourced services payable
|
213
|
|
|
1,466
|
||
Note payable
|
—
|
|
|
1,023
|
||
Capital lease obligations
|
218
|
|
|
11
|
||
Total current liabilities
|
6,737
|
|
|
10,475
|
||
NON-CURRENT LIABILITIES:
|
|
|
|
|||
Derivative warrant liability
|
3,013
|
|
|
16,098
|
||
Note payable, net of discount — less current portion
|
34,448
|
|
|
33,065
|
||
Other non-current liabilities
|
1,454
|
|
|
255
|
||
COMMITMENTS AND CONTINGENCIES
|
|
|
|
|||
STOCKHOLDERS’ EQUITY:
|
|
|
|
|||
Preferred stock
|
|
|
|
|||
Series A Convertible Preferred Stock
|
19,227
|
|
|
19,227
|
||
Series B Convertible Preferred Stock
|
49,568
|
|
|
49,568
|
||
Common stock
|
445
|
|
|
443
|
||
Additional paid-in capital
|
296,871
|
|
|
292,851
|
||
Common stock warrants
|
1,497
|
|
|
1,497
|
||
Accumulated deficit
|
(333,187)
|
|
|
(313,255)
|
||
Accumulated other comprehensive loss
|
(1,060)
|
|
|
(812)
|
||
TOTAL STOCKHOLDERS’ EQUITY
|
33,361
|
|
|
49,519
|
||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
79,013
|
|
|
$
|
109,412
|
|
Three Months Ended,
September 30,
|
|
Nine Months Ended,
September 30,
|
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
|
(Unaudited)
|
||||||||||||||
GAAP COST OF GOODS SOLD
|
$
|
(634)
|
|
|
$
|
(372)
|
|
|
$
|
(1,293)
|
|
|
$
|
(1,312)
|
|
Adjustments to costs of goods sold:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Reserve for potential product expiration
|
|
253
|
|
|
|
184
|
|
|
|
312
|
|
|
|
813
|
|
NON-GAAP ADJUSTED COST OF GOODS SOLD
|
$
|
(381)
|
|
|
$
|
(188)
|
|
|
$
|
(981)
|
|
|
$
|
(499)
|
|
|
|
|
|
|
|
|
|
|
|||||||
GAAP GROSS PROFIT
|
$
|
6,267
|
|
|
$
|
2,036
|
|
|
$
|
15,322
|
|
|
$
|
5,370
|
|
Adjustments to gross profit:
|
|
|
|
|
|
|
|
|
|
|
|||||
Reserve for potential product expiration
|
|
253
|
|
|
|
184
|
|
|
|
312
|
|
|
|
813
|
|
NON-GAAP ADJUSTED GROSS PROFIT
|
$
|
6,520
|
|
|
$
|
2,220
|
|
|
$
|
15,634
|
|
|
$
|
6,183
|
|
|
|
|
|
|
|
|
|
|
|||||||
GAAP NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$
|
(1,543)
|
|
|
$
|
(7,009)
|
|
|
$
|
(19,932)
|
|
|
$
|
(26,652)
|
|
Adjustments to net loss:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized foreign currency loss, net
|
|
63
|
|
|
|
255
|
|
|
|
34
|
|
|
|
457
|
|
Loss on early extinguishment of debt
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
440
|
|
Change in fair value of derivative warrant liability
|
|
(8,363)
|
|
|
|
(2,324)
|
|
|
|
(13,085)
|
|
|
|
2,752
|
|
Reserve for potential product expiration
|
|
253
|
|
|
|
184
|
|
|
|
312
|
|
|
|
813
|
|
NON-GAAP ADJUSTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$
|
(9,590)
|
|
|
$
|
(8,894)
|
|
|
$
|
(32,671)
|
|
|
$
|
(22,190)
|
|
|
|
|
|
|
|
|
|
|
|||||||
GAAP NET LOSS PER SHARE - Basic and diluted
|
$
|
(0.03)
|
|
|
$
|
(0.17)
|
|
|
$
|
(0.45)
|
|
|
$
|
(0.68)
|
|
Adjustments to net loss:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized foreign currency loss, net
|
|
0.00
|
|
|
|
0.01
|
|
|
|
0.00
|
|
|
|
0.01
|
|
Loss on early extinguishment of debt
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
0.01
|
|
Change in fair value of derivative warrant liability
|
|
(0.19)
|
|
|
|
(0.06)
|
|
|
|
(0.29)
|
|
|
|
0.07
|
|
Reserve for potential product expiration
|
|
0.01
|
|
|
|
0.00
|
|
|
|
0.01
|
|
|
|
0.02
|
|
NON-GAAP ADJUSTED NET LOSS PER SHARE - Basic and diluted
|
$
|
(0.21)
|
|
|
$
|
(0.22)
|
|
|
$
|
(0.73)
|
|
|
$
|
(0.57)
|
|
|
|
|
|
|
|
|
|
|
|||||||
WEIGHTED AVERAGE SHARES OUTSTANDING - Basic and diluted
|
44,436,224
|
|
|
41,062,814
|
|
|
44,393,831
|
|
|
39,083,187
|
|
|
Three Months Ended
September 30, 2015 |
|
Three Months Ended
September 30, 2014 |
||||||||||||||||||||
|
U.S.
|
|
International
|
|
Consolidated
|
|
U.S.
|
|
International
|
|
Consolidated
|
||||||||||||
|
(Unaudited)
|
||||||||||||||||||||||
NET REVENUE
|
$
|
5,032
|
|
|
$
|
1,869
|
|
|
$
|
6,901
|
|
|
$
|
—
|
|
|
$
|
2,408
|
|
|
$
|
2,408
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(245
|
)
|
|
(389
|
)
|
|
(634
|
)
|
|
—
|
|
|
(372
|
)
|
|
(372
|
)
|
||||||
GROSS PROFIT
|
4,787
|
|
|
1,480
|
|
|
6,267
|
|
|
—
|
|
|
2,036
|
|
|
2,036
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
2,320
|
|
|
1,758
|
|
|
4,078
|
|
|
2,595
|
|
|
1,550
|
|
|
4,145
|
|
||||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
1,712
|
|
|
1,319
|
|
|
3,031
|
|
|
1,788
|
|
|
1,170
|
|
|
2,958
|
|
||||||
SALES AND MARKETING EXPENSES
|
4,546
|
|
|
2,403
|
|
|
6,949
|
|
|
1,186
|
|
|
2,290
|
|
|
3,476
|
|
||||||
DEPRECIATION AND AMORTIZATION
|
639
|
|
|
14
|
|
|
653
|
|
|
82
|
|
|
—
|
|
|
82
|
|
||||||
OPERATING EXPENSES
|
9,217
|
|
|
5,494
|
|
|
14,711
|
|
|
5,651
|
|
|
5,010
|
|
|
10,661
|
|
||||||
NET LOSS FROM OPERATIONS
|
(4,430
|
)
|
|
(4,014
|
)
|
|
(8,444
|
)
|
|
(5,651
|
)
|
|
(2,974
|
)
|
|
(8,625
|
)
|
||||||
OTHER INCOME AND EXPENSES, NET
|
|
|
|
|
6,983
|
|
|
|
|
|
|
1,661
|
|
||||||||||
NET LOSS BEFORE TAXES
|
|
|
|
|
$
|
(1,461
|
)
|
|
|
|
|
|
$
|
(6,964
|
)
|
|
Nine Months Ended
September 30, 2015 |
|
Nine Months Ended
September 30, 2014 |
||||||||||||||||||||
|
U.S.
|
|
International
|
|
Consolidated
|
|
U.S.
|
|
International
|
|
Consolidated
|
||||||||||||
|
(Unaudited)
|
||||||||||||||||||||||
NET REVENUE
|
$
|
11,279
|
|
|
$
|
5,336
|
|
|
$
|
16,615
|
|
|
$
|
—
|
|
|
$
|
6,682
|
|
|
$
|
6,682
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(573
|
)
|
|
(720
|
)
|
|
(1,293
|
)
|
|
—
|
|
|
(1,312
|
)
|
|
(1,312
|
)
|
||||||
GROSS PROFIT
|
10,706
|
|
|
4,616
|
|
|
15,322
|
|
|
—
|
|
|
5,370
|
|
|
5,370
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
5,176
|
|
|
6,046
|
|
|
11,222
|
|
|
4,136
|
|
|
4,704
|
|
|
8,840
|
|
||||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
6,080
|
|
|
4,391
|
|
|
10,471
|
|
|
5,103
|
|
|
3,540
|
|
|
8,643
|
|
||||||
SALES AND MARKETING EXPENSES
|
14,274
|
|
|
6,729
|
|
|
21,003
|
|
|
1,968
|
|
|
7,795
|
|
|
9,763
|
|
||||||
DEPRECIATION AND AMORTIZATION
|
1,819
|
|
|
45
|
|
|
1,864
|
|
|
151
|
|
|
—
|
|
|
151
|
|
||||||
OPERATING EXPENSES
|
27,349
|
|
|
17,211
|
|
|
44,560
|
|
|
11,358
|
|
|
16,039
|
|
|
27,397
|
|
||||||
NET LOSS FROM OPERATIONS
|
(16,643
|
)
|
|
(12,595
|
)
|
|
(29,238
|
)
|
|
(11,358
|
)
|
|
(10,669
|
)
|
|
(22,027
|
)
|
||||||
OTHER INCOME AND EXPENSES, NET
|
|
|
|
|
9,461
|
|
|
|
|
|
|
(4,511
|
)
|
||||||||||
NET LOSS BEFORE TAXES
|
|
|
|
|
$
|
(19,777
|
)
|
|
|
|
|
|
$
|
(26,538
|
)
|