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Theravance Inc. Q1 2010 Earnings Call Transcript

Theravance Inc. Q1 2010 Earnings Call Transcript

Theravance Inc. (THRX)

Q1 2010 Earnings Call

April 21, 2010 05:00 pm ET


Mr. Mike Aguiar - SVP & CFO

Rick Winningham - CFO

Dr. Mathai Mammen - SVP of Research and Early Clinical Development.


John Eckard - Leerink Swann

John Stephenson - Summer Street Research

Michael Olson - Piper Jaffray



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Ladies and gentlemen, good afternoon. At this time I would like to welcome everyone to the Theravance Conference Call to review results for the quarter ended March 31, 2010. (Operator Instructions). Today’s conference call is being recorded.

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




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 & 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 fourth quarter and 2009 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, financial result 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-K and in the perspective supplement filed with the SEC during the first quarter 2010.

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

Rick Winningham

Thanks Mike. Good afternoon everyone. I am very pleased with the progress we’ve made thus far in 2010. In particular in our long acting bid antagonist or LABA, collaboration GSK recently initiated a very large RELOVAIR Phase 3 program in asthma patients and complements the ongoing Phase 3 and COPD.

We also recently initiated a Phase 2 proof of concept study of a Theravance discovered compound TD-1211. This compound is an orally dosed peripherally restricted opioid antagonist for the treatment of Opioid-Induced Constipation.

And finally on the corporate front, we recently completed a public offering of approximately 80.6 million shares of common stock in March. Now, I will provide more details on RELOVAIR, VIBATIV and 5HT-4 program and Dr. Mathai Mammen will expand on the peripheral Mu-Opioid Antagonist and MARIN program for the treatment of pain.

Mike will walk you through the financials later on the call. Let me start with the RELOVAIR program. As I said, I'm pleased with the progress of the RELOVAIR programs in both asthma and COPD.

In March 2010, the first patient was dosed in a global Phase 3 asthma program. As a remainder, RELOVAIR is a next generation, once daily combination of an inhaled corticosteroid with fluticasone furoate also known as FF and a long acting beta-agonist ‘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 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.

These studies are described in our press release. 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 to first exacerbation in patients who’s Asthma remains uncontrolled on current therapy

Turning to the RELOVAIR COPD program, enrolment in the pivotal Phase 3 studies is progressing. Phase 3program consists of a broad range of large scale Phase 3 studies to evaluate vilanterol in combination with FF for the treatment of COPD.

The overall program will study more than 6000 patients and includes 2, 12 month exacerbation studies, 2, 6 month efficacy and safety studies and a detailed long functioned profile study.

We believe RELOVAIR has the potential to be the best in class next generation treatment for the patient suffering from COPD and asthma and as a reminder Theravance is entitled to receive royalties of 15% on the first $3 billion of annual net sales and 5% on annual net sales above $3 billion for approved single agent long-acting beta agonists and combination long-acting beta agonists inhaled corticosteroid medicines.

GSK is planning a number of presentations this year that will highlight the work completed to-date of a RELOVAIR program in both COPD and asthma. At the upcoming American Thoracic Society or ATS conference in New Orleans in May GSK will present data from pre-clinical Phase 1 and Phase 2-A data.

Phase 2-A studies on the components of RELOVAIR fluticasone furoate and vilanterol. 12 abstracts have been accepted for presentation at ATS. In addition, GSK has submitted two Phase 2-B data to the European Respiratory Society meeting scheduled for September in Barcelona.

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