SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement and the information incorporated by reference in this prospectus supplement, contain “forward-looking statements” within the meaning of the federal securities laws, which statements involve substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this prospectus and the information incorporated by reference in this prospectus, including statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, financing needs, plans or intentions relating to products and markets, and business trends and other information are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan,” “anticipate,” “target,” “forecast” or the negative of these terms, and similar expressions intended to identify forward-looking statements. Forward-looking statements are not historical facts, and reflect our current views with respect to future events. Given the significant uncertainties, you should not place undue reliance on these forward-looking statements.
There are a number of risks, uncertainties, and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this prospectus and the information incorporated by reference in this prospectus. Such risks, uncertainties, and other factors include, among others, the following risks, uncertainties, and factors:
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any further increases in raw material, labor, fuel or other input costs, particularly if we are unable to pass these cost increases along to our customers;
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our ability to negotiate favorable agreements with major customers and obtain and/or retain major customers and distributors;
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the duration over which our cash balances will fund our operations;
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our ability to grow our business;
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our expectations for generating revenue or maintaining profitability on a sustained basis;
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our ability to obtain additional financing and raise capital as necessary to fund operations or pursue business opportunities;
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our expectations regarding our ability to enter into marketing and other partnership agreements, including amendments to our existing agreements;
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our ability to comply with affirmative and negative covenants under our secured loan with Innovatus Life Sciences Lending Fund I, LP;
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the effects of macroeconomic conditions, geopolitical events and pandemics on patients, our customers and distributors, and our business, including manufacturing operations and suppliers;
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the availability of adequate reimbursement for our products from insurance companies and the government;
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our ability to use existing inventory before shelf life expiration;
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the safety and efficacy of our products;
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our estimates regarding the capacity of manufacturing and other facilities to support our products;
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our ability to successfully commercialize our products;
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our ability to compete against other companies;
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our ability to attract and retain key personnel;
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our expectations for increases or decreases in expenses;
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our expectations for incurring capital expenditures to expand our manufacturing capabilities;
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our expectations regarding the effect of changes in accounting guidance or standards on our operating results;