Allergan Inc. (AGN)
March 28, 2012 1:00 pm ET
Unknown Executive -
Scott M. Whitcup - Chief Scientific Officer and Executive Vice President of Research & Development
David E.I. Pyott - Chairman, Chief Executive officer and President
Mitchell Brin -
Frederick Beddingfield -
Gregory H. Altman - Founder, Chief Executive Officer, President and Director
David Risinger - Morgan Stanley, Research Division
David Amsellem - Piper Jaffray Companies, Research Division
Aaron Gal - Sanford C. Bernstein & Co., LLC., Research Division
Shibani Malhotra - RBC Capital Markets, LLC, Research Division
Douglas D. Tsao - Barclays Capital, Research Division
John T. Boris - Citigroup Inc, Research Division
Gary Nachman - Susquehanna Financial Group, LLLP, Research Division
Catherine J. Arnold - Crédit Suisse AG, Research Division
Seamus Fernandez - Leerink Swann LLC, Research Division
David G. Buck - The Buckingham Research Group Incorporated
Christopher Schott - JP Morgan Chase & Co, Research Division
Gregory B. Gilbert - BofA Merrill Lynch, Research Division
Annabel Samimy - Stifel, Nicolaus & Co., Inc., Research Division
Larry Biegelsen - Wells Fargo Securities, LLC, Research Division
Gregory Waterman - Goldman Sachs Group Inc., Research Division
So I wanted to welcome everyone to the 2012 R&D Technology Review. Just find your seats. And with that, I'd like to introduce Dr. Scott Whitcup.
Scott M. Whitcup
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Well, thank you, Jim, and I want to thank everyone for coming out to our R&D Technology Review. As you know, what we try to do in these is give you insight into some of the pipeline that some of you haven't seen before and some balance. We'll have some updates on late-stage programs, but importantly give you some look at early-stage science as well.
I want to start by introducing myself. I'm Scott Whitcup, I'm the Executive Vice President of R&D and Chief Scientific Officer and lead the group on Pharma and Medical Device side and want to start off by thanking the vast number of scientists and clinical developers who really did all the work on the science and clinical trials that we present today, and also a thanks to the IR staff, especially Joann Bradley and David Nakasone who really helped organize this.
I'll give you a brief, just look at the agenda today. So after David gives off some introductory remarks, I'm going to give you an overview of what you'll see today, including what our R&D strategy is, our priorities and then overview of the pipeline that you'll see later today. We'll kick it off with BOTOX. Dr. Haag [ph] will talk not only about the Phase III OAB results that you saw today but a little bit of an update on our prostate program, and then Dr. Brin will talk about a new indication for BOTOX. We always try to reveal what's next for BOTOX. And you'll see that, that's going to be osteoarthritis pain, as well as what we now call targeted exocytosis modulators, that's the platform the artist previously known as targeted toxin.
We'll then move to ophthalmology. Dr. Carter [ph], who's our Chief Medical Officer, will update you on the glaucoma programs. I'll update on retina, and then we'll finish off on dermatology medical aesthetics and plastic surgery with Dr. Beddingfield [ph], giving you an update and medical aesthetics and derm. And then Greg Altman [ph] from Allergan Medical, will talk about a unique new late-stage opportunity SeriScaffold biodegradable mesh that we plan to launch in the near future.
So with that, I'd like to introduce David Pyott, Chairman and CEO, to echo some of the introductory remarks.
David E.I. Pyott
Thank you. So you can certainly see what happens when the IR guys spend too much time poking around the labs. You know I told not to do it, right? Results were quite remarkable, Jim. Now the reason I'm wearing this is it's not because I find it a particularly cold day in New York, but a lot of people were trying to egg me on to wear my kilt. Now from a practical point of view, those of you won't know kilt, they weigh about 18 pounds, and I'm going to Europe straight after this, including Scotland so this is my kilt for the day, I'm sorry. You're not going to see anymore legs.
So on with the real program. So a very exciting time for the company. As we've explained many, many times, Scott and his team did a fantastic job getting many, many programs approved not only in the United States, 7 in total, both between pharma and device but also an enormous number of approvals around the world in 2010 and '11. So it's now all about reloading the pipeline using our specialized knowledge of our areas, continuing to enter the diversity of our portfolio. And I hope yet again we have examples on this chart of where we've been able to create markets where really markets didn't exist in the past. And I hope when you are looking at the scientific side of some of these new programs today you know very little about, you can imagine that once again, we'll be able to deliver new therapies, new alternatives to patients that will, in fact, create brand new market segments.
Of course, to fuel all of this requires a lot of money, and I remember maybe a year and a bit ago talking to both sell-side, as well as buy-side investors that I think a lot of you were surprised that we were signaling further increases to R&D, which initially didn't seem totally logical because you'd say, "Well, you just got all these programs finishing off, now since approved." Normally, expensive Phase IIIs completed, the budget should go sideways or down. And we were saying "No, it will continue to go up." And today, you will see why is that. Well, because we put a lot of new programs into the clinic.
So this year, about $920 million taking the midpoint of our outlook that we gave you at the end of January. About 16% this year, although we've also made comments that if you looked into the future, we would like to move that up even further to 17%. And of course, this is the offset to the famous leverage story of SG&A where over time, we plan to bring it down from these very high levels around the 40% mark down gradually into the mid-30s.
So that completes my opening remarks. I hope you will find there's some many new things that you didn't really know about or you might have been aware of the existence of the program but no further details. And so I'll now hand over to the R&D team because it's their day.
Scott M. Whitcup
Thank you, David. My goal now is to make sure that you feel that the investment in R&D was money well spent. As you know, with my boss David, although it's $920 million, I have to account for every penny.
So what I'm going to do is really start with the strategies and then go into the pipeline. So the R&D goal, one, which is probably what every pharmaceutical company says is to develop differentiated commercially successful products that address unmet medical need, and that's clearly what our R&D goal is. But I think what's unique about Allergan is that we employ a model where our probability of success, once we get things in the clinic, is higher than the rest of the industry. We clearly want to be either first in class or best-in-class, but because we're specialty focused and know our areas better than anyone, and because today, if you look at our pipeline, everything is locally administered, no systemic drugs, we have a success rate far beyond what you see in the rest of the industry.
I want to start with some late-stage updates. Lots has been written about R&D day, and people are always looking for either some late-stage pipeline opportunities that we've not yet heard about. So this morning, there was a press release. We announced that we had positive idiopathic OAB data in both of our Phase III studies that allowed us to get files both for the U.S. and for Europe, and those have been filed with an incremental global peak year sales of about $350 million-plus.
At the end of today, you'll hear about SeriScaffold for plastic surgery. This is the biodegradable mesh, and we expect to launch this next year in 2013 with $100 million to $250 million of global peak year sales. 2 products that I'm not going to talk a lot about today but they're in our glaucoma type line, our unit dose is our preservative-free unit dose formulations of both LUMIGAN and GANFORT, but predominantly for the Europe market, we expect those to be launched next year. The LUMIGAN has already been filed. The GANFORT, we expect to file this year with $50 million to $100 million of incremental peak year sales.
And then a program as well for competitive reasons that we had not disclosed that Dr. Beddingfield [ph] will talk about, BOTOX for crow feet lines, we expect to file that end of this year with the approval 2013 and '14, and again, with incremental global peak year sales here of $100 million-plus. So here a number of late-stage opportunities that as of to date, we have not really talked a lot about.
Our strategy, which really is focus is power is to keep our R&D focused on the specialties that we're in, ophthalmology, neurotoxins, neuroscience, urology, dermatology, medical aesthetics, plastic surgery obesity surgery. We're fortunate that we treat diseases of an aging population, and so the demographics, the aging population will help drive growth in our markets. We spend a lot of time making sure the therapies that we develop are cost-effective, gathering how outcomes data so that once we're approved, we can go to payers both in the U.S. countries globally, make sure that our products are well reimbursed, make sure we have an efficient R&D model so that every penny that we spend in R&D goes to programs as best as we can. And then again, what's unique about Allergan, our programs are really focused on local delivery wherever possible. Doesn't mean we'll never do a systemic drug but today, everything are examples of local therapy.
And to give you examples, this would be eyedrops or implants that's in the eye, creams, dermatology products where you apply them directly to the skin, BOTOX, and our next-generation chem program. Again, you're injecting those products exactly where you need them. Even medical devices are an example of locally-administered treatment. And this allows us to have a risk-benefit ratio much greater than systemic drugs.
Because what regulatory agencies are worried about not only does the drug or device work, but what are the side effects that I have to worry about years down the line. With local therapy, you can get a much better safety profile, and it also allows us in our pipeline to have innovation not only from new chemical entities but also novel ways to administer known drugs.
And if you look, this graph shows that if you look at Phase I to market, we're about 1.6-fold better than the overall industry success rate. And based on CMR [ph] data, as you can see in a study of 17 companies, Allergan was ranked second in terms of overall probability of success of getting drugs to market, and I think a lot of this is dependent on not focusing on specialties we do well and local therapy.
Our first priority is getting drugs approved to drive sales growth. And since we were here last time at our R&D day, we've had a number of major approvals including BOTOX for chronic migraine, upper limb spasticity, neurogenic overactivity, LUMIGAN 0.01%, JUVÉDERM, just a large number of approvals so the focus today is not only what else do we have in the late-stage pipeline but how are we reloading the pipeline.
Second priority, global expansion. So you've heard on a number of meetings with us that we want to maximize the sales of all of our products, especially into emerging markets. And over the last several years, we've expanded our R&D infrastructure around the world, especially in Asia Pacific and in Eastern Europe, and we're developing a number of products like glaucoma combinations specifically for some of these emerging markets. And over the last couple of years, we've been very successful of getting a large number of our products approved in these emerging markets. No single product, large amount of sales. But when you expand and look at the emerging markets, together it's really a sizable amount of sales and will continue to drive our growth over time.
What we're going to focus on today clearly is how we fill and optimize the R&D pipeline to support long-term growth. And we have a very rigorous portfolio process. It's a process that initially was developed with the London School of Economics. We put all of our programs into the model. It's predominantly based on a risk-adjusted NPV, but it also incorporates business needs, unmet medical needs, timing, you can adjust the portfolio for risk. And at the end of the day, it helps us not only make the best bets on internal programs, but when we look at in-licensing opportunities, we also put those into this model to decide whether they buy into the portfolio and whether they're a good spend the for Allergan's R&D money.
There are a couple of programs that we have in the pipeline that for competitive reasons you're not going to hear anything about. One is BOTOX X. So you're going to hear about the 10 program, the old targeted toxin program. This is different. This is taking the existing BOTOX, optimizing it to make a better Allergan. R&D has a long history of optimizing our products to make them better. BOTOX X is one example, RESTASIS X, which you've heard about, is another. So we have a number of things in the pipeline related to these 2, we won't talk about them today.
We will talk about BOTOX. So when you talk to people about BOTOX, they assume it's all about Cosmetic. As you know, in 2011, therapeutic eclipsed cosmetics as the majority of sales, and as we continue to get new therapeutic indications, that divide will continue to grow. As you know, chronic migraine is a big indication for us, and so as these indications like chronic migraine, like overactive bladder are rolled out globally, then I think you'll continue to see that our therapeutic business will continue to be larger than the cosmetic business although we continue to support that as you'll hear from Dr. Beddingfield [ph] with crow feet lines later today.
So our strategy around neuromodulators, new indications with existing BOTOX, make BOTOX better with BOTOX X and then really disruptive technology, get something innovative and new, and you'll hear from Dr. as well on our targeted exocytosis modulators, the targeted toxin program.
So this graph just shows the number of indications. These are U.S. approvals, 8 approved, 4 in development, 2 brand new ones that you'll hear about, crow's feet lines and osteoarthritis pain. But again, you'll also see the idiopathic overactive bladder data and an update on BPH.
Today, we announced that we filed idiopathic overactive bladder. These were data and I've been doing clinical trials for 25 years, some of the most striking Phase III data that I've seen. Dr. Haag [ph] will go over it. And why it's exciting? It's a huge unmet medical need. Just in the United States, the 3.2 million Americans on medications, and we know from talking to urologists and patients that the medication fail in a large number of patients. Well over 50% discontinue their medication either because they don't work or they don't tolerate them. And the Phase III data clearly showed that in the first clinical study, we got highly statistically significant decreases in urinary incontinence episodes that were not only statistically significant but also very clinically relevant, and data that were well replicated in the second Phase III studies. So Dr. Haag [ph] will go over these data, some of the other efficacy endpoints.
But also important was the safety. So as you know, with our neurogenic program, the question was what would the urinary retention rate be. And most of the people looking at this said, "We really want rates as low as possible, potentially under 10%." And so we're very excited to see that the urinary retention rates in the 2 Phase III studies were 5.4% and 5.8%.
BPH also a big market, big unmet medical need. 4.2 million men on oral BPH medications. Over 400,000 requiring surgery for the condition. Our Phase IIb trial is in progress, and the people ask how does BOTOX work? Does it treat the prostate? And I've always said, you show the man the needle, the prostate shrinks 50%. And then BOTOX then takes into effect. So Dr. Haag [ph] will talk about the little bit of program and update you, but if the Phase II program in progress is positive, we'd like to advance that into Phase III next year.
So really, the strategy is that indications tend to follow the mechanism of action. So how does BOTOX work? So this slide shows that BOTOX blocks the communication of various nerves with the target tissue. So blocks release of neurotransmitters from skeletal muscle nerves and blocks muscle contraction, blocks release of pain mediators from pain nerves so that you don't get pain or block some of the muscle nerve communication to smooth muscle in the bladder or in the gland, blocking bladder contraction and gland function.
In osteoarthritis pain, we focused on this mechanism in the center. Why does it make sense? Well, we've seen that it's effective in chronic migraine, in pain -- neck pain associated with cervical dystonia, and now we're moving to osteoarthritis pain. Clearly osteoarthritis, a huge unmet medical need. It makes sense for us because this therapy will be specialty focused, you're injecting it into the joint. Orthopedists, rheumatologists, pain specialists will administer this. And like a number of our other indications, there's positive safety and efficacy data already in some small trials in the literature, and so we've already started a Phase II trial. You can find it on clinicaltrials.gov, and Dr. Brin will talk to you a little bit more about this indication.