Theravance, Inc. (THRX)

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Theravance Inc. (THRX)

Credit Suisse 2012 Healthcare Conference Call

November 14, 2012, 10:30 am ET


Mike Aguiar - SVP & CFO


Jason Kantor - Credit Suisse


Jason Kantor - Credit Suisse

Welcome to another session here at the Credit Suisse Healthcare Conference. My name Jason Kantor; I am the newest biotechnology analyst on the platform and its my pleasure today to introduce Theravance. This is a company that's got a rich pipeline, a lot of the exciting news flow in terms of new drugs that are coming to market today. Its my pleasure to introduce the CFO of the company, Mike Aguiar. Thank you.

Mike Aguiar

Very well, thank you Jason and before I get started here, I would like to make a couple of quick comments. Number one, just to thank CS for it’s thoughts and again for providing us the opportunity to come and present here. And then also to whoever on the web there's our Safe Harbor statement, we will be making forward-looking statements at the presentation today.

So with that let's go ahead and turn to Theravance. Theravance is a company that was established in 1998. We were established based upon some technology that came out of Harvard Medical School based on the concept of potentially designing small molecules that were multivalent, meaning that they have the ability to attach to more than one binding point on a particular target. The theory at that time was that if you had a multivalent compound you would provide either the dual pharmacology, better selectivity, extended duration, potentially peripheral restriction etcetera.

And in the 14 years that we've been around we have created more than 20 plus development candidates. We have issued over 1,200 patents, have improved medicine by data for the treatment of resistant gram-positive infections and have three respiratory programs that are partnered with GSK and are currently in late stage. We will spend the majority of our time talking about our respiratory programs today.

In addition to that, our partnerships have resulted in over $800 million coming into the company through various upfront, milestones, and purchase of equity, etcetera. So the partnership strategy is quite important to what we do.

The programs we are focused on today really are going to be the three respiratory programs part of the GSK, Relvar or Breo or what we are now calling FF/VI; our LAMA/LABA program which we are now calling UMEC/VI and our MABA program, so the three of those will again constitute the majority of what we are talking about today and then we will spend a little bit of time talking about TD-1211. This is a program for the treatment of opioid induced constipation. And it isn't that again, we do have a relatively diverse pipeline of internally discovered compounds, certainly happy to getting asked any or answer any questions that come up on that during the presentation today, but again the vast majority of the conversation will be focused around the respiratory program.

Here is our pipeline, as you can see we have a very late-stage pipeline. In the respiratory section, the FF/VI for both asthma and COPD. These programs are filed currently. For COPD, we are filed in the US, Europe and Japan. For treatment of asthma, we are filed in Europe and Japan as well as several other countries. These are ongoing at this point in time and we have a PDUFA date in the US for COPD at May 2013.

UMEC/VI has completed the Phase III programs, we will talk about the results of that a little further on in the presentation today and filings are planned to begin late this year and probably roll over the turn of the year into early next year, so I would expect those kind of in the late November or early December timeframe to begin started.

In addition to that again, we have our programs in bacterial infections, I won't spend a lot of time on it today. We have a number of programs in CNS and pain. We will focus on one of those today, again TD-1211 and then a number of other programs.

Turning now to respiratory. I would like to really frame the conversations with two things. Number one, we will talk about the market opportunity and as you look on the slide on the left hand side of the slide, you look at the historical sales of bronchodilators and (inaudible) steroid for the Theravance COPD, this is a very large market. Most recently add to June 2012, suggest this market is over $19 billion on a global basis. It's been growing in the high single digits over the last several years. As you look on the right side of the chart and looking at population, you will see that population of patients particularly with COPD is projected to grow throughout the next decade. So as we look forward, we can expect this market to continue to grow, providing a very substantial opportunity for new product influence.

Recently, ERS Conference happened in Vienna, Austria. This is the major respiratory conference of the year and I think there were a couple key themes that came out of here that are quite important to think about as we begin discussing our respiratory program and we're talking about three of them.

Number one is the importance of managing that exacerbation. Exacerbation is worsening of the symptoms that require some sort of medical intervention. Those data presented at ERS suggested that not only is this an acute (inaudible) but actually has the potential to permanently change along the (inaudible). So the management of exacerbation is quite important going forward, in particular we're focusing on once-a-day compound, which should provide improved compliance for patients, improved compliance has been shown in a number of instances to provide better overall patient outcomes.

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