BioDelivery Sciences International's (BDSI)
`CEO Mark Sirgo Presents at Morgan Stanley
`Healthcare Conference (Transcript)
`
`Sep. 9, 2014 7:22 PM ET | About: BioDelivery Sciences International, Inc. (BDSI)by: SA
`Transcripts
`
`BioDelivery Sciences International, Inc. (NASDAQ:BDSI)
`
`Morgan Stanley Healthcare Conference
`
`September 9, 2014 4:40 PM ET
`
`Executives
`
`Mark Sirgo - President and CEO
`
`Analysts
`
`Chris Caponetti - Morgan Stanley
`
`Chris Caponetti - Morgan Stanley
`
`Thanks everyone for joining the BDSI session. I am Chris Caponetti and I encourage you to
`please visit morganstanley.com/researchdisclosures for disclaimers. With that it’s my pleasure to
`welcome Mark Sirgo, BDSI’s President and CEO to the stage.
`
`Let me tell you a little bit about Mark. He has over 30 years of experience in the pharmaceutical
`industry, including 16 years in clinical drug development, seven years in marketing, sales and
`business development and 12 in executive management positions. He’s been with BDSI since
`2004 and he also serves on the Board of Directors and is the Chairman of the Compensation
`Committee at Salix.
`
`Mark thanks so much for coming out today.
`
`Mark Sirgo
`
`You’re welcome, pleasure to be here.
`
`Chris Caponetti - Morgan Stanley
`
`Yes. So we’ll turn over to you for some opening remarks. You had your Investor Day last Friday
`which I understand was very well received by investors. So if you could just provide us with an
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`RB Ex. 2048
`BDSI v. RB PHARMACEUTICALS LTD
`IPR2014-00325
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`introduction to BDSI, the progress year-to-date, talk a little bit about your upcoming drug launch
`and any key takeaways from last Friday’s Analyst Meeting. That would be great.
`
`Mark Sirgo
`
`Yes thank you Chris. BDSI is a specialty pharmaceutical company. We use drug delivery to
`reinvent proven therapeutics. We’ve got two products now approved through FDA in the 10
`years I have been at the company. Most recently we had BUNAVAIL approved for the treatment
`of opioid dependence, which is a product that will compete with Suboxone. In that particular
`space, we have also had two very positive Phase 3 study results for BEMA Buprenorphine
`chronic pain product that we’ve got part of a vendor pharmaceuticals first study read out in
`January and the second one read out in June, NDA scheduled for submission late this year
`hopefully no later than in January ’15. And we had an interim analysis on our first Phase 3
`pivotal trial for Clonidine Topical Gel which was a positive signal and we’re adding a few more
`patients to that trial, but it should have read out sometime first quarter of next year. So we
`continue to focus in pain and addiction medicine using drug delivery also falling to 505(b)(2)
`regulatory pathway where we can reference the originating companies pre-clinical data. And I
`think we’ve done it effectively through our first two approvals.
`
`Chris Caponetti - Morgan Stanley
`
`That’s a great introduction. So I wanted to start off on BUNAVAIL if we can. Just the
`commercialization plans in your marketing strategy for that product. How many sales reps, what
`physicians, what geographies are you targeting that sort of things?
`
`Mark Sirgo
`
`Sure. The nice thing about this category is that it’s really consolidated geographically and in the
`physician base as well there is about 5,000 physicians that treat opioid addiction and 80% of the
`business is consolidated East to the Mississippi. And because of such small group of physicians
`you can cover with a small number of sales representatives. So for a company like us launching
`our first product, it’s very manageable in terms of the commercial spends, we’re going to have
`about 60 sales people for regional managers and two individuals, one at Quintiles because this is
`a contract salesforce and then David Acheson who have got sales and manage markets for us
`overseeing the entire effort.
`
`So we’re set to launch our national sales meeting is actually is this Friday it runs through early
`next week and we’ll have our feet on the ground the following week. We’ve had five MSLs,
`Medical Science Liaison on individuals out in the field since last April, sort of paving the way
`first talking about the technology and then after the approval talking about the product itself. So
`we’ve been in some of the highest practicing offices in this space for about six months.
`Salesforce of course will hit the ground as I said week after next. Again about 60 people targeted
`80% of these individuals would be East of the Mississippi the rest in Texas, Phoenix and West
`Coast.
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`Chris Caponetti - Morgan Stanley
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`Yes well those 60 sales reps, how does that compete against Reckitt-Benckiser who is there
`Suboxone?
`
`Mark Sirgo
`
`Right, we don’t have any exact figure on their salesforce at this point in time it is somewhere
`next to certainly of 100, could be up to 150 individuals at this point. They cover a more
`expansive physician base, it is still that 5,000 but within that they have lot of touches on all 5,000
`where ours would be more focused on the highest prescribers of that group. Having said that, I
`think more importantly it is the -- what we’ve learned about in the last year or two prior to
`launch in terms of the unmet need in that marketplace, so just talking a little bit about the
`products themselves Suboxone has done extremely well, it’s been in the market for 12 years.
`Record has started with a sublingual tablet and they transitioned over to a sublingual film.
`
`These products, Record products they are placed under the tongue, there is no MucoAdhesive
`properties so patients are instructed to place it in that sublingual cavity and for 10 minutes not to
`talk or to swallow which both of those things it’s hard to not do in a 10 minute timeframe
`particularly physiologically. But having said that, you need to do that in order to get the drug
`absorbed and under best circumstances they get about 20% of that drug absorbed. With our
`product it’s a transmucosal film, it fits inside the lining of the cheek, it’s MucoAdhesive so it
`sticks and it’s in place. Patient just goes about in their normal data routine, so they can talk, they
`can swallow, they can do whatever they’d like to do.
`
`The efficiency of our system is also important because we actually give half the amount of drug
`you get the same plasma concentration. So less drug exposure has been a very positive thing with
`physicians. Even though Buprenorphine is an highly abused opioid it’s not that patients aren’t
`going to attempt to do that. So less drug better for us for available for diversion and so on. The
`other thing about having less drugs available is that less so that Buprenorphine is swallowed on a
`daily basis and we all know that one of the primary side effects of Buprenorphine is or any
`opioid is constipation and largely a topical phenomena in GI track with these receptors are
`present. So we’ve actually seen in our safety study. So FDA required us to do a 250 patient
`safety study where we converted these patients over from Suboxone on to our product and
`followed them for three months. We asked a lot of questions as they came off of Suboxone, one
`of which was the issue of constipation. 41% of them indicated they actually were suffering from
`constipation.
`
`After three months on BUNAVAIL, two-thirds of those patients had resolution. So it dropped
`from 41% to 13%. This is not a well-controlled study I am not suggesting that it is, but
`intuitively knowing how opioids work on the GI track the less that goes down there the better. So
`I think we have a product because it’s more efficient in its delivery for giving less count on the
`GI track you are going to see certain types of side effects particularly constipation. So that was
`another important I think finding. And then just the ease of use and we collected that information
`in that particular study as well and patients found the product extremely easy to use particularly
`given the ritual they have to go through every day on Suboxone. That’s a little bit of a flavor for
`how the products actually differ.
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`Chris Caponetti - Morgan Stanley
`
`And in your slide deck, you have a hypothetical illustration of how you got to $250 million in
`sales for BUNAVAIL. Is that a reasonable target? Walk us through how we get there to the 250.
`And then is that a reasonable target for your guys?
`
`Mark Sirgo
`
`Well I think it’s very reasonable. And the way we get there, we use like most people market
`researched it to arrive at that information. But having said that a large sample a quantitative
`sample of addiction medicine specialists. As we look at this entire category and we are looking
`out now over five years to reach peak which is that number. We’re suggesting that the generic
`piece in the market is going to be roughly 40%. I mean right now it’s about 18% and there is no
`real good visibility and as to why it’s going to get to 40% at this point but that’s what we are
`allowing for us with maybe a bit conservative. That leaves 60% on the branded side which
`translates into about 1.5 billion. And our expectation based on our market research is what we
`described is profile that I’ve just explain, it suggests we will get between 20% and 25% of that
`1.5 branded business.
`
`Chris Caponetti - Morgan Stanley
`
`And of that 1.5 billion, so we have Orexo, they have their own product that’s recently launched,
`that’s annualizing about 36 million according to IMS. You think Record has some life cycle
`management. So out five years what does branded market looked like and then what do you
`make of the Orexo launch trends and is that a fair comparison for BUNAVAIL, how does your
`product differ?
`
`Mark Sirgo
`
`Right, so looking at the market out that far I mean there is no reason I believe that Suboxone will
`still be the primary product in this space and they will manage the majority the 1.5 million we
`should be second. And when you consider recent launch with Orexo and when I criticize but I
`think it’s not a differentiated product, it’s a sublingual tablet, so they are really competing with
`the sublingual generic tablets in many respects. So it’s tough to enter a market where you’ve got
`a competitor like Suboxone where you don’t really have any differentiating features. I think the
`other thing is Record did an outstanding job of converting people from their sublingual tablet to
`their sublingual film and it convinced physicians that it’s a better product, it’s something that
`patients prefer. Just about every powerful attribute I think that they convinced physicians that is
`just better overall than tablets. And I think that is also heard Orexo is opportunity in this
`particular space.
`
`So I don’t think it’s a good proxy now, I think you need to differentiate a product and I am
`hopeful by the way I will describe BUNAVAIL you can see that we have that and certainly on
`market research that we are conducted supports that. And we had a great Analyst Day last week.
`In the last Investor Day two addiction specialists speak at the meeting and I think in a very
`unbiased fashion they just talked about the opportunities that existed in the space for novel ways
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`to deliver Buprenorphine in these patients and they’re convinced that we meet that. And again
`we’re not suggesting we’re going to overtake Record here. They have done a very good job
`they’re entrenched in the space right now, but we have a better product and that’s why we think
`we can achieve that 20%-25% market share.
`
`Chris Caponetti - Morgan Stanley
`
`That’s great and just to wrap-up on BUNAVAIL, what’s the IP look like for that product?
`
`Mark Sirgo
`
`Well, we think it’s quite strong, we’ve got a series of patents overtime, it is supported but the
`most important one is the most recent one that we had in branded and which we call the dual PH
`patent and it runs through 2032. We create a PH environment in the film and the way we
`construct that film for this product at least as having Buprenorphine in the MucoAdhesive layer,
`the naloxone is in the backing layer. There is PH environment in each of those it is unique to the
`product and that’s the under fittings really of that patent. So I think it’s very, very strong IP very
`difficult I mean to try to design around that following on those PH ranges you would never be
`able to show bioequivalence. So either infringe it or given the marketplace basically as we would
`look at it.
`
`Chris Caponetti - Morgan Stanley
`
`That’s great and audience before we switch to BEMA any final questions on BUNAVAIL? Yes,
`she is running up with the mic so we can get you on the webcast sorry about that. Thank you.
`
`Unidentified Analyst
`
`I probably should know this, but just talk about the relative pricing in the space at this pointing
`time?
`
`Mark Sirgo
`
`Yes, the relative pricing in the space right, it’s published now so we priced it fairly in the
`Suboxone film. The most utilized strength is their 8 milligram which is our 4 milligram which is
`around $7 per film. Well, 16 milligrams is the average dose so it would be two films.
`
`Unidentified Analyst
`
`Orexo price in the generic?
`
`Mark Sirgo
`
`Orexo price pretty much the same price point.
`
`Chris Caponetti - Morgan Stanley
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`Any additional questions? No. Perfect, well we’re just at the half right point so I think it makes
`sense to switch over to BEMA. We just had our session with Endo’s CEO and he said that we
`talked about organic growth in their business and one of the key drivers to Endo driving positive
`organic growth in their North American brand business is the commercialization of their
`pipeline. So Aviv which has recently launched their testosterone product but also BEMA which
`is obviously your pain drug that continues with your platform, so it is a high priority for Endo so
`it sounds like you have great partners committed there but I was wondering if you can just tell us
`a little bit more about what BEMA is? What makes it special? And talk us little bit more about
`your partnership with Endo.
`
`Mark Sirgo
`
`Sure. So really focus is on the molecule Buprenorphine is not get deep into the pharmacology but
`it’s the only next new agonist, anti-agonist in the opioid space all the other opioids you can think
`of are pure new agonist and it is because of that pharmacology that you have a different profile.
`But the most important thing I could say about Buprenorphine is that it has a very low propensity
`to cause euphoria and that’s why it is used to treat people that are addicted to opioids and that’s
`really the feature of why it is so significant for something to use to treat chronic pain. We’re
`getting benefits of the efficacy of an opioid, but it doesn’t come with all the side effect liability.
`
`So that’s really the presence that is creating and it is right now because the recent DEA decision
`to move Vicodin or hydrocodone combination products back to schedule two, Buprenorphine is
`the only meaningful schedule three narcotic and schedule three allows physicians to phone in
`their prescription and it also allows them to do that with refill. So the accessibility around the
`schedule three product is what really provides commercial opportunities and Vicodin had it, or
`the combination products had it, they don’t have it anymore. So there is really only meaningful
`product in that category right now is Buprenorphine so it’s just a huge opportunity for us, for
`Endo. This is the upside case scenario we all knew this was going to happen eventually we are
`not exactly sure of the timing and actually we all were just kind of surprised it came as early as it
`did and with a very short implementation period of 45 days, so, a fantastic opportunity for our
`partner and ourselves.
`
`Chris Caponetti - Morgan Stanley
`
`And in BEMA is for chronic pain, that’s correct?
`
`Mark Sirgo
`
`Correct.
`
`Chris Caponetti - Morgan Stanley
`
`And so why its scheduled three is so advantageous for chronic pain, aren’t these patients,
`shouldn’t they be going to their doctors regularly anyway?
`
`Mark Sirgo
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`Sure.
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`Chris Caponetti - Morgan Stanley
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`They’re just practically thinking about the benefit of being a schedule three for a chronic use
`drug?
`
`Mark Sirgo
`
`I don’t think there is any medical issue more prominent today than the concern over opioids and
`addiction to opioids. I mean everyday you’re reading an article at somewhere about another
`death, another overdose. So the fact is it’s not whether people visit the doctor, or don’t visit it’s
`really getting them a product that not only works but it is safe and we think Buprenorphine
`provides if you are going to use opioids it is the safest alternative. So in that realm I think
`physicians are looking for something that they can prescribe where they don’t worry about
`addiction, because once they’ve got somebody there it’s a real problem, they’ve all been there,
`none of them like it nor want it. So this gives them an option that they otherwise wouldn’t have
`had so tremendous upside potential here.
`
`Chris Caponetti - Morgan Stanley
`
`And on Endo’s last conference call they said that the second Phase 3 in the opioid experience
`patients exceeded their expectations. So what were the key surprises to the upside there that you
`saw?
`
`Mark Sirgo
`
`I mean, I guess we had different expectations perhaps but I always felt that this was a winner. I
`think there is no flaws in either of these studies and I think probably that’s what they were
`referring to. And when I say no flaws, I mean it’s just robust efficacy. There is not any safety
`signals with Buprenorphine it is extremely safe opioid. So I mean it’s pretty exciting. There is no
`overhang on this, right I think it’s going to be a solid NDA and I think FDA if I am them, I am
`looking for some alternatives to these other opioids. Let’s face it, opioids are going away. They
`work extremely well better than any other pain medication that I am aware of. But what we need
`to do is either better control how physicians prescribe them or give them some better alternatives
`and just think we’ve got one here.
`
`Chris Caponetti - Morgan Stanley
`
`And how about side effects? So things like constipation, nausea, vomiting. What did you show in
`your trials and then how does that compare to the oxys and the hydros?
`
`Mark Sirgo
`
`I don’t have the exact figures in front me but constipation for instance in both trials opioid
`experienced and opioid naïve it was somewhere around 5% or 6% which is about half of what
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`you see or even less than half of what you see with the other opioids that are usually in the 12%
`to 15% range. But here again it’s a mixed opioid. So you do expect to see a better profile we see
`typically less constipation, less respiratory depression which is extremely important. I mean
`that’s what kills people when they overdose on the opioids. In fact it’s well documented that
`Buprenorphine it’s a flat dose response, or in other words you can keep giving more and more
`Buprenorphine but you don’t get more respiratory depression. So difficult to kill yourself on
`Buprenorphine it’s certainly impossible but much less so than other opioids.
`
`Mark Sirgo
`
`Purdue has Butrans, in its fourth year of launch I know I think produce private so this is IMS
`data. $176 million, I think you’re targeting 5 million of peak sales right you’re still targeting 500
`million in peak sales. So what’s the difference there? How do we get beyond the 176 million to
`500 million?
`
`Mark Sirgo
`
`Yes sure, Butrans is a seven day transthermal patch and it’s a cumbersome way to try to treat
`chronic pain particularly in the early phases when you’re titrating patients to pain control, to try
`to do that on a seven day basis it’s very difficult. Not only that for the first two years of post
`launch they only had two strengths available, they just recently added third. So there is not a lot
`of flexibility within dosing, more problematic is the fact that they don’t go very high in the dose
`response curve. So our top dose gets plasma concentrations twice of what Butrans can do. So
`they have been limited in the types of patients they can actually treat that have more severe pain.
`So for all those reasons it’s performed at that level, I don’t know if it met exceptions for Purdue
`or not? But having said that what we hear about that profile which is less constipating, certainly
`less addicting, lower respiratory depressions, less cognitive impairment has played out in our
`market research when we talked to physicians that use it. And they also like it to use it in elderly
`patients because those are particularly problematic in elderly. So I think it’s been relatively well
`given the inflexibility of the dosage form.
`
`Chris Caponetti - Morgan Stanley
`
`So you have the data, you met with the FDA was it end of July?
`
`Mark Sirgo
`
`Yes.
`
`Chris Caponetti - Morgan Stanley
`
`You’re filling at the end of the year. What’s that gap? Why do you need that much time to file?
`
`Mark Sirgo
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`Well I think it’s more of a question for and/or answer than me but having said that there is a lot
`of information has to be integrated with these different trials overtime. And I guess I’ll just leave
`at that.
`
`Chris Caponetti - Morgan Stanley
`
`So 2016 we think we can have a launch?
`
`Mark Sirgo
`
`First quarter 2016, yes.
`
`Chris Caponetti - Morgan Stanley
`
`And how should we think about, will that be a robust trend do you think? Will it be slower…
`
`Mark Sirgo
`
`If the current environment is present where the it is see three space stays the way it is right now
`with the Vicodin products moving out and so on. I think it’s going to be a very robust launch, I
`sort of that would Endo wants to hear from me but I think it should be because it’s providing an
`opportunity to these physicians don’t currently have. So anybody stepping up from an non-
`steroidal inflammatory where that’s no longer controlling our chronic pain what do you go to.
`Meaning the past it was Vicodin, Tramadol or C2 opioid. So they never had this opportunity
`before to use an opioid that works as well as the C2s but with better side effect profile.
`
`Chris Caponetti - Morgan Stanley
`
`And is there any upcoming royalties that you receive or how should we think about any cash
`things with respect to payments from Endo?
`
`Mark Sirgo
`
`Next payment from Endo would be on milestone payments for the successful NDA filing there is
`$10 million payment behind that and then a $50 million payment upon the approval. So that
`would be -- if it works out next year that both of those things happen it would be $60 million.
`
`Chris Caponetti - Morgan Stanley
`
`And then just switching gears to the financials for a second. Can you remind us what your
`current cash position is, how we should think about SG&A next year going into the BUNAVAIL
`launch. I know you have a contract salesforce but I assume that spending will step up. So how
`should we think about your balance sheet uses of cash and then the company on its path to its
`profitability?
`
`Mark Sirgo
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`Sure. So end of the second quarter we had a roughly 80 million and we did the financing back in
`February raised 60 million, it was really to support the launch and to facilitate this planting
`program. So we are well funded around the launch burn for next year on the commercial side we
`are talking about $12 million for the salesforce roughly 60 people $200,000 per person another
`10, 12 on the marketing side. So all in commercial spend and probably in the $25 million, $27
`million range on an annualized basis behind BUNAVAIL.
`
`Chris Caponetti - Morgan Stanley
`
`And then in terms of any R&D, does R&D step down next year because…
`
`Mark Sirgo
`
`R&D is pretty level with this year and we did in the $25 million to $30 million range last year it
`was much more expensive we had two ongoing pivotals for Buprenorphine pain program but
`steps down this year but it should be consistent next year.
`
`Chris Caponetti - Morgan Stanley
`
`Got it and then -- oh sorry.
`
`Mark Sirgo
`
`Well I am just saying as we look ahead. If we have a reasonable launch for BUNAVAIL and if
`we keep the Endo program on the target and receive those milestone payments. By the second
`half of 2016, we should be getting very, very close to profitability as an overall organization.
`
`Chris Caponetti - Morgan Stanley
`
`To take a point to turn over it to the audience for any questions about BEMA so I think we have
`one right here. He’s getting you a mic.
`
`Unidentified Analyst
`
`Hi, could you actually just talk a little bit about Buprenorphine and compared to other because
`it’s been around for a long, long time. Obviously people have known about it. So why haven’t it
`been used for pain and what have been the impediments and why I don’t understand that it
`doesn’t cause the same kind of Euphoria but I mean what have been the prospects and almost it
`seems like if it’s taken this long to get here. You sort of asked yourself the question why has that
`been the case so maybe so just talk a little bit about the product itself, the molecule?
`
`Mark Sirgo
`
`Well, your point is well taken but it had its origins in Europe and if you talk to any physician that
`treats pain in Europe I think Buprenorphine would be on the top of their list for the exact reasons
`that I have described here in terms of its profile. In fact we did our early market research in
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`Europe because nobody knew about it in the United States. Record think brought the injectable
`product to the states I don’t know 15 years, 20 years ago but its benefits as a product or as a
`molecule aren’t well served in a hospital environment. So nobody ever knew about it, in fact our
`biggest struggle over the past five or six years it was really educating people on Buprenorphine
`whether it’s our BUNAVAIL product or the pain product but this profile once people actually
`get in front of it and understand it, they begin to see the benefits of the opportunity and again you
`can’t deny back that it’s different. DEA has classified as such I think it will continue to remain as
`such and as a fact you can use it both to treat someone who has become addictive to other
`opioids yet in a much lower dose give it as a chronic pain medication I think gives us the
`opportunity to really capture the benefits of both.
`
`So it’s clearly a unique molecule. The pain product is one tenth or one twentieth the amount of
`Buprenorphine that we find in BUNAVAIL. So it’s a very different product, there is no overlap
`in those doses. And I think the other thing is that the big pharma stays away from 505(b)(2) so it
`is not attractive to them. And then also stay away from drug delivery and Buprenorphine because
`of its inability to be absorbed well from the gastrointestinal track has to be given by some other
`mechanism so we had to put it in a transmucosal or a sublingual form. So there are a few
`companies that actually have expertise and I don’t want to do that. So I think for those reasons,
`it’s had a slow sort of uptake here on the learning curve but having said that I think we’re now
`getting traction. And I mean Endo saw this a number of years ago when they partnered with us.
`But I think it’s just took people time to sit down listen to the story a few times start to understand
`it.
`
`Chris Caponetti - Morgan Stanley
`
`That’s great. I think we are out of time. Mark, thanks so much.
`
`Mark Sirgo
`
`Yes, you are welcome. Pleasure. Thank you.
`
`Question-and-Answer Session
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`BioDelivery Sciences International, Inc. (NASDAQ:BDSI)
`
`Morgan Stanley Healthcare Conference
`
`September 9, 2014 4:40 PM ET
`
`Executives
`
`Mark Sirgo - President and CEO
`
`Analysts
`
`Chris Caponetti - Morgan Stanley
`
`Chris Caponetti - Morgan Stanley
`
`Thanks everyone for joining the BDSI session. I am Chris Caponetti and I encourage you to
`please visit morganstanley.com/researchdisclosures for disclaimers. With that it’s my pleasure to
`welcome Mark Sirgo, BDSI’s President and CEO to the stage.
`
`Let me tell you a little bit about Mark. He has over 30 years of experience in the pharmaceutical
`industry, including 16 years in clinical drug development, seven years in marketing, sales and
`business development and 12 in executive management positions. He’s been with BDSI since
`2004 and he also serves on the Board of Directors and is the Chairman of the Compensation
`Committee at Salix.
`
`Mark thanks so much for coming out today.
`
`Mark Sirgo - President and CEO
`
`You’re welcome, pleasure to be here.
`
`Chris Caponetti - Morgan Stanley
`
`Yes. So we’ll turn over to you for some opening remarks. You had your Investor Day last Friday
`which I understand was very well received by investors. So if you could just provide us with an
`
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`introduction to BDSI, the progress year-to-date, talk a little bit about your upcoming drug launch
`and any key takeaways from last Friday’s Analyst Meeting. That would be great.
`
`Mark Sirgo - President and CEO
`
`Yes thank you Chris. BDSI is a specialty pharmaceutical company. We use drug delivery to
`reinvent proven therapeutics. We’ve got two products now approved through FDA in the 10
`years I have been at the company. Most recently we had BUNAVAIL approved for the treatment
`of opioid dependence, which is a product that will compete with Suboxone. In that particular
`space, we have also had two very positive Phase 3 study results for BEMA Buprenorphine
`chronic pain product that we’ve got part of a vendor pharmaceuticals first study read out in
`January and the second one read out in June, NDA scheduled for submission late this year
`hopefully no later than in January ’15. And we had an interim analysis on our first Phase 3
`pivotal trial for Clonidine Topical Gel which was a positive signal and we’re adding a few more
`patients to that trial, but it should have read out sometime first quarter of next year. So we
`continue to focus in pain and addiction medicine using drug delivery also falling to 505(b)(2)
`regulatory pathway where we can reference the originating companies pre-clinical data. And I
`think we’ve done it effectively through our first two approvals.
`
`Chris Caponetti - Morgan Stanley
`
`That’s a great introduction. So I wanted to start off on BUNAVAIL if we can. Just the
`commercialization plans in your marketing strategy for that product. How many sales reps, what
`physicians, what geographies are you targeting that sort of things?
`
`Mark Sirgo - President and CEO
`
`Sure. The nice thing about this category is that it’s really consolidated geographically and in the
`physician base as well there is about 5,000 physicians that treat opioid addiction and 80% of the
`business is consolidated East to the Mississippi. And because of such small group of physicians
`you can cover with a small number of sales representatives. So for a company like us launching
`our first product, it’s very manageable in terms of the commercial spends, we’re going to have
`about 60 sales people for regional managers and two individuals, one at Quintiles because this is
`a contract