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Executives

Mike Aguiar - SVP and CFO

Rick Winningham - CEO

Mathai Mammen - SVP of Research and Early Clinical Development.

Analysts

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

Theravance Inc (THRX) Q2 2010 Earnings Call April 21, 2010 5:00 PM ET

Operator

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.

The overall program will study more than 6,000 patients and includes two month exacerbation studies, two 6-month efficacy and safety studies and a detailed lung function profile study. All five COPD studies are progressing and the detailed lung function study has completed enrolment and is ongoing.

We believe RELOVAIR has the potential to be the best in class treatment for patients suffering from these serious diseases. 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 LABA and combination LABA ICS medicines. Theravance has no cost obligation through the approval of these products through the RELOVAIR program approval.

Now we will turn to VIBATIV. VIBATIV, an antibiotic discovered and developed by Theravance was launched by our partner, Astellas, in the US for complicated skin and skin structure infections in the fourth quarter.

VIBATIV revenues were modest during the second quarter of 2010. We believe that wholesalers have now distributed the bulk of the initial launch inventories and in the coming week, sales should begin to reflect the use of the product in the market.

Astellas's sales and marketing efforts remain focused on achieving additional access to hospital's formularies and increasing the appropriate use of VIBATIV by physicians.

Regarding Telavancin in Europe, the marketing authorization application is under review for the treatment of nosocomial pneumonia and complicated skin and soft tissue infection in adults.

The European medicine agency or EMEA began to review process in November 2009 and we anticipate completion of the process during the first half of 2011. As a reminder under our Telavancin collaborations as Telesis responsible for the sales of the product including commercialization cost. Theravance is entitled to receive royalties on VIBATIV net sales from the high teens to the upper 20s depending on sales volume.

I now like to turn the call over to Dr. Mathai Mammen, our Senior Vice President of Research and Early Clinical Development, who will take you through our earlier stage clinical programs. Mathai?

Dr. Mathai Mammen

Thank you, Rick. I am very excited to talk about our earlier stage clinical programs all of which were discovered by Theravance. The Phase 2 study of TD-1211 and oral peripherally selective Mu-Opioid receptor antagonist or PUMA for the treatment of Opioid induced constipation is currently ongoing.

The proof of concept Phase 2 study is a randomized double-blind multiple-ascending dose study designed to evaluate constipation relieving effects, safety and tolerability in approximately 50 patients experiencing constipation while receiving their chronic opioid therapy. These patients are randomized to TD-1211 or placebo while being maintained on their existing opioid therapy.

Study treatment is administered once daily orally for 14 days. The primary efficacy end point of the study is the change from base line of the frequency of spontaneous bowel movements or SBMs. The study will compare this outcome in patients receiving TD-1211 to patients receiving a placebo. We remain on track to report results in this study maybe end of the year.

As many of you know, opioids are one of the largest, most effective class of medicine used in the management of pain. However, their numerous side effects including constipation, nausea and pruritus. These limit the use of opioid for many patients and there are currently no oral medicines approved in the US to help alleviate these affects.

TD-1211 was selected as our lead compound for development, based on preclinical data that demonstrated excellent peripheral restrictions, which we believe will enable it relieve gastrointestinal and potentially other undesirable, sometimes dose limiting side effects of opioid therapy but without affecting analgesia.

TD-1211 which was designed using our multivalent approach to the discovery of new agents has excellent selectivity over non-opioid receptors by binding to both the primary and secondary binding site on the new opioid receptor.

The Phase 1 single and multiple ascending-dose programs show that TD-1211 was generally well tolerated up to doses that significantly exceed the anticipated therapeutic dose. The Phase 1 program also demonstrated predictable and linear pharmacokinetics with a 16 hour pharmacokinetics cast life enabling oral once-daily administration.

Now turning to our 5HT 4 agonist program in Alzheimer's and gastrointestinal motility dysfunction. TD-5108 and TD-8954 have completed Phase 1 studies affecting CNS penetration. Based on the results of the Phase 1 study of these compounds we will continue to evaluate TD-5108 for both Alzheimer's disease and gastrointestinal dysfunction such as chronic constipation and chronic irritable bowel syndrome, while TD-8954 will be evaluated for GI motility dysfunction.

Last quarter we announced encouraging results from TD-5108 Phase 1 study in which we have achieved the targeted CNS penetration and doses for which we already have significant clinical experience. While these data are promising we are still early in the Alzheimer's program.

I will turn now to our MARIN program for the treatment of pain. Our goal in this program is to make a best-in-class norepinephrine serotonin reuptake inhibitor optimized for the treatment of chronic pain associated with conditions such as neuropathic pain, osteoarthritis. Our lead compound TD-9855, is modestly more selective as the norepinephrine transporter than as a Serotonin transporter, which we believe based on the pre-clinical data will be optimal for the treatment of pain.

We have completed the Phase 1 single ascending study of oral TD-9855, our lead compounds. In this study TD-9855, was generally well tolerated and had a profile showing consistent and linear exposures, with a long half-life enabling once-daily dosing.

During the third quarter of this year, we are planning to progress, TD-9855 into multiple ascending dose safety studies designed to further access safety, tolerability, pharmacokinetics in healthy subjects.

There is a lot to look forward to in our earlier stage clinical program. I would now like to turn the call back to Rick.

Rick Winningham

Thanks Mathai. In summary the RELOVAIR program with GSK continues to advance in both asthma and COPD Phase studies, VIBATIV is progressing in the US market in the Phase 2 study with TD-1211 for the treatment opioid-induced constipation. It's also progressing well as our earlier clinical stage programs.

I would now like to turn the call over to Mike Aguiar, our Chief Financial Officer who will take you through our financial results. Mike?

Mike Aguiar

Thanks Rick. Today I will discuss results of the quarter ended June 30, 2010 and will review non-GAAP expense guidance for the full year. For the second quarter of 2010, Theravance had a net loss of $20.8 million or $0.28 per share. Total research and development plus total general and administrative expense, excluding stock-based compensation was $20.4 million for the second quarter and $42.7 million for the first half which is largely in line with our expectations and guidance.

Revenues totaled $6.3 million during the second quarter 2010 and consisted primarily of the amortization of deferred revenues for the company's partnerships with GFK and Astellas of $5.7 million.

In addition we also recognized approximately 500,000 of net revenue related to $1.4 million of VIBATIV inventory that we sold to Astellas, which was net against the cost of goods of approximately $900,000. We also recognized approximately $100,000 of royalty revenue earned from VIBATIV net sales of approximately $600,000.

Total R&D expenses for the second quarter 2010, were $18.7 million compared to $20 million for the same period last year.

I would like to remind everyone that the results for the second quarter of 2009 included a one-time expense reimbursement from Astellas that reduced our total R&D expense by $1 million. Expenses were down year-over-year due primarily to lower external spending and facility costs.

External R&D costs excluding the reimbursements were $3.3 million compared to $4 million in the same quarter of 2009 versus 2010. General and administrative costs was $7 million during the second quarter of 2010 compared to $6.8 million from the same period last year. Excluding stock-based compensations, non-GAAP G&A expense was $4.3 million during the second quarter of 2010 compared to $4.6 million in the same period last year.

Cash, cash equivalent and marketable securities totaled $210.7 million as of June 30, 2010. This decrease of approximately $14.7 million during the second quarter was primarily due to cash used in operations.

Now, turning to our guidance regarding Non-GAAP expenses for 2010. For the full year, we expect to be at the upper end of our guidance range of $80 million to $85 million. As a reminder, our guidance includes total research and development expense and total general and administrative expense but excludes stock-based compensation. Total cash used will be offset by any other milestone payments earned or other cash inflows.

Now. Let me turn the call back to Rick for final closing comments.

Rick Winningham

Thanks. Throughout the remainder of the year, we have a number of important events including the GSK's presentation of the RELOVAIR Phase 2B data at ERS; the results of our Phase 2 proof of concept study with TD-1211; and the results of our Phase 1 studies in the MARIN program as well as the continued progress of our other programs.

Now I would like to turn the call over to the conference facilitator and open the call for questions.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions) First question comes from Brian Skorney from Thinkequity.

Brian Skorney - Thinkequity Llc

Hey, good afternoon guys. Thanks for taking my question and congratulations on the great progress on the quarter. First, I could just get a sense of timing as far as when we might see data from the RELOVAIR program. Do you think that as far as enrollment goes in the two 12 month exacerbation studies, is that going to be [gating] for when we get data or do you anticipate that will be more of a rollout from GSK as far as getting the six-month COPD studies, maybe we will see data than in the 12 months?

Rick Winningham

Well I think we are still in discussions with GSK as to how we roll out the data from the RELOVAIR Phase 3 asthma and COPD studies. I think the best general guide that we have at least to date of the completion date for all these studies can be found on the clintrial.gov. website sort of by study and you see sort of range of date there on the website, really covering from about mid year or next year or through October, November 2011. So, we will just have to see, we will work with GSK on making a timely announcement of this data. Mike?

Mike Aguiar

I think I have some pretty guidance to date, Brian, we sort have the caveat, obviously it's going to depend upon enrollment rates for most of the studies. The one study that's little bit different is the asthma exacerbation study where you have two pieces.

One is enrollment rates and the second piece is rate of exacerbation, because as I think this is an rate driven study. So you have a number of events you are going to be looking for and so the rate is just higher than we expect. It could be a little sooner or lower than we expect, it can take a little bit longer.

Then the final piece, the dates that's out there on clinicaltrial are generally estimates of the last patient, last visit. So there will be some amount of time after for GSK to collect the data and analyze it. So again that would be last patient, last visit by dates that you would see out there.

Brian Skorney - Thinkequity Llc

Great. Will you and GSK kind of give data piecemeal or we waiting for let's say the longest trial to finish before we are going to see top line data for that reason?

Mike Aguiar

I though Rick has mentioned that. We don't have the discussion completed with GSK in terms of how we are going to roll this out.

Brian Skorney - Thinkequity Llc

Okay.

Mike Aguiar

My suspicion is you probably wouldn't have 13 separate press releases, one for every study. That would seem unusual, but whether we end up having some reduced number of that, there were kind of bunching certain studies together or whether we ended up waiting till the whole thing was complete. That is still something we have not completely agreed to with GSK and really haven't finalized that. So we'll have to wait and see.

I think the big [net was] data and this is certainly something we are quite excited about is the upcoming ERS data. This will pretty important as we mentioned during the call. This will be the first scientific presentation of the data coming out of about 3,000 patients and that will here in September. So that's probably the third big piece. So with regard to specific timing around Phase 3 data that's still [COPD] with GFK and Theravance.

Brian Skorney - Thinkequity Llc

Then I just want to return very quickly to VIBATIV. Do you guys have any active dialogue in terms of how the EU filing is progressing. There is tendency for little more back and forth between the EMA and sponsor of a filing over there and I'm just wondering have you guys heard of what the initial assessment report by the Rapp/Co-Rapporteur may has been and are we potentially at or near to the 180 day clock stop at this point?

Rick Winningham

I think, the summary of the dialogue is generally encompassed in my comment in the call that we expect to hear from the EU the final decision on this in the first half of 2011 after filing it and getting the review underway in November 2009. So, that's really Brian all l am able to comment on right now.

Mike Aguiar

The only thing I would add on that Brian is that to date we have not had any indication from the EMEA that they are looking at they are at it in the way somewhat where the FDA is, meaning looking at some other endpoint. Things are not in that place, so we seem to have a pretty straight forward path, as of today.

Operator

Next question comes from Jon Stephenson from Summer Street Research.

Jon Stephenson - Summer Street Research

Just wanted to talk a little, first I got to talk about VIBATIV and can you provide a little more clarity in terms of end market demand and what we can really can we glean from the royalty income that you recognized both at 0.5 and 0.2, and how timing of revenue recognition impact things?

Mike Aguiar

Sure, well let me just explain to make sure and clear what those two pieces are and then I will write a little top level discussion in terms of other market opportunities.With regard to the two pieces, the 500,000 that exclusively relates to inventories that Astellas purchased of this quarter. So they purchased $1.4 million worth of inventory from us, it had a net note value of 900,000 and so we recognized the net of that in revenue. So that is you simply inventories transferred to Astellas.

With regard to the $100 000 or approximately $100,000 of royalty income, that related to approximately $600,000 of inventory that was shipped from Astellas into the wholesaler channel.So those were sales that went in from us, into the wholesaler channel and subsequently be distributed to end users. So we had modest sales this quarter as Rick had mentioned, and that's largely in line with our guidance to-date to expect a fairly slow ramp of sales in 2010 for VIBATIV particularly, since we only have the approval for the skin indication.

Now with regard to the total market size, the total market size in the US, for agent active against the treatment of methicillin-resistant Staph aureus is in the neighborhood of $34 million treatment days and the most recent data we have is that approximately a third of those treatment days are related to treatment of complicated skin and skin structure infections.

So that's somewhere in the neighborhood of $10 million or $11 million treatment days. As of the year ended, I believe it was December 31, 2009. So there is still a large market opportunity out there. Again, it is a slow ramp as is typical for [hostile] based antibiotics and in our guidance that's where we are today. Rick do have any comments on, on that?

Rick Winningham

No, I mean, I think we anticipated the initial launch too have as Mike said a relatively shallow ramp which is typical for [hostile] antibiotics, we are getting into hospital formularies, and we are then directionally optimistic about the future.

Jon Stephenson - Summer Street Research

Did you make a comment earlier that you believe that the inventory levels that were shipped in the last couple of quarter you announced starting to be base there reflective of about the cumulative end market demand. Are you implying that?

Rick Winningham

No what I said was that, the bulk of the shipment, initial shipments in to the wholesaler had been worked off.

Jon Stephenson - Summer Street Research

Okay.

Rick Winningham

I expect to see sales going forward being more reflective of end market demand.

Jon Stephenson - Summer Street Research

Okay, so, but these two can't take that one step further if the inventories have been worked off and I back date to what the shipments were and the estimated royalty that should be some approximation of what the cumulative end market demand has been to date, albeit very early?

Rick Winningham

Yes, albeit very early. I think that's a reasonable proxy.

Jon Stephenson - Summer Street Research

Okay and then shifting gears really quickly, what are you and Glaxo saying in terms of whether or not you will file in the US with both indications simultaneously or lead with COPD and follow with asthma?

Rick Winningham

Our plan is to file asthma and COPD in the United States and Europe.

Jon Stephenson - Summer Street Research

Okay, simultaneously in both geographies.

Rick Winningham

Yes.

Operator

Our next question comes from Ian Somaiya from Piper Jaffray.

Ian Somaiya - Piper Jaffray

Thanks for taking my question. Just a question on the 2000 patient exacerbation study. Can we just go through the endpoint of the goal of the trial, I have getting a lot of questions related to what the trial needs to show to be successful or positive in the mindset of the FDA and the EMEA. If you could just comment on that?

Rick Winningham

Thanks for the question. Without getting into all the details of the trial which you can find on clinicaltrials.gov, it is a 2000 patient study and in this study, what we are trying to show is with the addition of a long-acting beta agonist to an inhaled corticosteroid therapy, it reduces the time to first exacerbation, which is the endpoint, primary endpoint of the study.

The secondary endpoint are rate of exacerbation as well as a measure of FEV1. I think this study is really undertaken to accomplish this objective of showing that it provides a benefit to adding a long-acting beta agonist to an inhaled corticosteroid therapy.

This is really targeted to answer a key question I think that at least has been shown positively and as secondary end points other studies, but do the study so as to show it and demonstrate as a primary end point in this study. That's probably all I can, a statistically significant reduction in exacerbations would be important?

Jon Stephenson - Summer Street Research

So you have to see this is a safety study or an efficacy trial?

Rick Winningham

We see this is an efficacy study and that the prevention or delay of time to exacerbation is an efficacy measure, the time.

Mathai Mammen

I don't know that I have lot to add to that, but Rick summarized it well. The study is intended to show that on a base line the patients who are receiving steroid, there is benefit to be had with respect to exacerbation if they are also receiving a beta-agonist. That is what our expectation would be. looking at all the data that's been published to date on Advair and salmetrol and steroids. So where we are attempting the show that in this program.

Jon Stephenson - Summer Street Research

Is that the rate limiting stuff at this point in terms of a filing?

Mathai Mammen

Well it depends on which program you are looking at today. It's likely that would be the last study to finish enrollment and then treatment for asthma less likely and its likely to be 12 months exacerbation study in COPD as the last one to finish there. So, it's really going to depend upon enrollment rates.

Then as I mentioned in the exacerbation study for asthma there is some assumption around rate of exacerbation, in sense it's an event driven study that rate will have a bearing on that as well. So, we are still little bit early to know exactly what we are going to roll out on those but it's likely that those two are the mixed studies for their individual indications.

Jon Stephenson - Summer Street Research

Okay. Then just one last question, more of housekeeping. I think you mentioned you are still discussing with Glaxo when and I guess what the timing would be in before putting out press release of the data. Should we expect data presentation at medical conferences next year?

Mike Aguiar

I think the long-term goal is certainly to present the data at medical presentation. Its likely there is going to have to be some interim step where we have top level data that comes up before that. So it really depends upon the timing of this going forward. So I would just say we and Glaxo have not yet agreed on the publication nor the presentation strategy around this, but it's certainly area that we will begin exploring with them in the not too distant future.

Operator

Our next question comes from Brian Bourdot from Barclays Capital.

Brian Bourdot - Barclays Capital.

Hi, thanks for taking the questions. First off, are you going to have any combination data for vilanterol with the ERS and also if you could remind us what kind of work you've with the combination?

Mike Aguiar

We haven't disclosed yet all of the specific studies that we are going to be presenting yet at ERS. I would just say at this point the only guidance I can give is that the primary focus will be the Phase 2b study. We have done some work with the combination but I can't say whether that's in there or not at ERS. So I j would just say right now the focus will be on the Phase 2b study and then are a number of presentations that are planned.

Rick Winningham

Again, I would direct you back to the clinicaltrials.gov listing for 444 as well as 698, the steroid and there is a complete list of all the studies that are ongoing and have been completed in both asthma and COPD.

Brian Bourdot - Barclays Capital.

Okay, thanks. Then with RELOVAIR program how does this new device that you are using differ from that's being used for Advair?

Mike Aguiar

We haven't disclosed a lot of detail. I would just make a couple of points that I think should be obvious. Number one the Diskus was a terrific device but we think potentially we have something better here. We did receive a lot of positive feedback from patients, as we were going to the earlier studies and so I think we feel pretty good about it today.

The only real information, we give and this is one-step inhaler, but I think at this point, I would just say, we were quiet pleased with the device. The Diskus is a great device, but we saw there were hurdles and then we think potentially there is something better than that.

Rick Winningham

I have to just add that, again to remind everybody, this device has been in use in the clinical program for quiet sometime, all 3000 patients as an example of the Phase 2b program used this device.

Operator

Our next question comes from Tom Russo from Robert W. Baird & Co., Inc.

Thomas Russo - Robert W. Baird & Co

Good afternoon and thanks for taking the question, Just to start out with VIBATIV. Can you give us your latest expected timings for publication of the nosocomial pneumonia results, and then may be how you think that could impact things in the market?

Rick Winningham

We anticipate that we will have a publication in the second half of 2010 and relative to how the drug is used, certainly the drug will only be promoted for complicated skin and skin structure infections by Astellas, but clearly we believe its important to publish the attained data just in terms of getting all the data out there, regarding those nosocomial pneumonia but the promotion will continue to focus on complicated skin and skin structure infections until we hopefully reach eventually a positive resolution with those nosocomial pneumonia.

Thomas Russo - Robert W. Baird & Co

Then just to check in on two R&D Projects, I didn't hear mentioned. Can you give us the status of the Phase 2 for LAMA and the timing of the results and what may be the path forward from there would like and also just the latest on the MABA?

Rick Winningham

Sure. Just to touch on the work going on the long-acting muscarinic antagonist combining with 444, there is a series of studies going on with 719 a long-acting muscarinic antagonist discovered and develop by GlaxoSmithKline. There is a complete list of the studies in this program. Again a most complete list is again posted on clinicaltrials.gov.

Importantly work is ongoing with combining 719 and 444 in the treatment of patients with chronic obstructive pulmonary disease. We will hope that data we will read out later this year and we will have an update on that program at that particular points in time.

Relative to the MABA. Work continues on MABA. We and GSK continue to be very excited about this program and we plan, assuming other all the work between now and the start is successful, we plan on initiating, a larger Phase 2b setting late this year.

Thomas Russo - Robert W. Baird & Co

Then last question, just be interested in your current talks. I think most, just come to believe that generic Advair in the US is pretty unlikely anytime soon but I would be interested of your current expectation on when we might look for that in Europe?

Rick Winningham

Well my respective is just based on public observation, the public information and certainly it appears, I think its been written in a number of different places that the hurdles with the development of that inhaled combination of product as a generic are relatively high in the United States and perhaps somewhat lower in Europe, which probably has a effect on timing of entry in each of those regions. So that's really all the perspective I can offer. Mike?

Mike Aguiar

Yes Tom. I don't think we have any news with regard to generic Advair, really we would just point you back to GSK. They are going to have probably the best view on that. At the end of the day, I still believe that the best medicine is going to win. If you take our Phase 2b results that we saw with RELOVAIR, it looks like we have an opportunity to have a better medication here if those results were to repeat in Phase 3.

So it's certainly possible that generic Advair will be out there in Europe at some point, but I think we have a shot at having a medicine that is very differentiable from the safety and efficacy side and if that's turned out to the case, I think that there are going to be enough benefit to patients, that we are going to be quite successful with it. So, at the end of the day, best medicine is going to win and the data we have seen to-date particularly in the Phase 2b study is very, very good.

Operator

Our next question comes from Howard Liang from Leerink Swann.

Howard Liang - Leerink Swann

Thanks very much. Based on the recent approval of DULERA, what in your view is a minimal package for asthma for example, does the exacerbation trial have to work showing a reduction of the combination I guess alone.

Mike Aguiar

Well I don't know today what the minimum package would be. We do not today have agreement with the FDA about what the specific set of studies will be that we are going to have to have to get our product approved in the US for asthma. So I don't know, but I was certainly encouraged by the approval of DULERA. This is a beta agonist inhaled corticosteroid and that certainly gives us some level of comfort that these products are being reviewed thoughtfully by the FDA. So, today I don't know what the minimum level of studies are.

With regard to the exacerbation study this is a clearly an important study that we are doing and its sort of corner stone of the asthma program and not a study that you could fail and completely have that result there in a good position, but again I don't have any comment what the minimum package would be at this point until we get further feedback from the FDA.

Rick Winningham

I'd just say that I think the DULERA approval as well as comments that have been made over the past few months indicates that a fixed dose ICS and long acting beta-agonist remain an important treatment option for patients who has asthma that [purely] controlled on alternative therapies and that's certainly quite encouraging for the RELOVAIR program.

Howard Liang - Leerink Swann

Just a follow-up so for the exacerbation trial, a equivalent rate for the combination of ICS will be consider a failure in the trial?

Mike Aguiar

I don't know that we said that.

Rick Winningham

No, we didn't say that. I think we would just have to see, we have to look at the data when we finish the study. Clearly of we believe based on history and which is the reason the study is being conducted that we should see a reduction and exacerbation when you [have to allow] to base line inhaled corticosteroid therapy.

Howard Liang - Leerink Swann

Okay. Great. For the 100 patients head-to-head trial for RELOVAIR versus Advair, can you talk about what is the goal of that study, is that comparative study?

Rick Winningham

Yes, the studies that we are talking about today and are listed today is ongoing, are either ongoing in terms of enrollment or ongoing in terms of treatment are really part of the Phase 3a registrational package. There will certainly be another portion of RELOVAIR program 3b that we will be talking about and I'm sure GSK will be talking about later.

The head-to-head comparative 100 patient study is really a study targeted at the European authorities to satisfy European regulators and certainly we hope to have important data out of that relatively small study that shows certain differences between Advair and RELOVAIR. So that's about all that I can say right now Howard.

Howard Liang - Leerink Swann

Okay, great that's very helpful. Just on VIBATIV, first to get an idea of end user sales to date. Can you remind us what was the total amount of inventory that been shifted to wholesaler since launch?

Mike Aguiar

The initial launch supply they went out was just over $400 million and that was shipped during the fourth quarter of last year. Then in between there have been some small other amount that have gone out, but the big bolus was really the initial launch supply plus what was shipped this quarter.

Operator

Our next question comes from Matt Duffy from BDR Research.

Matt Duffy - BDR Research

Thanks for taking my question. Just really go back to VIBATIV for just minute or two, would you mind giving us any more metrics in terms of formulary acceptances or how the hospital stocking has been going and whether you are focusing on the outpatient area as well?

Rick Winningham

Yes, I think on formulary I can't give any specific formulary information, we gave some account shipment information in the last quarterly call and I don't have really any further updates than that on this call. I will say we are seeing formulary successes and we are seeing VIBATIV used both inpatient and in outpatient setting. So with that I am fairly encouraged by the use in both of those settings

Matt Duffy - BDR Research

Okay, very good, and then just anecdotally, when you are seeing the formulary successes, how are they positioning VIBATIV them within the formulary in terms of use relative to vancomycin or daptomycin or any of the other competing agents?

Rick Winningham

I think the one thing that we are extremely pleased about in the development program of VIBATIV is the label that we have and I think the label for VIBATIV it really provides very solid instructions on how to use the product to the maximum benefit of the patients, including the largest sub-set of patients, studied in a randomized clinical study to date, clearly if a patient is going to a physician who thinks that the patient is going to respond, well to a drug like vancomycin.

That is likely to get the patients likely to use vancomycin, but if for whatever reasons, be it patient condition, the microbiological ecology within the hospital that they have question about response to vancomycin for the person with complicated skin and skin structural infections, then that is really an opportunity to use VIBATIV.

Mike Aguiar

Matt, what I would just add on top of that is, as you would expect this is totally typical with a hospital base launch, it is simpler, its easier to treat patients who are not the first choice for the new agents as there tends to be, when you have a patient who is a little bit sicker or somebody for example who vancomycin didn't work on the first time or there is some reason where they have to ramp up the therapy.

So that is typically what we are seeing today is in the sicker patients who have a little bit tougher to treat infections. So again that was completely expected from our perspective, the patient with the run of the mill very easy to treat, susceptible to vancomycin skin infections is not typically the place where they would start with the new agents.

Operator

Our next question comes from John Stephenson from Summer Street Research.

John Stephenson - Summer Street Research.

Well, thanks for taking my follow up. A couple question on the exacerbation study, as one of you. I was wondering if you might be able to provide any clarity in terms what a reasonable exacerbation rate would be for a patient population such as the one you are studying over twelve months and then what kind of treatment benefit would you expect?

Mike Aguiar

We really we can't give the guidance on that and the reason why John is, if you look at these overall asthma over the overall COPD population the rate of exacerbation event is very low. However in both of these studies we can reach the population with patients who are more prone to exacerbation, so who have had an exacerbation event. The rate of exacerbation you can see on these patients is really and a GSK proprietary and I can't get into that.

Note that I can't unfortunately talk about what the specific rate of improvement we would want to see, but I would say that ideally you are going to see a statistically significant reduction on the combination versus the single agent, but today that's about as far as I can go into, just because of the unique nature of these patient populations.

John Stephenson - Summer Street Research.

Then you commented in terms of numbers of exacerbation the patients might have needed to have in the prior, say three to six month, before enrollment?

Mike Aguiar

No, it if you go actually pull on clinicaltrials there an inclusion criteria and then I believe it say and I am recalling from memory, but the patients has to have had an exacerbation its seems like when you have six months or twelve months. So there is an inclusion criteria related that but on the top my head, I don't whether its six months or twelve months.

John Stephenson - Summer Street Research.

Great and then if once a patient has exacerbation, how do you treat them in terms of the follow-up? Do they cease therapy, do they extend the study, but in [asthma] they get enrolled into a open label extension, and what happens once they do exacerbate?

Rick Winningham

John, the only information we are really able to provide on the study right now is that it's the data that you find in clinicaltrials.gov, that's all the way further comments that we can make.

John Stephenson - Summer Street Research.

Then just a one last follow-up on this. In terms of the 12-month safety study on the asthma side, that's just 500 patients, right? What if any assurances or clarity do you have in terms of a appropriate size of the number of patients in asthma followed for 12 months?

Rick Winningham

Well, as Mike had mentioned earlier, I think the FDA clinical trials review for [all lobbyist] are ongoing. At this point in time, we don't have an indication as to the content or output that might be required for the asthma program, but importantly we continue to progress the RELOVAIR program as part of the original plan because the plan satisfies regulatory authorities all over the world, not just in the United States.

So we will have to see the FDA is continuing to review the requirements, however to go back to an earlier comment that was made, I think all of us were encouraged by the DULERA approval a few weeks ago and the opportunity there that that may provide for future products to enter the market in the treatment of asthma.

John Stephenson - Summer Street Research.

Just one another question, has there been any more discussions with the FDA on the nosocomial pneumonia side?

Rick Winningham

I would say dialogue with the FDA is ongoing. We've mentioned we are not going to provide sort of a back and forth until some materially significant event occurs.

John Stephenson - Summer Street Research.

Okay. Thanks.

Mike Aguiar

John, this is Mike. Just quickly, we pulled out the asthma exacerbation information. It's there on clinicaltrials right now. Just to answer your question earlier what it says an inclusion criteria, the history of one or more asthma exacerbation requiring treatment of oral or systemic corticosteroids or emergency department visits or end-patient hospitalization in the previous year.

John Stephenson - Summer Street Research.

Okay.

Mike Aguiar

So that's the inclusion criteria.

John Stephenson - Summer Street Research.

Okay. Thanks.

Mike Aguiar

Yes.

John Stephenson - Summer Street Research.

Would that have been on top of base line therapy or during with base line therapy?

Mike Aguiar

Yes, that would gave been on whatever medication they are on.

Operator

Our next question comes from Brian Skorney from Thinkequity.

Brian Skorney - Thinkequity Llc

Thanks for the follow-up guys. I just want to touch base with you guys on VIBATIV again. I know the FDA is having a clinical trial, its on workshop, I think the first week in August and I was just wondering if you guys have received anything more than a just preliminary agenda there in terms of what the discussions can be focused on or if you guys will be presenting now.

Rick Winningham

Yes, It's August second, third, I think it's an interesting agenda that hopefully will be somewhat informative where you have not been asked to present there but we will be watching that eagerly.

Operator

This concludes our Q&A section for today. I would now like to hand the conference back over to Mr. Winningham. Sir?

Rick Winningham

All right. Thank you very much, operator. I'd like to thank everyone for joining us today and have a great day.

Operator

Ladies and gentlemen, thank you for participating in today's conference. This concludes our program for today. You may all disconnect. Have a wonderful day.

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