Print Page     Close Window     

SEC Filings

20-F
AC IMMUNE SA filed this Form 20-F on 03/21/2019
Entire Document
 

 

We are currently advancing our product candidates through clinical development, either together with a collaboration partner (crenezumab, ACI-35 and anti-Tau antibody, Tau-PET imaging tracer, Morphomer Tau) or independently (ACI-24 for AD and Down syndrome). We expect our research and development expenses to continue to increase in connection with our ongoing activities, particularly as we and/or our collaboration partners continue our ongoing studies and initiate new studies of crenezumab, ACI-24 for AD and DS, ACI-35, Morphomer Tau, Tau-PET imaging tracer and anti-Tau antibody and initiate preclinical and clinical development of our other product candidates. As of December 31, 2018, we had cash and cash equivalents of CHF 156.5 million and short-term financial assets of CHF 30.0 million for total liquidity of CHF 186.5 million. We currently believe that our existing capital resources, not including potential milestone payments, will be sufficient to meet our projected operating requirements through at least the third quarter of fiscal year 2023. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than we currently expect. Our future funding requirements will depend on many factors, including but not limited to:

 

  · the scope, rate of progress, results and cost of our pre-clinical and clinical studies and other related activities;

 

  · the cost of manufacturing clinical supplies and establishing commercial supplies of our existing product candidates and any other products we may develop;

 

  · the cost, timing, and outcomes of regulatory approvals;

 

  · the cost and timing of establishing sales, marketing and distribution capabilities;

 

  · the terms and timing of any collaborative, licensing, and other arrangements that currently exist or that we may establish in the future, including any required milestone and royalty payments thereunder;

 

  · the emergence of competing technologies or other adverse market developments; and

 

  · the potential cost and timing of managing and protecting our portfolio of intellectual property.

 

We expect that we will require additional capital to commercialize certain of our product candidates. If we receive regulatory approval for our current and future product candidates, and if we have not already licensed such product candidate to a collaboration partner and choose to commercialize such product candidate independently, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing, distribution and establishing a regulatory structure, depending on where we choose to commercialize. Our costs have also increased as a result of our being a publicly traded company. Additional funds may not be available on a timely basis, on favorable terms, or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy. If we are not able to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.

 

Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our intellectual property or future revenue streams.

 

Until such time, if ever, as we can generate substantial product royalty revenue, we expect to finance our liquidity needs through a combination of equity offerings, debt financings, grants and license and development agreements in connection with collaborations. We do not have any committed external source of funds. In the event we need to seek additional funds, we may raise additional capital through the sale of equity, convertible debt or other securities. In such an event, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a holder of our common shares. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or proposing dividends to our shareholders.

 

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to grant or otherwise relinquish valuable rights to our intellectual property or future revenue streams. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

 

 28


© AC Immune 2015