|AVEXIS, INC. filed this Form 10-K on 03/18/2016|
Table of Contents
- conducting sales and marketing activities.
expect our financial condition and operating results to continue to fluctuate from quarter to quarter and year to year due to a variety of factors, many of which are beyond our
control. We will need to transition at some point from a company with a research and development focus to a company capable of undertaking commercial activities. We may encounter unforeseen expenses,
difficulties, complications and delays and may not be successful in such a transition.
We will need to raise additional funding, which may not be available on acceptable terms, or at all.
Failure to obtain this necessary capital when needed may force us to delay, limit or terminate certain of our product development efforts or other operations.
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development
of, initiate further clinical trials of, and seek marketing approval for, AVXS-101. In addition, if we obtain marketing approval for our product candidate, we expect to incur significant expenses
related to product sales, medical affairs, marketing, manufacturing and distribution. Furthermore, we expect to incur additional costs associated with operating as a public company. While we believe
that our existing cash, cash equivalents and short-term investments will be sufficient to fund our current operating plans through the end of 2017, we anticipate that we will need additional funding
to complete the development of AVXS-101 and any future product candidates.
future capital requirements will depend on many factors, including:
- the progress and results of our current and planned clinical trials of AVXS-101;
- the scope, progress, results and costs of drug discovery, laboratory testing, manufacturing, preclinical development and clinical
trials for any other product candidates that we may pursue in the future, if any;
- the costs, timing and outcome of regulatory review of AVXS-101 and any other product candidates we may develop;
- the costs of establishing and maintaining our own commercial-scale cGMP manufacturing facility;
- the costs associated with the manufacturing process development and evaluation of third-party manufacturers;
- the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for AVXS-101 or
any other product candidates we may develop for which we receive marketing approval;
- revenue, if any, received from commercial sale of AVXS-101 or other product candidates, should any of our product candidates receive
- the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and
defending intellectual property-related claims;
- our current collaboration and license agreements remaining in effect and our achievement of milestones under those agreements;
- our ability to establish and maintain additional collaborations and licenses on favorable terms, if at all; and
- the extent to which we acquire or in-license other product candidates and technologies.
potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we
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