SEC Filings

10-K
AVEXIS, INC. filed this Form 10-K on 02/28/2018
Entire Document
 

Many of these factors are beyond our control. If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our product candidates, which would materially harm our business.

Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

We are a development‑stage company founded in 2010, and we did not begin research and development activities for the treatment of SMA with AVXS‑101 until 2013. Our efforts to date, with respect to the development of AVXS‑101, have been limited to organizing and staffing our company, business planning, raising capital, acquiring our technology, identifying AVXS‑101 as a potential gene therapy product candidate, undertaking clinical trials of that product candidate, investing in our manufacturing facility and manufacturing equipment and establishing collaborations. We have not yet demonstrated the ability to complete late stage clinical trials of AVXS‑101 or any other product candidate, obtain marketing approvals, manufacture a commercial‑scale product or conduct sales and marketing activities necessary for successful commercialization. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had more experience developing gene therapy products.

We do not currently have the ability to perform the sales, marketing and manufacturing functions necessary for the production and sale of AVXS‑101 on a commercial scale. Our only product candidate is AVXS‑101, which may be required to undergo significant additional clinical trials before it can be commercialized, if at all. The successful commercialization of AVXS‑101 will require us to perform a variety of functions, including:

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continuing clinical development of AVXS‑101;

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obtaining required regulatory approvals;

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formulating and manufacturing product candidates; and

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conducting sales and marketing activities.

We 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 may need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this 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 into 2020, we anticipate that we may need additional funding to complete the development of AVXS‑101 and any future product candidates and commercialize any such products.

Our future capital requirements will depend on many factors, including:

·

the progress and results of our current and planned clinical trials of AVXS‑101;

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