Wednesday March 14, 2012
by John McCamant, editor The Medical Technology Stock Letter
We expect 2012 to be the year that investors both discover and learn to appreciate the broad potential of antisense technology in drug development. As such, we continue to recommend Isis Pharmaceuticals (ISIS).
The company finished 2011 with a pro forma net operating loss (NOL) of $61.3 million compared to a pro forma NOL of $36.2 million for 2010. At year-end, the firm had nearly $344 million in cash.
On a GAAP basis, Isis reported a loss from operations of $18.6 million and $71.1 million for the three and twelve months ended December 31, 2011, respectively, compared to $15.9 million and $48.4 million for the same periods in 2010.
In 2012, Isis plans to achieve the following goals itself and with its partners:
The company also reported that they are in the process of finalizing the detailed planning for their APOc-III program. ISIS is considering a variety of options as they prepare to move into Phase II to ensure that they retain as much of the backend economics as possible.
Their approach is similar to Kynamro since just as there are severe LDL problems there are severe triglyceride programs. Severe hypertriglyceridemia is typically defined as greater than 500 mg/dL, some people think a 1000 mg/dL
High levels of triglycerides are associated with acute pancreatitis and consensus opinion is that the acute pancreatitis that happens in those patients is more severe than the acute pancreatitis that occurs in others.
Next these people get recurrent pancreatitis and they can't get their triglycerides down. So, there is a clear differentiation between severe and less severe high triglycerides and ISIS believes the fastest route to commercialization is one that focuses initially on the severe patient population.
And, just like Kynamro, there is also a genetic abnormality in which you have the mutation and the enzyme that is used to degrade triglycerides in blood, LPL, and there are homozygous LPL people and heterozygous LDL people just like there are homozygous and heterozygous FH patients.
The company believes that the Phase II data may point to an accelerated filing strategy with the first data set expected by year-end. This could lead to a rapid move to the market in various parts of the world.
ISIS stock is finally gaining some momentum and we expect 2012 to be a very good year for the company as they enjoy the increased visibility among biotech investors in accordance with the Kynamro launch. ISIS is a buy under $12.
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