SEC Filings

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

AveXis, Inc.

Notes to Consolidated Financial Statements

1. Background

AveXis, Inc. was formed on March 8, 2010 in the state of Delaware as Biolife Cell Bank, LLC. In January 2012, the Company converted from a limited liability company to a corporation, Biolife Cell Bank, Inc. In January 2014, the Company amended and restated its Certificate of Incorporation to change its name to AveXis, Inc. (“AveXis” or “the Company”).

The Company is a clinical‑stage gene therapy company dedicated to developing and commercializing novel treatments for patients suffering from rare and life‑threatening neurological genetic diseases. The Company’s initial product candidate, AVXS‑101, is its proprietary gene therapy product candidate for the treatment of spinal muscular atrophy, (“SMA). SMA is a severe neuromuscular disease characterized by the loss of motor neurons, leading to progressive muscle weakness and paralysis. SMA is generally divided into sub‑categories termed SMA Type 1, 2, 3 and 4. The Company is conducting a pivotal clinical trial for AVXS‑101 for the treatment of SMA Type 1, the leading genetic cause of infant mortality, and has initiated a Phase 1 clinical trial for the treatment of SMA Type 2.

Liquidity and Risks

As of December 31, 2017, the Company generated an accumulated deficit of $359.6 million since inception and had cash and cash equivalents of $324.1 million.

The Company believes its cash and cash equivalents as of December 31, 2017 together with the net proceeds from its January 2018 underwritten public offering of approximately $431.9 million (Note 15), are sufficient to fund its current planned operations for at least the next twelve months from the issuance of these consolidated financial statements. As the Company continues to incur losses, transition to profitability is dependent upon the successful manufacturing, development, approval, and commercialization of its product candidate and achieving a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional capital. Management intends to fund future operations through additional private or public debt or equity offerings and may seek additional capital through arrangements with strategic partners or from other sources.

The Company is subject to risks common to companies in the biotechnology industry, including, but not limited to, development by the Company or its competitors of technological innovations, risks of failure of clinical studies, dependence on key personnel, protection of proprietary technology, compliance with government regulations, and ability to transition from preclinical manufacturing to commercial production of products.

Initial Public Offering

On February 10, 2016, the Company completed an initial public offering (“IPO”), which resulted in the issuance and sale of 4,750,000 shares of its common stock at a public offering price of $20.00 per share, resulting in net proceeds of $88.4 million after deducting underwriting discounts. Upon the closing of the IPO, the 3,278,938 shares of Class B-1 preferred stock, 326,557 shares of Class B-2 preferred stock, 2,365,020 shares of Class C preferred stock and 3,105,000 of Class D preferred stock were automatically converted into shares of the Company’s common stock.

On March 3, 2016, the underwriters of the Company’s IPO exercised their over-allotment option to purchase an additional 527,941 shares of the Company’s common stock at the initial public offering price of $20.00 per share, resulting in additional net proceeds of $9.8 million after deducting underwriting discounts.



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