Alkermes Plc. (NASDAQ:ALKS)
Citi Global Healthcare Conference
February 25, 2013; 11:05 a.m. ET
Richard Pops - Chairman & Chief Executive Officer
Jon Eckard (ph) here on Citi’s biotech research team. Welcome to the company presentation for Alkermers and here today we have Richard Pops, Chairman and CEO.
Thank you Jon. Good morning everybody or afternoon, whatever it is. So, we’ll see today about [three of the stories] (ph) on Alkermers. On the PowerPoint presentation is this idea of creating value through two portfolios and to know our company is to gain an understanding of these two portfolios that we’ve been building over the last several years and we’re really excited about where we are right now and where we are going to be going over the next 12 months and beyond.
I will make forward-looking statements and as I always do, I encourage you to read our disclosures in our SEC filing to try and capture the risks of our business.
The simplest way to think about these two portfolios is that one is our commercial portfolio, and that is drugs that are approved by the FDA and regulatory authorities around the world and are generating revenue for us and being sold in the market around the world. This portfolio is remarkable in terms of complexity, the lack of coherence between the various elements and its long patent life.
The other one is the commercial, is the pipeline, the development pipeline, the products in development, and while most of the world is in focus over the last year on our building the commercial portfolio and the news coming from that, almost in the background this pipeline has been maturing and getting more and more exciting and is filled with all kinds of news events in 2013.
So the commercial portfolio is comprised of, right now about over 25, but we ask people to focus on what we call the Big 5. These five products are singular products in their classes really. They are early in their patent life and they are going to drive the growth of our revenue line into the next decade.
The pipeline is also quite rich and is popular with primarily the new drivers, the new chemical entities, no longer simply based on their delivery technologies, but entirely new molecules that are designed to satisfy specific needs that we’ve identified in the market place. It’s a whole theory. This concept is about value. The way we select product is based on the idea of finding a value, both for patients and the families, but also for payers and the whole ecosystem in general.
There are papers on the rocks, as well as our long acting form of identifying currently stage three for the treatment of schizophrenia, 5461. We’ll talk about also the compression, 3831 also for schizophrenia. And then with our commercial pipeline still with us, we also have follow-on product line extensions that will drive those franchises in the future as well.
So these Big 5 in the commercial portfolio are driving a revenue line, a value creation line that we are really, really pleased with and what’s so interesting about this business is the story about this business is far from completely told. These five products are early in the line and there still remains many potential outcomes for how this portfolio is going to grow.
For example, take Bydureon. How big a product is Bydureon going to be? How big a product is Vivitrol going to be? And what we liked so much about the portfolio is any aggregate, when we model all these discreet elements, there’s many different ways that this portfolio will grow in non-linear ways into the future.
We say this portfolio by itself was referenced, was comprised of a really exciting biotechnology company, but its important to understand that way we are managing the company, the way we are building the company and that we are playing even in a bigger arena. The idea is that we are creating a much bigger company using this as a financial foundation for a potential blockbuster product. And if you’re able to finance your own R&D, if your proving the technical capabilities to make innovative new products and you have the capital to keep doing this repeatedly, we see the probability of us having a breakout of success in the pipeline as being very high over time.
(Inaudible) saw the first opportunity for that happen this year, 5461 and 3831, which we’ll talk more about, represent not theoretical ideas, but products that fully conceive in the clinic, being tested in patients or data’s being just developed for you over time.
So, if there were a single picture that captures what we’ve done on the commercial side over the last two years or so, that’s it. We’ve built the company now, we’re comparing fiscal years 2011 for a March year end to fiscal year 2013, which is the year we’re in right now, which we’ll complete at the end of this month.
So we took revenues from about $180 million to over $500 million and we went from loosing money as we invested aggressively in the development portfolio, to making money on an ongoing sustained basis, while being able to grow the R&D expenses at a rate not as great as we grew the revenue line or the product line. And what we liked so much about this, at this level of finance, of funding, around $150 million to $160 million a year, we can do an enormous amount of R&D. We are still perpetuating and we can still deliver on our financial goals that we think are important in managing the company with discipline.
So if we look at the individual picked file, just a brief snap shot of these products, the first two, comprised of what we call are long acting, atypical antipsychotic franchise. Both of these products are sold by Johnson&Johnson. We developed them for them. They are sold globally by J&J. Risperdal Consta is the first product, the first atypical, long acting antipsychotic given by injection once every two weeks, followed by Invega Sustenna, given by injection once a month. And these have become a $2 billion global franchise over time and the figure speaks for itself, just kind of consistent growth in revenues around the world from these products.
Why? Because they are really, really good medicine and they also make sense economically for paying the systems to keep patients from relapsing from this terrible chronic disease and we expect this to continue to grow. And why? Primarily because Invega Sustenna is just rolling out in territories around the world. Consta is sold in 92 countries around the world and Sustenna now is following in its footsteps and rolling out in additional territory all over.
I mentioned the progression from two Consta to one month of Sustenna. Now there’s a three-month Sustenna currently in phase III clinical trials by J&J, with planned filing in the U.S. for 2014 and outside the U.S. in 2015. But this is a strong business. It’s a dominant franchise along with the schizophrenia business and its also kind of the intellectual pre cursor to what we are going to be doing with our own product, which I’ll explain in a second. These products demonstrate the value and utility of long acting medicines in this particular disease and we and others have picked up this challenge and are going to build on this market.
Vivitrol is also a long acting medicine. In fact it originated from the success that we had in the schizophrenia market where we asked, what’s another indication here? Chronic non-compliance affects the outcome, even for drugs that we know could be useful and that led us to working out all in opioid detection in general.
Here where we have patients that are often unable or unwilling to take their medications everyday, the idea of a once in a month drug that blocks opioid receptors in the brain, prevents a relapse of opioid dependence; it’s a really remarkable medicine. It’s a small drug growing nicely. It’s about a $15 million drug now, but it has the enormous potential because of its efficacy and the scope of this problem in the U.S.
We see continued growth for Vivitrol, primarily because we are pioneering this deal, so we are seeing broader adoption in the key treatment centers, but we’re using it more frequently in more patient types than ever before.
But also, and I’ll mention this at the end of the conversation, we are seeing really specific interest from state and criminal justice systems in the idea of using a once a month antagonist to prevent patients from relapsing to their opioid dependence and becoming a receptor, an expensive receptor in the criminal justice system and that’s the thing that we think is going to play out over time, but are very favorably for Vivitrol in particular compared to any other drug in this space.
Ampyra is a drug that we developed and sold by Acorda in the U.S., and its sold by Biogen outside the U.S. It’s the only product of its kind. It’s a one of a kind product that improves walking in patients with multiple sclerosis; it’s a singular product. We received about 18% of the tillable live sales of this drug. It’s an important drug for us already. It’s about a $300 million drug and it’s expected to grow.
It also has potential clinical indications beyond improving walking in MS and some of those things are underway this year with Acorda running in the U.S. in stroke and in treatment policy. So we expect to see this drug continue to grow organically from the key indication, but also a potential for a chronic indication beyond walking.
Bydureon; it’s the latest addition to our commercial portfolio. Still one of the most exciting new medicines developed in biotechnology in the last several years. Its first and only, once weekly medication for Type II diabetic patients. It’s a GLP-1 agonist. It’s on a new class of molecule and this is a drug developed by our partners at Amylin and that company was acquired by Bristol-Myers Squibb and AstraZeneca last summer for $7 billion, primarily for Bydureon.
This is a product that has a potential to address millions of people with this debilitating chronic disease and already we are planning for the future, the first line extension of this drug, the newest introduction only last year. We are already planning step 2, 3 and 4 for the expansion of this franchise over time. So we’re quite high with either this drug, either with the shape of the curve looking like it does right now, its just the beginning, we are just getting going and seeing what’s this class and what this drug can particularly, could become.
When you look at that dosage size though in the aggregate, in the context of the patent license, protection, you see it’s a quite remarkable portfolio. In the industry that I can say is characterized by patent clearance and loss of exclusivity, this is a remarkable portfolio, because the numbers are so long; 2023, 2019, 2022, 2029, 2025, 2027; this is serious protection and gives us and our partners the ability to invest in these drugs for a long period of time and that’s why we are so confident about that financial foundation it provides the platform for the potential export to grow of our company.
So now lets shift to the pipeline, what’s coming next. The pipeline is actually quite rich. There’s many things going on, but for the purposes of this presentation, we’ll focus on three. Aripiprazole Lauroxile, this is our long acting atypical antipsychotic. They will join Consta and Sustenna in addressing this need globally. 5461, which is a major depressive disorder, proprietary molecule of ours; and 3831, also a proprietary molecule for schizophrenia. So lets start with that one. That’s the newest one that we’ve been talking about.
3831 is a very simple concept. It’s an oral compound designed to compete with the best in class in the oral antipsychotic agents. It’s a combination of a proprietary new clinical entity of ours, and one of the most important antipsychotic drugs in the world called olanzapine, otherwise known as Zyprexa.
Zyprexa is recognized to have the highest efficacy in the treatment of schizophrenia, but its efficacy comes at a significant clinical cost and that’s significant weight gain. Weight gain so sensitive that it can lead to diabetes. So there’s been a desire to develop an agent that has the efficacy of olanzapine without the associated metabolic liability.
We because of our experience with opioid modulation through work with Vivitrol and other things, had a hypotheses that opioid modulator could have an effect in reward systems that control the gaining of weight in the context of taking olanzapine. We tested the hypotheses pre-clinical and we were quite encouraged to see what happened.
We chose olanzapine because of all the antipsychotic agents, when we talked to physicians about why they needed to change a patient from one antipsychotic to the next, the primary reason as you see in this figure is because of the lack of efficacy.
In this figure, the question was asked to a physician, why did you change the medicine that you have the patient on. The blue bar is the tallest bar for all medications, Risperidone, Aripiprazole, Quetiapine, Ziprasidone, except for Olanzapine, in which case the primary reason that physicians change this medication is not because its not working well, its because of the weight gain on metabolics. So the forced reason, that accumulation of that weight gain with maintenance of that type of efficacy will give you a best in class agent.
So this is something that many people have been trying to do for many years and so we were skeptical that it was able to be done. We first tested this in non – actually in rodents and we saw a very, very clear effect that would block the weight gain associated with olanzapine.
We then moved to non-human primate and demonstrated the same effect that if will give patients, in this case a money, olanzapine will gain a significant amount of bodyweight. But if you combine that olanzapine with ALKS 33, what we call 3831, we could significantly intimidate that weight gain.
And so last year we decided to test this in humans before we announced this program publicly. In a test system in human, where in 106 volunteers we can have people voluntarily go on olanzapine, experience weight gain for a period of time and see whether you could change that shape of that curve with the use of 3831. And indeed after only three weeks, the normal volunteers did not get schizophrenic. The normal volunteers taking therapeutic doses of olanzapine had already began to see this curve separate in a statically significant way after only three weeks.
So we were quite excited about this data and now we are moving the most important population of patients, which is patients with schizophrenic and we’ll start the study this year and in probably only about 200 or so patients, to test the weight gain effect, the retaliation effect of 3831 over three, six, nine month periods. That’s certainly is going to be a very important study for us.
The field on our presence in schizophrenia, which began first with Consta and Sustenna, as our partnership with J&J and more recently with what we call Aripiprazole Lauroxile. This now is our proprietary drug. It is a long acting, one a month from of Abilify, the core drug of Abilify. It’s important generically in Aripiprazole Lauroxile (EZ).
Once in the body this more complicated molecule antibody clips down to Aripiprazole, for the active moiety in the blood stream of these patients for the month and time is Aripiprazole, and that way we can build off of a huge clinical foundation of safety and efficacy of this molecule.
We designed a product that had very specific futures that make it a better injective of the same lease product rather than an better antipsychotic product and it’s actually a very efficacious molecule. So this year, much of our emphasis in this program shifts from the scientific foundation of whether to work or not, what the PK profile looks like, to what the product presentation looks like.
As shown in page three, we designed it to be the best in class of the long acting forms of Aripiprazole. Why? For two primary reasons. One is in the picture, a very simple type of product presentation. A pre-filled syringe at the table dispensary. You put the needle on and inject. No refrigeration, no reconstitution and we know that’s important in the real world.
The second reason relates to the range of doses that we can cover with this drug. There are three major doses of Aripiprazole that are used; 10 milligram, 20 milligram and 30 milligram and we’ve got kind of a deeper formulation that matches directly on to each of those forms and we think that’s been providing a very, very simple easy, clean product to use in the clinic and for physicians to transfer patients from more Aripiprazole to an shakable form.
We plan to launch this drug in the U.S. and we plan to partner for markets outside the U.S., and the markets are remarkable mostly. It’s almost a $25 billion market worldwide, even with some of the major brands now off patent. Zyprexa is now off patent, Risperdal is now off patent, Abilify will be off patent in 2015, but you can see why we went after the big blue wedge on the right, because it’s the big blue wedge on the right, the $7 billion business.
The green wedges are our products with J&J, Consta and Sustenna; that’s a $2 billion wedge. I want to compare it and think about it as the oral pill, Risperdal tablets was about $5 billion business and it’s driving about $2.2 billion of long acting injectable sales now. Aripiprazole is a $7 billion wedge. We will see how to get a corresponding share the long acting from of Abilify, but we think they are going to be significant.
When we think about brining this drug to market ourselves in the U.S., it’s actually a fairly clear path of what it might do. And the way we set up this grid is the lowest left side, that lower left quarter is a easy quarter. That’s what we expect to do first at launch, the commercial priority, and also the ease of converting patients from other medicines into Aripiprazole Lauroxile.
I’ll orient you on this slide. The green circle up at the top represents 88,000 paintings in the U.S. that are currently taking Consta or Sustenna. So that green circle is the U.S. element of the $2.2 billion franchise, okay. So at the beginning there are 357,000, and all on Abilify in the U.S. So you don’t need to get all or most of these patients to have a very, very significant business and our belief is that almost all of these patients, with schizophrenia, are candidates for a discussion to talk about a long acting form, just based on data, given the lack of compliances in some these patients.
But the story doesn’t end there, because Abilify is one of the antipsychotics in the U.S. But with market shares that are long ended and typically very low, 2% in the U.S., there’s another 1.9 million patients with schizophrenia on oral agents that are frequently switching medications that will benefit from a long acting dosage from ours or somebody else’s. So many of these patients would benefit from a long acting atypical antipsychotic, and Abilify is even further interesting, because of its recent bipolar disease.
There’s nearly 570,000 patients in the U.S. taking Abilify for bipolar and not every patient with bipolar is used as a candidate for long acting atypical, but many are, and beyond that another 1.6 million people who are taking other agents for the treatment of bipolar. And so go back to the green circle at 88,000, you can why the actually commercial rollout at this point is very focused. We know where to go and many of the types are currently even Consta and Sustenna right now, with these additional therapeutic entities to consider for the patient as well.
Now what drives this product now, having had Consta and Sustenna in the market for so many years? I think physicians are aware of the efficacy. I think what’s driving more and more of its use and will drive more and more of its uses, more of this gets part of the education of payers and physicians or the economics.
These are the data actually presented by a bigger, based on experiences in managed care of our products with Consta and Sustenna. Looking at managed care databases and seeing the kind of patients on our long acting drug versus oral and the conclusion that they drew from this paper were that we managed care with new patients to deeper antipsychotic agents is less costly than putting them on the oral, even though the orals are general magnifications and are often very, very expensive.
So what is the answer then? Why would that be? Because of the timing, if you look at the data of avoiding hospitalization, because hospitalization is extremely expensive. A single hospitalization then can be measured in the order of $10,000.
So the economics skew very quickly to the use of long acting atypical, because you can assure compliance and can be brought to the hospital, that just makes sense. That’s why market share for the long acting atypical is being permutable 30% compared to 2% in the U.S., because its single payer system to capture the whole experience over a patient’s lifetime, of the expense of managing someone with a chronic disease are more inclined to use these long acting atypical. This bodes very, very favorable I think for ours and other entrants into this market.
We will shift gears now to 5461. 5461 is our drug for depression; again, another oral compound. A combination of two opioid modulator. One is our proprietary ALKS 33, a new chemical entity with patent protection into ‘30. In this case an opioid antagonist called Buprenorphine, and the idea here is to have an alternative pathway, a mechanistic pathway separate from serotonin or norepinephrine to treat patients with refracted depression.
We showed very exciting data last year in our first clinical trial because of this drug, and we’re currently replicating that and are seeking to replicate that in 130 patients, Phase II (b) study which we completed enrolment in maybe December of last year and we expect data in the second calendar quarter of this year.
The reason we are so interested in this clinically, is because the numbers are so extensive and the clinical need is so bad. There is almost 10 million people a year who get treated with drugs for depression every year; that’s an astonishing number. And of those, over 60% require another medication. They start on Abilify, typically generic Abilify and it takes several weeks; three, four, five weeks to determine whether that drug is working for those patient.
60% of them will require another drug and another 40% of those patients will require a third drug, and many start running out of options, running several weeks or months into feeling like somebody. They maybe suicidal, they maybe clinically – obviously clinical depressed, unable to function, unable to work; what do you do?
So the reason we describe this as a treatment gap is that the space between the first round of inexpensive efficacious oral agents from the next step, which can be heavy antipsychotics, it could be electro convulsive therapy, it can be hospitalization, it’s a very huge step-out. So does it really need for well-tolerated oral medication, that has an alternative mechanism capacity that can complement the use of our antipsychotic agent and that’s what 5461 is. So, it’s basically for that we’ll have data in the second quarter.
And I’ll finish with just two slides on VIVITROL. VIVITROL is a really interesting product. It’s a very efficacious drug, it’s a one of a kind drug. It’s the only drug of its kind; long acting and definitely an antagonist. It doesn’t get people high. It has no street values. It blocks addiction, it reduces rating, prevents relapse of opioid dependence, it keeps people out of prison, but its brand new medicine and its treatment facility is not particularly well medicalised and we are real pioneers.
But we have been chipping away at this for the last couple of years and we are getting more and more optimistic. We’ve always been optimistic about its efficacy, but we are more and more optimistic, that ultimately like this question asked in our physicians’ brochure, are you ready to move forward? Is the treatment world ready to start actually treating these people who just have a medical condition. I think the answer is increasingly, yes.
One example of that is just what’s happening in the criminal justice facility as I mentioned at the out set. So a year ago January, when we first presented it, we had seven states. They kind of had been pushed against these pilot programs to investigate the use of Vivitrol in the criminal justice system.
Secondly, if a patient’s been improving, it could be in the course of a drug course, it could be in county and today we are there. We have 21 county -- I’m sorry, states and multiple counties, just kind of organically, and this is because people are beginning to talk to each other. So there’s different flavors I think. The Massachusetts just being used in a (inaudible) for patients that have been in prison for a couple of years, that are coming back into the population. The opioid act that they are on the entry going Vivitrol and we know that in the parole they maintain on Vivitrol, they won’t relapse (inaudible).
In Missouri, extent use of Vivitrol in drug courts. The judges our giving the people the option of incarceration, for staying in the community, in treatment on Vivitrol or they can continue to work, pay taxes and become like a member of the society.
In California it has its own case, because California statewide is closing dozens of prisons for budget reasons and pushing non-violence offenders, which are largely drug addicts back into the community. So the community feels its a big problem that they can’t re-incarcerate all these folks. So how can we keep people in the community without the threat of this in the business and Vivitrol we can test I think in 11 different counties in California.
So that’s something why we are just going to keep going with Vivitrol and we keep hearing testimonials and see peoples lives being saved, but it’s a change, it’s a changing – it contracts that with we’re doing a long antipsychotic space, where we know the doctors, we know the types, we know the economics. This is a new world and we are probably going to use it out there a lot more. We are actually quite proud of the work we are doing.
So I’ll finish then with the milestones for the year. Commercial portfolios speaks for itself. I think this is going to continue to grow and I direct your attention really to the data that’s coming on Ampyra, because I think that if it shows efficacy its an indication that means they are very positive, and also for Bydureon as Bydureon begins to ramp with the full force of Bristol-Myers Squibb and AstraZeneca behind it in markets around the world. It would be fun to see how that goes.
On the development portfolio, two big milestones at least this year; 5461. That 130 patient Phase II study leads out into Q2 as I mentioned, and then of course Aripiprazole Lauroxil, our Phase III we should get approving data at the end of this year from the Phase III programs and I believe that data will be sufficient to file in the U.S. in 2014.
Financially, we raised our financial targets three times this year. So we improved our guidance on our last call or we’ll meet that improved guidance. Our goal will be for the 3331 this year, and then we’ll guide in May for the new fiscal year, consistent with this idea of being able to sum our R&D, while hitting these goals of growth and financial disciplines when dropping money at the bottom line as well.
I’m finished John, we can take some questions.
What does the VIVITROL sales force look like? How many people are they targeting?
The VIVITROL sales force in the seal is 65 people, and that group is targeting primarily treatment centers. It’s complemented by a nascent small, what we call a policy team and the policy team is helping some of these initiatives in the state.
So for example, a rep doesn’t go and call in a judge, yet somebody needs to talk to the judge, and who goes and talks to the warden or the sheriff and who talks to the governor and the attorney general, and so we are organizing ourselves, getting pilots for the sates to be able do that as well. So actually in the future with the complementary between the classics, more classic personal promotion targeting doctors and treatment centers, as well as the policy overlay.
If the patient on Vivitrol has an accident or needs a surgery or something like that where normally they will get opioid post-surgery or pertain management, is there enough in the armamentarium to use other drugs for that purpose.
That’s a really good question, and I’m happy to say yes, with all kinds of collective experience now. When you ascertain the development coming, there’s that other non-opioid related (inaudible) that people can do, but in the real world now with Vivitrol, we actually have a lot of data on that. There is medical affairs folks that can provide information to treatment providers and it hasn’t been a major problem.
What are you developing an (Inaudible). Why are you developing an injectable compared to a no or extended release product?
It’s a great question, because its such a fundamental question I felt even the answer you have there. So normally when you think about developing drugs, the event of your formulation work would be a once a day oral table and what we know is (inaudible) and they have spent it, and this was J&J’s original insight, was that in certain diseases, schizophrenia being one of them, alcohol and opioid dependence being another priority, patients are often unable to take their medication every day or unwilling to take their medication every day; its part of the disease.
And so there is data from managed care databases that shows that schizophrenia could miss oral doses, the risk of hospitalization quantitatively changes. It can double with only missing between one and 10 does a month. So the idea is if you can give a dosage from where you can assure compliance or its for a month period of time, for a patient who might be erratic otherwise, a month later you know if they are not back in the office, that they are not complying, then you have two months of protection.
And now with the first approval of Consta happening in 2002 in U.S., if you go to the American Psychiatric Association meetings each year, the data they are presenting on Consta and Sustenna are no longer about is it efficacious; its all about long term follow up studies, looking in to curve separating from patients who are proved to be stable on their oral medications and comparing the risk of hospitalization and relapse we’re getting on the one month injectable. And what we find is the relapse rate is dropping dramatically, so that’s the logic. There’s not many drugs; its compliance adherence, mapping on to a particular disease where that happens to be a big problem.
Const competes against generic Risperdal and it has for the last several years.
It’s the same dynamic, the predecessor drug for Consta as it was for oral Risperdal, Zyprexa in the long acting forum. So the answer is, we believe that in the real world what will happen is that most patient will be started on the oral generic medication, to see whether they tolerate it, whether it’s the right agent for them. If they are well controlled and compliant, they won’t be a candidate for the long acting injectable.
That’s why you see that total spear of 88,000 patients against the backup of 1.9 million. I actually believe that if you were somehow able to quantify these patients that you are getting, even the doctor may consider them to be adherent, if they actually quantify them from the most different patent are now 100% adherent with the medication.
How comprehensive is coverage for Vivitrol as they are covered my Medicaid?
It’s actually covered pretty well now and the issue is not so much covered yet. Its how easy or hard it is to get it for a particular doctor and a particular patient.
One of the things that we found with opioid dependence and alcohol dependence, unlike Type II diabetes for example, where there’s a moment in time when your patients are willing to go into treatment, you need to capture them then, otherwise they tend to go back to their old ways and you have a moment of insight or desperation or something.
So if a physician has a hard time getting prioritization, get the paperwork done and everything to get Vivitrol, because they are not going to have another short three or four weeks later. So that’s a very much improved from where we would have seen it three or four years ago. We put a lot of energy into making that a much more easy process, but its generally pretty well reimbursed now.
Okay. I see nothing else. Thank you very much.
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