SEC Filings

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

in prepaid expenses and other long-term assets, partially offset by a $5.4 million increase in accounts payable and accrued expenses and other current liabilities.

 

Investing Activities

 

For the nine months ended September 30, 2017, net cash used in investing activities consisted of $23.4 million of capital expenditures, primarily related to our manufacturing facility and purchases of property and equipment.  For the nine months ended September 30, 2016, net cash used in investing activities consisted of $11.7 million of capital expenditures, primarily related to our manufacturing facility and purchases of property and equipment.

 

During the nine months ended September 30, 2017, we transferred a significant amount of our capital assets from Construction in progress to Equipment upon the successful completion of GMP manufacturing runs. We expect to continue to transfer capital assets as we complete the build-out of our scalable GMP manufacturing facility.

 

Financing Activities

 

For the nine months ended September 30, 2017, net cash provided by financing activities of $270.7 million consisted primarily of funds raised from our June 2017 underwritten public offering. For the nine months ended September 30, 2016, net cash provided by financing activities consisted primarily of $246.3 million from our initial public offering and our September 2016 public offering. 

 

Future Funding Requirements

 

To date, we have not generated any revenues from the commercial sale of approved gene therapy products or drug therapies and we do not expect to generate substantial revenue for at least the next few years. If we fail to complete the development of our product candidates in a timely manner or fail to obtain their regulatory approval, our ability to generate future revenue will be compromised. We do not know when, or if, we will generate any revenue from our gene therapy core business. We do not expect to generate significant revenue unless and until we obtain regulatory approval of and commercialize AVXS-101. In addition, we expect our expenses to increase in connection with our ongoing development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval for, product candidates, including with respect to development of AVXS-101 for other types of SMA and other product candidates for other diseases. We also expect to continue to incur costs associated with operating as a public company. In addition, subject to obtaining regulatory approval of product candidates, we expect to incur significant commercialization expenses for product sales, marketing, manufacturing and distribution. We anticipate that we will need additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

 

Based upon our current operating plan, we believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2019. We intend to devote the majority of our capital resources for clinical development, manufacturing and regulatory approval of AVXS-101. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development of product candidates.

 

Our future capital requirements will depend on many factors, including:

 

·

the progress and results of our studies and clinical trials for AVXS-101;

·

the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our other product candidates, including our planned new programs in Rett syndrome and ALS;

·

the number and development requirements of other product candidates that we may pursue;

·

the costs, timing and outcome of regulatory review of our product candidates;

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