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Emergent BioSolutions Inc. (EBS)
Lazard Capital Markets Healthcare Conference 2011
November 16, 2012 10:00 AM ET
Don Elsey – Senior Vice President Finance & Administration and Chief Financial Officer
Hi, good morning, and today we are here to hear more about Emergent BioSolutions, and speaking to you is Don Elsey.
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So let me tell you about EBS for those of you who don’t know us, EBS at a glance. So we have got one licensed product, which is the only FDA approved anthrax vaccine, and that we sell on a regular basis to the US government for stockpiling purposes. We will get into that more later on. We are organized into two divisions, biodefense and biosciences, focused on three disease areas, infectious diseases, oncology and autoimmune. We will get into the components of each of those as we go through the presentation, and we have got eight clinical stage product candidates currently, and a nine-year track record of profitability, and hopefully making that a 10-year track record of profitability.
So let us go and take a look at the eight clinical candidates, and we will come back to BioThrax, our licensed anthrax vaccine in a moment. So starting at the top and what you see here is mixture of bio defense and bioscience candidates. So Anthrivig, which is a polyclonal anthrax therapeutic, basically in a phase 3. This is of course all animal studies. This is underwritten by the government as it currently stands, whether it gets to a procurement stage, we will have to see.
As the government’s appetite for therapeutics at this point in time in the anthrax market is one that I think has been examined along with all of the areas of funding that they are pursuing and the current budgetary constraints. Zemab is a product that we inlicensed earlier in 2011 targeted for PTCL and CTCL. This particular product was in the middle of
a Phase 3 clinical trial, when the company that had its rights, Tenax, entered bankruptcy, and we invested in this product to see if we could resuscitate the phase 3.
That investigation and evaluation of the data is ongoing as we speak. I would expect in the beginning of 2012 we will have ascertained with FDA what exactly can be done with that phase 3. I believe that if it is a product that we can resuscitate the Phase 3 it is one we will certainly pursue and pursue aggressively. If on the other hand, the phase 3 work that had been done previously has to be restarted, then there is whole another evaluation to be done because it is a fairly small market. It is one that is moving rapidly with new developments everyday. So we will have to take a look at that.
MVA85A, this is our tuberculosis booster vaccine. This is in a phase IIb infant efficacy study in South Africa as we speak. This trial will conclude in 2012, and we will have the clinical results that we anticipate publishing by the end of 2012. In addition to the phase IIb infant efficacy study, a study has also been undertaken to examine MVA85A in HIV compromised individuals. That is being run by a European consortium. So we are going to benefit from that trial, but we are not directly involved in that trial.
PreviThrax is a Recombinant Protective Antigen for anthrax. This is an alternate vaccine that the government is investigating. For those of you that may have followed us, this has been a program that has waxed and waned with the government for quite some time. But we received a $187 million contract to develop this alternate vaccine. It is a two-year base contract with three option years associated with it.
This product, as well as, (inaudible) which is a parallel sort of a program, we believe is a number of years away from licensure if it ever gets licensed, probably looking 5 to 8 years from now before this product could be licensed.
Switching over to two candidates on the bioscience side that came to us from the acquisition of Trubion in 2010. SBI-087, you can see that is a phase 2 for rheumatoid arthritis. It is also indicated for lupus. This is a candidate that has been 100% outsourced to Pfizer. So it is totally in their hands. We will benefit over the long run from milestones and double-digit royalty arrangement, but from a purely development perspective that is being driven by Pfizer. We anticipate that phase 2 results will be seen sometime in the first half of 2012.
TRU-016, which is indicated for CLL and NHL, we have a 50-50 partnership with Abbot on this particular candidate. We are doing the work on CLL. Abbot is doing the work on NHL, and here again we expect that we will see some clinical data in the first half of 2012. So 2012 seems to be the convergence of all things clinical for us. So it is going to be a big year from a data disclosure perspective.