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SEC Filings

20-F
AC IMMUNE SA filed this Form 20-F on 03/21/2019
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complete the development of, and obtain the marketing approvals necessary to commercialize, one or more of our product candidates. We do not anticipate generating revenue from product sales unless and until we or our collaboration partners obtain regulatory approval for, and commercialize, our product candidates. Our ability to generate future revenue from product sales depends heavily on our and our collaboration partners’ success in many areas, including but not limited to:

 

  · completing research and clinical development of our product candidates, including us or our collaboration partners, as the case may be, successfully completing a Phase 2 clinical study of crenezumab, a Phase 2 clinical study of anti-Tau antibody, a Phase 2 clinical study of ACI-24 for AD, a Phase 1b clinical study of ACI-24 in Down syndrome, a Phase 1b/2a clinical study of ACI-35 and a Phase 1 for Tau-PET Imaging tracer;

 

  · obtaining marketing approvals for our product candidates, including crenezumab, ACI-24 for AD and DS, ACI-35, Morphomer Tau or anti-Tau antibody, for which we complete clinical studies;

 

  · developing a sustainable and scalable manufacturing process for any approved product candidates and maintaining supply and manufacturing relationships with third parties that can conduct the process and provide adequate (in amount and quality) products to support clinical development and the market demand for our product candidates, if approved;

 

  · launching and commercializing product candidates for which we obtain marketing approval, either directly or with a collaborator or distributor;

 

  · obtaining market acceptance of our product candidates as viable treatment options;

 

  · addressing any competing technological and market developments;

 

  · identifying, assessing, acquiring and/or developing new product candidates;

 

  · negotiating favorable terms in any collaboration, licensing, or other similar arrangements into which we may enter;

 

  · maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; and

 

  · attracting, hiring and retaining qualified personnel.

 

Because of the numerous risks and uncertainties with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. Our expenses could increase beyond expectations if we are required by the FDA, the EMA, or other regulatory agencies, domestic or foreign, to change our manufacturing processes, or to perform clinical, nonclinical, or other types of studies in addition to those that we currently anticipate. In cases where we are successful in obtaining regulatory approvals to market one or more of our product candidates, our revenue will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval, the accepted price for the product, the ability to obtain coverage and reimbursement at any price, and whether we own the commercial rights for that territory. If the number of our addressable patients is not as significant as we estimate, the indication approved by regulatory authorities is narrower than we expect, or the treatment population is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products, even if approved. Accordingly, we may not be profitable in the future from the sale of any approved products.

 

We or our collaboration partners may be unable to develop and commercialize any of our current or future product candidates and, even if we do, may not achieve profitability in the future. Even if we do achieve profitability in the future, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to be profitable in the future would decrease the value of our company and could impair our ability to raise capital, expand our business or continue our operations. A decline in the value of our company could cause you to lose all or part of your investment.

 

We expect that we will need substantial additional funding before we can expect to become profitable from royalties on sales of our products. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.

 

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© AC Immune 2015