SEC Filings

10-Q
AVEXIS, INC. filed this Form 10-Q on 11/09/2017
Entire Document
 

Results of Operations

 

Comparison of the Three and Nine Months ended September 30, 2017 and 2016

 

The following table summarizes our results of operations for the three and nine months ended September 30, 2017 and 2016, together with the dollar increase or decrease in those items (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30, 

 

Nine Months Ended September 30, 

 

 

 

 

2017

 

 

2016

 

Period-to-Period Change

 

 

2017

 

 

2016

 

Period-to-Period Change

 

Net revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

 —

 

$

 —

 

$

 —

 

$

 —

 

$

 —

 

$

 —

 

Operating expenses:

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

General and administrative

 

 

16,095

 

 

7,083

 

 

9,012

 

 

38,898

 

 

17,325

 

 

21,573

 

Research and development

 

 

33,425

 

 

14,098

 

 

19,327

 

 

98,946

 

 

40,542

 

 

58,404

 

Total operating expenses

 

 

49,520

 

 

21,181

 

 

28,339

 

 

137,844

 

 

57,867

 

 

79,977

 

Interest income

 

 

881

 

 

99

 

 

782

 

 

1,458

 

 

230

 

 

1,228

 

Net loss

 

$

(48,639)

 

$

(21,082)

 

$

(27,557)

 

$

(136,386)

 

$

(57,637)

 

$

(78,749)

 

 

General and Administrative Expense

 

General and administrative expense increased from $7.1 million for the three months ended September 30, 2016, to $16.1 million for the three months ended September 30, 2017. This $9.0 million increase included increases of $2.7 million in salaries and personnel-related costs, $2.6 million in non-cash stock-based compensation expense, $2.1 million in other administrative costs driven by increased headcount across all general and administrative functions to support our overall growth, and $1.6 million in legal, professional and consulting fees.

 

General and administrative expense increased from $17.3 million for the nine months ended September 30, 2016, to $38.9 million for the nine months ended September 30, 2017. This $21.6 million increase included increases of $6.9 million in salaries and personnel-related costs, $5.8 million in other administrative costs driven by increased headcount across all general and administrative functions to support our overall growth, $5.3 million in non-cash stock-based compensation expense, and $3.6 million in legal, professional and consulting fees.

 

Research and Development Expense

 

Research and development expense increased from $14.1 million for the three months ended September 30, 2016, to $33.4 million for the three months ended September 30, 2017. The $19.3 million increase was primarily attributable to product manufacturing expenses and associated accelerated spending, including increased headcount, in our product manufacturing facility, as well as expenses related to the conclusion of our Phase 1 clinical trial of AVXS-101 in SMA Type 1 and commencement of our pivotal trial of AVXS-101. More specifically, this amount included increases of $5.6 million in research and development supplies and materials, $5.2 million in third-party clinical and manufacturing research and development expense associated with product manufacturing, $3.8 million in salaries and personnel-related expenses, driven by increased headcount across all research and development and manufacturing functions,  $2.6 million in other research and development expenses, $2.3 million in non-cash stock-based compensation expense and, partially offset by decreases of $0.2 million in license fees.  

 

Research and development expense increased from $40.5 million for the nine months ended September 30, 2016, to $99.0 million for the nine months ended September 30, 2017.  This  $58.4 million increase included the benefit of a $4.4 million decrease in non-cash stock-based compensation expense that was primarily attributable to the recognition of $10.4 million of additional stock compensation expense upon the vesting in full of Dr. Kaspar’s restricted stock award during the year ended December 31, 2016. Excluding this non-cash stock-based compensation benefit, research and development expense increased $62.9 million which was primarily attributable to increased product manufacturing expenses and associated accelerated spending, including increased headcount, in our product manufacturing facility as

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