Michael Heffernan - President and Chief Executive Officer Paul Brannelly - Executive Vice President and Chief Financial Officer Barry Duke - Executive Vice President and Chief Commercial Officer.

David Amsellem - Piper Jaffray & Co. Timothy Lugo - William Blair & Company Serge Belanger - Needham and Company David Steinberg - Jefferies & Company, Inc. Ken Trbovich - Janney Montgomery Scott LLC..

Good day, ladies and gentlemen, and welcome to the Collegium Pharmaceutical, Inc. Third 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] As a remainder, this call is being recorded.

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 patent infringement litigation and may in the future be subject to additional litigation, which may be expensive to depend and delay the commercialization of our 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. I would now to turn the call over to Collegium’s CEO, Mike Heffernan. You may begin..

Thank you. Good afternoon, everyone. This is Mike Heffernan, CEO of Collegium and with me today is Barry Duke, our Chief Commercial Officer, who will provide an update on our commercial launch of Xtampza ER and Paul Brannelly our CFO who will review Collegium’s quarterly financial results.

Let me start by saying that we are very pleased with the overall progress we made during the third quarter, particularly the progress we have made on significantly enhancing the commercial profile and overall visibility Xtampza ER. Barry will provide the commercial details in a few minutes. I will highlight additional recently achieved milestones.

A few summery comments on the Xtampza commercial launch. We finally received FDA feedback on our promotion materials in September and fully launched our sales and marketing campaign, which has been on hold since June and October a few weeks ago. The feedback from the field to-date has been very encouraging.

In the quarter, we have made significant advancements in overall payer coverage, pharmacy stocking, customers contracting and a number of physicians prescribing Xtampza ER.

We have also had very encouraging feedback from both hospital and long-term care portions of our business with some significant early wins and many ongoing and productive discussions with large integrated delivery networks.

In addition to the commercial gains, we have recently announced the filing of an Xtampza NDA supplement that includes data from head-to-head Xtampza ER, which is OxyContin pharmacokinetic study.

The data from both studies clearly and consistently demonstrates that upon crushing Xtampza it retains the same PK profile and the extended-release properties, well after crushing OxyContin, there is a complete loss of extended-release properties and its bioequivalent and immediate release control products.

The goal of the sNDA is to gain FDA approval to include this data in section 9.2 of product label, which is the drug these section. This could allow us to use this data as part of our promotion message. We expect feedback from the FDA as early if April of 2017.

It’s important though we continue to expand the Xtampza scientific literature with publications and peer-reviewed medical journals, as well as present new data in major pain related conferences.

This quarter, we had three articles that republished including publications on Xtampza oral abuse, deterrents clinical data, scientific data supporting the flexible dosing options of Xtampza and an independent product review in the medial letter. We also presented multiple posters at Pain Week conference held in September.

It is our goal to continue to support clinical investigations of Xtampza into aggressively published the resulting data. This serves to enhance the clinical profile and product differentiation of the product. We also announced the filing of our drug application or NDS in Canada. This is our first filing outside the U.S.

and we’re in the process of analyzing our commercial launching, including evaluating partnerships opportunities for Canada. In addition, we continue to export additional international opportunities, as one of our corporate priorities is to expand the geographic footprint of Xtampza outside the U.S. into select high potential market.

A key part of our corporate mission to support and educate clinicians on the appropriate and responsible prescribing of opioid with a focus on the problem of unintentional misuse, as well as prescription opioid abuse.

In close collaboration with four opinion leaders in the pain field, we developed and online educational program focusing on these key issues. The program is called OpioidIQ, it can be access at OpioidIQ.com, this is an important educational tool that is consistent with our mission.

Our product pipeline continues to advance with ONSOLIS, tech transfer of the commercial manufacturing is preceding as plan with the goal product availability in late 2017. ONSOLIS is fentanyl Transmucosal product for the treatment of breakthrough cancer pain.

In addition, we are in the process of manufacturing clinical supplies for DETERx Hydrocodone, our second product using the DETERx technology and we will initiate the next clinical trial in early 2017. Proof-off-concepts studies to-date have shown that DETERx Hydrocodone has a very similar clinical benefits as those seen with Xtampza ER.

And finally, a few weeks ago we completed an equity financing raising $75 million to enable us to fully fund our commercial initiatives in development programs through the end of 2018 and into 2019. I will now turn it over to Barry to provide additional detail on our commercial progress over the last three months..

Thanks Mike. I’ll provide a commercial overview as Mike mentioned and I also wanted to reiterate as noted that we are most encouraged with our progress during the quarter. First, some comments on overall prescriptions and prescribers. To-date we have 3,616 Xtampza prescriptions and 804 prescribers.

We have reached 72% of our original 11,500 targets including 88% of our A or most valuable targets. Our average call frequency for A targets is 6.8 calls to-date and they are responsible for 79% of our prescriptions.

Less than 1% of our prescriptions are from outside of our representative called universe reflecting Xtampza as low awareness during the early launch period, because of our limited ability to utilize our pool of complimented marketing tools and tactics as we awaited response from the OPDP division of the FDA.

Most encouraging is our early adopter analysis. Of the first of 102 physicians who used Xtampza within the first five weeks of launch, 79% of prescribed new product in the most recent month, and their weekly prescription have increased from 1.5 per week to over two per week.

We are encouraged by the continued use of the product after initial product trial.

Broadly speaking, feedback on Xtampza ER’s product attributes continues to be positive both from an anecdotal and market research perspective with the only consisted barrier sided is payer coverage an prior organization issues and pharmaceutical fulfillment challenges, in essence hassle factors for the prescribers and patients.

We will discuss both in just a minute. As we move forward from here, we are encouraged by the foundation that we have built. Additionally, we are encouraged by the improvement in our managed care position and our recent ability to ramp up a promotional activity. I want to turn to these two topics.

Let's look at managed care, we will focus on claims data versus covered lives information as they maybe more relevant to understand in the payer dynamics. While our percentage pay claims rate for commercial patients has improved from our low of 24% of claims paid during June to 69% in September.

30% plus rejections rates can still be discouraging for physicians as they consider prescribing a new product. Of note, contracted commitments to Xtampza with commercial payers continue to grow. At the end of Q2 2016 when we launched, we had no contracted commitments.

At the end of Q3, we had 17 billion commercial lives contracted and we will move into the first quarter of 2017 with over 60 million commercial lives under contracted commitments with expected enhancements to those numbers, as we continue to gain momentum with payers.

I want to highlight two key formulary wins as previously note about both United and Cigna in the recent communications regarding our 2017 formularies. Effective November 1st, the NDC block for Xtampza was removed at United Healthcare, which is 15.6 million commercialized. Xtampza ER is now a preferred Tier-3 formulary product with no step edit.

OxyContin remains on formulary at United through year-end, but is behind the triple-step. This triple-step includes trying three or five products first, one of which is now Xtampza ER. OxyContin will be removed in NDC block from United formulary beginning on January 1st.

United Healthcare begun this communications effective last week to notify providers and patients of this change. Of course, we are most encouraged by this opportunity and have a robust communication plan highlight these changes and increase awareness more broadly with our targeted prescribers. Regarding Cigna, which is 6.4 million commercialized.

While we were approved for commercial coverage on October 1st of this year, we had been not covered prior to this date. We are currently behind the double step edit there. Effective January 1, 2017, we will become one preferred products and no longer subject to the step edit.

Like our plans within United, we will optimize this positive changing in coverage with targeted communications and marketing plans for prescribers.

In addition to United and Cigna Palm therapeutics 10.5 million commercialize, the PBM for several large blues plans has announced Xtampza ER as part of its formulary as a Tier-3 unrestricted product effective October 1st of this year 2016.

With one of the largest natural PBMs, we are also in final stages of sign an agreement and Xtampza ER should be a Tier-3 unrestricted additions to its formulary effective January 1, 2017. These contractor changes should provide clarity and confidence for physicians to prescribe as we transition into new year. To-date, Part D access has been limited.

Although, that is generally true for branded ER opioids. To add some perspective, even the most establish brands only have 40% to 50% coverage of Part D life, though rejection rates in Part D tend to be low.

We have recently gained contract to coverage with Medimpact 750,000 Part D lives are now in the process of submitting Part D bids broadly for 2018. As a new brand, if plan accepts our bid for 2018, there is an opportunity for inclusion in 2017. We will provide quarterly updates on notable managed care changes in the future.

Product accessibility is another potential barrier for new product adoption. Especially with the C2 or Control 2 like Xtampza. In generally, pharmacies do not auto shifts C2 products, it’s an on-demand market for stocking. If a pharmacy gets a prescription then they are likely to order and dispense it.

At the end of June, we had only 40 pharmacies stocking the product, due to diligent work of our sales team, we now have approximately 1,500 stores that have purchased Xtampza and that number grow daily as demand grows.

We are also develop international and regional network of specialty pharmacies to support fulfillment as more and more pain starches and patience prefer that enhanced level of support and service.

We have educated or distribution partners about the recent favorable managed care changes and we will continue toward expanding our product availability with pharmacies. We will also continue to expand or patient support services to make it easier for patients to locate convenient fulfillment options.

Our goal is continue to elevate our efforts so that product fulfillment is minimized as a potential barrier. Now let’s turn our attention to our promotional activities. We received feedback from OPDP in September, regarding our promotion material that we had submitted during the first week of May, just after our final FDA approval.

Based on FDA advise, we updated our materials includes sales aids for each of our three different sales teams and retrained them during the weeks of October 10th, and 17th. During the same period, we updated our promotional speaker decks and trained a 130 speakers.

By October 21st, we began utilizing our new tools on sales cause as well as conducting speaker programs. We have conducted 100 peer-to-peer programs, which are particularly important during the new price introduction over the past three weeks and have 100 more scheduled for the remainder of 2016.

We are in the process of rolling out full multi channel marketing campaign utilizing direct mail, e-mail marketing, digital, general ads, supplements and tele-detailing. As mentioned earlier, the favorable managed care changes will also be highlighted in many of our communications.

We will be updating our xtampzaer.com website with full promotional content in December. We are excited to finally be able to supplement our sales team's efforts with this more complete promotional tools.

An important part of our strategy is an integrate a commercial model, not only are we providing sales force coverage for our pain specialist as we have discussed, we are also covering the hospital in long-term care channels.

The product attributes of Xtampza ER an appealing a natural fit for this facilities with institution concerned about the diversion and abuse and the need for more flexible dosing and administration options for patients for swallowing difficulties and/or patients with feeding tubes. In the hospital channel, we continue to make significant progress.

At launch, we overlaid our hospital sales representative to mere the territory alignments of our outpatient sales team. As a remainder, approximately 12,000 institutions purchased over 600 million in opioid annually of which 300 million is contributed from extended-release opioids.

We are currently target about approximately 500 hospitals that represents approximately 60% of the total extended-release market. The primary strategy in deploying a dedicated hospital team is to realize synergies from patients discharged from the hospital, they will ultimately be treated in the outpatient clinic, nursing home or rehab facility.

Hospital system formulary decisions are often influential of local medical communities and can influence product adoption. Even though the sales cycle in the hospital setting can be long, we have already seen notable third quarter achievement in this channel.

Recently, we gained formulary access in one of the largest cancer treatment and research institutions in the North East.

We also recently gained formulary access to a top five nationally recognized hospital system which operates 30 acute care hospitals, long-term care centers, outpatients surgery centers and an array of other services including family clinical, home care and hospice centers and outpatient pharmacies.

We also recently contracted with one of the largest cancer treatment and research providers in the Southwest with over 40 oncology outpatient pharmacies, approximately 100 practices and a total over 400 healthcare providers. We also continue to make progress with multiple national and regional hospital systems.

We have also made progress in the long-term care channel, a significant number of patients in nursing facilities both rehab and long-term care are discharged from the local hospital, thus establishing a strong connection between our hospital and long-term are sales team essential to our strategy.

As a remainder, there are over 600,000 OxyContin prescriptions per year, and 1.5 million prescriptions of fentanyl patches per year in skilled nursing facilities. We are targeted in 11 states that represent a approximately 50% of that value.

Xtampza is available through the three major GPOs in this channel MHA, Innovatix and Jer Med an important first step facility purchase and prescribing. We have begun to see signs of early demand, despite the longer sales cycle and minimal Part D coverage.

We have added our Director of Strategic Accounts for the long-term care channel, who will be working with the large national long-term care pharmacy providers, the GPOs and large nursing home chain to drive national opportunities.

We have already experienced success with regional facilities in Ohio and Florida as an example, who have committed to converting patients in their facility from OxyContin to Xtampza ER. More to come as we move into 2017.

In conclusion, with significant improvements in managed care access, growing pharmacy options for fulfillment an access now to a box or promotional materials and programs. We are looking forward to accelerating Xtampza’s adoption as we close 2016 and move into 2017. Let me turn it over to Paul Brannelly for financial updates..

Thanks, Barry. Good afternoon, everyone. As of September 30th, our cash balance was $91 million, this amount does includes a net proceeds of approximately $74.8 million from our October 2016 follow-on offering.

In the third quarter of 2016, cash used by operating and investing activities was approximately $19.5 million, which is a decrease from $23.4 million used in the second quarter of 2016.

Based on our current operating plans, we believe that our existing cash together with the expected cash and flows from the commercialization of Xtampza along with the net proceeds from our recent follow-on offering are sufficient to fund our operations into 2018 For the third quarter of 2016, our net loss was $26.4 million, compared to $9.4 million for the third quarter of 2015.

Resulting in a net loss per share of $1.13 and $0.46 per share for 2016 and 2015 quarters respectively. The net loss includes stock-based compensation of $1.6 million and $503,000 for the third quarter of 2016 and 2015 respectively. The large increased in our net loss is primarily due to cost related to the commercial launch of Xtampza.

During the quarter, we recorded net sales of $408,000 with the gross-to-net discount of approximately 49.9%. During the quarter, the majority of our gross-to-net discount was driven by our copay assistance program. We expect the impact of the copay assistance program on a gross-to-net discount to decrease overtime as payer coverage improves.

As of September 30th, we’ve recorded $3.9 million of deferred revenue on our balance sheet for product shipped to wholesalers. As previously discussed, we expect to recognize revenue based on the sell-through method, which recognizes revenue based on patient level prescription data.

Since we lack history required to estimate certain items including rebates, charge backs and returns. I will now turn the call back over to Mike..

Thanks, Barry ad Paul. We will now open it up to questions..

[Operator Instructions]. Our first question comes from David Amsellem of Piper Jaffray. Your line is open..

Thanks. So on the gross-to-net. Can you just walk us through how you are thinking about gross-to-net early in 2017 as the impact of the OxyContin exclusion happens and presumably, there will be a lot of fore switching. And then as you go further into 2017, how do you expect steady state gross-to-net to shake out.

And also just any changes in your thinking about that compared to your past comments? So that’s number one.

And then number two, in terms of the long-term care market, you talked about kind of traction you are getting, maybe give us a label and/or how much of the mix you think that’s going to be for you steady state? And what is it as a portion of the OxyContin mix as of now? Thanks..

Great David, so this is Paul. I’ll take the first question about gross-to-net, so nothing has changed in our thinking related to gross-to-net.

In early part of the launch our gross-to-net discount is going to be in the mid to high-40s, and as we get better payer coverage, copay assistance program will have less and less of an impact and going through as well as we get better coverage and more plans.

I think early in the launch more of our business will be driven from plans where there might be a bigger impact on gross-to-net as well, and as we get more and more coverage that will have less of an impact.

And Barry or Mike, do you want to take the long-term care question?.

Yes, thanks David, its Mike. So on a long-term care question, as Barry said, we have had some opportunistic early success in the long-term care market, earlier success than we expect. I mean the first step in getting into the long-term care market is getting our GPO contracts all in place and starting to create demand at the home level.

The market is large, it is 600,000 prescriptions for OxyContin in the long-term care channel. It's too early for us right now to predict how much of that we are going to get, because of the longer sale cycle.

And it is a key strategy for us to overtime start to get the opportunistic accounts, but really bring in a national sales directive and go out and start to calling a large change and that’s really just begun.

We expect that the 2017 impact to be early on will be small, but we are hoping as we get into later in 2017 we will be able to give more specific guidance around the opportunity in LTC..

Okay. That’s helpful. Thanks..

Thanks David..

Our next question comes from Tim Lugo of William Blair. Your line is open..

I guess, can you maybe quantify the Oxy opportunity United a little bit more.

I think you mentioned it might be small, but I know on the triple step edit was put in place, a lot of patients switched from the brand, whether those patients come back to OxyContin or have they been just kind of a loss to other products in the class?.

Hey Tim, this is Barry. So we look at sort of the Cigna and United opportunities. We kind of look at a $30 million to $50 million type of opportunity with OxyContin in both of those plans. Obviously at United with the block on OxyContin that’s certainly a place where we should accelerate our adoption much faster.

So in regards to your question about patients who previously were treated with OxyContin within United and they got triple step about a year and half ago, the product got triple step.

You have to think there are some patients in there and physicians within United that would like to use extended-release OxyContin and certainly, we certainly want to make a lot of noise of our availability. To tell you exactly what we will get of that, what we will bring back, that is really hard to pinpoint..

This is Mike. The other thing I would to add to that is. Early on, a big portion of our business comes from immediate-release opioid, but a portion of our business in the 30% range comes from extended-release opioid. Only 40% of that comes from OxyContin, the other 60% comes from other extended-release opioid.

So we would fully expect that as doctors get more experience with Xtampza ER that it wouldn’t just be OxyContin patients that we are looking forward in the United, it would be patients on any extended-release opioid who need to switch..

Okay, understood. And maybe for the pharmacy stocking, can you give us an update on your progress there, how many pharmacy are stocking the product now.

How many do you hope to reach maybe within a year and where is that trend going to be and may be how many of the pharmacy that stock Oxy also are stocking Xtampza now?.

Yes. So Tim I’ll take that as well, this is Barry. So we have about 1,500 pharmacies now that stock the product. Stock means they purchase at some point, hard enough they exactly have it on their shop at every given moment. But about 1,500 and it’s a big uptick from where we started.

In terms of just kind of where we like to go, I mean obviously we need more stocking out there. And what the magic number is, we know where our targets are located, physician target. So we would probably like to ideally sort of double that number if at all possible.

We also are gaining some traction with specialty pharmacies that’s become an important offering in the marketplace. A lot of pain specialists are comfortable and have begun working with specialty pharmacies to meet the fulfillment demand.

So we are creating a national and regional network of specialty pharmacies to sort of help as well and meet the need of physicians and patients..

Okay. Thanks for that. And also maybe one more, out of 804 physicians writing scripts. I have heard kind of supervisors out there. Are you broadening that the number of supervisors or you just hoping to kind of get that 1.5 to two maybe four over the next couple of quarters.

What is your plan?.

Yes, I mean, it’s a certainly good question. As you could imagine at this stage of our adoption. Most of our writer are in sort of one prescription category. I think from the numbers and I'm going off the top of my ahead a little bit about the 40% are around have just written prescription.

I think we have another bucket of 30% of our prescribers who have written two or four. And then you have about 20% to 25% of our prescribers, who have written more than five prescriptions. And we do have handful of prescribers who have written more than 50 prescriptions to-date.

So we are still very early in the adoption process in terms of getting our physicians to get more experienced with the product..

Okay. Thanks for all the questions..

Thanks Tim..

Our next question comes from Serge Belanger of Needham and Company. Your line is open..

Hi, good afternoon. I guess my first question is, if you can talk a little bit about the negotiation process around some of the key recent formulary wins with United and Cigna. More specifically how much of the Xtampza label attributes come into play versus the rebate and discounts that were offered.

And maybe how the OxyContin block also happen and whether that’s a blueprint that you can use in future negotiation?.

Yes Serge, this is Mike. So from a negotiation standpoint, I mean we lead with the clinical differentiation, when we meet with any payer group we give them our full scientific data and walk them through the advantages of the product. In a lot of cases, we wouldn’t get into the next into the next conversion unless that was positive.

And the clinical group within the plan endorses the product. Once we get over the contracting group its rebate discussion, and in those cases, we have obviously got to be competitive. But when you look at United for example, and you look at what United presented in their slides for 2017 formulary.

They spent a lot of time talking about how they are going to manage the opioid category, how they are going to put the CDC guidelines in place and Xtampza was a part of that overall strategy. So we do think there is an important clinical component associated with that..

Okay, and I think in prior quarter you have given us an idea of how many Xtampza ER scripts consisted of patients that were switching from IR to ER, I don’t know if you can give us that update as well as Xtampza ER patient that are dysphasia patient?.

Yes, so we don’t have any focus on the dysphasia patients, although maybe when I tell you about the IR, ER data it would be something that would be indicative.

So when we look at our most recent data through September for example, as I mentioned before about 25% of our prescriptions come from somebody who is on another ER opioid, and 75% of our prescriptions come from somebody who is on immediate-release opioid, that was exactly what we expected from our market research.

And if you really think about it, you think about doctor who is going to try Xtampza ER for the first time, then likely they are going to take somebody off another extended-release opioid maybe doing well.

But when it is time for somebody to take somebody from an IR opioid to long-term chronic treatment and move them to an ER opioid, Xtampza for their first patient could be a good place for them to try. And that’s really where this is played out..

Okay.

And one last one from me, in terms of the IMS and Symphony RX data we are tracking, I guess how accurate is it and what is missing from the numbers at this point?.

Yes, it's really too early for us to tell, we track both IMS and Symphony and they are relatively close. One is a little bit higher one week, one is a little bit higher than next. The real question is how much are we missing from IMS and Symphony, especially since we have an institutional business space. We don’t know the answer to that yet.

Our intent is as we get more experience with that data and our business grows in institutions in long-term care, and specialty pharmacy, which may or may not report. Once we start to better understand that trend, we will give guidance on it..

Okay. Thanks for the detail out there..

Our next question comes from David Steinberg of Jefferies. Your line is open..

Thanks very much. With regard to launch, I know you launched it in the summer, but it's only recently that the sales reps got their full marketing materials, you can start your [KOL] (Ph) dinners, and you just got some managed care wins.

So I know everyone wants instant result, but realistically, what do you think is a proper timeframe in which to get a really good measure of the launch, would it be Q1, Q2 could you give us your thoughts on that?.

Yes. Thanks David for the question. You are absolutely right. Our promotional material launched two weeks ago, our dinners launched two weeks ago and we have got hundreds of them setup between now and the end of the year and the managed care wins really started in October and don’t really kick into November through January.

We have got lot of things planned and lots of additional things to talk about over the next three months ,in the following three months in terms of things that are in negotiation.

So our expectation is that it wouldn’t be until the first quarter as we really started ramping up in the United and into the second quarter that you would see a major acceleration of the growth of Xtampza.

Now we would expect to continue to see growth through that period, but we think that we really start to optimize, when we get into the end of the first, end of the second quarter..

Okay. Thanks Mike. And then now that your reps have had a number of calls to the key prescribers.

What is the principal pushback, if there is any? And then secondly, what are you seeing in the field as far as counter detailing efforts from produce if there are any?.

So Dave, this is Barry, I’ll take that. As far as sort of push back, it’s really - so what I mentioned earlier in my prepared remarks, is just physicians love the product, they really like the product attributes.

What they sort of respond to is being a new product, be in a C2, they have a lot of perceptions around access challenges, both access from a payer coverage and from pharmacy fulfillment.

That’s the biggest pushback we get and with some of the early sort of rejections that we are getting at the pharmacy level, we are lack of stocking and it was making it hard for some of the patients to get it.

Few physicians got discouraged early, but again with all the things we have going on now with the growing pharmacy stocking with the managed care wins we talk about, we expect to see that diminish greatly over the coming weeks and months. As far as counter detailing.

So we have seen very little quite frankly from produce or anyone else as far as counter detailing with Xtampza, I think they maybe focus on other products and priorities. So we have not seen a lot of counter detailing at all..

Okay. And just my final question is more theoretical and long-term in nature.

But there is a body of thought that once a number of product ADFs like yourself get out in the market and you can show the FDA that you can fully supply the market that at some point the FDA might remove all the non-abuse deterrent products, which would create a massive marketing for one reason higher price points.

What are your current thoughts on that?.

Yes. It’s a good question and it’s a question a lot of people are thinking and talking about. Last week, there was a hearing at the FDA, public hearing on abuse-deterrent opioids and the generic guidance. And we participated and I attended. And so there was a discussion about what the appropriate time point for that.

The FDA clearly reiterated that its goal is to ultimately convert the whole market. And question it is when and how. There is clear sensitivity about the need for lower cost abuse-deterrent products and that’s the need for the generic guidance.

So I think it’s a collective belief of the brand companies that until there is a generic guidance that’s finalized in a pathway for generic ADF that the FDA would have a hard time removing all of the generic products on the market and not provided pathway for approval.

No again that assumes two things, one that all the Orange book patents for each of these products have been validated. And number two, that there is a pathway and people can actually meet the abuse-deterrents equivalent that’s going to be required in the guidance.

But again, I think its important first step to have a guidance available, so that it give the opportunity for lower cost ADF products overtime..

Great, thanks..

[Operator Instruction] Our next question comes from Ken Trbovich of Janney. Your line is open..

Barry, I was wondering if you could go back, I think when you are going the managed care contracts, I might have missed one, you mentioned you Prime therapeutics, did you mention fourth one after that?.

Yes, I did kind of go through that pretty fast Ken, thanks. So I didn’t mentioned the specific name, iv are inches close to finalizing agreement with one of the biggest PBMs in the nation, so stay tuned, but it's not finalized yet, so that’s why we didn’t gave the name..

Okay.

And then specifically when it comes to comments, Mike I guess around the sNDA, you mentioned the possibility that you could hear back from the FDA as early as April, is that simply a commentary on the application, or is that the earliest stages which you would expect a national action?.

That’s actually the date that the FDA mentioned to us in their letter of acceptance of our sNDA that our PDUFA date would be an April..

Okay.

And then if in fact you got that type of label, or the label that you are hoping for with the comparative data, are there any plans that you would be able to reach out to in order to perhaps get a midyear inclusion on plans that you are not currently able or have not had success thus far in penetrating?.

Yes, it's a really good question. And if you think about we have been able to accomplish so far this year. We came into the market in June. We have been able since June till here we are in the beginning of November to penetrate up to 60 million lives that we will contracted in the beginning of next year.

In a lot of cases those were situations where people were not reviewing the extended-release opioid class, and we came in with our clinical package, we explained to them why this is an important add and we were able to get them to take the product seriously.

We will continue to do that, that’s our strategy, there are certain plans that we have been excluded. And OxyContin is extended-release that exclusive to that plan. We are working hard to convince those individual plans to reconsider Xtampza ER and we will continue to that.

And obviously if we can get this information in a label, it's an important discussion on the payer side, but it's even more important discussion on the provider side, on a physician side, because obviously OxyContin has abuse BC turn claims.

But our sales reps at this point in time, because it's not in our label can’t go out and show comparative data head-to-head versus OxyContin. In market research, when we look at that data we know that physician find that very interesting and so it is our goal to get that included and make that part of our promotional message..

And with regard to including it in the promotional message, would there be a delay in the timing between the PDUFA date, and your ability to roll out.

I mean what we see in several months delay as we did here at launch or is it something that now that you have heard initial feedback from the agency, you feel more so you get faster feedback on the second round?.

Yes. I’m not sure we would get faster feedback. I think what is encouraging to us is that it's important to recognize that the data in our current label in the Category 2 material on the label and the pharmacokinetic Section 9.2 is data from the same study that OxyContin was included in.

All of the arms of that study are included except OxyContin, they took that arm out until we could replicate the data. We have replicated the data and now we have submitted to add that arm back in to data that’s already included in the label.

And so for us to add this to our promotional material, it’s really adding it to existing graphs and it is not something that we are going to have to spend a lot of time doing, we will be prepared ASAP after the April timeframe to launch the message into the field..

Got it.

But it doesn’t require rearview by FDA and to add that once it’s in the label?.

No. So we have no requirement to submit our materials and get a pre-approval for any materials. It would be purely a voluntary submission if we choose to do that..

Okay. Terrific. Thank you..

Very good. Thanks Ken..

Our next question comes from Serge Belanger of Needham and Company. Your line is open..

Hi guys. Thanks for taking a couple of additional questions.

Just on the pipeline, can you remind us again what the pivotal study is for the Hydrocodone product and what is the timeline for potential filings for that product?.

Yes, Serge, we haven’t disclosed the full clinical development plan yet, because there are some unknowns and some of the unknowns are around what our ultimate by equivalents profile is versus the reference product, we decide to use, which as you can imagine is a strategic question and something that we are spending a lot of time thinking about.

That’s going to dictate the specific studies that we have to do and how many studies. So we will be prepared in the first quarter of next year to come out and layout the full clinical development plan for the product..

Okay.

And then on ONSOLIS, the only thing that is required there is the tech transfer?.

Yes. So we have to do to tech transfer to commercial manufacture, we have to filed the prior approval supplement for the tech transfer with the FDA, and getting approval of that prior approval supplements. So that’s all built into our timeline..

Got it. All right Thank you..

Thanks Serge..

There are no further questions. I would like to turn the call back over to Mike Heffernan for any closing remarks.

I would like to thank everyone for joining our third quarter conference call and we will continue to keep you updated on our progress. Thank you and have a good day..

Ladies and gentlemen, thank you for participating in today’s conference. This does conclude the program and you may all disconnect. Everyone have a great day..