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Emergent BioSolutions Inc. (EBS)
JPMorgan SMid Cap Conference
November 30, 2011 8:45 a.m. ET
R. Don Elsey - CFO
W. James Jackson - SVP and Chief Scientific Officer
Cory Kasimov - JPMorgan
Previous Statements by EBS
» Emergent BioSolutions' Management Presents at Lazard Capital Markets Healthcare Conference 2011 (Transcript)
» Emergent Biosolutions' CEO Discusses Q4 2011 Results - Earnings Call Transcript
» Emergent BioSolutions' President Presents at the 30th Annual J.P. Morgan Healthcare Conference (Transcript)
And following Don's presentation, we will have a Q&A session right here in this room. So, with that I will turn it over to Don.
R. Don Elsey
Thank you, Cory. I would welcome, everybody, to the first presentation of the day. We got you up early. And I do want to say Emergent is the most successful biotechnology that is at this SMid Conference this week. Of course, we're the only biotech company. So – and we do have a lot of competition in that I understand Tupperware is presenting a couple of doors down and so they put a lid on it. I just couldn't resist. I'm sorry.
All right. So now that we got that out of the way, as Cory is like going, why did I invite these guys. We'll start with the obligatory forward-looking. We're going to make some forward-looking comments and actual results may differ. Let's move on.
To give everybody and I see some familiar faces here, so I apologize if I go over old news but for those of you who don't know Emergent, we have the only FDA licensed anthrax vaccine, which is BioThrax. We're organized into two divisions, BioDefense, which primarily is focused on the anthrax infectious disease. As well as BioSciences, and that's oncology and autoimmune. And you see those are the three disease areas that we're focused on.
We have eight clinical-stage candidates at this point in time. And we've had nine years of profitability and look forward to completing this year as a profitable biotech as well.
This gives you a very quick overview of the clinical candidates that we have today and it's a mixture of BioD and BioDefense. I'm not going to go through each and every one. That could take up to 20 minutes by itself. I will highlight a couple of them a little bit further into the presentation. You can see we've got a couple in Phase 3, couple in Phase 2, couple in Phase 1. We've also got a number of pre-clinical candidates, which we will not be talking about.
So, to get into the BioDefense division and give you a little bit of background on BioThrax. As I said, it's the only FDA-licensed anthrax vaccine. It's been in over 2.5 million individuals to date. It's got a safety profile, which is well established and quite enviable in the vaccine field. We now have four-year dating on this product and one might say, why is that so special.
Number one, BioThrax is primarily purchased by the government today for stockpiling purposes. So the longer the shelf life, the better. And at four-year dating, we have the longest shelf life of any vaccine that's licensed today.
Today's regimen is five doses over 18 months with an annual boost. We're working on improving that and I'll talk to that in just a moment. We manufacture this at a single manufacturing location. Our current capacity is about 7 million to 9 million doses per year. We're increasing that manufacturing capacity. We've got a new building and I'll take you through some of the details of that in just a moment.
Moving on with the enhancements. So, today BioThrax is labeled for a pre-exposure. The government is buying it in the stockpile for a post-exposure application. So, if you're exposed to anthrax, the regimen is to go on broad-spectrum antibiotics for the initial toxins that are released and to go on BioThrax at the same time. Anthrax spores can exist in your lungs up to nine months and during that time, can release toxins and kill you. So the thought is you come off the antibiotics, you've been on the vaccine, and you're now protected.
We have filed a supplemental BLA with the FDA. That would take the five doses over 18 months down to three doses over six months with a triennial boost. We're hoping to hear back from the FDA on that in early 2012. Again, this is – this would facilitate the government procurement. They are buying assuming a three-dose regimen. So when one talks about the stockpile of 75 million doses, they're assuming three doses per person.
We've also filed for five-year dating. As I said, four-year dating is the longest dated vaccine. What the probability is of getting five-year dating from the FDA is a question. In order to get the four-year dating, we've got samples of 6, 7, 8, 9 and 10 years showing stability over that point in time. But you're going to need lots of data points for the FDA to be convinced.
And then the ambient temperature stability is the next key component for a stockpile asset and that's trying to break the cold chain. Our studies have shown that BioThrax can be stable for up to six months at room temperature.