AMRN (AMARIN CORP PLC ) BEARISH WEEK AHEAD
. Company dealing with many difficulties .
• We believe that our cash and cash equivalents balance of $119.5 million at December 31, 2014 is sufficient to fund our projected operations for at least the next twelve months.
• As we evolve from a company primarily involved in research and development to a company also focused on establishing an infrastructure for commercializing Vascepa, we may encounter difficulties in managing our growth and expanding our operations successfully.
• There is no assurance that the FDA will ultimately approve a drug product for marketing in the United States. Even if future indications for Vascepa are approved, the FDA’s review will be lengthy and we may encounter significant difficulties or costs during the review process.
• Amarin believes its 30-month stay extends until September 2016. This three-year form of exclusivity may also not prevent the FDA from approving an NDA that relies only on its own data to support the change or innovation.
• If we are not successful in our efforts to market and sell Vascepa, our anticipated revenues will be materially and negatively affected, and we may not obtain profitability, may need to cut back on research and development activities or need to raise additional funding that could result in substantial dilution
Vascepa is a prescription-only omega-3 fatty acid. Omega-3 fatty acids are also marketed by other companies as non-prescription dietary supplements. As a result, Vascepa would be subject to non-prescription competition and consumer substitution.
• We currently operate with limited resources. We believe that our cash and cash equivalents balance of $119.5 million at December 31, 2014 will be sufficient to fund our projected operations for at least the next twelve months.
• In order to fully realize the market potential of Vascepa, we may need to enter into a new strategic collaboration or raise additional capital. We may also need additional capital to fully complete our REDUCE-IT cardiovascular outcomes trial.
• Our gross margin for the years ended December 31, 2014 and 2013 was 62% and 55%, respectively. This improvement was primarily driven by lower unit cost purchases. In addition, over time we expect continued lower average unit cost purchases of . We also expect that costs will be lower in the future due to advantages derived from the mix of our suppliers. The average cost may be variable from period to period depending upon the timing and quantity of purchased from each supplier.
• The decrease in research and development expenses for the year ended December 31, 2014, as compared to the prior year period, is primarily due to a decrease in costs associated with the REDUCE-IT study, a decrease in expenses associated with pre-commercial inventory supply, and a decrease in staffing and overhead costs, as further described below.
• . We currently estimate that Vascepa revenue levels will not be high enough in each quarter to support repayment to BioPharma in accordance with threshold amounts in the repayment schedule.
source : AMRN website.