Good day, ladies and gentlemen, and welcome to the Collegium Pharmaceutical, Inc. Second Quarter 2016 Earnings Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. [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 risks 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 infringement litigation relating to Xtampza and may in the future be subject to additional litigation relating to our product candidates which may be expensive to depend 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 would 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. 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 receive the 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 for study comparing the effect of crushing Xtampza ER versus OxyContin and an immediate release oxycodone and intent to file this data and the supplemental NDA by the end of this year. We reported positive proof of concept data on our Hydrocodone DETERx ER candidate and working on designing the full clinical development program within additional study to be – by the end of the year. We in-licensed the U.S. 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 the potential launch in the second half of 2017. We also reported that we receive notice of pending allowance of our first European patent and continued to aggressively build out pattern state to ensure that we have long term protection at 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 a launch and Barry will provide some additional detail. After winning the patent…

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 supports the pain patients, out-patient 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 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 prescribing. Some examples to name just a few includes showing 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 payors 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 the July, while majority 63% of Xtampza prescriptions are for commercial patients, we have also seen Part D and Medicaid prescriptions. Approximately 70% of the patients started on Xtampza were transitioned from immediate release opioids and 30% were changed from another extended-release opioids mostly OxyContin. While I again caution it's very early, this data…

Thanks, Barry. Good afternoon, everyone. As of June 30 our cash balance was $110.7 million compared to our December 31 cash balance of $97.5 million. Cash burn increase during the second quarter due to higher net loss to $2.5 million upfront fee paid to be 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 sufficient to fund our operations since 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 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 cost related to the preparation for the commercial launch of the Xtampza including hiring approximately190 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, charge-backs and returns during the launch we expect to recognize revenue based on the sell-through method which recognizes revenue based on patient level prescription data. I will now turn the call back over to Mike Heffernan.

Thanks, Paul. We will open it up now for questions.

[Operator Instructions]. Our first question comes from the line of Tim Lugo from William Blair. Your question please.

Hi guys. Thanks for all the details for the early kind of launch feedback, and 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 hospital you have had interactions with, and what is the time frame before you really start to get any sort of penetration into hospital settings or at least the initial ramp in hospitals?

Yes, thanks, Tim. This is Barry. I will take that. So we've seen 75% of those priority A physicians at this point. So we have actually had meetings, conversations with 75% and again average 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 are 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 brand. So we're in negotiations and discussion with them right now, so we could see some update 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 traditional IMS, TRX data. So we will have to find other ways to report that to you as we get little clear on what is happening there.

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

Yes, I'll take that. This is Mike, thanks, Tim, for the question. So as we talked about we would launch into the summer but we spend 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 what vacations so on, and we felt like we needed to be out there for that. We also, as you know, have new sales force, that's not likely been calling 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 payor environment over time, payors are now some large payors have changed their policies even this year where they no longer will cover a new product as a default. They will cover it as -- they will not cover it as a default. And that doesn’t mean that we're not going to be on contract, but it means that we will take little bit of time to get that taking care of. And then clearly the availability of our sales and marketing materials and our ability to use the primary launch, 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 got a full promotion material out there, we've got a full speaker programs out there and our reps have seen the doctors, our target is five to seven times, we are going to have a pretty good indication of the future of Xtampza.

Okay. Understood. And have you heard any, I guess, negative patient experience from the patients that have been prescribing Xtampza, has there been any feedback that's kind of product specific outside of obviously the difficulties in the first five weeks of the summer launch with no marketing materials et cetera?

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 out pharmacy or needed prior authorization and we’re working through those types of things with our hub services and our co-pay program and working with physicians and 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 physician will use how the product stock. As you might imagine or if you look at what’s changed kind of in the world opioids, big chains don’t auto shift and auto stock opioids anymore. So what that means is retail pharmacies typically will not order the product until they seen the script. So that’s a big part of our process its making sure that all the basis are touched so that when the doctor writes the scripts, they patient can get the script at the retail pharmacy and that can get reimbursed in copay program can work. So greasing that whole process is a very important part of what we were doing right now.

Thank you. Our next question comes from the line of David Amsellem from Piper Jaffray. Your question please.

Hi, guys this is Sameer on for David, just a few quick ones here. Can you remind how we should be thinking about gross net spreads for the TENS ER over the long term and what portion of the underlying target market are commercialize versus Medicare? Also, can you talk more about your dialog with the long term and assisted living facilities and any color on potential contract with larger customers in that area? Thank you.

Okay, let me start at the top make sure I get all your questions answered. So on the gross to net we obviously haven’t given guidance what I think what we said so far it is very, very early for us to tell as. Our gross to nets are going to be relatively high on launch because we’re going to be having number of patients with prior authorizations using copays and the like and working on our coverage. We think and what we said at our Analyst Day that these products were settle out in the 40% range longer term but it’s going to take some time to get there. So 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 its very early in that process we just, as Barry mentioned, got access for PharMerica and Omnicare pharmacies with contracting. So its early for us to really understand what the uptick is going to be, but when people look at the product attributes its ability to be sprinkled for patients with the dysphagia, patients who have feeding tubes, patients who can’t swallow pills, patients who have chronic pain in the current issue of diversion in the nursing home, the product really is the natural for that market, and so we are doing the 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 sort of the commercial percentage of the lives et cetera, it’s very similar to which you see in the broad pain market, we are expecting sort of 60:30:10, 60% commercial, 30% Part D, 10% kind of other which includes Medicaid and cash patients.

Okay, perfect and then – yeah that’s it. Thank you.

Okay, thank you very much.

Thank you. Our next question comes from the line of Serge Belanger from Needham and Company. Your question please.

Hi, good afternoon. First question for Mike. I think in your opening comments you mentioned that you’re planning to file supplemental NDA by the end of the year, I assume it’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 issue will take to approve?

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

Okay, and well that trigger an additional -- obviously that you have to update 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 FDA and 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 number of people behind us. So again, I think we're a little bit of kind 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 and you look at their promotional messages, they are 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 is available in our label, that is new to the FDA. Again, we didn’t think we are 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 that you were planning an NDS filing for Canada, just want to know the timing around that and what kind of I guess sales force would be required for that territory?

Yes so we will file the NDS in Canada in Q3, we are in the final close of putting that together now, we have already had a pre-NDS meeting. We have not made a strategic decision of whether we would sell ourselves or whether we would partner in and 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.

Thank you.

Thank you. [Operator Instructions]. Our next question comes from the line of Ken Trbovich from Janney. Your question please.

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 sort of counter detailing efforts and if you could give us a sense to where Purdue stands with regarding 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 other competitors. So it's been so far relatively quiet as far as the counter detailing.

Got it. And just for comparative purposes can you give us a sense of the relative scale I know in the past certain times Purdue sales organizations sort of in that 500 plus range, I just didn't know where it is today or roughly?

Yes, so we don’t know the exact number of sales reps, it is our belief that it's in the range of 500, I think that is probably a pretty good number, how they allocate that 500 people across their product mix is again something that we're not necessarily privy to and obviously the size of our sales organization. Just as a comment on that, obviously produce calling out 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 that line.

Sure. And then specifically I guess for Paul the question about how to track the hospital and long-term care, I mean obviously you talked about using the pull through for revenue recognition for Collegium's purposes, but is that data can't be captured by IMS or Symphony how will you make that determination on that sort of segment on the market in terms of revenue recognition?

Yes, so we'll spend a lot of time with our commercial ops team analyzing data and we will 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. And 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, so the upfront was capitalized and it will be amortized over the life of patents, now there is 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. Yes. So gets start over that.

And then the subsequent milestone that's owed, I think it's $4 million?

Yes, now would get on approval it would get spread over the same life.

Got it. The same life. Okay. And then Mike I guess you opened in the commentary with the 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 sort of push that because state by state obviously creates huge challenges not just from a sales and marketing perspective but obviously from a payor 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 sort of step edit exist because I think lot of folks misunderstand sort of lip service the payors make with regard to abuse-deterrent opioids but it certainly not backed reimbursement practices?

Yes, so let me start with the federal legislation. We are, as are a number of other companies of 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 are being paid for line extensions of ADF opioids and that was successful. The second primary thing is trying to get legislation around and effort around making sure that CMS makes available both on Medicare and Medicaid through their programs ADF opioids as a real option. So that's where we spend most of our time. As it relates to step edits, there is, as you probably know lots of level of steps edits. There is what we call soft PAs or soft edits and hard edits. The softer edits are you 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 is the next step in some cases. And before it didn’t go to an ER opioid. And then another common step you will see if 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 physician. So each plan, each organization and each plan within the organization are different. And 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 are not disadvantage for any one of these step edits.

Got it. And then can you give us senses to as to sort of where you think from a covereds perspective and then you said 70% of lives, wasn’t clear to me whether that was 70% commercial, 70% of total but could you give us a senses to whether or not you see any preferential treatment or bias us against Xtampza relates to the step edits thus far?

Yes, so we as to early to for us to see why this is all going to play out. One of the issues launching into July as you end up in 2017 conversation and because they lot of times, have already negotiated their 2016 situation. So we have not seen, as a matter of effect I would argue see other way around. We had a lot of interest in Xtampza, a true understanding of the difference in the product and willingness to have a conversation about where Xtampza fits on that formulary. And then there is a individual business decision as to be made about what kind of rebate we’re willing to pay for a Tier 3 status or Tier 2 status and what level of edits. So that 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. And then last question are there any post marketing studies I know obviously this data that you are submitting with this sNDA is obviously extremely important but are there any other sort of post approval marketing studies that you have planned, you think would be importance to the commercial strategy longer term?

Yes, we have a strategy around post marketing studies and we haven’t talked about what those are specifically to-date but if you think about some of the differentiation of the product in dysphagia and nursing home patients and cancer pain patients and so on, those are the types of areas that we're interested in.

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 would 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.