Earnings Labs

Innoviva, Inc. (INVA)

Q2 2013 Earnings Call· Thu, Jul 25, 2013

$23.04

-2.74%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-1.85%

1 Week

+3.03%

1 Month

+1.90%

vs S&P

+3.64%

Transcript

Operator

Operator

Ladies and gentlemen, good afternoon. At this time, I’d like to welcome everyone to the Theravance Conference Call to review result for the quarter ended June 30, 2013. During the presentation, all participants will be in a listen-only mode. A question-and-answer session will follow the company's formal remarks. (Operator Instructions) Today's conference call is being recorded. And 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

Management

Good afternoon, everyone, and thanks for joining us. With me on the call today is, Rick Winningham, our Chief Executive Officer. First, Rick will review highlights of the quarter and then I will review our financial results. Following our comments, we will open up the call for questions. Earlier today Theravance issued a press release detailing second quarter 2013 financial results and recent corporate developments. A copy of the press release can be downloaded from website or you can call Investor Relations at 650-808-4100 and we’ll 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, strategy and beliefs. These statements are based upon the 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’ll now turn the call over to Rick Winningham, our Chief Executive Officer.

Rick Winningham

Chief Executive Officer

Thanks Mike. Good afternoon, everyone. Theravance is off to a strong start 2013 with three regulatory approvals, BREO ELLIPTA for the treatment of COPD in both the U.S. and Canada, and VIBATIV for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia in the United States. In addition, we announced our plan to separate the late stage respiratory assets partnered with GSK from a biopharmaceutical operations to create two independently publicly traded companies and to continue our business in the new structure that’s designed to unlock potential value, facilitate return of capital to shareholders and further our strategy of advancing medicines that address unmet medical needs. Let me begin with the plan separation, we announced in our last quarter’s earnings call with company plans to create two highly focus businesses with the potential increase overall shareholder value. The separation is designed to provide investors with the opportunity to unlock that potential value from two different sets of assets, to facilities return of capital to stockholders and further our strategy as I said earlier of advancing medicines that address significant unmet medical needs. As a reminder one company referred to as Royalty Management Company will continue to manage all development commercialization, responsibilities under the LABA collaboration with GSK and associated potential near-term royalty revenues from RELVAR, ELLIPTA, BREO ELLIPTA, ANORO ELLIPTA and VI monotherapy. Royalty Management Company will focus on returning capital to stockholders. The other company referred to as Theravance Biopharma will focus on discovery, development and commercialization of small molecule medicines and exploiting insights created by our extensive experience at multivalent drug designed. Importantly, partnering will remain a key strategy and we will continue to work on our existing partnered programs. The result will be two independent publicly traded companies with different business model enabling investors to align their investment…

Mike Aguiar

Management

Thank you, Rick. Today I’ll discuss the results of the quarter ended June 30, 2013, and will review guidance for the full year 2013 expense. For the quarter ended June 30, 2013 Theravance has a net loss of $36.4 million or $0.37 per diluted share. Revenues totaled $1.3 million during the second quarter of 2013 comparable with $1.4 million for the same period of 2012. For the first six months of 2013, revenue was $2.7 million, compared with $128.5 million for the same period last year. The decrease in 2013 was primarily due to the termination of our VIBATIV agreement with Astellas last January that resulted in a one-time recognition of $125.8 million of deferred revenue. Total R&D expenses for the second quarter of 2013 were $31.7 million, compared to $29.5 million for the same period last year. This increase was primarily due to higher external R&D cost resulting from ongoing enrollment in our two Phase 2 clinical studies with TD-9855, one in fibromyalgia and one in ADHD, a Phase 2b study of TD-4208 COPD, as well as cost associated with our preclinical and late-stage discovery programs. General and administrative expenses for the second quarter of 2013 were $11.4 million compared to $7.6 million for the same period in 2012. This increase was primarily due to an increase in external legal and accounting fees in connection with the company’s strategic initiatives, as well as an increase in the external costs in connection with commercialization activities related to VIBATIV. Total external expenses included in G&A related to the proposed company separation or $1.8 million for the first three months, excuse me -- for the three months ended on June 20 -- June 30, 2013 and $2.3 million for the six month end June 30, 2013. Cash, cash equivalent and marketable securities…

Rick Winningham

Operator

Thank you, Mike. We just completed a very productive first half of the very important year of the transformation with their events, with approvals for BREO ELLIPTA and COPD in the U.S. and Canada and FDA approval for VIBATIV in hospital-acquired and ventilator-associated bacterial pneumonia as well as announcing the plant separation of Theravance and the two companies. Our focus for the remainder of 2013 will be on the upcoming regulatory events for RELVAR and ANORO, completing the separation of Theravance and the results from our internal pipeline. In summary, I’m pleased with the progress of Theravance and look forward to keeping you posted as our program advance. And now, I’d like to turn the call over to the conference facilitator and open the call for questions.

Operator

Operator

(Operator Instructions) Okay. So now, we’ll have our first question from Steve Byrne of Bank of America. Steve, please go ahead?

Steve Byrne - Bank of America

Analyst · Bank of America. Steve, please go ahead

Hi. Can you talk about what are key gating events that must be resolved before you execute on the separation -- the company’s separation and does it matter to you whether it’s in this calendar year or not, whether ANORO was approved or not. Are those meaningful?

Mike Aguiar

Management

Hey, Steve. It’s Mike. I will talk quickly about the separation but clearly just from an ANORO perspective, we are very focused on December 18 and whole proportion of the approval on that date. So we are clearly aiming at all the corporation activities towards that. That is certainly important. It is not particularly connected to the separations. Separation is proceeding right according to case right now. It has a tremendous amount of work required over here to get this completed. The big gating items really are the SEC and the IRS. We have asked both of those regulatory agencies before we get to the finish line. With regard to the SEC, we are going to be filing the Form 10 shortly and then that process will kick off. And we have made a fair amount of progress with regard to the IRS determining the taxability of the spend and how potentially this could be executed? So sitting here today, I’m feeling pretty good about where we are. I would have slight preference of getting it done this year, if possible. But again, I think I will keep my guidance either late this year or early next year, given that I don’t have a lot of control over the timeline by either the SEC or the IRS.

Steve Byrne - Bank of America

Analyst · Bank of America. Steve, please go ahead

And any comments, Mike on changing the domicile for either entity?

Mike Aguiar

Management

We were clearly looking at that for biopharma. Biopharma again is the entity that’s going to be continued in the vast majority of the current Theravance operation. That is the entity that’s being dividended up. So of the two, this is reminder, the loyalty management company because they are guessing Theravance Corporation and then again Biopharma is the new entity. We have clearly looked at the possibility of re-domiciling this into a different location. I think I have some good initial dealings on this one and potentially we can do this. I would just say, stay tuned if not a complete done deal yet so. We do need to get through some of our IRS discussions but that is clearly a direction we are going and hopefully will be successful and have the right back pattern for the IRS.

Steve Byrne - Bank of America

Analyst · Bank of America. Steve, please go ahead

And one clinical question for you and that is regarding the triples. Do you view a market opportunity for both triples, does it make sense to go ahead with both the triples in the Phase 3? And the closed triple, does that one make sense to wait until after the approval of ANORO is in hand?

Rick Winningham

Operator

This is -- Steve, this is Rick. I think we view the triple therapy as an extraordinarily important component of the treatment of COPD. And by triple therapy, I am talking about a long-acting muscarinic antagonist, long-acting beta agonist and combined with an inhale corticosteroids. That triple therapy -- and that opportunity we view today is in COPD and potentially down the road in asthma, given some of the favorable data that has been presented by Pfizer and Boehringer-Ingelheim adding tiotropium, the current LABA ICS therapies. Now, do the question of do I view both the combinations is valuable absolutely. I think the triple therapy is moving along at a pace that we’ve described before, that being UMEC, VI and FF and MABA ICS has begun Phase 3 labeling preclinical studies. But I view that both programs can deliver value that are separate and distinct to patients and to Theravence and to GSK.

Steve Byrne - Bank of America

Analyst · Bank of America. Steve, please go ahead

Thank you.

Rick Winningham

Operator

Thanks, Steve.

Operator

Operator

Okay. Thank you. And our next question is from Ronny Gal from Sanford Bernstein. So, Ronny, please go ahead.

Ronny Gal - Sanford Bernstein

Analyst · Sanford Bernstein. So, Ronny, please go ahead

Thank you for taking my questions. I have two. First with regarding the MABA, is there a question that the MABA will move forward as a monotherapy or I guess, a dual MABA ICS, or is it I am pretty clear, that it will, the question is just when?

Rick Winningham

Operator

Yeah. I mean, the -- good question, Ronny. The MABA news in terms of not starting the Phase 3 program for MABA therapy in 2013 is very new to us. So we will be discussing this with GSK. On MABA ICS therapy as I said that is Phase 3 enabling non-clinical studies have been initiated, so those are progressing forward.

Ronny Gal - Sanford Bernstein

Analyst · Sanford Bernstein. So, Ronny, please go ahead

So, I hear you about the enabling study, but you know the reason we do studies is to figure out something. But I am guessing is it actually crossing these involving VIs, or is there something about those trials that might derail the program, reasonably derail the program, so the program will never go into Phase 3?

Rick Winningham

Operator

Right. I mean at the end of the day, all studies are complete, you never know, but the -- these are just -- these are standard non-clinical studies that you need to do to go into progress into a Phase 3 program. If you step back for a moment and look at the history here, a lot of the early work MABA with the steroid was done with FP, twice a day steroid. We even have the Phase 2B data come out that was presented at VRS last year clearly indicating that MABA 081 was a once-a-day product and then that catch up work had to begin in combing MABA with FF and that's really what we are talking about with the Phase 3 enabling work right now. So, you know that is ongoing. We will see how those studies go and I look forward to completing them with the level of optimism.

Ronny Gal - Sanford Bernstein

Analyst · Sanford Bernstein. So, Ronny, please go ahead

Great. But is there a couple of late Phase 2b program launched -- when those things finish the Phase 2, you go on to Phase 3 legally where people put them in their models. So I was wondering if you can help us a little bit in terms of understanding how those products differentiate from a previous generation of product. So especially about the SNRI and the MABA nebulizer, why is that the world needs another SNRI, how does that differentiate from the previous 10 or 15 or so that exists. Iam just asking it in a provocative way and equivalent about the MABA, why should somebody use your brand in MABA when you know Glycopyrrolate is just generic or tiotropium will be generic by 2018?

Rick Winningham

Operator

Good one. I will take the LAMA question, 4208 is a long-acting muscarinic antagonist and we are developing it on a nebulizer. Well, I think, number one, there is about 5% to 10% of patients that have COPD that we estimate mechanically, our challenge with using a dry powder inhaler or and MDI device. And those patients prefer a nebulizer and there is some other societal reasons that their preference exists for nebulizer,. I think if -- and right now based on the earlier days that we had from the Phase 2A study, it looks like the curves will support 4208 as a once-a-day product. But that is a very important, that will be a very important finding from the ongoing study as 4208 a once-a-day study because the curves resemble the curves of a Umeclidinium or tiotropium, older the curves represent aclidinium or Glycopyrrolate. And we know when we get the data, which should be relatively soon. And so that's why LAMA and I think the other aspect of LAMA is, is simply LAMA as a platform because if we are fortunate and the drug is a once-a-day drug, it can be -- we believe from a physical perspective, its provides the ability to be not only in a nebulizer but in a dry powder inhaler or a metered-dose inhaler and combined with other products going forward. So, there aren’t many long-acting muscarinic antagonist that are once-a-day that can be combined easily with other products, and if MABA is in fact once a day we believe it will be able to be combined easily with other potential products. And on the NSRI, I have Mathai here with us, so I’ll let Mathai answer that question on differentiation of 9855.

Mathai Mammen

Analyst · a Umeclidinium or tiotropium, older the curves represent aclidinium or Glycopyrrolate

Hi Ronny.

Ronny Gal - Sanford Bernstein

Analyst · a Umeclidinium or tiotropium, older the curves represent aclidinium or Glycopyrrolate

Hi.

Mathai Mammen

Analyst · a Umeclidinium or tiotropium, older the curves represent aclidinium or Glycopyrrolate

This is Mathai speaking. So on 9855, I would say the scene that it would go forward into is one where most compounds that have been attempted in the past and exist in the marketplace are SSRIs, selective serotonin reuptake inhibitors. There is an example in duloxetine, a molecule that carries both serotonin and some norepinephrine, but the profile of that compound is quite different. It’s still heavily serotonin, even though brings in some norepinephrine. Our compound 9855 brings in a great deal of norepinephrine and it’s truly a NSRI as opposed to a SSRI that’s how we’re referring to it now, and that has numerous advantages especially on potentially on executive function level that we think is important in a variety of different indication. So the two trials that are ongoing, one is in ADHD where we feel exactly the profile that I’ve described is useful relative to alternatives that mostly includes stimulants right now using alternatives to stimulants, as well as in various pain conditions and right now we have an ongoing study in fibromyalgia. So the norepinephrine to us is key is critical in fact in pain conditions where pure SSRIs shouldn’t work and in fact in trials don’t work. So we feel that the NSRI is that pharmacological profile is critical. On top of that the molecule itself is attractive, in that we’ve shown that it’s very CNS conditions, it’s completely CNS conditions, which is actually in itself good and unusual, and importantly, it has a very prolonged half-life. We’ve described it as 30 or 40 hours which leads to low peak to trough and very steady levels in the brain, and sometimes the ups and downs of neurotransmitter reuptake inhibitor programs cause problems. So we feel that too is a very attractive feature of this compound apart from its pharmacology.

Ronny Gal - Sanford Bernstein

Analyst · a Umeclidinium or tiotropium, older the curves represent aclidinium or Glycopyrrolate

We have by any chance looked at the rest of the assumption of effect of this drug?

Mathai Mammen

Analyst · a Umeclidinium or tiotropium, older the curves represent aclidinium or Glycopyrrolate

Yeah. So we’ve talked about that little bit internally but it’s not one of our focus points right now. There are other CNS indications either pain conditions, other CNS conditions, including anxiety and depression that I personally would put more immediately behind the two indications or after right now, if we were to pursue anything else.

Ronny Gal - Sanford Bernstein

Analyst · a Umeclidinium or tiotropium, older the curves represent aclidinium or Glycopyrrolate

Great. Thank you very much.

Rick Winningham

Operator

Thanks Ronny.

Operator

Operator

Okay. Thank you. (Operator Instructions) And we’ll take our next question from Kyle Rasbach from Cowen and Company. Kyle, please go ahead.

Kyle Rasbach - Cowen and Company

Analyst · Cowen and Company. Kyle, please go ahead

Great. Thanks for taking the questions. Maybe first if you could give us a little bit more color on what has delayed the BREO launch, what Glaxo relate to you and whether or not you believe we should anticipate similar delays in the EU rollout or whether some of these conditions or some of these reasons have been kind of ironed out and we should have a more smooth rollout in the EU relative to what we’ve seen in the U.S.? And secondly, maybe if you could give us a little bit of color on what Phase 3 data will see for ANORO at ERS and whether or not this is new data or a rehash of existing Phase 3 data? And then maybe lastly a little bit of an update on when we should expect to see the data from the ongoing asthma study here in the United States? Thanks.

Mike Aguiar

Management

Hey Kyle. It’s Mike. So, let me -- I’ll just talk very briefly about ANORO. So there is a little bit of additional Phase 3 data coming up and it’s certainly nothing earth shattering. I’m not going here for example. So, I mean, I would say all of the material data at this point from ANORO is out. So like I said, I wouldn’t expect a lot of new information coming out on that and I’ll let Rick talk a little bit about BREO. I certainly have a trouble using kind of the delay word that much. I think this is really not a big deal at all, but I’ll let Rick talk about that perfect. Rick?

Rick Winningham

Operator

Yeah. I think is you the comments that Andrew Witty made yesterday and Simon Dingemans as I understand. I mean this is we’re talking about a couple of weeks here and we, it’s -- I think we’re just being conservative and it’s slipping out of the third quarter into the beginning of fourth quarter. So we don’t see this as any big deal, is big deal at all. We’ve -- I think everything is lined up very well in the United States to progress with this launch and whether it’s you’re talking about sales force or manage care other elements of the strategy are all lined up quite well and it’s a matter of just getting going and what looks like to now to be in the fourth quarter. So we’re very optimistic and very excited about it because the fourth quarter is just around the corner. And then you had -- did you have one more question, Kyle?

Kyle Rasbach - Cowen and Company

Analyst · Cowen and Company. Kyle, please go ahead

I did have another question. I’m trying to remember myself what exactly.

Rick Winningham

Operator

Oh! The BREO asthma study?

Kyle Rasbach - Cowen and Company

Analyst · Cowen and Company. Kyle, please go ahead

BREO asthma study, correct.

Rick Winningham

Operator

Yeah. So the BREO asthma study right now I think the last patient last visit in clinicaltrials.gov is October. Right now as far as we know that patient, that study is going right along with hitting that goal and a little while after that we should have data available. It’s a large study as you know, 900 plus patients in asthma. It’s an important study for us and that positive. I think we take that data with the rest of the asthma data that’s already been submitted in terms of clinical study reports to support the COPD application take all that data back into the FDA and have a discussion about going forward in asthma.

Kyle Rasbach - Cowen and Company

Analyst · Cowen and Company. Kyle, please go ahead

Great. Thanks.

Mike Aguiar

Management

Thanks Kyle.

Operator

Operator

Thank you. It appears we have no further questions on the phone. I’d now like to turn the conference back to Mr. Winningham. Please go ahead, sir.

Rick Winningham

Operator

Sure. Thanks very much to all the attendees on the phone call. We’re very excited about where we are as a company as we look forward into the second half of the year with product launch, with the potential for ANORO approval and the separation of the company to align, hopefully, assets with different types of investors to drive fat value for shareholders. So thank you for your attention. We look forward to the second half of the year.

Operator

Operator

Yeah. This does conclude today’s conference call. We thank you for your participation. You may now disconnect.