Isis Pharmaceuticals' Management Presents At Barclays Capital 2012 Global Healthcare Conference (Transcript)

ISIS Pharmaceuticals Inc. ( ISIS)

Barclays Capital 2012 Global Healthcare Conference Call

March 14, 2011 11:00 am ET

Executives

B. Lynne Parshall – Chief Operating Officer & Chief Financial Officer

Analysts

Ying Huang – Barclays Capital

Presentation

Ying Huang – Barclays Capital

Good afternoon everyone. My name is Ying Huang and I’m the Senior Analyst here covering U.S. Valtech at Barclays. It’s my pleasure to introduce our next presenting company ISIS Pharmaceuticals. On behalf of Company to present here is Lynne Parshall, the CFO of the company. So, Lynne?

B Lynne Parshall

Good afternoon and I’m glad I could keep at least somebody off the beach this afternoon. I’m happy to be here to be able to present about ISIS pharmaceuticals. ISIS is the leading company in antisense technology and we’ve built that leadership position by starting with innovation. Innovation is the core of our company, it’s the reason we’ve been able to persevere and create what we think is the third new platform for drug discovery and that technology platform is now a proven platform.

We have utilized the technology platform to create a pipeline of over 26 drugs and development and we’ve built around that as a unique business strategy that enables us to continue to add the pipeline, while maintaining a small and highly innovative workforce. Our goal for antisense technology is to use the technology platform, to create as many drugs in as many different disease areas to help as many patients as possible live healthier life.

So, ISIS is the leader in RNA therapeutics. We create an antisense technology and antisense technology networks. It works in cell culture, it works in animal and more importantly it works in many, many different models of diseases in human including four very robust Phase III clinical trials that have been completed for our lead drug KYNAMRO.

We control antisense technology through continued innovation and patent. We’re one of the largest patent holders in the United States with over 1,500 issued patents, which on a per capita basis makes us far and away of the most innovative company around. We’ve used this technology platform to create a pipeline of 26 exciting drugs in numerous different therapeutic areas in development. We’ve done all of this with a workforce of fewer than 350 people and that includes our manufacturing group, which enables us to maintain a very manageable cost structure and minimize our cashes.

Our partnership strategy also supports this by maximizing long-term return and minimizing short-term risk and creating sustained financial strength. Antisense technology is the only direct root from genes to drugs. If you know the gene that’s associated with the disease you can create an antisense drug to inhibit it. It’s uniquely specific and then an antisense drug stops the production of a single disease-causing protein without affecting other related proteins. But it’s very broadly applicable. So many, many, many different diseases are minimal to antisense.

Because it’s a platform technology, early drug discovery and early development are extremely efficient because we know about the physical, chemical properties of our drugs and what that means in terms of what they do in the human body, that allows us to have dramatically reduced costs in our early drug discovery, increased success because of lot of the question marks that you would have about, for example a traditional small molecule drug or question marks with antisense technology and it also allows us to move drugs more rapidly into development.

Every time we make an investment, that investment is amortized across our entire pipeline, so if we develop a new analytical method, if we develop an improvement to our manufacturing technology, if we develop a chemical modification that enhances potency. We can turn around and take the research investment in that improvement and apply it to all of our programs in research. So it provides tremendous efficiency benefits and this allows us to generate a robust diverse pipeline by adding three to five new drugs a year.

This is the pipeline. You can see our principle focuses are in cardiovascular, metabolic disease, and cancer and our newest franchises are severe and rare disease franchise. And then we have numerous other collaborations and drugs that we’ve worked on with partners to target some interest for them.

KYNAMRO or mipomersen is our most advanced drug and it really represents a very significant initial commercial opportunity with lots of opportunities for growth in the future. We’ve filed our MAA in Europe last summer for both homozygous familial hypercholesterolemia and severe heterozygous FH. Our U.S. NDA will be for homozygous FH will be filed this month.

And our partners at Genzyme and Sanofi are very actively preparing for the commercial launch of this drug this year. But importantly, we’re also investing in the future of this drug with our focused FH study underway, which will support potential expansion of the market for the drug in both the U.S. and Europe, as well as introducing a new dosage form of the drug to provide alternatives for patient in terms of the dose form.

Mipomersen represents as I said a very significant near-term commercial opportunity. Our first filing in the U.S. will be for homozygous FH, which is about 3,000 patients. Our first filing in Europe is for the homozygous FH patient population, plus the severe heterozygous FH population so that’s about 18,000 patients in Europe. And as I said we’re conducting the FOCUS FH study, which could provide support for the potential expansion of the U.S. indication to also include the severe heterozygous FH patient population adding 15,000 additional patients in the U.S.

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