Theravance Inc Q2 2010 Earnings Call Transcript

Theravance Inc Q2 2010 Earnings Call Transcript
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Theravance Inc (THRX)

Q2 2010 Earnings Call

April 21, 2010 5:00 pm ET


Mike Aguiar - SVP and CFO

Rick Winningham - CEO

Mathai Mammen - SVP of Research and Early Clinical Development.


Brian Skorney - Thinkequity Llc

Jon Stephenson - Summer Street Research

Ian Somaiya - Piper Jaffray

Brian Bourdot - Barclays Capital.

Thomas Russo - Robert W. Baird & Co

Howard Liang - Leerink Swann

Matt Duffy - BDR Research


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At this time I would like to welcome everyone to the Theravance Conference Call to review results for the quarter ended June 30, 2010. (Operator Instructions). Today's conference call is being recorded.

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 and thank you for joining us. With me on the call today is Rick Winningham, our Chief Executive Officer and Dr. Mathai Mammen, Senior Vice President of Research and Early Clinical Development.

Today's call will be in three parts. First, Rick will review highlights from the quarter and he and Dr. Mammen will provide an update on our clinical programs, and then I will review our financial results and finally we will open up the call for questions.

Earlier today, Theravance issued a press release detailing second quarter 2010 financial results and recent corporate developments. A copy of the press release can be downloaded from our web site or you can 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 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 in 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. Good afternoon everyone. I am pleased with the progress Theravance has made since our last quarterly call as we have remained focused on advancing our key programs.

First in our RELOVAIR collaboration with GSK ten Phase 3 studies in asthma and COPD are now underway out of the total 13 planned studies. We continue to make progress in the US of VIBATIV launch for the treatment of complicated skin and skin structure infections. Finally in our earlier phase clinical programs we completed two Phase 1 CNS penetration studies with our 5-HT4 agonist compounds and we are on track to complete by the end of the year both the Phase 2 proof of concept study of TD-1211 for the treatment of opioid-induced constipation and the Phase 1 single and multiple ascending dose studies with TD-9855 for the treatment of pain.

Now to provide more details on RELOVAIR and VIBATIV, Dr. Mathai will expand on the peripheral Mu-Opioid Antagonist and the 5-HT4 agonist and the MARIN program. Then Mike will walk will walk you through the financials later in the call.

First let me start with the RELOVAIR program. In May 2010, GSK presented preclinical Phase 1, Phase 2a data on components of RELOVAIR at the American Thoracic Society Conference in New Orleans. Twelve posters were presented at ATS, four or which described the results of the Phase 1 and Phase 2a studies. These posters of GSK noted that vilanterol produced a rapid and prolonged bronchodilation that suggests the potential for once-daily administration for both asthma and COPD.

More importantly in September, additional key data will be available at the European Respiratory Society meeting in Barcelona. GSK will make numerous presentations at ERS. The majority of which will highlight data from the Phase 2b program.

The decision to progress to Phase 3 in COPD and asthma was based on the extensive Phase 2b program which comprised approximately 3000 patients COPD or asthma. As I mentioned enrollment is progressing in the Phase 3 asthma and COPD programs. Ten studies are now underway our of a total of 13 planned Phase 3 registrational studies.

RELOVAIR is a once-daily combination of an inhaled corticosteroid fluticasone furoate also known as FF and a long-acting beta agonist or 444 or vilanterol trifenatate for the treatment of patients suffering from asthma and COPD.

The asthma Phase 3 program consists of eight studies, designed to evaluate the potential benefit of RELOVAIR against that of a component products and existing treatments for asthma. These eight studies include a 2000 patient exacerbation study, a 12 month safety study and six additional studies including three comparator studies.

As a remainder, the 2000 patient exacerbation study is designed to evaluate the safety and the potential benefit of adding the LABA 2NICS with a primary end point of time the first exacerbation in patients who's asthma remains uncontrolled on current therapy.

Four of these studies are currently recruiting patients and the 12-month safety study will support the asthma and COPD indications has completed enrollment and is ongoing.

Turning to the RELOVAIR COPD program, enrolment in the pivotal Phase 3 studies is also progressing. The Phase 3 program consists of a broad range of large scale studies to evaluate RELOVAIR and its individual components for the treatment of COPD.

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