Rick Winningham - Chairman & CEO
Theravance, Inc. (THRX) 2013 Citi Global Healthcare Conference Call February 27, 2013 3:00 PM ET
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 and 12 months ending September 2012 it was approximately $20 billion market segment. If you look at long-acting bronchodilators over this period of 2009 to 2012 has increased at a rate of about 8.8%, so a significant market for long-acting bronchodilators. That includes not only beta agonist, but also long-acting muscarinic antagonist namely tiotropium.
What is driving the growth? Well, the driver of the growth primarily up to this point-in-time, but specifically for 2011 to 2021, we expect to be Chronic Obstructive Pulmonary Disease. Patient growth is expected to be about 2.5% in COPD; asthma relatively flat at about four-tenths of percent. But these are very large existing markets and as I mentioned are expected to grow over the next decade.
So if we step back for a moment and we look at what are the key things in asthma and COPD and we focus on the information that was presented at the European Respiratory Society Meeting in 2012, I think we took away three key things. One of them was the importance of managing exacerbation. Importantly, data presented there in COPD patients said that an exacerbation actually changes the rate in pulmonary function decline.
When patients have a COPD exacerbation, they experience an acute decline in their lung function. It rebound somewhat of that trough, but never reaches a previous level of lung function and then declines from there. That’s important, because that is paramount, preventing exacerbation, a paramount objective of therapy.
There is an increasing important of long-acting muscarinic antagonist containing therapies in COPD and in COPD data they are presented that the value of combining a long-acting beta agonist as well as with the long-acting muscarinic antagonist for improving bronchodilation.
And finally the third take-away was the emerging importance of triple therapy. Overall, patients with dual mechanisms in COPD demonstrated greater FEV1 improvements in single agents, so that deals with the two product combination.
And then importantly the addition of a long-acting muscarinic antagonist to the LABA/ICS combination was shown to reduce exacerbation in asthmatics. There was data presented at ERS, there was also additional data presented at an allergy meeting last week where the addition of LABA, two LABA/ICS therapy reduced exacerbation rates in asthmatics. This is critically important because if you look at the evolution of care in COPD or in asthma, we believe the evolution of care is likely to go towards triple mechanism therapy.
And Theravance with our partner GSK is in a strong strategic position with our respiratory portfolio. If you look at single-agent compounds vilanterol, the long-acting beta agonist contained in the LABA/ICS combination of RELVAR or BREO and single agent TD-4208 which we are developing on our own in COPD as a nebulized product for those COPD patients who mechanically are unable to use a dry powder or a meter dose inhaler.
Moving from single-agent to dual mechanism, we have a product RELVAR outside the United States, same product BREO inside in the United States for the treatment of both COPD and asthma. ANORO the product that we are developing LAMA/LABA once a day product, developed and filed in the United States and Europe in COPD. And finally, MABA a by functional program of muscarinic antagonist the beta agonist, both activities in the same molecular structure that provides significant bronchodilation as demonstrated in the presentation at the European Respiratory Society Meeting back in September. So three products featuring dual mechanisms either by combining two mechanisms in a single inhaler or by a bi-functional molecule is in MABA.
Finally, triple mechanism where we think overtime the respiratory market is likely to go; we have two potential shops on triple mechanism therapy. One of them being the functional compound combined with an inhaled corticosteroid. That product is entering Phase 3 enabling studies this year and UMEC/VI and FF as listed on the slide. Umeclidinium is a once a day long-acting muscarinic antagonist and ANORO/VI is the beta agonist and ANORO as well as RELVAR, BREO and FF is the once a day inhaled corticosteroid in the RELVAR, BREO product. Those three products combine into a single device to deliver triple mechanism therapy to patients with COPD and potentially asthma in the future. The UMEC/VI, FF product is in Phase 1 clinical trials now checking out the ability of the device to deliver those three products to patients.
So if we look at our investigational medicines that we have in partnership with GSK, another benefit of those medicines is that they are all in the same device, the ELLIPTA device. So you look at the LAMA/LABA product or ANORO, the RELVAR BREO product, which is the LABA/ICS or the potential triple umeclidinium, UMEC with any of VI and FF, all can be delivered via the ELLIPTA device. This is very important to patients because particularly in COPD where there is a progression of disease over time as patients move from one therapy to another on this platform they will not have to be retrained in different devices.
They will be able to use and learn how to use one single device and this is a very simple device to use and then as they move from therapy-to-therapy they will continue to be able to use this particular device. So, one common dry powder inhaler for these all of these investigational medicines that we believe with GSK is a strategic strength of the respiratory portfolio.
Now, I'll begin to talk about the individual products. RELVAR BREO or FF VI partnered with GSK is a once daily again inhaled corticosteroid long acting beta agonists for the treatment of COPD and asthma. We have this significant global need. I've already outlined the global need in earlier slides.
Regulatory applications have been submitted for this product COPD at a dose of 100 of the steroid 25 micrograms of vilanterol, submitted in COPD for the US, Europe and Japan. We have an FDA advisory committee coming up on March 7 next week and we have a PDUFA goal date in May.
The asthma program for RELVAR BREO we have submitted the asthma application in both the European Union as well as Japan. We have an ongoing 900 patient asthma study that should be complete before the end of the year and GSK and Theravance are reviewing the future filing strategy for asthma given the significant opportunity that we believe they are for once a day in LABA ICS in improving the treatment of asthmatics.
Moving from RELVAR BREO to ANORO, once daily LAMA/LABA bronchodilator for COPD. This is umeclidinium, the LAMA and vilanterol, the long-acting beta agonist, the same long-acting beta agonist that's contained in RELVAR BREO. Again, significant unmet medical need within the COPD market.
If you look at marketing research of patients on Spiriva, the single biggest complaint that they have is I'm still breathless, I'm still short of breath. So obviously there, even though Spiriva is a very successful product and a very good product, there's an additional need by most patients of being able to breathe better and that's where the value of the LAMA/LABA comes in.
We have regulatory applications submitted in both the US and the EU and we anticipate that we will be submitting additional regulatory applications during the course of 2013.
I'll now move from RELVAR BREO and ANORO into MABA and the potential for Triple Mechanism Therapy. MABA or sometimes referred to as ‘081 is a muscarinic antagonist or Beta2 Antagonist discovered by Theravance that again has both of those activities in a single molecular structure.
Data was presented at the European Respiratory Society meeting and you can find that data on the Theravance website and an 8-K that we filed at that time. Late last year in December, we made a decision with GSK to advance ‘081 monotherapy into Phase 3 this year an important milestone for the program.
MABA monotherapy enables a Triple Mechanism Therapy which would be bronchodilator therapy plus anti-inflammatory. We have two shots, our potential shots on gold there. One of them is the MABA ICS combination. The combination of MABA with fluticasone furoate.
As I said earlier, we made a decision to advance that combination into Phase 3 enabling study this year and we have the second shot on Triple Mechanism Therapy, which is the ANORO product combined with FF and that product is in a Phase 1 safety study as we speak. Triple Mechanism Therapy and the MABA monotherapy both exciting products for the future for Theravance and for GSK.
So if you look at our events that we have this year, for RELVAR and BREO, as everyone in this room knows, we have an upcoming advisory committee next week. We have a PDUFA goal date in May and we have the potential action from the European Medicines Agency on RELVAR potential action date later this year.
In ANORO, there will be a submission of further regulatory filings around the world for ANORO. We got an FDA PDUFA goal date in December and the potential for EMA action on ANORO in 2014.
Turning to MABA, the earliest program in terms of (inaudible) and development, ‘081 monotherapy, again advertising in to Phase 3 and ‘081 FF being progressed into Phase 3 enabling studies very shortly. So 2013 for Theravance is a very exciting year with regard to the development of our respiratory portfolio.
Now I'll talk for a moment about our global partnership, really highlighted by our GSK respiratory collaboration. If you look at our GSK respiratory partnership, there is really informed by two agreements, one in 2002 and one in 2004. The LABA collaboration which governs the RELVAR BREO product as well as ANORO is quite significant in terms of the potential economic impact on Theravance.
For sales on RELVAR BREO, up to $3 billion, we earn 15% royalty rate and 5% annually thereafter. For product as ANORO, such that assuming its launch after RELVAR BREO which is our current expectation, we get opportunities royalties starting at 6.5% and pairing up to 10%.
Now we will potentially own GSK $220 million in milestones if the RELVAR product and RELVAR BREO as well as ANORO are approved around the world. This is $220 million is divided in the more than 10 in payments; it's divided by approval by launch by region and product. So it is not a single check but a number of different payments.
So that’s the LABA collaboration, now turning to the strategic alliance that’s really governs the MABA program. In that program, we have the opportunity to receive millstone the $10 million milestone for a successful Phase 2 combination study and then $25 million, a milestone for initiation of MABA monotherapy Phase 3 study as well as hopefully, eventually the MABA ICS Phase 3 study.
The royalties on this program are attractive to us that begin at 10% and peak to 20% on sales are up to $3.5 billion and sales greater than $3.5 billion or 7.5%. That’s single agent royalties to calculate the combination royalties that you find in MABA ICS product you just take the single agent royalties multiplied by 70% that would be the royalties on the combination product.
Importantly, Theravance has no R&D cost, no commercial cost obligations on these programs. This is GSK’s, these are GSK’s responsibility. So with additional pipeline partnerships that we entered into in 2012, we entered into a partnership with Merck in cardiovascular disease in heart failure and hypertension. This particular program has a significant opportunity for Theravance and I am hopeful that it can evolve to a state where is every bit is important as the GSK collaboration. We have collaboration with Alfa Wassermann, a European company in the development of our product for gastroparesis that is in the Phase 2 study currently ongoing and we have a partnership with Russian pharmaceutical company on bacterial infection.
The total funding of Theravance was received from all partnerships and since our inception has been over $830 million. I will now move from our global partnerships into our deep pipeline and talk about a just couple other programs that we have in the pipeline. This is the pipeline sheet, so I am not going to go through the lines individually, but you see where respiratory bacterial infections, central nervous system as well as GI motility dysfunction.
I will highlight for a moment TD-1211, a drug for opioid induced constipation, we see this market is quite significant and particularly in the United States where opioids are used to control chronic pain. There is a significant unmet medical need and levitation account of what levitating constipating side effects of opioid therapy but without affecting the analgesia.
We got positive Phase 2B results. We have achieved primary and secondary endpoints in our Phase 2B study. Our product was relatively low tolerated, and the Phase 2B programs support progression of this product into Phase 3. We are currently evaluating the Phase 3 strategy and working with FDA to develop a Phase 3 study that meets their evolving requirement.
Just the highlight the effectiveness of the product what you see here on the bars is the weekly average complete spontaneous down movement is measured by placebo, 1211 at 5 milligrams, 10 milligrams and 15 milligrams, statistically significant highly at both 10 and 15 milligrams and really in fact returning these patients to normal bowl function and quite exciting data. This is one of those rare clinical programs that when you close the study patients are calling the study sites back to find out whether they can continue on therapy. The product was relatively well tolerated overall adverse events in the three dosing groups were similar to placebo, GI disorders relatively similar to placebo, the primary GI adverse event was abdominal pain occurring at about 11% and placebo patients is 13% in patients on TD-1211.
Now turning to another product in the CNS pain category, TD-9855 for ADHD and fibromyalgia. This is a dual norepinephrine and serotonin reuptake inhibitor more heavily weighted towards the serotonin, towards the norepinephrine reuptake and the serotonin reuptake. In the Phase 1 study this is generally well tolerated. It has predictable linear pharmacokinetic, it has a very long half-life supported by once daily dosing and the support for once daily dosing also would cover a patient if in fact they miss the dose in a given day without dramatically affecting levels of serotonin or norepinephrine which we see as a potential benefit of the product.
We've run a pep study. We confirmed a high degree of CNS penetration and selectivity for both norepinephrine and serotonin but with selectivity with norepinephrine over serotonin transporter. We are currently in a Phase 2 program with this product in ADHD and another program in fibromyalgia targeting a total of 650 patients. We should finish one of those studies this year and should finish the other study either late this year or early next year.
We are in a very strong financial position at Theravance. We ended the year last year with $344 million in cash. In January, we did an additional convertible debt instrument raising debt of about $245 million in cash. We have projected 2013 expenses of somewhere between $125 million and $135 million of R&D and SG&A. That excludes stock based compensation expenses and excludes the potential milestone payments to GSK, which we estimate we could be making $140 million in milestone payments for GSK potentially in the next 12 months.
As I noted we’ve got access to significant development funding and the GSK pays all development costs for the RELVAR BREO program, the ANORO program and the MABA program, VI monotherapy and what we called the closed triple which is UMEC/VI and FF. We've got potential model milestone payments coming in from GSK this year with a progression of MABA monotherapy into Phase 3.
So success in 2013 should lead to a period of transformative growth for the company. Currently we've got one approved product which has an antibiotic VIBATIV approved for complicated skin, skin structure infections in the US, hospital acquired pneumonia in Europe. We look forward to resolving the nosocomial pneumonia indications as well as products supply with VIBATIV in the middle of the year, but hopefully we are going to do as we move in from one approved product to multiple approved products in the GSK respiratory collaboration.
Our partnership revenue from development milestones that's where it come from historically moving to significant revenue growth from royalties on major products and the respiratory area. Our pipeline focus has primarily been on late stage respiratory program and over the past couple of weeks; the pipeline focus I would say is almost solely on the upcoming BREO advisory committee. But that will be moving with success to the pipeline focused on respiratory Triple Therapy as well as our late-stage CNS and pain programs. So success in 2013 will transform and leave the company to a period of significant growth.
So with that, I will close out my presentation and open it up for questions. Thank you very much for your attention. Questions?
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?
Yes, BREO is anticipated to be the brand name inside the US with RELVAR being the brand name outside the US.
I must have missed it. I didn’t get a date for the PDUFA.
It's May the 12.
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?
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.
And didn’t the FDA require another Phase 3 trial for the BREO?
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.
Is that similar to the Advair 100/50 and the 250/50 in terms of strength?
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.
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?
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.
Are you on the same track in Europe and EU for approval?
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.
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.
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.
And just to go back to my question, for the parameters serious adverse cardiovascular event, all the aggregate datasets was there any numerical imbalance?
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.
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?
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.
In the studies with Vilanterol, I presume that has much less toxicity than Salmeterol as LABA?
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.
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?
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.
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