SEC Filings

10-K
AVEXIS, INC. filed this Form 10-K on 02/28/2018
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Operating Expenses

We classify our operating expenses into two categories: research and development and general and administrative expenses. Personnel costs including salaries, benefits, bonuses and stock‑based compensation expense, comprise a significant component of each of these expense categories. We allocate expenses associated with personnel costs based on the nature of work associated with these resources.

Research and Development Costs

Research and development expense consists of expenses incurred while performing research and development activities to discover and develop potential gene therapy treatments. This includes conducting preclinical studies and clinical trials, investment in our manufacturing facility, manufacturing equipment and manufacturing development efforts and activities related to regulatory filings for product candidates. We recognize research and development expenses as they are incurred. Up‑front fees incurred in obtaining technology licenses for research and development activities are expensed as incurred if the technology licensed has no alternative future use. Our research and development expense primarily consists of:

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salaries and personnel‑related costs, including benefits and any employee stock‑based compensation, for our scientific personnel performing research and development activities;

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stock‑based compensation expense related to restricted common stock grants and, prior to our initial public offering, or IPO, stock warrant issuances to consultants assisting us in the research and development of our product candidate;

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costs related to executing preclinical studies and clinical trials;

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costs related to acquiring, developing and manufacturing materials for preclinical studies and clinical trials;

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costs related to developing processes and analytical methods to manufacture and test product from a significant number of small scale and full-scale engineering runs;

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fees paid to consultants and other third parties who support our product candidate development;

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other costs incurred in seeking regulatory approval of our product candidates; and

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allocated facility‑related costs and overhead.

We typically utilize our employee, consultant and infrastructure resources across our development programs. To date, substantially all of our research and development expenses have been associated with AVXS‑101.

We plan to increase our research and development expense for the foreseeable future as we continue our effort to develop and manufacture AVXS‑101 and to advance the development of future product candidates, subject to the availability of sufficient funding.

The successful development of product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs required to complete the remaining development of AVXS‑101 or any future product candidates. This is due to the numerous risks and uncertainties associated with the development of product candidates.

General and Administrative Expense

General and administrative expense consists primarily of salaries and personnel‑related costs, including employee benefits and any stock‑based compensation, for employees performing functions other than research and development. This includes personnel in executive, business operations, finance and administrative support functions.

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