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Alkermes plc (ALKS)
Morgan Stanley Global Healthcare Conference Transcript
September 11, 2012 10:55 AM ET
Richard Pops - Chairman and CEO
Rebecca Peterson - Investor Relations
David Friedman - Morgan Stanley
David Friedman - Morgan Stanley
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And Richard has been CEO of the company since he joined over 20 years ago and he has led the recent successful merger with Elan Drug Technologies which closed in May of last year, and it’s a great opportunity to have you with us today. So thanks for joining. I thought that I turn it over to you to provide some brief opening remarks and then we’ll go into Q&A.
Perfect. Thanks everybody. Thanks for having us. So actually that, the transaction with Elan closed September 16th of last year. So we were just -- this is the one year anniversary of what would turned out to be a merger that made a lot of sense and it made sense looking at it from prospectively and I think, now with one year under our belt, its performing exactly the way we would have hoped, if it could.
So 33,000 feet, what we’re so excited about at this moment for this company is this combination of the financial here and now with the exclusive potential of the pipeline and not a notional pipeline, not an early pipeline, but a late pipeline.
And those two elements are rare to find in biopharmaceutical companies, particularly of our current size. So on the financial here and now, we have assembled based on our technologies, which are, I think fairly easily understood, now they are quite advanced.
We have a pipeline or portfolio of five major commercial products and these are commercial products approved in markets around the world. Five products that are almost all of them early in their commercial life with long patent protection, patent protections 20s for the most part.
So these five commercial products are contributing topline now, which is about a $0.5 billion and growing, that’s generating positive non-GAAP income, positive cash flow, positive EBITDA, and that’s continue to be the case for the foreseeable future.
So we can cross the rubicon. We become an economic enterprise of certain scale with long lived assets that are not interrelated in terms of [their core entities], they are very independent, they comprise of portfolio that’s very power and can last for long time.
It originates from a certain technical capability, manufacturing capability that we built over the last couple decades. So the probability we think of our being able to build more products is quite high.
The difference between the next-generation of products and the first generation of products, is that the first generation of products were essentially done under a partnering model, where we used big pharmas money and resources, and development expertise to help us build our capabilities and generate cash flows from royalties and manufacturing products.
This next wave of products, our proprietary products that comprise the pipeline take that learning and that understanding the technology and apply to drug for Elan account. This is not a new story. This is what Elan did a couple decade or so ago and transform themselves into a $10 billion plus company.
So we have a number of drugs now in development, two which are very important stage for investors to understand. One is the drug called ALKS 9070. ALKS 9070 is our own long-acting injectable for the treatment of schizophrenia. In this case it’s a long-acting pro-drug of aripiprazole.
This will build up the foundation. It’s been build with RISPERDAL CONSTA and INVEGA SUSTENNA, two of our biggest commercial products already sold by Johnson & Johnson.
So we’ve come to understand the long-acting atypical antipsychotic market. It’s a big market. It’s a $2 billion franchise and growing double digits. Its still underserved in terms of the medical necessity for these products and ALKS 9070 fills a very clear niche in that market, which is a desire for long-acting form of one of the better tolerated antipsychotic.
And ABILIFY is that type of drug. It’s a $4 billion drug. We are developing the long-acting injectable in Phase 3. We should have results from that Phase 3 clinical trial next year and those data will be sufficient to file for FDA approval in United States.
So 9070 is Phase 3 asset. It’s right in our power alley in schizophrenia long-acting medications and we are quite excited about it. Has a major effect in our models on evaluation if that drug is successful.
Second drug I’ll mention then we can talk where we want to take is 5461. 5461 is a drug that you have to say is more risky at this moment, because its based on only one efficacy study so far.
And that’s a drug for the treatment of depression, but particularly treatment-resistant depression for patients who have failed treatment with SSRI and conventional any depression medication.
This is based on our deep understanding of opioid receptor biology, which is good in our chemistry capability and opioid receptor modulators, as well as our clinical experience with opioid receptor modulation through VIVITROL and other work.