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Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability .
Our operations to date have been limited to organization and staffing, developing and securing our technology, entering into licensing arrangements for elobixibat, raising capital and undertaking preclinical studies and clinical trials of our product candidates. We have not yet demonstrated our ability to successfully complete development of any product candidate, obtain marketing approval, manufacture a commercial scale product, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history.
Assuming we obtain marketing approval for any of our product candidates, we will need to transition from a company with a research and development focus to a company capable of supporting commercial activities. We may encounter unforeseen expenses, difficulties, complications and delays and may not be successful in such a transition.
Our independent registered public accounting firm has expressed doubt about our ability to continue as a going concern.
Based on Albireo Limited’s recurring losses and expectations to incur significant expenses and negative cash flows for the foreseeable future, its independent registered public accounting firm has included an explanatory paragraph in its report on Albireo Limited’s financial statements as of and for the years ended December 31, 2015 and December 31, 2014 expressing substantial doubt about our ability to continue as a going concern. If we are unable to continue as a going concern, we may be forced to liquidate our assets and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements.
We will need substantial additional funding and, in particular, may not have sufficient cash to fund a planned pivotal clinical trial of A4250 for the treatment of progressive familial intrahepatic cholestasis to completion. 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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