Theravance, Inc. (THRX)

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Theravance Inc. (THRX)

Morgan Stanley Healthcare Conference

September 12, 2012 9:10 am ET


Michael Aguiar - Chief Financial Officer, Senior Vice President


David Friedman - Morgan Stanley


David Friedman - Morgan Stanley

We will get started here and thanks everyone for joining us. Dave Friedman, one of the biotech analysts here and in terms of disclosures, personal and Morgan Stanley's, you can look on and I am joined by Mike Aguiar, Chief Financial Officer of Theravance and thank you for coming, everyone and thanks for coming, Mike.

We would love for this to be interactive. So if anyone has any questions at any time, please feel free to raise your hand, give a shout out and we will make sure to get your question asked. So, again, thanks for coming and maybe if we can just start. If you can give a couple of minute overview of the company for people who aren’t as familiar.

Michael Aguiar

Sure. Thanks for the introduction here. Theravance is a biotechnology company focused on late stage discovery and development of a variety of medicines. In particular, we have a very substantial relationship with GSK where we have three large respiratory programs and that’s grabbing the lion share of the industry attention today.

So that’s where I spend the vast majority of my time, running through those three programs. As David, mentioned, as we get to Q&A, if there is any other programs that folks have been talking about, we will be more than happy to chat about that. But again, I think the vast majority of the focus today is on our three respiratory programs in collaboration with GSK. So I will spend a few moments talking about those.

The programs are really focused on the treatment of chronic obstructive pulmonary disease or COPD and asthma. The lead program in there is what we call now Relvar/Breo. Relvar is the brand name in Europe. Breo is a proposed brand name in the United States.

It’s a combination of Long-Acting Beta Agonist and an inhaled corticosteroid. So these are similar mechanisms of action to either Advair today or Symbicort. This product is going to be targeted at the treatment of asthma and COPD. That has been submitted in Europe for both asthma and COPD and has been submitted for regulatory review in the United States for COPD.

We expect to have some information coming back on the acceptance of the filings in the U.S. here in the next several weeks. So that is well underway. That data has been previously presented.

The next program behind that is an interesting new product combination which is the combination of a Long-Acting Muscarinic Antagonist or Umeclidinium combined with the Long-Acting Beta Agonist from Relvar/Breo. We call that UMEC/VI and a substantial amount of data is coming up here and some data came out here at ERS here last week that generated a fair amount of discussion that was out there.

This product is for the treatment of COPD and is really targeted at the market that is occupied by tiotropium today. This is about $5 billion market today and has been growing fairly substantially.

The last of the programs is, what we call, our MABA program. This is a single molecule that is both a Muscarinic Antagonist-and a Beta Agonist. It has finished Phase IIb. We are in the process right now of evaluating how to move this forward in the Phase III here as a once-a-day medicine or as a twice-a-day medicine and probably before the end of the year, we will have an update back to investors on that.

So what is particularly interesting about these combinations is this really has the opportunity to provide GSK and Theravance with, what we will consider, the best respiratory suite out there. Really, it will provide the ability to take a patient from the very early stages of the disease all the way through fairly serious stage of disease in a single device.

So for example, I will talk about CPOD here. This is a pretty good example of that. The collaboration is developing single agent medicines. So either a single agent LABA or single agent LAMA that would be delivered in the (inaudible) device and that would be applicable for a patient who had early stage of COPD, as that particular patient continue to progress in their disease and perhaps it wasn’t controlled by a single agent you would be then able to step them up to the combination of LAMA/LABA again in the same exact device.

If the patient continues to progress in their disease and it has been exacerbation you would then again be able to step them up again into therapy to a higher level with Relvar/Breo where you would have an inhaled corticosteroid on board to help control the exasperations and again as the patient continues to progress further we have a number of opportunities for what we consider to be a triple product, either combining MABA with an ICS or potentially combining two different medicines, for example a single agent LAMA with a combination of the Relvar/Breo or potentially if you were be able to combine all three of the medicines in a single device.

So it gives you the ability to take a patient who has severe stages of the disease. So really it would be handle life cycle management for these patients in a manner that no other company out there today really has the ability to do.

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