NVUS 2018 Annual Report

United State regarding exposure to criminal sanctions, civil penalties, program exclusion, contractual damages, reputational harm, and diminished profits and future earnings.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business. We may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our nonclinical or clinical development or production efforts. Our failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions. Risks Related to the Commercialization of Our Product Candidates Even if any of our product candidates receives marketing approval, we may fail to achieve the degree of market acceptance by physicians, patients, third-party payers and others in the medical community necessary for commercial success. If any of our product candidates receives marketing approval, we may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payers and others in the medical community. In addition, physicians, patients and third-party payers may prefer other novel products to ours. If our product candidates do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including: x the efficacy and safety and potential advantages and disadvantages compared to alternative treatments; x the ability to offer our products for sale at competitive prices; x the convenience and ease of administration compared to alternative treatments; x the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; x the strength of our marketing and distribution support; x the availability of third-party coverage and adequate reimbursement, including patient cost-sharing programs such as copays and deductibles; x the ability to develop or partner with third-party collaborators to develop companion diagnostics; x the prevalence and severity of any side effects; and x any restrictions on the use of our products together with other medications. If our current product candidates, or a future product candidate receives marketing approval and we, or others, later discover that the product is less effective than previously believed or causes undesirable side effects that were not previously identified, the ability to market the product could be compromised. Clinical trials are conducted in carefully defined subsets of patients who have agreed to enter into clinical trials. Consequently, it is possible that our clinical trials may indicate an apparent beneficial effect of a product candidate that is greater than the actual positive effect in a broader patient population or alternatively fail to identify undesirable side effects. If, following approval of a product candidate, we, or others, discover that the product is less effective than previously believed or causes undesirable side effects that were not previously identified, any of the following events could occur: x regulatory authorities may withdraw their approval of the product or seize the product; x the product may be required to be recalled or changes may be required to the way the product is administered; x additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the product; x UHJXODWRU\ DXWKRULWLHV PD\ UHTXLUH WKH DGGLWLRQ RI ODEHOLQJ VWDWHPHQWV VXFK DV D ³EODFN ER[´ ZDUQLQJ RU D contraindication; x the creation of a Medication Guide outlining the risks of the previously unidentified side effects for distribution to patients; x additional restrictions may be imposed on the distribution or use of the product via a Risk Evaluation and Mitigation Strategy;

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