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.) |
6120 Windward Parkway, Suite 290 Alpharetta, GA | 30005 | |
(Address of principal executive offices) | (Zip Code) |
Large accelerated filer | o | Accelerated filer | x | |
Non-accelerated filer | o | (Do not check if a smaller reporting company) | Smaller reporting 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; |
• | uncertainty as to the pricing and reimbursement guidelines for ILUVIEN or any future products or product candidates, including ILUVIEN in new markets; |
• | 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; |
• | the extent of government regulations; and |
• | our need to raise additional financing. |
September 30, 2016 | December 31, 2015 | ||||||
(In thousands, except share and per share data) | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 33,853 | $ | 31,075 | |||
Restricted cash | 38 | 37 | |||||
Accounts receivable, net | 13,397 | 9,799 | |||||
Prepaid expenses and other current assets | 3,402 | 2,696 | |||||
Inventory, net (Note 5) | 913 | 1,552 | |||||
Total current assets | 51,603 | 45,159 | |||||
NON-CURRENT ASSETS: | |||||||
Property and equipment, net | 2,054 | 2,553 | |||||
Intangible asset, net (Note 6) | 21,093 | 22,549 | |||||
Deferred tax asset, net | 230 | 223 | |||||
TOTAL ASSETS | $ | 74,980 | $ | 70,484 | |||
CURRENT LIABILITIES: | |||||||
Accounts payable | $ | 3,449 | $ | 4,002 | |||
Accrued expenses (Note 7) | 4,169 | 3,911 | |||||
Note payable, net of discount (Note 9) | — | 31,786 | |||||
Capital lease obligations | 235 | 234 | |||||
Total current liabilities | 7,853 | 39,933 | |||||
NON-CURRENT LIABILITIES: | |||||||
Derivative warrant liability | 1,060 | 2,815 | |||||
Note payable, net of discount — less current portion (Note 9) | 33,425 | — | |||||
Capital lease obligations — less current portion | 401 | 582 | |||||
Other non-current liabilities | 2,209 | 834 | |||||
COMMITMENTS AND CONTINGENCIES | |||||||
STOCKHOLDERS’ EQUITY: | |||||||
Preferred stock, $.01 par value — 10,000,000 shares authorized at September 30, 2016 and December 31, 2015: | |||||||
Series A Convertible Preferred Stock, 1,300,000 authorized and 600,000 issued and outstanding at September 30, 2016 and December 31, 2015; liquidation preference of $24,000 at September 30, 2016 and December 31, 2015 | 19,227 | 19,227 | |||||
Series B Convertible Preferred Stock, 8,417 authorized and 8,416.251 issued and outstanding at September 30, 2016 and December 31, 2015; liquidation preference of $50,750 at September 30, 2016 and December 31, 2015 | 49,568 | 49,568 | |||||
Common stock, $.01 par value — 100,000,000 shares authorized, 64,710,724 shares issued and outstanding at September 30, 2016 and 45,005,833 shares issued and outstanding at December 31, 2015 | 647 | 450 | |||||
Additional paid-in capital | 329,467 | 299,376 | |||||
Common stock warrants | 3,338 | 2,747 | |||||
Accumulated deficit | (371,146 | ) | (343,900 | ) | |||
Accumulated other comprehensive loss | (1,069 | ) | (1,148 | ) | |||
TOTAL STOCKHOLDERS’ EQUITY | 30,032 | 26,320 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 74,980 | $ | 70,484 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
(In thousands, except share and per share data) | |||||||||||||||
NET REVENUE | $ | 8,298 | $ | 6,901 | $ | 23,656 | $ | 16,615 | |||||||
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (486 | ) | (634 | ) | (1,420 | ) | (1,293 | ) | |||||||
GROSS PROFIT | 7,812 | 6,267 | 22,236 | 15,322 | |||||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 3,261 | 4,078 | 9,486 | 11,222 | |||||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | 3,645 | 3,031 | 11,079 | 10,471 | |||||||||||
SALES AND MARKETING EXPENSES | 7,452 | 6,949 | 22,071 | 21,003 | |||||||||||
DEPRECIATION AND AMORTIZATION | 697 | 653 | 2,082 | 1,864 | |||||||||||
OPERATING EXPENSES | 15,055 | 14,711 | 44,718 | 44,560 | |||||||||||
NET LOSS FROM OPERATIONS | (7,243 | ) | (8,444 | ) | (22,482 | ) | (29,238 | ) | |||||||
INTEREST EXPENSE, NET AND OTHER | (1,330 | ) | (1,317 | ) | (3,842 | ) | (3,590 | ) | |||||||
UNREALIZED FOREIGN CURRENCY LOSS, NET | (51 | ) | (63 | ) | (31 | ) | (34 | ) | |||||||
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY | (588 | ) | 8,363 | 1,755 | 13,085 | ||||||||||
LOSS ON EARLY EXTINGUISHMENT OF DEBT | — | — | (2,564 | ) | — | ||||||||||
NET LOSS BEFORE TAXES | (9,212 | ) | (1,461 | ) | (27,164 | ) | (19,777 | ) | |||||||
PROVISION FOR TAXES | (33 | ) | (82 | ) | (84 | ) | (155 | ) | |||||||
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS | $ | (9,245 | ) | $ | (1,543 | ) | $ | (27,248 | ) | $ | (19,932 | ) | |||
NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS — Basic and diluted | $ | (0.16 | ) | $ | (0.03 | ) | $ | (0.56 | ) | $ | (0.45 | ) | |||
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted | 56,103,534 | 44,436,224 | 48,759,381 | 44,393,831 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
(In thousands) | |||||||||||||||
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS | $ | (9,245 | ) | $ | (1,543 | ) | $ | (27,248 | ) | $ | (19,932 | ) | |||
OTHER COMPREHENSIVE INCOME (LOSS) | |||||||||||||||
Foreign currency translation adjustments | 30 | 40 | 79 | (248 | ) | ||||||||||
TOTAL OTHER COMPREHENSIVE INCOME (LOSS) | 30 | 40 | 79 | (248 | ) | ||||||||||
COMPREHENSIVE LOSS | $ | (9,215 | ) | $ | (1,503 | ) | $ | (27,169 | ) | $ | (20,180 | ) |
Nine Months Ended September 30, | |||||||
2016 | 2015 | ||||||
(In thousands) | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | |||||||
Net loss | $ | (27,248 | ) | $ | (19,932 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization | 2,082 | 1,864 | |||||
Inventory reserve | 39 | — | |||||
Unrealized foreign currency transaction loss | 31 | 34 | |||||
Loss on early extinguishment of debt | 2,564 | — | |||||
Amortization of debt discount | 795 | 524 | |||||
Stock-based compensation expense | 3,753 | 3,702 | |||||
Change in fair value of derivative warrant liability | (1,755 | ) | (13,085 | ) | |||
Changes in assets and liabilities: | |||||||
Accounts receivable | (3,564 | ) | (8,455 | ) | |||
Prepaid expenses and other current assets | (514 | ) | 627 | ||||
Inventory | 612 | (88 | ) | ||||
Accounts payable | (2,101 | ) | (1,447 | ) | |||
Accrued expenses and other current liabilities | 1,256 | (828 | ) | ||||
Other non-current liabilities | 1,354 | 612 | |||||
Net cash used in operating activities | (22,696 | ) | (36,472 | ) | |||
CASH FLOWS FROM INVESTING ACTIVITIES: | |||||||
Purchases of property and equipment | (122 | ) | (370 | ) | |||
Net cash used in investing activities | (122 | ) | (370 | ) | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||||
Proceeds from exercise of stock options | 157 | 278 | |||||
Proceeds from sale of common stock | 27,547 | 42 | |||||
Payment of issuance cost of common stock | (1,227 | ) | — | ||||
Payment of Series B Convertible Preferred Stock offering costs | — | (327 | ) | ||||
Payment of debt costs | (715 | ) | — | ||||
Payment of capital lease obligations | (178 | ) | (207 | ) | |||
Net cash provided by (used in) financing activities | 25,584 | (214 | ) | ||||
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS | 12 | (301 | ) | ||||
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 2,778 | (37,357 | ) | ||||
CASH AND CASH EQUIVALENTS — Beginning of period | 31,075 | 76,697 | |||||
CASH AND CASH EQUIVALENTS — End of period | $ | 33,853 | $ | 39,340 | |||
SUPPLEMENTAL DISCLOSURES: | |||||||
Cash paid for interest | $ | 2,977 | $ | 2,904 | |||
Cash paid for income taxes | $ | 299 | $ | 9 | |||
Supplemental schedule of non-cash investing and financing activities: | |||||||
Property and equipment acquired under capital leases | $ | 76 | $ | 997 | |||
Common stock issuance costs accrued but unpaid | $ | 114 | $ | — | |||
Note payable end of term payment accrued but unpaid | $ | 1,400 | $ | — |
1. | NATURE OF OPERATIONS |
September 30, 2016 | December 31, 2015 | ||||||
(In thousands) | |||||||
Component parts (1) | $ | 172 | $ | 131 | |||
Work-in-process (2) | 214 | 333 | |||||
Finished goods | 566 | 1,525 | |||||
Total inventory | 952 | 1,989 | |||||
Inventory reserve | (39 | ) | (437 | ) | |||
Inventory — net | $ | 913 | $ | 1,552 |
Years Ending December 31 | |||
2016 | $ | 489 | |
2017 | 1,940 | ||
2018 | 1,940 | ||
2019 | 1,940 | ||
2020 | 1,940 | ||
Thereafter | 12,844 | ||
Total | $ | 21,093 |
September 30, 2016 | December 31, 2015 | ||||||
(In thousands) | |||||||
Accrued compensation expenses | $ | 1,561 | $ | 804 | |||
Accrued clinical investigator expenses | 1,092 | 732 | |||||
Accrued rebate and other revenue reserves | 724 | 452 | |||||
Accrued End of Term Payment (Note 9) | — | 1,050 | |||||
Other accrued expenses | 792 | 873 | |||||
Total accrued expenses | $ | 4,169 | $ | 3,911 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||
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 | 1,336,947 | 362,970 | 1,336,947 | 362,970 | |||||||
Stock options | 11,231,644 | 9,094,716 | 11,231,644 | 9,094,716 | |||||||
Total | 34,518,677 | 31,407,772 | 34,518,677 | 31,407,772 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||||||||||||||||
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 | 10,648,702 | $ | 3.30 | 9,292,947 | $ | 3.49 | 9,475,890 | $ | 3.43 | 7,681,256 | $ | 3.03 | |||||||||||||||||||
Grants | 749,250 | 1.53 | 69,000 | 4.39 | 2,169,750 | 2.06 | 1,902,500 | 5.38 | |||||||||||||||||||||||
Forfeitures | (114,837 | ) | 4.03 | (200,260 | ) | 5.25 | (313,297 | ) | 3.44 | (349,645 | ) | 4.84 | |||||||||||||||||||
Exercises | (51,471 | ) | 1.33 | (66,971 | ) | 2.09 | (100,699 | ) | 1.56 | (139,395 | ) | 1.99 | |||||||||||||||||||
Options outstanding at period end | 11,231,644 | 3.18 | 9,094,716 | 3.47 | 11,231,644 | 3.18 | 9,094,716 | 3.47 | |||||||||||||||||||||||
Options exercisable at period end | 7,116,615 | 3.26 | 5,510,064 | 3.19 | 7,116,615 | 3.26 | 5,510,064 | 3.19 | |||||||||||||||||||||||
Weighted average per share fair value of options granted during the period | $ | 1.17 | $ | 3.37 | $ | 1.56 | $ | 4.19 |
Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term | Aggregate Intrinsic Value | |||||||||
(In thousands) | ||||||||||||
Outstanding | 11,231,644 | $ | 3.18 | 6.69 years | $ | 71 | ||||||
Exercisable | 7,116,615 | 3.26 | 5.46 years | 70 | ||||||||
Outstanding, vested and expected to vest | 10,696,132 | 3.19 | 6.57 years | 71 |
Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term | Aggregate Intrinsic Value | |||||||||
(In thousands) | ||||||||||||
Outstanding | 9,475,890 | $ | 3.43 | 6.96 years | $ | 2,565 | ||||||
Exercisable | 5,808,528 | 3.27 | 5.87 years | 2,186 | ||||||||
Outstanding, vested and expected to vest | 9,016,217 | 3.41 | 6.86 years | 2,541 |
September 30, 2016 | |||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||
(In thousands) | |||||||||||||||
Assets: | |||||||||||||||
Cash equivalents (1) | $ | — | $ | — | $ | — | $ | — | |||||||
Assets measured at fair value | $ | — | $ | — | $ | — | $ | — | |||||||
Liabilities: | |||||||||||||||
Derivative warrant liability (2) | $ | — | $ | 1,060 | $ | — | $ | 1,060 | |||||||
Liabilities measured at fair value | $ | — | $ | 1,060 | $ | — | $ | 1,060 |
December 31, 2015 | |||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||
(In thousands) | |||||||||||||||
Assets: | |||||||||||||||
Cash equivalents (1) | $ | 1,010 | $ | — | $ | — | $ | 1,010 | |||||||
Assets measured at fair value | $ | 1,010 | $ | — | $ | — | $ | 1,010 | |||||||
Liabilities: | |||||||||||||||
Derivative warrant liability (2) | $ | — | $ | 2,815 | $ | — | $ | 2,815 | |||||||
Liabilities measured at fair value | $ | — | $ | 2,815 | $ | — | $ | 2,815 |
(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 September 30, 2016 | Three Months Ended September 30, 2015 | ||||||||||||||||||||||
U.S. | International | Consolidated | U.S. | International | Consolidated | ||||||||||||||||||
(In thousands) | |||||||||||||||||||||||
NET REVENUE | $ | 6,184 | $ | 2,114 | $ | 8,298 | $ | 5,032 | $ | 1,869 | $ | 6,901 | |||||||||||
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (374 | ) | (112 | ) | (486 | ) | (245 | ) | (389 | ) | (634 | ) | |||||||||||
GROSS PROFIT | 5,810 | 2,002 | 7,812 | 4,787 | 1,480 | 6,267 | |||||||||||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 2,204 | 1,057 | 3,261 | 2,320 | 1,758 | 4,078 | |||||||||||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | 2,232 | 1,413 | 3,645 | 1,712 | 1,319 | 3,031 | |||||||||||||||||
SALES AND MARKETING EXPENSES | 5,618 | 1,834 | 7,452 | 4,546 | 2,403 | 6,949 | |||||||||||||||||
DEPRECIATION AND AMORTIZATION | 674 | 23 | 697 | 639 | 14 | 653 | |||||||||||||||||
OPERATING EXPENSES | 10,728 | 4,327 | 15,055 | 9,217 | 5,494 | 14,711 | |||||||||||||||||
NET LOSS FROM OPERATIONS | (4,918 | ) | (2,325 | ) | (7,243 | ) | (4,430 | ) | (4,014 | ) | (8,444 | ) | |||||||||||
OTHER INCOME AND EXPENSES, NET | (1,969 | ) | 6,983 | ||||||||||||||||||||
NET LOSS BEFORE TAXES | $ | (9,212 | ) | $ | (1,461 | ) |
Nine Months Ended September 30, 2016 | Nine Months Ended September 30, 2015 | ||||||||||||||||||||||
U.S. | International | Consolidated | U.S. | International | Consolidated | ||||||||||||||||||
(In thousands) | |||||||||||||||||||||||
NET REVENUE | $ | 17,511 | $ | 6,145 | $ | 23,656 | $ | 11,279 | $ | 5,336 | $ | 16,615 | |||||||||||
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (964 | ) | (456 | ) | (1,420 | ) | (573 | ) | (720 | ) | (1,293 | ) | |||||||||||
GROSS PROFIT | 16,547 | 5,689 | 22,236 | 10,706 | 4,616 | 15,322 | |||||||||||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 6,024 | 3,462 | 9,486 | 5,176 | 6,046 | 11,222 | |||||||||||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | 6,569 | 4,510 | 11,079 | 6,080 | 4,391 | 10,471 | |||||||||||||||||
SALES AND MARKETING EXPENSES | 16,573 | 5,498 | 22,071 | 14,274 | 6,729 | 21,003 | |||||||||||||||||
DEPRECIATION AND AMORTIZATION | 2,015 | 67 | 2,082 | 1,819 | 45 | 1,864 | |||||||||||||||||
OPERATING EXPENSES | 31,181 | 13,537 | 44,718 | 27,349 | 17,211 | 44,560 | |||||||||||||||||
NET LOSS FROM OPERATIONS | (14,634 | ) | (7,848 | ) | (22,482 | ) | (16,643 | ) | (12,595 | ) | (29,238 | ) | |||||||||||
OTHER INCOME AND EXPENSES, NET | (4,682 | ) | 9,461 | ||||||||||||||||||||
NET LOSS BEFORE TAXES | $ | (27,164 | ) | $ | (19,777 | ) |
• | continue the commercialization of ILUVIEN in the U.S. and the EEA; |
• | continue to seek regulatory approval of ILUVIEN 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 September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
(In thousands) | |||||||||||||||
NET REVENUE | $ | 8,298 | $ | 6,901 | $ | 23,656 | $ | 16,615 | |||||||
GROSS PROFIT | 7,812 | 6,267 | 22,236 | 15,322 | |||||||||||
OPERATING EXPENSES | 15,055 | 14,711 | 44,718 | 44,560 | |||||||||||
NET LOSS FROM OPERATIONS | (7,243 | ) | (8,444 | ) | (22,482 | ) | (29,238 | ) | |||||||
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS | (9,245 | ) | (1,543 | ) | (27,248 | ) | (19,932 | ) |
• | salaries and related expenses for personnel, including medical sales liaisons; |
• | costs related to the provision of medical affairs support, including scientific advisory boards and symposia development for physician education; |
• | costs related to compliance with FDA, EU or other regulatory requirements; |
• | fees paid to consultants and contract research organizations 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; |
• | 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 development functions. |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
(In thousands) | |||||||||||||||
NET REVENUE | $ | 6,184 | $ | 5,032 | $ | 17,511 | $ | 11,279 | |||||||
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (374 | ) | (245 | ) | (964 | ) | (573 | ) | |||||||
GROSS PROFIT | 5,810 | 4,787 | 16,547 | 10,706 | |||||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 2,204 | 2,320 | 6,024 | 5,176 | |||||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | 2,232 | 1,712 | 6,569 | 6,080 | |||||||||||
SALES AND MARKETING EXPENSES | 5,618 | 4,546 | 16,573 | 14,274 | |||||||||||
DEPRECIATION AND AMORTIZATION | 674 | 639 | 2,015 | 1,819 | |||||||||||
OPERATING EXPENSES | 10,728 | 9,217 | 31,181 | 27,349 | |||||||||||
NET LOSS FROM OPERATIONS | $ | (4,918 | ) | $ | (4,430 | ) | $ | (14,634 | ) | $ | (16,643 | ) |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
(In thousands) | |||||||||||||||
NET REVENUE | $ | 2,114 | $ | 1,869 | $ | 6,145 | $ | 5,336 | |||||||
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (112 | ) | (389 | ) | (456 | ) | (720 | ) | |||||||
GROSS PROFIT | 2,002 | 1,480 | 5,689 | 4,616 | |||||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 1,057 | 1,758 | 3,462 | 6,046 | |||||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | 1,413 | 1,319 | 4,510 | 4,391 | |||||||||||
SALES AND MARKETING EXPENSES | 1,834 | 2,403 | 5,498 | 6,729 | |||||||||||
DEPRECIATION AND AMORTIZATION | 23 | 14 | 67 | 45 | |||||||||||
OPERATING EXPENSES | 4,327 | 5,494 | 13,537 | 17,211 | |||||||||||
NET LOSS FROM OPERATIONS | $ | (2,325 | ) | $ | (4,014 | ) | $ | (7,848 | ) | $ | (12,595 | ) |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
(In thousands) | |||||||||||||||
NET LOSS FROM OPERATIONS | $ | (7,243 | ) | $ | (8,444 | ) | $ | (22,482 | ) | $ | (29,238 | ) | |||
INTEREST EXPENSE, NET AND OTHER | (1,330 | ) | (1,317 | ) | (3,842 | ) | (3,590 | ) | |||||||
UNREALIZED FOREIGN CURRENCY LOSS, NET | (51 | ) | (63 | ) | (31 | ) | (34 | ) | |||||||
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY | (588 | ) | 8,363 | 1,755 | 13,085 | ||||||||||
LOSS ON EARLY EXTINGUISHMENT OF DEBT | — | — | (2,564 | ) | — | ||||||||||
NET LOSS BEFORE TAXES | (9,212 | ) | (1,461 | ) | (27,164 | ) | (19,777 | ) | |||||||
PROVISION FOR TAXES | (33 | ) | (82 | ) | (84 | ) | (155 | ) | |||||||
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS | $ | (9,245 | ) | $ | (1,543 | ) | $ | (27,248 | ) | $ | (19,932 | ) |
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). | |
4.15 | Third Amendment to Warrant Agreement dated July 21, 2016 by and among the Registrant and Hercules Capital, Inc. f/k/a Hercules Technology Growth Capital, Inc. | |
4.16 | Warrant Agreement dated October 20, 2016 by and among the Registrant and Hercules Capital, Inc. f/k/a Hercules Technology Growth Capital, Inc. | |
10.44 | Waiver by Hercules Capital, Inc. of Certain Defaults under Loan and Security Agreement dated July 21, 2016. | |
10.45 | Fourth Amendment to Loan and Security Agreement dated October 20, 2016 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. | ||
November 4, 2016 | By: | /s/ C. Daniel Myers |
C. Daniel Myers | ||
Chief Executive Officer | ||
(Principal Executive Officer) | ||
November 4, 2016 | 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). | |
4.15 | Third Amendment to Warrant Agreement dated July 21, 2016 by and among the Registrant and Hercules Capital, Inc. f/k/a Hercules Technology Growth Capital, Inc. | |
4.16 | Warrant Agreement dated October 20, 2016 by and among the Registrant and Hercules Capital, Inc. f/k/a Hercules Technology Growth Capital, Inc. | |
10.44 | Waiver by Hercules Capital, Inc. of Certain Defaults under Loan and Security Agreement dated July 21, 2016. | |
10.45 | Fourth Amendment to Loan and Security Agreement dated October 20, 2016 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. |
Where: | X = the number of shares of Common Stock to be issued to the Warrantholder. |
(1) | The undersigned Warrantholder hereby elects to purchase [_______] shares of the Common Stock of [_________________], pursuant to the terms of the Agreement dated the [___] day of [______, _____] (the "Agreement") between [_________________] and the Warrantholder, and tenders herewith payment of the Purchase Price in full, together with all applicable transfer taxes, if any. [NET ISSUANCE: elects pursuant to Section 3(a) of the Agreement to effect a Net Issuance.] |
(2) | Please issue a certificate or certificates representing said shares of Common Stock in the name of the undersigned or in such other name as is specified below. |
1. | ACKNOWLEDGMENT OF EXERCISE |
“ “Minimum Required Liquidity Reduction Period Termination Date” is (a) at all times through and including the date that is six (6) months after the Minimum Required Liquidity Reduction Period Commencement Date, the earlier to occur of (i) the Consolidated Group failing to maintain, as of any date of determination, positive net Adjusted EBITDA for the period (A) commencing upon the Liquidity Reduction Beginning Measurement Date, and (B) ending on such date of determination, and (ii) the Consolidated Group failing to maintain Adjusted EBITDA of at least ($1,500,000) for any three-month period ending on the last day of a calendar month, and (b) as of the date that is six (6) months after the Minimum Required Liquidity Reduction Period Commencement Date, and at all times thereafter, the occurrence of Borrower failing to maintain positive three (3) month Adjusted EBITDA for any three-month period ending on the last day of a calendar month.” |
Depository AC # | Financial Institution | Account Type (Depository / Securities) | Last Month Ending Account Balance | Purpose of Account | ||
BORROWER/GUARANTOR Name/Address: |
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SUBSIDIARY / AFFILIATE COMPANY Name/Address | ||||||
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LENDER | EXISTING TERM LOAN |
HERCULES CAPITAL FUNDING TRUST 2014-1 | $10,000,000 |
HERCULES CAPITAL, INC. | $25,000,000 |
TOTAL COMMITMENTS | $35,000,000 |
LENDER | TRANCHE | TERM COMMITMENT |
HERCULES CAPITAL, INC. | THIRD DRAW PERIOD | $5,000,000 |
HERCULES CAPITAL, INC. | FOURTH DRAW PERIOD | $5,000,000 |
TOTAL COMMITMENTS | $10,000,000 |
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: November 4, 2016 | /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: November 4, 2016 | /s/ Richard S. Eiswirth, Jr. | |||||
Richard S. Eiswirth, Jr. | ||||||
President and Chief Financial Officer (Principal Financial and Accounting Officer) |
Date: November 4, 2016 | /s/ C. Daniel Myers | ||
C. Daniel Myers | |||
Chief Executive Officer (Principal Executive Officer) | |||
Date: November 4, 2016 | /s/ Richard S. Eiswirth, Jr. | ||
Richard S. Eiswirth, Jr. | |||
President and Chief Financial Officer (Principal Financial and Accounting Officer) |
Document and Entity Information - shares |
9 Months Ended | |
---|---|---|
Sep. 30, 2016 |
Nov. 03, 2016 |
|
Document and Entity Information [Abstract] | ||
Entity Registrant Name | ALIMERA SCIENCES INC | |
Entity Central Index Key | 0001267602 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2016 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2016 | |
Document Fiscal Period Focus | Q3 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 64,862,904 |
Consolidated Balance Sheets (Parenthetical) - USD ($) |
Sep. 30, 2016 |
Dec. 31, 2015 |
---|---|---|
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 64,710,724 | 45,005,833 |
Common stock, shares outstanding | 64,710,724 | 45,005,833 |
Series A Convertible Preferred Stock | ||
Preferred stock, shares authorized | 1,300,000 | 1,300,000 |
Preferred stock, shares issued | 600,000 | 600,000 |
Preferred stock, shares outstanding | 600,000 | 600,000 |
Preferred stock, liquidation preference | $ 24,000,000 | $ 24,000,000 |
Series B Convertible Preferred Stock | ||
Preferred stock, shares authorized | 8,417 | 8,417 |
Preferred stock, shares issued | 8,416.251 | 8,416.251 |
Preferred stock, shares outstanding | 8,416.251 | 8,416.251 |
Preferred stock, liquidation preference | $ 50,750,000 | $ 50,750,000 |
Consolidated Statements of Operations - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Income Statement [Abstract] | ||||
NET REVENUE | $ 8,298 | $ 6,901 | $ 23,656 | $ 16,615 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (486) | (634) | (1,420) | (1,293) |
GROSS PROFIT | 7,812 | 6,267 | 22,236 | 15,322 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 3,261 | 4,078 | 9,486 | 11,222 |
GENERAL AND ADMINISTRATIVE EXPENSES | 3,645 | 3,031 | 11,079 | 10,471 |
SALES AND MARKETING EXPENSES | 7,452 | 6,949 | 22,071 | 21,003 |
DEPRECIATION AND AMORTIZATION | 697 | 653 | 2,082 | 1,864 |
OPERATING EXPENSES | 15,055 | 14,711 | 44,718 | 44,560 |
NET LOSS FROM OPERATIONS | (7,243) | (8,444) | (22,482) | (29,238) |
INTEREST EXPENSE, NET AND OTHER | (1,330) | (1,317) | (3,842) | (3,590) |
UNREALIZED FOREIGN CURRENCY LOSS, NET | (51) | (63) | (31) | (34) |
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY | (588) | 8,363 | 1,755 | 13,085 |
LOSS ON EARLY EXTINGUISHMENT OF DEBT | 0 | 0 | (2,564) | 0 |
NET LOSS BEFORE TAXES | (9,212) | (1,461) | (27,164) | (19,777) |
PROVISION FOR TAXES | (33) | (82) | (84) | (155) |
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS | $ (9,245) | $ (1,543) | $ (27,248) | $ (19,932) |
NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS — Basic and diluted (in dollars per share) | $ (0.16) | $ (0.03) | $ (0.56) | $ (0.45) |
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted | 56,103,534 | 44,436,224 | 48,759,381 | 44,393,831 |
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Statement of Comprehensive Income [Abstract] | ||||
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS | $ (9,245) | $ (1,543) | $ (27,248) | $ (19,932) |
OTHER COMPREHENSIVE INCOME (LOSS) | ||||
Foreign currency translation adjustments | 30 | 40 | 79 | (248) |
TOTAL OTHER COMPREHENSIVE INCOME (LOSS) | 30 | 40 | 79 | (248) |
COMPREHENSIVE LOSS | $ (9,215) | $ (1,503) | $ (27,169) | $ (20,180) |
Consolidated Statements of Cash Flows (Parenthetical) - USD ($) |
9 Months Ended | |
---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Statement of Cash Flows [Abstract] | ||
Dividend payments | $ 0 | $ 0 |
Nature of Operations |
9 Months Ended |
---|---|
Sep. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations | NATURE OF OPERATIONS Alimera Sciences, Inc., and its subsidiaries (the Company), is a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Alimera Sciences, Inc. was formed on June 4, 2003 under the laws of the State of Delaware. The Company is presently focused on diseases affecting the back of the eye, or retina, because the Company’s management believes these diseases are not well treated with current therapies and represent a significant market opportunity. The Company’s only commercial product is ILUVIEN®, which has received marketing authorization in the United States (U.S.), Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden and the United Kingdom. In the U.S., ILUVIEN is indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). In the European Economic Area (EEA) countries in which ILUVIEN has received marketing authorization, it is indicated for the treatment of vision impairment associated with DME considered insufficiently responsive to available therapies. As part of the approval process in the EEA, the Company has committed to conduct a five-year, post-authorization, open label registry study in 800 patients treated with ILUVIEN per the labeled indication. Through September 30, 2016, over 430 patients have been enrolled. The Company launched ILUVIEN in Germany and the United Kingdom in the second quarter of 2013 and in the U.S. and Portugal in the first quarter of 2015. In addition, the Company has entered into various agreements under which distributors will provide regulatory, reimbursement or sales and marketing support for future commercialization of ILUVIEN in numerous countries in the Middle East, Canada, Italy, Australia and New Zealand. In the third quarter of 2016, the Company's Middle East distributor initiated named patient sales of ILUVIEN in the Middle East. |
Basis of Presentation |
9 Months Ended |
---|---|
Sep. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | BASIS OF PRESENTATION The Company has prepared the accompanying unaudited interim condensed consolidated financial statements and notes thereto (Interim Financial Statements) in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP) for interim financial information and the instructions to Form 10-Q and Article 10-01 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of the Company’s management, the accompanying Interim Financial Statements reflect all adjustments, which include normal recurring adjustments, necessary to present fairly the Company’s interim financial information. The accompanying Interim Financial Statements and related notes should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2015 and related notes included in the Company’s Annual Report on Form 10-K, which was filed with the SEC on March 15, 2016. The financial results for any interim period are not necessarily indicative of the expected financial results for the full year. |
Summary of Significant Accounting Policies |
9 Months Ended |
---|---|
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The accounting policies followed for quarterly financial reporting are the same as those disclosed in the Notes to Financial Statements included in the Company’s Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2015. Allowance for Doubtful Accounts on Accounts Receivable Allowance for doubtful accounts on accounts receivable were $26,000 and $118,000 as of September 30, 2016 and December 31, 2015, respectively. Research and Development Expenses Research and development expenses were $1,567,000 and $940,000 for the three months ended September 30, 2016 and 2015, respectively. Research and development expenses were $4,438,000 and $1,958,000 for the nine months ended September 30, 2016 and 2015, respectively. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standard setting bodies that are adopted by us as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption. In May 2014, the FASB issued Accounting Standards Update (ASU) 2014-09, Revenue from Contracts with Customers (Topic 606). ASU 2014-09 provides a single, comprehensive revenue recognition model for all contracts with customers. The revenue guidance contains principles that an entity will apply to determine the measurement of revenue and timing of when it is recognized. The underlying principle is that an entity will recognize revenue to depict the transfer of goods or services to customers at an amount that the entity expects to be entitled to in exchange for those goods or services. The standard is effective for the first interim period within annual reporting periods beginning after December 15, 2017 for public entities, with early adoption permitted in the annual reporting period beginning after December 15, 2016. The Company is continuing to evaluate the new guidance and plans to provide additional information about its expected financial impact at a future date. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements-Going Concern. ASU 2014-15 provides guidance around management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. For each reporting period, management will be required to evaluate whether there are conditions or events that raise substantial doubt about a company’s ability to continue as a going concern within one year from the date the financial statements are issued. The new standard is effective for fiscal years and interim periods within those fiscal years, beginning after December 15, 2016. Early adoption is permitted. The Company does not expect the potential impact of adopting this guidance to have a material impact on its financial statements. In July 2015, FASB issued ASU 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory. This update requires entities to measure inventory at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. Subsequent measurement is unchanged for inventory measured using LIFO or the retail inventory method. This ASU is effective for annual reporting periods beginning after December 15, 2016 and interim periods within those years. The Company does not expect the impact of the adoption to have a material effect on its financial statements. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). This standard requires all leases with durations greater than twelve months to be recognized on the balance sheet and is effective for interim and annual reporting periods beginning after December 15, 2018, although early adoption is permitted. The Company is currently in the process of evaluating the impact of the adoption on its financial statements. In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718). This standard makes several modifications to Topic 718 related to the accounting for forfeitures, employer tax withholding on share-based compensation and the financial statement presentation of excess tax benefits or deficiencies. ASU 2016-09 also clarifies the statement of cash flows presentation for certain components of share-based awards. The standard is effective for interim and annual reporting periods beginning after December 15, 2016, although early adoption is permitted. The Company does not expect the impact of the adoption to have a material effect on its financial statements. |
Factors Affecting Operations |
9 Months Ended |
---|---|
Sep. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Factors Affecting Operations | FACTORS AFFECTING OPERATIONS To date, the Company has incurred negative cash flow from operations and has accumulated a deficit of $371,146,000 from inception through September 30, 2016. As of September 30, 2016, the Company had approximately $33,853,000 in cash and cash equivalents. Subsequent to September 30, 2016, the Company entered into the Fourth Loan Amendment (as defined below) with Hercules Capital, Inc. (Hercules) in order to modify certain terms of the Term Loan Agreement (as defined below) and obtain additional loan amounts (see Note 9 Loan Agreements). If there is an event of default, all amounts may become due under the Term Loan Agreement and there would be substantial doubt about the Company's ability to continue as a going concern. Further, due to the limited revenue generated by ILUVIEN to date, the Company may need to raise additional capital to fund the continued commercialization of ILUVIEN. If the Company were unable to raise additional financing, the Company would need to adjust its commercial plans so that it could continue to operate with its existing cash resources. The actual amount of funds that the Company would need would be determined by many factors, some of which may be beyond its control. The accompanying Interim Financial Statements have been prepared assuming the Company will continue as a going concern. However, the Company’s negative cash flow from operations and accumulated deficit raise substantial doubt about its ability to continue as a going concern. The Interim Financial Statements do not include any adjustments that might result from the outcome of this uncertainty. |
Inventory |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory | INVENTORY Inventory consisted of the following:
(1) Component parts inventory consists of manufactured components of the ILUVIEN applicator. (2) Work-in-process primarily consists of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing as required by regulatory authorities in Europe. |
Intangible Asset |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||
Intangible Assets, Net (Excluding Goodwill) [Abstract] | |||||||||||||||||||||||||||||||||||||||||
Intangible Asset | INTANGIBLE ASSET As a result of the U.S. Food and Drug Administration’s (FDA) approval of the New Drug Application (NDA) for ILUVIEN in September 2014, the Company was required to pay pSivida US, Inc. (pSivida) a milestone payment of $25,000,000 (the pSivida Milestone Payment) in October 2014 (see Note 8 License Agreements). The Company had no intangible assets prior to September 2014. The gross carrying amount of the intangible asset is $25,000,000, which is being amortized over approximately 13 years from the acquisition date. The amortization expense related to the intangible asset was $489,000 for both the three months ended September 30, 2016 and 2015. The amortization expense related to the intangible asset was $1,457,000 and $1,451,000 for the nine months ended September 30, 2016 and 2015, respectively. The net book value of the intangible asset was $21,093,000 and $22,549,000 as of September 30, 2016 and December 31, 2015, respectively. The estimated future amortization expense as of September 30, 2016 for the remainder of 2016, the next four years and thereafter is as follows (in thousands):
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Accrued Expenses |
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Payables and Accruals [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Expenses | ACCRUED EXPENSES Accrued expenses consisted of the following:
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License Agreements |
9 Months Ended |
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Sep. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License Agreements | LICENSE AGREEMENTS The Company entered into an agreement with pSivida for the use of fluocinolone acetonide (FAc) in pSivida’s proprietary delivery device in February 2005, which was subsequently amended in 2008 (the pSivida Agreement). The pSivida Agreement provides the Company with a worldwide exclusive license to utilize certain underlying technology used in the development and commercialization of ILUVIEN. The Company’s license rights to pSivida’s proprietary delivery device could revert to pSivida if the Company were to (i) fail twice to cure its breach of an obligation to make certain payments to pSivida following receipt of written notice thereof; (ii) fail to cure other breaches of material terms of the pSivida 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 pSivida in writing of its decision to abandon its license with respect to a certain product using pSivida’s proprietary delivery device. As a result of the FDA’s approval of the NDA for ILUVIEN in September 2014, the Company made the pSivida Milestone Payment of $25,000,000 in October 2014. The Company must share 20% of the Company's net profits of ILUVIEN, determined on a cash basis, in each country where the Company sells ILUVIEN directly or through its distributors or sub-distributors and 33% of any lump sum milestone payments received from a sub-licensee of ILUVIEN, as defined by the pSivida Agreement. In connection with this arrangement, the Company is entitled to recover 20% of commercialization costs of ILUVIEN incurred prior to product profitability out of pSivida’s share of net profits, as defined in the pSivida Agreement. As of September 30, 2016 and December 31, 2015, the Company was owed approximately $25,239,000 and $21,565,000, respectively, in commercialization costs. Due to the uncertainty of future net profits, the Company has fully reserved these amounts in the accompanying Interim Financial Statements. In the second quarter of 2016, pSivida disputed portions of the Company's claimed commercialization costs for the year ended December 31, 2014. As part of this dispute, pSivida notified the Company that it disagreed with $1,290,000 of the $12,956,000 in commercialization costs receivable that the Company had reported as of December 31, 2014 and claimed incremental profit sharing payments of $136,000 for the year ended December 31, 2014. The Company is disputing pSivida’s assertions using the alternative dispute resolution mechanism under the pSivida Agreement. If pSivida’s assertions were to prevail in the alternative dispute resolution mechanism and their assertions were then applied to the commercialization cost calculations for the year ended December 31, 2015 and the nine months ended September 30, 2016, then the Company believes the commercialization costs receivable from pSivida would be reduced from $21,565,000 to $18,504,000 at December 31, 2015 and from $25,239,000 to $20,931,000 at September 30, 2016. If pSivida’s assertions were to prevail in the alternative dispute resolution mechanism, the impact on the statements of operations for the year ended December 31, 2015 and the nine months ended September 30, 2016 would be immaterial. |
Loan Agreements |
9 Months Ended |
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Sep. 30, 2016 | |
Debt Disclosure [Abstract] | |
Loan Agreements | LOAN AGREEMENTS Hercules Loan Agreement 2014 Loan Agreement In April 2014, Alimera Sciences Limited (Limited), a subsidiary of the Company, entered into a loan and security agreement (2014 Loan Agreement) with Hercules Capital, Inc. (Hercules) providing for a term loan of up to $35,000,000 (2014 Term Loan), which Limited and Hercules amended in November 2015 (the First Loan Amendment), March 2016 (the Second Loan Amendment), May 2016 (the Third Loan Amendment) and October 2016 (the Fourth Loan Amendment and, collectively with the 2014 Loan Agreement, the First Loan Amendment, the Second Loan Amendment and the Third Loan Amendment, the Term Loan Agreement). Under the 2014 Loan Agreement, Hercules made an advance in the initial principal amount of $10,000,000 to Limited at closing to provide Limited with additional working capital for general corporate purposes and to repay a 2013 term loan with Silicon Valley Bank. Hercules made an additional advance of $25,000,000 to Limited in September 2014, following the approval of ILUVIEN by the FDA to fund the pSivida Milestone Payment. The 2014 Loan Agreement provided for interest only payments through November 2015. Interest on the 2014 Term Loan accrued at a floating per annum rate equal to the greater of (i) 10.90%, or (ii) the sum of (A) 7.65%, plus (B) the prime rate. Following the interest only period the 2014 Term Loan was due and payable to Hercules in equal monthly payments of principal and interest through May 1, 2018. The interest rate on the Term Loan Agreement was 11.15% as of September 30, 2016. First Loan Amendment In November 2015, Limited and Hercules amended the 2014 Loan Agreement to extend the interest only payments through May 2017. In connection with the First Loan Amendment, Limited paid to Hercules an amendment fee of $262,500 and agreed to make an additional payment of $1,050,000, equal to 3% of the 2014 Term Loan at the time of the final payment (End of Term Payment). Limited and the Company, on a consolidated basis with the Company’s other subsidiaries (the Consolidated Group), agreed to customary affirmative and negative covenants and events of default in connection with these arrangements. The occurrence of an event of default could result in the acceleration of Limited’s obligations under the Term Loan Agreement and an increase to the applicable interest rate and would permit Hercules to exercise remedies with respect to the collateral under the Term Loan Agreement. In connection with the First Loan Amendment, Limited agreed to covenants regarding certain revenue thresholds and a liquidity threshold. Second Loan Amendment In January 2016, the revenue threshold covenant was not met by the Consolidated Group and as a result, in March 2016, Limited and Hercules entered into the Second Loan Amendment, which further amended certain terms of the 2014 Loan Agreement. In conjunction with the Second Loan Amendment, Hercules waived this covenant violation. The Second Loan Amendment adjusted the revenue covenant to a rolling three-month calculation, first measured for the three months ended May 31, 2016. In addition, the Second Loan Amendment increased the liquidity covenant. Upon execution of the Second Loan Amendment, Limited paid Hercules an amendment fee of $350,000 and agreed to increase the End of Term Payment to $1,400,000 from $1,050,000, which was payable on the date that the 2014 Term Loan was to be paid in full. The Company concluded that the Second Loan Amendment resulted in a substantial modification of the terms of debt when considered with the First Loan Amendment in accordance with the guidance in ASC 470-50, Debt. As a result, the Company accounted for the Second Loan Amendment as an extinguishment and recognized a loss on early extinguishment of debt of approximately $2,564,000 within the consolidated statement of operations for the nine months ended September 30, 2016. The loss on early extinguishment consisted primarily of the unamortized debt discount associated with the warrant and debt issuance costs incurred prior to the Second Loan Amendment, the incremental fair value of the warrant as a result of modifying the terms of the warrant and the debt issuance costs of $360,000 paid to Hercules for the Second Loan Amendment. Third Loan Amendment and July 2016 Waiver In May 2016, Limited and Hercules entered into the Third Loan Amendment to expand the definition of liquidity to allow for the inclusion of cash of up to $2,000,000 in bank accounts outside of the U.S. and the United Kingdom. In July 2016, Limited obtained a waiver of the requirements of the liquidity covenant (the Waiver) because the Consolidated Group was not in compliance with the liquidity covenant as of June 30, 2016. The Waiver cured the default of the liquidity covenant then existing under the Term Loan Agreement and decreased the liquidity requirement. In addition, the Waiver modified the three-month revenue covenant so that it was not measured at July 31, 2016 and reduced the three-month revenue target to be measured at August 31, 2016. Following execution of the Waiver, Limited incurred a weekly ticking fee equal to 0.05% multiplied by the outstanding principal amount through the closing of the Company’s public offering in August 2016 (see Note 12 Common Stock), totaling $65,000. Further, Limited paid Hercules a fee of $350,000 associated with the Waiver. Fourth Loan Amendment In October 2016, Limited entered into the Fourth Loan Amendment with Hercules, which further amended certain terms of the Term Loan Agreement. Pursuant to the terms of the Fourth Loan Amendment, Hercules agreed to provide up to an additional $10,000,000 to Limited with (i) the first $5,000,000 available at Limited’s option through June 30, 2017 subject to (A) the Consolidated Group’s achievement of $12,000,000 in trailing three month net product revenue and (B) no event of default having occurred since October 20, 2016 (the Effective Date) and (ii) the second $5,000,000 available at Limited’s option through December 31, 2017 subject to (A) the Consolidated Group's achievement of $15,000,000 in trailing three month net product revenue, (B) no event of default having occurred since the Effective Date and (C) the prior $5,000,000 having been advanced to Limited (the Additional Advances and, together with the 2014 Term Loan, the Term Loan). The Fourth Loan Amendment provides for interest only payments through November 30, 2018 (the Interest-Only Period). Pursuant to the Fourth Loan Amendment, interest on the Term Loan accrues at a floating per annum rate equal the greater of (i) 11.0% and (ii) the sum of (A) 11.0% plus (B) the prime rate as reported in The Wall Street Journal, or if not reported, the prime rate most recently reported in The Wall Street Journal, minus 3.5%. In addition to the interest described above, the principal balance of the Term Loan will bear “payment-in kind” interest at the rate of 1.0% (PIK Interest), which PIK Interest will be added to the outstanding principal balance of the Term Loan so as to increase the outstanding principal balance of the Term Loan on each payment date for the Term Loan and which amount will be payable when the aggregate outstanding principal amount of the Term Loan is payable. The Term Loan will be due and payable to Hercules in 24 equal monthly payments of principal and interest following the Interest-Only Period beginning on December 1, 2018 and matures in full on November 1, 2020. Limited paid Hercules a facility charge of $337,500 and reimbursed Hercules for legal and diligence fees incurred in connection with the Fourth Loan Amendment. If Limited prepays the Term Loan, it will pay Hercules a prepayment penalty (i) if such amounts are prepaid in any of the first 12 months following the Effective Date, equal to 3.0% of the principal amount of the Term Loan being repaid, (ii) if such amounts are prepaid after 12 months but prior to 24 months following the Effective Date, equal to 2.0% of the principal amount of the Term Loan being repaid, and (iii) if such amounts are prepaid at any time thereafter, equal to 1.0% of the principal amount of the Term Loan being repaid. The Consolidated Group also agreed to customary affirmative and negative covenants, including, without limitation, covenants relating to minimum liquidity, minimum trailing six-month net revenue and adjusted EBITDA, and events of default in connection with these arrangements. The occurrence of an event of default could result in the acceleration of Limited’s obligations under the Term Loan Agreement, as amended by the Fourth Loan Amendment and an increase to the applicable interest rate, and would permit Hercules to exercise remedies with respect to the collateral under the Term Loan Agreement, as amended by the Fourth Loan Amendment. In the event that the Company maintains $35,000,000 in liquidity, including cash and eligible accounts receivable, at the end of the month and has not been and is not in breach of the amended debt facility, the six-month trailing revenue covenant is effectively waived for such month. General Discussion of the Term Loan Agreement Pursuant to the Term Loan Agreement, Limited’s obligations to Hercules are secured by a first-priority security interest in substantially all of Limited’s assets, excluding intellectual property. Hercules does, however, maintain a negative pledge on Limited’s intellectual property requiring Hercules’ consent prior to the sale of such intellectual property. The Company and certain of the Company’s other subsidiaries are guarantors of the obligations of Limited to Hercules under the Term Loan Agreement pursuant to separate guaranty agreements between Hercules and each of Limited and such subsidiaries (Guaranties). Pursuant to the Guaranties, the Company and these subsidiaries granted Hercules a first-priority security interest in substantially all of their respective assets excluding intellectual property. The Term Loan Agreement also places limitations on the Company’s ability to declare or pay any dividend or distribution on any shares of capital stock. 2014 Warrant In connection with Limited entering into the 2014 Loan Agreement, the Company issued a warrant to Hercules to purchase up to 285,016 shares of the Company’s common stock at an exercise price of $6.14 per share (the 2014 Warrant). Sixty percent of the 2014 Warrant was exercisable at the closing in April 2014 and the remaining forty percent became exercisable upon the funding of the additional $25,000,000 to Limited in September 2014. The Company agreed to amend the 2014 Warrant in connection with the First Loan Amendment to increase the number of shares issuable upon exercise to 660,377 and decrease the exercise price to $2.65 per share. Upon entering into the Second Loan Amendment, the Company agreed to further amend the 2014 Warrant to increase the number of shares issuable upon exercise to 862,069 and decrease the exercise price to $2.03 per share. In connection with the July 2016 Waiver, the Company agreed to further amend the 2014 Warrant to increase the number of shares issuable upon exercise to 1,258,993 and decrease the exercise price to $1.39 per share. 2016 Warrant In connection with Limited entering into the Fourth Loan Amendment, the Company agreed to issue a new warrant to Hercules (the 2016 Warrant) to purchase up to the number of shares of the Company’s common stock equal to $500,000 divided by the lowest volume-weighted average sale price for a share of the Company’s common stock reported over any ten consecutive trading days during the period commencing on and including September 23, 2016 and ending on the earlier to occur of (i) December 30, 2016 (inclusive of such date), and (ii) the second trading day immediately preceding the date of closing of a merger event (as defined in the 2016 Warrant). Fair Value of Debt The weighted average interest rates of the Company’s notes payable approximate the rate at which the Company could obtain alternative financing; therefore, the carrying amount of the notes approximated their fair value at September 30, 2016 and December 31, 2015. |
Loss Per Share (EPS) |
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Loss Per Share (EPS) | LOSS PER SHARE (EPS) Basic EPS is calculated in accordance with ASC 260, Earnings per Share, by dividing net income or loss attributable to common stockholders by the weighted average common stock outstanding. Diluted EPS is calculated in accordance with ASC 260 by adjusting weighted average common shares outstanding for the dilutive effect of common stock options, warrants and convertible preferred stock. In periods where a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be anti-dilutive. Common stock equivalent securities that would potentially dilute basic EPS in the future, but were not included in the computation of diluted EPS because to do so would have been anti-dilutive, were as follows:
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Preferred Stock |
9 Months Ended |
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Sep. 30, 2016 | |
Equity [Abstract] | |
Preferred Stock | PREFERRED STOCK Series A Convertible Preferred Stock On October 2, 2012, the Company closed its preferred stock financing in which it sold units consisting of 1,000,000 shares of Series A Convertible Preferred Stock and warrants to purchase 300,000 shares of Series A Convertible Preferred Stock for gross proceeds of $40,000,000, prior to the payment of approximately $560,000 of related issuance costs. The powers, preferences and rights of the Series A Convertible Preferred Stock are set forth in the certificate of designation filed by the Company with the Secretary of State of the State of Delaware on October 1, 2012. Each share of Series A Convertible Preferred Stock, including any shares of Series A Convertible Preferred Stock issued upon exercise of the warrants, is convertible into shares of the Company’s common stock at any time at the option of the holder at the rate equal to $40.00 divided by $2.66 (Conversion Price). The initial Conversion Price was subject to adjustment based on certain customary price based anti-dilution adjustments. These adjustment features lapsed in September 2014. Each share of Series A Convertible Preferred Stock shall automatically be converted into shares of common stock at the Conversion Price upon the occurrence of the later to occur of both (i) the Company receives and publicly announces the approval by the FDA of the Company’s NDA for ILUVIEN and (ii) the date on which the Company consummates an equity financing transaction pursuant to which the Company sells to one or more third party investors either (a) shares of common stock or (b) other equity securities that are convertible into shares of common stock and that have rights, preference or privileges, senior to or on a parity with, the Series A Convertible Preferred Stock, in each case having an as-converted per share of common stock price of not less than $10.00 and that results in total gross proceeds to the Company of at least $30,000,000. The rights and preferences of Series A Convertible Preferred Stock also place limitations on the Company’s ability to declare or pay any dividend or distribution on any shares of capital stock. Each unit sold in the preferred stock financing included a warrant to purchase 0.30 shares of Series A Convertible Preferred Stock at an exercise price equal to $44.00 per share. At the election of the holder of a warrant, the warrant may be exercised for the number of shares of common stock then issuable upon conversion of the Series A Convertible Preferred Stock that would otherwise be issued upon such exercise at the then-effective Conversion Price. These warrants are considered derivative instruments because the agreements provide for settlement in Series A Convertible Preferred Stock shares or common stock shares at the option of the holder, an adjustment to the warrant exercise price for common shares at some point in the future and contain anti-dilution provisions whereby the number of shares for which the warrants are exercisable and/or the exercise price of the warrants are subject to change in the event of certain issuances of stock at prices below the then-effective exercise price of the warrants. Therefore, the warrants were recorded as a liability at issuance. The warrant anti-dilution provisions lapsed in September 2014. At September 30, 2016 and December 31, 2015, the fair market value of the warrants was estimated to be $1,060,000 and $2,815,000, respectively. During the three months ended September 30, 2016, the Company recorded a loss of $588,000 and during the three months ended September 30, 2015, the Company recorded a gain of $8,363,000, as a result of the change in fair value of the warrants. During the nine months ended September 30, 2016 and 2015, the Company recorded gains of $1,755,000 and $13,085,000, respectively, as a result of the change in fair value of the warrants. In April 2014, 2,255,639 shares of common stock were issued pursuant to the conversion of 150,000 shares of Series A Convertible Preferred Stock held by an investor. In September 2014, 3,759,398 shares of common stock were issued pursuant to the conversion of 250,000 shares of Series A Convertible Preferred Stock held by another investor. As of September 30, 2016, there were 600,000 shares of Series A Convertible Preferred Stock issued and outstanding. Series B Convertible Preferred Stock On December 12, 2014, the Company closed a preferred stock financing in which it sold 8,291.873 shares of Series B Convertible Preferred Stock for a purchase price of $6,030 per share, or an aggregate purchase price of $50,000,000, prior to the payment of approximately $432,000 of related issuance costs. The Company issued an additional 124.378 shares of Series B Convertible Preferred Stock as a subscription premium to the purchasers. The powers, preferences and rights of the Series B Convertible Preferred Stock are set forth in the certificate of designation filed by the Company with the Secretary of State of the State of Delaware. Each share of Series B Convertible Preferred Stock is convertible into 1,000 shares of the Company’s common stock at any time at the option of the holder, provided that the holder will be prohibited from converting Series B Convertible Preferred Stock into shares of the Company’s common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.98% of the total number of shares of the Company’s common stock then issued and outstanding. The Series B Convertible Preferred Stock ranks junior to the Company’s existing Series A Convertible Preferred Stock and senior to the Company’s common stock, with respect to rights upon liquidation. The Series B Convertible Preferred Stock ranks junior to all existing and future indebtedness. Except as otherwise required by law (or with respect to approval of certain actions), the Series B Convertible Preferred Stock do not have voting rights. The Series B Preferred Stock is not redeemable at the option of the holder. The Series B Convertible Preferred Stock is not subject to any price-based or other anti-dilution protections and does not provide for any accruing dividends. The Company determined that the conversion option of the preferred shares represented a beneficial conversion feature, as the conversion feature had intrinsic value to the holder on the commitment date as a result of the subscription premium. Therefore, the Company recorded a beneficial conversion feature of $750,000 as an increase in additional paid in capital. Because the Series B Convertible Preferred Stock was immediately convertible into common stock at the option of the holder at issuance, the Company immediately accreted the full value of the beneficial conversion feature to the carrying value of the Series B Convertible Preferred Stock on that date. |
Common Stock |
9 Months Ended |
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Sep. 30, 2016 | |
Equity [Abstract] | |
Common Stock | COMMON STOCK In September 2014, the Company entered into a sales agreement with Cowen and Company, LLC (Cowen) to offer shares of its common stock from time to time through Cowen up to an aggregate offering price of $35,000,000. During the nine months ended September 30, 2016, the Company sold a total of 662,779 shares of its common stock at a weighted average purchase price of $1.83 per share, resulting in gross proceeds of $1,211,000, prior to the payment of approximately $62,000 of underwriter discounts and commissions and related issuance costs. In addition, in August, 2016, pursuant to an underwriting agreement with Cowen, as representative of the several underwriters named therein, the Company closed a public offering in which it sold 18,900,000 shares of its common stock at a price to the public of $1.40 per share. The offering resulted in gross proceeds of $26,460,000, prior to the payment of approximately $1,309,000 of underwriter discounts and commissions and related issuance costs. During the nine months ended September 30, 2016 and 2015, 41,413 and 10,993 shares of the Company’s common stock were acquired through its employee stock purchase plan resulting in proceeds of $78,000 and $42,000, respectively. |
Stock Incentive Plans |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock Incentive Plans | STOCK INCENTIVE PLANS Stock Option Plans During the three months ended September 30, 2016 and 2015, the Company recorded compensation expense related to stock options of approximately $1,116,000 and $1,355,000, respectively. During the nine months ended September 30, 2016 and 2015, the Company recorded compensation expense related to stock options of approximately $3,683,000 and $3,623,000, respectively. As of September 30, 2016, the total unrecognized compensation cost related to non-vested stock options granted was $9,448,000 and is expected to be recognized over a weighted average period of 2.57 years. The following table presents a summary of stock option activity for the three and nine months ended September 30, 2016 and 2015:
The following table provides additional information related to outstanding stock options, exercisable stock options and stock options expected to vest as of September 30, 2016:
The following table provides additional information related to outstanding stock options, exercisable stock options and stock options expected to vest as of December 31, 2015:
Employee Stock Purchase Plan During the three months ended September 30, 2016 and 2015, the Company recorded compensation expense related to its employee stock purchase plan of approximately $18,000 and $38,000, respectively. During the nine months ended September 30, 2016 and 2015, the Company recorded compensation expense related to its employee stock purchase plan of approximately $69,000 and $79,000, respectively. |
Income Taxes |
9 Months Ended |
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Sep. 30, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES In accordance with ASC 740, Income Taxes, the Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of its assets and liabilities at the enacted tax rates in effect for the year in which the differences are expected to reverse. The Company records a valuation allowance against its net deferred tax asset to reduce the net carrying value to an amount that is more likely than not to be realized. At the end of each interim period, the Company makes its best estimate of the effective tax rate expected to be applicable for the full fiscal year. This estimate reflects, among other items, the Company’s best estimate of operating results and foreign currency exchange rates. The Company’s quarterly income tax rate may differ from its estimated annual effective tax rate because accounting standards require the Company to exclude the actual results of certain entities expected to generate a pretax loss when applying the estimated annual effective tax rate to the Company’s consolidated pretax results in interim periods. In estimating the annual effective tax rate, the Company does not include the estimated impact of unusual and/or infrequent items, including the reversal of valuation allowances, which may cause significant variations in the customary relationship between income tax expense (benefit) and pretax income (loss) in quarterly periods. The income tax expense (benefit) for such unusual and/or infrequent items is recorded in the quarterly period such items are incurred. The Company’s income tax expense and resulting effective tax rate are based upon the respective estimated annual effective tax rates applicable for the respective periods adjusted for the effects of items required to be treated as discrete to the period, including changes in tax laws, changes in estimated exposures for uncertain tax positions and other items. The Company’s effective tax rate for the three months ended September 30, 2016 properly excluded tax benefits associated with year-to-date pre-tax losses generated in the U.S. and the Netherlands. Income tax positions are considered for uncertainty in accordance with ASC 740-10. The Company believes that its income tax filing positions and deductions are more likely than not to be sustained on audit; therefore, no ASC 740-10 liabilities and no related penalties and interest have been recorded. The Company does not anticipate any material changes to its uncertain tax positions within the next 12 months. Tax years since 2003 remain subject to examination in Georgia, Tennessee and at the federal level. The time period is longer than the standard statutory 3-year period due to net operating losses (NOLs) from 2003 being available for utilization. The statute of limitations on these years will close when the NOLs expire or when the statute closes on the years in which the NOLs are utilized. Tax years since 2012 remain subject to examination in the United Kingdom and the Netherlands. Tax years since 2013 remain subject to examination in Germany. Significant management judgment is involved in determining the provision for income taxes, deferred tax assets and liabilities and any valuation allowance recorded against U.S. net deferred tax assets. Due to uncertainties with respect to the realization of U.S. deferred tax assets due to the history of operating losses, a valuation allowance has been established against the entire U.S. net deferred tax asset balance. The valuation allowance is based on management’s estimates of taxable income in the jurisdictions in which the Company operates and the period over which deferred tax assets will be recoverable. In the event that actual results differ from these estimates or the Company adjusts these estimates in future periods, a change in the valuation allowance may be needed, which could materially impact its financial position and results of operations. At December 31, 2015, the Company had federal NOL carry-forwards of approximately $100,835,000 and state NOL carry-forwards of approximately $78,762,000 available to reduce future income. The Company’s federal NOL carry-forwards remain fully reserved as of September 30, 2016. If not utilized, the federal NOL carry-forwards will expire at various dates between 2029 and 2035 and the state NOL carry-forwards will expire at various dates between 2020 and 2035. The Company’s NOL carry-forwards may be subject to annual limitations under Internal Revenue Code (IRC) Section 382 (or comparable provisions of state law) in the event that certain changes in ownership of the Company were to occur. The Company periodically evaluates its NOL carry-forwards and whether certain changes in ownership, including its August 2016 common stock issuance, have occurred that would limit its ability to utilize a portion of the Company’s NOL carry-forwards. Currently, a full valuation allowance has been recorded against the NOL deferred tax asset. As of December 31, 2015, the Company had cumulative book losses in foreign subsidiaries of $67,452,000. The Company has not recorded a deferred tax asset for the excess of tax over book basis in the stock of its foreign subsidiaries. The Company anticipates that its foreign subsidiaries will be profitable and have earnings in the future. Once the foreign subsidiaries do have earnings, the Company intends to indefinitely reinvest in its foreign subsidiaries all undistributed earnings of and original investments in such subsidiaries. As a result, the Company has not recorded a deferred tax liability related to excess of book over tax basis in the stock of its foreign subsidiaries in accordance with ASC 740-30-25. |
Fair Value |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value | FAIR VALUE The Company applies ASC 820, Fair Value Measurements, in determining the fair value of certain assets and liabilities. Under this standard, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date. In determining fair value, the Company uses various valuation approaches. The hierarchy of those valuation approaches is broken down into three levels based on the reliability of inputs as follows: Level 1 inputs are quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. An active market for the asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. The valuation under this approach does not entail a significant degree of judgment. Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include: quoted prices for similar assets or liabilities in active markets, inputs other than quoted prices that are observable for the asset or liability, (e.g., interest rates and yield curves observable at commonly quoted intervals or current market) and contractual prices for the underlying financial instrument, as well as other relevant economic measures. Level 3 inputs are unobservable inputs for the asset or liability. Unobservable inputs shall be used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at the measurement date. There have been no changes in the methodologies used at September 30, 2016 and December 31, 2015. The following fair value table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis:
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Segment Information |
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Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Information | SEGMENT INFORMATION During the three months ended September 30, 2016 and 2015, two customers within the U.S. segment accounted for 75% and 73%, respectively, of the Company's consolidated revenues as a result of our sales to two pharmaceutical distributors in the U.S. During the nine months ended September 30, 2016 and 2015, these two customers within the U.S. segment accounted for 74% and 68%, respectively, of the Company's consolidated revenues. These two customers within the U.S. segment accounted for approximately 89% and 88% of the Company’s consolidated accounts receivable at September 30, 2016 and December 31, 2015, respectively. The following table presents a summary of the Company's reporting segments for the three months ended September 30, 2016 and 2015:
The following table presents a summary of the Company's reporting segments for the nine months ended September 30, 2016 and 2015:
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Subsequent Event |
9 Months Ended |
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Sep. 30, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Event | SUBSEQUENT EVENT In October 2016, Limited and Hercules entered into the Fourth Loan Amendment (see Note 9 Loan Agreements). In connection with the Fourth Loan Amendment, the Company agreed to issue to Hercules the 2016 Warrant (see Note 9 Loan Agreements). |
Summary of Significant Accounting Policies (Policies) |
9 Months Ended |
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Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Basis of Presentation | The Company has prepared the accompanying unaudited interim condensed consolidated financial statements and notes thereto (Interim Financial Statements) in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP) for interim financial information and the instructions to Form 10-Q and Article 10-01 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of the Company’s management, the accompanying Interim Financial Statements reflect all adjustments, which include normal recurring adjustments, necessary to present fairly the Company’s interim financial information. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standard setting bodies that are adopted by us as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption. In May 2014, the FASB issued Accounting Standards Update (ASU) 2014-09, Revenue from Contracts with Customers (Topic 606). ASU 2014-09 provides a single, comprehensive revenue recognition model for all contracts with customers. The revenue guidance contains principles that an entity will apply to determine the measurement of revenue and timing of when it is recognized. The underlying principle is that an entity will recognize revenue to depict the transfer of goods or services to customers at an amount that the entity expects to be entitled to in exchange for those goods or services. The standard is effective for the first interim period within annual reporting periods beginning after December 15, 2017 for public entities, with early adoption permitted in the annual reporting period beginning after December 15, 2016. The Company is continuing to evaluate the new guidance and plans to provide additional information about its expected financial impact at a future date. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements-Going Concern. ASU 2014-15 provides guidance around management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. For each reporting period, management will be required to evaluate whether there are conditions or events that raise substantial doubt about a company’s ability to continue as a going concern within one year from the date the financial statements are issued. The new standard is effective for fiscal years and interim periods within those fiscal years, beginning after December 15, 2016. Early adoption is permitted. The Company does not expect the potential impact of adopting this guidance to have a material impact on its financial statements. In July 2015, FASB issued ASU 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory. This update requires entities to measure inventory at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. Subsequent measurement is unchanged for inventory measured using LIFO or the retail inventory method. This ASU is effective for annual reporting periods beginning after December 15, 2016 and interim periods within those years. The Company does not expect the impact of the adoption to have a material effect on its financial statements. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). This standard requires all leases with durations greater than twelve months to be recognized on the balance sheet and is effective for interim and annual reporting periods beginning after December 15, 2018, although early adoption is permitted. The Company is currently in the process of evaluating the impact of the adoption on its financial statements. In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718). This standard makes several modifications to Topic 718 related to the accounting for forfeitures, employer tax withholding on share-based compensation and the financial statement presentation of excess tax benefits or deficiencies. ASU 2016-09 also clarifies the statement of cash flows presentation for certain components of share-based awards. The standard is effective for interim and annual reporting periods beginning after December 15, 2016, although early adoption is permitted. The Company does not expect the impact of the adoption to have a material effect on its financial statements. |
Inventory (Tables) |
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Inventory | Inventory consisted of the following:
(1) Component parts inventory consists of manufactured components of the ILUVIEN applicator. (2) Work-in-process primarily consists of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing as required by regulatory authorities in Europe. |
Intangible Asset (Tables) |
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||
Intangible Assets, Net (Excluding Goodwill) [Abstract] | |||||||||||||||||||||||||||||||||||||||||
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | The estimated future amortization expense as of September 30, 2016 for the remainder of 2016, the next four years and thereafter is as follows (in thousands):
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Accrued Expenses (Tables) |
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Payables and Accruals [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Accrued Expenses | Accrued expenses consisted of the following:
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Loss Per Share (EPS) (Tables) |
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of antidilutive securities excluded from computation of earnings per share | Common stock equivalent securities that would potentially dilute basic EPS in the future, but were not included in the computation of diluted EPS because to do so would have been anti-dilutive, were as follows:
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Stock Incentive Plans (Tables) |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of stock option transactions | The following table presents a summary of stock option activity for the three and nine months ended September 30, 2016 and 2015:
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Summary of additional stock option transactions | The following table provides additional information related to outstanding stock options, exercisable stock options and stock options expected to vest as of September 30, 2016:
The following table provides additional information related to outstanding stock options, exercisable stock options and stock options expected to vest as of December 31, 2015:
|
Fair Value (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assets Measured at Fair Value on Recurring Basis | The following fair value table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis:
|
Segment Information (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Reporting Segments | The following table presents a summary of the Company's reporting segments for the three months ended September 30, 2016 and 2015:
The following table presents a summary of the Company's reporting segments for the nine months ended September 30, 2016 and 2015:
|
Nature of Operations (Detail) - ILUVIEN |
9 Months Ended |
---|---|
Sep. 30, 2016
Patient
| |
Nature Of Operations [Line Items] | |
Post-authorization open study period | 5 years |
Planned drug study, number of patients | 800 |
Number of patients enrolled (more than) | 430 |
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Dec. 31, 2015 |
|
Accounting Policies [Abstract] | |||||
Allowance for doubtful accounts receivable | $ 26 | $ 26 | $ 118 | ||
Research and development expense | $ 1,567 | $ 940 | $ 4,438 | $ 1,958 |
Factors Affecting Operations (Detail) - USD ($) $ in Thousands |
Sep. 30, 2016 |
Dec. 31, 2015 |
Sep. 30, 2015 |
Dec. 31, 2014 |
---|---|---|---|---|
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Accumulated deficit | $ 371,146 | $ 343,900 | ||
Cash and cash equivalents | $ 33,853 | $ 31,075 | $ 39,340 | $ 76,697 |
Inventory (Detail) - USD ($) $ in Thousands |
Sep. 30, 2016 |
Dec. 31, 2015 |
|||||
---|---|---|---|---|---|---|---|
Inventory net realizable value | |||||||
Component parts | [1] | $ 172 | $ 131 | ||||
Work-in-process | [2] | 214 | 333 | ||||
Finished goods | 566 | 1,525 | |||||
Total inventory | 952 | 1,989 | |||||
Inventory reserve | (39) | (437) | |||||
Inventory — net | $ 913 | $ 1,552 | |||||
|
Intangible Asset - Narrative (Details) - USD ($) |
1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
---|---|---|---|---|---|---|---|
Oct. 31, 2014 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Dec. 31, 2015 |
Aug. 31, 2014 |
|
Finite-Lived Intangible Assets [Line Items] | |||||||
Net intangible assets | $ 21,093,000 | $ 21,093,000 | $ 22,549,000 | $ 0 | |||
License | |||||||
Finite-Lived Intangible Assets [Line Items] | |||||||
Net intangible assets | 21,093,000 | 21,093,000 | $ 22,549,000 | ||||
Gross intangible assets | 25,000,000 | $ 25,000,000 | |||||
Useful life | 13 years | ||||||
Amortization of intangible assets | $ 489,000 | $ 489,000 | $ 1,457,000 | $ 1,451,000 | |||
pSivida | |||||||
Finite-Lived Intangible Assets [Line Items] | |||||||
Milestone payment after the first product approved by the FDA | $ 25,000,000 |
Intangible Asset - Future Amortization (Details) - USD ($) |
Sep. 30, 2016 |
Dec. 31, 2015 |
Aug. 31, 2014 |
---|---|---|---|
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | |||
Total | $ 21,093,000 | $ 22,549,000 | $ 0 |
License | |||
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | |||
2016 | 489,000 | ||
2017 | 1,940,000 | ||
2018 | 1,940,000 | ||
2019 | 1,940,000 | ||
2020 | 1,940,000 | ||
Thereafter | 12,844,000 | ||
Total | $ 21,093,000 | $ 22,549,000 |
Accrued Expenses - Summary of Accrued Expenses (Detail) - USD ($) $ in Thousands |
Sep. 30, 2016 |
Dec. 31, 2015 |
---|---|---|
Summary of accrued expenses | ||
Accrued compensation expenses | $ 1,561 | $ 804 |
Accrued clinical investigator expenses | 1,092 | 732 |
Accrued rebate and other revenue reserves | 724 | 452 |
Accrued End of Term Payment (Note 9) | 0 | 1,050 |
Other accrued expenses | 792 | 873 |
Total accrued expenses | $ 4,169 | $ 3,911 |
License Agreements (Detail) - pSivida - USD ($) |
1 Months Ended | 9 Months Ended | 12 Months Ended | |
---|---|---|---|---|
Oct. 31, 2014 |
Sep. 30, 2016 |
Dec. 31, 2014 |
Dec. 31, 2015 |
|
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Minimum days to require to revert license in case of breaches of contract | 30 days | |||
Maximum days to require to revert license in case of breaches of contract | 90 days | |||
Period of bankruptcy petition proceedings remains undismissed | 60 days | |||
Additional milestone payment after the first product approved by the FDA | $ 25,000,000 | |||
Share of net profits | 20.00% | |||
Share of any lump sum milestone payments received from a sub-licensee of ILUVIEN | 33.00% | |||
Recovery of commercialization costs | 20.00% | |||
Commercialization costs receivable | $ 25,239,000 | $ 12,956,000 | $ 21,565,000 | |
Commercialization costs receivable disputed by licensor | 1,290,000 | |||
Incremental profit sharing payments claimed | $ 136,000 | |||
Commercialization costs receivable post report | $ 20,931,000 | $ 18,504,000 |
Common Stock (Detail) - USD ($) |
1 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Aug. 31, 2016 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2014 |
|
Class of Stock [Line Items] | ||||
Maximum value of common stock to be sold | $ 35,000,000.0 | |||
Proceeds from sale of common stock | $ 27,547,000 | $ 42,000 | ||
Payment of stock issuance cost | $ 1,227,000 | $ 0 | ||
Private placement | Common stock | ||||
Class of Stock [Line Items] | ||||
Issuance of stock (in shares) | 662,779 | |||
Share purchase price of shares issued (in dollars per share) | $ 1.83 | |||
Proceeds from sale of common stock | $ 1,211,000 | |||
Payment of stock issuance cost | $ 62,000 | |||
Public Offering | Common stock | ||||
Class of Stock [Line Items] | ||||
Issuance of stock (in shares) | 18,900,000 | |||
Share purchase price of shares issued (in dollars per share) | $ 1.40 | |||
Proceeds from sale of common stock | $ 26,460,000 | |||
Payment of stock issuance cost | $ 1,309,000 | |||
Employee Stock | Common stock | ||||
Class of Stock [Line Items] | ||||
Issuance of stock (in shares) | 41,413 | 10,993 | ||
Proceeds from sale of common stock | $ 78,000 | $ 42,000 |
Stock Incentive Plans - Additional Information (Detail) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | 12 Months Ended | ||
---|---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Dec. 31, 2015 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted average contractual term | 5 years 5 months 15 days | 5 years 10 months 13 days | |||
Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based compensation expense | $ 1,116 | $ 1,355 | $ 3,683 | $ 3,623 | |
Share-based compensation not yet recognized | 9,448 | $ 9,448 | |||
Weighted average contractual term | 2 years 6 months 25 days | ||||
Employee Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based compensation expense | $ 18 | $ 38 | $ 69 | $ 79 |
Stock Incentive Plans - Summary of Stock Option Transactions (Detail) - $ / shares |
3 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Dec. 31, 2015 |
|
Options | |||||
Options outstanding at beginning of period (in shares) | 10,648,702 | 9,292,947 | 9,475,890 | 7,681,256 | |
Grants (in shares) | 749,250 | 69,000 | 2,169,750 | 1,902,500 | |
Forfeitures (in shares) | (114,837) | (200,260) | (313,297) | (349,645) | |
Exercises (in shares) | (51,471) | (66,971) | (100,699) | (139,395) | |
Options outstanding at year end (in shares) | 11,231,644 | 9,094,716 | 11,231,644 | 9,094,716 | |
Options exercisable at year end (in shares) | 7,116,615 | 5,510,064 | 7,116,615 | 5,510,064 | 5,808,528 |
Weighted average per share fair value of options granted during the period (in dollars per share) | $ 1.17 | $ 3.37 | $ 1.56 | $ 4.19 | |
Weighted Average Exercise Price | |||||
Options outstanding at beginning of period (in dollars per share) | 3.30 | 3.49 | 3.43 | 3.03 | |
Grants (in dollars per share) | 1.53 | 4.39 | 2.06 | 5.38 | |
Forfeitures (in dollars per share) | 4.03 | 5.25 | 3.44 | 4.84 | |
Exercises (in dollars per share) | 1.33 | 2.09 | 1.56 | 1.99 | |
Options outstanding at year end (in dollars per share) | 3.18 | 3.47 | 3.18 | 3.47 | |
Options exercisable at year end (in dollars per share) | $ 3.26 | $ 3.19 | $ 3.26 | $ 3.19 | $ 3.27 |
Income Taxes (Detail) $ in Thousands |
Dec. 31, 2015
USD ($)
|
---|---|
Operating Loss Carryforwards [Line Items] | |
Cumulative book losses in foreign subsidiaries | $ 67,452 |
Federal | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carry-forwards | 100,835 |
State | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carry-forwards | $ 78,762 |
Fair Value (Detail) - Recurring basis - USD ($) $ in Thousands |
Sep. 30, 2016 |
Dec. 31, 2015 |
|||||
---|---|---|---|---|---|---|---|
Assets: | |||||||
Cash equivalents | [1] | $ 0 | $ 1,010 | ||||
Assets measured at fair value | 0 | 1,010 | |||||
Liabilities: | |||||||
Derivative warrant liability | [2] | 1,060 | 2,815 | ||||
Liabilities measured at fair value | 1,060 | 2,815 | |||||
Level 1 | |||||||
Assets: | |||||||
Cash equivalents | [1] | 0 | 1,010 | ||||
Assets measured at fair value | 0 | 1,010 | |||||
Liabilities: | |||||||
Derivative warrant liability | [2] | 0 | 0 | ||||
Liabilities measured at fair value | 0 | 0 | |||||
Level 2 | |||||||
Assets: | |||||||
Cash equivalents | [1] | 0 | 0 | ||||
Assets measured at fair value | 0 | 0 | |||||
Liabilities: | |||||||
Derivative warrant liability | [2] | 1,060 | 2,815 | ||||
Liabilities measured at fair value | 1,060 | 2,815 | |||||
Level 3 | |||||||
Assets: | |||||||
Cash equivalents | [1] | 0 | 0 | ||||
Assets measured at fair value | 0 | 0 | |||||
Liabilities: | |||||||
Derivative warrant liability | [2] | 0 | 0 | ||||
Liabilities measured at fair value | $ 0 | $ 0 | |||||
|
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