FORM 10-K
ANIKA THERAPEUTICS, INC.
For Fiscal Year Ended December 31, 2011
This Annual Report on Form 10-K, including the documents incorporated by reference into this Annual Report on Form 10-K, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including, without limitation, statements regarding:
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Our future sales and product revenue, including geographic expansions, possible retroactive price adjustments, and expectations of unit volumes or other offsets to price reductions;
Our manufacturing capacity and efficiency gains and work-in-process manufacturing operations;
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The timing, scope and rate of patient enrollment for clinical trials;
The development of possible new products;
Our ability to achieve or maintain compliance with laws and regulations;
The timing of and/or receipt of the Food and Drug Administration (“FDA”), foreign or other regulatory approvals, clearances, and/or reimbursement approvals of current, new or potential products, and any limitations on such approvals;
Our intention to seek patent protection for our products and processes, and protect our intellectual property;
Our ability to effectively compete against current and future competitors;
Negotiations with potential and existing partners, including our performance under any of our existing and future distribution or supply agreements or our expectations with respect to sales and sales threshold milestones pursuant to such agreements;
The level of our revenue or sales in particular geographic areas and/or for particular products, and the market share for any of our products;
Our current strategy, including our Corporate objectives and research and development and collaboration opportunities;
Our and Bausch & Lomb’s performance under the non-exclusive, three-year contract for the supply agreement for AMVISC® and AMVISC® Plus ophthalmic viscoelastic products, and our expectations regarding revenue from ophthalmic products;
Our ability to commercialize AnikaVisc and AnikaVisc Plus and our expectations regarding such commercialization and the potential profits generated thereby;
Our expectations regarding our joint health products, including expectations regarding new products, expanded uses of existing products, new distribution and revenue growth;
Our intention to increase market share for joint health products in international and domestic markets or otherwise penetrate growing markets for osteoarthritis of the knee and other joints;
Our expectations regarding next generation osteoarthritis/joint health product developments, clinical trials, regulatory approvals and commercial launches;
Our expectations regarding next generation osteoarthritis/joint health product developments, clinical trials, regulatory approvals and commercial launches;
Our expectations regarding HYVISC sales;
Our ability to identify a new distribution partner for HYDRELLE™ in the United States and the impact this may have on future sales of this product;
Our ability to license our aesthetics product to new distribution partners outside of the United States; our ability, and the ability of our distribution partners, to market our aesthetic dermatology product; and our expectations regarding the distribution and sales of our ELEVESSTM product and the timing thereof;
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Our expectations regarding our existing aesthetics product line’s extensions;
Our expectations regarding product gross margin;
Our expectations regarding our U.S. MONOVISC® trials and the results of the related premarket approval (“PMA”) filing with the FDA, including the escalation of the appeal process with the FDA as we actively seek an objective review of the scientific and clinical data, and the likelihood of our obtaining such approval and/or the anticipated timing thereof;
Our expectations regarding the commencement of a clinical trial for CINGAL™ and our ability to obtain regulatory approvals for CINGAL;
Our expectation for increases in operating expenses, including research and development and selling, general and administrative expenses;