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Amarin Corporation plc (AMRN)
Q2 2008 Earnings Call
September 25, 2008 8:30am ET
Darren Cunningham - Executive Vice President, Developments and Investor Relations
Tom Lynch - Chairman and Chief Executive Officer
Alan Cooke - President and Chief Operating Officer
Dr. Declan Doogan - Head of Research and Developments
Stephen Handley - JM Dutton Associates
Vishal Daga - IMSL
Welcome to the Amrain’s second quarter 2008 conference call. (Operator Instructions) Mr. Cunningham you may begin the conference.
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Earlier this morning Amarin announced its second quarter 2008 results and the company also announced a strategic business and pipeline update. If you have not received this new release or if you would like to be added to the company’s distribution list, please contact Amarin Investor Relations in Dublin at 3531-669-9020 or by email at firstname.lastname@example.org.
Before we begin I would like to caution that comments made during this conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Amarin. I encourage you to view the company’s past and future filings with the Securities and Exchange Commission including without limitation, the company’s Form 20-F, 20-F(a) and 6-K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
Furthermore the content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast September 25, 2008. Amarin undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.
With that said I would like to turn the call over to Tom Lynch.
Amarin has now emerged from an extensive period of planning and transition to present what we believe to be the new opportunity for Amarin’s shareholders. We have successfully recapitalized the company and we strategically repositioned our research and development pipeline.
Amarin is now focused as a principle research and development program on cardiovascular disease, specifically AMR101, Amarin’s ultra-pure EPA product for hypertriglyceridemia. This is a near-term, low risk, high value development opportunity, where safety has been established and the efficacy of EPA based product has proven in multiple studies around the world.
In this quarter we met with the United States Food and Drug Administration and reviewed our development plans with the agency. We are now preparing to enter Phase III clinical trials next year. Following this period of intense and effective planning, we are moving into a period of execution.
We are building a purpose built, senior research and clinical development management team interest in our new location in Connecticut, United States of America to take the product forward into Phase III. We are building a team of highly experienced to our development personnel to ensure that we properly capitalize on this opportunity.
On completion of the announced $60 million funding, we look approximately two years cash available to us. So, I’m very pleased to report that Amarin has been successfully repositioned to take advantage of this very exciting and low risk opportunity in cardiovascular disease.
I’d like Alan perhaps to discuss the quarter and the market opportunity in hypertriglyceridemia.
Starting with the brief comments on the Q2 results and details of which are available in the press release we issued earlier today. Operating expenditure for the second quarter of 2008 was $5.8 million; this excluded non-cash share based compensation. Of the $5.8 million SG&A accounts to $3.8 million and R&D was $2 million. The SG&A has decreased from last quarter and this trend will continue in the coming quarters as the benefit of cost saving measures executed earlier this year takes effect.
We expect R&D expenditures to increase from these levels especially when we commence our Phase III program in cardiovascular disease. Net income in the quarter of $0.3 million is driven by a non-cash finance of credits of $6.3 million related to the option we granted to investors in our May financing and this is explained in detail in our press release.
Turning to our balance sheet, Amarin has approximately $26.3 million of cash at the end of the quarter and in shares we have $27 million ordinary in issue and options and warrants outstanding to purchase approximately $4.8 million shares.
So, turning to our new strategic direction; we announced this morning that we have repositioned the company to capitalize on our expertise in the field of lipid science and on the known therapeutic benefits of essential fatty acids in cardiovascular disease. Specifically, we are prioritized the development of AMR101 for hypertriglyceridemia and the related cardiovascular applications including mixed dyslipidemia. Over 100 million people in the U.S., dyslipidemia with over 10 million of those diagnosed with hypertriglyceridemia.
Amarin’s AMR101 is an ultra pure ethyl-EPA prescription grade Omega-3. Global annual sales of prescription Omega-3 products now exceed $1 billion and are expected to grow into a multibillion dollar market in the coming years. Growth has been driven by combination of strong safety and tolerability combined with established efficacy in treating cardiovascular disease.
At this time there is only one FDA approved prescription Omega-3 in the U.S. known as Lovaza. This product is currently on annualized global sales run rate of $700 million and is currently growing at over 60% year-over-year in the U.S. GSK acquired this product late last year when it bought Reliance Pharmaceuticals for $1.6 billion in cash. Lovaza is Reliance’s top selling drug. This drug is also available in Europe under the brand Omacor. Amarin estimates the peak global sales for the Lovaza/Omacor franchise could exceed $3 billion.