Earnings Labs

Innoviva, Inc. (INVA)

Q4 2015 Earnings Call· Thu, Feb 4, 2016

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Transcript

Operator

Operator

Ladies and gentlemen, good afternoon. At this time, I’d like to welcome everyone to the Innoviva Fourth Quarter 2015 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. Eric d’Esparbes: 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 fourth quarter financial results for 2015. A copy of the press release can be found on our website. Before we get started, we’d 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, to be filed with the Securities and Exchange Commission. Additionally, adjusted EBITDA, a non-GAAP financial measure, will be discussed on this conference call. 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?

Michael Aguiar

Analyst

Thank you, Eric, and good afternoon everybody. Innoviva had a strong fourth quarter of 2015, and I’m pleased to announce that we generated quarterly net income of $4.3 million, our first quarterly profit since inception. When we designed the spinoff of our research and development activities in 2014, our goal was that Innoviva would have a short path to profitability, due to its lower cost profile and high revenue growth prospects. I’m pleased that we have now met this goal. This achievement was largely due to the successful work of the team in building BREO and ANORO towards becoming leading global respiratory franchises. Revenues and market share continued to expand for both products in the fourth quarter, highlighted by the performance of BREO, which has sales growth of more than 79% in the US market, and 43% in non-US markets compared to the third quarter. Fourth quarter income from operations more than doubled to $17.3 million, compared with $8.4 million in the third quarter, due to higher revenues and below guidance operating expenses. As a result, we remain confident in our overall financial trajectory, capital return plan and business model. As you know, in October, we announced a $150 million share repurchase program that extends through the end of 2016. As of January 29, we have repurchased a total of $37.3 million of stock, including shares repurchased in the tender offer completed in December. I will now turn to our program updates. RELVAR/BREO is our lead respiratory program, partnering with GSK for the treatment of patients with asthma and chronic obstructive pulmonary disease, or COPD. It’s a combination inhaled respiratory medicine, consisting of Vilanteral, a long-acting beta2-agonist, or LABA, and Fluticasone Furoate, an inhaled corticosteroid, or ICS, both of which are delivered in the ELLIPTA dry powder inhaler. Total net…

Michael Aguiar

Analyst

Thank you, Eric. In summary, we had a very solid fourth quarter of 2015, with increased prescription volumes, higher market share and continued optimization of the commercial efforts for both products. As a result, we remain optimistic about the long-term potential of our product portfolio, which supports our capital return plan. Our primary focus remains the optimization of the commercial success and global rollout of BREO and ANORO. There are many exciting developments happening here at Innoviva and we remain optimistic about the future prospects for the company. I’d now like to turn the call over to the conference facilitator and open the call for questions.

Operator

Operator

[Operator Instructions] We have our first question from the line of Stephen Willey with Stifel.

Stephen Willey

Analyst

Was just wondering, I think if you look at the IMS data that we have, just trying to extrapolate. I think the data relative to what was announced today, it looks like there is a meaningful improvement in gross to net. And I’m not sure if Glaxo discussed this at all on their call today, but just wondering, Mike, if you could provide some color around this and maybe how that relates to the level of couponing that might be going on right now?

Michael Aguiar

Analyst

We were very pleased with the results of the quarter and we’ve been looking forward to having positive net income for a while. So it was a great quarter. Regarding the question of sales, scripts and all of that, this is clearly something I think that is going to be an ongoing situation where you tend to have a fair amount of volatility in this. And if you go back and take a look at quarter-over-quarter, generally there is a disconnect either on the positive side or the negative side between scripts and sales. And that is really resulting from a variety of different factors. You have sales mix, things like that. You have inventory changes that happen at wholesalers, you have couponing, and depending on how that goes, what the impact from growth to net is, et cetera. So there have been, and will continue to be, I would say, fluctuations in the script growth versus the sales growth going forward. So my strong guess would be going forward that will continue to be the norm rather than the exception. Now, regarding this quarter in particular, GSK did advise us that there was some additional – some true-ups that were happening relative to returns and rebates accruals and that was from prior periods. So there was a piece of that that was happening here this quarter in addition to other items. And I thought I saw some mention of this in the GSK’s transcript as well. But again, I would just say, on a going forward, I think script is a pretty good proxy long-term for where we are going. But don’t be surprised if you do see a level of fluctuation that happens on a quarter-over-quarter basis.

Stephen Willey

Analyst

And then maybe just lastly, with liquidity tightening across all of biotech, I’m just wondering if that’s resulted in – or if you expect that result to result in more optionality on maybe some of these royalty assets that are being made available? And second to that, how competitive do you feel the company is right now in that bidding process and maybe what you might be doing to try to further enhance that competitiveness?

Michael Aguiar

Analyst

On that front, I think we’ve mentioned before there is a hierarchy of our priorities here, with number one being ensuring that our existing portfolio reaches maximum potential. And that’s really the operation of the joint steering committee working with GSK. And I think we’re pleased with where we’ve come so far. Obviously, there is always more work to do on that one, but that’s clearly number one. Number two is focusing on managing our cost of capital down and that’s an area that we are definitely continuing to look at in a variety of areas. On the last piece, which is what you were referring to, in terms of new opportunities, I think it is highly dependent upon what type of opportunities you’re looking at. We have certainly seen opportunities that are, I guess I will call them fully competed, if you will. And those are things we haven’t put a lot of effort into. And there are other places where there is less competition. So again, as our third of our three priorities, I think we continue to believe there are places that we could do something. But I would really want to reemphasize the final piece, which is it’s our third of our three priorities and we are going to continue to be very fiscally thoughtful on this should we come up against an idea that warrants our attention. But again, there are definitely things that are fully competed today.

Operator

Operator

Our next question comes from the line of Ronny Gal with Bernstein.

Ronny Gal

Analyst · Bernstein.

Actually, I’ve got three questions. The first one is, the international lower numbers that you have for sales, especially for BREO, is this just a lower trend line? Should this rebound just like some of the US numbers might be a bit stronger than average? This quarter, is there an offsetting numbers on the international sales side or should we think about this is the case? Second, do you have any concrete data points that suggest to you that Salford trial, positive results from Salford trial will actually lead to better coverage? I’m thinking specifically about Europe where some of this data might be useful. The UK, do you have any indication that actually will make a difference for them? And then third, just broadening the point around other priorities beyond BREO and ANORO, 2016 looks like a quiet year for you guys in terms of risk simply because generics for ADVAIR are not there yet. If you have to think about things you have to get done before you see ADVAIR generic, are there anything that you basically sit there and go this would be a lot harder to do, come mid-2017 or early 2018 or essentially you are in no rush at this point?

Michael Aguiar

Analyst · Bernstein.

With regard to international, international continues to grow. Obviously, it’s a little bit lower rate here recently than what you were seeing in the US. My guess is a big portion of that is some of those things that I talked with Steve about where you do have some level of variability in the gross to net that you see if you were just literally taking sales and dividing it by scripts. And so I think there is a piece that’s just that fluctuation. But we had in the 40% plus quarter-over-quarter growth for BREO internationally, so I’m certainly okay with that. If you follow that trend out that will result in good things happening. The second question around Salford, Salford is an important study for us. Do I have direct evidence that if we have a successful study, we will absolutely get coverage? No. That being said, I think this is one of the fundamental potential differentiators that we have out there. If it turns out that we are able to show once-a-day dosing is better in certain aspects, for example, in compliance and exacerbations and hospitalizations, things like that, all of which will be looked at in this study, I do think that could provide some pretty compelling evidence. For example, if you remember the TOY study that we’ve had in our investor deck for a while, they were looking at the various dosing regimens and they had a conclusion in there that going from twice-a-day dosing to once-a-day dosing was a net savings to the healthcare system of approximately $300,000 per thousand patient years. And that was net of hospital costs and everything else. And given that the cost focuses going on not only in Europe, but increasingly so in the US, I think our view is…

Operator

Operator

It appears we have no further questions on the phone. I’d now like to turn the conference back to Mr. d’Esparbes. Please go ahead, sir. Eric d’Esparbes: Thank you very much, operator, and thanks everyone for participating and have a great day. Thank you.

Operator

Operator

Ladies and gentlemen, this does conclude today’s conference. We thank you for your participation. You may now disconnect.