|
|
|
|
|
|
x
|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
¨
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
|
|
Delaware
|
|
20-0028718
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification Number)
|
Common Stock, $0.01 par value per share
|
|
The NASDAQ Stock Market LLC
|
(Title of each class)
|
|
(Name of each exchange on which registered)
|
|
|
|
Large accelerated filer
|
o
|
|
Accelerated filer
|
o
|
|
|
|
|
|
Non-accelerated filer
|
o
|
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
x
|
|
|
|
|
|
Page
|
|
|
|
|
Special
Note Regarding Forward-Looking Statements
and Projections
|
|
Item 1.
|
||
Item 1A.
|
||
Item 1B.
|
||
Item 2.
|
||
Item 3.
|
||
Item 4.
|
||
|
|
|
|
|
|
Item 5.
|
||
Item 6.
|
||
Item 7.
|
||
Item 7A.
|
||
Item 8.
|
||
Item 9.
|
||
Item 9A.
|
||
Item 9B.
|
||
|
|
|
|
|
|
Item 10.
|
||
Item 11.
|
||
Item 12.
|
||
Item 13.
|
||
Item 14.
|
||
|
|
|
|
|
|
Item 15.
|
||
Item 16.
|
||
|
||
|
||
|
•
|
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.
|
•
|
Maximize the Commercial Success of ILUVIEN.
We 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. We have approval in 14 additional countries in the EEA and we are pursuing opportunities to sell ILUVIEN in some of these countries, including Austria and Ireland. In Italy, our distributor plans to launch ILUVIEN in 2017. In addition, outside the EEA, our distributor launched in the Middle East and began selling ILUVIEN in the United Arab Emirates in the second half of 2016.
|
•
|
Pursue Approval in Additional Countries
. We plan to pursue regulatory approval for ILUVIEN, directly or with a partner, in other countries. In addition to the distribution agreements for the Middle East and Italy, we entered into agreements to distribute ILUVIEN in Australia, New Zealand and Canada. Pursuant to these agreements, our distributors will assist us in obtaining approval or seek approval with our oversight in those countries. In addition,
|
•
|
Assess the Effectiveness of ILUVIEN for Additional Retinal Diseases
. We believe that ILUVIEN has the potential to address additional retinal diseases including, among others, Non-Proliferative Diabetic Retinopathy (NPDR), retinal vein occlusion (RVO), dry aged-related macular degeneration (AMD) and wet AMD.
|
•
|
Expand Our Ophthalmic Product Pipeline.
We believe there are further unmet medical needs in the treatment of ophthalmic diseases. Toward that end, we intend to evaluate in-licensing and acquisition opportunities for compounds and technologies with potential treatment applications for diseases affecting the eye.
|
•
|
ILUVIEN delivers FAc.
The active pharmaceutical ingredient in ILUVIEN is FAc, which has demonstrated efficacy in the treatment of DME in clinician
’
s real world experience and in the two completed Phase 3 pivotal clinical trials, collectively referred to as our FAME Study, over multiple years.
|
•
|
ILUVIEN delivers a continuous daily microdose of steroid to the eye.
The delivery mechanism of ILUVIEN provides lower daily and aggregate exposure to corticosteroids than other intraocular dosage forms currently available. ILUVIEN has shown to provide sustained sub-microgram levels of FAc through in vitro release kinetics and in vivo over time. The results of our FAME Study demonstrated that ILUVIEN provides a sustained, therapeutic effect in the treatment of DME patients for up to 36 months.
|
•
|
Macular edema associated with RVO.
According to GlobalData, a provider of global business intelligence, there are 16 million adults affected with RVO around the world. In September 2009, Allergan, Inc. (Allergan) introduced Ozurdex (a short duration corticosteroid) as the first approved product for macular edema following branch or RVO. The U.S. Food and Drug Administration
’
s (FDA) approval of Ozurdex provides additional evidence that corticosteroids work effectively to treat RVO.
|
•
|
Moderately severe to severe NPDR progression to proliferative diabetic retinopathy (PDR)
. NPDR is the most at-risk stage of diabetic retinopathy for risk of progression to PDR. Prevention of progression to PDR is clinically important as the risk of severe vision loss, blindness and retinal detachment increase when diabetic retinopathy progresses from NPDR to PDR.
|
•
|
Dry AMD.
Dry AMD patients account for 90% of AMD patients, with the greatest unmet need among these patients being a treatment for geographic atrophy (GA) for which there are currently no treatments available. Pre-clinical studies in two established rat models of retinal degeneration reported at the Association for Research in Vision and Ophthalmology meetings in 2006, 2007 and 2008, described the efficacious effects of a miniaturized version of ILUVIEN in retinal degeneration. While there are no standard preclinical models of GA, we believe these results support the exploration of ILUVIEN to treat this condition.
|
•
|
Wet AMD.
The size of the wet AMD market was $2 billion in 2008 according to VisionGain, an independent competitive intelligence organization. According to American Academy of Ophthalmology, more than 11 million people in America are affected by AMD and are now benefiting from advanced treatment options such as anti-VEGF agents and photodynamic therapy (PDT). Anti-VEGF antibodies require persistent dosing to maintain a therapeutic effect which is a burden on both the patient and the physician. Estimates as of March 2015 of the global cost of visual impairment due to AMD is $343 billion, including $255 billion in direct health care costs according to BrightFocus Foundation. We believe ILUVIEN has the potential to be synergistic with the market leading anti-VEGF antibody therapies in the treatment of wet AMD given that corticosteroids have been shown to suppress the production of VEGF.
|
•
|
Roche’s products Lucentis (ranibizumab injection) and Avastin (bevacizumab) are both antibodies that inhibit VEGF signaling pathways. Lucentis is marketed in the EEA by Novartis. Lucentis is currently approved for the treatment of DME, the treatment of diabetic retinopathy in patients with DME, the treatment of neovascular wet AMD and the treatment of macular edema following RVO in the U.S. In the EEA, the indications are similar except for the indication to treat diabetic retinopathy in patients with DME. Avastin, an oncology product, is used by retinal specialists in both the U.S. and in certain countries of the EEA in the treatment of numerous retinal diseases off label but is not formulated or approved for any ophthalmic use.
|
•
|
Regeneron
’
s Eylea (aflibercept), an anti-VEGF inhibitor, is approved for the treatment of DME, the treatment of diabetic retinopathy in patients with DME, neovascular wet AMD and RVO in the U.S. As with Lucentis, in the EEA, the indication does not include diabetic retinopathy. Eylea is marketed in the EEA by Bayer.
|
•
|
Allergan’s product Ozurdex (dexamethasone intravitreal implant), is a short duration biodegradable implant that delivers the corticosteroid dexamethasone. Ozurdex is approved for the treatment of DME, macular edema following branch or central RVO and non-infectious uveitis affecting the posterior segment of the eye in the U.S. In the EEA, the indication for DME is for visual impairment due to diabetic macular oedema who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.
|
•
|
cost of treatment;
|
•
|
pricing and availability of alternative products;
|
•
|
our ability to obtain third-party coverage or reimbursement for ILUVIEN at appropriate levels;
|
•
|
perceived prevalence and severity of adverse side effects associated with treatment;
|
•
|
perceived efficacy relative to other available therapies;
|
•
|
relative convenience and ease of administration; and
|
•
|
shifts in the medical community to new treatment paradigms or standards of care.
|
•
|
the level of success of the commercialization of ILUVIEN in the U.S., Germany, Portugal, the United Kingdom and any other territories we may launch in,
|
•
|
expenses relating to the commercialization of ILUVIEN;
|
•
|
the level of success of the commercialization of ILUVIEN by our distributors in Italy and the Middle East;
|
•
|
the timing of approvals, if any, of ILUVIEN in additional jurisdictions;
|
•
|
the extent to which we enter into, maintain, and derive revenues from licensing agreements, including agreements to out-license ILUVIEN, research and other collaborations, joint ventures and other business arrangements;
|
•
|
the amount of our research, development and medical affairs, marketing and general and administrative expenses;
|
•
|
the need and cost of conducting additional clinical trials for ILUVIEN;
|
•
|
the extent to which we acquire, and our success in integrating, technologies or companies;
|
•
|
regulatory changes and technological developments in our markets; and
|
•
|
the extent to which we can manage the use of cash in our business operations.
|
•
|
extended collection timelines for accounts receivable and greater working capital requirements;
|
•
|
multiple legal systems and unexpected changes in legal requirements;
|
•
|
tariffs, export restrictions, trade barriers and other regulatory or contractual limitations on our ability to sell or develop our products in certain foreign markets;
|
•
|
trade laws and business practices favoring local competition;
|
•
|
potential tax issues, including restrictions on repatriating earnings, multiple and conflicting and complex tax laws and regulations;
|
•
|
weaker intellectual property protection in some countries;
|
•
|
political instability, including war and terrorism or the threat of war and terrorism; and
|
•
|
adverse economic conditions, including the stability and solvency of business financial markets, financial institutions and sovereign nations.
|
•
|
our inability to recruit and retain adequate numbers of effective personnel;
|
•
|
the inability of sales personnel to obtain access to or persuade adequate numbers of ophthalmologists to prescribe our products;
|
•
|
the lack of complementary products or additional labeled indications for ILUVIEN to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines;
|
•
|
the inability of market access personnel to obtain sufficient levels of pricing and reimbursement in each jurisdiction; and
|
•
|
unforeseen costs and expenses associated with creating a commercial organization.
|
•
|
regulatory agencies may interpret data from preclinical and clinical testing in different ways from those which we do;
|
•
|
they may not approve of our manufacturing processes;
|
•
|
a drug candidate may not be safe or effective;
|
•
|
they may conclude that the drug candidate does not meet quality standards for stability, quality, purity and potency; and
|
•
|
they may change their approval policies or adopt new regulations.
|
•
|
the commercial success of ILUVIEN;
|
•
|
timing and ordering patterns from our distributors;
|
•
|
our ability to obtain regulatory approval of ILUVIEN in additional jurisdictions;
|
•
|
sales, marketing and medical affairs expenses;
|
•
|
manufacturing or supply issues;
|
•
|
seasonality caused by insurance renewals for patients in the U.S., and by doctor and or patient absences due to holidays and vacations;
|
•
|
regulatory developments affecting ILUVIEN, our future product candidates or our competitors’ products;
|
•
|
the emergence of products that compete with ILUVIEN;
|
•
|
cost of product sales;
|
•
|
variations in the level of expenses related to our products or future development programs;
|
•
|
the timing and amount of royalties, milestone payments, or product purchases by our distributors;
|
•
|
the status of our preclinical and clinical development programs;
|
•
|
our execution of collaborative, licensing or other arrangements, and the timing of payments we may make or receive under these arrangements;
|
•
|
any intellectual property infringement or other lawsuit in which we may become involved; and
|
•
|
the timing and recognition of stock-based compensation expense.
|
•
|
are more effective;
|
•
|
receive better reimbursement terms;
|
•
|
are more accepted by physicians;
|
•
|
have fewer or less severe adverse side effects;
|
•
|
are better tolerated;
|
•
|
are more adaptable to various modes of dosing;
|
•
|
have better distribution channels;
|
•
|
are easier to administer; or
|
•
|
are less expensive, including but not limited to a generic version of ILUVIEN.
|
•
|
our collaboration agreements are expected to be for fixed terms and subject to termination under various circumstances, including, in many cases, on short notice without cause;
|
•
|
our collaborators may not promote and market our drugs in the manner we would or as well as we would if we had the resources to do so in their countries;
|
•
|
our collaborators may change the focus of their development and commercialization efforts. In recent years there have been a significant number of mergers and consolidations in the pharmaceutical and biotechnology industries, some of which have resulted in the participant companies reevaluating and shifting the focus of their business following the completion of these transactions. The ability of our products to reach their potential could be limited if any of our future collaborators decreases or fails to increase spending relating to such products
|
•
|
our collaboration agreements will likely require us to not conduct specified types of research and development in the field that is the subject of the collaboration. These agreements may have the effect of limiting the areas of research and development that we may pursue, either alone or in cooperation with third-parties;
|
•
|
our collaborators may develop and commercialize, either alone or with others, products and services that are similar to or competitive with our products which are the subject of their collaboration with us.
|
•
|
the research methodology used may not be successful in identifying potential products or product candidates; or
|
•
|
potential products or product candidates may on further study be shown to have harmful side effects or other characteristics that indicate they are unlikely to be effective drugs.
|
•
|
we may be unable to license or acquire the relevant technology on terms that would allow us to make an appropriate return from the product;
|
•
|
companies that perceive us to be their competitors may be unwilling to assign or license their product rights to us; or
|
•
|
we may be unable to identify suitable products or product candidates within our areas of expertise.
|
•
|
our inability to manufacture or obtain from third-parties materials sufficient for use in preclinical studies and clinical trials;
|
•
|
delays in patient enrollment and variability in the number and types of patients available for clinical trials;
|
•
|
difficulty in maintaining contact with patients after treatment, resulting in incomplete data;
|
•
|
poor effectiveness of product candidates during clinical trials;
|
•
|
unforeseen safety issues or side effects; and
|
•
|
governmental or regulatory delays and changes in regulatory requirements and guidelines.
|
•
|
failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
|
•
|
inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;
|
•
|
unforeseen safety issues or any determination that a trial presents unacceptable health risks; and
|
•
|
lack of adequate funding to continue the clinical trial, including the incurrence of unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our contract research organizations, and other third parties.
|
•
|
our ability to successfully commercialize ILUVIEN in the U.S., Germany, Portugal and the United Kingdom;
|
•
|
the ability of ILUVIEN to be approved in any additional jurisdiction;
|
•
|
the ability of ILUVIEN or any future products or product candidates, if approved in additional jurisdictions, to achieve and maintain commercial success;
|
•
|
FDA or international regulatory actions, including failure to receive or maintain regulatory approval for ILUVIEN or any future products or product candidates;
|
•
|
quarterly variations in our results of operations or those of our competitors;
|
•
|
announcements by us or our competitors of acquisitions, regulatory approvals, clinical milestones, new products, significant contracts, commercial relationships or capital commitments;
|
•
|
third-party coverage and reimbursement policies;
|
•
|
our ability to meet our repayment and other obligations under our loan agreements;
|
•
|
additions or departures of key personnel;
|
•
|
commencement of, or our involvement in, litigation;
|
•
|
changes in governmental regulations or in the status of our regulatory approvals;
|
•
|
changes in earnings estimates or recommendations by securities analysts;
|
•
|
any major change in our board of directors or management;
|
•
|
results from our clinical trial programs;
|
•
|
our ability to develop and market new and enhanced products or product candidates on a timely basis;
|
•
|
general economic conditions and slow or negative growth of our markets; and
|
•
|
political instability, natural disasters, war and/or events of terrorism.
|
•
|
increase or decrease the authorized number of shares of Series A Convertible Preferred Stock;
|
•
|
authorize, create, issue or obligate us to issue (by reclassification, merger or otherwise) any security (or any class or series thereof) or any indebtedness, in each case that has any rights, preferences or privileges senior to, or on a parity with, the Series A Convertible Preferred Stock, or any security convertible into or exercisable for any such security or indebtedness, subject to limited exceptions for certain debt transactions;
|
•
|
amend our certificate of incorporation or the certificate of designation of the Series A Convertible Preferred Stock, in each case in a manner that adversely affects the rights, preference or privileges of the Series A Convertible Preferred Stock;
|
•
|
redeem, purchase or otherwise acquire (or pay into or set aside for a sinking fund for such purpose) any shares of common stock or preferred stock; provided, however, that this restriction shall not apply to (A) the redemption of rights issued pursuant to any “poison pill” rights plan or similar plan adopted by us after the closing of the Series A Convertible Preferred Stock financing or (B) the repurchases of stock from former employees, officers, directors or consultants who performed services for us in connection with the cessation of such employment or service pursuant to the terms of existing agreements with such individuals;
|
•
|
declare or pay any dividend or distribution on any shares of capital stock; provided, however, that this restriction shall not apply to (A) dividends payable to holders of common stock that consist solely of shares of common stock for which adjustment to the conversion price of the Series A Convertible Preferred Stock is made pursuant to the certificate of designation or (B) dividends or distributions issued pro rata to all holders of capital stock (on an as-converted basis) in connection with the implementation of a “poison pill” rights plan or similar plan by us;
|
•
|
authorize or approve any increase to the number of aggregate shares of capital stock reserved for issuance pursuant to stock option, stock purchase plans or other equity incentive plans such that the total aggregate number of shares issued under such plans and reserved for issuance under such plans (on an as-converted basis) exceeds the number of shares issued and reserved for issuance under such plans (on an as-converted basis) on the date of the closing of the Series A Convertible Preferred Stock financing by more than 20% (as adjusted for stock splits, combinations, stock dividends, recapitalizations and the like), provided that any increases resulting solely from the annual increases resulting from the “evergreen” provisions of equity incentive plans in effect on the date of the closing of the Series A Convertible Preferred Stock financing shall not be subject to this restriction and shall not be included for purposes of determining whether such 20% increase has occurred; or
|
•
|
issue stock or other equity securities of any subsidiary (other than to us or another of our wholly-owned subsidiaries or declare or pay any dividend or other distribution of cash, shares or other assets or redemption or repurchase of shares of any subsidiary; or (viii) incur any secured indebtedness other than certain limited debt transactions. There is no guarantee that the holders of the Series A Convertible Preferred Stock would approve any such restricted action, even where such an action would be in the best interests of our stockholders. Any failure to obtain such approval could harm our business and result in a decrease in the value of our common stock.
|
•
|
authorize the issuance of “blank check” preferred stock that could be issued by our Board of Directors to thwart a takeover attempt;
|
•
|
do not provide for cumulative voting in the election of directors, which would allow holders of less than a majority of our outstanding common stock to elect some directors;
|
•
|
establish a classified Board of Directors, as a result of which the successors to the directors whose terms have expired will be elected to serve from the time of election and qualification until the third annual meeting following their election;
|
•
|
require that directors only be removed from office for cause;
|
•
|
provide that vacancies on the Board of Directors, including newly created directorships, may be filled only by a majority vote of directors then in office;
|
•
|
contain certain protective provisions in favor of the holders of Series A Convertible Preferred Stock;
|
•
|
limit who may call special meetings of stockholders;
|
•
|
prohibit common stockholder action by written consent, requiring all actions of the holders of common stock to be taken at a meeting of the stockholders; and
|
•
|
establish advance notice requirements for nominating candidates for election to the Board of Directors or for proposing matters that can be acted upon by stockholders at stockholder meetings.
|
Year Ended December 31, 2016
|
High
|
|
Low
|
||||
First quarter 2016
|
$
|
2.75
|
|
|
$
|
1.49
|
|
Second quarter 2016
|
$
|
5.15
|
|
|
$
|
1.21
|
|
Third quarter 2016
|
$
|
2.40
|
|
|
$
|
1.01
|
|
Fourth quarter 2016
|
$
|
1.54
|
|
|
$
|
1.03
|
|
Year Ended December 31, 2015
|
High
|
|
Low
|
||||
First quarter 2015
|
$
|
5.92
|
|
|
$
|
4.12
|
|
Second quarter 2015
|
$
|
5.18
|
|
|
$
|
3.98
|
|
Third quarter 2015
|
$
|
5.03
|
|
|
$
|
1.94
|
|
Fourth quarter 2015
|
$
|
3.45
|
|
|
$
|
2.00
|
|
•
|
continue the commercialization of ILUVIEN in the U.S. and EEA and through our distributor, in the Middle East;
|
•
|
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.
|
•
|
salaries and related expenses for personnel, including medical sales liaisons;
|
•
|
costs related to the provision of medical affairs support, including symposia development for physician education;
|
•
|
costs related to compliance with FDA, EEA or other regulatory requirements;
|
•
|
fees paid to consultants and contract research organizations (CRO) in conjunction with independently monitoring clinical trials and acquiring and evaluating data in conjunction with clinical trials, including all related fees such as investigator grants, patient screening, lab work and data compilation and statistical analysis;
|
•
|
costs incurred with third parties related to the establishment of a commercially viable manufacturing process for products or product candidates;
|
•
|
costs related to production of clinical materials, including fees paid to contract manufacturers;
|
•
|
costs related to post marketing authorization studies;
|
•
|
consulting fees paid to third-parties involved in research and development activities; and
|
•
|
costs related to stock options or other stock-based compensation granted to personnel in development functions.
|
|
Years Ended
December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(In thousands)
|
||||||
NET REVENUE
|
$
|
25,765
|
|
|
$
|
15,170
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(1,694
|
)
|
|
(792
|
)
|
||
GROSS PROFIT
|
24,071
|
|
|
14,378
|
|
||
|
|
|
|
||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
7,875
|
|
|
9,712
|
|
||
GENERAL AND ADMINISTRATIVE EXPENSES
|
9,316
|
|
|
8,244
|
|
||
SALES AND MARKETING EXPENSES
|
22,134
|
|
|
19,777
|
|
||
DEPRECIATION AND AMORTIZATION
|
2,678
|
|
|
2,491
|
|
||
OPERATING EXPENSES
|
42,003
|
|
|
40,224
|
|
||
NET LOSS FROM OPERATIONS
|
$
|
(17,932
|
)
|
|
$
|
(25,846
|
)
|
|
Years Ended
December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(In thousands)
|
||||||
NET REVENUE
|
$
|
8,568
|
|
|
$
|
7,268
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(650
|
)
|
|
(970
|
)
|
||
GROSS PROFIT
|
7,918
|
|
|
6,298
|
|
||
|
|
|
|
||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
4,500
|
|
|
5,128
|
|
||
GENERAL AND ADMINISTRATIVE EXPENSES
|
5,947
|
|
|
5,946
|
|
||
SALES AND MARKETING EXPENSES
|
7,297
|
|
|
8,313
|
|
||
DEPRECIATION AND AMORTIZATION
|
89
|
|
|
64
|
|
||
OPERATING EXPENSES
|
17,833
|
|
|
19,451
|
|
||
NET LOSS FROM OPERATIONS
|
$
|
(9,915
|
)
|
|
$
|
(13,153
|
)
|
|
Years Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(In thousands)
|
||||||
NET LOSS FROM OPERATIONS
|
$
|
(27,847
|
)
|
|
$
|
(38,999
|
)
|
|
|
|
|
||||
INTEREST EXPENSE AND OTHER
|
(5,178
|
)
|
|
(4,693
|
)
|
||
UNREALIZED FOREIGN CURRENCY LOSS, NET
|
(40
|
)
|
|
(106
|
)
|
||
LOSS ON EARLY EXTINGUISHMENT OF DEBT
|
(2,564
|
)
|
|
—
|
|
||
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY
|
2,627
|
|
|
13,283
|
|
||
NET LOSS BEFORE TAXES
|
(33,002
|
)
|
|
(30,515
|
)
|
||
PROVISION FOR TAXES
|
(172
|
)
|
|
(130
|
)
|
||
NET LOSS
|
$
|
(33,174
|
)
|
|
$
|
(30,645
|
)
|
•
|
pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets;
|
•
|
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
|
•
|
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on our financial statements.
|
|
A
|
|
B
|
|
C
|
|
||||
|
Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants, and Rights
|
|
Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights
|
|
Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in Column (A))
|
|
||||
Plan Category
|
|
|||||||||
Equity compensation plans approved by security holders
|
10,804,412
|
|
(1)
|
$
|
3.22
|
|
|
1,080,492
|
|
(2)
|
Equity compensation plans not approved by security holders
|
—
|
|
|
—
|
|
|
—
|
|
|
|
Total
|
10,804,412
|
|
|
$
|
3.22
|
|
|
1,080,492
|
|
|
(1)
|
Of these shares, 9,736,130 were subject to options then outstanding under the 2010 Plan, 65,072 were subject to options then outstanding under the 2005 Plan and 1,003,210 were subject to options then outstanding under the 2004 Plan.
|
(2)
|
Represents 668,830 shares of common stock available for issuance under our 2010 Plan and 411,662 shares of common stock available for issuance under our ESPP. No shares are available for future issuance under the 2005 Plan or 2004 Plan. In addition, our 2010 Plan provides for annual increases in the number of shares available for issuance thereunder on the first day of each fiscal year equal to the least of: (1) 2,000,000 shares of our common stock; (2) 4% of the shares of common stock outstanding at that time; and (3) such other amount as our board of directors may determine. On January 1, 2017, an additional 2,000,000 shares became available for future issuance under our 2010 Plan in accordance with the annual increase. In addition, our ESPP provides for annual increases in the number of shares available for issuance thereunder equal to such number of shares necessary to restore the number of shares reserved thereunder to 494,422 shares of our common stock. As such, on January 1, 2017, an additional 82,760 shares became available for future issuance under our ESPP. These additional shares from the annual increase under the 2010 Plan and the ESPP are not included in the table above.
|
|
ALIMERA SCIENCES, INC.
|
|
|
|
|
|
By:
|
/s/ C. Daniel Myers
|
|
|
Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ C. Daniel Myers
|
|
Chief Executive Officer and Director
(Principal Executive Officer)
|
|
March 3, 2017
|
C. Daniel Myers
|
|
|
|
|
|
|
|
|
|
/s/ Richard S. Eiswirth, Jr.
|
|
President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
|
|
March 3, 2017
|
Richard S. Eiswirth, Jr.
|
|
|
|
|
|
|
|
|
|
/s/ James R. Largent
|
|
Chairman of the Board of Directors
|
|
March 3, 2017
|
James R. Largent
|
|
|
|
|
|
|
|
|
|
/s/ Glen Bradley, Ph.D.
|
|
Director
|
|
March 3, 2017
|
Glen Bradley, Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/ Mark J. Brooks
|
|
Director
|
|
March 3, 2017
|
Mark J. Brooks
|
|
|
|
|
|
|
|
|
|
/s/ Brian K. Halak, Ph.D.
|
|
Director
|
|
March 3, 2017
|
Brian K. Halak, Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/ Garheng Kong, M.D., Ph.D.
|
|
Director
|
|
March 3, 2017
|
Garheng Kong, M.D., Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/ Peter J. Pizzo, III
|
|
Director
|
|
March 3, 2017
|
Peter J. Pizzo, III
|
|
|
|
|
|
|
|
|
|
/s/ Calvin W. Roberts, M.D.
|
|
Director
|
|
March 3, 2017
|
Calvin W. Roberts, M.D.
|
|
|
|
|
|
Page
|
Consolidated Financial Statements as of December 31, 2016 and 2015 and for the years ended December 31, 2016 and 2015:
|
|
Consolidated
Balance Sheets
|
|
Consolidated
Statements of Operations
|
|
Consolidated
Statements of Cash Flows
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(In thousands, except share and per share data)
|
||||||
CURRENT ASSETS:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
30,979
|
|
|
$
|
31,075
|
|
Restricted cash
|
31
|
|
|
37
|
|
||
Accounts receivable, net
|
13,839
|
|
|
9,799
|
|
||
Prepaid expenses and other current assets
|
2,107
|
|
|
2,696
|
|
||
Inventory, net (Note 4)
|
446
|
|
|
1,552
|
|
||
Total current assets
|
47,402
|
|
|
45,159
|
|
||
NON-CURRENT ASSETS:
|
|
|
|
||||
Property and equipment — at cost less accumulated depreciation
|
1,787
|
|
|
2,553
|
|
||
Intangible asset, net
|
20,604
|
|
|
22,549
|
|
||
Deferred tax asset
|
436
|
|
|
223
|
|
||
TOTAL ASSETS
|
$
|
70,229
|
|
|
$
|
70,484
|
|
CURRENT LIABILITIES:
|
|
|
|
||||
Accounts payable
|
$
|
4,986
|
|
|
$
|
4,002
|
|
Accrued expenses (Note 7)
|
3,758
|
|
|
3,911
|
|
||
Derivative warrant liability
|
188
|
|
|
—
|
|
||
Note payable (Note 9)
|
—
|
|
|
31,786
|
|
||
Capital lease obligations
|
191
|
|
|
234
|
|
||
Total current liabilities
|
9,123
|
|
|
39,933
|
|
||
NON-CURRENT LIABILITIES:
|
|
|
|
||||
Derivative warrant liability
|
—
|
|
|
2,815
|
|
||
Note payable — less current portion (Note 9)
|
33,084
|
|
|
—
|
|
||
Capital lease obligations — less current portion
|
274
|
|
|
582
|
|
||
Other non-current liabilities
|
2,162
|
|
|
834
|
|
||
COMMITMENTS AND CONTINGENCIES (Note 10)
|
|
|
|
|
|
||
STOCKHOLDERS’ EQUITY:
|
|
|
|
||||
Preferred stock, $.01 par value — 10,000,000 shares authorized at December 31, 2016 and 2015:
|
|
|
|
|
|
||
Series A Convertible Preferred Stock, 1,300,000 authorized and 600,000 issued and outstanding at December 31, 2016 and 2015; liquidation preference of $24,000 at December 31, 2016 and 2015
|
19,227
|
|
|
19,227
|
|
||
Series B Convertible Preferred Stock, 8,417 authorized and 8,416.251 issued and outstanding at December 31, 2016 and 2015; liquidation preference of $50,750 at December 31, 2016 and 2015
|
49,568
|
|
|
49,568
|
|
||
Common stock, $.01 par value — 150,000,000 shares authorized, 64,862,904 shares issued and outstanding at December 31, 2016 and 100,000,000 shares authorized 45,005,833 shares issued and outstanding at December 31, 2015
|
649
|
|
|
450
|
|
||
Additional paid-in capital
|
330,781
|
|
|
299,376
|
|
||
Common stock warrants
|
3,707
|
|
|
2,747
|
|
||
Accumulated deficit
|
(377,074
|
)
|
|
(343,900
|
)
|
||
Accumulated other comprehensive loss
|
(1,272
|
)
|
|
(1,148
|
)
|
||
TOTAL STOCKHOLDERS’ EQUITY
|
25,586
|
|
|
26,320
|
|
||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
70,229
|
|
|
$
|
70,484
|
|
|
Years Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(In thousands, except share and per share data)
|
||||||
NET REVENUE
|
$
|
34,333
|
|
|
$
|
22,438
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(2,344
|
)
|
|
(1,762
|
)
|
||
GROSS PROFIT
|
31,989
|
|
|
20,676
|
|
||
|
|
|
|
||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
12,375
|
|
|
14,840
|
|
||
GENERAL AND ADMINISTRATIVE EXPENSES
|
15,263
|
|
|
14,190
|
|
||
SALES AND MARKETING EXPENSES
|
29,431
|
|
|
28,090
|
|
||
DEPRECIATION AND AMORTIZATION
|
2,767
|
|
|
2,555
|
|
||
OPERATING EXPENSES
|
59,836
|
|
|
59,675
|
|
||
NET LOSS FROM OPERATIONS
|
(27,847
|
)
|
|
(38,999
|
)
|
||
|
|
|
|
||||
INTEREST EXPENSE AND OTHER
|
(5,178
|
)
|
|
(4,693
|
)
|
||
UNREALIZED FOREIGN CURRENCY LOSS, NET
|
(40
|
)
|
|
(106
|
)
|
||
LOSS ON EARLY EXTINGUISHMENT OF DEBT
|
(2,564
|
)
|
|
—
|
|
||
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY
|
2,627
|
|
|
13,283
|
|
||
NET LOSS BEFORE TAXES
|
(33,002
|
)
|
|
(30,515
|
)
|
||
PROVISION FOR TAXES
|
(172
|
)
|
|
(130
|
)
|
||
NET LOSS
|
$
|
(33,174
|
)
|
|
$
|
(30,645
|
)
|
NET LOSS PER SHARE — Basic and diluted
|
$
|
(0.63
|
)
|
|
$
|
(0.69
|
)
|
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted
|
52,801,603
|
|
|
44,450,216
|
|
|
Years Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(In thousands)
|
||||||
NET LOSS
|
$
|
(33,174
|
)
|
|
$
|
(30,645
|
)
|
|
|
|
|
||||
OTHER COMPREHENSIVE LOSS
|
|
|
|
||||
Foreign currency translation adjustments
|
(124
|
)
|
|
(336
|
)
|
||
TOTAL OTHER COMPREHENSIVE LOSS
|
(124
|
)
|
|
(336
|
)
|
||
COMPREHENSIVE LOSS
|
$
|
(33,298
|
)
|
|
$
|
(30,981
|
)
|
|
Common Stock
|
|
Series A Convertible Preferred Stock
|
|
Series B Convertible Preferred Stock
|
|
Additional
Paid-In
Capital
|
|
Common Stock
Warrants
|
|
Accumulated
Deficit
|
|
Accumulated Other Comprehensive Loss
|
|
Total
|
|||||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
||||||||||||||||||||||||
|
(In thousands, except share data)
|
|||||||||||||||||||||||||||||||||||||||
BALANCE — December 31, 2014
|
44,320,342
|
|
|
$
|
443
|
|
|
600,000
|
|
|
$
|
19,227
|
|
|
8,416
|
|
|
$
|
49,568
|
|
|
$
|
292,851
|
|
|
$
|
1,497
|
|
|
$
|
(313,255
|
)
|
|
$
|
(812
|
)
|
|
$
|
49,519
|
|
Issuance of common stock, net of issuance costs
|
341,239
|
|
|
4
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
920
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
924
|
|
||||||||
Exercise of stock options
|
344,252
|
|
|
3
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
568
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
571
|
|
||||||||
Modification of common stock warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,250
|
|
|
—
|
|
|
—
|
|
|
1,250
|
|
||||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,037
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,037
|
|
||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(30,645
|
)
|
|
—
|
|
|
(30,645
|
)
|
||||||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(336
|
)
|
|
(336
|
)
|
||||||||
BALANCE — December 31, 2015
|
45,005,833
|
|
|
450
|
|
|
600,000
|
|
|
19,227
|
|
|
8,416
|
|
|
49,568
|
|
|
299,376
|
|
|
2,747
|
|
|
(343,900
|
)
|
|
(1,148
|
)
|
|
26,320
|
|
||||||||
Issuance of common stock, net of issuance costs
|
19,645,539
|
|
|
197
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
26,225
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
26,422
|
|
||||||||
Exercise of stock options
|
211,532
|
|
|
2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
291
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
293
|
|
||||||||
Modification of common stock warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
590
|
|
|
—
|
|
|
—
|
|
|
590
|
|
||||||||
Issuance of common stock warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
370
|
|
|
—
|
|
|
—
|
|
|
370
|
|
||||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,889
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,889
|
|
||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(33,174
|
)
|
|
—
|
|
|
(33,174
|
)
|
||||||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(124
|
)
|
|
(124
|
)
|
||||||||
BALANCE — December 31, 2016
|
64,862,904
|
|
|
$
|
649
|
|
|
600,000
|
|
|
$
|
19,227
|
|
|
8,416
|
|
|
$
|
49,568
|
|
|
$
|
330,781
|
|
|
$
|
3,707
|
|
|
$
|
(377,074
|
)
|
|
$
|
(1,272
|
)
|
|
$
|
25,586
|
|
|
Years Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(In thousands)
|
||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
||||
Net loss
|
$
|
(33,174
|
)
|
|
$
|
(30,645
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
2,767
|
|
|
2,555
|
|
||
Inventory reserve
|
104
|
|
|
445
|
|
||
Unrealized foreign currency transaction loss
|
40
|
|
|
106
|
|
||
Amortization of debt discount
|
1,038
|
|
|
836
|
|
||
Deferred taxes (benefit)
|
(213
|
)
|
|
(223
|
)
|
||
Loss on early extinguishment of debt
|
2,564
|
|
|
—
|
|
||
Stock compensation expense
|
4,889
|
|
|
5,037
|
|
||
Change in fair value of derivative warrant liability
|
(2,627
|
)
|
|
(13,283
|
)
|
||
Changes in assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
(4,096
|
)
|
|
(8,919
|
)
|
||
Prepaid expenses and other current assets
|
556
|
|
|
405
|
|
||
Inventory
|
1,000
|
|
|
(386
|
)
|
||
Accounts payable
|
1,073
|
|
|
(487
|
)
|
||
Accrued expenses and other current liabilities
|
1,035
|
|
|
(1,401
|
)
|
||
Other long-term liabilities
|
(55
|
)
|
|
596
|
|
||
Net cash used in operating activities
|
(25,099
|
)
|
|
(45,364
|
)
|
||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
||||
Purchases of property and equipment
|
(186
|
)
|
|
(451
|
)
|
||
Net cash used in investing activities
|
(186
|
)
|
|
(451
|
)
|
||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
||||
Proceeds from exercise of stock options
|
292
|
|
|
571
|
|
||
Proceeds from sale of common stock
|
27,763
|
|
|
1,002
|
|
||
Payment of issuance cost of common stock
|
(1,341
|
)
|
|
(27
|
)
|
||
Payment of Series B convertible preferred stock offering costs
|
—
|
|
|
(327
|
)
|
||
Payment of debt issuance costs (Note 9)
|
(1,069
|
)
|
|
(264
|
)
|
||
Payments on capital lease obligations
|
(227
|
)
|
|
(293
|
)
|
||
Changes in restricted cash
|
6
|
|
|
(37
|
)
|
||
Net cash provided by financing activities
|
25,424
|
|
|
625
|
|
||
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS
|
(235
|
)
|
|
(432
|
)
|
||
NET DECREASE IN CASH AND CASH EQUIVALENTS
|
(96
|
)
|
|
(45,622
|
)
|
||
CASH AND CASH EQUIVALENTS — Beginning of year
|
31,075
|
|
|
76,697
|
|
||
CASH AND CASH EQUIVALENTS — End of year
|
$
|
30,979
|
|
|
$
|
31,075
|
|
SUPPLEMENTAL DISCLOSURES:
|
|
|
|
||||
Cash paid for interest
|
$
|
3,958
|
|
|
$
|
4,177
|
|
Cash paid for income taxes
|
$
|
193
|
|
|
$
|
263
|
|
Supplemental schedule of noncash investing and financing activities:
|
|
|
|
||||
Property and equipment acquired under capital leases
|
$
|
76
|
|
|
$
|
1,098
|
|
Note payable end of term payment accrued but unpaid
|
$
|
1,400
|
|
|
$
|
1,050
|
|
Common Stock offering costs accrued but unpaid
|
$
|
—
|
|
|
$
|
52
|
|
1.
|
NATURE OF OPERATIONS
|
2.
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
|
Years Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(in thousands)
|
||||||
Beginning balance
|
$
|
118
|
|
|
$
|
—
|
|
Bad debt expense
|
—
|
|
|
118
|
|
||
Recovery of bad debt reserve
|
(118
|
)
|
|
—
|
|
||
Ending balance
|
$
|
—
|
|
|
$
|
118
|
|
|
Years Ended December 31,
|
||||
|
2016
|
|
2015
|
||
Series A convertible preferred stock
|
9,022,556
|
|
|
9,022,556
|
|
Series B convertible preferred stock
|
8,416,251
|
|
|
8,416,251
|
|
Series A convertible preferred stock warrants
|
4,511,279
|
|
|
4,511,279
|
|
Common stock warrants
|
1,795,663
|
|
|
738,331
|
|
Stock options
|
10,804,412
|
|
|
9,475,890
|
|
Total
|
34,550,161
|
|
|
32,164,307
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(In thousands)
|
||||||
Component parts (1)
|
$
|
115
|
|
|
$
|
131
|
|
Work-in-process (2)
|
18
|
|
|
333
|
|
||
Finished goods
|
353
|
|
|
1,525
|
|
||
Total inventory
|
486
|
|
|
1,989
|
|
||
Inventory reserve
|
(40
|
)
|
|
(437
|
)
|
||
Inventory — net
|
$
|
446
|
|
|
$
|
1,552
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(In thousands)
|
||||||
Furniture and fixtures
|
$
|
391
|
|
|
$
|
376
|
|
Office equipment
|
838
|
|
|
794
|
|
||
Automobiles
|
762
|
|
|
1,028
|
|
||
Software
|
973
|
|
|
902
|
|
||
Leasehold improvements
|
460
|
|
|
439
|
|
||
Manufacturing equipment
|
997
|
|
|
970
|
|
||
Total property and equipment
|
4,421
|
|
|
4,509
|
|
||
Less accumulated depreciation and amortization
|
(2,634
|
)
|
|
(1,956
|
)
|
||
Property and equipment — net
|
$
|
1,787
|
|
|
$
|
2,553
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(In thousands)
|
||||||
Accrued clinical investigator expenses
|
$
|
1,122
|
|
|
$
|
732
|
|
Accrued other compensation expenses
|
1,020
|
|
|
804
|
|
||
Accrued rebate, chargeback and other revenue reserves
|
809
|
|
|
452
|
|
||
Accrued End of Term Payment (Note 9)
|
—
|
|
|
1,050
|
|
||
Other accrued expenses
|
807
|
|
|
873
|
|
||
Total accrued expenses
|
$
|
3,758
|
|
|
$
|
3,911
|
|
Years Ending December 31
|
(In thousands)
|
||
2017
|
$
|
—
|
|
2018
|
$
|
1,300
|
|
2019
|
$
|
16,526
|
|
2020
|
$
|
17,174
|
|
Total
|
$
|
35,000
|
|
Years Ending December 31
|
(In thousands)
|
||
2017
|
$
|
547
|
|
2018
|
512
|
|
|
2019
|
459
|
|
|
2020
|
350
|
|
|
2021
|
268
|
|
|
Total
|
$
|
2,136
|
|
Years Ending December 31
|
(In thousands)
|
||
2017
|
$
|
300
|
|
2018
|
289
|
|
|
2019
|
107
|
|
|
2020
|
3
|
|
|
Total
|
699
|
|
|
Less amount representing interest
|
(41
|
)
|
|
Less amount representing executory costs
|
(193
|
)
|
|
Present value of minimum lease payments
|
465
|
|
|
Less current portion
|
(191
|
)
|
|
Non-current portion
|
$
|
274
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(In thousands)
|
||||||
Automobiles
|
$
|
762
|
|
|
$
|
1,028
|
|
Office equipment
|
63
|
|
|
63
|
|
||
Less accumulated depreciation
|
(342
|
)
|
|
(212
|
)
|
||
Total
|
$
|
483
|
|
|
$
|
879
|
|
|
Years Ended December 31,
|
||||||||||||||
|
2016
|
|
2015
|
||||||||||||
|
Options
|
|
Weighted
Average
Exercise
Price
|
|
Options
|
|
Weighted
Average
Exercise
Price
|
||||||||
Options outstanding at beginning of period
|
9,475,890
|
|
|
$
|
3.43
|
|
|
7,681,256
|
|
|
$
|
3.03
|
|
||
Grants
|
2,195,250
|
|
|
2.05
|
|
|
2,570,000
|
|
|
4.62
|
|
||||
Forfeitures
|
(581,497
|
)
|
|
3.15
|
|
|
(431,114
|
)
|
|
4.79
|
|
||||
Exercises
|
(285,231
|
)
|
|
1.41
|
|
|
(344,252
|
)
|
|
1.66
|
|
||||
Options outstanding at year end
|
10,804,412
|
|
|
3.22
|
|
|
9,475,890
|
|
|
3.43
|
|
||||
Options exercisable at year end
|
7,363,400
|
|
|
3.29
|
|
|
5,808,528
|
|
|
3.27
|
|
||||
Weighted average per share fair value of options granted during the year
|
$
|
1.55
|
|
|
|
|
$
|
3.58
|
|
|
|
|
Years Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
Risk-free interest rate
|
1.57
|
%
|
|
1.55
|
%
|
||
Volatility factor
|
93.54
|
%
|
|
96.80
|
%
|
||
Grant date fair value of common stock options
|
$
|
1.55
|
|
|
$
|
3.58
|
|
Weighted-average expected life
|
5.99 years
|
|
|
6.03 years
|
|
||
Assumed forfeiture rate
|
10.00
|
%
|
|
10.00
|
%
|
|
Years Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(In thousands)
|
||||||
Sales and marketing
|
$
|
1,109
|
|
|
$
|
925
|
|
Research, development and medical affairs
|
886
|
|
|
1,271
|
|
||
General and administrative
|
2,814
|
|
|
2,732
|
|
||
Total employee stock-based compensation expense
|
$
|
4,809
|
|
|
$
|
4,928
|
|
|
Years Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(In thousands)
|
||||||
United States
|
$
|
(8,516
|
)
|
|
$
|
(6,026
|
)
|
Foreign
|
(24,486
|
)
|
|
(24,489
|
)
|
||
Loss before provision for income taxes
|
$
|
(33,002
|
)
|
|
$
|
(30,515
|
)
|
|
Years Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(In thousands)
|
||||||
Current expense (benefit):
|
|
|
|
||||
Federal
|
$
|
—
|
|
|
$
|
—
|
|
State
|
—
|
|
|
—
|
|
||
Foreign
|
385
|
|
|
353
|
|
||
Current income tax expense
|
385
|
|
|
353
|
|
||
|
|
|
|
||||
Deferred expense (benefit):
|
|
|
|
||||
Federal
|
3,099
|
|
|
6,509
|
|
||
State
|
(858
|
)
|
|
819
|
|
||
Foreign
|
(213
|
)
|
|
(223
|
)
|
||
|
2,028
|
|
|
7,105
|
|
||
Valuation allowance
|
(2,241
|
)
|
|
(7,328
|
)
|
||
Deferred income tax benefit
|
(213
|
)
|
|
(223
|
)
|
||
Total income tax expense
|
$
|
172
|
|
|
$
|
130
|
|
|
Years Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(In thousands)
|
||||||
Valuation allowance at beginning of period
|
$
|
(53,727
|
)
|
|
$
|
(46,399
|
)
|
Income tax provision
|
(2,241
|
)
|
|
(7,328
|
)
|
||
Release of valuation allowance
|
—
|
|
|
—
|
|
||
Other
|
—
|
|
|
—
|
|
||
Valuation allowance at end of period
|
$
|
(55,968
|
)
|
|
$
|
(53,727
|
)
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Deferred tax assets
|
(In thousands)
|
||||||
Depreciation and amortization
|
$
|
12
|
|
|
$
|
3
|
|
Other deferred tax assets
|
5,824
|
|
|
4,643
|
|
||
NOL carry-forwards
|
38,183
|
|
|
36,941
|
|
||
Research and development costs
|
3,063
|
|
|
4,193
|
|
||
Collaboration agreement receivable reserves
|
9,327
|
|
|
8,186
|
|
||
Valuation allowance
|
(55,968
|
)
|
|
(53,727
|
)
|
||
Total deferred tax assets
|
$
|
441
|
|
|
$
|
239
|
|
Deferred tax liabilities
|
|
|
|
||||
Unrealized foreign currency gains
|
$
|
—
|
|
|
$
|
(12
|
)
|
Other deferred tax liabilities
|
(5
|
)
|
|
(4
|
)
|
||
Total deferred tax liabilities
|
(5
|
)
|
|
(16
|
)
|
||
Net deferred tax assets and deferred tax liabilities
|
$
|
436
|
|
|
$
|
223
|
|
|
Years Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(In thousands)
|
||||||
Balance of uncertain tax positions at beginning of period
|
$
|
46
|
|
|
$
|
—
|
|
Gross increases - tax positions in current period
|
16
|
|
|
3
|
|
||
Gross increases - tax positions in prior period
|
13
|
|
|
43
|
|
||
Gross decreases - tax positions in prior period
|
(16
|
)
|
|
—
|
|
||
Settlements
|
—
|
|
|
—
|
|
||
Lapse of statute of limitations
|
—
|
|
|
—
|
|
||
Balance of uncertain tax positions at end of period
|
$
|
59
|
|
|
$
|
46
|
|
|
December 31, 2016
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
|
(In thousands)
|
||||||||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents (1)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Assets measured at fair value
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Derivative warrant liability (2)
|
$
|
—
|
|
|
$
|
188
|
|
|
$
|
—
|
|
|
$
|
188
|
|
Liabilities measured at fair value
|
$
|
—
|
|
|
$
|
188
|
|
|
$
|
—
|
|
|
$
|
188
|
|
|
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. Assumptions used are generally consistent with those disclosed for stock based compensation (see Note 12).
|
|
Year Ended
December 31, 2016 |
||||||||||
|
U.S.
|
|
International
|
|
Consolidated
|
||||||
|
(In thousands)
|
||||||||||
NET REVENUE
|
$
|
25,765
|
|
|
$
|
8,568
|
|
|
$
|
34,333
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(1,694
|
)
|
|
(650
|
)
|
|
(2,344
|
)
|
|||
GROSS PROFIT
|
24,071
|
|
|
7,918
|
|
|
31,989
|
|
|||
|
|
|
|
|
|
||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
7,875
|
|
|
4,500
|
|
|
12,375
|
|
|||
GENERAL AND ADMINISTRATIVE EXPENSES
|
9,316
|
|
|
5,947
|
|
|
15,263
|
|
|||
SALES AND MARKETING EXPENSES
|
22,134
|
|
|
7,297
|
|
|
29,431
|
|
|||
DEPRECIATION AND AMORTIZATION
|
2,678
|
|
|
89
|
|
|
2,767
|
|
|||
OPERATING EXPENSES
|
42,003
|
|
|
17,833
|
|
|
59,836
|
|
|||
NET LOSS FROM OPERATIONS
|
(17,932
|
)
|
|
(9,915
|
)
|
|
(27,847
|
)
|
|||
OTHER INCOME AND EXPENSES, NET
|
|
|
|
|
(5,155
|
)
|
|||||
NET LOSS BEFORE TAXES
|
|
|
|
|
$
|
(33,002
|
)
|
|
Year Ended
December 31, 2015 |
||||||||||
|
U.S.
|
|
International
|
|
Consolidated
|
||||||
|
(In thousands)
|
||||||||||
NET REVENUE
|
$
|
15,170
|
|
|
$
|
7,268
|
|
|
$
|
22,438
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(792
|
)
|
|
(970
|
)
|
|
(1,762
|
)
|
|||
GROSS PROFIT
|
14,378
|
|
|
6,298
|
|
|
20,676
|
|
|||
|
|
|
|
|
|
||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
9,712
|
|
|
5,128
|
|
|
14,840
|
|
|||
GENERAL AND ADMINISTRATIVE EXPENSES
|
8,244
|
|
|
5,946
|
|
|
14,190
|
|
|||
SALES AND MARKETING EXPENSES
|
19,777
|
|
|
8,313
|
|
|
28,090
|
|
|||
DEPRECIATION AND AMORTIZATION
|
2,491
|
|
|
64
|
|
|
2,555
|
|
|||
OPERATING EXPENSES
|
40,224
|
|
|
19,451
|
|
|
59,675
|
|
|||
NET LOSS FROM OPERATIONS
|
(25,846
|
)
|
|
(13,153
|
)
|
|
(38,999
|
)
|
|||
OTHER INCOME AND EXPENSES, NET
|
|
|
|
|
8,484
|
|
|||||
NET LOSS BEFORE TAXES
|
|
|
|
|
$
|
(30,515
|
)
|
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
|
(In thousands, except share and per share data)
|
||||||||||||||
2016
|
|
|
|
|
|
|
|
||||||||
NET REVENUE
|
$
|
5,801
|
|
|
$
|
9,557
|
|
|
$
|
8,298
|
|
|
$
|
10,677
|
|
COST OF GOOD SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(378
|
)
|
|
(556
|
)
|
|
(486
|
)
|
|
(924
|
)
|
||||
GROSS PROFIT
|
5,423
|
|
|
9,001
|
|
|
7,812
|
|
|
9,753
|
|
||||
LOSS FROM OPERATIONS
|
(8,790
|
)
|
|
(6,449
|
)
|
|
(7,243
|
)
|
|
(5,365
|
)
|
||||
NET LOSS BEFORE TAXES
|
(11,136
|
)
|
|
(6,816
|
)
|
|
(9,212
|
)
|
|
(5,838
|
)
|
||||
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS
|
(11,145
|
)
|
|
(6,858
|
)
|
|
(9,245
|
)
|
|
(5,926
|
)
|
||||
NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS - Basic and diluted
|
(0.25
|
)
|
|
(0.15
|
)
|
|
(0.16
|
)
|
|
(0.09
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
2015
|
|
|
|
|
|
|
|
||||||||
NET REVENUE
|
$
|
3,938
|
|
|
$
|
5,776
|
|
|
$
|
6,901
|
|
|
$
|
5,823
|
|
COST OF GOOD SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(283
|
)
|
|
(376
|
)
|
|
(634
|
)
|
|
(469
|
)
|
||||
GROSS PROFIT
|
3,655
|
|
|
5,400
|
|
|
6,267
|
|
|
5,354
|
|
||||
LOSS FROM OPERATIONS
|
(10,994
|
)
|
|
(9,800
|
)
|
|
(8,444
|
)
|
|
(9,761
|
)
|
||||
NET LOSS BEFORE TAXES
|
(9,793
|
)
|
|
(8,596
|
)
|
|
(1,543
|
)
|
|
(10,713
|
)
|
||||
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS
|
(9,793
|
)
|
|
(8,596
|
)
|
|
(1,543
|
)
|
|
(10,713
|
)
|
||||
NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS - Basic and diluted
|
(0.22
|
)
|
|
(0.19
|
)
|
|
(0.03
|
)
|
|
(0.24
|
)
|
Exhibit
|
|
Exhibit
|
Number
|
|
Title
|
|
|
|
3.1
|
|
Restated Certificate of Incorporation of Registrant, as amended on various dates (filed as Exhibit 3.2 to Amendment No. 4 to the Registrant’s Registration Statement on Form S-1 (SEC File No. 333-162782), as filed on April 6, 2010, and incorporated herein by reference)
|
|
|
|
3.2
|
|
Amended and Restated Bylaws of the Registrant, as amended (filed as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, as filed on November 5, 2015, and incorporated herein by reference)
|
|
|
|
3.3
|
|
Certificate of Designation of Series A Convertible Preferred Stock (filed as Exhibit 3.5 to the Registrant’s Current Report on Form 8-K, as filed on October 2, 2012, and incorporated herein by reference)
|
|
|
|
3.4
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (filed as Exhibit 3.6 to the Registrant’s Current Report on Form 8-K, as filed on December 15, 2014, and incorporated herein by reference)
|
|
|
|
3.5*
|
|
Certificate of Amendment to the Restated Certificate of Incorporation of the Registrant
|
|
|
|
4.1
|
|
Second Amended and Restated Investor Rights Agreement, dated March 17, 2008, by and among the Registrant, certain stockholders and the investors listed on the signature pages thereto (filed as Exhibit 4.3 to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 (SEC File No. 333-162782), as filed on December 23, 2009, and incorporated herein by reference)
|
|
|
|
4.2
|
|
Second Amended and Restated Stock Sale Agreement, dated March 17, 2008, by and among the Registrant, certain stockholders and the investors listed on the signature pages thereto (filed as Exhibit 4.4 to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 (SEC File No. 333-162782), as filed on December 23, 2009, and incorporated herein by reference)
|
|
|
|
4.3
|
|
Omnibus Amendment, dated August 25, 2009, by and among the Registrant, certain stockholders and the investors listed on the signature pages thereto (filed as Exhibit 4.5 to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 (SEC File No. 333-162782), as filed on December 23, 2009, and incorporated herein by reference)
|
|
|
|
4.4
|
|
Warrant to Purchase Stock dated October 14, 2010 issued to Silicon Valley Bank (filed as Exhibit 4.1 to the Registrant’s Current Report, as filed on October 18, 2010, and incorporated herein by reference)
|
|
|
|
4.5
|
|
Warrant to Purchase Stock dated October 14, 2010 issued to MidCap Funding III, LLC (filed as Exhibit 4.2 to the Registrant’s Current Report, as filed on October 18, 2010, and incorporated herein by reference)
|
|
|
|
4.6
|
|
Warrant to Purchase Stock dated May 16, 2011 issued to MidCap Funding III, LLC (filed as Exhibit 4.1 to the Registrant’s Current Report, as filed on May 17, 2011, and incorporated herein by reference)
|
|
|
|
4.7
|
|
Warrant to Purchase Stock dated May 16, 2011 issued to Silicon Valley Bank (filed as Exhibit 4.2 to the Registrant’s Current Report, as filed on May 17, 2011, and incorporated herein by reference)
|
|
|
|
4.8.A
|
|
Warrant to Purchase Shares of Series A Preferred issued to Sofinnova Venture Partners VIII, L.P. (filed as Exhibit 4.10.A to the Registrant’s Current Report on Form 8-K, as filed on October 2, 2012, and incorporated herein by reference)
|
|
|
|
4.8.B
|
|
Warrant to Purchase Shares of Series A Preferred issued to Growth Equity Opportunities Fund III, LLC (filed as Exhibit 4.10.B to the Registrant’s Current Report on Form 8-K, as filed on October 2, 2012, and incorporated herein by reference)
|
|
|
|
4.8.C
|
|
Warrant to Purchase Shares of Series A Preferred issued to Micro Cap Partners, L.P. (filed as Exhibit 4.10.C to the Registrant’s Current Report on Form 8-K, as filed on October 2, 2012, and incorporated herein by reference)
|
|
|
|
4.8.D
|
|
Warrant to Purchase Shares of Series A Preferred issued to Palo Alto Healthcare Master Fund, L.P. (filed as Exhibit 4.10.D to the Registrant’s Current Report on Form 8-K, as filed on October 2, 2012, and incorporated herein by reference)
|
|
|
|
4.8.E
|
|
Warrant to Purchase Shares of Series A Preferred issued to Palo Alto Healthcare Master Fund II, L.P. (filed as Exhibit 4.10.E to the Registrant’s Current Report on Form 8-K, as filed on October 2, 2012, and incorporated herein by reference)
|
|
|
|
4.9
|
|
Registration Rights Agreement dated October 2, 2012 between the Registrant and Palo Alto Healthcare Master Fund, L.P., Palo Alto Healthcare Master Fund II, L.P., Micro Cap Partners, L.P., Sofinnova Venture Partners VIII L.P. and Growth Equity Opportunities Fund III, LLC (filed as Exhibit 4.11 to the Registrant’s Current Report on Form 8-K, as filed on October 2, 2012, and incorporated herein by reference)
|
|
|
|
4.10
|
|
Amendment No. 1 to Warrant to Purchase Stock dated May 7, 2013 by and between Silicon Valley Bank and the Registrant (filed as Exhibit 4.10 to the Registrant
’
s Quarterly Report on Form 10-Q, as filed on August 14, 2013, and incorporated herein by reference)
|
|
|
|
4.11
|
|
Irrevocable Waiver of Rights to Designate Series A Director dated May 16, 2014 (filed as Exhibit 4.11 to the Registrant’s Current Report on Form 8-K, as filed on May 16, 2014, and incorporated herein by reference)
|
|
|
|
4.12
|
|
Warrant Agreement dated as of April 24, 2014 issued to Hercules Technology Growth Capital, Inc. (filed as Exhibit 4.11 to the Registrant’s Quarterly Report on Form 10-Q, as filed on August 11, 2014, and incorporated herein by reference)
|
|
|
|
4.13
|
|
First Amendment to Warrant Agreement dated November 2, 2015 by and among the Registrant and Hercules Technology Growth Capital, Inc. (filed as Exhibit 4.13 to the Registrant’s Annual Report on Form 10-K, as filed on March 15, 2016, and incorporated herein by reference)
|
|
|
|
4.14
|
|
Second Amendment to Warrant Agreement dated March 14, 2016 by and among the Registrant and Hercules Technology Growth Capital, Inc. (filed as Exhibit 4.14 to the Registrant’s Quarterly Report on Form 10-Q, as filed on May 6, 2016, 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. (filed as Exhibit 4.15 to the Registrant’s Quarterly Report on Form 10-Q, as filed on November 4, 2016, and incorporated herein by reference)
|
|
|
|
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. (filed as Exhibit 4.16 to the Registrant’s Quarterly Report on Form 10-Q, as filed on November 4, 2016, and incorporated herein by reference)
|
|
|
|
10.1
|
|
Form of Indemnification Agreement between the Registrant and each of its directors and executive officers (filed as Exhibit 10.1 to the Registrant’s Registration Statement on Form S-1 (SEC File No. 333-162782), as filed on October 30, 2009, and incorporated herein by reference)
|
|
|
|
10.2
|
|
Alimera Sciences, Inc. 2004 Incentive Stock Plan, as amended (filed as Exhibit 10.7 to the Registrant’s Registration Statement on Form S-1 (SEC File No. 333-162782), as filed on October 30, 2009, and incorporated herein by reference)
|
|
|
|
10.3
|
|
Form of Option Certificate under the Alimera Sciences, Inc. 2004 Incentive Stock Plan (filed as Exhibit 10.7.A to the Registrant’s Registration Statement on Form S-1 (SEC File No. 333-162782), as filed on October 30, 2009, and incorporated herein by reference)
|
|
|
|
10.4
|
|
Alimera Sciences, Inc. 2005 Incentive Stock Plan (filed as Exhibit 10.8 to the Registrant’s Registration Statement on Form S-1 (SEC File No. 333-162782), as filed on October 30, 2009, and incorporated herein by reference)
|
|
|
|
10.5
|
|
Form of Option Certificate under the Alimera Sciences, Inc. 2005 Incentive Stock Plan (filed as Exhibit 10.8.A to the Registrant’s Registration Statement on Form S-1 (SEC File No. 333-162782), as filed on October 30, 2009, and incorporated herein by reference)
|
|
|
|
10.6
|
|
2010 Equity Incentive Plan (filed as Exhibit 10.9 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)
|
|
|
|
10.7
|
|
2010 Employee Stock Purchase Plan (filed as Exhibit 10.10 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)
|
|
|
|
10.7.A
|
|
Amendment No. 1 to 2010 Employee Stock Purchase Plan
|
|
|
|
10.8
|
|
Management Cash Incentive Plan (filed as Exhibit 10.11 to the Registrant’s Registration Statement on Form S-1 (SEC File No. 333-162782), as filed on October 30, 2009, and incorporated herein by reference)
|
|
|
|
10.9
|
|
Compensation Program for Non-Employee Directors (filed as Exhibit 10.12 to the Registrant’s Registration Statement on Form S-1 (SEC File No. 333-162782), as filed on October 30, 2009, and incorporated herein by reference)
|
|
|
10.10‡
|
|
Amended and Restated Collaboration Agreement by and between pSivida, Inc. (f/k/a/Control Delivery Systems, Inc.) and Alimera Sciences, Inc., dated as of March 14, 2008 (filed as Exhibit 10.13 to Amendment No. 5 to the Registrant’s Registration Statement on Form S-1 (SEC File No. 333-162782), as filed on April 16, 2010, and incorporated herein by reference)
|
|
|
|
10.11
|
|
Office Lease by and between Rubicon, L.C. and Alimera Sciences, Inc., dated as of May 27, 2003, as amended (filed as Exhibit 10.18 to the Registrant’s Registration Statement on Form S-1 (SEC File No. 333-162782), as filed on October 30, 2009, and incorporated herein by reference)
|
|
|
|
10.12‡
|
|
Commercial Contract Manufacturing Agreement, between Alimera Sciences, Inc. and Alliance Medical Products, Inc., dated February 5, 2010 (filed as Exhibit 10.26 to Amendment No. 6 to the Registrant’s Registration Statement on Form S-1 (SEC File No. 333-162782), as filed on April 20, 2010, and incorporated herein by reference)
|
|
|
|
10.13
|
|
Form of Notice of Stock Option Grant and Stock Option Agreement under 2010 Equity Incentive Plan (filed as Exhibit 10.30 to Registrant
’
s Annual Report on Form 10-K, as filed on March 25, 2011, and incorporated herein by reference)
|
|
|
|
10.14‡
|
|
Amendment to Manufacturing Agreement between Registrant and Alliance Medical Products, Inc. (filed as Exhibit 10.3 to Registrant
’
s Quarterly Report on Form 10-Q, as filed on August 5, 2011, and incorporated herein by reference)
|
|
|
|
10.15
|
|
Form of Notice of Stock Unit Award and Stock Unit Agreement under 2010 Equity Incentive Plan (filed as Exhibit 10.34 to Registrant’s Annual Report on Form 10-K, as filed on March 30, 2012, and incorporated herein by reference)
|
|
|
|
10.16‡
|
|
Manufacturing Agreement by and between the Registrant and Flextronics Medical Sales and Marketing, Ltd. (filed as Exhibit 10.35 to Registrant
’
s Quarterly Report on Form 10-Q, as filed on August 14, 2012, and incorporated herein by reference)
|
|
|
|
10.17
|
|
Securities Purchase Agreement dated July 17, 2012 (filed as Exhibit 10.36 to the Registrant
’
s Current Report, as filed on July 18, 2012, and incorporated herein by reference)
|
|
|
|
10.18
|
|
Amendment No. 1 to Securities Purchase Agreement dated September 21, 2012 (filed as Exhibit 10.37 to the Registrant
’
s Current Report, as filed on October 2, 2012, and incorporated herein by reference)
|
|
|
|
10.19
|
|
UK Sub-Plan of the 2010 Equity Incentive Plan of Alimera Sciences, Inc. (filed as Exhibit 10.38 to the Registrant
’
s Quarterly Report on Form 10-Q, as filed on November 7, 2012, and incorporated herein by reference and replaced by exhibit 10.46)
|
|
|
|
10.20
|
|
Form of UK Sub-Plan Notice of Stock Option Grant and Stock Option Agreement (filed as Exhibit 10.39 to the Registrant
’
s Quarterly Report on Form 10-Q, as filed on November 7, 2012, and incorporated herein by reference)
|
|
|
|
10.21
|
|
Form of France Sub-Plan of the 2010 Equity Incentive Plan of Alimera Sciences, Inc. (filed as Exhibit 10.21 to the Registrant’s Annual Report on Form 10-K, as filed on March 15, 2016, and incorporated herein by reference)
|
|
|
|
10.22
|
|
Employment Contract dated November 3, 2012 by and between the Registrant and Philip Ashman (filed as Exhibit 10.40 to the Registrant
’
s Annual Report on Form 10-K, as filed on March 28, 2013)
|
|
|
|
10.23
|
|
Loan and Security Agreement dated May 7, 2013 between Silicon Valley Bank and Alimera Sciences Limited (filed as Exhibit 10.42 to the Registrant’s Quarterly Report on Form 10-Q, as filed on August 14, 2013)
|
|
|
|
10.24
|
|
Security Agreement entered into as of May 7, 2013 by and between Silicon Valley Bank and the Registrant (filed as Exhibit 10.43 to the Registrant’s Quarterly Report on Form 10-Q, as filed on August 14, 2013)
|
|
|
|
10.25
|
|
Unconditional Guaranty entered into as of May 7, 2013 by Alimera Sciences B.V. in favor of Silicon Valley Bank (filed as Exhibit 10.44 to the Registrant’s Quarterly Report on Form 10-Q, as filed on August 14, 2013)
|
|
|
|
10.26
|
|
Unconditional Guaranty entered into as of May 7, 2013 by AS C.V. in favor of Silicon Valley Bank (filed as Exhibit 10.45 to the Registrant’s Quarterly Report on Form 10-Q, as filed on August 14, 2013)
|
|
|
|
10.27
|
|
Unconditional Guaranty entered into as of May 7, 2013 by the Registrant in favor of Silicon Valley Bank (filed as Exhibit 10.46 to the Registrant’s Quarterly Report on Form 10-Q, as filed on August 14, 2013)
|
|
|
|
10.28
|
|
Second Loan Modification Agreement entered into as of May 7, 2013 by and between Silicon Valley Bank and the Registrant (filed as Exhibit 10.47 to the Registrant’s Quarterly Report on Form 10-Q, as filed on August 14, 2013)
|
|
|
|
10.29
|
|
Securities Purchase Agreement dated January 27, 2014 (filed as Exhibit 10.42 to the Registrant
’
s Current Report, as filed on January 27, 2014, and incorporated herein by reference)
|
|
|
|
10.30
|
|
Loan and Security Agreement dated as of April 24, 2014 by and among Alimera Sciences Limited, the several banks and other financial institutions or entities from time to time parties thereto and Hercules Technology Growth Capital, Inc. (filed as Exhibit 10.49 to the Registrant’s Quarterly Report on Form 10-Q, as filed on August 11, 2014, and incorporated herein by reference)
|
|
|
|
10.31
|
|
First Amendment to Loan and Security Agreement dated November 2, 2015 by and among Alimera Sciences Limited, Hercules Capital Funding Trust and Hercules Technology Growth Capital, Inc. (filed as Exhibit 10.31 to the Registrant’s Annual Report on Form 10-K, as filed on March 15, 2016, and incorporated herein by reference)
|
|
|
|
10.32
|
|
Unconditional Guaranty entered into as of April 24, 2014 by the Registrant in favor of Hercules Technology Growth Capital, Inc. (filed as Exhibit 10.50 to the Registrant’s Quarterly Report on Form 10-Q, as filed on August 11, 2014, and incorporated herein by reference)
|
|
|
|
10.33
|
|
Unconditional Guaranty entered into as of April 24, 2014 by Alimera Sciences B.V. in favor of Hercules Technology Growth Capital, Inc. (filed as Exhibit 10.51 to the Registrant’s Quarterly Report on Form 10-Q, as filed on August 11, 2014, and incorporated herein by reference)
|
|
|
|
10.34
|
|
Unconditional Guaranty entered into as of April 24, 2014 by AS C.V. in favor of Hercules Technology Growth Capital, Inc. (filed as Exhibit 10.52 to the Registrant’s Quarterly Report on Form 10-Q, as filed on August 11, 2014, and incorporated herein by reference)
|
|
|
|
10.35
|
|
Sales Agreement dated September 22, 2014 (filed as Exhibit 10.53 to the Registrant
’
s Current Report on Form 8-K, as filed on September 22, 2014, and incorporated herein by reference)
|
|
|
|
10.36†
|
|
Amended and Restated Employment Agreement, effective as of October 23, 2014, by and between the Registrant and C. Daniel Myers (filed as Exhibit 10.53 to the Registrant
’
s Current Report on Form 8-K, as filed on October 23, 2014, and incorporated herein by reference)
|
|
|
|
10.37†
|
|
Amended and Restated Employment Agreement, effective as of October 23, 2014, by and between the Registrant and Richard S. Eiswirth, Jr. (filed as Exhibit 10.54 to the Registrant
’
s Current Report on Form 8-K, as filed on October 23, 2014, and incorporated herein by reference)
|
|
|
|
10.38†
|
|
Amended and Restated Employment Agreement, effective as of October 23, 2014, by and between the Registrant and Kenneth Green, Ph.D. (filed as Exhibit 10.55 to the Registrant
’
s Current Report on Form 8-K, as filed on October 23, 2014, and incorporated herein by reference)
|
|
|
|
10.39†
|
|
Amended and Restated Employment Agreement, effective as of October 23, 2014, by and between the Registrant and David Holland (filed as Exhibit 10.39 to the Registrant’s Annual Report on Form 10-K, as filed on March 15, 2016, and incorporated herein by reference)
|
|
|
|
10.40
|
|
Securities Purchase Agreement dated November 26, 2014 (filed as Exhibit 10.56 to the Registrant
’
s Current Report on Form 8-K, as filed on November 28, 2014, and incorporated herein by reference)
|
|
|
|
10.41‡
|
|
First Amended and Restated Commercial Contract Manufacturing Agreement dated as of February 5, 2016 by and between Alimera Sciences, Inc. and Alliance Medical Products, Inc. d.b.a. Siegfried Irvine (filed as Exhibit 10.41 to the Registrant’s Quarterly Report on Form 10-Q, as filed on May 6, 2016, and incorporated herein by reference)
|
|
|
|
10.42
|
|
Second Amendment to Loan and Security Agreement dated March 14, 2016 by and among Alimera Sciences Limited, Hercules Capital Funding Trust and Hercules Capital, Inc. f/k/a Hercules Technology Growth Capital, Inc. (filed as Exhibit 10.42 to the Registrant’s Quarterly Report on Form 10-Q, as filed on May 6, 2016, and incorporated herein by reference)
|
|
|
|
10.43
|
|
Third Amendment to Loan and Security Agreement dated May 26, 2016 by and among Alimera Sciences Limited, Hercules Capital Funding Trust and Hercules Capital, Inc. f/k/a Hercules Technology Growth Capital, Inc. (filed as Exhibit 10.43 to the Registrant’s Current Report on Form 8-K, as filed on May 27, 2016, and incorporated herein by reference)
|
|
|
|
10.44
|
|
Waiver by Hercules Capital, Inc. of Certain Defaults under Loan and Security Agreement dated July 21, 2016 (filed as Exhibit 10.45 to the Registrant’s Quarterly Report on Form 10-Q, as filed on November 4, 2016 and incorporated herein by reference)
|
|
|
|
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. (filed as Exhibit 10.45 to the Registrant’s Quarterly Report on Form 10-Q, as filed on November 4, 2016 and incorporated herein by reference)
|
|
|
|
10.46*
|
|
(2017) UK Sub-Plan of the 2010 Equity Incentive Plan of Alimera Sciences, Inc.
|
|
|
|
10.47*
|
|
Forms of Notice of Restricted Stock Unit Award and restricted Stock Unit Agreement under 2010 Equity Incentive Plan for the U.S., Germany, Portugal and the United Kingdom
|
|
|
|
21.1
|
|
List of subsidiaries of the Registrant (including jurisdiction of organization and names under which subsidiaries do business) (filed as Exhibit 21.1 to the Registrant’s Annual Report on Form 10-K, as filed on March 15, 2016, and incorporated herein by reference)
|
|
|
|
23.1*
|
|
Consent of Grant Thornton LLP, Independent Registered Public Accounting Firm
|
|
|
|
31.1*
|
|
Certification of the Chief Executive Officer, as required by Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
31.2*
|
|
Certification of the Chief Financial Officer as required by Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
32.1*
|
|
Certifications of the Chief Executive Officer and Chief Financial Officer as required by 18 U.S.C. 1350
|
|
|
|
101.INS+*
|
|
XBRL Instance Document
|
|
|
|
101.SCH+*
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
101.CAL+*
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
101.DEF+*
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
101.LAB+*
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
101.PRE+*
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
†
|
Compensation Arrangement.
|
‡
|
Confidential treatment has been granted with respect to certain portions of this document.
|
*
|
Filed herewith.
|
/s/ Richard S. Eiswirth, Jr.
|
Richard S. Eiswirth. Jr.
|
President and Chief Financial Officer
|
1.
|
The purpose of this Sub-Plan is to provide incentives for present and future UK tax resident employees of Alimera Sciences Limited through the grant of options over shares of Common Stock of Alimera Sciences, Inc. (the "Company").
|
2.
|
Capitalized terms are defined in the Company’s 2010 Equity Incentive Plan (the “Plan”), subject to the provisions of this Sub-Plan.
|
3.
|
References to ISOs and NSOs shall not apply to Options granted under the Sub-Plan.
|
4.
|
Options granted under this Sub-Plan shall be taxed in the UK as Unapproved Options.
|
5.
|
This Sub-Plan is governed by THE Plan and all its provisions shall be identical to those of the Plan SAVE THAT (i) "Sub-Plan" shall be substituted for "Plan" where applicable and (ii) the following provisions shall be as stated in this Sub-Plan in order to accommodate the specific requirements of the laws of England and Wales and the appropriate UK tax legislation.
|
6.
|
ARTICLE 1.
INTRODUCTION.
|
7.
|
ARTICLE 2.
ADMINISTRATION.
|
8.
|
ARTICLE 3.
SHARES AVAILABLE FOR GRANTS.
|
9.
|
ARTICLE 4.
ELIGIBILITY.
|
10.
|
ARTICLE 5.
OPTIONS.
|
(a)
|
An unauthorized use or disclosure by the Participant of the Company’s confidential information or trade secrets, which use or disclosure causes material harm to the Company;
|
(b)
|
A material breach by the Participant of any agreement between the Optionee and the Company;
|
(c)
|
A material failure by the Participant to comply with the Company’s written policies or rules;
|
(d)
|
The Participant’s conviction of, or plea of “guilty” or “no contest” to, a felony under the laws of the United States or any State thereof, or crime under any other applicable law;
|
(f)
|
A continuing failure by the Participant to perform assigned duties after receiving written notification of such failure from the Board; or
|
(g)
|
A failure by the Participant to cooperate in good faith with a governmental or internal investigation of the Company or its directors, officers or employees, if the Company has requested the Participant’s cooperation.
|
Name of Recipient:
|
[Insert Name]
|
Total Number of Units Granted:
|
[Insert Number]
|
Date of Grant:
|
[Date of Grant]
|
Vesting Schedule:
|
100% of the units subject to this award will vest on [Insert Vesting Date]
|
Payment for Units
|
No payment is required for the units that you are receiving.
|
Vesting
|
The units vest as shown in the Notice of Stock Unit Award. No additional units vest after your Service has terminated for any reason.
|
Forfeiture
|
If your Service terminates for any reason, then your units will be forfeited to the extent that they have not vested before the termination date. This means that any units that have not vested under this Agreement will be cancelled immediately. You receive no payment for units that are forfeited.
The Company determines when your Service terminates for this purpose.
|
Settlement of Units
|
Each unit will be settled on the Vesting Date, or the next Trading Day (as defined below) if the Vesting Date is not a Trading Day. However, each unit must be settled no later than the March 15th of the calendar year following the calendar year in which it vests.
At the time of settlement, you will receive one share of the Company’s Common Stock for each vested unit.
|
“Permissible Trading Day”
|
“Permissible Trading Day” means a day that satisfies each of the following requirements:
• The Nasdaq Global Market is open for trading on that day;
• You are permitted to sell shares of the Company’s Common Stock on that day without incurring liability under Section 16(b) of the Securities Exchange Act of 1934, as amended;
• Either (a) you are not in possession of material non-public information that would make it illegal for you to sell shares of the Company’s Common Stock on that day under Rule 10b-5 of the Securities and Exchange Commission or (b) Rule 10b5 1 of the Securities and Exchange Commission is applicable;
• Under the Company’s
Securities Trading Policy
, you are permitted to sell shares of the Company’s Common Stock on that day; and
• You are not prohibited from selling shares of the Company’s Common Stock on that day by a written agreement between you and the Company or a third party.
|
Section 409A
|
This paragraph applies only if the Company determines that you are a “specified employee,” as defined in the regulations under Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”), at the time of your “separation from service,” as defined in those regulations. If this paragraph applies, then any units that otherwise would have been settled during the first six months following your separation from service will instead be settled during the seventh month following your separation from service, unless the settlement of those units is exempt from Section 409A of the Code.
|
Nature of Units
|
Your units are mere bookkeeping entries. They represent only the Company’s unfunded and unsecured promise to issue shares of Common Stock on a future date. As a holder of units, you have no rights other than the rights of a general creditor of the Company.
|
No Voting Rights or Dividends
|
Your units carry neither voting rights nor rights to cash dividends. You have no rights as a stockholder of the Company unless and until your units are settled by issuing shares of the Company’s Common Stock.
|
Units Nontransferable
|
You may not sell, transfer, assign, pledge or otherwise dispose of any units. For instance, you may not use your units as security for a loan.
|
Withholding Taxes
|
Unless you elect prior to March 31, 2017, which election must be made on a Permissible Trading Day, to satisfy Withholding Taxes through any of the following means or by a combination of such means: (i) withholding from any compensation otherwise payable to you by the Company or an Affiliate; or (ii) tendering a cash payment to the Company (which may be in the form of a check, electronic wire transfer or other method permitted by the Company), then to the greatest extent permitted under the Plan and applicable law, applicable Withholding Taxes will be satisfied through the mandatory sale of a number of the shares subject to the Award and the remittance of the cash proceeds of such sale to the Company, pursuant to a “same day sale.” You authorize the Company to make payment from the cash proceeds of this sale directly to the appropriate taxing authorities in an amount equal to the Withholding Taxes.
It is the Company’s intent that the mandatory sale to cover Withholding Taxes imposed by the Company on the Participant in connection with the receipt of this Award comply with the requirements of Rule 10b5-1(c)(1)(i)(B) under the Exchange Act and be interpreted to comply with the requirements of Rule 10b5-1(c).
If, for any reason, such “same day sale” commitment does not result in sufficient proceeds to satisfy the Withholding Taxes, the Company or an Affiliate may, in its sole discretion, satisfy all or any portion of the Withholding Taxes relating to your Award by any of the following means or by a combination of such means: (i) withholding from any compensation otherwise payable to you by the Company or an Affiliate; or (ii) causing you to tender a cash payment (which may be in the form of a check, electronic wire transfer or other method permitted by the Company). Unless the tax withholding obligations of the Company and/or any Affiliate are satisfied, the Company shall have no obligation to deliver to you any Common Stock. Withholding Taxes shall be equal to the Company’s required tax withholding obligations using the minimum statutory withholding rates for federal, state, local and foreign tax purposes, including payroll taxes, that are applicable to supplemental taxable income.
|
Restrictions on Resale
|
You agree not to sell any shares at a time when applicable laws, Company policies or an agreement between the Company and its underwriters prohibit a sale. This restriction will apply as long as your Service continues and for such period of time after the termination of your Service as the Company may specify.
|
Employment at Will
|
Your award or this Agreement does not give you the right to be retained by the Company or a subsidiary of the Company in any capacity. The Company and its subsidiaries reserve the right to terminate your Service at any time, with or without cause.
|
Adjustments
|
In the event of a stock split, a stock dividend or a similar change in Company stock, the number of your units will be adjusted accordingly, as the Company may determine pursuant to the Plan.
|
Name of Recipient:
|
[Insert Name]
|
Total Number of Units Granted:
|
[Insert Number]
|
Date of Grant:
|
[Date of Grant]
|
Vesting Schedule:
|
100% of the units subject to this award will vest on [Insert Vesting Date]
|
Payment for Units
|
No payment is required for the units that you are receiving.
|
Vesting
|
The units vest as shown in the Notice of Stock Unit Award. No additional units vest after your Service has terminated for any reason.
|
Forfeiture
|
If your Service terminates for any reason, then your units will be forfeited to the extent that they have not vested before the termination date. This means that any units that have not vested under this Agreement will be cancelled immediately. You receive no payment for units that are forfeited.
The Company determines when your Service terminates for this purpose.
|
Settlement of Units
|
Each unit will be settled on the first Permissible Trading Day that occurs on or after the day when the units vest. However, each unit must be settled no later than the March 15th of the calendar year following the calendar year in which it vests.
At the time of settlement, you will receive one share of the Company’s Common Stock for each vested unit.
|
“Permissible Trading Day”
|
“Permissible Trading Day” means a day that satisfies each of the following requirements:
• The Nasdaq Global Market is open for trading on that day;
• You are permitted to sell shares of the Company’s Common Stock on that day without incurring liability under Section 16(b) of the Securities Exchange Act of 1934, as amended;
• Either (a) you are not in possession of material non-public information that would make it illegal for you to sell shares of the Company’s Common Stock on that day under Rule 10b-5 of the Securities and Exchange Commission or (b) Rule 10b5 1 of the Securities and Exchange Commission is applicable;
• Under the Company’s
Securities Trading Policy
, you are permitted to sell shares of the Company’s Common Stock on that day; and
• You are not prohibited from selling shares of the Company’s Common Stock on that day by a written agreement between you and the Company or a third party.
|
Section 409A
|
This paragraph applies only if the Company determines that you are a “specified employee,” as defined in the regulations under Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”), at the time of your “separation from service,” as defined in those regulations. If this paragraph applies, then any units that otherwise would have been settled during the first six months following your separation from service will instead be settled during the seventh month following your separation from service, unless the settlement of those units is exempt from Section 409A of the Code.
|
Nature of Units
|
Your units are mere bookkeeping entries. They represent only the Company’s unfunded and unsecured promise to issue shares of Common Stock on a future date. As a holder of units, you have no rights other than the rights of a general creditor of the Company.
|
No Voting Rights or Dividends
|
Your units carry neither voting rights nor rights to cash dividends. You have no rights as a stockholder of the Company unless and until your units are settled by issuing shares of the Company’s Common Stock.
|
Units Nontransferable
|
The units are non-tradable. You may not sell, transfer, assign, pledge or otherwise dispose of any units. For instance, you may not use your units as security for a loan.
|
Withholding Taxes
|
Unless you elect prior to March 31, 2017, which election must be made on a Permissible Trading Day, to satisfy Withholding Taxes through any of the following means or by a combination of such means: (i) withholding from any compensation otherwise payable to you by the Company, a Subsidiary or an Affiliate; or (ii) tendering a cash payment to the Company, a Subsidiary or the Affiliate (which may be in the form of a check, electronic wire transfer or other method permitted by the Company), then to the greatest extent permitted under the Plan and applicable law, applicable Withholding Taxes will be satisfied through the mandatory sale of a number of the shares subject to the Award and the remittance of the cash proceeds of such sale to the Company, pursuant to a “same day sale” also known as a "exercise-and-sell-version". You authorize the Company, a Subsidiary or an Affiliate to make payment from the cash proceeds of this sale directly to the appropriate taxing authorities in an amount equal to the Withholding Taxes.
It is the Company’s intent that the mandatory sale to cover Withholding Taxes imposed by the Company on the Participant in connection with the receipt of this Award comply with the requirements of Rule 10b5-1(c)(1)(i)(B) under the Exchange Act and be interpreted to comply with the requirements of Rule 10b5-1(c).
If, for any reason, such “same day sale” commitment does not result in sufficient proceeds to satisfy the Withholding Taxes, the Company, a Subsidiary or an Affiliate may, in its sole discretion, satisfy all or any portion of the Withholding Taxes relating to your Award by any of the following means or by a combination of such means: (i) withholding from any compensation otherwise payable to you by the Company, a Subsidiary or an Affiliate; or (ii) causing you to tender a cash payment (which may be in the form of a check, electronic wire transfer or other method permitted by the Company). Unless the tax withholding obligations of the Company and/or any Subsidiary or Affiliate are satisfied, the Company shall have no obligation to deliver to you any Common Stock. Withholding Taxes shall be equal to the Company’s or its Subsidiary's or Affiliate's required tax withholding obligations using the minimum statutory withholding rates for federal, state, local and foreign tax purposes, including payroll taxes, that are applicable to supplemental taxable income.
|
Restrictions on Resale
|
You agree not to sell any shares at a time when applicable laws, Company policies or an agreement between the Company and its underwriters prohibit a sale. This restriction will apply as long as your Service continues and for such period of time after the termination of your Service as the Company may specify.
|
Employment at Will
|
Your award or this Agreement does not give you the right to be retained by the Company or an Affiliate or a Subsidiary in any capacity. The Company and its Affiliates or Subsidiaries reserve the right to terminate your Service at any time, with or without cause.
|
Adjustments
|
In the event of a stock split, a stock dividend or a similar change in Company stock, the number of your units will be adjusted accordingly, as the Company may determine pursuant to the Plan.
|
Name of Recipient:
|
[Insert Name]
|
Total Number of Units Granted:
|
[Insert Number]
|
Date of Grant:
|
[Date of Grant]
|
Vesting Schedule:
|
100% of the units subject to this award will vest on [Insert Vesting Date]
|
Payment for Units
|
No payment is required for the units that you are receiving.
|
Vesting
|
The units vest as shown in the Notice of Stock Unit Award. No additional units vest after your Service has terminated for any reason.
|
Forfeiture
|
If your Service terminates for any reason, then your units will be forfeited to the extent that they have not vested before the termination date. This means that any units that have not vested under this Agreement will be cancelled immediately. You receive no payment for units that are forfeited.
The Company determines when your Service terminates for this purpose.
|
Settlement of Units
|
Each unit will be settled on the Vesting Date, or the next Trading Day (as defined below) if the Vesting Date is not a Trading Day. However, each unit must be settled no later than the March 15th of the calendar year following the calendar year in which it vests.
At the time of settlement, you will receive one share of the Company’s Common Stock for each vested unit.
|
“Permissible Trading Day”
|
“Permissible Trading Day” means a day that satisfies each of the following requirements:
• The Nasdaq Global Market is open for trading on that day;
• You are permitted to sell shares of the Company’s Common Stock on that day without incurring liability under Section 16(b) of the Securities Exchange Act of 1934, as amended;
• Either (a) you are not in possession of material non-public information that would make it illegal for you to sell shares of the Company’s Common Stock on that day under Rule 10b-5 of the Securities and Exchange Commission or (b) Rule 10b5 1 of the Securities and Exchange Commission is applicable;
• Under the Company’s
Securities Trading Policy
, you are permitted to sell shares of the Company’s Common Stock on that day; and
• You are not prohibited from selling shares of the Company’s Common Stock on that day by a written agreement between you and the Company or a third party.
|
Section 409A
|
This paragraph applies only if the Company determines that you are a “specified employee,” as defined in the regulations under Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”), at the time of your “separation from service,” as defined in those regulations. If this paragraph applies, then any units that otherwise would have been settled during the first six months following your separation from service will instead be settled during the seventh month following your separation from service, unless the settlement of those units is exempt from Section 409A of the Code.
|
Nature of Units
|
Your units are mere bookkeeping entries. They represent only the Company’s unfunded and unsecured promise to issue shares of Common Stock on a future date. As a holder of units, you have no rights other than the rights of a general creditor of the Company.
|
No Voting Rights or Dividends
|
Your units carry neither voting rights nor rights to cash dividends. You have no rights as a stockholder of the Company unless and until your units are settled by issuing shares of the Company’s Common Stock.
|
Units Nontransferable
|
You may not sell, transfer, assign, pledge or otherwise dispose of any units. For instance, you may not use your units as security for a loan.
|
Withholding Taxes
|
Presently, there is no withholding tax in relation to your Award, since benefits in kind, although taxable, are excluded from the scope of withholding tax obligations, pursuant to the Portuguese tax legislation in force.
If the Portuguese legislation is altered in the future, and withholding tax obligations arise in connection with the Award, the Company or an Affiliate may, in its sole discretion, satisfy all or any portion of the Withholding Taxes relating to your Award by any of the following means or by a combination of such means: (i) withholding from any compensation otherwise payable to you by the Company or an Affiliate; or (ii) causing you to tender a cash payment (which may be in the form of a check, electronic wire transfer or other method permitted by the Company). Unless the tax withholding obligations of the Company and/or any Affiliate are satisfied, the Company shall have no obligation to deliver to you any Common Stock. Withholding Taxes shall be equal to the Company’s required tax withholding obligations as established in the applicable law, if withholding tax becomes due in the future, over benefits in kind attributed to employees.
|
Restrictions on Resale
|
You agree not to sell any shares at a time when applicable laws, Company policies or an agreement between the Company and its underwriters prohibit a sale. This restriction will apply as long as your Service continues and for such period of time after the termination of your Service as the Company may specify.
|
Employment at Will
|
Your award or this Agreement does not give you the right to be retained by the Company or a subsidiary of the Company in any capacity. The Company and its subsidiaries reserve the right to terminate your Service at any time, with or without cause.
|
Total Number of Units Granted:
|
[Insert Number]
|
Date of Grant:
|
[Date of Grant]
|
Vesting Schedule:
|
100% of the units subject to this award will vest on [Insert Vesting Date]
|
Payment for Units
|
No payment is required for the units that you are receiving.
|
Vesting
|
The units vest as shown in the Notice of Stock Unit Award. No additional units vest after your Service has terminated for any reason.
|
Forfeiture
|
If your Service terminates for any reason, then your units will be forfeited to the extent that they have not vested before the termination date. This means that any units that have not vested under this Agreement will be cancelled immediately. You receive no payment for units that are forfeited.
The Company determines when your Service terminates for this purpose.
|
Settlement of Units
|
Each unit will be settled on the Vesting Date, or the next Trading Day (as defined below) if the Vesting Date is not a Trading Day. However, each unit must be settled no later than the March 15th of the calendar year following the calendar year in which it vests.
At the time of settlement, you will receive one share of the Company’s Common Stock for each vested unit.
|
“Permissible Trading Day”
|
“Permissible Trading Day” means a day that satisfies each of the following requirements:
• The Nasdaq Global Market is open for trading on that day;
• You are permitted to sell shares of the Company’s Common Stock on that day without incurring liability under Section 16(b) of the Securities Exchange Act of 1934, as amended;
• Either (a) you are not in possession of material non-public information that would make it illegal for you to sell shares of the Company’s Common Stock on that day under Rule 10b-5 of the Securities and Exchange Commission or (b) Rule 10b5 1 of the Securities and Exchange Commission is applicable;
• Under the Company’s
Securities Trading Policy
, you are permitted to sell shares of the Company’s Common Stock on that day; and
• You are not prohibited from selling shares of the Company’s Common Stock on that day by a written agreement between you and the Company or a third party.
|
Section 409A
|
This paragraph applies only if the Company determines that you are a “specified employee,” as defined in the regulations under Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”), at the time of your “separation from service,” as defined in those regulations. If this paragraph applies, then any units that otherwise would have been settled during the first six months following your separation from service will instead be settled during the seventh month following your separation from service, unless the settlement of those units is exempt from Section 409A of the Code.
|
Nature of Units
|
Your units are mere bookkeeping entries. They represent only the Company’s unfunded and unsecured promise to issue shares of Common Stock on a future date. As a holder of units, you have no rights other than the rights of a general creditor of the Company.
|
No Voting Rights or Dividends
|
Your units carry neither voting rights nor rights to cash dividends. You have no rights as a stockholder of the Company unless and until your units are settled by issuing shares of the Company’s Common Stock.
|
Units Nontransferable
|
You may not sell, transfer, assign, pledge or otherwise dispose of any units. For instance, you may not use your units as security for a loan.
|
Tax Obligations
|
(a)
Withholding of Taxes. In the event that the Company or any Subsidiary determines that it is required to account to HM Revenue & Customs for any Award Tax Liability or Secondary NIC Liability arising from the grant, vesting, release, cancellation or any other disposal of this Award or arising out of the acquisition, retention and disposal of the Common Stock acquired pursuant to this Award, you, as a condition to the issue of units in connection with the vesting of an Award, or on the grant, release or cancellation of an Award, shall make such arrangements satisfactory to the Company to enable it or any Subsidiary to satisfy any requirement to account for any Award Tax Liability (and any Secondary NIC Liability) that may arise in connection with the Award or the issue of Common Stock pursuant to it including, but not limited to, arrangements satisfactory to the Company for withholding shares that would otherwise be issued.
(b)
Section 431 election. As a further condition of the vesting of the Award you shall have signed a Section 431 Election in the form set out in Attachment A or in such other form as may be determined by HM Revenue & Customs from time to time.
|
|
(c)
Secondary NIC Liability. As a further condition of the vesting of the Award you shall join with the Company and any other company who is or becomes a Secondary Contributor in making a Joint Election which has been approved by HM Revenue & Customs, for the transfer of the whole of any Secondary NIC Liability.
|
|
(d)
Your Tax Indemnity.
(i) Indemnity. To the extent permitted by law, you hereby agree to indemnify and keep indemnified the Company, and the Company as trustee for and on behalf of any related corporation, for any Award Tax Liability and Secondary NIC Liability.
|
|
(ii) No Obligation to Issue Shares. The Company shall not be obliged to allot or deliver any Common Stock or any interest in Common Stock pursuant to this Agreement unless and until you have paid to the Company such sum as is, in the opinion of the Company, sufficient to indemnify the Company in full against the Award Tax Liability and the Secondary NIC Liability, or you have made such other arrangement as in the opinion of the Company will ensure that the full amount of any Award Tax Liability and any Secondary NIC Liability will be recovered from you within such period as the Company may then determine.
|
|
(iii) Right of Retention. In the absence of any such other arrangement being made, the Company shall have the right to retain out of the aggregate number of shares to which the you would have otherwise been entitled under this Agreement, such number of shares as, in the opinion of the Company, will enable the Company to sell as agent for you (at the best price which can reasonably expect to be obtained at the time of the sale) and to pay over to the Company sufficient monies out of the net proceeds of sale, after deduction of all fees, commissions and expenses incurred in relation to such sale, to satisfy your liability under such indemnity.
|
Data Protection
|
By entering into this Agreement, and as a condition of the grant of the units, you consent to the collection, use, and transfer of personal data, including but not limited to, name, home address and telephone number, date of birth, social insurance number, salary, nationality, job title, any stock, units or directorships held in the Company or any Subsidiary, details of all Restricted Share Units, options or other entitlement to Common Stock awarded, cancelled, exercised, vested, unvested, or outstanding in your favour (“Data”) to the full extent permitted by and in full compliance with applicable laws.
You understand that the Company and its Subsidiaries hold Data about you for the purpose of managing and administering the Plan.
You further understand that the Company and/or its Subsidiaries will transfer Data among themselves as necessary for the purposes of implementation, administration, and management of your participation in the Plan, and that the Company and/or its Subsidiary may each further transfer Data to any Data Recipients.
You understand that these Data Recipients may be located in your country of residence or elsewhere, such as the United States. You authorize the Data Recipients to receive, possess, use, retain, and transfer Data in electronic or other form, for the purposes of implementing, administering, and managing your participation in the Plan, including any transfer of such Data, as may be required for the administration of the Plan and/or the subsequent holding of Shares on your behalf, to a broker or third party with whom the Shares acquired on exercise may be deposited. Where the transfer is to be to a destination outside the European Economic Area, the Company shall take reasonable steps to ensure that your Data continues to be adequately protected and securely held.
You understand that you may, at any time, review the Data, request that any necessary amendments be made to it, or withdraw your consent herein in writing by contacting the Company. You further understand that withdrawing consent may affect your ability to participate in the Plan.
|
Additional terms
|
You have no right to compensation or damages for any loss in respect of the Award where such loss arises (or is claimed to arise), in whole or in part, from the termination of your employment; or notice to terminate employment given by or to you. This exclusion of liability shall apply however termination of employment, or the giving of notice, is caused other than in a case where a competent tribunal or court, from which there can be no appeal (or which the relevant employing company has decided not to appeal), has found that the cessation of your employment amounted to unfair or constructive dismissal of you and however compensation or damages may be claimed.
|
|
You have no right to compensation or damages for any loss in respect of the Award where such loss arises (or is claimed to arise), in whole or in part, from any company ceasing to be a Subsidiary of the Company; or the transfer of any business from a Subsidiary of the Company to any person which is not a Subsidiary of the Company. This exclusion of liability shall apply however the change of status of the relevant company, or the transfer of the relevant business, and however compensation or damages may be claimed.
|
Restrictions on Resale
|
You agree not to sell any shares at a time when applicable laws, Company policies or an agreement between the Company and its underwriters prohibit a sale. This restriction will apply as long as your Service continues and for such period of time after the termination of your Service as the Company may specify.
|
Adjustments
|
In the event of a stock split, a stock dividend or a similar change in Company stock, the number of your units will be adjusted accordingly, as the Company may determine pursuant to the Plan.
|
Effect of Merger
|
If the Company is a party to a merger, consolidation or reorganization, then your units will be subject to the applicable provision of the Plan, provided that any action taken must either (a) preserve the exemption of your units from Section 409A of the Code or (b) comply with Section 409A of the Code.
|
Applicable Law
|
This Agreement will be interpreted and enforced under the laws of the State of Delaware (without regard to their choice-of-law provisions). The Joint Election and the Section 431 Election are governed by the laws of England and Wales.
|
The Plan and Other Agreements
|
The text of the Plan is incorporated in this Agreement by reference.
The Plan, this Agreement, the Notice of Restricted Stock Unit Award, the Joint Election and the Section 431 Election constitute the entire understanding between you and the Company regarding this award. Any prior agreements, commitments or negotiations concerning this award are superseded. This Agreement may be amended only by another written agreement between the parties.
|
Definitions
|
The definitions contained in the Plan are hereby incorporated into this Agreement unless otherwise defined herein.
|
1.
|
I have reviewed this annual report on Form 10-K of Alimera Sciences, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statements 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 consolidated 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 and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
|
a.
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
b.
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision; to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
c.
|
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
d.
|
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
a.
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
b.
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
|
|
|
|
Date: March 3, 2017
|
|
|
|
/s/ C. Daniel Myers
|
|
|
|
|
C. Daniel Myers
Chief Executive Officer
(Principal Executive Officer)
|
1.
|
I have reviewed this annual report on Form 10-K of Alimera Sciences, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statements 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 consolidated 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 and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
|
a.
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
b.
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision; to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
c.
|
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
d.
|
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
a.
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
b.
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
|
|
|
|
|
|
Date: March 3, 2017
|
|
|
|
|
|
/s/ Richard S. Eiswirth, Jr.
|
|
|
|
|
|
|
Richard S. Eiswirth, Jr.
President and Chief Financial Officer
(Principal Financial and Accounting Officer)
|
|
(1)
|
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.
|
|
|
|
|
|
|
|
Date: March 3, 2017
|
|
|
|
|
|
/s/ C. Daniel Myers
|
|
|
|
|
|
|
C. Daniel Myers
|
|
|
|
|
|
|
Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
|
|
|
|
Date: March 3, 2017
|
|
|
|
|
|
/s/ Richard S. Eiswirth, Jr.
|
|
|
|
|
|
|
Richard S. Eiswirth, Jr.
|
|
|
|
|
|
|
President and Chief Financial Officer
(Principal Financial and Accounting Officer)
|