The unavailability or inadequacy and variability
of third-party coverage and reimbursement could have a material adverse effect on the market acceptance of our product candidates
and the future revenues we may expect to receive from those products. In addition, we are unable to predict what additional legislation
or regulation relating to the healthcare industry or third-party coverage and reimbursement may be enacted in the future, or what
effect such legislation or regulation would have on our business.
Our products may not gain market acceptance,
in which case we or our collaboration partners may not be able to generate product revenues, which will materially adversely affect
our business, financial condition and results of operations.
Even if the FDA, the EMA or other regulatory
authority approves the marketing of any product candidates that we develop, physicians, healthcare providers, patients or the medical
community may not accept or use them. Efforts to educate the medical community and third-party payors on the benefits of our product
candidates may require significant resources and may not be successful. If any of our current or future product candidates does
not achieve an adequate level of acceptance, we may not generate significant product or royalty revenues or any profits from operations.
The degree of market acceptance of our product candidates that are approved for commercial sale will depend on a variety of factors,
||how clinicians and potential patients perceive our novel products;|
||the timing of market introduction;|
||the number and clinical profile of competing products;|
||our ability to provide acceptable evidence of safety and efficacy or clinical utility;|
||the prevalence and severity of any side effects;|
||relative convenience and ease of administration;|
||patient diagnostics and screening infrastructure in each market;|
||marketing and distribution support;|
||availability of coverage, reimbursement and adequate payment from health maintenance organizations and other third-party payors, both public and private; and|
||other potential advantages over alternative treatment methods.|
If our product candidates fail to gain
market acceptance, this will have a material adverse impact on our ability to generate revenues to provide a satisfactory, or any,
return on our investments. Even if some products achieve market acceptance, the market may prove not to be large enough to allow
us to generate significant revenues.
In addition, the potential market opportunity
of our product candidates is difficult to precisely estimate. Our estimates of the potential market opportunity are predicated
on several key assumptions such as industry knowledge and publications, third-party research reports and other surveys. These assumptions
involve the exercise of significant judgment on the part of our management, are inherently uncertain and the reasonableness of
these assumptions could not have been assessed by an independent source in every detail. If any of the assumptions proves to be
inaccurate, then the actual market for our product candidates could be smaller than our estimates of the potential market opportunity.
If the actual market for our product candidates is smaller than we expect, or if any approved products fail to achieve an adequate
level of acceptance by physicians, health care payors and patients, our product or royalty revenue may be limited and it may be
more difficult for us to achieve or maintain profitability.
We depend on enrollment of patients in our
clinical studies for our product candidates. If we are unable to enroll patients in our clinical studies, our research and development
efforts could be materially adversely affected.