Risks Related to the Commercialization and Marketing of our Products and Product Candidates Risks Related to Commercialization and Marketing Our business depends entirely on the commercial success of our products and product candidates. Even if approved, our product candidates may not be accepted in the marketplace and our business may be materially harmed. To date, we have expended significant time, resources and effort on the development of our product candidates, and a substantial portion of our resources recently has been and will continue to be focused on launching, marketing and commercializing our products, Gvoke, Keveyis and Recorlev, in the United States. Our business and future success are substantially dependent on our ability to generate and increase product revenues in the near term. Our estimates of the potential market opportunity for Gvoke, Keveyis, Recorlev and our product candidates include several key assumptions of the current market size and current pricing for commercially available products and are based on industry and market data obtained from industry publications, studies conducted by us, our industry knowledge, third-party research reports and other surveys. While we believe that our internal assumptions are reasonable, if any of these assumptions proves to be inaccurate, the actual market for our product and product candidates could be smaller than our estimates of our potential market opportunity. Our product candidates are in various stages of development and subject to the risks of failure inherent in developing drug products. Any delay or setback in the regulatory approval, product launch, commercialization or distribution of any of our product candidates will adversely affect our business. There is no guarantee that the infrastructure, systems, processes, policies, relationships and materials we have built for the commercialization of Gvoke, Keveyis and Recorlev will be sufficient for us to achieve success at the levels we expect. Further, our products may contain undetected manufacturing defects, including mislabeling, which might require product replacement, re-labeling or product recalls, which could further harm our business. See the section entitled, “Business — Coverage and Reimbursement”. Even if all regulatory approvals are obtained, the commercial success of our products and product candidates will depend on gaining market acceptance among physicians, patients, patient advocacy groups, healthcare payors and the medical community. The degree of market acceptance of our products and product candidates will depend on many factors, including: < the scope of regulatory approvals, including limitations or warnings contained in a product's regulatory-approved labeling; < our ability to produce, through a validated process, sufficiently large quantities of our products to permit successful commercialization; < our ability to establish and maintain commercial manufacturing arrangements with third-party manufacturers; < our ability to build and maintain sales, distribution and marketing capabilities sufficient to launch commercial sales of our products; < the acceptance in the medical community of the potential advantages of the products, including with respect to our efforts to increase adoption of our products by patients and healthcare providers; < the incidence, prevalence and severity of adverse side effects of our products; < the willingness of physicians to prescribe our products and of the target patient population to try these therapies; < the price and cost-effectiveness of our products; < the availability of sufficient third-party coverage and reimbursement, including the extent to which each product is approved for use at, or included on formularies of, hospitals and managed care organizations; < any negative publicity related to our or our competitors’ products or other formulations of products that we administer, including as a result of any related adverse side effects; < alternative treatment methods and potentially competitive products; < the potential advantages of our products over existing and future treatment methods; and < the strength of our sales, marketing and distribution support. Additionally, if, after marketing approval of any of our products or product candidates, we or others later identify undesirable or unacceptable side effects caused by such products, a number of potentially significant negative consequences could result, including: 44
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