Risks Related to Our Financial Position and Need for Additional Capital
We have incurred significant losses to date, expect to incur losses over the next several years and may never achieve or maintain profitability.
We have incurred significant losses to date. We had a net loss of €20.4 million in the first nine months of 2013, €14.7 million in 2012 and €17.3 million in 2011. As of September 30, 2013, we had an accumulated deficit of €138.0 million. To date, we have financed our operations primarily through the sale of equity securities and convertible debt and, to a lesser extent, through milestone payments, subsidies and grants from governmental agencies and fees for services. We have devoted substantially all of our financial resources and efforts to research and development, including preclinical studies and clinical trials. Our product, Glybera, received marketing approval under exceptional circumstances from the European Commission in October 2012. We plan in the future to apply for marketing approval for Glybera in the United States and other countries and expect that we will be required to conduct one or more additional clinical trials of Glybera. We are still in the early stages of development of the other product candidates in our pipeline. We expect to continue to incur significant expenses and losses over the next several years. Our net losses may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially as we:
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complete the EMA-mandated post-approval clinical trial of Glybera and implementation of an LPLD patient registry;
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conduct a confirmatory clinical trial of Glybera, either as part of the EMA-mandated post-approval clinical trial or separately, to obtain data needed to file a BLA for Glybera with the FDA;
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seek marketing approval of Glybera in the United States and other countries;
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initiate a Phase I/II clinical trial of AMT-060 for hemophilia B in collaboration with Chiesi;
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advance the clinical development of our other product candidates, most of which are at early stages of development, and seek to discover and develop additional product candidates;
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seek marketing approval for any product candidates that successfully complete clinical trials;
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establish a sales, marketing and medical affairs infrastructure in the United States;
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continue the build-out of our manufacturing facility in Lexington, Massachusetts to expand our manufacturing capabilities for Glybera and our pipeline of product candidates;
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maintain, expand and protect our intellectual property portfolio, including in-licensing additional intellectual property rights from third parties;
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hire additional personnel, particularly in our manufacturing, research, clinical development, medical affairs, commercial and quality control groups; and
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add operational, financial and management information systems and related finance and compliance personnel necessary to operate as a public company.
We are only in the preliminary stages of most of these activities. We and our collaborators may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability.