Theravance, Inc. (THRX)

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Theravance, Inc. (THRX)

Q3 2012 Earnings Call

October 30, 2012; 05:00 p.m. ET


Rick Winningham - Chief Executive Officer

Mike Aguiar - Senior Vice President & Chief Financial Officer


Steve Byrne - Bank of America

David Friedman - Morgan Stanley

Ronny Gal - Bernstein

Anant Padmanabhan - Cowen & Company

Unidentified Participant

Ian Somaiya - Piper Jaffray



Ladies and gentlemen, good afternoon. At this time I’d like to welcome everyone to the Theravance conference call to review the results for the third quarter ended September 30, 2012.

During the presentation all participants will be in a listen-only mode. A question-and-answer session will follow the company’s formal remarks. (Operator Instructions).

And now, I would like to turn the call over to Mike Aguiar, Senior Vice President and Chief Financial Officer. Please go ahead sir.

Mike Aguiar

Good afternoon everyone. With me on the call today is Rick Winningham, our Chief Executive Officer. Before we review results for the quarter, we would like to thank everyone for joining us on what is a tough day for those on the east cost. Rick and I would like to send our thoughts to everyone impacted by the hurricane and hope that you and your families safely weather the storm.

Now, we’ll move to our review of the quarter. Earlier today Theravance issued a press release detailing third quarter 2012 financial results and recent corporate development. A copy of the press release can be downloaded from our website or you could call Investor Relations at 650-808-4100 and we will be happy to assist you.

Before we get started we would like to remind you that this conference call contains forward-looking statements regarding future events and the future performance of Theravance. Forward-looking statements include anticipated results and other statements regarding Theravance’s goals, expectations, strategies and beliefs. These statements are based upon the information available to the company today and Theravance assumes no obligation to update these statements as circumstances change.

Future events and actual results could differ materially from those projected in the company’s forward-looking statements. Additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail on the company’s Form 10-Q filed with the SEC.

I will now turn the call over to Rick Winningham, our Chief Executive Officer. Rick.

Rick Winningham

Thanks Mike and good afternoon everyone. There have been many positive developments in Theravance during the third quarter. In our respiratory collaboration with GSK, presentations of FF/VI Phase 3 data were made, European Respiratory Society Annual Congress and review of the regulatory filings was commenced in the U.S. and Europe.

In addition the Phase 3 program with UMEC/VI and Chronic Obstructive Pulmonary Disease or COPD was completed and we remain on track to commence global regulatory filings for COPD from the end of this year.

For our non-respiratory programs, it’s a positive results from the TD-1211 Phase 2b study. In addition, Theravance recently entered into partnership agreements for velusetrag with Alfa Wassermann and cardio vascular research development commercialization with Merck.

I’m also pleased to announce today that Theravance entered into two partnership agreements with R-Pharm, a major Russian pharmaceutical company covering TD-1792 and telavancin. These collaborations are strategically important to Theravance and that they progress the programs, leverage the individual company’s infrastructure and competencies and optimize our deployment of financial resources.

Let me describe the progress in the respiratory programs in some more detail. The major respiratory event for the third quarter was the European Respiratory Society Annual Congress in Vienna, which included a number of presentations by GSK, Theravance and others. We believe there were several key scientific themes emerging from the conference as a whole that are worth noting.

First, was the importance of reducing the overall rate of exacerbations. COPD exacerbations not only lead to an acute and harmful event for the patient, but also may lead to a permanent loss of lung function. Second, there was increased importance of therapy, containing a Long-Acting Muscarinic Antagonist or LAMA in the treatment of COPD.

Third was the appreciation of the potential utility of combining three pharmacologys, LAMA, LABA and an inhaled corticosteroid or ICS, also known as triple therapy for treating severe COPD and asthma. We believe our respiratory programs with GSK are particularly well positioned to meet these evolving treatment needs. Our collaboration is evaluating potential strategies to develop a triple therapy, including a closed triple of UMEC/VI and FF in a single device, as well as MABA combined with an inhaled corticosteroid.

Turning to FF/VI, the proposed brand name Relvar in the European Union and Japan and Breo in the United States, FF/VI is an investigational, once a day inhaled combination medicine comprised fluticsone furoate an inhaled corticosteroid and vilanterol or LABA for the maintenance treatment of COPD and asthma. For both indications FF/VI would be administered using a new dry powder inhaler with the proposed brand name, Ellipta.

The global registration process with FF/VI is well under way. GSK has now submitted FF/VI for approval in the U.S., E.U., Australia, Canada, Japan, New Zealand, Philippines and Switzerland, with further submissions planned in Brazil, Taiwan, Turkey, Russia and Korea over the next few months. In total, GSK plans to submit the FF/VI for approval in over 100 countries over the next several years.

Now turning to our second respiratory program with GSK, which is UMEC/VI. UMEC/VI is a once a day investigational medicine, combining a long-acting muscarinic antagonist umeclidinium bromide or UMEC and a LABA, VI, for the maintenance treatment of patients with COPD; UMEC/VI is also administered by the new Ellipta inhaler.

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