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SEC Filings

10-Q
PROTEON THERAPEUTICS INC filed this Form 10-Q on 08/07/2017
Entire Document
 
 

 

If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of any approved products or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially adversely affect our business, financial condition and results of operations.

 

We have never generated any revenue from product sales and may never be profitable.

 

As a company, we have never obtained regulatory approval for, or commercialized, any product candidate. Our ability to generate substantial revenue and achieve profitability depends on our ability, alone or with strategic collaboration partners, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize, vonapanitase or any additional product candidates. We do not anticipate generating revenues from product sales for at least the next several years, if ever. If vonapanitase or any additional product candidates fail in clinical trials or do not gain regulatory approval, or if vonapanitase or any additional product candidates, if approved, fail to achieve market acceptance, we may never become profitable. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. Our ability to generate future revenues from product sales depends heavily on our success in:

 

  · completing clinical development of vonapanitase for one or more indications and research and preclinical and clinical development of additional product candidates;

  · seeking and obtaining regulatory and marketing approvals for vonapanitase if and when we complete clinical trials;

  · establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate (in amount and quality) products and services to support clinical development and the market demand for vonapanitase, if approved;

  · launching and commercializing vonapanitase if we obtain regulatory and marketing approval, either by collaborating with a partner or, if launched independently, by establishing our own sales, marketing and distribution infrastructure;

  · obtaining and maintaining adequate timely coverage and reimbursement from third-party payors for vonapanitase;

  · obtaining market acceptance of vonapanitase as a viable treatment option;

  · addressing any competing technological and market developments;

  · implementing additional internal systems and infrastructure, as needed;

  · identifying and validating new product candidates;

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

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

  · developing vonapanitase such that, if approved, it can be commercialized without infringing the intellectual property rights of third parties; and

  · attracting, hiring and retaining qualified personnel. 

 

Even if vonapanitase or any additional product candidates that we may develop is approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. Our expenses could increase beyond expectations if we are required by the United States Food and Drug Administration, or the FDA, the European Medicines Agency, or EMA, or other regulatory agencies, domestic or foreign, to perform clinical trials and other studies in addition to those that we currently anticipate. Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations. Our failure to become and remain profitable would depress the market price of our Common Stock and could impair our ability to raise capital, expand our business, diversify our product offerings or continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.

 

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