If Seelos or any of its third-party manufacturers fail to maintain regulatory compliance, the FDA, the EMA or comparable foreign authorities can impose regulatory
sanctions including, among other things, refusal to approve a pending application for a product candidate, withdrawal of an approval, or suspension of production. As a result, Seelos' business,
financial condition and results of operations may be materially and adversely affected.
Additionally, if supply from one manufacturer is interrupted, an alternative manufacturer would need to be qualified through an NDA supplement or MAA variation, or
equivalent foreign regulatory filing, which could result in further delay. The regulatory agencies may also require additional studies or trials if a new manufacturer is relied upon for commercial
production. Switching manufacturers may involve substantial costs and is likely to result in a delay in Seelos' desired clinical and commercial timelines.
These factors could cause Seelos to incur higher costs and could cause the delay or termination of clinical trials, regulatory submissions, required approvals, or
commercialization of Seelos' product candidates. Furthermore, if Seelos' suppliers fail to meet contractual requirements and Seelos is unable to secure one or more replacement suppliers
capable of production at a substantially equivalent cost, Seelos' clinical trials may be delayed or Seelos could lose potential revenue.
Any collaboration arrangement that Seelos may enter into in the future may not be successful, which could adversely affect Seelos' ability to develop and
commercialize Seelos' current and potential future product candidates.
Seelos may seek collaboration arrangements with biopharmaceutical companies for the development or commercialization of its current and potential future
product candidates. To the extent that Seelos decides to enter into collaboration agreements, Seelos will face significant competition in seeking appropriate collaborators. Moreover,
collaboration arrangements are complex and time consuming to negotiate, execute and implement. Seelos may not be successful in its efforts to establish and implement collaborations or other
alternative arrangements should Seelos choose to enter into such arrangements, and the terms of the arrangements may not be favorable to Seelos. If and when Seelos collaborates with a
third party for development and commercialization of a product candidate, Seelos can expect to relinquish some or all of the control over the future success of that product candidate to the third
party. The success of Seelos' collaboration arrangements will depend heavily on the efforts and activities of its collaborators. Collaborators generally have significant discretion in determining
the efforts and resources that they will apply to these collaborations.
Disagreements between parties to a collaboration arrangement can lead to delays in developing or commercializing the applicable product candidate and can be difficult
to resolve in a mutually beneficial manner. In some cases, collaborations with biopharmaceutical companies and other third parties are terminated or allowed to expire by the other party. Any
such termination or expiration would adversely affect Seelos' business, financial condition and results of operations.
If Seelos is unable to develop its own commercial organization or enter into agreements with third parties to sell and market Seelos' product candidates,
Seelos may be unable to generate significant revenues.
Seelos does not have a sales and marketing organization, and Seelos has no experience as a company in the sales, marketing and distribution of
pharmaceutical products. If any of Seelos' product candidates are approved for commercialization, Seelos may be required to develop its sales, marketing and distribution capabilities, or make
arrangements with a third party to perform sales and marketing services. Developing a sales force for any resulting product or any product resulting from any of Seelos' other product
candidates is expensive and time consuming and could delay any product launch. Seelos may be unable to establish and manage an effective sales force in a timely or cost-effective manner, if
at all, and any sales force Seelos does establish may not be capable of generating sufficient demand for Seelos' product candidates. To the extent that Seelos enters into arrangements with
collaborators or other third parties to perform sales and marketing services, Seelos' product revenues are likely to be lower than if Seelos marketed and sold its product candidates
independently. If Seelos is unable to establish adequate sales and marketing capabilities, independently or with others, Seelos may not be able to generate significant revenues and may not
The commercial success of Seelos' product candidates depends upon their market acceptance among physicians, patients, healthcare payors and the
Even if Seelos' product candidates obtain regulatory approval, Seelos' products, if any, may not gain market acceptance among physicians, patients, healthcare
payors and the medical community. The degree of market acceptance of any of Seelos' approved product candidates will depend on a number of factors, including:
- the effectiveness of Seelos' approved product candidates as compared to currently available products;
- patient willingness to adopt Seelos' approved product candidates in place of current therapies;
- Seelos' ability to provide acceptable evidence of safety and efficacy;
- relative convenience and ease of administration;
- the prevalence and severity of any adverse side effects;