By John Vandermosten, CFA
For its fourth quarter and full year, Cardiome Pharma Corp (CRME) reported revenues of $7.0 million and $24.0 million respectively, a (0.3%) and (5.1%) decline. Fourth quarter net loss was ($8.3) million or ($0.24) per share and full year net loss was ($29.8) million or ($0.90) per share. Expansion of the company’s sales force in Europe related to the launch of Xydalba, Zevtera/Mabelio and initiation of the Canadian sales force contributed to a rise in expenses and a larger year over year loss.
Cardiome was involved in substantial activity during the prior twelve months, beginning with the recognition of sales for Zevtera/Mabelio, the launch of Xydalba in several new geographies, and the expansion of the reach of Brinavess. China’s regulatory authority granted Aggrastat an additional indication and SteadyMed is on track for its new drug application (NDA) for Trevyent. As we began 2018, Esmocard posted record months in both January and February.
As of year-end, cash stands at $22.1 million and debt at $40.8 million.
Cardiome highlighted the potential for each of its products as they navigate the approval and pricing processes in the European, Canadian and other partner regions. Below we provide the graphic from the corporate presentation summarizing the potential for each product.
With the expansion of the European sales force, new geographies for Xydalba have followed. Commercial launches in Sweden, Finland and Ireland have begun and the sales force is marketing to hospitals in these countries.
Aggrastat, which is indicated to reduce the rate of thrombotic cardiovascular events in patients with non-ST elevation acute coronary syndrome, recently received an expansion of its indication. The Chinese Center for Drug Evaluation (CDE) approved the expansion to include patients with ST segment elevation myocardial infarction who are intended for primary percutaneous coronary intervention. The incidence of ST segment elevation is thought to be much higher than non-ST elevation suggesting accelerating growth opportunity in the country. The CDE also approved the high-dose bolus regimen, which aligns the administration of the drug with methods used elsewhere.
In December 2017, Cardiome also entered into a distribution agreement with ZAO Firma Euroservice to commercialize Aggrastat in Russia. Zao will obtain regulatory approvals and commercially launch in the country and may see first sales before year end.
Brinavess was launched in South Africa by partner Aspen Medical and new markets in the UAE and Pakistan will be developed by other partners in 2018. A registration study in China is on the verge of launch by partner Eddingpharm for patients with recent onset atrial fibrillation.
The FDA agreed with SteadyMed on the materials needed to resubmit an NDA for Trevyent in pulmonary arterial hypertension, clearing the way for an NDA. No additional clinical trials are needed for the drug and submission is anticipated prior to the end of the year. Following SteadyMed’s submission, Cardiome will deliver its own regulatory filings to the EMA and Health Canada.
In mid-2016, Cardiome began its launch of Esmocard and the drug has begun to hit its stride with record sales in the first two months of 2018. The product was recently launched in France and Italy and it won two tenders in Italy in the last several weeks.
Cardiome continues to execute on its efforts to obtain regulatory approval for its portfolio of products, create new relationships with partners for distribution outside its core areas and penetrate individual countries with price negotiation efforts and product inclusion on hospital formularies. We expect a sharp increase in 2018 revenue growth as 2017’s groundwork results in increased penetration with a larger salesforce and additional products to sell.
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By John Vandermosten, CFA