Earnings Labs

Innoviva, Inc. (INVA)

Q1 2013 Earnings Call· Thu, Apr 25, 2013

$23.04

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Transcript

Rick Winningham

Management

Thanks very much. I would like to thank Citi for inviting us here to present today. We've got a terrific year ahead of us at Theravance; I'll walk you through in the presentation some of the significant events and significant programs that we are working on this year. Before I get started, there is a Safe Harbor, of course we'll be making some forward-looking statements and you should refer to our SEC documents that are currently on our website. Theravance, so what do we focus on? Well, medicines that makes a difference. We focus on discovery and development of medicines. We are working on building value from drug discovery through commercialization. We have multiple major late stage programs in Phase 3 in front of regulatory authorities. We have a very deep pipeline behind those programs and as I noted 2013 is a path to significant growth for the company. If you look at the growth drivers for us for 2013 and beyond, three late stage respiratory programs with the potential to enter very large markets with Chronic Obstructive Pulmonary Disease as well as asthma. Also our high value strategic partnerships with GlaxoSmithKline and the significant funding that they have provided to advance the company. Another key driver for growth in 2013 and beyond is the deep pipeline beyond the late stage respiratory programs. We've taken over 20 development candidates into the clinic and we have over 1,430 patents that have been issued to Theravance discovered molecules and we are in a very strong financial position, strong cash position going into 2013 and beyond. First, I'll start with the advanced respiratory programs in partnership with GSK. Stepping back for a moment, looking at the size of the opportunity, here you see a graph of sales of products containing long-acting beta agonist…

Unidentified Analyst

Management

In the slide way, you mentioned FDA meeting, Advisory Committee meeting next week and then PDUFA date sometime later. First of all, is BREO the US or is that the outside the US?

Rick Winningham

Management

Yes, BREO is anticipated to be the brand name inside the US with RELVAR being the brand name outside the US.

Unidentified Analyst

Management

I must have missed it. I didn’t get a date for the PDUFA.

Rick Winningham

Management

It's May the 12.

Unidentified Analyst

Management

May the 12? So if you are successful in this upcoming meeting, in the May meeting, when might BREO be on the market in the US?

Rick Winningham

Management

Well, we will have to get through both of those date, and I hope that we're ready to launch relatively quickly after the approval. So GSK has a commercialization responsibility. We're working with them now on the launch plan, but we would hope to be able to be in the market relatively quickly after an approval. I can’t give you a specific date.

Unidentified Analyst

Management

And didn’t the FDA require another Phase 3 trial for the BREO?

Rick Winningham

Management

So in the asthma program which we haven't filed, we have done a series of asthma studies and when GSK went to the FDA to talk about this and came away with one more study which we have initiated the 900 patient asthma study, that study looks at patient 100 micrograms new steroid and then compares that to those patients on 100 microgram new steroid, the patient’s got 100 microgram new steroid plus 25 microgram of vilanterol and compares that to patient’s on 200 microgram new steroid and 25 microgram of vilanterol. Well that study I believe should be finished sometime late this year and when it is I think work with GSK we’ll go back to the FDA and finalize the asthma strategy.

Unidentified Analyst

Management

Is that similar to the Advair 100/50 and the 250/50 in terms of strength?

Rick Winningham

Management

Well, I think it's we haven’t done any head to head studies in the program in asthma versus Advair. I think the rationale for the study and in fact if you look at the entire program, we previously did execute a very large asthma exacerbation study. In asthma which looked at a 100 microgram steroid versus a 100 microgram new steroid combined to a 25 microgram of vilanterol showed a benefit to exacerbation and a benefit to FEV-1. In a separate study in moderate to severe asthmatic we did a study where there is 200 microgram in the steroid combined with 200/25 of vilanterol and showed a significant improvement in FEV-1 function. What we did not have than the program is actually a study that had all both of those doses in one study, and as you know in asthma therapy many times physicians like to escalate dose from steroid from a lower to higher dose in order to potentially get a better control over asthmatics and I believe that’s the underlying purpose, the regulatory purpose behind this particular study. I can't say for sure but this was the study that the FDA wanted that.

Unidentified Analyst

Management

Does the GSK control, when this is going to be commercialized assuming you get the approval because this is cannibalized Advair if it’s successful. I mean once a day versus twice a day presumably less toxicity in the LABA (inaudible) versus the salmeterol. Doesn’t that have several years to run the pattern for (inaudible). If they want to delay it until those run out?

Rick Winningham

Management

So I think the commercialization of the collaboration is governed by joint steering committee. So there is four people from Theravance and four people from GSK on the joint steering committee. The joint steering committee has to review and approve the marketing plan and which is inclusive of the launch plan. So I feel like that the government responsibilities for Theravance provide us with quite a bit of oversight and thinking aspect of the program. Now to your point on Advair which is the very good product, it is the twice a day product, there is a paper by toy which says, and Boehringer Ingelheim sponsored the study, a compliance with twice day medicine is somewhere in the 35%, 37% range. And compliance with once a day medicine is up into the mid-40. Well that should lead to better outcomes what it leads for company of course is better compliance equals more volume and that’s about 30% increase in volume between those two numbers. So I think the fact of the matter is that if we can have a better therapy, therapy that’s once a day, that’s more convenient for patients with COPD or asthma, and we get that to the market, that’s going to be a benefit to GSK and it is going to be a benefit obviously to Theravance.

Unidentified Analyst

Management

Are you on the same track in Europe and EU for approval?

Rick Winningham

Management

So the EU, unlike the US and the EU both the asthma application was filed as well as the COPD application. The European review is progressing. That was filed in either late June or early July of last year and I think all I can say is that it’s progressing.

Unidentified Analyst

Management

Just regarding the cardio event, cardiovascular adverse event like the (inaudible) cardiovascular event rate, when GSK issued that press release back at the end of last year for UMEC/VI or ANORO, they mentioned the couple of parameters which they said were balanced between the groups but they made no mention to serious adverse cardiovascular events which is stood out given the degree of safety issues around cardiovascular LAMA there's a mechanism, could you tell us from the pool data whether there is any numerical imbalance to serious adverse cardiovascular events when you take the whole of the Phase 3 UMEC/VI datasets combined so the full long-term efficacy trials, the safety trials and the additional 304 short duration trials.

Rick Winningham

Management

Yeah, so overall the cardiovascular adverse event rate for ANORO is not a concern based on all the data that Theravance has reviewed. I mean, we've, that the 12 months safety data, we've got two exercise studies, we've had two compare studies versus the Tiotropium and we have had two placebo controlled studies. That's a fairly rich dataset of patients with COPD and to-date we do not have a concern about the cardiovascular event rate. I think what you are referring to is an underlying concern of something that was surfaced with Tiotropium and delivered by the device as a muscarinic antagonist, that isn't. We haven't seen that to-date with the work that's been done on umeclidinium. I think its important to understand that muscarinic antagonists are not only marketed for COPD but muscarinic antagonists are marketed for overactive bladder and there's a significant population of patients who use muscarinic antagonists to use for overactive bladder when there's not an overt concern with muscarinic antagonists in the use of overactive bladder where you are getting generally much, much higher concentration for the drug in a systemic circulation. So I think we feel very good about where we are right now with umeclidinium and look forward to getting to the regulatory reviews and hopefully at the a PDUFA date later this year.

Unidentified Analyst

Management

And just to go back to my question, for the parameters serious adverse cardiovascular event, all the aggregate datasets was there any numerical imbalance?

Rick Winningham

Management

So I'm not going to comment on what the numbers are, I'll just say that we have not, we do not have concerns Theravance on the cardiovascular event rate in the study.

Unidentified Analyst

Management

And the second question is you took two doses of the LAMA in your Phase 3 and the timing of that, the move to migration was actually fast [unlike] what the market anticipated. Did you have and I'm sure well maybe ask the question, did GSK and just how is that in the Phase 2 meeting with the FDA and did they request additional work to be on the low dosage range of the LAMA which precipitates the Phase 2B trials, can you give us some sense as A, if there was an end of Phase 2 meeting and if you can any guidance that they may have recommended?

Rick Winningham

Management

Well, given the significance of the investment of course there was a regulatory discussion between GSK and the FDA on the progression of the product into Phase 3. I think the program overall has been quite successful. Again, we didn’t have any priory concern going in. We decided to take two doses both 62.5 and 125 dose of umeclidinium into the Phase 3 program. I think, you look at the data sort of a beauty is in the eye of the beholder, the 125 data looks very good and the 62.5 data looks very good. The 125 provides a little bit better level of bronchodilation than the 62.5 but both doses look good. As you may know, the dose range has been studied all the way down to 16 or so micrograms, one today, and clearly the, where we were targeting and this was presented at the European Respiratory Society meeting. We were targeting to get into [EDE70] range or so with this long-acting muscarinic antagonist because unlike Tiotropium and the side effects that are associated with Tiotropium, you are able to dose umeclidinium up to those rate, up to that level of efficacy and the ED50 is around kind of 31, 32 micrograms and you get the ED70 in the 62.5 to 125 range with no dose forming side effect and that’s quite different than the experience, the development experience with Tiotropium and there are reasons for that and that will help umeclidinium is a process (inaudible) body. So I think GSK did an extraordinarily thorough dose ranging, better dose ranging work with umeclidinium. We got the dose response profile defined quite well and we got two doses, the potential two doses going into the market, whether one makes it, two makes it both make it I can't say, that will be decided by of course the regulatory review. But we feel pretty good about where we are right now.

Unidentified Analyst

Management

In the studies with Vilanterol, I presume that has much less toxicity than Salmeterol as LABA?

Rick Winningham

Management

Well, I think some Salmeterol is pretty much stood the test of time. It’s a component in a $8 million drug, a drug in Advair that came very close to achieving a statistically significant benefit in mortality in the [TORP] study. So I don't know I wouldn’t discourage Salmeterol I think it's a very good twice a day beta2 agonist. Vilanterol and the reason we got to this collaboration with GSK in the first place Vilanterol is a very good once a day beta agonist, and there is a lot of data both on GSK website as well as almost infinite number of SEC filings that Theravance has done overtime as 8-K is supplementing different medical meeting. Vilanterol is a very well behaved, well characterized, once a day long acting beta agonist that appears to be quite well tolerated, in patients with COPD and asthma based on clinical work that have been done so far. Whether it's better than some Salmeterol, I think Salmeterol is a very good drugs dose twice a day. I think Vilanterol is a very good drug once a day.

Unidentified Analyst

Management

Just one set of follow up from the quantity of dose selection and UMEC/VI. Is there any lead through from the way the FDA handled total (inaudible) which is approved by the same division, and just like (inaudible) need to demonstrate the affective dose well most affective dose, because in that particular case similarly they put two doses forward there was a lower dose which looks to be affective and they decided to add that middle those through the lower dose (inaudible). Is there any relevant of that as a case study and how the agency may assess dosing and risk benefit albeit in a very different indication?

Rick Winningham

Management

Yeah, I think you can always learn things from watching review division and the way they deliberate and way they write briefing documents and medical reviews that are posted on the FDA one side. I think it’s a very different conditions; I think it’s the very different process. I think those selection overall and the development of the drug is absolutely critical and there are areas where you’ve got very, very narrow dose ranges that you can work with other drugs because of their characteristics, you can work with a little bit wider dosing range and not effect negatively patient. So I think it’s a very, very specific. I do believe that whether you look at the long-acting beta agonist, you look at the inhaled corticosteroid or you look at the long-acting muscarinic antagonist, the dose selections, the dosing studies, dose selection process has been executed by GSK has been pretty thorough and has defined the dose response relationship quite well, both in terms of the absolute dose as well as the frequency of dose. Okay. So no other questions; thanks very much for your attention.