Research and Development
Research and development expense consists of expenses incurred while performing research and development activities to discover and develop our product candidates. This includes conducting preclinical studies and clinical trials, manufacturing development efforts and activities related to regulatory filings for product candidates. We recognize research and development expenses as they are incurred. Our research and development expense primarily consists of:
| • | clinical trial and regulatory-related costs; |
| • | expenses incurred under agreements with investigative sites and consultants that conduct our clinical trials; |
| • | manufacturing and testing costs and related supplies and materials; |
| • | employee-related expenses, including salaries, benefits, travel and stock-based compensation; and |
| • | facility expenses dedicated to research and development. |
We typically use our employee, consultant and infrastructure resources across our development programs. We track outsourced development costs by product candidate or development program, but we do not allocate personnel costs, other internal costs or external consultant costs to specific product candidates or development programs.
Substantially all of our research and development expenses to date have been incurred in connection with our product candidates. We expect our research and development expenses to increase significantly for the foreseeable future as we advance an increased number of our product candidates through clinical development, including the conduct of our planned clinical trials. The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. The successful development of product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs required to complete the remaining development of any product candidates. This is due to the numerous risks and uncertainties associated with the development of product candidates.
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The costs of clinical trials may vary significantly over the life of a project owing to, but not limited to, the following:
| • | per patient trial costs; |
| • | the number of sites included in the clinical trials; |
| • | the countries in which the clinical trials are conducted; |
| • | the length of time required to enroll eligible patients; |
| • | the number of patients that participate in the clinical trials; |
| • | the number of doses that patients receive; |
| • | the cost of comparative agents used in clinical trials; |
| • | the drop-out or discontinuation rates of patients; |
| • | potential additional safety monitoring or other studies requested by regulatory agencies; |
| • | the duration of patient follow-up; and |
| • | the efficacy and safety profile of the product candidate. |
We do not expect any of our product candidates to be commercially available for at least the next several years, if ever.