SEC Filings

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

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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;

·

the cost and timing of establishing and validating manufacturing processes and facilities, including our own, for development and commercialization of our product candidates, if approved;

·

the efforts necessary to institute post‑approval regulatory compliance requirements;

·

the costs and timing of future product in-licensing arrangements and associated upfront and milestone payments;

·

the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval;

·

the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval, which may be affected by market conditions, including obtaining coverage and adequate reimbursement of our product candidates from third‑party payors, including government programs and managed care organizations, and competition within the therapeutic class to which our product candidates are assigned;

·

the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property‑related claims; and

·

the extent to which we acquire or in‑license other product candidates and technologies.

Our future commercial revenue, if any, will be derived from sales of gene therapy products that we do not expect to be commercially available for several years, if at all. Accordingly, we may need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the terms of these equity securities or this debt may restrict our ability to operate. Any future debt financing and equity financing, if available, may involve agreements that include, covenants limiting and restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, entering into profit‑sharing or other arrangements or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.

Contractual Obligations, Commitments and Contingencies

Our principal commitments consist of obligations under our license milestone payment commitments, tax indemnification obligation and operating lease commitments. The following table summarizes these contractual obligations as of December 31, 2017 (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Less Than

 

1 to 3

 

4 to 5

 

More Than

Contractual Obligations(1)(2)(3)

    

Total

    

1 Year Total

    

Years

    

Years

    

5 Years

Tax indemnification obligation

 

$

2,787

 

$

2,787

 

$

 —

 

$

 —

 

$

 —

Operating lease commitments

 

 

17,306

 

 

1,414

 

 

4,044

 

 

4,305

 

 

7,543

Total contractual obligations

 

$

20,093

 

$

4,201

 

$

4,044

 

$

4,305

 

$

7,543


(1)

Excludes potential milestone payments under the REGENXBIO SMA, REGENXBIO Rett and ALS, AskBio, NCH SMA, NCH Rett and NCH ALS Licenses. The actual amounts and timing of some of these payments are uncertain, as the payments are contingent upon future events.

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