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Share Name | Share Symbol | Market | Type |
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Alimera Sciences Inc | NASDAQ:ALIM | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.17 | 4.89% | 3.65 | 3.42 | 65.00 | 3.78 | 3.43 | 3.56 | 143,580 | 01:00:00 |
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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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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, $0.01 par value per share
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ALIM
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The Nasdaq Stock Market LLC
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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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Smaller reporting company
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x
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Emerging growth company
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o
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Page
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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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Item 16.
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•
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uncertainty associated with our need to replace our key third-party manufacturer of certain component parts of the ILUVIEN injector before our manufacturing contract with the manufacturer expires on September 30, 2020;
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•
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dependence on third-party manufacturers to manufacture ILUVIEN or any future products or product candidates in sufficient quantities and quality and in a timely manner;
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•
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the possibility that we may fail to regain compliance with the listing standards of The Nasdaq Global Market in the near future as we expect, and the possibility that even if we do regain compliance, we may again fail to comply with the Nasdaq listing standards in the future;
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•
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a slowdown or reduction in our sales in due to a reduction in end user demand, unanticipated competition, regulatory issues, or other unexpected circumstances;
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•
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uncertainty regarding our ability to achieve profitability and positive cash flow through the commercialization of ILUVIEN® in the U.S., the European Economic Area and other regions of the world where we sell ILUVIEN;
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•
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uncertainty regarding the pricing and reimbursement guidelines for ILUVIEN or any future products or product candidates, including ILUVIEN in new markets;
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•
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uncertainty associated with our pursuit of reimbursement approval from local health authorities in certain countries for the recently obtained additional indication for ILUVIEN for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIU-PS);
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•
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uncertainty associated with our ability to meet any post-market requirements for NIU-PS in the European Economic Area;
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•
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our ability to successfully commercialize ILUVIEN following regulatory approval in additional markets;
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•
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delay in or failure to obtain regulatory and reimbursement approval of ILUVIEN or any future products or product candidates in additional countries;
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•
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our ability to operate our business in compliance with the covenants and restrictions in our loan agreement;
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•
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our possible need to raise additional financing;
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•
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our ability to retain and recruit appropriate employees, in particular a productive sales force; and
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•
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current and future laws and regulations.
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Indication for the
Treatment of DME
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Countries
Where ILUVIEN Has
Received Marketing Authorization
to Treat DME
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Countries
Where ILUVIEN Has
Received Reimbursement Approval to Treat DME
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Countries Where
ILUVIEN is
Currently Marketed
to Treat DME
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Treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure
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U.S., Australia, Canada, Kuwait, Lebanon and the United Arab Emirates
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U.S., Kuwait, Lebanon and the United Arab Emirates
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U.S., Kuwait, Lebanon and the United Arab Emirates
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Treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies
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The United Kingdom (U.K.), Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czech Republic, the Netherlands, and Luxembourg
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The U.K., Germany, France, Italy, Spain, Portugal, Ireland and Austria
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The U.K., Germany, France, Italy, Spain, Portugal, Ireland, and Austria
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Indication for the
Treatment of NIU-PS
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Countries
Where ILUVIEN Has
Received Marketing Authorization
to Treat NIU-PS
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Countries
Where ILUVIEN Has
Received Reimbursement Approval to Treat NIU-PS
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Countries Where
ILUVIEN is
Currently Marketed
to Treat NIU-PS
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The prevention of relapse in recurrent NIU-PS
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The U.K., Germany, France, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden
and Poland
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The U.K. and Germany
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The U.K. and Germany
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•
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Maximize the commercial success of ILUVIEN for treatment of DME in the U.S. and Europe where we have obtained regulatory approval. We are seeking to increase our direct sales and sales to distributors in the U.S. and Europe where we have obtained regulatory approval and are currently marketing ILUVIEN. We are also pursuing opportunities to sell ILUVIEN in the remaining countries where we have obtained regulatory approval but are not currently marketing ILUVIEN.
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•
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Pursue commercialization of ILUVIEN for treatment of DME in additional countries outside the U.S. and Europe where we have obtained regulatory approval. We have established distribution relationships in Australia, New Zealand, Canada and the Middle East. Our distributor in the Middle East began selling ILUVIEN in 2016 and launched commercial sales in 2019. Our distributor in Canada received regulatory approval in 2018 and is currently pursuing reimbursement approval. Our distributor in Australia secured regulatory approval during 2019 and is currently pursuing reimbursement approval.
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•
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Pursue commercialization of ILUVIEN for NIU-PS in Europe where we have obtained regulatory approval. We are seeking to increase our direct sales in Germany and the U.K. where we have obtained regulatory approval and are currently marketing ILUVIEN for NIU-PS. We are pursuing opportunities to sell ILUVIEN for NIU-PS in another 14 additional countries where we have obtained regulatory approval but are not currently marketing ILUVIEN.
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•
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Pursue approval for ILUVIEN for DME and NIU-PS in additional countries. We will evaluate seeking regulatory approval for the treatment of DME in countries where we do not have approval and of NIU-PS in the remainder of Europe and in the Middle East and Africa where we have the license to use ILUVIEN.
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•
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Expand our ophthalmic product offerings. We believe there are further unmet medical needs in the treatment of retinal diseases. We intend 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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•
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infectious uveitis (bacterial, viral, fungal, or parasitic), which is treated with an appropriate antimicrobial drug as well as corticosteroids and cycloplegics; and
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•
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NIU-PS, where corticosteroids are used to reduce inflammation and prevent adhesions in the eye.
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•
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the manufacture of the ILUVIEN implant and final assembly and packaging of ILUVIEN (Alliance Medical Products Inc., a Siegfried Company (Alliance))
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•
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the manufacturer of the components of the ILUVIEN applicator (FlexMedical or an affiliate of Flextronics International, Ltd. (Flextronics))
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•
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the manufacture of ILUVIEN’s active pharmaceutical ingredient (FARMABIOS SpA/Byron Chemical Company Inc.) and
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•
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the quality release testing of ILUVIEN in the EEA including the U.K., post Brexit (AndersonBrecon Limited trading as Packaging Coordinators, Inc.).
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•
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Lucentis© (ranibizumab injection), marketed by Genentech (Roche) in the U.S. and Novartis in the rest of the world, and Avastin (bevacizumab), an oncology product marketed by the Roche group, are both antibodies that inhibit VEGF signaling pathways. Lucentis is currently approved for the treatment of DME, the treatment of diabetic retinopathy in patients with DME, the treatment of neovascular wet AMD and the treatment of macular edema following RVO in the U.S. In the EEA, the indications are similar except for the indication to treat diabetic retinopathy in patients with DME.
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•
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Avastin©, 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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•
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Eylea© (aflibercept), marketed by Regeneron in the U.S. and by Bayer in the EEA, is a VEGF antagonist that is approved for the treatment of DME, diabetic retinopathy in patients with DME, neovascular wet AMD and RVO in the U.S. In the EEA, the indication does not include diabetic retinopathy.
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•
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Ozurdex© (dexamethasone intravitreal implant), marketed by Allergan, 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 in the U.S. In the EEA, the indication for DME is for visual impairment due to diabetic macular edema in persons who are pseudophakic (persons who have had an artificial lens implanted after the natural eye lens has been removed) or who are considered insufficiently responsive to, or unsuitable for, non-corticosteroid therapy. It is also indicated for macular edema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) and inflammation of the posterior segment of the eye presenting as non-infectious uveitis.
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•
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Humira© (adlimumab), marketed by Abbvie, is a TNF-blocker that has an ophthalmic indication. It works by targeting and blocking a specific source of inflammation that plays a role in non-infectious uveitis. In the U.S., Humira is indicated for the treatment of non-infectious intermediate, posterior and pan uveitis. In the EEA, Humira is indicated for the treatment of chronic non-infectious anterior uveitis in children aged two years or older who have had an inadequate response to or are intolerant to conventional therapy.
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•
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Beovu®(brolucizumab-dbll), marketed by Novartis, is a VEGF inhibitor indicated for the treatment of neovascular wet AMD. Beovu is the first FDA approved anti-VEGF to offer both greater fluid resolution versus aflibercept and the ability to maintain eligible wet AMD patients on a three-month dosing interval immediately after a three-month loading phase with uncompromised efficacy. Beovu is also approved by the European commission for the treatment of wet AMD in all 27 European Union member states as well as the U.K., Iceland, Norway and Liechtenstein. Beovu is currently recruiting patients in trials for the treatment of DME.
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•
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Intravitreal triamcinolone is used by some physicians for the treatment of DME although it is not approved for DME.
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•
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Laser photocoagulation is currently used to treat DME and may be used in conjunction with drug therapies as well. Other laser or surgical treatments for DME may also compete against ILUVIEN.
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•
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the manufacture of the ILUVIEN implant, final assembly of the injector with the implant and release testing for the U.S. (Alliance Medical Products, Inc., a Siegfried Company (Alliance)),
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•
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the manufacture of the ILUVIEN applicator (FlexMedical or an affiliate of Flextronics International, Ltd. (Flextronics)),
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•
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the manufacture of ILUVIEN’s active pharmaceutical ingredient (FARMABIOS SpA./Byron Chemical Company Inc. (FARMABIOS)), and
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•
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the quality release testing of ILUVIEN in the European Economic Area (EEA) including the U.K., post Brexit (AndersonBrecon Limited trading as Packaging Coordinators, Inc. (PCI)).
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•
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to continue to support our sales efforts in the U.S., Germany, Ireland, Portugal and the U.K.,
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•
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to pursue the regulatory and reimbursement approval for ILUVIEN in other countries for both DME and NIU-PS and
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•
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to grow our operational capabilities.
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•
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the level of continued success of the commercialization of ILUVIEN in the U.S., and in our international markets,
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•
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expenses relating to the commercialization of ILUVIEN;
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•
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our research, development and general and administrative expenses;
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•
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the timing of approvals, if any, of ILUVIEN for additional indications or in additional jurisdictions;
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•
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the extent to which we enter into, maintain and derive revenues from licensing agreements, including agreements to license ILUVIEN in additional countries or regions; research and other collaborations; joint ventures; and other business arrangements;
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•
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the extent to which we acquire, and our success in integrating, technologies or companies;
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•
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regulatory changes and technological developments in our markets; and
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•
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the extent to which we can manage the use of cash in our business operations.
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•
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extended collection timelines for accounts receivable and greater working capital requirements;
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•
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multiple legal systems and unexpected changes in legal requirements;
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•
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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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•
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trade laws and business practices favoring local competition;
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•
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potential tax issues, including restrictions on repatriating earnings, resulting from multiple, conflicting and complex tax laws and regulations;
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•
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weaker intellectual property protection in some countries;
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•
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political instability, including war and terrorism or the threat of war and terrorism; and
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•
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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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•
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our inability to recruit and retain adequate numbers of effective personnel;
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•
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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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•
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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; and
|
•
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unforeseen costs and expenses associated with creating a commercial organization.
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(a)
|
fail twice to cure our breach of an obligation to make certain payments to EyePoint following receipt of written notice of the breach;
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(b)
|
fail to cure other breaches of material terms of our agreement with EyePoint within 30 days after notice of such breaches or such longer period (up to 90 days) as may be reasonably necessary if the breach cannot be cured within such 30-day period;
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(c)
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file for protection under the bankruptcy laws, make an assignment for the benefit of creditors, appoint or suffer appointment of a receiver or trustee over our property, file a petition under any bankruptcy or insolvency act or have any such petition filed against us and such proceeding remains undismissed or unstayed for a period of more than 60 days; or
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(d)
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notify EyePoint in writing of our decision to abandon our license with respect to a certain product using EyePoint’s proprietary delivery device.
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•
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are more effective;
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•
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receive better reimbursement terms;
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•
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have higher rates of acceptance by physicians;
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•
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have fewer or less severe adverse side effects;
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•
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are better tolerated;
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•
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are more adaptable to various modes of dosing;
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•
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have better distribution channels;
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•
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are easier to administer; or
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•
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are less expensive, including a generic version of ILUVIEN.
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•
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the research methodology used may not be successful in identifying potential products or product candidates; or
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•
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we may learn after further study that potential products or product candidates have harmful side effects or other characteristics that indicate they are unlikely to be effective drugs.
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•
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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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•
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we may need to obtain our lender’s consent to any significant payment or potential payment in conjunction with a license of acquisition of technology;
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•
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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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•
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we may be unable to identify suitable products or product candidates within our areas of expertise.
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•
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the ongoing commercial success of ILUVIEN (or lack thereof);
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•
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inconsistent timing and ordering patterns from our U.S. distributors;
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•
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seasonality caused by insurance renewals for patients in the U.S. and by doctor and or patient absences due to holidays and vacations;
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•
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sales, marketing and medical affairs expenses;
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•
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the timing and amount of royalties, milestone payments or product purchases by our distributors;
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•
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our ability to obtain regulatory approval of ILUVIEN in additional jurisdictions or for additional indications;
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•
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regulatory developments affecting ILUVIEN, our future product candidates or our competitors’ products;
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•
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the emergence of products or treatments that compete with ILUVIEN;
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•
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variations in the level of expenses related to our products or future development programs;
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•
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the status of our clinical development programs;
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•
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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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•
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any lawsuit or intellectual property infringement in which we are or may become involved; and
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•
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the timing and recognition of stock-based compensation expense.
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•
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result in us incurring substantial costs,
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•
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affect our ability to timely file our periodic reports until the restatement is completed,
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•
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divert the attention of our management and employees from managing our business,
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•
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result in material changes to our historical and future financial results,
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•
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result in investors losing confidence in our operating results,
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•
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subject us to securities class action litigation, and
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•
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cause our stock price to decline.
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•
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service interruptions, system malfunction, natural disasters, terrorism, war and telecommunication and electrical failures, as well as security breaches from inadvertent or intentional actions by our employees, contractors, consultants, business partners or other third parties, and
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•
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cyber-attacks by malicious third parties, including cyber-related threats of spoofed or manipulated electronic communications that lead to misdirected or fraudulent payments, the deployment of harmful malware or ransomware, malicious websites, denial-of-service attacks, and social engineering and other means to adversely affect service reliability and threaten the confidentiality, integrity and availability of information.
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regulatory agencies may interpret data from preclinical and clinical testing in different ways than we do;
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regulatory agencies may not approve of our manufacturing processes;
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a drug candidate may not be safe or effective;
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regulatory agencies may conclude that the drug candidate does not meet quality standards for stability, quality, purity and potency; and
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regulatory agencies may change their approval policies or adopt new regulations.
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the submission of regulatory filings,
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the notification of the results of regulatory filings,
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the anticipated commercial launch of ILUVIEN in various new jurisdictions or for new or expanded indications,
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•
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any future products or product candidates and
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•
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the commencement or completion of scientific studies and clinical trials.
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•
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increase or decrease the authorized number of shares of Series A Convertible Preferred Stock;
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•
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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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•
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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 we adopt in the future 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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•
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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 our implementation of a “poison pill” rights plan or similar plan;
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•
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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)
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•
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issue stock or other equity securities of any subsidiary (other than to us or another of our wholly-owned subsidiaries);
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declare or pay any dividend or other distribution of cash, shares or other assets or redemption or repurchase of shares of any subsidiary; or
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•
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incur any secured indebtedness other than certain limited debt transactions.
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•
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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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•
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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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•
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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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•
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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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•
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contain certain protective provisions in favor of the holders of Series A Convertible Preferred Stock;
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•
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limit who may call special meetings of stockholders;
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•
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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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•
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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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Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands, except share and per share data)
|
||||||
NET REVENUE
|
$
|
53,943
|
|
|
$
|
46,599
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(6,626
|
)
|
|
(4,308
|
)
|
||
GROSS PROFIT
|
47,317
|
|
|
42,291
|
|
||
|
|
|
|
||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
10,992
|
|
|
11,274
|
|
||
GENERAL AND ADMINISTRATIVE EXPENSES
|
13,954
|
|
|
14,525
|
|
||
SALES AND MARKETING EXPENSES
|
25,004
|
|
|
23,517
|
|
||
DEPRECIATION AND AMORTIZATION
|
2,641
|
|
|
2,645
|
|
||
OPERATING EXPENSES
|
52,591
|
|
|
51,961
|
|
||
NET LOSS FROM OPERATIONS
|
(5,274
|
)
|
|
(9,670
|
)
|
||
|
|
|
|
||||
INTEREST EXPENSE AND OTHER
|
(4,869
|
)
|
|
(4,775
|
)
|
||
UNREALIZED FOREIGN CURRENCY LOSS, NET
|
(84
|
)
|
|
(65
|
)
|
||
LOSS ON EARLY EXTINGUISHMENT OF DEBT
|
—
|
|
|
(1,766
|
)
|
||
NET LOSS BEFORE TAXES
|
(10,227
|
)
|
|
(16,276
|
)
|
||
PROVISION FOR TAXES
|
(216
|
)
|
|
(106
|
)
|
||
NET LOSS
|
(10,443
|
)
|
|
(16,382
|
)
|
||
GAIN ON EXTINGUISHMENT OF PREFERRED STOCK
|
—
|
|
|
$
|
38,330
|
|
|
NET (LOSS) INCOME AVAILABLE TO STOCKHOLDERS
|
$
|
(10,443
|
)
|
|
$
|
21,948
|
|
NET (LOSS) INCOME PER SHARE — Basic (Note 2)
|
$
|
(2.19
|
)
|
|
$
|
3.74
|
|
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic
|
4,770,204
|
|
|
5,866,809
|
|
||
NET (LOSS) INCOME PER SHARE — Diluted (Note 2)
|
$
|
(2.19
|
)
|
|
$
|
3.71
|
|
WEIGHTED AVERAGE SHARES OUTSTANDING — Diluted
|
4,770,204
|
|
|
5,915,872
|
|
|
Years Ended
December 31, |
||||||
|
2019
|
|
2018
|
||||
|
(In thousands, except share and per share data)
|
||||||
Net (loss) income available to stockholders
|
$
|
(10,443
|
)
|
|
$
|
21,948
|
|
Allocation of undistributed (loss) income:
|
|
|
|
||||
(Loss) income attributable to common stock
|
$
|
(10,443
|
)
|
|
$
|
17,459
|
|
Income attributable to participating securities
|
$
|
—
|
|
|
$
|
4,489
|
|
|
|
|
|
||||
Basic shares:
|
|
|
|
||||
Weighted average common shares
|
4,770,204
|
|
|
4,666,856
|
|
||
Weighted average participating shares
|
—
|
|
|
1,199,953
|
|
||
Total basic weighted average shares
|
4,770,204
|
|
|
5,866,809
|
|
||
|
|
|
|
||||
Diluted shares:
|
|
|
|
||||
Weighted average common shares
|
4,770,204
|
|
|
4,666,856
|
|
||
Dilutive weighted average shares
|
—
|
|
|
49,063
|
|
||
Total dilutive weighted common shares
|
4,770,204
|
|
|
4,715,919
|
|
||
Weighted average participating shares
|
—
|
|
|
1,199,953
|
|
||
Total dilutive weighted average shares
|
4,770,204
|
|
|
5,915,872
|
|
||
|
|
|
|
||||
Basic EPS
|
$
|
(2.19
|
)
|
|
$
|
3.74
|
|
Diluted EPS
|
$
|
(2.19
|
)
|
|
$
|
3.71
|
|
|
Years Ended
December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
NET REVENUE
|
$
|
32,283
|
|
|
$
|
31,966
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(3,487
|
)
|
|
(2,875
|
)
|
||
GROSS PROFIT
|
28,796
|
|
|
29,091
|
|
||
|
|
|
|
||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
5,943
|
|
|
6,457
|
|
||
GENERAL AND ADMINISTRATIVE EXPENSES
|
8,449
|
|
|
8,147
|
|
||
SALES AND MARKETING EXPENSES
|
17,591
|
|
|
16,569
|
|
||
OPERATING EXPENSES
|
31,983
|
|
|
31,173
|
|
||
SEGMENT LOSS FROM OPERATIONS
|
$
|
(3,187
|
)
|
|
$
|
(2,082
|
)
|
|
Years Ended
December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
NET REVENUE
|
$
|
21,660
|
|
|
$
|
14,633
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(3,139
|
)
|
|
(1,433
|
)
|
||
GROSS PROFIT
|
18,521
|
|
|
13,200
|
|
||
|
|
|
|
||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
4,634
|
|
|
3,946
|
|
||
GENERAL AND ADMINISTRATIVE EXPENSES
|
3,944
|
|
|
3,259
|
|
||
SALES AND MARKETING EXPENSES
|
6,933
|
|
|
5,910
|
|
||
OPERATING EXPENSES
|
15,511
|
|
|
13,115
|
|
||
SEGMENT INCOME FROM OPERATIONS
|
$
|
3,010
|
|
|
$
|
85
|
|
|
Years Ended
December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
$
|
415
|
|
|
$
|
871
|
|
GENERAL AND ADMINISTRATIVE EXPENSES
|
1,561
|
|
|
3,119
|
|
||
SALES AND MARKETING EXPENSES
|
480
|
|
|
1,038
|
|
||
DEPRECIATION AND AMORTIZATION
|
2,641
|
|
|
2,645
|
|
||
OPERATING EXPENSES
|
5,097
|
|
|
7,673
|
|
||
SEGMENT LOSS FROM OPERATIONS
|
$
|
(5,097
|
)
|
|
$
|
(7,673
|
)
|
•
|
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
|
908,235
|
|
(1)
|
$
|
35.46
|
|
(2)
|
491,867
|
|
(3)
|
Equity compensation plans not approved by security holders
|
—
|
|
|
—
|
|
|
—
|
|
|
|
Total
|
908,235
|
|
|
$
|
35.46
|
|
|
491,867
|
|
|
(1)
|
Of these shares, 30,620 were subject to options then outstanding under the 2019 Plan, 840,852 were subject to options then outstanding under the 2010 Plan and 36,763 were outstanding restricted stock units then outstanding under the 2010 Plan.
|
|
|
(2)
|
The weighted-average exercise price does not take into account restricted stock units, which do not have an exercise price.
|
|
|
(3)
|
Represents 464,561 shares of common stock available for issuance under our 2019 Plan and 27,306 shares of common stock available for issuance under our ESPP. No shares are available for future issuance under the 2010 Plan. 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 32,961 shares of our common stock. As such, on January 1, 2020, an additional 5,655 shares became available for future issuance under our ESPP. These additional shares from the annual increase under the ESPP are not included in the table above.
|
|
Page
|
Consolidated Financial Statements as of December 31, 2019 and 2018 and for the years ended December 31, 2019 and 2018:
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands, except share and per share data)
|
||||||
CURRENT ASSETS:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
9,426
|
|
|
$
|
13,043
|
|
Restricted cash
|
33
|
|
|
32
|
|
||
Accounts receivable, net
|
19,331
|
|
|
17,259
|
|
||
Prepaid expenses and other current assets
|
2,565
|
|
|
2,109
|
|
||
Inventory (Note 6)
|
1,390
|
|
|
2,405
|
|
||
Total current assets
|
32,745
|
|
|
34,848
|
|
||
NON-CURRENT ASSETS:
|
|
|
|
||||
Property and equipment, net
|
940
|
|
|
1,355
|
|
||
Right of use assets, net
|
1,107
|
|
|
—
|
|
||
Intangible asset, net
|
14,783
|
|
|
16,723
|
|
||
Deferred tax asset
|
734
|
|
|
1,182
|
|
||
TOTAL ASSETS
|
$
|
50,309
|
|
|
$
|
54,108
|
|
CURRENT LIABILITIES:
|
|
|
|
||||
Accounts payable
|
$
|
7,077
|
|
|
$
|
6,355
|
|
Accrued expenses (Note 9)
|
4,716
|
|
|
3,643
|
|
||
Finance lease obligations
|
255
|
|
|
236
|
|
||
Total current liabilities
|
12,048
|
|
|
10,234
|
|
||
NON-CURRENT LIABILITIES:
|
|
|
|
||||
Note payable (Note 11)
|
38,658
|
|
|
37,873
|
|
||
Finance lease obligations — less current portion
|
94
|
|
|
305
|
|
||
Other non-current liabilities
|
3,954
|
|
|
2,974
|
|
||
COMMITMENTS AND CONTINGENCIES (Note 12)
|
|
|
|
|
|
||
STOCKHOLDERS’ (DEFICIT) EQUITY:
|
|
|
|
||||
Preferred stock, $.01 par value — 10,000,000 shares authorized at December 31, 2019 and 2018:
|
|
|
|
|
|
||
Series A Convertible Preferred Stock, 1,300,000 authorized and 600,000 issued and outstanding at December 31, 2019 and 2018; liquidation preference of $24,000 at December 31, 2019 and 2018
|
19,227
|
|
|
19,227
|
|
||
Series C Convertible Preferred Stock, 10,150 authorized issued and outstanding at December 31, 2019 and 2018; liquidation preference of $10,150 at December 31, 2019 and 2018
|
11,117
|
|
|
11,117
|
|
||
Common stock, $.01 par value — 150,000,000 shares authorized, 4,965,949 shares issued and outstanding at December 31, 2019 and 4,671,921 shares issued and outstanding at December 31, 2018 (Note 2)
|
50
|
|
|
47
|
|
||
Additional paid-in capital
|
350,117
|
|
|
346,762
|
|
||
Common stock warrants
|
3,707
|
|
|
3,707
|
|
||
Accumulated deficit
|
(387,570
|
)
|
|
(377,127
|
)
|
||
Accumulated other comprehensive loss — foreign currency translation adjustments
|
(1,093
|
)
|
|
(1,011
|
)
|
||
TOTAL STOCKHOLDERS’ (DEFICIT) EQUITY
|
(4,445
|
)
|
|
2,722
|
|
||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
50,309
|
|
|
$
|
54,108
|
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands, except share and per share data)
|
||||||
NET REVENUE
|
$
|
53,943
|
|
|
$
|
46,599
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(6,626
|
)
|
|
(4,308
|
)
|
||
GROSS PROFIT
|
47,317
|
|
|
42,291
|
|
||
|
|
|
|
||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
10,992
|
|
|
11,274
|
|
||
GENERAL AND ADMINISTRATIVE EXPENSES
|
13,954
|
|
|
14,525
|
|
||
SALES AND MARKETING EXPENSES
|
25,004
|
|
|
23,517
|
|
||
DEPRECIATION AND AMORTIZATION
|
2,641
|
|
|
2,645
|
|
||
OPERATING EXPENSES
|
52,591
|
|
|
51,961
|
|
||
NET LOSS FROM OPERATIONS
|
(5,274
|
)
|
|
(9,670
|
)
|
||
|
|
|
|
||||
INTEREST EXPENSE AND OTHER
|
(4,869
|
)
|
|
(4,775
|
)
|
||
UNREALIZED FOREIGN CURRENCY LOSS, NET
|
(84
|
)
|
|
(65
|
)
|
||
LOSS ON EARLY EXTINGUISHMENT OF DEBT
|
—
|
|
|
(1,766
|
)
|
||
NET LOSS BEFORE TAXES
|
(10,227
|
)
|
|
(16,276
|
)
|
||
PROVISION FOR TAXES
|
(216
|
)
|
|
(106
|
)
|
||
NET LOSS
|
(10,443
|
)
|
|
(16,382
|
)
|
||
GAIN ON EXTINGUISHMENT OF PREFERRED STOCK
|
—
|
|
|
38,330
|
|
||
NET (LOSS) INCOME AVAILABLE TO STOCKHOLDERS
|
$
|
(10,443
|
)
|
|
$
|
21,948
|
|
NET (LOSS) INCOME PER SHARE — Basic (Note 2)
|
$
|
(2.19
|
)
|
|
$
|
3.74
|
|
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic
|
4,770,204
|
|
|
5,866,809
|
|
||
NET (LOSS) INCOME PER SHARE — Diluted (Note 2)
|
$
|
(2.19
|
)
|
|
$
|
3.71
|
|
WEIGHTED AVERAGE SHARES OUTSTANDING — Diluted
|
4,770,204
|
|
|
5,915,872
|
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
NET LOSS
|
$
|
(10,443
|
)
|
|
$
|
(16,382
|
)
|
|
|
|
|
||||
OTHER COMPREHENSIVE LOSS
|
|
|
|
||||
Foreign currency translation adjustments
|
(82
|
)
|
|
(190
|
)
|
||
TOTAL OTHER COMPREHENSIVE LOSS
|
(82
|
)
|
|
(190
|
)
|
||
COMPREHENSIVE LOSS
|
$
|
(10,525
|
)
|
|
$
|
(16,572
|
)
|
|
Common Stock
|
|
Series A
Convertible
Preferred Stock
|
|
Series B
Convertible
Preferred Stock
|
|
Series C
Convertible
Preferred Stock
|
|
Additional
Paid-In
Capital
|
|
Common
Stock
Warrants
|
|
Accumulated
Deficit
|
|
Accumulated
Other
Comprehensive
Loss
|
|
Total
|
||||||||||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|||||||||||||||||||||||||||
|
(In thousands, except share data)
|
||||||||||||||||||||||||||||||||||||||||||||||
BALANCE — December 31, 2017
|
4,609,754
|
|
|
$
|
46
|
|
|
600,000
|
|
|
$
|
19,227
|
|
|
8,416
|
|
|
$
|
49,568
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
342,267
|
|
|
$
|
3,707
|
|
|
$
|
(399,075
|
)
|
|
$
|
(821
|
)
|
|
$
|
14,919
|
|
Issuance of common stock, net of issuance costs
|
62,063
|
|
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
82
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
83
|
|
|||||||||
Exercise of stock options
|
104
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2
|
|
|||||||||
Preferred stock exchange, net of transaction costs (Note 13)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(8,416
|
)
|
|
(49,568
|
)
|
|
10,150
|
|
|
11,117
|
|
|
—
|
|
|
—
|
|
|
38,330
|
|
|
—
|
|
|
(121
|
)
|
|||||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,411
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,411
|
|
|||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(16,382
|
)
|
|
—
|
|
|
(16,382
|
)
|
|||||||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(190
|
)
|
|
(190
|
)
|
|||||||||
BALANCE — December 31, 2018
|
4,671,921
|
|
|
$
|
47
|
|
|
600,000
|
|
|
$
|
19,227
|
|
|
—
|
|
|
$
|
—
|
|
|
10,150
|
|
|
$
|
11,117
|
|
|
$
|
346,762
|
|
|
$
|
3,707
|
|
|
$
|
(377,127
|
)
|
|
$
|
(1,011
|
)
|
|
$
|
2,722
|
|
Issuance of common stock, net of issuance costs
|
294,028
|
|
|
3
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
899
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
902
|
|
|||||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,456
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,456
|
|
|||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(10,443
|
)
|
|
—
|
|
|
(10,443
|
)
|
|||||||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(82
|
)
|
|
(82
|
)
|
|||||||||
BALANCE — December 31, 2019
|
4,965,949
|
|
|
$
|
50
|
|
|
600,000
|
|
|
$
|
19,227
|
|
|
—
|
|
|
$
|
—
|
|
|
10,150
|
|
|
$
|
11,117
|
|
|
$
|
350,117
|
|
|
$
|
3,707
|
|
|
$
|
(387,570
|
)
|
|
$
|
(1,093
|
)
|
|
$
|
(4,445
|
)
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
||||
Net loss
|
$
|
(10,443
|
)
|
|
$
|
(16,382
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
2,641
|
|
|
2,645
|
|
||
Unrealized foreign currency transaction loss
|
84
|
|
|
65
|
|
||
Amortization of debt discount and deferred financing costs
|
837
|
|
|
842
|
|
||
Deferred taxes expense (benefit)
|
454
|
|
|
(653
|
)
|
||
Loss on early extinguishment of debt
|
—
|
|
|
1,766
|
|
||
Stock compensation expense
|
2,456
|
|
|
4,411
|
|
||
Changes in assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
(2,160
|
)
|
|
(5,995
|
)
|
||
Prepaid expenses and other current assets
|
(828
|
)
|
|
129
|
|
||
Inventory
|
996
|
|
|
(933
|
)
|
||
Accounts payable
|
779
|
|
|
556
|
|
||
Accrued expenses and other current liabilities
|
641
|
|
|
1,547
|
|
||
Other long-term liabilities
|
391
|
|
|
449
|
|
||
Net cash used in operating activities
|
(4,152
|
)
|
|
(11,553
|
)
|
||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
||||
Purchases of property and equipment
|
(174
|
)
|
|
(175
|
)
|
||
Net cash used in investing activities
|
(174
|
)
|
|
(175
|
)
|
||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
||||
Proceeds from exercise of stock options
|
—
|
|
|
2
|
|
||
Proceeds from sale of common stock, net of issuance costs
|
902
|
|
|
83
|
|
||
Issuance of debt
|
42,500
|
|
|
40,000
|
|
||
Payment of principal on notes payable
|
(40,000
|
)
|
|
(35,000
|
)
|
||
Payment of extinguishment of debt costs
|
—
|
|
|
(2,544
|
)
|
||
Payment of debt costs, including end of term payment
|
(2,227
|
)
|
|
(1,142
|
)
|
||
Payment of preferred stock exchange costs
|
—
|
|
|
(122
|
)
|
||
Payments on finance lease obligations
|
(306
|
)
|
|
(327
|
)
|
||
Net cash provided by financing activities
|
869
|
|
|
950
|
|
||
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH
|
(159
|
)
|
|
(248
|
)
|
||
NET DECREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH
|
(3,616
|
)
|
|
(11,026
|
)
|
||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — Beginning of year
|
13,075
|
|
|
24,101
|
|
||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — End of year
|
$
|
9,459
|
|
|
$
|
13,075
|
|
SUPPLEMENTAL DISCLOSURES:
|
|
|
|
||||
Cash paid for interest
|
$
|
4,041
|
|
|
$
|
3,571
|
|
Cash paid for income taxes
|
$
|
239
|
|
|
$
|
239
|
|
Supplemental schedule of noncash investing and financing activities:
|
|
|
|
||||
Property and equipment acquired under finance leases
|
$
|
154
|
|
|
$
|
575
|
|
Property and equipment acquired under operating leases
|
$
|
676
|
|
|
$
|
—
|
|
Note payable end of term payment accrued but unpaid
|
$
|
2,125
|
|
|
$
|
1,800
|
|
1.
|
NATURE OF OPERATIONS
|
2.
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands, except share and per share data)
|
||||||
Net (loss) income available to stockholders
|
$
|
(10,443
|
)
|
|
$
|
21,948
|
|
Allocation of undistributed (loss) income:
|
|
|
|
||||
(Loss) income attributable to common stock
|
$
|
(10,443
|
)
|
|
$
|
17,459
|
|
Income attributable to participating securities
|
$
|
—
|
|
|
$
|
4,489
|
|
|
|
|
|
||||
Basic shares:
|
|
|
|
||||
Weighted average common shares
|
4,770,204
|
|
|
4,666,856
|
|
||
Weighted average participating shares
|
—
|
|
|
1,199,953
|
|
||
Total basic weighted average shares
|
4,770,204
|
|
|
5,866,809
|
|
||
|
|
|
|
||||
Diluted shares:
|
|
|
|
||||
Weighted average common shares
|
4,770,204
|
|
|
4,666,856
|
|
||
Dilutive weighted average shares
|
—
|
|
|
49,063
|
|
||
Total dilutive weighted common shares
|
4,770,204
|
|
|
4,715,919
|
|
||
Weighted average participating shares
|
—
|
|
|
1,199,953
|
|
||
Total dilutive weighted average shares
|
4,770,204
|
|
|
5,915,872
|
|
||
|
|
|
|
||||
Basic EPS
|
$
|
(2.19
|
)
|
|
$
|
3.74
|
|
Diluted EPS
|
$
|
(2.19
|
)
|
|
$
|
3.71
|
|
|
Years Ended December 31,
|
||||
|
2019
|
|
2018
|
||
Series A convertible preferred stock
|
601,503
|
|
|
—
|
|
Series C convertible preferred stock
|
676,667
|
|
|
—
|
|
Common stock warrants
|
119,712
|
|
|
119,712
|
|
Stock options
|
871,472
|
|
|
830,100
|
|
Restricted stock units
|
36,763
|
|
|
—
|
|
Total
|
2,306,117
|
|
|
949,812
|
|
Years Ending December 31
|
|
(In thousands)
|
||
2020
|
|
$
|
615
|
|
2021
|
|
461
|
|
|
2022
|
|
162
|
|
|
2023
|
|
162
|
|
|
2023
|
|
165
|
|
|
Total
|
|
1,565
|
|
|
Less amount representing interest
|
|
(267
|
)
|
|
Present value of minimum lease payments
|
|
1,298
|
|
|
Less current portion
|
|
(469
|
)
|
|
Non-current portion
|
|
$
|
829
|
|
|
December 31, 2019
|
|
December 31, 2018
|
||||
|
(In thousands)
|
||||||
NON-CURRENT ASSETS:
|
|
|
|
||||
Property and equipment, net
|
$
|
414
|
|
|
$
|
615
|
|
Total lease assets
|
$
|
414
|
|
|
$
|
615
|
|
|
|
|
|
||||
CURRENT LIABILITIES:
|
|
|
|
||||
Finance lease obligations
|
$
|
255
|
|
|
$
|
236
|
|
NON-CURRENT LIABILITIES:
|
|
|
|
||||
Finance lease obligations — less current portion
|
94
|
|
|
305
|
|
||
Total lease liabilities
|
$
|
349
|
|
|
$
|
541
|
|
Years Ending December 31
|
|
(In thousands)
|
||
2020
|
|
272
|
|
|
2021
|
|
87
|
|
|
2022
|
|
10
|
|
|
Total
|
|
369
|
|
|
Less amount representing interest
|
|
(20
|
)
|
|
Present value of minimum lease payments
|
|
349
|
|
|
Less current portion
|
|
(255
|
)
|
|
Non-current portion
|
|
$
|
94
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
Component parts (1)
|
$
|
389
|
|
|
$
|
129
|
|
Work-in-process (2)
|
399
|
|
|
924
|
|
||
Finished goods
|
602
|
|
|
1,352
|
|
||
Total inventory
|
1,390
|
|
|
2,405
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
Furniture and fixtures
|
$
|
392
|
|
|
$
|
392
|
|
Office equipment
|
543
|
|
|
809
|
|
||
Finance leases
|
890
|
|
|
930
|
|
||
Software
|
1,301
|
|
|
1,275
|
|
||
Leasehold improvements
|
471
|
|
|
474
|
|
||
Manufacturing equipment
|
1,154
|
|
|
1,087
|
|
||
Total property and equipment
|
4,751
|
|
|
4,967
|
|
||
Less accumulated depreciation and amortization
|
(3,811
|
)
|
|
(3,612
|
)
|
||
Property and equipment — net
|
$
|
940
|
|
|
$
|
1,355
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
Accrued clinical investigator expenses
|
$
|
576
|
|
|
$
|
781
|
|
Accrued compensation expenses
|
2,159
|
|
|
1,427
|
|
||
Accrued rebate, chargeback and other revenue reserves
|
766
|
|
|
346
|
|
||
Accrued lease liabilities (note 4)
|
469
|
|
|
—
|
|
||
Other accrued expenses
|
746
|
|
|
1,089
|
|
||
Total accrued expenses
|
$
|
4,716
|
|
|
$
|
3,643
|
|
•
|
From December 12, 2018 through December 12, 2020, the royalty has been and will continue to be reduced from 6%, to 4% for net revenues and other related consideration up to $75,000,000 annually and from 8% to 5% for net revenues and other related consideration in excess of $75,000,000 on an annual basis; and
|
•
|
Beginning December 13, 2020, the royalty will be reduced from 6% to 5.2% for net revenues and other related consideration up to $75,000,000 annually and from 8% to 6.8% for net revenues and other related consideration in excess of $75,000,000 on an annual basis.
|
(i)
|
fail twice to cure its breach of an obligation to make certain payments to EyePoint following receipt of written notice thereof;
|
(ii)
|
fail to cure other breaches of material terms of the EyePoint Agreement within 30 days after notice of such breaches or such longer period (up to 90 days) as may be reasonably necessary if the breach cannot be cured within such 30-day period;
|
(iii)
|
file for protection under the bankruptcy laws, make an assignment for the benefit of creditors, appoint or suffer appointment of a receiver or trustee over its property, file a petition under any bankruptcy or insolvency act or have any such petition filed against it and such proceeding remains undismissed or unstayed for a period of more than 60 days; or
|
(iv)
|
notify EyePoint in writing of its decision to abandon its license with respect to a certain product using EyePoint’s proprietary insert technology.
|
a.
|
first, if the Company achieves revenues of $80,000,000 or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured on a trailing 12-month basis during the term of the agreement, tested at the end of each month; and
|
b.
|
second, if the Company achieves revenues of $100,000,000 or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured in the same manner.
|
a.
|
2.00% of the principal amount prepaid for a prepayment made on or after December 31, 2019 through and including December 31, 2020;
|
b.
|
1.00% of the principal amount prepaid for a prepayment made after December 31, 2020 through and including December 31, 2021; and
|
c.
|
0.50% of the principal amount prepaid for a prepayment made after December 31, 2021 and greater than 30 days before the maturity date.
|
a.
|
first, if the Company achieves revenues of $75,000,000 or more from the sale of ILUVIEN in the ordinary course of business to third party customers, measured on a trailing 12-month basis during the term of the 2019 Exit Fee Agreement, tested at the end of each month; and
|
b.
|
second, if the Company achieves revenues of $95,000,000 or more from the sale of ILUVIEN in the ordinary course of business to third party customers, measured in the same manner.
|
Years Ending December 31
|
(In thousands)
|
||
2020
|
—
|
|
|
2021
|
—
|
|
|
2022
|
—
|
|
|
2023
|
22,885
|
|
|
2024
|
19,615
|
|
|
Total
|
42,500
|
|
|
Less unamortized debt discount and deferred financing costs
|
(3,842
|
)
|
|
Less current portion
|
—
|
|
|
Non-current portion
|
$
|
38,658
|
|
|
Years Ended December 31,
|
||||||||||||||
|
2019
|
|
2018
|
||||||||||||
|
Options
|
|
Weighted
Average
Exercise
Price
|
|
Options
|
|
Weighted
Average
Exercise
Price
|
||||||||
Options outstanding at beginning of period
|
830,100
|
|
|
$
|
39.41
|
|
|
773,295
|
|
|
$
|
43.50
|
|
||
Grants
|
128,283
|
|
|
13.36
|
|
|
140,836
|
|
|
16.11
|
|
||||
Forfeitures
|
(86,911
|
)
|
|
40.49
|
|
|
(83,927
|
)
|
|
38.10
|
|
||||
Exercises
|
—
|
|
|
—
|
|
|
(104
|
)
|
|
15.90
|
|
||||
Options outstanding at year end
|
871,472
|
|
|
35.46
|
|
|
830,100
|
|
|
39.41
|
|
||||
Options exercisable at year end
|
674,952
|
|
|
41.25
|
|
|
609,428
|
|
|
46.33
|
|
||||
Weighted average per share fair value of options granted during the year
|
$
|
8.28
|
|
|
|
|
$
|
10.59
|
|
|
|
|
Shares
|
|
Weighted
Average
Exercise
Price
|
|
Weighted
Average
Contractual
Term
|
|
Aggregate
Intrinsic
Value
|
|||||
|
|
|
|
|
|
|
(In thousands)
|
|||||
Outstanding
|
871,472
|
|
|
$
|
35.46
|
|
|
5.83 years
|
|
$
|
4,043
|
|
Exercisable
|
674,952
|
|
|
41.25
|
|
|
5.04 years
|
|
13
|
|
||
Outstanding, vested and expected to vest
|
849,285
|
|
|
36.00
|
|
|
5.75 years
|
|
3,324
|
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Risk-free interest rate
|
2.39
|
%
|
|
2.63
|
%
|
||
Volatility factor
|
67.29
|
%
|
|
72.60
|
%
|
||
Grant date fair value of common stock options
|
$
|
8.28
|
|
|
$
|
10.59
|
|
Weighted-average expected life
|
6.03 years
|
|
|
6.02 years
|
|
||
Assumed forfeiture rate
|
10.00
|
%
|
|
10.00
|
%
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
Sales and marketing
|
$
|
339
|
|
|
$
|
685
|
|
Research, development and medical affairs
|
328
|
|
|
565
|
|
||
General and administrative
|
1,240
|
|
|
2,130
|
|
||
Total employee stock-based compensation expense related to stock options
|
$
|
1,907
|
|
|
$
|
3,380
|
|
|
Years Ended December 31,
|
||||||||||||
|
2019
|
|
2018
|
||||||||||
|
RSUs
|
|
Weighted Average Grant Date Fair Value
|
|
RSUs
|
|
Weighted Average Grant Date Fair Value
|
||||||
Restricted stock units outstanding at beginning of period
|
60,041
|
|
|
$
|
17.30
|
|
|
55,979
|
|
|
$
|
18.15
|
|
Grants
|
36,763
|
|
|
13.15
|
|
|
72,814
|
|
|
17.29
|
|
||
Vested units
|
(59,341
|
)
|
|
17.30
|
|
|
(55,979
|
)
|
|
18.15
|
|
||
Forfeitures
|
(700
|
)
|
|
17.40
|
|
|
(12,773
|
)
|
|
17.28
|
|
||
Restricted stock units outstanding at year end
|
36,763
|
|
|
13.15
|
|
|
60,041
|
|
|
17.30
|
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
United States
|
$
|
(1,840
|
)
|
|
$
|
(2,908
|
)
|
Foreign
|
(8,387
|
)
|
|
(13,368
|
)
|
||
Loss before provision for income taxes
|
$
|
(10,227
|
)
|
|
$
|
(16,276
|
)
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
Current expense (benefit):
|
|
|
|
||||
Federal
|
$
|
—
|
|
|
$
|
—
|
|
State
|
—
|
|
|
—
|
|
||
Foreign
|
(238
|
)
|
|
759
|
|
||
Current income tax expense
|
(238
|
)
|
|
759
|
|
||
|
|
|
|
||||
Deferred expense (benefit):
|
|
|
|
||||
Federal
|
34
|
|
|
256
|
|
||
State
|
(562
|
)
|
|
411
|
|
||
Foreign
|
448
|
|
|
(654
|
)
|
||
|
(80
|
)
|
|
13
|
|
||
Valuation allowance
|
534
|
|
|
(666
|
)
|
||
Deferred income tax benefit
|
454
|
|
|
(653
|
)
|
||
Total income tax expense
|
$
|
216
|
|
|
$
|
106
|
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
Valuation allowance at beginning of period
|
$
|
(42,151
|
)
|
|
$
|
(41,485
|
)
|
Income tax provision
|
534
|
|
|
(666
|
)
|
||
U.S. Tax Reform
|
—
|
|
|
—
|
|
||
Valuation allowance at end of period
|
$
|
(41,617
|
)
|
|
$
|
(42,151
|
)
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Deferred tax assets
|
(In thousands)
|
||||||
Depreciation and amortization
|
$
|
61
|
|
|
$
|
55
|
|
Other deferred tax assets
|
662
|
|
|
1,382
|
|
||
NOL carry-forwards
|
34,530
|
|
|
34,217
|
|
||
Research and development costs
|
203
|
|
|
813
|
|
||
Equity compensation
|
4,774
|
|
|
4,485
|
|
||
Collaboration agreement receivable reserves
|
2,121
|
|
|
2,381
|
|
||
Valuation allowance
|
(41,617
|
)
|
|
(42,151
|
)
|
||
Total deferred tax assets
|
$
|
734
|
|
|
$
|
1,182
|
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
|
(In thousands)
|
||||||
Balance of uncertain tax positions at beginning of period
|
$
|
68
|
|
|
$
|
52
|
|
Gross increases - tax positions in current period
|
8
|
|
|
13
|
|
||
Gross increases - tax positions in prior period
|
—
|
|
|
10
|
|
||
Gross decreases - tax positions in prior period
|
—
|
|
|
(7
|
)
|
||
Settlements
|
—
|
|
|
—
|
|
||
Lapse of statute of limitations
|
—
|
|
|
—
|
|
||
Balance of uncertain tax positions at end of period
|
$
|
76
|
|
|
$
|
68
|
|
|
Year Ended
December 31, 2019 |
||||||||||||||
|
U.S.
|
|
International
|
|
Other
|
|
Consolidated
|
||||||||
|
(In thousands)
|
||||||||||||||
NET REVENUE
|
$
|
32,283
|
|
|
$
|
21,660
|
|
|
$
|
—
|
|
|
$
|
53,943
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(3,487
|
)
|
|
(3,139
|
)
|
|
—
|
|
|
(6,626
|
)
|
||||
GROSS PROFIT
|
28,796
|
|
|
18,521
|
|
|
—
|
|
|
47,317
|
|
||||
|
|
|
|
|
|
|
|
||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
5,943
|
|
|
4,634
|
|
|
415
|
|
|
10,992
|
|
||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
8,449
|
|
|
3,944
|
|
|
1,561
|
|
|
13,954
|
|
||||
SALES AND MARKETING EXPENSES
|
17,591
|
|
|
6,933
|
|
|
480
|
|
|
25,004
|
|
||||
DEPRECIATION AND AMORTIZATION
|
—
|
|
|
—
|
|
|
2,641
|
|
|
2,641
|
|
||||
OPERATING EXPENSES
|
31,983
|
|
|
15,511
|
|
|
5,097
|
|
|
52,591
|
|
||||
SEGMENT (LOSS) INCOME FROM OPERATIONS
|
(3,187
|
)
|
|
3,010
|
|
|
(5,097
|
)
|
|
(5,274
|
)
|
||||
OTHER INCOME AND EXPENSES, NET
|
|
|
|
|
(4,953
|
)
|
|
(4,953
|
)
|
||||||
NET LOSS BEFORE TAXES
|
|
|
|
|
|
|
$
|
(10,227
|
)
|
|
Year Ended
December 31, 2018 |
||||||||||||||
|
U.S.
|
|
International
|
|
Other
|
|
Consolidated
|
||||||||
|
(In thousands)
|
||||||||||||||
NET REVENUE
|
$
|
31,966
|
|
|
$
|
14,633
|
|
|
$
|
—
|
|
|
$
|
46,599
|
|
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
|
(2,875
|
)
|
|
(1,433
|
)
|
|
—
|
|
|
(4,308
|
)
|
||||
GROSS PROFIT
|
29,091
|
|
|
13,200
|
|
|
—
|
|
|
42,291
|
|
||||
|
|
|
|
|
|
|
|
||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
|
6,457
|
|
|
3,946
|
|
|
871
|
|
|
11,274
|
|
||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
8,147
|
|
|
3,259
|
|
|
3,119
|
|
|
14,525
|
|
||||
SALES AND MARKETING EXPENSES
|
16,569
|
|
|
5,910
|
|
|
1,038
|
|
|
23,517
|
|
||||
DEPRECIATION AND AMORTIZATION
|
—
|
|
|
—
|
|
|
2,645
|
|
|
2,645
|
|
||||
OPERATING EXPENSES
|
31,173
|
|
|
13,115
|
|
|
7,673
|
|
|
51,961
|
|
||||
SEGMENT (LOSS) INCOME FROM OPERATIONS
|
(2,082
|
)
|
|
85
|
|
|
(7,673
|
)
|
|
(9,670
|
)
|
||||
OTHER INCOME AND EXPENSES, NET
|
|
|
|
|
(6,606
|
)
|
|
(6,606
|
)
|
||||||
NET LOSS BEFORE TAXES
|
|
|
|
|
|
|
$
|
(16,276
|
)
|
Exhibit
|
|
Exhibit
|
Number
|
|
Title
|
|
|
|
3.1*
|
|
|
|
|
|
3.2*
|
|
|
|
|
|
4.1
|
|
|
|
|
|
4.2.A
|
|
|
|
|
|
4.2.B
|
|
|
|
|
|
4.2.C
|
|
|
|
|
|
4.2.D
|
|
|
|
|
|
4.2.E
|
|
|
|
|
|
4.3*
|
|
|
|
|
|
10.1
|
|
|
|
|
|
10.2
|
|
|
|
|
|
10.3.A†
|
|
|
|
|
|
10.3.B†
|
|
|
|
|
|
10.3.C†
|
|
|
|
|
|
10.3.D†
|
|
|
|
|
|
10.3.E†
|
|
|
|
|
|
10.3.F†
|
|
|
|
|
|
10.3.G†
|
|
|
|
|
|
10.3.H†
|
|
|
|
|
|
10.4.A†
|
|
|
|
|
|
10.4.B†
|
|
|
|
|
|
10.5.A†
|
|
|
|
|
|
10.5.B†
|
|
|
|
|
|
10.6†
|
|
|
|
|
|
10.7†
|
|
|
|
|
|
10.8.A†
|
|
|
|
|
|
10.8.B†
|
|
|
|
|
|
10.8.C†
|
|
|
|
|
|
10.8.D†
|
|
|
|
|
|
10.8.E†
|
|
|
|
|
|
10.9.A
|
|
|
|
|
|
10.9.B
|
|
|
|
|
|
10.10.A
|
|
|
|
|
|
10.10.B
|
|
|
|
|
|
10.11‡
|
|
|
|
|
|
10.12‡
|
|
|
|
|
|
10.13‡
|
|
|
|
|
|
10.14.A
|
|
|
|
|
|
10.14.B
|
|
|
|
|
|
10.14.C
|
|
|
|
|
|
10.15
|
|
|
|
|
|
21.1*
|
|
|
|
|
|
23.1*
|
|
|
|
|
|
31.1*
|
|
|
|
|
|
31.2*
|
|
|
|
|
|
32.1*
|
|
|
|
|
|
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
|
†
|
Management contracts and compensatory plans and arrangements required to be filed as exhibits pursuant to Item 15(b) of Form 10-K.
|
‡
|
Confidential treatment has been granted with respect to certain portions of this document.
|
**
|
Certain confidential information contained in this agreement has been omitted because it is not material and would be competitively harmful if publicly disclosed.
|
*
|
Filed herewith.
|
|
ALIMERA SCIENCES, INC.
|
|
|
|
|
|
By:
|
/s/ Richard S. Eiswirth, Jr.
|
|
Name:
|
Richard S. Eiswirth, Jr.
|
|
Title:
|
President and Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
/s/ Richard S. Eiswirth, Jr.
Richard S. Eiswirth, Jr.
|
|
President, Chief Executive Officer and Director (Principal Executive Officer)
|
|
March 2, 2020
|
/s/ J. Philip Jones
J. Philip Jones
|
|
Chief Financial Officer (Principal Financial and Accounting Officer)
|
|
March 2, 2020
|
/s/ C. Daniel Myers
C. Daniel Myers
|
|
Chairman of the Board of Directors
|
|
March 2, 2020
|
/s/ James Largent
James Largent
|
|
Lead Independent Director
|
|
March 2, 2020
|
/s/ Brian K. Halak
Brian K. Halak, Ph.D.
|
|
Director
|
|
March 2, 2020
|
/s/ Garheng Kong
Garheng Kong, M.D., Ph.D.
|
|
Director
|
|
March 2, 2020
|
/s/ Peter J. Pizzo, III
Peter J. Pizzo, III
|
|
Director
|
|
March 2, 2020
|
/s/ John Snisarenko
John Snisarenko
|
|
Director
|
|
March 2, 2020
|
/s/ Mary T. Szela
Mary T. Szela
|
|
Director
|
|
March 2, 2020
|
1 Year Alimera Sciences Chart |
1 Month Alimera Sciences Chart |
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