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SEC Filings

20-F
AC IMMUNE SA filed this Form 20-F on 03/21/2019
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The highly competitive nature of and rapid technological changes in the biotechnology and pharmaceutical industries could render our product candidates or our technology obsolete or non-competitive. Our competitors may, among other things:

 

  · develop and commercialize products that are safer, more effective, less expensive, or more convenient or easier to administer;

 

  · obtain quicker regulatory approval;

 

  · establish superior intellectual property and proprietary positions;

 

  · have access to more manufacturing capacity;

 

  · implement more effective approaches to sales, marketing and distribution; or

 

  · form more advantageous strategic alliances.

 

Should any of these occur, our business, financial condition and results of operations could be materially adversely affected.

 

We may not be successful in our efforts to use and expand our Morphomer proprietary technology platform to build additional product candidates for our pipeline.

 

A key element of our strategy is to use and expand our Morphomer proprietary technology platform to create unique drug therapies for conformational diseases, such as AD, and progress these product candidates through clinical development. Although our research and development efforts to date have resulted in a pipeline of product candidates, we may not be able to develop product candidates that are safe and effective in the future. Even if we are successful in continuing to build our pipelines, the potential product candidates that we identify may not be suitable for clinical development, potentially as a result of having harmful side effects or other characteristics indicating they may be unlikely to receive marketing approval and achieve market acceptance. If we or our collaboration partners do not continue to successfully develop and begin to commercialize product candidates, we will face difficulty in obtaining product or royalty revenues in the future, which could result in significant harm to our financial position and adversely affect the price of our common shares.

 

Our business is subject to economic, political, regulatory and other risks associated with international operations.

 

Our business is subject to risks associated with conducting business internationally. We and a number of our suppliers and collaborative and clinical study relationships are located outside the United States. Accordingly, our future results could be harmed by a variety of factors, including:

 

  · economic weakness, including inflation, or political instability in particular non-U.S. economies and markets;

 

  · differing regulatory requirements for drug approvals in non-U.S. countries;

 

  · potentially reduced protection for intellectual property rights;

 

  · difficulties in compliance with non-U.S. laws and regulations;

 

  · changes in non-U.S. regulations and customs, tariffs and trade barriers;

 

  · changes in non-U.S. currency exchange rates and currency controls;

 

  · changes in a specific country’s or region’s political or economic environment;

 

  · trade protection measures, import or export licensing requirements or other restrictive actions such as sanctions by U.S. or non-U.S. governments;

 

  · negative consequences from changes in tax laws;

 

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