AKAO 2017 Annual Report

47 Even if a product candidate does obtain regulatory approval it may never achieve market acceptance by physicians, patients, hospitals, third-party payors and others in the medical community necessary for commercial success and the market opportunity may be smaller than we estimate. Even if we obtain FDA or other regulatory approvals and are able to launch plazomicin or any other product candidate commercially, the product candidate may not achieve market acceptance among physicians, patients, hospitals (including pharmacy directors) and third-party payors and, ultimately, may not be commercially successful. Market acceptance and market opportunity of any product candidate for which we receive approval depends on a number of factors, including: • the efficacy and safety of the product candidate as demonstrated in clinical trials; • relative convenience and ease of administration; • the clinical indications for which the product candidate is approved; • the potential and perceived advantages and disadvantages of the product candidates, including cost and clinical benefit relative to alternative treatments; • the willingness of physicians to prescribe the product; • the willingness of hospital pharmacy directors to purchase our products for their formularies; • acceptance by physicians, operators of hospitals and treatment facilities and parties responsible for reimbursement of the product; • the availability of adequate coverage and reimbursement by third-party payors and government authorities; • the effectiveness of sales and marketing efforts, including the effectiveness of the sales and marketing efforts of any collaboration partners, if any; • the strength of our marketing and distribution support, including the strength of marketing and distribution support of any collaboration partners, if any; • limitations or warnings, including distribution or use restrictions, contained in the product’s approved labeling or an approved risk evaluation and mitigation strategy; • whether and how the product is designated under physician treatment guidelines for particular infections; • continued development of MDR infections such as CRE; • the approval of other new products for the same indications; • the timing of market introduction of the approved product as well as competitive products; • adverse publicity about the product or favorable publicity about competitive products; • the emergence of bacterial resistance to the product candidate; and • the rate at which resistance to other drugs in the target infections grow. Any failure by plazomicin or any other product candidate that obtains regulatory approval to achieve market acceptance or commercial success would adversely affect our business prospects.