Theravance, Inc. (THRX)
Q2 2008 Earnings Call Transcript
July 24, 2008 5:00 pm ET
Rick Winningham – CEO
Mike Aguiar – SVP and CFO
Rachel McMinn – Cowen & Co.
May-Kin Ho – Goldman Sachs
Michael Aberman – Credit Suisse
Jim Birchenough – Lehman Brothers
Biren Amin – Stanford Group
Marshall Urist – Morgan Stanley
Tom Russo – Robert W. Baird
Ian Somaiya – Thomas Weisel
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Good afternoon everyone and thank you for joining us. With me on the call today is Rick Winningham, our Chief Executive Officer. Today's call will be in three parts. First, Rick will review the highlights in the quarter and 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 2008 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'll 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 these results to differ materially from our forward-looking statements are described in greater detail in the company's most recent 10-Q filed with the SEC. I will now turn the call over to Rick Winningham, our Chief Executive officer.
Thanks, Mike. Good afternoon everyone.
During the second quarter, we made progress on our clinical and regulatory activities. Most importantly, we announced positive Phase II results of our MABA program for the treatment of COPD with the lead candidate '081 achieving proof of concept. We also recently announced Phase I results in our LAMA program and the GSK intends to return that program to Theravance. The Horizon Program in collaboration with GSK recently completed enrollment in two of the three Phase IIb asthma studies with the ICS '698, and we expect to complete enrollment in the LABA study with '444 in asthma during the third quarter
With regard to our Telavancin skin NDA, we've audited a number of sites and based on the work completed to date, we've not identified issues we believe we should call into question the integrity of the data contained in our NDA. Also for Telavancin, we believe there has been positive progress by our contract manufacturer towards resolving its issues with the FDA, which I remind you were unrelated to Telavancin. And we are on track to file the HAP NDA in the fourth quarter of the year.
And finally, we have substantially completed our restructuring activities and have realigned the company's resources towards support our priority programs.
Now I'll provide more details on these developments and Michael will walk you through our financials later in the call.
I'll start with our MABA program. Early last week, we announced positive results in a proof-of-concept Phase II study with '081, the lead compound. These results show that '081 dosed once daily to COPD patients, exhibited 24-hr bronchodilation that was similar to a combination therapy control of salmeterol dosed twice daily plus tiotropium dosed once daily. '081 was generally well tolerated with a similar overall incidence of adverse events compared to the active control and placebo arms of the study and no serious adverse events were noted in the study.
We are encouraged by these results as '081 is the first bifunctional molecule that serves as both the muscarinic antagonist and the beta 2 agonist dosed in patients with COPD. We believe that this compound may provide new treatment options for patients suffering from COPD either as monotherapy or potentially in combination with an anti-inflammatory medication.
Based on these positive data, we are discussing with GSK the next phase of development, and we'll provide a public update in the future. Another recent announcement was the completion of the Phase I study with TD-4208, our long-acting muscarinic antagonist for the treatment of COPD. We were pleased with the results of the study which demonstrated that TD-4208 was generally well-tolerated with an overall incidence of adverse events similar to placebo.
Additionally, TD-4208 demonstrated evidence of bronchodilation in subjects who were responsive to muscarinic antagonist. I would like to highlight, while this evidence is encouraging, further studies will need to be completed to determine if TD-4208 is efficacious in patients with COPD. As previously disclosed, GSK recently informed us that they intend to return the LAMA program to Theravance as the current formulation is incompatible with GSK’s proprietary inhaler device.
We are working with GSK to facilitate transfer of materials and information back to Theravance and intend to begin exploring the possibility of licensing the program to another partner.