|AVEXIS, INC. filed this Form S-1/A on 02/09/2016|
Table of Contents
If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the
value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. A decline in the value of our company
also could cause you to lose all or part of your investment.
of the numerous risks and uncertainties associated with pharmaceutical product and biological development, we are unable to accurately predict the timing or amount of increased
expenses or when, or if, we will be able to achieve profitability. If we are required by the U.S. Food and Drug Administration, or FDA, or the European Medicines Agency, or EMA, or other regulatory
authorities to perform studies in addition to those currently expected, or if there are any delays in completing our clinical trials or the development of AVXS-101, our expenses could increase and
revenue could be further delayed.
We have never generated revenue from product sales and may never be profitable.
Our ability to generate revenue from product sales and achieve profitability depends on our ability, alone or with collaborative
partners, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize, AVXS-101 and any additional product candidates that we may pursue in the future.
We do not anticipate generating revenues from product sales for the next several years, if ever. Our ability to generate future revenues from product sales depends heavily on our, or our future
collaborators', success in:
- completing research and preclinical and clinical development of our current product candidate in a timely and successful manner;
- seeking and obtaining regulatory and marketing approvals for any future product candidates for which we complete clinical trials;
- launching and commercializing any future product candidates for which we obtain regulatory and marketing approval by establishing a
sales force, marketing and distribution infrastructure or, alternatively, collaborating with a commercialization partner;
- qualifying for coverage and adequate reimbursement by government and third-party payors for AVXS-101 both in the U.S. and
- maintaining and enhancing a commercially viable, sustainable, scalable, reproducible and transferable manufacturing process for
AVXS-101 that is compliant with cGMPs;
- establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate, in both amount and
quality, products and services to support clinical development and the market demand for our product candidate, if approved;
- obtaining market acceptance, if and when approved, of our product candidate as a viable treatment option by patients, the medical
community, and third-party payors;
- effectively addressing any competing technological and market developments;
- implementing additional internal systems and infrastructure, as needed;
- negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter and performing our
obligations in such collaborations;
- maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how;
- avoiding and defending against third-party interference or infringement claims; and
- attracting, hiring and retaining qualified personnel.
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