Q3 2019 Earnings Call
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Welcome to clean Pharmaceuticals third quarter 2019 earnings Conference call. This is Alan the Dol head of Investor Relations for Collegium I'm joined today by Joshi Pony, Our Chief Executive Officer, Paul Brannelly, Our Chief Financial Officer.
Our chief commercial officer.
People will begin today's call will watch remind participants that none of the information presented today is intended to be promotional and the any forward looking statements made today I made pursuant to the safe Harbor provision of the private Securities Litigation Reform Act of Nike manufacturer.
You are cautioned that such forward looking statements involve risks and uncertainties, including without limitation. The risks that we may not be able to successfully commercialize xtampza yar and the new center franchise and that we may incur significant significant expense I may not prevail encouraged or feature opioid industry litigation and investigation.
Patent infringement litigation or other litigation pertaining to our product.
These risks and other stuff the company are detailed in the company's periodic reports filed with the Securities Exchange Commission all future results may differ materially like part expectations that stuff today, our earnings press release and this call will include discussion of certain non-GAAP information you can find our earnings press release, including.
non-GAAP reconciliation on our corporate website at <unk> you can find the dot com I will now turn the call over to clean CEO , Joe Shipone Bang for our good afternoon, and thank you everyone for joining the call.
We're pleased to report there were on track to make 2019, a breakthrough year for Collegium pharmaceutical we continue to make meaningful progress against our key strategic and operational priorities and all organization is focused on finishing strong in 2019.
Accomplishments for the third quarter include net revenue of $72.9 million, which represents a 4% increase over the third quarter 2018.
Xtampza your third quarter net revenue increased to $26.5 million, which represents a 56% increase versus third quarter 20 team.
Exam for New York total prescriptions grew 44% in comparison to the third quarter 2018 as anticipated exam C.E.R. grew at a moderated weighing on a sequential basis and we expect prescriptions to grow at a similar rate in the fourth quarter.
As a reminder, exam, so youre prescription growth and 29 team was driven by 13, new exclusively are oxy code on payer wins, representing approximately 11 million wise that took effect on January 1st 29 thing.
Opex for the quarter was down in comparison to the third quarter 2018, we remain committed to leveraging not growing collegians cost structure and 29 team and beyond.
On a non-GAAP basis, we generated income from operations for the second consecutive quarter and increase cash on hand.
Finally, we strengthened the leadership team with the appointment of Bart down to the won't executive Vice President strategy in corporate development and member of the Executive Committee, but really the execution of our midterm growth strategy.
As it pertains to the ongoing industry wide opioid litigation, we have no material updates to provide from our last call.
Our quarterly report has always includes de pounds of all of our pending litigation matters.
As a brief recap as of today, there are over 2600 lawsuits against manufacturers distributors and others relating to prescription opioids.
Of these we're aware of 26 in which we are currently named where we have an opportunity to do so we are pursuing dismissal based on Collegium slate entry to the market and the absence of allegations that we engaged and conduct that resulted in the abuse mid shoes were diversion of our products.
For the 26 cases in which we are named or in the multi district litigation and none of them or a track or bellwether case. So we did not expect to have engagement in the MTL for some time.
Finally, we did not assume any liability for new sent the promotion or sales that occurred prior to January of 21 thing.
Looking forward to 2020, we believe that Xtampza E.R. is well positioned to take a significant step towards becoming the number one prescribed E. R. Oxy codell.
I'm excited to report that Collegium market access team has secured additional exclusive youre Oxy code on formulary wins that cover over 35 million predominantly commercial lives. This is a major accomplishment.
These wins all take effect on January 1st 2020.
Our commercial team is preparing to successfully through these new opportunities, while leveraging expands our existing exclusive coverage and broad availability to fuel the next stage of growth.
Collegium pharmaceutical is committed to its mission of becoming the leader in responsible pain management. In addition, we're confident that extend him. So he ours well positioned to become the branded market leader no later than 2023.
We're encouraged by the progress that we've made in 29 and we recognize that we have a lot of work to do we're focused on finishing strong and 29 thing well at the same time preparing for a strong start to 2020 I'll now hand, the call over to call for a discussion of the financials.
Thanks, Joe Good afternoon, everyone.
Financial highlights in the third quarter 2019 include.
During the first nine months of 2019 extensive you are net product revenues were 77.6 million, which represents a 52% increase compared to the prior year period.
Cash increased by 5.1 billion $253.8 million compared to the prior quarter.
And although we had a net loss of 6.1 million, we were profitable on a non-GAAP basis for the second consecutive quarter.
Net product revenues for extend CDR were 26.5 million in Q3, 2019, which is a 56% increase from Q3 2018, and a 2% increase from Q2 2019.
Extensive revenue growth was driven by prescription growth, partially offset by a reduction in wholesaler inventory of approximately three days.
Gross to net discount was 58% in Q3 2019 compared to 58.4% in Q2 2018.
We expect our gross to net discomfort stanza to remain in the high 50% range for the remainder of 2019.
Next year as a result of the 15, new exclusive IAR Oxy code on formulary wins that add 35 million exclusive lives, we expect gross to net discount to be in the low 60% range.
Net product revenue for the new Synta franchise decreased to 46.4 million from 53.1 million in the third quarter 2018, and 49 million in the second quarter of 2019.
The decrease in new sensor revenue was driven by lower prescription volume as well as a reduction in wholesaler inventory of approximately four days.
Operating expenses, excluding cost of product revenues were 32.5 million for the third quarter 2019.
We continue to maintain financial discipline by leveraging our existing costs infrastructure.
Although we expect some fluctuations from quarter to quarter.
For the third quarter 2019, net loss was 6.1 million, which includes approximately 4.1 million of stock based compensation and 3.7 million of amortization expense related to the new simply intangible asset.
Our non-GAAP adjusted income was 1.7 million for the third quarter 2019.
Please see our press release issued earlier today for a reconciliation of GAAP to non-GAAP results.
As of September Thirtyth 2019, our cash balance was 153.8 million, which is a 5.1 million dollar increase from June Thirtyth 2019 balance.
Due to the timing of payments, our cash position fluctuate throughout the year, but we expect the second and fourth quarters to be the strongest quarters from a cash generation perspective.
We recently filed the $300 million shelf registration statement with the FCC, which went into effect today.
Our old shelf registration statement expired in October .
We believe that it is good corporate housekeeping tab, the shelf lunch on file.
We remain encouraged by our financial progress for the full year, we expect extends to revenue to be at the high end of our 2019 annual guidance of 95 to 105 million.
As we continue to leverage our existing cost structure, we expect our operating expenses being near the midpoint of our guidance of 125 to 135 million.
With continued pressure on new Synta prescriptions. We currently expect we sent to revenue to fall below our guidance range of 200 to 210 million.
These comments on guidance takes into account that we do not expect to see an increase in days on hand at wholesalers in the fourth quarter as we have as we've seen in prior years.
Wholesalers are more closely managing inventory levels of opioids. We believe this will be the new norm going forward.
Lastly, similar to 2019, we expect to announce 2020 annual guidance by issuing a press release in early January 2020.
I will now handover the call to Scott Schrier for commercial update.
Thanks, Paul.
In the third quarter, we continue to make progress against our goal of establishing extends the E. R. As the our oxy corner of choice for appropriate patients extends the E. R achieved all time highs for total prescriptions market share and total prescribers in the quarter.
Total prescriptions grew to 120409, representing 44% growth over the third quarter of 2018, and 3.3% growth over the second quarter of 2019, Xtampza yard group branded the our market share to 13% and Roxy code on market share to 18%.
The prescriber base for extensive IAR grew to 13550 prescribers.
We saw strong market share performance for Xtampza E R across all exclusive.
He could on formulary positions Xtampza IAR has achieved branded E. Our market share leadership within 19 of 26 formulary positions and has a 62% share of the E. R. Oxy code on market within exclusive positions.
We expect next steps that you already grow in the fourth quarter at a similar rate to the third quarter.
New since a franchise total prescriptions were down 3% to 131000 and brand equity our market share was stable at 6%. Thus far in 2019, we've been up the unable to achieve stabilization of total prescriptions for the franchise and we anticipate continued pressure in the fourth quarter.
We're encouraged by results from quantitative market research that was fielded in October with our targeted health care providers highlights include Collegium ranked second as the leader in responsible pain management and closing the gap versus Pfizer.
Collegium Salesforce ranked number one and extending our leadership position versus other companies promoting in this space.
Jim's pain portfolio is seen as highly differentiated and extends to E. Ours ranked number one on product favorability.
51% of prescribers intend to increase their utilization of Xtampza, aer and 60% intend to decrease their prescribing of oxycontin.
Specific to act staffs that Youre, our market access team has made significant progress transforming the payer landscape and securing new exclusive IAR oxycodone formulary wins for 2020.
Effective January Onest 2020, we have secured 15, new wins covering more than 35 million lives most of which always in the commercial book of business, we're not yet able to name all the plans, but I can communicate the largest which is Cvs caremark commercial.
We didn't part D extends to IAR will be the exclusive VR oxycodone for an additional 1 million lives within 11 regional plans the states with the greatest opportunity, our Florida, North Carolina, New Jersey in Pennsylvania.
There are approximately 187 million commercially insured lives within the United States and these wins take the number of exclusive lives from approximately 38 million in 2019 to approximately 73 million in 2020.
Hi staff CDR will be the exclusive VR oxycodone for 39% of commercial lives up from 20% in 2019 and 40% of part D lies.
Xtampza ER has surpassed oxy contin in terms of breath and strength of market access.
We're now working with these payers to ensure a strong pull through of the new wins. The commercial team is laser focused on finishing the year strong and preparing for a fast start to 2020 with that I'll turn it back to Jeff.
Thanks, Scott I will now open the call up for questions.
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Our first question comes from David Amsellem of Piper Jaffray. Your line is open.
Thanks, So get a couple of questions first on the contract index to the details on the exclusive contracts.
I guess the question here as well a couple of questions. One is are there any other big national sizable national plans that are included in the 35 million. Besides Cvs caremark.
And also.
How much wood to chop do you have on the Medicare part D front, you mentioned that.
Most of the wins our commercial so can you talk about.
What kind of work you have left on the Medicare part D flawed and then.
Switching gears changes since.
Given where the trajectory of the franchise is going and given your agreement with a certain though and I know you've gone from this Alan the past.
Is it is it possible that you may put right stack to asserting though when you can.
In in a couple of years and talk to you or your thought process there. Thanks.
Sure. Thanks, David This is Joe I'm going ask Scott to comment on the contracts and then I'll give some perspective with regards to new center.
Yes, Thanks, David So first related to your question our commercial yes. There was another national plan that is in the wins, but I can't name with that plan is at this time and then second related to part D and kind of our run room Weve added a million lives in regional plans, where that puts US is there's 42 million lives in Medicare part D nationally.
And we're now exclusive at 40%. So there is still running room, there for additional wins going forward.
And one additional comment with regards to contracts David.
Obviously, you've now we're at a point in commercial one part D, where we have about 40% of lives in each and in an exclusive position as we move forward. The runway theoretically is an additional 60%, but we're going to be very focused and disciplined and as we move into 2020, that's where we'll make determinations of how.
Much more we feel we need to go after to continue on track to market leadership look with New Center I. Appreciate the question I would make the following comments one we have a very strong partnership with asserting though it's a franchise and a molecule that we believe in and then.
In terms of the core fundamentals of when we did the deal in terms of it being creative the year, we did it accelerating our time to profitability and giving us different scale across the value chain that has all been realized that as we move into 2020 as we haven't yet stabilize the brand.
Obviously, that's something that we'll be evaluating throughout the year, but right now we're focused on trying to stabilize a franchise that we believe.
Thanks, Joe Let me sneak in a follow up on the center.
Do you think the problem with the product.
And not being able to stabilize it has to do with the product being in the headlines for the wrong raise and perhaps dr. instinct skittish about writing it given given the headlines me how big of a role is that playing.
Yeah. So great question I don't believe and I don't think we would have any information to say that is a challenge with regards to new center I would really focus to two things in particular with the are the first is post the supply outage, although the market perception in the view of the asset in terms.
Terms of it being differentiated viewed favorably and in particular thought of for patients with diabetic peripheral neuropathy. Although that has been maintained the market position was impaired. The second thing is we're coming through 2019 as an atypical opioid that is really folks.
Yes, the patients where they have more of a moderate analgesic need I do think theres some overlap with BELBUCA, that's putting pressure to the E. R and I think with the IR being in a marketplace, that's 99.9% Genericized, there's some payer dynamics at play there.
Okay. Thanks for the insight I'll jump back in the Q.
Thanks, David.
Our next question comes from David Steinberg of Jefferies. Your line is open.
Thanks, I have three questions first regarding the new managed care wins.
So this year looks like your incremental revenues on Xtampza, an 11 million lives would come in around 30 435 million. So is there anything about the current wins you just mentioned that will be disproportionate next year or looked at another way.
Does the massive around 100 million an incremental.
Sales work given its three X times, what you probably do this year. The second question is I think last quarter, you exited with an E oxycodone E our share of about 17%.
What's sort of the Aspirationally share do you think you can get over the next couple of years, particularly with produce problems and then thirdly you mentioned.
The shelf of 300 million largely being a housekeeping as the previous shelf had expired that said you have almost 150 million in cash and your cash flow positive. So clearly don't need to raise money.
The assumption here, you're doing this because you're going to make an acquisition anytime soon and can you remind us what the buckets what types of acquisitions, you're looking for thanks.
Yep. Thank you David I'm going to what Paul take the question on managed care as it pertains to 2020 revenue and to talk about the shell and then I'll give some perspective on our what we think we can accomplish in aspire to with extends over the next couple of years. Okay. Thanks, David So.
So as you think about as we think about 2020 will provide guidance early next year and I think that will be the timeframe that's appropriate for us to lay out what impact we think that these wins will have as compared to 2019.
And then show and Okay.
Yes, so for the shell fit.
We have filed that as a matter of good what we think is good corporate housekeeping.
And as we've we've looked at TD opportunities.
Over the last year. So we do want to have that potential flexibility out there. So we think it's it's important to have a shelf on file to allow us. If there was something that we wanted to act on that we have the flexibility to finance it at an appropriate time yep.
And David with regards to expand so over the next couple of years, our aspiration and belief is that expansive becomes the number one prescribed.
Branded IAR opioid and obviously in doing that we also become the number one extended release Oxy co down as we move into 2020, we're we're optimistic about the 35 million exclusive lives. We added predominantly in the commercial book of business that that will fuel the net.
Phase of growth and one comment I would make that I think Scott and his entire commercial organization have really built a strong confidence and as reflected by the fact of in our 26 wins.
Historically, we have 19 were in a leadership position in 2018 or 29 team, we have grown market share and a significant way I think we've really develop they pull through capability in terms of our commercial team inclusive of how we partner with these payers to maximize the operative.
Please.
Our next question comes from Tim Lugo of William Blair. Your line is open.
Hey, This is welcome Tim Thanks for taking the questions.
I was just wondering if you've you've sandy sort of market disruptions since the the total bankruptcy in and if you have a sense of.
How many of you will you to brand.
Patients.
Sorry, xtampza might be coming from Oxy Oxy Contin buses elsewhere, you to eat overall.
Secondly, I was I was wondering.
In terms of you seem to you.
Well have the difference is come from compared to what you forecasted or expected when you licensee asset.
What's what's changed or what hasn't met expectations.
Thanks.
Okay. So this is Joe with regards to.
Market disruption as a result of what it is the Purdue is dealing with I don't think that theres been any disruption to the market. So the product continues to be available.
He has a position with regards to.
The payer so I don't see anything as a result of that impacting the marketplace. The one area in which I do think it has impact is in our conversations with payers. So in addition to payers being interested in us focusing the discussion on the differentiated label of Xtampza E are being able to talk.
About the success that we've had where we've had exclusive positions I think clearly right now with the payers. That's something that's part of their consideration set in terms of sourcing of business with extensive first stamps E are the new to brand share or new to brand prescriptions are predominantly.
Driven at this point in the year by patients transitioning from an immediate release oxycodone over to Xtampza, IAR and I'll, let Scott comment on New Center.
So the question on us into if you could repeat it I couldn't quite understand it.
Yeah sure sorry, So I was just wondering obviously when you acquired.
Licensees into you sort of how to certain set of expectations for outperforming the market and I'm wondering what's what is different from what you had expected where these differences are coming from that relating to the.
The decline.
Yes. Thank you, yes, I think I.
I'd reiterate what you already mentioned earlier about the market position of the product. So when we had a supply outage right at the time, we acquired in the first quarter. It fundamentally change the market position a less of it led to patients, leaving the therapy and now we're in a battle of fighting back for new patients essentially that's the number one thing that has changed the position now.
Al versus when we did the deal and our focus now is on stabilization specifically focused on new since the E. R and the differentiated label an indication for pain associated with diabetic peripheral neuropathy.
Okay, great. Thank you.
Our next question comes from Gregg Gilbert of Suntrust. Your line is open.
Thank you have a few questions.
First.
Perhaps the naive question and the parents that have not contracted with you.
In an exclusive position as it simply due to the rebates to get from Purdue or is it more nuanced complicated than that.
It would seem to be a no brainer.
In this environment in particular.
Okay, Hey, Greg This is Joe Thanks for the question look with regards to the payer. So we don't yet have contracts in place I think is a complex situation, where you get into the ins and outs in terms of.
What is the discount of which they would make that type of decision in some instances relative to what it is that we're.
Willing to put forward. The one thing that I would emphasize with regards to the discussions that we've had this fear in the ones that continue to be on going.
The thing that.
We start with and I think every pay or for the most part is onboard with is the differentiation of the label in the clinical attributes of Xtampza Aer. The second thing that we have taken I think for the most part out of the consideration set with perhaps the exception of those plans that don't.
Have the ability to control is our ability to work with them if they put xtampza in an exclusive position to move the market share and then like I said earlier one of the dynamic that is fundamentally different this year is they all in our discussions are contemplating a split the proof.
Okay. Thanks.
In terms of the overall market situation at looking.
Decline rate.
I agree moderating somewhat.
Can you talk about that that team is it something you're noticing as well and.
Thank you could moderate further.
Into 2020 based on your end.
Internal research and sort of de appropriate use.
Of the category versus in the path.
Yeah, So Greg look Big picture, what we're seeing this year, obviously is a double digit decline within the market. We anticipate a thing somewhere in that area next year at least in our models and over a five year period, beginning to moderate more to mid single digit decline probably the.
Piece of evidence at least in and our view that would support that is at that point, you're getting too about the level of opioid prescribing that there was in the early two thousands. The reason we think thats relevant is that was before pain became identified as the fifth vital sign which was one of the drivers of increased though.
Our utilization.
The final point that I would make on that is a company committed to being the leader in responsible pain management.
One we think it's important and we would expect the market to continue to decline.
We certainly are not focused on or doing anything to drive volume within the market will be want to make sure that physicians that pain specialists are educated our portfolio. So that when they choose to go that route which is a serious decision that they understand the benefits of our products.
Relative to other choices.
Great and my last question on business development, how would you characterize the availability and pricing of the opportunities that fit the criteria that you. So clearly laid out in the past them have you found yourselves tweaking your criteria at all.
Is available out there thanks.
Right. So great questions, Greg So look as you know.
We're focused on two windows in the mid term, we're essentially looking for non opioid pain solutions later stage development that have the potential to be generating revenue in 2023, that's obviously a process of which were always looking refreshing.
The list than what I would say there as we are active we are focused we know what it is that we're interested in and to the degree that we did it in a way that we believe will drive value. We're prepared to take action in the short term window, we have a pretty high bar there it's important to us at anything we bring into.
Our portfolio that it's meaningfully differentiated and that it also would be a creative either in the year. We did it if not that year. The following year and what that criteria. Obviously, that's a much smaller group of things that we're focused on.
Thank you.
Well.
Our next question comes from Serge Belanger of Needham and company. Your line is open.
Hey, Thanks, guys. This is Ken.
Good question. So first on your center.
Is there any changes that are expected as far as.
It's going into 2020, and how that might impact the sales in 2020, and then on to the time plans.
The 26.
What is the market share.
<unk>.
And that's what are some of the limitations.
Limiting.
The drive of these part D plans.
To go to the same level in the commercial plan.
And is there any renewals.
Since that are coming up.
Extends into 2020.
Okay. So thank you for the question I'll have Scott comment on New Synta, and then perhaps I'll take a shot at the Xtampza.
Yes, so when we look at the landscape for incentive Theres no significant changes for 2020 and when we look at your broad covered availability across all commercial plans as well as part D plans broad coverage available there as well. So we feel we have the assets we need to continue due to work with that okay, and then with regard.
Just to extend EMSA E. Our first off Big picture, where were exclusive we have 62% market share of the extended release Oxy code on market one of the things that we have learned over the past couple of years is that market share seems to move faster within the commercial books of.
Business within Medicare part D. We move share in a meaningful manner and then we get other opportunities to continue to grow so our expectation is in Medicare part D and the dynamic there is at the beginning of the year. That's when the majority of medical exceptions take place what's different in part.
The then commercial office is if a medical exceptions approved it's a 12 month upon approval. So you don't get another opportunity to have that patient switched over to extend MCR. So as we work.
From a commercial perspective and with those payers, what we really want to make sure is that our messaging is on point and that the plan that they are implementing from a payer perspective in part D is being operationalize correctly.
Great. Thanks for the details.
Sure.
Our next question comes from ester Hong of Janney. Your line is open.
Hi, Thanks for taking my questions. So Joe in your opening remarks, you mentioned the aim for Xtampza ER to be the branded market leader by 2023.
Can you provide any additional details on the east try to eat reach that goal by that specific here and guys. Steve feature per deal impact ambition and then my second question is separately do you anticipate a similar cadence to an extent the sales in 2020 as observed.
In 2019 thanks.
Yes.
So thank you asked for I appreciate the question.
First off when you look at the aspiration of being in the market leader No later than 2023. The reason we're focused there as we believe that is the earliest of which there could potentially be a generic version of oxy cotton and one of the things that we think is important as the clinical differentiation.
Of Xtampza via via its label is what ultimately per tax.
The base of sales from a potential generic so that's where that has always been the aspiration of no later than 2023, becoming the market leader in terms of why said no later in my comments right now with the 35 million exclusive wins that we'll be adding effective January .
The first we expect that the fuel a next phase of growth for the brand and at a certain point. We believe we'll have enough critical mass from a payer perspective, along with the commercial infrastructure I think it's important for us to emphasize we have the number one field force in the eyes of these high.
South care providers were out there educating on the brand, where we will hit that inflection point that puts us on that pathway to market leadership. So 2020 threes. The target we're focused on the messaging. We know we have a significant influx of new payer wins, we know the payers that we would potentially focus.
Sean as we go forward to get us there.
And then and then additionally.
Yeah and on cadence I think as we move into 2020, and we give guidance will give perspective on what we believe the shape of the curve.
We'll be in 2020 in terms of how the pulsing of the growth will occur.
Great. Thanks congratulations.
Thank you.
Our next question comes from Brandon Folkes of Cantor fixed Fitzgerald. Your line is open.
Hi, Thanks for taking my questions and 50 seat you talked a lot about 2023 fit can you give us some color and how this new scale that you will have in 2020 can beyond in terms of have excuses life coverage, how does that give you a dish new and.
Sort of leveraged to go in and drive more exclusive wins beyond 2021, and anything on the supply side and we need to be considered about testing.
2023, obviously showing that you can supply the market rely being 2021 I think we'll go one way there and then lastly can you just provide some color in terms of the percentage of scripts that when wintry outside of the exclusive contracts this quarter. Thank you.
Okay, So brand and I'm going to let Scott comment on your first question with regards to exclusive wins beyond 2020 in the percent of scripts that flow through.
The nonexclusive accounts, and then I'll come back and make a comment on supply. So first starting with the percent of prescriptions the flow outside of our exclusives about 35% of our prescriptions come through nonexclusive in totality about 65% through our exclusive to the additional exclusives beyond 2020 .
I think.
We'll see what happened so we know that by adding these 35 million lives. We've passed oxy cotton from a standpoint of strength and breadth of position and exclusivity and the beauty of that is it'll help us see if that actually creates additional tipping points to perform even better in the non exclusive.
Books, So our focus is pulling through what we want we won looking at how that will spill over to the nonexclusive and then we'll evaluate the addition, additional exclusives and we may do going forward from that Okay, and then Brandon from a supply perspective, we feel we're well positioned from a supply perspective.
Give as you know one of the things that we've been working on and we would expect over the next 12 to 18 months is our dedicated facility, which will give us additional manufacturing capacity will come online, but were it will be in a good position from a supply perspective as we move for.
Great. Thank you very much.
Okay. Thanks Brendan.
Our next question comes from Kevin Kedra of GE Research. Your line is open.
Hi, Thanks for taking the questions.
Wanted to ask about the exclusive contracts that you've had now for several years.
Good metrics.
They have leadership keep 26 plants, but.
The plans, where you've been on them for now a couple years have you seen the share move much from Q1, two year to has that been stable does it go up it does go down and then competitively I think you guys actually the last.
On markets.
Long acting schedule to opioid that's been approved by the FDA.
But there are few products that are pending at the FDA could be filed in the next year or so.
So over the next couple of years, how do you see the landscape evolving.
With potential new entrants into the opioid market.
Okay. So Kevin I'll, let Scott comment on the performance of the exclusive accounts in particular, the ones, where we've been on the longest and then I'll give a little perspective on our view of potential entrance into the opioids landscape.
Thanks, Kevin So when we look at the exclusive contracts that are a couple of years into the running what we see is we see exponential growth in commercial right away and then we see continued growth.
Year after year in part D. We see that we come out of the gates more methodically and then we have steps at the beginning of each year and consistent growth there as well. So overall the exclusives continue to grow share as we go forward.
And Kevin with regards to the evolution of the marketplace number one we feel very good that at the TYRX technology, which is the abuse deterrent technology that accompanies xtampza is a differentiated technology sets a very high bar.
For anybody that were to come to the market to follow in particular with an extended release version of Oxy co down and I think the reason that's relevant as you know the FDA has been spending a lot of time thinking about in having hearings around what would be the standards or what would a new product have to achieve.
I think in general what feels Directionally, it's going in the direction that they need to represent an improvement and a meaningful improvement over currently available therapy. So when you look at Xtampza IAR were focus to the our oxy code own portion of the market. We are very confident and the determined second.
Knowledge and believe the standard for approval is a pretty high bar.
There are no further questions like just trying to call back over to Joe Shipone for any closing remarks.
Okay. Thank you before we conclude todays call I'd like to take a moment to recognize my colleagues that Collegium as a result of their efforts 29 team will be a breakthrough year for Collegium and we believe extensively ours position for its next stage of growth in 2020, I'm confident that Collegium us.
On track to become the leader and responsible pain management and I look forward to updating you on our progress have a good evening.
Ladies and gentlemen. This concludes today's conference call. Thank you for participation you may now disconnect.