Our ability to use tax loss carryforwards in
Switzerland may be limited.
As of December 31, 2018, we reported tax
loss carryforwards from financial years 2012 until 2018 for purposes of Swiss corporate income tax in the aggregate amount of CHF
109.3 million that could be available to offset future taxable income. If not used, these tax losses will expire seven years after
the year in which they were incurred. Due to our limited income, there is a high risk that the tax loss carryforwards will expire
partly or entirely and cannot be used to offset future taxable income thereafter for Swiss corporate income tax purposes.
Exchange rate fluctuations may materially affect
our results of operations and financial condition.
Under our existing agreements, we receive
and make a significant amount of payments in Swiss Franc, USD and Euro. As a result, changes and fluctuations in currency exchange
rates between the Swiss Franc and other currencies, especially the USD and Euro could have a materially adverse effect on our operating
results. Since our reporting currency is the Swiss Franc, financial line items are converted into Swiss Francs at the applicable
exchange rates. We also expect that in the future, a significant portion of our revenues and expenses will be denominated in Swiss
Franc, USD and Euro. Therefore, unfavorable developments in the value of the Swiss Franc as compared to the USD and Euro or any
other currency could have a material adverse effect on our business, financial condition and results of operations.
Risks Related to the Regulatory Environment
We cannot give any assurance that any of our
product candidates will receive regulatory approval, which is necessary before they can be commercialized.
Our future success is dependent on our
and our collaboration partners’ ability to successfully develop, obtain regulatory approval for, and then successfully commercialize
one or more product candidates. We currently have one product candidate that has completed Phase 2 clinical studies and is in a
Phase 2 study in people with an autosomal dominant mutation who are at risk of developing familial AD. We are not permitted to
market or promote any of our product candidates before we receive regulatory approval from the FDA, EMA or comparable foreign regulatory
authorities, and we may never receive such regulatory approval for any of our product candidates.
We cannot be certain that any of our product
candidates will be successful in clinical studies or receive regulatory approval. Applications for our product candidates could
fail to receive regulatory approval for many reasons, including but not limited to the following:
||the FDA, EMA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical studies;|
||the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full population for which we seek approval;|
||the FDA, EMA or comparable foreign regulatory authorities may disagree with our interpretation of data from nonclinical or clinical studies;|
||the data collected from clinical studies of our product candidates may not be sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the United States or elsewhere;|
||we may be unable to demonstrate to the FDA, EMA or comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable;|
||the FDA, EMA or other regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications, or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and|
||the approval policies or regulations of the FDA, EMA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.|