AKAO 2017 Annual Report

39 We are substantially dependent on the success of our lead product candidate, plazomicin. If we are unable to obtain marketing approval for and successfully commercialize plazomicin, or experience significant delays in doing so, our business could be materially harmed. We currently have no products approved for sale, and since 2007, we have invested a significant portion of our efforts and financial resources in the development of plazomicin. Our future success is substantially dependent on our ability to successfully develop, obtain regulatory approval for and, ultimately, successfully commercialize plazomicin. Our ability to develop, obtain regulatory approval for, and successfully commercialize plazomicin effectively will depend on several factors, including the following: • receipt of marketing approvals from the FDA and similar regulatory authorities outside the United States; • receiving the product labeling that enables the successful promotion of plazomicin; • the findings and questions of the FDA if any, during its review of our NDA for plazomicin, and our ability to promptly and adequately address any such findings or questions; • satisfying pre- or post-approval conditions or suggestions, if any, based on feedback and discussions with the FDA; • establishing commercial manufacturing and supply arrangements; • establishing a commercial infrastructure; • identifying and successfully establishing one or more collaborations to commercialize plazomicin; • acceptance of the product by patients, the medical community and third-party payors; • establishing market share while competing with other therapies; • successfully executing our pricing and reimbursement strategy; • a continued acceptable safety and adverse event profile of the product following regulatory approval; and • qualifying for, identifying, registering, maintaining, enforcing and defending intellectual property rights and claims covering the product. In addition, our product development and commercialization program includes the development of an in vitro diagnostic (“IVD”) assay or related diagnostic which must be developed and would need to successfully complete a clinical performance study in order to be approved or cleared for marketing by the FDA and certain other foreign regulatory agencies and then be commercialized concurrently with plazomicin in the associated markets for the appropriate populations. If we are unable to develop, receive marketing approval for plazomicin or an IVD assay in a timely manner or at all, we could experience significant delays to successfully commercialize plazomicin, which would materially and adversely affect our business, financial condition, and results of operations. We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate our product development, other operations or commercialization efforts and this would impact our status as a going concern. Developing biopharmaceutical products, including conducting preclinical studies and clinical trials, is an expensive and highly uncertain process that takes years to complete. We expect our expenses to increase substantially as we seek marketing approval for our lead product candidate, plazomicin, and continue the development of our other product candidates. If we obtain marketing approval of plazomicin, we also expect to incur significant sales, marketing, manufacturing and supply expenses. As of December 31, 2017, we had working capital of $141.5 million and unrestricted cash, cash equivalents and short-term investments of $164.8 million. Management expects that, based on its current operating plans, our