Collegium Pharmaceutical Inc (COLL) 2016 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Collegium Pharmaceutical, Inc., second-quarter 2016 earnings conference call. (Operator Instructions)

Before we begin today's call, we wish to inform participants that the forward-looking statements made today are pursuant to the Safe Harbor provision of the Private Securities Litigation Reform Act of 1995. You are cautioned that such forward-looking statements involve risks and uncertainties including and without limitation to the risk that we will not be able to successfully commercialize Xtampza ER and achieve the rate and degree of market acceptance for Xtampza ER. Furthermore, we are subject to patient (sic - see press release, "patent") infringement litigation relating to Xtampza and may in the future be subject to additional litigation relating to our product candidate, which may be expensive to defend and delay the commercialization of Xtampza or our other product candidates. These risks and other risks of the Company are detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission. Our future results may differ materially from our current expectations discussed today.

Now I'd like to hand the program over to Mike Heffernan, Chief Executive Officer. Please go ahead.

Thank you. Good afternoon. I'm Mike Heffernan, CEO of Collegium, and with me today is Paul Brannelly, our CFO, who will review the Company's financial results, and Barry Duke, our Chief Commercial Officer, who will provide an update on our commercial launch of Xtampza ER, our abuse-deterrent extended-release oxycodone for the treatment of chronic pain.

The second quarter has been extremely productive at Collegium. We received FDA approval on April 26 with what we believe is the most comprehensive abuse-deterrent label of any ADF product approved to date.

We released positive top-line data from a study comparing the effect of crushing on Xtampza ER versus OxyContin and an immediate-release oxycodone control, and intend to file this data in a supplemental NDA by the end of this year. We reported positive proof-of-concept data on our hydrocodone-deterrent ER candidate and are working on designing a full clinical development program with an additional study to be started by the end of the year.

We in-licensed the US rights for ONSOLIS, an FDA-approved product for the treatment of breakthrough cancer pain. The manufacturing site transfer for that product is on track for an early 2017 FDA filing, with a potential launch in the second-half 2017.

We also reported that we received notice of pending allowance of our first European patent and continue to aggressively build our patent estate to ensure that we have long-term protection of the DETERx franchise. We are also working on our NDS filing in Canada, which is on track for a Q3 submission.

The most significant milestone of the second quarter was the commercial launch of Xtampza the week of June 20, the last week of the quarter. I will provide high-level observations on the launch, and Barry will provide some additional detail.

After winning the patent infringement Purdue lawsuit in February and subsequently receiving the final FDA approval at the end of April, we made a decision to move quickly and launch at the beginning of the summer. As you may recognize, launching into the summer, with holidays and vacations looming, is not ideal; but waiting until the fall was not either.

Our goal was for our sales organization to start setting up appointments and meeting with our physician targets as soon as possible, knowing that approximately 50% of our sales organization was either new to the pain field or new to their geography. Changing physician behavior typically takes five to seven calls, so the sooner we started the process of introducing clinicians to Xtampza ER the better, especially knowing that we have approximately 11,000 total targets, with 3,700 being high-priority or A targets.

We also needed to obtain full FDA approval prior to being able to finalize contracting with many wholesalers, retailers, GPOs, and payers. Since our approval at the end of April, we are encouraged with the progress that we have made in contracting at this early days of launch, and as the year progresses we expect to announce contract wins across all three segments of our business: outpatient pain clinics, hospitals, and long-term care facilities.

One issue that we did not anticipate is the length of time it would take the FDA Promotional Review Division to provide feedback on our launch marketing and sales material. We submitted our launch materials on May 3, just one week after the final label was approved. To date, we have not yet received feedback from the FDA.

Prior to FDA approval, we made the decision to voluntarily submit our materials for feedback to the FDA, in the spirit of our Company mission of focusing on responsible opioid prescribing, and we were initially told that the review period would be weeks. Collegium and the FDA staff significantly underestimated the amount of time it would take to get full alignment within the FDA, likely due to the meaningful differences in the Xtampza ER label versus all other previously approved ADF products.

Not having FDA-approved promotional materials means that our commercial organization has had to promote Xtampza only using a package insert. We also have not been able to kick off any of our major launch programs, including speaker programs, educational programs, etc. Based upon our weekly communication with the FDA, we now expect to have their feedback in the coming weeks and are prepared to rapidly revise our draft promotion materials to incorporate their advice.

We are now five weeks into the launch. Our sales organization consistently reports receiving very positive feedback on the product from clinicians they are calling on.

I, along with a number of members of our management team, have spent time in the field gauging this initial reaction. Based upon the overall feedback, we remain very optimistic that Xtampza ER will be a meaningful product for patients with chronic pain due to its unique attributes.

As we discussed prior to our launch in May at our Analyst Day, the initial launch period will be slow and steady. As clinicians gain experience with the product we expect to see acceleration of adoption, as they try a few patients at a time on Xtampza ER and way to get feedback prior to broadening their use. It has been our expectation that it will not be until later in the fall, after we initiate the full promotional and educational launch program, that you will start to see significant growth in scripts.

Now just a few words on the abuse-deterrent market in general. Today, only 21% of the extended-release opioid scripts are for ADF products. That means almost 20 million prescriptions per year are for non-ADF extended-release opioid.

I believe that we are finally beginning to reach an inflection point in the ADF market. There are 23 states that initiated legislation in 2016 and five states that have enacted laws to require some form of parity in reimbursement by payers between ADF and non-ADF opioids. This is a clear recognition of the importance ADF opioids play in a multidimensional strategy to address the epidemic of prescription and illicit opioid abuse.

This along with the potential for three additional ADF opioids to be approved this year, based on recent positive FDA Ad Com votes, means that the overall level of communication will be dramatically increasing regarding ADF opioids, with the long-term goal of converting all 25 million ER opioid prescriptions a year to ADF formulations.

I will now turn it over to Barry to provide some additional details on the commercial launch.

Thanks, Mike. As Mike noted some of the expected and unexpected elements of our launch, I will provide an update on our progress, key indicators, and near-term next steps for the commercial organization. As we have communicated previously, our commercial model is one integrated around the three channels that support the pain patient: outpatient pain clinics, hospitals, and long-term care. We have seen early collaboration from our teams as we have identified opportunities that otherwise could be missed without this coordination.

In fact, just yesterday we heard about a partnering example between an outpatient pain clinic representative and a long-term care representative who call on the same physician target, who sees patients in both his office and in the long-term care facilities, resulting in the physician choosing to treat 10 patients at two different long-term care facilities with Xtampza. We have had early glimpses of success in each channel, and I will comment more on that in a moment.

Much of our initial launch focus has been on the blocking and tackling activities necessary to support sustainable, long-term Xtampza subscribing. Some examples, to name just a few, include shoring up the distribution network -- we now have stocking at all the major and mid-tier wholesalers; facilitating retail and long-term care pharmacy stocking; fine-tuning our patient hub support services; engaging with important payers regarding more permanent access status -- more to come on that in a minute; and ensuring Xtampza addition to the multiple e-prescribing platforms.

Through the end of July, while the majority, 63%, of Xtampza prescriptions are for commercial patients, we've also seen Part D and Medicaid prescriptions. Approximately 70% of the patients started on Xtampza were transitioned from immediate-release opioids and 30% more change from another extended-release opioid, mostly OxyContin. While I again caution that it's very early, this data is consistent with what we would have expected.

It's important to note that hospital and long-term care utilization will unlikely show up in IMS data, though some long-term care prescriptions will and actually already have shown up there. We will keep you advised as we move forward and gain a better understanding of the channel mix, and we'll report on the different data sets for these channels.

In the outpatient pain clinic setting through the end of July, we've made over 16,000 physician calls and reached 60% of our 11,000 targets, with some of the challenges that Mike noted regarding time of year, etc., in reaching a larger percentage of that group. Importantly, we have reached 75% of our high-priority A targets, with an average frequency of just over two calls to date.

Frequency is an important metric as it typically can take five to seven calls, as Mike mentioned, to get an interested physician to turn good intent into action with an initial prescription. It can take one to three months or more, depending on access to the physician, to reach that level of frequency.

Early feedback and reaction to Xtampza has been positive and consistent with what we had heard through market research and Advisory Boards. We've been encouraged by the fact that the sales representatives report that first sales calls with providers have been much longer than what they had been accustomed to in this outpatient clinic setting, as providers are intrigued by the differentiated label and novel technology.

The only consistent objection question raised focuses on the physician's perception of poor access, market access coverage, for any new product. Of course, we offer a competitive co-pay program and a patient hub service in an effort to mitigate this concern.

Based on standard industry reporting services, Xtampza launched coverage for commercial lives at 70%, and we are currently in active negotiations with approximately 15 or so payers and PBMs, both on the commercial and Part D sides as we aim to open up more permanent access for Xtampza. We are encouraged by early discussions and hope to have more specific views as we move forward in the year.

For the hospital and long-term care channels, early feedback has been very positive. Customers react favorably to the flexible administration attributes and lack of dose dumping after common manipulation techniques with Xtampza. Diversion is also an important concern at the executive suite levels within these institutions, and the novel DETERx ADF features are recognized as different from other extended-release opioids.

We have already seen examples of hospitals stocking Xtampza and adding it to the formulary. We have ongoing discussions in several larger hospital systems regarding making Xtampza ER a preferred addition to their formulary.

We continue to work closely with them and support with education (technical difficulty) stakeholders. While our hospital team has over 500 target hospitals, they are focusing on the top 200 target hospitals during the early launch period, having reached 175 of them to date.

Xtampza has just recently, within the last couple weeks, been made available through the ordering channels for Omnicare and PharMerica, which together provide pharmacy services for 60% of the long-term care market. We continue to be bullish on the prospects within long-term care, as our experienced sales team has made positive progress since launch in laying the foundation necessary with pharmacy providers, physicians, and long-term care facilities to pull through Xtampza prescriptions in this channel.

We have had some early adoption in this channel already and have seen long-term care pharmacy providers purchase inventory. We look forward to reporting more on our progress in this setting later in the year.

Regarding next steps, we will continue to focus on expanding our reach and frequency with our target physicians. Assuming we receive FDA feedback within the next few weeks, we look forward to soon having our full launch promotional marketing materials and sales aids to drive message recall and impact, including our XtampzaER.com website and other digital assets. We are currently fielding message recall research and will use that feedback to fine-tune our approach.

Peer-to-peer speaker programs are important tools in driving adoption with launches; and they, too, have been on hold as we await FDA response. We will have trained over 100 speakers by mid-August and expect to conduct multiple programs per territory, both in-office virtual programs as well as traditional dinner programs, over the rest of the year. We will attend and display at Pain Week in September and have a number of activities and interactions planned there.

We are adding headcounts to support our national account level activities in the long-term care and hospital channels. Finally, as mentioned earlier, we will continue to focus on expanding access both with commercial and Part D plans.

We on the commercial team recognize that we are only in the early stages and are most excited about the future with Xtampza. Now let me turn it over to our CFO, Paul Brannelly.

Thanks, Barry. Good afternoon, everyone. As of June 30, our cash balance was $110.7 million compared to our December 31 cash balance of $95.7 million. Cash burn increased during the second quarter due to higher net loss, the $2.5 million upfront fee paid to BDSI for the ONSOLIS license, as well as initial stocking at wholesalers that have 90-day payment terms. We believe that our existing cash resources are sufficient to fund our operations into early 2018, including the commercial launch of Xtampza as well as the continued clinical development of our second product candidate, hydrocodone DETERx.

For the second quarter of 2016, our net loss was $24.5 million compared to $4.7 million for the second quarter of 2015, resulting in a net loss per share of $1.05 and $0.45 for 2016 and 2015 quarters, respectively. The large increase in our net loss is primarily due to costs related to the preparation for the commercial launch of Xtampza, including hiring approximately 190 employees this year, as well as the initiation of additional clinical trials for Xtampza and our hydrocodone product candidate.

The net loss included stock-based compensation of $1.4 million for the second quarter of 2016 versus $601,000 for the second quarter of 2015.

As of June 30, we've recorded $3.9 million of deferred revenue on our balance sheet for inventory shipped to major wholesalers. Since we lack the history required to estimate items including rebates, chargebacks, and returns, during the launch we expect to recognize revenue based on the sellthrough method, which recognizes revenue based on patient-level prescription data.

I will now turn the call back over to Mike Heffernan.

Thanks, Paul. We'll open it up now for questions.

(Operator Instructions) Tim Lugo, William Blair.

Hi, guys. Thanks for all the detail for the early launch feedback. Maybe digging more into that forum, I think you mentioned 3,700 priority targets. How many of those have your reps actually been able to meet with?

And can you also repeat the hospital number? I think you mentioned the number of hospitals you've had interactions with. And what is the time frame before you really start to get any sort of penetration into the hospital setting, or at least the initial ramp in the hospitals?

Yes, thanks, Tim; this is Barry. I'll take that. We've seen 75% of those priority A physicians at this point, so we've actually had meetings, conversations with 75% and again averaged just over two times with those doctors.

Regarding hospitals, our big target is 500 hospitals, but we really narrowed it down to 200 that we're going to focus on during the early launch stage to really get some traction. And yes, the hospital environment is a little bit slower, just because you have to go through the P&T additions, so I wouldn't expect any real traction there broadly until six months or so.

But as I noted in my comments, we have actually had three really large systems come to us and already begin talking to us about putting Xtampza on its preferred brands. We're in negotiations and discussions with them right now, so we could see some uptake sooner in that space.

That's interesting. And that probably won't be flowing through the script services, right?

That's right. You wouldn't see that in the traditional IMS, TRx data, so we'll have to find other ways to report that to you as we get a little clearer on what's happening there.

All right, thanks. That's helpful. For those of us who do follow the weekly scripts, when do you think we should have a good sense of the true uptake in the market? Will it be as we exit the summer and you get your launch materials approved and out to a force in the fall? Or should it be -- maybe we even look for a Q1 2017, I guess, ramping?

Yes, I'll take that; this is Mike. Thanks, Tim, for the question. As we talked about, we launched into the summer. We spent a lot of time internally talking about whether that was the right thing to do or not, knowing it was going to be more difficult getting -- with vacations and so on. We felt like we needed to be out there for that.

We also, as you know, have a new salesforce. It's not like we can call on these pain care specialists for a number of years with other products and can add this one to the bag.

So, with all that being said, including a changing payer environment over time, payers are now -- some large payers have changed their policies even this year, where they no longer will cover a new product, as a default. They'll not cover it as a default. That doesn't mean that we're not going to be on contract, but it means that it takes a little bit of time to get that taken care of.

Then, clearly, the availability of our sales and marketing materials and our ability to use the primary launch tools, all of these things, again, are part of the mix. But to answer your question directly, I can't tell you exactly because we don't know; but my guess is that come late fall when we've got our full promotional material out there, we've got our full speaker programs out there, and our reps have seen the doctors, our targets, five to seven times, we're going to have a pretty good indication of the future of Xtampza.

Okay, understood. Have you heard any negative patient experience from the patients that have been prescribed Xtampza? Has there been any feedback that's product-specific? Outside of, obviously, the difficulties in the first five weeks of a summer launch with no marketing material, etc.

Yes, I mean I think from a therapeutic standpoint we don't have a lot of feedback. We just haven't had enough prescriptions to get feedback.

I think what we typically hear, as Barry mentioned, is somebody had difficulty getting it at a pharmacy, or needed a prior authorization. And we're working through those types of things with our hub services and our co-pay program and working with physicians.

Our reps spend a lot of time working with the targeted physician who is interested in prescribing Xtampza and working very closely to make sure that the pharmacies that that physician will use have the product stocked.

As you might imagine, or if you look at what's changed in the world of the opioids, big chains don't auto-ship and auto-stock opioids anymore. So what that means is retail pharmacies typically will not order the product until they've seen a script.

So that's a big part of our process, is making sure that all the bases are touched, so that when the doctor writes the script the patient can get the script at the retail pharmacy, and that it can get reimbursed and the co-pay program can work. So greasing that whole process has been a very important part of what we're doing right now.

Great. Thanks for all the detail.

David Amsellem, Piper Jaffray.

Hi, guys. This is Sameer on for David. Just a few quick ones here. Can you remind us how we should be thinking about gross net spreads for Xtampza ER over the long term? And what portion of the underlying target market are commercial lives versus that are on Medicaid?

Also can you talk more about your dialogue with long-term and assisted living facilities? And any color on potential contracts with larger customers in that area. Thank you.

Okay. Let me start at the top, make sure I get all your questions answered. On the gross to net, we obviously haven't given guidance. I think what we said so far -- and it is very, very early for us to tell -- is our gross to nets are going to be relatively high on launch, because we're going to be having a number of patients with prior authorizations using co-pays and the like and working on our coverage.

We think, and what we said at our Analyst Day, that these products will settle out in the 40% range, longer term. But it's going to take some time to get there.

The second question was -- well, I'll jump through the different questions. In terms of long-term care discussions, we have a very experienced long-term care sales organization that we hired who had long-term relationships with a number of the larger providers. And again, it's very early in that process.

We just, as Barry mentioned, got access at PharMerica and Omnicare pharmacies with contracting. So it's early for us to really understand what the uptake's going to be. But when people look at the product attributes -- its ability to be sprinkled for patients with dysphasia, patients who have feeding tubes, patients who can't swallow pills, patients who have chronic pain -- and the current issue of diversion in the nursing home, the product really is a natural for that market.

So we're hearing a lot of positive feedback. We now need to convert that into sales in that channel. The other two questions were?

I think one was related to the commercial percentage of the lives, etc. It's very similar to what you see in the broad pain market. We're expecting 60/30/10: 60% commercial, 30% Part D, 10% other, which includes Medicaid and cash patients.

Okay, perfect. Then -- yes, that was it. Thank you.

Serge Belanger, Needham & Company.

Hi, good afternoon. First question for Mike, I think in your opening comments you mentioned you were planning to file a supplemental NDA by the end of the year. I assume that's going to include the comparative study with OxyContin.

Is there anything else that's going to be part of the supplement? And how long do you think the FDA will take to approve?

Yes, so the supplement approval time will typically be a 10-month approval time. As it relates to what else we're going to put in there, we're not going to publicly talk about that at this point in time, for competitive reasons. But you can assume that the competitive data with OxyContin will be part of it.

Okay, and will that trigger an additional -- obviously, you'll have to update your promotional material again. Will that involve another cycle of review for those materials?

Assuming we get approval with those additional -- that additional data in the label, we would certainly look to promote that information. And yes, we would likely voluntarily submit that to the FDA.

Again, I think the FDA is going to have a lot more experience over the next 12 months on abuse-deterrent claims, as we come to market as well as a number of people behind us. So, again, I think we're a little bit of the first person there.

When you look at the other abuse-deterrent opioids that have been in the market so far, like Hysingla and OxyContin and so on, when you look at the promotional messages, they're really not focused around the abuse-deterrent aspects of the product. Clearly with our label, and some of the unique aspects of the product, we would like to focus our promotional message around unintentional misuse, because of the lack of dose dumping on crushing, chewing, and breaking, and some of the PK data that's available in our label. That is new to the FDA.

Again, we didn't think it was going to take this long, and I don't think they did either. But with that said, I would hope it would not take the same length of time if we went back again. But you never know.

You also mentioned you were planning an NDS filing for Canada. Just wanted to know the timing around that and what kind of salesforce would be required for that territory.

Yes. We will file the NDS in Canada in Q3. We are in the final throes of putting that together now. We have already had our pre-NDS meeting.

But we have not made a strategic decision of whether we would sell it ourselves or whether we would partner it. We certainly have some time to make that decision because the approval time will be 12 months in Canada. So that is something that we're currently evaluating and looking at our options.

Okay, thanks for the details.

(Operator Instructions) Ken Trbovich, Janney.

Thanks for taking the question. I think from my perspective, I know it's quite early, but I'm curious to hear if at all there has been any counter-detailing effort, and if you could give us a sense for where Purdue stands with regard to the size of their sales organization at this point.

Yes. Hey, Ken; this is Barry. No, it's really funny; we haven't heard a lot broadly in the market from really any of the competitors. So it's been so far relatively quiet as far as the counter-detailing.

Got it. Just for comparative purposes, can you give us a sense as to relative scale? I know in the past there have been times Purdue sales organization is in that 500-plus range, and just didn't know where it is today, or roughly.

Yes. We don't know the exact number of sales reps. It's our belief that it's in the range of 500; I think that's probably a pretty good number. How they allocate those 500 people across their product mix is, again, something that we are not necessarily privy to.

And obviously you know the size of our sales organization. Just as a comment on that, obviously Purdue is calling on a lot broader audience than us.

Our strategy has been to call on 11,500 doctors who make up 55% of the extended-release opioids, so these are high productivity doctors who write lots of ER and IR scripts, versus going broader to people who would be less productive and lower decile.

Sure. Then specifically I guess for Paul, the question about how to track the hospital and long-term care. Obviously, you talked about using the pull-through for revenue recognition for Collegium's purposes.

But if that data can't be captured by IMS or Symphony, how will you make that determination on that segment of the market in terms of revenue recognition?

Yes. We'll spend a lot of time with our commercial ops team analyzing data, and we'll provide guidance to analysts and investors on how to help calculate that, based on what becomes publicly available with Symphony and IMS. So whatever the differential rate is, we'll help provide some guidance there.

Got it. Then with regard to another accounting question, the upfront and the future milestone payment on ONSOLIS, how should we think about the accounting for those from a Collegium perspective?

Yes. The upfront was capitalized and it will be amortized over the life of patents. Now, there's a patent that could issue over the next handful of months that would change that. But the initial patent expires in 2020 -- or January 2021, so it gets spread out over that period.

And then there's a subsequent milestone that's owed? I think it's a $4 million.

Yes, and that would get -- on approval it would get spread over the same life.

Got it. The same life? Okay. Then, Mike, you opened in the commentary with a discussion about state-level legislative efforts to ensure reimbursement for abuse-deterrent opioids. I'm curious about legislation at a federal level and efforts maybe even among trade associations to push that. Because state-by-state obviously creates huge challenges, not just from a sales and marketing perspective, but obviously from a payer perspective as well.

Can you give us a sense as to whether or not you see efforts in that regard, and then help us to understand what step edits exist? Because I think a lot of folks misunderstand lip service that payers make with regard to abuse-deterrent opioids but it's certainly not backed by their reimbursement practices.

Yes. Let me start with the federal legislation. We are, as are a number of other companies with ADF products, very active in Washington as well as at the state level. We have a person who is dedicated to that effort.

I think a lot of the effort right now on the federal side was really around CMS and figuring out how CMS could put rules in place, one, to make sure that rebates aren't being paid for line extensions of ADF opioids, and that was successful. The second primary thing is trying to get legislation around -- an effort around making sure that CMS makes available both on Medicare and Medicaid through their program ADF opioids as a real option. So that's where we spend most of our time.

As it relates to step edits, as you probably know there's lots of levels of step edits. There's what we call soft PAs, or soft-edits, and hard edits.

The softer edits are you've got to ensure that the person has chronic pain; we think that's good medicine. You have to ensure a patient has taken an IR opioid as the next step, in some cases, before they can go on an ER opioid.

Then another common step you'll see is somebody has to fail an extended-release generic non-ADF opioid. And then the next level is somebody has to fail a brand of some sort and in some cases, two brands; and those are typically things that people have paid for that preferred position.

So each plan, each organization and each plan within the organization are different. So as you can probably imagine, it's a pretty complex process of making sure that you can contract in each one of these large plans to make sure that you're not disadvantaged for any one of these step edits.

Got it. Then can you give us a sense as to where you think from a coverage perspective -- I know you said 70% of lives. It wasn't clear to me whether that was 70% of commercial or 70% of total. But could you give us a sense as to whether or not you see any preferential treatment or bias against Xtampza as it relates to the step edit before?

Yes, it's too early for us to see where this is all going to play out. One of the issues, as you know, launching into July is you end up in a 2017 conversation, because they have a lot of times have already negotiated their 2016 situation.

So we have not seen -- as a matter fact, I would argue it's the other way around. We've had a lot of interest in Xtampza, a true understanding of the difference in the product, and a willingness to have a conversation about where Xtampza fits on that formulary.

And then there's an individual business decision that has to be made about what kind of rebate we're willing to pay for Tier 3 status or Tier 2 status, and what level of edits. So those, as Barry said, we are in conversations with a significant number of lives, and our goal is to get unrestricted access. Not just to get covered lives, but unrestricted access, and that's going to take a little bit of time.

Got it. Then last question, are there any postmarketing studies -- I know, obviously, this data that you're submitting with the sNDA is obviously extremely important, but are there any other postapproval marketing studies that you have planned that you think would be important to the commercial strategy longer term?

Yes, we have a study around postmarketing studies. We haven't talked about what those are specifically to date.

But if you think about some of the differentiation of the product in dysphasia, nursing home patients and cancer pain patients and so on, those are the types of areas that we're interested in.

Okay, terrific. Thank you.

Thank you and this does conclude the question-and-answer session of today's program. I'd like to hand the program back to Mike Heffernan, CEO.

I'd like to thank everyone for joining the Collegium conference call today and we will continue to keep you updated on our progress. Thank you very much.

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.