INVA - NASDAQ

Eric d’Esparbes - CFO Mike Aguiar - CEO

Tyler Van Buren - Cowen and Company Stephen Willey - Stifel Nicolaus

Thanks Eric. In summary we had a very positive first quarter of 2016 with increased prescription volumes, higher market share, and continued optimization of commercial efforts for both products. As a result, we remain optimistic about the long term potential of our product portfolio. Our primary focus in 2016 remains the optimization of the commercial success in global roll-out of BREO and ANORO, and believe that both products have significant untapped commercial potential. There are many exciting developments happening here and we remain optimistic about the future prospects of the company. I’d now like to turn the call over to the conference facilitator and open the call for questions.

[Operator Instructions] And our first question comes from Tyler Van Buren with Cowen and Company. Your line is open.

So over the last few months prescription growth for BREO has been great, and you spoke a little bit about some of the growth drivers. But as we think about the sustainability of the growth of prescriptions moving through the end of the year and moving forward, can you just touch upon a little bit more on some of the growth drivers such as DTC, the asthma indication, new-to-brand prescriptions, when will the new-to-brand prescriptions convert and, for example, its clearly the winter should we expect some decline in growth from the fact that we will keep moving in to the warmer months. Just curious to hear your thoughts out there, may be a little more granularity. And the secondly on ANORO, maybe just an update on the competition that you’re seeing. Obviously Stiolto was out there and potentially we’ll see some other competitors. So curious to get your thoughts there, thank you.

To the first of your question, I think we are feeling pretty good today about BREO and trajectory of the scripts. As you take a look at the underlying demand which is really our primary focus as opposed to the actual revenue dollars each quarter, we had a pretty strong quarter. As I think I mentioned earlier, we are up 37% in terms of TRx script growth from this quarter looking back to Q4. So the underlying trends are very solid. We’ve been picking up market share at a rate about 2% to 2.5% depending upon your starting day here, Q4 say then to Q1 and so we continue to see nice things across there. We mentioned some of the big growth factors that are happening there. One very big important point I mentioned in this last quarter and I will highlight again is quite a bit of improvement happening in GSKs US sales and marketing operations. That group is really performing well and I think that is a big piece of what’s happening. In addition to that, of course DTC started here in Q4. As you know DTC takes several months to really come up to speed and so we’re just starting to see the full impact of that now, and we expect that to continue to deliver here going forward. Asthma was launched less than a year ago, so I would asthma very much in to the early stages of launch. There also is sort of a treatment paradigm that a lot of doctors follow which is by getting comfortable on asthma they get comfortable on COPD, so it’s certainly possible that we could see some halo effect from that. Additionally recently, there was an approval for the open triple. So this is a combination of BREO on top of Incruse. That is a detail that GSK is doing now and again we would expect to see additional growth from that. So overall the fundamentals of the market look pretty good. The execution of the sales and marketing teams is really kicking in to gear here, and I would add on top that at the steering committee level at the leadership level the relationship with GSK, the teams have been quite productive and it really implemented a number of important changes in a variety of areas. So we look forward here with a fair degree of confidence. Finally you’d asked about the conversion of our new-to-brand scripts in to TRx. This is a very important metric for us. If you look historically you’re going to see to-date that the NBRx market share, the new-to-brand market share is converting in to TRx market share in the 6 to 12 months timeframe. Today the NBRx is more than doubled where we are with TRx, and so again one would assume if history repeats itself that implies a significant amount of growth looking forward. And then potentially even a little farther looking forward metric is where you look at the market share for NBRx with pulmonologist, which is again significantly higher the new-to-brand in general, and so all of our indicators here suggest that we have quite a bit of runway left in front of us here. I think the final piece I would add patient feedback on BREO and the device has been very, very good. Andrew Witty noted in our last call, we hear very, very good things about the patient experience with medicine. So overall I think we feel very good. Second part of your question was with regard to ANORO with Stiolto. The message I have around ANORO Stiolto I think is very similar to what I have mentioned the last couple of quarters. This has been much more of a physician education oriented effort I think it’s probably than we had anticipated off of the start. The standard treatment paradigm frequently for many doctors is to start on a single agent LAMA and education is pretty important to help them understand the benefit of going from the idea of starting out LAMA to starting with a LAMA/LABA. So that has been probably a little slow than I had initially anticipated. If you look at the relative market shares of Stiolto and ANORO, looking at the date from launch, you’re going to see very similar trajectories. ANORO on weeks from launch curve,, looks slightly higher than Stiolto, but I would say they are both fairly similar overall. So this is probably going to be a little bit longer term effort in terms of building that brand perhaps than I had initially thought, given some of the characteristics of the product. So I would call that more of a focused on physician education, particularly focused on primary care doctors. So more work to do on ANORO, probably more confidence on BREO, in summary.

[Operator Instructions] our next question comes from Stephen Willey with Stifel. Your line is open.

Just a quick question, I know Glaxo is also talking about some pretty encouraging metrics for Incruse, and I know Mike you talked about the patient experience with ELLIPTA and increase there on the market now for a couple of years now. So just kind of wondering if you guys have any insight or any kind of metrics that would allow you to may be understand the progression of patients from a single agent LAMA on to a combination product, and whether or not the experience that a patient is gaining with ELLIPTA while on Incruse, subsequently leads to a stickiness that ensures that you’re going to get that patient on to either BREO or ANORO post progression.

I don’t have a great metric for you on that one that is not a piece of information that we have. As you probably recall Incruse is GSK’s product and so we have less visibility in to what’s happening there. I will say that I am and have been a longtime supporter of Incruse, because one of the frequent pieces of feedback that you would hear doing market research on patients who were taking Spiriva, which is the single agent LAMA from BILLION was that even though many patients were taking it primarily due to a shortness of breath, many of them were still feeling shortness breath, that was one of the primary complaints on that. And so it’s not unexpected that patients on single agent LAMA’s would progress in the therapeutic needs and a very logical next step for patient going from a single agent LAMA would be to go to ANORO. We have a combination LAMA LABA medicine which is going provide statistically superior broncho-dilation. And if the patient is already comfortable and familiar with the ELLIPTA device, and likes the ELLIPTA device, and as I mentioned all of the feedback I have seen on that has been very positive. The next logical step would be to maintain the same device and go ahead and step up to ANORO there. So we have always assumed that that would be beneficial in terms of long term growth prospects for ANORO. And it could potentially facilitate the further uptake of BREO as well as I mentioned with the open triple that is again adding BREO on top of Incruse, and so as that promotional effort continues to get additional exposure and doctor education, we think that that could drive additional sales out of BREO as well. So I wish I could give you some really hard metrics, those are not something I have a lot of visibility towards. But we have always looked at Incruse as facilitating the uptake of our products here and it’s something that would be very important overall portfolio.

Understood, and then maybe just a question on the closed triple. I know that there is going to be some lung function data I think made available later this year. But a question on exacerbation study that’s ongoing and just wondering if you guys have any kind of insight on the regulatory side as to what needs to be demonstrated in the impact study specifically if they need to show an exacerbation benefit against both BREO and ANORO to be considered for regulatory purposes. Thanks.

As you probably know there are two studies out there, there’s a lung function which we’ll be reading out this year, the primary focus of that is now SEB1. Our best understanding of the regulatory requirements is that that potentially will be sufficient outside the US potentially. Inside the US the guidance that we’ve been operating under is that an exacerbation study was required and so that would be adding an impact to that impact right now its current anticipated to finish up late next year. So the best possible expectation I would said, would be what we’ve heard from the FDA, which is we need both of those studies whether that ultimately proves to be sure or not, we’ll wait have to wait and see. But I operate under the assumption that historically the respiratory division has been pretty predictable in terms of what they were looking for. So the impact study that we have designed is to compare the closed triple versus BREO and versus ANORO. The study is powered, so there’s roughly twice as many patients on BREO as there are on ANORO and that was to account for the expectation that the addition to the steroid would probably provide a little additional exacerbation coverage relative to medicines that do not have a steroid. And if you were just to go back and look at the guidance of multiple therapeutic classes, you’re going to see that you would need to show superiority on both arms. So that would be successful study if you showed exacerbation benefit on both of the arms. Whether that ultimately is required or not is hard to say, we’d say the expectation is that you would need to show superiority and an exacerbation benefit versus BREO and versus ANORO is our going in expectation on that. So we’ll have to see how that all shakes out. I think there is some additional data that came in subsequent to starting this study, which potentially adds some additional wrinkle to it which is the result of the FLAME study run by Novartis, where they showed that LAMA LABAs have a pretty significant impact on exacerbation and as a result it is possible that the closed triple versus ANORO on could be a little tougher, comparison that we had initially anticipated. But we’ll have to wait and see what that data looks like.

Okay. So I think in the FLAME study too there was quite a bit of background ICS you selling the LAMA LABA arm is that correct?

Yeah, I don’t remember the exact numbers. You are right, but again I don’t recall the numbers actually.