SEC Filings

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

Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of these agreements, independent development or publication of information including our trade secrets by third parties. A competitor’s discovery of our trade secrets would impair our competitive position and have an adverse impact on our business, financial condition, results of operations and prospects.

Although we established our own AVXS‑101 manufacturing facility, we may utilize third parties as needed to conduct our product manufacturing. Therefore, we are subject to the risk that these third parties may not perform satisfactorily. 

Even following the completion and validation of our cGMP manufacturing facility, which we expect will be the primary source of clinical and commercial supply for AVXS-101, we intend to evaluate potential third‑party manufacturing capabilities in order to provide potential multiple sources of clinical and commercial supply. We currently utilize third-party manufacturers for the production of AVXS-201 and AVXS-301. In the event we engage third party manufacturers and they do not successfully carry out their contractual duties, meet expected deadlines or manufacture AVXS‑101 in accordance with regulatory requirements or if there are disagreements between us and these third‑party manufacturers, we may not be able to meet commercial demand for AVXS‑101 or preclinical or clinical demand for other product candidates. In such instances, we may need to locate an appropriate replacement third‑party relationship, which may not be readily available or on acceptable terms, which would cause additional delay or increased expense and would thereby have a material adverse effect on our business, financial condition, results of operations and prospects.

We will need to perform analytical and other animal or cell‑based tests to demonstrate that materials produced by any third‑party manufacturer that we engage are safe, pure, and potent. There is no assurance that any third‑party manufacturer that we engage will be successful in producing AVXS‑101, that any such product will pass the required comparability testing, or that any materials produced by any third‑party manufacturer that we engage will have the same effect in patients that we have observed to date with respect to materials produced by us and NCH. We believe that our own manufacturing facility will have sufficient capacity to meet demand for AVXS‑101 for our future clinical trials. There is a risk that if supplies are interrupted or result in poor yield or quality, it would materially harm our business. In addition, we may change our manufacturing process for AVXS‑101, which could cause delays in production as we and our third‑party manufacturers seek to improve the process.

If the gene therapy industry were to grow, we may encounter increasing competition for the raw materials and consumables necessary for the production of AVXS‑101. Furthermore, demand for third‑party cGMP manufacturing facilities may grow at a faster rate than existing manufacturing capacity, which could disrupt our ability to find and retain third‑party manufacturers capable of producing sufficient quantities of raw materials for AVXS‑101 to meet initial commercial demand in the U.S. We currently rely, and expect to continue to rely, on additional third parties to manufacture ingredients of AVXS‑101 and to perform quality testing. Even following the establishment of our own cGMP‑compliant manufacturing capabilities, we intend to maintain third‑party manufacturers for these raw materials and components, which will expose us to risks including:

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reduced control for certain aspects of manufacturing activities;

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termination or nonrenewal of manufacturing and service agreements with third parties in a manner or at a time that is costly or damaging to us; and

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disruptions to the operations of our third‑party manufacturers and service providers caused by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or service provider.

Any of these events could lead to clinical trial delays or failure to obtain regulatory approval, or impact our ability to successfully commercialize AVXS‑101. Some of these events could be the basis for FDA action, including injunction, recall, seizure or total or partial suspension of product manufacture.

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