Vascepais currently indicated as an adjunct to diet to reduce TG levels in adults with severe (TG³500 mg/dL) hypertriglyceridemia, an important but much smaller patient population than can be addressed with an approval of this sNDA.
To date, the FDA has not informed Amarin as to whether it plans to convene an Advisory Committee meeting (AdCom) to review the sNDA. As previously disclosed, Amarin continues to prepare in the event that an AdCom is convened. If Amarin is informed definitively that there will or will not be an AdCom, the company plans to update investors accordingly.
Preliminary (Unaudited) First Half 2019 Financial Results
Record Revenue Levels Achieved: Net total revenue for the three and six months ended June 30, 2019 are estimated to have reached between $97 and $101 million and between $170 and $174 million, respectively. Both the second quarter and first half of 2019 results represent record revenue levels for Amarin. These results, which are subject to auditor review, represent an increase of approximately $44 to $48 million (approximately 84% to 92%) for the second quarter of 2019 over the corresponding period of 2018 and an increase of approximately $73 to $77 million (approximately 76% to 80%) for the first half of 2019 over the corresponding period of 2018. These results consist predominantly of U.S. sales-driven increases in prescriptions forVascepa. Wholesaler inventory levels ofVascepawere within normal industry ranges at the end June 2019.
Current Assets: Amarin ended June 2019 with cash and cash equivalents of approximately $221 million (compared to $211 million at March 31, 2019), approximately $94 million in net accounts receivable and approximately $47 million in inventory.
No Debt, Except Remaining Balance of Royalty Bearing Instrument: Amarin ended June 2019 with no debt except the remaining balance on its royalty bearing instrument which is repaid at a rate of 10% ofVascepa revenues; aggregate repayment of less than $74 million remains until this royalty-like obligation is fully extinguished.
2019 Financial and Operational Guidance
Amarin initially provided guidance for 2019 in its press release dated January 4, 2019. Amarin now makes the following updates to that guidance:
2019 Revenue Guidance:ForecastingVascepa revenue levels at this early stage remains difficult. Based on estimated total revenue results for the first half of 2019 which exceeded prior expectations, Amarin increases its guidance for 2019 net total revenue to a range of $380 to $420 million. While Amarin remains optimistic thatVascepa will generate billions of dollars in revenue in the years to come, the history of other therapies for chronic conditions suggests that growth builds over multiple years, and thus, the company is not prepared to provide quantified guidance regarding revenue levels beyond 2019.
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