SEC Filings

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

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 few years, if ever. Our ability to generate future revenues from product sales depends heavily on our, or our future collaborators’, success in:

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completing research and preclinical and clinical development of AVXS-101 and any future product candidates in a timely and successful manner;

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seeking and obtaining regulatory and marketing approvals for AVXS-101 and any future product candidates for which we complete clinical trials;

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launching and commercializing AVXS-101 and 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;

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qualifying for coverage and adequate reimbursement by government and third‑party payors for AVXS‑101 and any future product candidates both in the U.S. and internationally;

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maintaining and enhancing a commercially viable, sustainable, scalable, reproducible and transferable manufacturing process for AVXS‑101 and any future product candidates that is compliant with cGMPs;

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establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services as needed to support clinical development and the market demand for our product candidates, if approved;

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obtaining market acceptance, if and when approved, of our product candidates as viable treatment options by patients, the medical community, and third‑party payors;

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effectively addressing any competing technological and market developments;

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implementing additional internal systems and infrastructure, as needed;

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negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter and performing our obligations in such collaborations;

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maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know‑how;

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avoiding and defending against third‑party interference or infringement claims; and

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attracting, hiring and retaining qualified personnel.

Even if any product candidate that we develop is approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. Our expenses could increase beyond expectations if the FDA, the EMA or other regulatory authorities require us to perform clinical and other studies in addition to those that we currently anticipate. Even if we are able to generate revenues from the sale of any approved product candidates, we may not become profitable and may need to obtain additional funding to continue operations.

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