Innoviva Inc. (NASDAQ:INVA)
Q1 2016 Earnings Conference Call
April 28, 2016 05:00 PM ET
Eric d’Esparbes - CFO
Mike Aguiar - CEO
Tyler Van Buren - Cowen and Company
Stephen Willey - Stifel Nicolaus
Ladies and gentlemen, good afternoon. At this time, I’d like to welcome everyone to the Innoviva First Quarter 2016 Financial Results Webcast and Conference Call. [Operator Instructions] Today’s conference call is being recorded.
And now, I’d like to turn the call over to Eric d’Esparbes, Chief Financial Officer of Innoviva. Please go ahead, sir.
Good afternoon everyone and thank you for joining us. With me on the call today is Mike Aguiar, our Chief Executive Officer. On today’s call, Mike will review the highlights from the quarter, and I will review our financial results. Following our comments, we will open up the call for questions. Earlier today, Innoviva issued a press release announcing recent corporate developments and first quarter financial results. A copy of the press release can be found on our website.
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 Innoviva. Forward-looking statements include anticipated results, and other statements regarding Innoviva’s goals, plans, objectives, expectations, strategies and beliefs. These statements are based upon information available to the company today, and Innoviva assumes no obligations 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 press release and Form 10-K for the year ended December 31, 2015, which on file with the Securities and Exchange Commission and Form 10-Q for the quarter ended March 31, 2016 to be filed with the Securities and Exchange Commission.
Additionally, adjusted EBITDA and adjusted cash EPS, two non-GAAP financial measures will be discussed on this conference call. A reconciliation to the most directly comparable GAAP financial measure can also be found in our press release.
I would now like to turn the call over to Mike Aguiar, our Chief Executive Officer. Mike?
Thank you Eric and good afternoon everybody. Q1 2016 was another strong quarter for Innoviva, which included share and volume gains for products, positive earnings and cash flow and a continuation of our share repurchase program. In particular, we are pleased with the performance of both BREO and ANORO in the US where prescriptions and market share reached all-time highs.
According to IMS, BREO TRx market share is almost 9% and ANORO was approximately 7%. During the first quarter of the year, we saw an acceleration in BREO’s market share growth, as the brand gained over 2 percentage points of TRx. These market share gains are largely due to improved collaboration productivity and to a successful work of the commercial team in building BREO and ANORO towards becoming leading global respiratory franchises.
As discussed during our February results call, we expect to see quarter-over-quarter volatility in reported sales compared to the underlying TRx performance on an ongoing basis. This volatility is related to a number non-demand factors such as changes is wholesaler inventory levels, customer mix, accounting reserve true-ups, couponing levels etcetera.
For example, during Q4 2015 this volatility produced a positive effect on revenue, with reported net sales outpacing prescription volume growth; following Q1 prescription volume growth outpaced reported revenue growth. As a result, we believe metrics have focused on underlying demand such as TRx and NBRx prescriptions and changed the market share our important analytical to consider in addition to quarterly revenues when assessing our progress of our medicines.
I’ll now turn to our program and updates. RELVAR BREO our lead respiratory program partnered with GSK for the treatment of patients from asthma and Chronic Obstructive Pulmonary Disease or COPD. It is a combination inhaled respiratory medicine consisting of vilanterol a Long-acting BETA-2 agonist or LABA and fluticasone furoate inhaled corticosteroid or ICS both delivered in the ELLIPTA dry-powder inhaler.
First quarter 2016 net sales for RELVAR BREO were $161.9 million, up from 59.9 million in the first quarter of 2015 and from 154.7 million during Q4 2015. According to GSK, this increase was driven by higher product volumes and market share, offset by seasonal channel inventory fluctuations.
Additionally during our February call, we noted that Q4 2015 revenues were favorably impacted by an accounting true-up booked by GSK that would not recur during Q1 2016. According to IMS, TRx prescription volumes in the US increased significantly during Q1 compared to the fourth quarter of 2015, up approximately 37% quarter-over-quarter. We believe this growth was primarily driven by further improvements in the US sales and marketing activities, the approval of the asthma indication earlier in 2015, and the continuation of the BREO asthma DTC campaign.
Since the US asthma launch in May 2015, IMS reports that BREO TRx and new-to-brand growth has outperformed the LABA ICS market in average compound weekly growth by approximately 2.4% and 2.1% respectively through the end of Q1. We also remain confident in the growth potential for BREO due to continued strength in new-to-brand prescription performance.
For example, according to IMS in the week ending April 15, new-to-brand market share increased to 14.8% overall and to 27.1% for pulmonologists. As we have previously mentioned, we believe that new-to-brand market share is an important forward looking indicator as the potential growth trajectory of these products. As a result we believe, BREO is well positioned for a solid year in 2016.
Our second program ANORO is a combination dual bronchodilator medicine for the treatment of COPD consisting of the LABA vilanterol and the long-acting muscarinic antagonist or LAMA umeclidinium. Total net sales for ANORO during the first quarter of 2016 were approximately $48.1 million compared to 17.7 million in the first quarter of 2015 and to 45.4 million in the fourth quarter.
Sales of ANORO were driven by higher TRx prescription volumes of approximately 23% in the US market, offset by seasonal reductions in distribution channel inventories compared to the fourth quarter. Overall, we remain optimistic about the long term potential of both products and look forward to the upcoming clinical study results and the Salford Lung study of RELVAR in COPD.
Finally, on a personal note, last week we made a filing with George Abercrombie, our Senior Vice President and Chief Commercial Officer announced that he was retiring. I am pleased to let you know that we will be updating his filings to reflect that George will remain with Innoviva in its current capacity. I am extremely pleased with this outcome and George and his organization have contributed significantly to the positive improvement in our relationship with GSK.
Now I will turn the call back to Eric to review our first quarter 2016 financial results.
Thanks Mike. We are starting 2016 with a good first quarter in terms of financial performance. Total revenues included 27.4 million in royalties earning, a 171% increase over the first quarter of 2015, offset by 3.2 million of net non-cash amortization expenses and other revenues. Royalty revenues included $24.3 million for BREO and $3.1 million for ANORO. The positive impact of currency movements between the fourth quarter of 2015 and the first quarter of 2016 on our revenues from non-US markets was slightly less than 1% overall.
The long term growth trend in our royalty revenues remained strongly positive in the first quarter. Looking at the prior seven quarters, on average our royalties earned have grown at a compounded rate of approximately 36% which reinforces our confidence in its prospects of the company for 2016.
Total operating expenses in the first quarter of 2016 were $6.6 million, compared to $6.2 million in the first quarter of 2015, representing a slight increase in expenses mostly associated with customary public company activities in the first quarter of the year. On an annual basis, we maintain our guidance level for operating expenses of R&D and G&A cost before stock based compensation accruals in a range of between $18 million and $20 million.
During the first quarter of 2016, we repurchased approximately $25.4 million of government stock at an average price of $10.35 per share. Since the start of the $150 million repurchase program, we’ve now repurchased a total of $50.2 million of stock. We continue to generate positive and growing cash flow from our operations in the first quarter of 2016.
Income from operations increased to $17.5 million, compared to $0.7 million in the first quarter of 2015, and adjusted EBITDA more than tripled to reach 22.9 million compared to $6.2 million in the first quarter of 2015.
Looking forward, we are initiating the reporting of adjusted cash EPS, which we believe provides useful information about a company’s core operating performance and cash returned on investment. For the first quarter of 2016, our adjusted cash EPS was $0.09 per share, up significantly compared to an adjusted cash EPS of negative $0.05 per share in the first quarter of 2015.
Cash, cash equivalents, short term investments and marketable securities totaled a $168.2 million as of March 31, 2016. Additionally, we had 27.4 million of royalty receivables from GSK at the end of the first quarter, which puts us in a strong liquidity position for the remainder of 2016.
And now I’d like to turn the call over to Mike for final closing comments.
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.
Tyler Van Buren
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.
It appears we have no further from the phone. I’d now like to turn the conference back to Mr. d’Esparbes. Please go ahead sir.
Alright, thank you very much operator, and thanks everyone for joining the call. Have a good day.
This does conclude today’s conference call. We thank you for your participation. You may now disconnect.
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