SEC Filings

S-1/A
AVEXIS, INC. filed this Form S-1/A on 02/01/2016
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Table of Contents


RISK FACTORS

          Investing in our common stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this prospectus, including our consolidated financial statements and the related notes and "Management's Discussion and Analysis of Financial Condition and Results of Operations," before deciding whether to invest in our common stock. The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations and growth prospects. In such an event, the market price of our common stock could decline and you may lose all or part of your investment.

Risks related to our financial position and need for capital

We have incurred net losses since inception and anticipate that we will continue to incur net losses for the foreseeable future and may never achieve or maintain profitability.

          Since inception, we have incurred significant net losses. Our net losses were $2.7 million and $15.7 million for the years ended December 31, 2013 and 2014, respectively, and $25.3 million for the nine months ended September 30, 2015. As of September 30, 2015, we had an accumulated deficit of $45.4 million. We have devoted substantially all of our efforts to research and development, including clinical development of our gene therapy product candidate, AVXS-101, as well as to building out our management team and infrastructure. We expect that it could be several years, if ever, before we have a commercialized product candidate. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses we incur may fluctuate significantly from quarter to quarter. We anticipate that our expenses will increase substantially if, and as, we:

    continue our research and the preclinical and clinical development of our product candidate, including our ongoing Phase 1 and other planned clinical trials for AVXS-101;

    initiate additional clinical trials and preclinical studies for any additional product candidates that we may pursue in the future;

    prepare our biologics license application, or BLA, and marketing authorization application for AVXS-101;

    manufacture current good manufacturing practices, or cGMP, material for clinical trials or potential commercial sales;

    establish and validate a commercial-scale cGMP manufacturing facility;

    further develop our gene therapy product candidate portfolio;

    establish a sales, marketing and distribution infrastructure to commercialize any product candidate for which we may obtain marketing approval;

    develop, maintain, expand and protect our intellectual property portfolio;

    acquire or in-license other product candidates and technologies; and

    seek marketing approval for AVXS-101 in the European Union and in other key geographies.

          To become and remain profitable, we must develop and eventually commercialize one or more product candidates with significant market potential. This will require us to be successful in a range of challenging activities, including completing preclinical testing and clinical trials of AVXS-101, developing and validating commercial scale manufacturing processes, obtaining marketing approval for this product candidate, manufacturing, marketing and selling any future product candidates for which we may obtain marketing approval and satisfying any post-marketing requirements. We currently only have one product candidate, AVXS-101 and we may never acquire, in-license or develop additional product candidates. We may never succeed in any or all of these activities and, even if we do, we may never generate revenues that are significant or large enough to achieve

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