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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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20-0028718
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification Number)
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Common Stock, $0.01 par value per share
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The NASDAQ Stock Market LLC
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(Title of each class)
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(Name of each exchange on which registered)
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Large accelerated filer
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o
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Accelerated filer
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x
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Non-accelerated filer
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o
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(Do not check if a smaller reporting company)
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Smaller reporting company
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o
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Page
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Special
Note Regarding Forward-Looking Statements
and Projections
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Item 1.
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Item 1A.
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Item 1B.
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Item 2.
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Item 3.
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Item 4.
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Item 5.
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Item 6.
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Item 7.
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Item 7A.
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Item 8.
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Item 9.
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Item 9A.
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Item 9B.
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Item 10.
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Item 11.
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Item 12.
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Item 13.
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Item 14.
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Item 15.
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•
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uncertainty as to our, or our distributors
’
, ability to successfully commercialize ILUVIEN in the United States (U.S.), the European Economic Area (EEA) or any other region;
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our limited sales and marketing infrastructure;
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our ability to raise sufficient alternative or additional financing;
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our ability to operate our business in compliance with the covenants and restrictions that we are subject to under our credit facility;
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uncertainty as to the pricing and reimbursement guidelines for ILUVIEN or any future products or product candidates, including ILUVIEN;
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delay in or failure to obtain regulatory approval of ILUVIEN in additional countries or any future products or product candidates;
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our inability to successfully market and sell ILUVIEN following regulatory approval in additional markets;
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uncertainty as to the relationship between the benefits of ILUVIEN or any future products or product candidates and the risks of their side-effect profiles;
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the extent of government regulations; and
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dependence on third-party manufacturers to manufacture ILUVIEN or any future products or product candidates in sufficient quantities and quality.
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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.
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•
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Pursue Approval in Additional Countries
. We plan to pursue regulatory approval for ILUVIEN, directly or with a partner, in other countries. We entered into distribution agreements to distribute ILUVIEN in numerous countries in the Middle East, Canada and Australia. In addition, under a Mutual Recognition Procedure (MRP) available in the EEA, we can submit ILUVIEN for approval in any or all of the remaining 12 European Union (EU) countries where we do not have marketing approval.
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Assess the Effectiveness of ILUVIEN for Additional Retinal Diseases
. We believe that ILUVIEN has the potential to address additional retinal diseases including, among others, retinal vein occlusion (RVO), dry AMD and wet AMD.
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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 leverage our management’s expertise and its broad network of relationships to continue to evaluate in-licensing and acquisition opportunities for compounds and technologies with potential treatment applications for diseases affecting the eye.
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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.
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ILUVIEN delivers a constant daily micro-dose of a steroid to the eye.
The delivery mechanism of ILUVIEN provides lower daily and aggregate exposure to corticosteroids than other intraocular dosage forms currently available. In vitro release kinetics have shown that ILUVIEN provides sustained sub-microgram levels of FAc and in vivo over time. Based on the results of our FAME Study, ILUVIEN provides a sustained, therapeutic effect in the treatment of DME patients for up to 36 months.
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•
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ILUVIEN is inserted using a 25-gauge needle.
Needle gauge determines the size of the wound that is created. ILUVIEN is inserted into the eye in a non-surgical procedure using a 25-gauge needle, which results in a wound that is small enough to seal itself after the needle is removed, thus eliminating the need for additional intervention. Using a larger needle would require a more complicated procedure to create a self-sealing wound, or may require a suture to ensure closure of the wound.
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•
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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 retinal vein occlusion. The Food and Drug Administration
’
s (FDA) approval of Ozurdex provides additional evidence that corticosteroids work effectively to treat RVO.
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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.
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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 age-related macular degeneration 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.
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Roche’s products Lucentis (ranibizumab injection) and Avastin (bevacizumab) are both antibodies that inhibit VEGF pathways. Lucentis is marketed in the EEA by Novartis. Lucentis is currently approved for 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. and the EEA. 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.
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Regeneron
’
s Eylea (aflibercept), a anti-VEGF inhibitor, is approved for the treatment of diabetic retinopathy in patients with DME, neovascular wet AMD and RVO in the U.S. and in the EEA. Eylea is marketed in the EEA by Bayer.
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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 both the U.S. and the EEA.
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cost of treatment;
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pricing and availability of alternative products;
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our ability to obtain third-party coverage or reimbursement for ILUVIEN at appropriate levels;
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perceived prevalence and severity of adverse side effects associated with treatment;
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perceived efficacy relative to other available therapies;
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relative convenience and ease of administration; and
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shifts in the medical community to new treatment paradigms or standards of care.
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the level of success of the commercialization of ILUVIEN in the U.S., Germany, Portugal and the United Kingdom,
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expenses relating to the commercialization of ILUVIEN;
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the timing of approvals, if any, of ILUVIEN in additional jurisdictions;
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the need and cost of conducting additional clinical trials for ILUVIEN;
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the amount of our research, development and medical affairs, marketing and general and administrative expenses;
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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;
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the extent to which we acquire, and our success in integrating, technologies or companies;
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the extent to which we can manage the use of cash in our business operations; and
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regulatory changes and technological developments in our markets.
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extended collection timelines for accounts receivable and greater working capital requirements;
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multiple legal systems and unexpected changes in legal requirements;
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tariffs, export restrictions, trade barriers and other regulatory or contractual limitations on our ability to sell or develop our products in certain foreign markets;
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trade laws and business practices favoring local competition;
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potential tax issues, including restrictions on repatriating earnings, multiple and conflicting and complex tax laws and regulations;
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weaker intellectual property protection in some countries;
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political instability, including war and terrorism or the threat of war and terrorism; and
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adverse economic conditions, including the stability and solvency of business financial markets, financial institutions and sovereign nations.
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our inability to recruit and retain adequate numbers of effective personnel;
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the inability of sales personnel to obtain access to or persuade adequate numbers of ophthalmologists to prescribe our products;
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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;
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the inability of market access personnel to obtain sufficient levels of pricing and reimbursement in each jurisdiction; and
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unforeseen costs and expenses associated with creating a commercial organization.
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regulatory agencies may interpret data from preclinical and clinical testing in different ways from those which we do;
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they may not approve of our manufacturing processes;
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a drug candidate may not be safe or effective;
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they may conclude that the drug candidate does not meet quality standards for stability, quality, purity and potency; and
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they may change their approval policies or adopt new regulations.
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the commercial success of ILUVIEN;
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our ability to obtain regulatory approval of ILUVIEN in additional jurisdictions;
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sales, marketing and medical affairs expenses;
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manufacturing or supply issues;
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regulatory developments affecting ILUVIEN, our future product candidates or our competitors’ products;
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the emergence of products that compete with ILUVIEN;
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cost of product sales;
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variations in the level of expenses related to our products or future development programs;
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the timing and amount of royalties or milestone payments;
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the status of our preclinical and clinical development programs;
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our execution of collaborative, licensing or other arrangements, and the timing of payments we may make or receive under these arrangements;
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any intellectual property infringement or other lawsuit in which we may become involved; and
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the timing and recognition of stock-based compensation expense.
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Mandatory rebates for drugs sold into the Medicaid program have been increased, and the rebate requirement has been extended to drugs used in risk-based Medicaid managed care plans.
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The 340B Drug Pricing Program under the Public Health Services Act has been extended to require mandatory discounts for drug products sold to certain critical access hospitals, cancer hospitals and other covered entities.
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Pharmaceutical companies are required to offer discounts on brand-name drugs to patients who fall within the Medicare Part D coverage gap, commonly referred to as the “Donut Hole.”
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Pharmaceutical companies are required to pay an annual non-tax deductible fee to the federal government based on each company’s market share of prior year total sales of branded products to certain federal healthcare programs, such as Medicare, Medicaid, Department of Veterans Affairs and Department of Defense. The aggregate industry wide fee is expected to total $28 billion through 2019, of which $3.0 billion will be payable in 2016. Since we expect our branded pharmaceutical sales to constitute a small portion of the total federal health program pharmaceutical market, we do not expect this annual assessment to have a material impact on our financial condition.
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The law provides that biologic products may receive 12 years of market exclusivity, with a possible six-month extension for pediatric products. After this exclusivity ends, generic manufacturers will be permitted to enter the market, which is likely to reduce the pricing for such products and could affect the company’s profitability. In addition, generic manufacturers will be permitted to challenge one or more of the patents for a branded drug after a product is marketed for four years.
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are more effective;
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have fewer or less severe adverse side effects;
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are better tolerated;
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receive better reimbursement terms;
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are more accepted by physicians;
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are more adaptable to various modes of dosing;
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have better distribution channels;
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are easier to administer; or
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are less expensive, including but not limited to a generic version of ILUVIEN.
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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;
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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;
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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
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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;
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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.
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the research methodology used may not be successful in identifying potential products or product candidates; or
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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.
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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;
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companies that perceive us to be their competitors may be unwilling to assign or license their product rights to us; or
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we may be unable to identify suitable products or product candidates within our areas of expertise.
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our inability to manufacture or obtain from third-parties materials sufficient for use in preclinical studies and clinical trials;
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delays in patient enrollment and variability in the number and types of patients available for clinical trials;
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difficulty in maintaining contact with patients after treatment, resulting in incomplete data;
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poor effectiveness of product candidates during clinical trials;
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unforeseen safety issues or side effects; and
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governmental or regulatory delays and changes in regulatory requirements and guidelines.
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failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
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inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;
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unforeseen safety issues or any determination that a trial presents unacceptable health risks; and
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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.
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our ability to successfully commercialize ILUVIEN in the U.S., Germany, Portugal and the United Kingdom;
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the ability of ILUVIEN to be approved in any additional jurisdiction;
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the ability of ILUVIEN or any future products or product candidates, if approved in additional jurisdictions, to achieve commercial success;
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FDA or international regulatory actions, including failure to receive or maintain regulatory approval for ILUVIEN or any future products or product candidates;
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quarterly variations in our results of operations or those of our competitors;
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announcements by us or our competitors of acquisitions, regulatory approvals, clinical milestones, new products, significant contracts, commercial relationships or capital commitments;
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third-party coverage and reimbursement policies;
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our ability to meet our repayment and other obligations under our loan agreements;
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additions or departures of key personnel;
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commencement of, or our involvement in, litigation;
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changes in governmental regulations or in the status of our regulatory approvals;
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changes in earnings estimates or recommendations by securities analysts;
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any major change in our board of directors or management;
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results from our clinical trial programs;
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our ability to develop and market new and enhanced products or product candidates on a timely basis;
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general economic conditions and slow or negative growth of our markets; and
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political instability, natural disasters, war and/or events of terrorism.
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increase or decrease the authorized number of shares of Series A Convertible Preferred Stock;
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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;
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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;
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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;
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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;
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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
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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.
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authorize the issuance of “blank check” preferred stock that could be issued by our Board of Directors to thwart a takeover attempt;
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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;
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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;
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require that directors only be removed from office for cause;
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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;
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contain certain protective provisions in favor of the holders of Series A Convertible Preferred Stock;
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limit who may call special meetings of stockholders;
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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
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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.
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Year Ended December 31, 2015
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High
|
|
Low
|
||||
First quarter 2015
|
$
|
5.92
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|
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$
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4.12
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Second quarter 2015
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$
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5.18
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|
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$
|
3.98
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Third quarter 2015
|
$
|
5.03
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|
|
$
|
1.94
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Fourth quarter 2015
|
$
|
3.45
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|
|
$
|
2.00
|
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Year Ended December 31, 2014
|
High
|
|
Low
|
||||
First quarter 2014
|
$
|
8.44
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|
|
$
|
4.29
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Second quarter 2014
|
$
|
8.36
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|
|
$
|
5.00
|
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Third quarter 2014
|
$
|
6.54
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|
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$
|
4.58
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Fourth quarter 2014
|
$
|
6.48
|
|
|
$
|
4.64
|
|
|
Years Ended December 31,
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||||||||||||||||||
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2015
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2014
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2013
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2012
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2011
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||||||||||
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(In thousands, except share and per share data)
|
||||||||||||||||||
NET REVENUE
|
$
|
22,438
|
|
|
$
|
8,423
|
|
|
$
|
1,872
|
|
|
$
|
—
|
|
|
$
|
—
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(1,762
|
)
|
|
(1,442
|
)
|
|
(1,863
|
)
|
|
—
|
|
|
—
|
|
|||||
GROSS PROFIT
|
20,676
|
|
|
6,981
|
|
|
9
|
|
|
—
|
|
|
—
|
|
|||||
|
|
|
|
|
|
|
|
|
|
||||||||||
OPERATING EXPENSES
|
59,675
|
|
|
39,928
|
|
|
34,413
|
|
|
22,039
|
|
|
21,407
|
|
|||||
NET LOSS FROM OPERATIONS
|
(38,999
|
)
|
|
(32,947
|
)
|
|
(34,404
|
)
|
|
(22,039
|
)
|
|
(21,407
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
||||||||||
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS
|
$
|
(30,645
|
)
|
|
$
|
(36,660
|
)
|
|
$
|
(51,179
|
)
|
|
$
|
(19,746
|
)
|
|
$
|
(22,516
|
)
|
NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS — Basic and diluted
|
$
|
(0.69
|
)
|
|
$
|
(0.91
|
)
|
|
$
|
(1.62
|
)
|
|
$
|
(0.63
|
)
|
|
$
|
(0.72
|
)
|
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted
|
44,450,216
|
|
|
40,397,224
|
|
|
31,579,553
|
|
|
31,462,120
|
|
|
31,362,574
|
|
•
|
continue the commercialization of ILUVIEN in the U.S. and EEA;
|
•
|
continue to seek regulatory approval of ILUVIEN in other jurisdictions;
|
•
|
evaluate the use of ILUVIEN for the treatment of other diseases; and
|
•
|
advance the clinical development of any future products or product candidates either currently in our pipeline, or that we may license or acquire in the future.
|
•
|
salaries and related expenses for personnel, including medical sales liaisons;
|
•
|
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;
|
•
|
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;
|
•
|
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,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
(In thousands)
|
||||||||||
NET REVENUE
|
$
|
15,170
|
|
|
$
|
17
|
|
|
$
|
—
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(792
|
)
|
|
(1
|
)
|
|
—
|
|
|||
GROSS PROFIT
|
14,378
|
|
|
16
|
|
|
—
|
|
|||
|
|
|
|
|
|
||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
9,712
|
|
|
5,400
|
|
|
4,110
|
|
|||
GENERAL AND ADMINISTRATIVE EXPENSES
|
8,244
|
|
|
7,496
|
|
|
5,048
|
|
|||
SALES AND MARKETING EXPENSES
|
19,777
|
|
|
4,704
|
|
|
891
|
|
|||
DEPRECIATION AND AMORTIZATION
|
2,491
|
|
|
657
|
|
|
138
|
|
|||
OPERATING EXPENSES
|
40,224
|
|
|
18,257
|
|
|
10,187
|
|
|||
NET LOSS FROM OPERATIONS
|
$
|
(25,846
|
)
|
|
$
|
(18,241
|
)
|
|
$
|
(10,187
|
)
|
|
Years Ended
December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
(In thousands)
|
||||||||||
NET REVENUE
|
$
|
7,268
|
|
|
$
|
8,406
|
|
|
$
|
1,872
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(970
|
)
|
|
(1,441
|
)
|
|
(1,863
|
)
|
|||
GROSS PROFIT
|
6,298
|
|
|
6,965
|
|
|
9
|
|
|||
|
|
|
|
|
|
||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
5,128
|
|
|
6,411
|
|
|
4,748
|
|
|||
GENERAL AND ADMINISTRATIVE EXPENSES
|
5,946
|
|
|
4,875
|
|
|
4,427
|
|
|||
SALES AND MARKETING EXPENSES
|
8,313
|
|
|
10,383
|
|
|
15,051
|
|
|||
DEPRECIATION AND AMORTIZATION
|
64
|
|
|
2
|
|
|
—
|
|
|||
OPERATING EXPENSES
|
19,451
|
|
|
21,671
|
|
|
24,226
|
|
|||
NET LOSS FROM OPERATIONS
|
$
|
(13,153
|
)
|
|
$
|
(14,706
|
)
|
|
$
|
(24,217
|
)
|
|
Years Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
(In thousands)
|
||||||||||
NET LOSS FROM OPERATIONS
|
$
|
(38,999
|
)
|
|
$
|
(32,947
|
)
|
|
$
|
(34,404
|
)
|
|
|
|
|
|
|
||||||
INTEREST EXPENSE AND OTHER
|
(4,693
|
)
|
|
(2,090
|
)
|
|
(533
|
)
|
|||
UNREALIZED FOREIGN CURRENCY (LOSS) GAIN, NET
|
(106
|
)
|
|
(542
|
)
|
|
825
|
|
|||
LOSS ON EARLY EXTINGUISHMENT OF DEBT
|
—
|
|
|
(440
|
)
|
|
(153
|
)
|
|||
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY
|
13,283
|
|
|
283
|
|
|
(11,964
|
)
|
|||
NET LOSS BEFORE TAXES
|
(30,515
|
)
|
|
(35,736
|
)
|
|
(46,229
|
)
|
|||
PROVISION FOR TAXES
|
(130
|
)
|
|
(174
|
)
|
|
—
|
|
|||
NET LOSS
|
$
|
(30,645
|
)
|
|
$
|
(35,910
|
)
|
|
$
|
(46,229
|
)
|
|
Payments Due by Future Period
|
||||||||||||||||||
|
Total
|
|
Less than 1 Year
|
|
1-3 Years
|
|
3-5 Years
|
|
5+ Years
|
||||||||||
|
(in thousands)
|
||||||||||||||||||
Note payable (1)
|
$
|
35,000
|
|
|
$
|
35,000
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating leases
|
2,816
|
|
|
557
|
|
|
1,641
|
|
|
618
|
|
|
—
|
|
|||||
Capital leases
|
1,284
|
|
|
396
|
|
|
888
|
|
|
—
|
|
|
—
|
|
|||||
Total
|
$
|
39,100
|
|
|
$
|
35,953
|
|
|
$
|
2,529
|
|
|
$
|
618
|
|
|
$
|
—
|
|
•
|
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
|
9,475,890
|
|
(1)
|
$
|
3.43
|
|
|
830,812
|
|
(2)
|
Equity compensation plans not approved by security holders
|
—
|
|
|
—
|
|
|
—
|
|
|
|
Total
|
9,475,890
|
|
|
$
|
3.43
|
|
|
830,812
|
|
|
(1)
|
Of these shares, 8,104,754 were subject to options then outstanding under the 2010 Plan, 68,190 were subject to options then outstanding under the 2005 Plan and 1,302,946 were subject to options then outstanding under the 2004 Plan.
|
(2)
|
Represents 408,651 shares of common stock available for issuance under our 2010 Plan and 422,161 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, 2016, an additional 1,800,233 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, 2016, an additional 72,261 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 15, 2016
|
C. Daniel Myers
|
|
|
|
|
|
|
|
|
|
/s/ Richard S. Eiswirth, Jr.
|
|
President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
|
|
March 15, 2016
|
Richard S. Eiswirth, Jr.
|
|
|
|
|
|
|
|
|
|
/s/ James R. Largent
|
|
Chairman of the Board of Directors
|
|
March 15, 2016
|
James R. Largent
|
|
|
|
|
|
|
|
|
|
/s/ Mark J. Brooks
|
|
Director
|
|
March 15, 2016
|
Mark J. Brooks
|
|
|
|
|
|
|
|
|
|
/s/ Brian K. Halak, Ph.D.
|
|
Director
|
|
March 15, 2016
|
Brian K. Halak, Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/ Peter J. Pizzo, III
|
|
Director
|
|
March 15, 2016
|
Peter J. Pizzo, III
|
|
|
|
|
|
|
|
|
|
/s/ Calvin W. Roberts, M.D.
|
|
Director
|
|
March 15, 2016
|
Calvin W. Roberts, M.D.
|
|
|
|
|
|
|
|
|
|
/s/ Glen Bradley, Ph.D.
|
|
Director
|
|
March 15, 2016
|
Glen Bradley, Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/ Garheng Kong, M.D., Ph.D.
|
|
Director
|
|
March 15, 2016
|
Garheng Kong, M.D., Ph.D.
|
|
|
|
|
|
Page
|
Consolidated Financial Statements as of December 31, 2015 and 2014 and for the years ended December 31, 2015, 2014 and 2013:
|
|
Consolidated
Balance Sheets
|
|
Consolidated
Statements of Operations
|
|
Consolidated
Statements of Cash Flows
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
|
(In thousands, except share and per share data)
|
||||||
CURRENT ASSETS:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
31,075
|
|
|
$
|
76,697
|
|
Restricted cash
|
37
|
|
|
—
|
|
||
Accounts receivable, net
|
9,799
|
|
|
850
|
|
||
Prepaid expenses and other current assets
|
2,696
|
|
|
3,234
|
|
||
Inventory, net (Note 4)
|
1,552
|
|
|
1,734
|
|
||
Total current assets
|
45,159
|
|
|
82,515
|
|
||
NON-CURRENT ASSETS:
|
|
|
|
||||
Property and equipment — at cost less accumulated depreciation
|
2,553
|
|
|
1,653
|
|
||
Intangible asset, net
|
22,549
|
|
|
24,490
|
|
||
Deferred tax asset
|
223
|
|
|
—
|
|
||
TOTAL ASSETS
|
$
|
70,484
|
|
|
$
|
108,658
|
|
CURRENT LIABILITIES:
|
|
|
|
||||
Accounts payable
|
$
|
4,002
|
|
|
$
|
5,021
|
|
Accrued expenses (Note 7)
|
3,594
|
|
|
954
|
|
||
Accrued milestone payments
|
—
|
|
|
2,000
|
|
||
Outsourced services payable
|
317
|
|
|
1,466
|
|
||
Note payable (Note 9)
|
31,786
|
|
|
1,023
|
|
||
Capital lease obligations
|
234
|
|
|
11
|
|
||
Total current liabilities
|
39,933
|
|
|
10,475
|
|
||
NON-CURRENT LIABILITIES:
|
|
|
|
||||
Derivative warrant liability
|
2,815
|
|
|
16,098
|
|
||
Note payable — less current portion (Note 9)
|
—
|
|
|
32,311
|
|
||
Capital lease obligations — less current portion
|
582
|
|
|
8
|
|
||
Other non-current liabilities
|
834
|
|
|
247
|
|
||
COMMITMENTS AND CONTINGENCIES (Note 10)
|
|
|
|
|
|
||
STOCKHOLDERS’ EQUITY:
|
|
|
|
||||
Preferred stock, $.01 par value — 10,000,000 shares authorized at December 31, 2015 and 2014:
|
|
|
|
|
|
||
Series A Convertible Preferred Stock, 1,300,000 authorized and 600,000 issued and outstanding at December 31, 2015 and 2014; liquidation preference of $24,000 at December 31, 2015 and 2014
|
19,227
|
|
|
19,227
|
|
||
Series B Convertible Preferred Stock, 8,417 authorized and 8,416.251 issued and outstanding at December 31, 2015 and 2014; liquidation preference of $50,750 at December 31, 2015 and 2014
|
49,568
|
|
|
49,568
|
|
||
Common stock, $.01 par value — 100,000,000 shares authorized, 45,005,833 shares issued and outstanding at December 31, 2015 and 44,320,342 shares issued and outstanding at December 31, 2014
|
450
|
|
|
443
|
|
||
Additional paid-in capital
|
299,376
|
|
|
292,851
|
|
||
Common stock warrants
|
2,747
|
|
|
1,497
|
|
||
Accumulated deficit
|
(343,900
|
)
|
|
(313,255
|
)
|
||
Accumulated other comprehensive loss
|
(1,148
|
)
|
|
(812
|
)
|
||
TOTAL STOCKHOLDERS’ EQUITY
|
26,320
|
|
|
49,519
|
|
||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
70,484
|
|
|
$
|
108,658
|
|
|
Years Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
(In thousands, except share and per share data)
|
||||||||||
NET REVENUE
|
$
|
22,438
|
|
|
$
|
8,423
|
|
|
$
|
1,872
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(1,762
|
)
|
|
(1,442
|
)
|
|
(1,863
|
)
|
|||
GROSS PROFIT
|
20,676
|
|
|
6,981
|
|
|
9
|
|
|||
|
|
|
|
|
|
||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
14,840
|
|
|
11,811
|
|
|
8,858
|
|
|||
GENERAL AND ADMINISTRATIVE EXPENSES
|
14,190
|
|
|
12,371
|
|
|
9,475
|
|
|||
SALES AND MARKETING EXPENSES
|
28,090
|
|
|
15,087
|
|
|
15,942
|
|
|||
DEPRECIATION AND AMORTIZATION
|
2,555
|
|
|
659
|
|
|
138
|
|
|||
OPERATING EXPENSES
|
59,675
|
|
|
39,928
|
|
|
34,413
|
|
|||
NET LOSS FROM OPERATIONS
|
(38,999
|
)
|
|
(32,947
|
)
|
|
(34,404
|
)
|
|||
|
|
|
|
|
|
||||||
INTEREST EXPENSE AND OTHER
|
(4,693
|
)
|
|
(2,090
|
)
|
|
(533
|
)
|
|||
UNREALIZED FOREIGN CURRENCY (LOSS) GAIN, NET
|
(106
|
)
|
|
(542
|
)
|
|
825
|
|
|||
LOSS ON EARLY EXTINGUISHMENT OF DEBT
|
—
|
|
|
(440
|
)
|
|
(153
|
)
|
|||
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY
|
13,283
|
|
|
283
|
|
|
(11,964
|
)
|
|||
NET LOSS BEFORE TAXES
|
(30,515
|
)
|
|
(35,736
|
)
|
|
(46,229
|
)
|
|||
PROVISION FOR TAXES
|
(130
|
)
|
|
(174
|
)
|
|
—
|
|
|||
NET LOSS
|
(30,645
|
)
|
|
(35,910
|
)
|
|
(46,229
|
)
|
|||
BENEFICIAL CONVERSION FEATURE OF PREFERRED STOCK
(Note 11)
|
—
|
|
|
(750
|
)
|
|
(4,950
|
)
|
|||
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS
|
$
|
(30,645
|
)
|
|
$
|
(36,660
|
)
|
|
$
|
(51,179
|
)
|
NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS — Basic and diluted
|
$
|
(0.69
|
)
|
|
$
|
(0.91
|
)
|
|
$
|
(1.62
|
)
|
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted
|
44,450,216
|
|
|
40,397,224
|
|
|
31,579,553
|
|
|
Years Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
(In thousands)
|
||||||||||
NET LOSS
|
$
|
(30,645
|
)
|
|
$
|
(35,910
|
)
|
|
$
|
(46,229
|
)
|
|
|
|
|
|
|
||||||
OTHER COMPREHENSIVE LOSS
|
|
|
|
|
|
||||||
Foreign currency translation adjustments
|
(336
|
)
|
|
(324
|
)
|
|
(488
|
)
|
|||
TOTAL OTHER COMPREHENSIVE LOSS
|
(336
|
)
|
|
(324
|
)
|
|
(488
|
)
|
|||
COMPREHENSIVE LOSS
|
$
|
(30,981
|
)
|
|
$
|
(36,234
|
)
|
|
$
|
(46,717
|
)
|
|
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
|
|
|
|||||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
Total
|
|||||||||||||||||||||||
|
(In thousands, except share data)
|
|||||||||||||||||||||||||||||||||||||||
BALANCE — December 31, 2012
|
31,541,286
|
|
|
$
|
315
|
|
|
1,000,000
|
|
|
$
|
32,045
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
237,485
|
|
|
$
|
415
|
|
|
$
|
(231,116
|
)
|
|
$
|
—
|
|
|
$
|
39,144
|
|
Issuance of common stock
|
26,123
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
53
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
53
|
|
||||||||
Exercise of stock options
|
43,582
|
|
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
71
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
72
|
|
||||||||
Modification of common stock warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
46
|
|
|
—
|
|
|
—
|
|
|
46
|
|
||||||||
Forfeiture of common stock warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
49
|
|
|
(49
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Intrinsic value of beneficial conversion feature
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,950
|
)
|
|
—
|
|
|
—
|
|
|
4,950
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Accretion of beneficial conversion feature
|
—
|
|
|
—
|
|
|
—
|
|
|
4,950
|
|
|
—
|
|
|
—
|
|
|
(4,950
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Issuance of preferred stock, net of issuance costs
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,477
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,477
|
|
||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(46,229
|
)
|
|
—
|
|
|
(46,229
|
)
|
||||||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(488
|
)
|
|
(488
|
)
|
||||||||
BALANCE — December 31, 2013
|
31,610,991
|
|
|
316
|
|
|
1,000,000
|
|
|
32,045
|
|
|
—
|
|
|
—
|
|
|
240,135
|
|
|
412
|
|
|
(277,345
|
)
|
|
(488
|
)
|
|
(4,925
|
)
|
||||||||
Issuance of common stock, net of issuance costs
|
6,284,915
|
|
|
63
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
35,146
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
35,209
|
|
||||||||
Exercise of stock options
|
391,307
|
|
|
4
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
770
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
774
|
|
||||||||
Issuance of preferred stock, net of issuance costs
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
8,416
|
|
|
49,568
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
49,568
|
|
||||||||
Conversion of preferred stock
|
6,015,037
|
|
|
60
|
|
|
(400,000
|
)
|
|
(12,818
|
)
|
|
—
|
|
|
—
|
|
|
12,758
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Issuance of common stock warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,277
|
|
|
—
|
|
|
—
|
|
|
1,277
|
|
||||||||
Exercise of common stock warrants
|
18,092
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
192
|
|
|
(192
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Intrinsic value of beneficial conversion feature
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(750
|
)
|
|
750
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Accretion of beneficial conversion feature
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
750
|
|
|
(750
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,850
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,850
|
|
||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(35,910
|
)
|
|
—
|
|
|
(35,910
|
)
|
||||||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(324
|
)
|
|
(324
|
)
|
||||||||
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
|
|
|
Years Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
(In thousands)
|
||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(30,645
|
)
|
|
$
|
(35,910
|
)
|
|
$
|
(46,229
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||
Depreciation and amortization
|
2,555
|
|
|
659
|
|
|
138
|
|
|||
Inventory reserve
|
445
|
|
|
857
|
|
|
410
|
|
|||
Unrealized foreign currency transaction loss (gain)
|
106
|
|
|
542
|
|
|
(825
|
)
|
|||
Amortization of debt discount
|
836
|
|
|
466
|
|
|
159
|
|
|||
Deferred taxes (benefit)
|
(223
|
)
|
|
—
|
|
|
—
|
|
|||
Loss on early extinguishment of debt
|
—
|
|
|
440
|
|
|
153
|
|
|||
Stock compensation expense
|
5,037
|
|
|
3,850
|
|
|
2,477
|
|
|||
Change in fair value of derivative warrant liability
|
(13,283
|
)
|
|
(283
|
)
|
|
11,964
|
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable
|
(8,919
|
)
|
|
(444
|
)
|
|
(483
|
)
|
|||
Prepaid expenses and other current assets
|
405
|
|
|
206
|
|
|
(1,355
|
)
|
|||
Inventory
|
(386
|
)
|
|
(992
|
)
|
|
(1,416
|
)
|
|||
Accounts payable
|
(487
|
)
|
|
2,987
|
|
|
(259
|
)
|
|||
Accrued expenses and other current liabilities
|
(1,401
|
)
|
|
3,077
|
|
|
(2,347
|
)
|
|||
Other long-term liabilities
|
596
|
|
|
244
|
|
|
(208
|
)
|
|||
Net cash used in operating activities
|
(45,364
|
)
|
|
(24,301
|
)
|
|
(37,821
|
)
|
|||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
||||||
Payment of license intangible (Note 6)
|
—
|
|
|
(25,000
|
)
|
|
—
|
|
|||
Purchases of property and equipment
|
(451
|
)
|
|
(842
|
)
|
|
(973
|
)
|
|||
Net cash used in investing activities
|
(451
|
)
|
|
(25,842
|
)
|
|
(973
|
)
|
|||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
||||||
Proceeds from exercise of stock options
|
571
|
|
|
774
|
|
|
72
|
|
|||
Proceeds from sale of common stock
|
1,002
|
|
|
37,598
|
|
|
53
|
|
|||
Payment of issuance cost of common stock
|
(27
|
)
|
|
(2,389
|
)
|
|
—
|
|
|||
Proceeds from issuance of Series B convertible preferred stock
|
—
|
|
|
50,000
|
|
|
—
|
|
|||
Payment of Series B convertible preferred stock offering costs
|
(327
|
)
|
|
(105
|
)
|
|
—
|
|
|||
Proceeds from issuance of notes payable (Note 9)
|
—
|
|
|
35,000
|
|
|
5,000
|
|
|||
Payment of debt issuance costs (Note 9)
|
(264
|
)
|
|
(1,016
|
)
|
|
(291
|
)
|
|||
Payment of principal on notes payable
|
—
|
|
|
(4,861
|
)
|
|
(3,169
|
)
|
|||
Payment of debt extinguishment costs
|
—
|
|
|
(246
|
)
|
|
—
|
|
|||
Payments on capital lease obligations
|
(293
|
)
|
|
(10
|
)
|
|
(11
|
)
|
|||
Changes in restricted cash
|
(37
|
)
|
|
—
|
|
|
—
|
|
|||
Net cash provided by financing activities
|
625
|
|
|
114,745
|
|
|
1,654
|
|
|||
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS
|
(432
|
)
|
|
(533
|
)
|
|
204
|
|
|||
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
|
(45,622
|
)
|
|
64,069
|
|
|
(36,936
|
)
|
|||
CASH AND CASH EQUIVALENTS — Beginning of year
|
76,697
|
|
|
12,628
|
|
|
49,564
|
|
|||
CASH AND CASH EQUIVALENTS — End of year
|
$
|
31,075
|
|
|
$
|
76,697
|
|
|
$
|
12,628
|
|
SUPPLEMENTAL DISCLOSURES:
|
|
|
|
|
|
||||||
Cash paid for interest
|
$
|
4,177
|
|
|
$
|
1,247
|
|
|
$
|
607
|
|
Cash paid for income taxes
|
$
|
263
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Supplemental schedule of noncash investing and financing activities:
|
|
|
|
|
|
||||||
Property and equipment acquired under capital leases
|
$
|
1,098
|
|
|
$
|
—
|
|
|
$
|
33
|
|
Note payable end of term payment accrued but unpaid
|
$
|
1,050
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Common Stock offering costs accrued but unpaid
|
$
|
52
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Series B Convertible Preferred Stock offering costs accrued but unpaid
|
$
|
—
|
|
|
$
|
327
|
|
|
$
|
—
|
|
Conversion of Series A Convertible Preferred Stock to common stock
|
$
|
—
|
|
|
$
|
12,818
|
|
|
$
|
—
|
|
1.
|
NATURE OF OPERATIONS
|
2.
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
|
Years Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
(in thousands)
|
||||||||||
Beginning balance
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Bad debt expense
|
118
|
|
|
21
|
|
|
—
|
|
|||
Write-offs
|
—
|
|
|
(21
|
)
|
|
—
|
|
|||
Ending balance
|
$
|
118
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Years Ended December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Series A convertible preferred stock
|
9,022,556
|
|
|
9,022,556
|
|
|
15,037,594
|
|
Series B convertible preferred stock
|
8,416,251
|
|
|
8,416,251
|
|
|
—
|
|
Series A convertible preferred stock warrants
|
4,511,279
|
|
|
4,511,279
|
|
|
4,511,279
|
|
Common stock warrants
|
738,331
|
|
|
362,970
|
|
|
109,772
|
|
Stock options
|
9,475,890
|
|
|
7,681,256
|
|
|
7,566,437
|
|
Total
|
32,164,307
|
|
|
29,994,312
|
|
|
27,225,082
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
|
(In thousands)
|
||||||
Furniture and fixtures
|
$
|
376
|
|
|
$
|
367
|
|
Office equipment
|
794
|
|
|
652
|
|
||
Automobiles
|
1,028
|
|
|
—
|
|
||
Software
|
902
|
|
|
601
|
|
||
Leasehold improvements
|
439
|
|
|
417
|
|
||
Manufacturing equipment
|
970
|
|
|
974
|
|
||
Total property and equipment
|
4,509
|
|
|
3,011
|
|
||
Less accumulated depreciation and amortization
|
(1,956
|
)
|
|
(1,358
|
)
|
||
Property and equipment — net
|
$
|
2,553
|
|
|
$
|
1,653
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
|
(In thousands)
|
||||||
Accrued clinical investigator expenses
|
$
|
732
|
|
|
$
|
309
|
|
Accrued other compensation expenses
|
804
|
|
|
226
|
|
||
Accrued rebate, chargeback and other revenue reserves
|
452
|
|
|
—
|
|
||
Accrued End of Term Payment (Note 9)
|
1,050
|
|
|
—
|
|
||
Other accrued expenses
|
556
|
|
|
419
|
|
||
Total accrued expenses
|
$
|
3,594
|
|
|
$
|
954
|
|
Years Ending December 31
|
(In thousands)
|
||
2016
|
$
|
35,000
|
|
Total
|
$
|
35,000
|
|
Years Ending December 31
|
(In thousands)
|
||
2016
|
$
|
396
|
|
2017
|
391
|
|
|
2018
|
380
|
|
|
2019
|
117
|
|
|
Total
|
1,284
|
|
|
Less amount representing interest
|
(96
|
)
|
|
Less amount representing executory costs
|
(372
|
)
|
|
Present value of minimum lease payments
|
816
|
|
|
Less current portion
|
(234
|
)
|
|
Non-current portion
|
$
|
582
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
|
(In thousands)
|
||||||
Automobiles
|
$
|
1,028
|
|
|
$
|
—
|
|
Office equipment
|
63
|
|
|
33
|
|
||
Less accumulated depreciation
|
(212
|
)
|
|
(16
|
)
|
||
Total
|
$
|
879
|
|
|
$
|
17
|
|
|
Years Ended December 31,
|
||||||||||||||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||||||||||||||
|
Options
|
|
Weighted
Average
Exercise
Price
|
|
Options
|
|
Weighted
Average
Exercise
Price
|
|
Options
|
|
Weighted
Average
Exercise
Price
|
||||||||||||
Options outstanding at beginning of period
|
7,681,256
|
|
|
$
|
3.03
|
|
|
7,566,438
|
|
|
$
|
2.74
|
|
|
5,493,079
|
|
|
$
|
2.67
|
|
|||
Grants
|
2,570,000
|
|
|
4.62
|
|
|
716,500
|
|
|
5.56
|
|
|
2,630,000
|
|
|
2.71
|
|
||||||
Forfeitures
|
(431,114
|
)
|
|
4.79
|
|
|
(210,375
|
)
|
|
3.10
|
|
|
(513,059
|
)
|
|
1.96
|
|
||||||
Exercises
|
(344,252
|
)
|
|
1.66
|
|
|
(391,307
|
)
|
|
1.97
|
|
|
(43,582
|
)
|
|
1.64
|
|
||||||
Options outstanding at year end
|
9,475,890
|
|
|
3.43
|
|
|
7,681,256
|
|
|
3.03
|
|
|
7,566,438
|
|
|
2.74
|
|
||||||
Options exercisable at year end
|
5,808,528
|
|
|
3.27
|
|
|
4,452,274
|
|
|
3.17
|
|
|
3,304,981
|
|
|
3.09
|
|
||||||
Weighted average per share fair value of options granted during the year
|
$
|
3.58
|
|
|
|
|
$
|
4.43
|
|
|
|
|
$
|
2.14
|
|
|
|
|
Years Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Risk-free interest rate
|
1.55
|
%
|
|
1.79
|
%
|
|
1.73
|
%
|
|||
Volatility factor
|
96.80
|
%
|
|
102.54
|
%
|
|
100.76
|
%
|
|||
Grant date fair value of common stock options
|
$
|
3.58
|
|
|
$
|
4.43
|
|
|
$
|
2.14
|
|
Weighted-average expected life
|
6.03 years
|
|
|
5.89 years
|
|
|
5.92 years
|
|
|||
Assumed forfeiture rate
|
10.00
|
%
|
|
10.00
|
%
|
|
10.00
|
%
|
|
Years Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
(In thousands)
|
||||||||||
Sales and marketing
|
$
|
925
|
|
|
$
|
548
|
|
|
$
|
366
|
|
Research, development and medical affairs
|
1,271
|
|
|
981
|
|
|
504
|
|
|||
General and administrative
|
2,732
|
|
|
2,274
|
|
|
1,586
|
|
|||
Total employee stock-based compensation expense
|
$
|
4,928
|
|
|
$
|
3,803
|
|
|
$
|
2,456
|
|
|
Options Outstanding
|
|
Options Exercisable
|
||||||
Exercise Prices
|
Number
Outstanding
|
|
Weighted
Average
Remaining
Contractual
Life
|
|
Number
Exercisable
|
|
Weighted
Average
Remaining
Contractual
Life
|
||
$1.33 - $1.99
|
3,126,509
|
|
|
5.59
|
|
2,666,467
|
|
|
5.36
|
$2.00 - $2.99
|
2,875,955
|
|
|
7.44
|
|
1,381,561
|
|
|
6.01
|
$3.00 - $4.99
|
609,667
|
|
|
6.47
|
|
422,781
|
|
|
5.16
|
$5.00 - $5.99
|
2,329,197
|
|
|
8.78
|
|
817,324
|
|
|
8.28
|
$6.00 - $10.99
|
181,412
|
|
|
5.42
|
|
167,245
|
|
|
5.13
|
$11.00 - $11.91
|
353,150
|
|
|
4.79
|
|
353,150
|
|
|
4.79
|
|
9,475,890
|
|
|
|
|
5,808,528
|
|
|
|
|
Years Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
(In thousands)
|
||||||||||
United States
|
$
|
(6,026
|
)
|
|
$
|
(12,102
|
)
|
|
$
|
(29,303
|
)
|
Foreign
|
(24,489
|
)
|
|
(23,634
|
)
|
|
(16,926
|
)
|
|||
Loss before provision for income taxes
|
$
|
(30,515
|
)
|
|
$
|
(35,736
|
)
|
|
$
|
(46,229
|
)
|
|
Years Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
(In thousands)
|
||||||||||
Current expense (benefit):
|
|
|
|
|
|
||||||
Federal
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
State
|
—
|
|
|
—
|
|
|
—
|
|
|||
Foreign
|
353
|
|
|
174
|
|
|
—
|
|
|||
Current income tax expense
|
353
|
|
|
174
|
|
|
—
|
|
|||
|
|
|
|
|
|
||||||
Deferred expense (benefit):
|
|
|
|
|
|
||||||
Federal
|
6,509
|
|
|
3,050
|
|
|
(18,565
|
)
|
|||
State
|
819
|
|
|
355
|
|
|
(2,162
|
)
|
|||
Foreign
|
(223
|
)
|
|
(3,161
|
)
|
|
3,160
|
|
|||
|
7,105
|
|
|
244
|
|
|
(17,567
|
)
|
|||
Valuation allowance
|
(7,328
|
)
|
|
(244
|
)
|
|
17,567
|
|
|||
Deferred income tax expense (benefit)
|
(223
|
)
|
|
—
|
|
|
—
|
|
|||
Total income tax expense
|
$
|
130
|
|
|
$
|
174
|
|
|
$
|
—
|
|
|
Years Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
(In thousands)
|
||||||||||
Valuation allowance at beginning of period
|
$
|
(46,399
|
)
|
|
$
|
(46,155
|
)
|
|
$
|
(63,722
|
)
|
Income tax provision
|
(7,328
|
)
|
|
(244
|
)
|
|
17,567
|
|
|||
Release of valuation allowance
|
—
|
|
|
—
|
|
|
—
|
|
|||
Other
|
—
|
|
|
—
|
|
|
—
|
|
|||
Valuation allowance at end of period
|
$
|
(53,727
|
)
|
|
$
|
(46,399
|
)
|
|
$
|
(46,155
|
)
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Deferred tax assets
|
(In thousands)
|
||||||
Depreciation and amortization
|
$
|
3
|
|
|
$
|
8
|
|
Other deferred tax assets
|
4,643
|
|
|
3,305
|
|
||
NOL carry-forwards
|
36,941
|
|
|
32,191
|
|
||
Research and development costs
|
4,193
|
|
|
5,167
|
|
||
Collaboration agreement receivable reserves
|
8,186
|
|
|
5,749
|
|
||
Valuation allowance
|
(53,727
|
)
|
|
(46,400
|
)
|
||
Total deferred tax assets
|
$
|
239
|
|
|
$
|
20
|
|
Deferred tax liabilities
|
|
|
|
||||
Unrealized foreign currency gains
|
$
|
(12
|
)
|
|
$
|
(20
|
)
|
Other deferred tax liabilities
|
(4
|
)
|
|
—
|
|
||
Total deferred tax liabilities
|
(16
|
)
|
|
(20
|
)
|
||
Net deferred tax assets and deferred tax liabilities
|
$
|
223
|
|
|
$
|
—
|
|
|
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
|
|
|
December 31, 2014
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
|
(In thousands)
|
||||||||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents (1)
|
$
|
65,509
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
65,509
|
|
Assets measured at fair value
|
$
|
65,509
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
65,509
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Derivative warrant liability (2)
|
$
|
—
|
|
|
$
|
16,098
|
|
|
$
|
—
|
|
|
$
|
16,098
|
|
Liabilities measured at fair value
|
$
|
—
|
|
|
$
|
16,098
|
|
|
$
|
—
|
|
|
$
|
16,098
|
|
(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, 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
|
)
|
|
Year Ended
December 31, 2014 |
||||||||||
|
U.S.
|
|
International
|
|
Consolidated
|
||||||
|
(In thousands)
|
||||||||||
NET REVENUE
|
$
|
17
|
|
|
$
|
8,406
|
|
|
$
|
8,423
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(1
|
)
|
|
(1,441
|
)
|
|
(1,442
|
)
|
|||
GROSS PROFIT
|
16
|
|
|
6,965
|
|
|
6,981
|
|
|||
|
|
|
|
|
|
||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
5,400
|
|
|
6,411
|
|
|
11,811
|
|
|||
GENERAL AND ADMINISTRATIVE EXPENSES
|
7,496
|
|
|
4,875
|
|
|
12,371
|
|
|||
SALES AND MARKETING EXPENSES
|
4,704
|
|
|
10,383
|
|
|
15,087
|
|
|||
DEPRECIATION AND AMORTIZATION
|
657
|
|
|
2
|
|
|
659
|
|
|||
OPERATING EXPENSES
|
18,257
|
|
|
21,671
|
|
|
39,928
|
|
|||
NET LOSS FROM OPERATIONS
|
(18,241
|
)
|
|
(14,706
|
)
|
|
(32,947
|
)
|
|||
OTHER INCOME AND EXPENSES, NET
|
|
|
|
|
(2,789
|
)
|
|||||
NET LOSS BEFORE TAXES
|
|
|
|
|
$
|
(35,736
|
)
|
|
Year Ended
December 31, 2013 |
||||||||||
|
U.S.
|
|
International
|
|
Consolidated
|
||||||
|
(In thousands)
|
||||||||||
NET REVENUE
|
$
|
—
|
|
|
$
|
1,872
|
|
|
$
|
1,872
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
—
|
|
|
(1,863
|
)
|
|
(1,863
|
)
|
|||
GROSS PROFIT
|
—
|
|
|
9
|
|
|
9
|
|
|||
|
|
|
|
|
|
||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
4,110
|
|
|
4,748
|
|
|
8,858
|
|
|||
GENERAL AND ADMINISTRATIVE EXPENSES
|
5,048
|
|
|
4,427
|
|
|
9,475
|
|
|||
SALES AND MARKETING EXPENSES
|
891
|
|
|
15,051
|
|
|
15,942
|
|
|||
DEPRECIATION AND AMORTIZATION
|
138
|
|
|
—
|
|
|
138
|
|
|||
OPERATING EXPENSES
|
10,187
|
|
|
24,226
|
|
|
34,413
|
|
|||
NET LOSS FROM OPERATIONS
|
(10,187
|
)
|
|
(24,217
|
)
|
|
(34,404
|
)
|
|||
OTHER INCOME AND EXPENSES, NET
|
|
|
|
|
(11,825
|
)
|
|||||
NET LOSS BEFORE TAXES
|
|
|
|
|
$
|
(46,229
|
)
|
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
|
(In thousands, except share and per share data)
|
||||||||||||||
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
|
(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
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
2014
|
|
|
|
|
|
|
|
||||||||
NET REVENUE
|
$
|
2,084
|
|
|
$
|
2,190
|
|
|
$
|
2,408
|
|
|
$
|
1,741
|
|
COST OF GOOD SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(564
|
)
|
|
(376
|
)
|
|
(372
|
)
|
|
(130
|
)
|
||||
GROSS PROFIT
|
1,520
|
|
|
1,814
|
|
|
2,036
|
|
|
1,611
|
|
||||
LOSS FROM OPERATIONS
|
(7,444
|
)
|
|
(5,958
|
)
|
|
(8,625
|
)
|
|
(10,920
|
)
|
||||
NET LOSS
|
(20,759
|
)
|
|
1,116
|
|
|
(7,009
|
)
|
|
(9,258
|
)
|
||||
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS
|
(20,759
|
)
|
|
1,116
|
|
|
(7,009
|
)
|
|
(10,008
|
)
|
||||
NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS - Basic
|
(0.58
|
)
|
|
0.03
|
|
|
(0.17
|
)
|
|
(0.23
|
)
|
||||
NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS - Diluted
|
(0.58
|
)
|
|
(0.16
|
)
|
|
(0.17
|
)
|
|
(0.23
|
)
|
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)
|
|
|
|
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.
|
|
|
|
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)
|
|
|
|
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.
|
|
|
|
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.
|
|
|
|
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
|
|
|
|
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)
|
|
|
|
21.1*
|
|
List of subsidiaries of the Registrant (including jurisdiction of organization and names under which subsidiaries do business)
|
|
|
|
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.
|
Name of Wholly-Owned Subsidiary
|
Jurisdiction of Organization
|
Name under which the subsidiary conducts business
|
Alimera Sciences Limited
|
United Kingdom
|
Alimera Sciences Limited
|
Alimera Sciences B.V.
|
The Netherlands
|
Alimera Sciences B.V.
|
AS C.V.
|
The Netherlands
|
AS C.V.
|
Alimera Sciences (DE) LLC
|
United States
|
Alimera Sciences (DE) LLC
|
Alimera Sciences Opthamologie GmbH
|
Germany
|
Alimera Sciences Opthamologie GmbH
|
Alimera Sciences France, S.A.R.L.
|
France
|
Alimera Sciences France, S.A.R.L.
|
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:
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a.
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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;
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b.
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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;
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c.
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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
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d.
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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
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5.
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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):
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a.
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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
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b.
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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.
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Date: March 15, 2016
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/s/ C. Daniel Myers
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C. Daniel Myers
Chief Executive Officer
(Principal Executive Officer)
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1.
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I have reviewed this annual report on Form 10-K of Alimera Sciences, Inc.;
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2.
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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;
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3.
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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;
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4.
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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;
|
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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;
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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
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d.
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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
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5.
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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):
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|
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.
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Date: March 15, 2016
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/s/ Richard S. Eiswirth, Jr.
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Richard S. Eiswirth, Jr.
President and Chief Financial Officer
(Principal Financial and Accounting Officer)
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(1)
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The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2)
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.
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Date: March 15, 2016
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/s/ C. Daniel Myers
|
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C. Daniel Myers
|
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Chief Executive Officer
(Principal Executive Officer)
|
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Date: March 15, 2016
|
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/s/ Richard S. Eiswirth, Jr.
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Richard S. Eiswirth, Jr.
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President and Chief Financial Officer
(Principal Financial and Accounting Officer)
|