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Edited Transcript of COLL earnings conference call or presentation 7-Aug-19 8:30pm GMT

Q2 2019 Collegium Pharmaceutical Inc Earnings Call

Canton Sep 26, 2019 (Thomson StreetEvents) -- Edited Transcript of Collegium Pharmaceutical Inc earnings conference call or presentation Wednesday, August 7, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Alex Dasalla

Collegium Pharmaceutical, Inc. - Head of IR

* Joseph J. Ciaffoni

Collegium Pharmaceutical, Inc. - President, CEO & Director

* Paul J. Brannelly

Collegium Pharmaceutical, Inc. - Executive VP & CFO

* Scott Dreyer

Collegium Pharmaceutical, Inc. - Executive VP & Chief Commercial Officer

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Conference Call Participants

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* Brandon Richard Folkes

Cantor Fitzgerald & Co., Research Division - Analyst

* David A. Amsellem

Piper Jaffray Companies, Research Division - MD and Senior Research Analyst

* David Michael Steinberg

Jefferies LLC, Research Division - Equity Analyst

* Gregory Daniel Fraser

SunTrust Robinson Humphrey, Inc., Research Division - Research Analyst

* Kevin Kedra

G. Research, LLC - Research Analyst

* Lachlan Hanbury-Brown

William Blair & Company L.L.C., Research Division - Associate

* Tian Sun

Needham & Company, LLC, Research Division - Research Analyst

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Presentation

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Operator [1]

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Good day, and welcome to the Q2 2019 Collegium Pharmaceutical Earnings Conference Call. I will now turn the call over to Alex Dasalla. You may begin.

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Alex Dasalla, Collegium Pharmaceutical, Inc. - Head of IR [2]

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Welcome to the Collegium Pharmaceutical's Second Quarter 2019 Earnings Conference Call. This is Alex Dasalla, Head of Investor Relations for Collegium. I am joined today by Joe Ciaffoni, our Chief Executive Officer; Paul Brannelly, our Chief Financial Officer; and Scott Dreyer, our Chief Commercial Officer.

Before we begin today's call, we want to remind participants that none of the information presented today is intended to be promotional, and that any forward-looking statements made today are made 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, the risks that we may not be able to successfully commercialize Xtampza ER and the Nucynta franchise, and that we will incur significant expense and may not prevail in current or future opioid industry litigation and investigations, patent infringement litigation or other litigation pertaining to our products. These risks and other risks of the company are detailed 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.

Our earnings press release and this call will include discussion of certain non-GAAP information. You can find our earnings press release, including relevant non-GAAP reconciliations on our corporate website at collegiumpharma.com.

I will now turn the call over to Collegium's CEO, Joe Ciaffoni.

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Joseph J. Ciaffoni, Collegium Pharmaceutical, Inc. - President, CEO & Director [3]

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Thanks, Alex. Good afternoon and thank you, everyone, for joining the call. We're pleased with the progress that we made in the first half of 2019 versus our key strategic and operational priorities, and we are on track for 2019 to be a breakthrough year for Collegium Pharmaceutical. The second quarter marked another quarter of growth for Collegium, capping a strong first half performance.

Total net revenue for the first 6 months was $149.6 million, which represents a 9.3% increase over the first half of 2018. Xtampza ER delivered strong year-over-year growth driven by the 13 new exclusive ER oxycodone payer wins that came online at the beginning of the year. Compared to the first half of 2018, Xtampza ER total prescriptions grew 60% and Xtampza ER total net revenue increased 51% to $51.2 million. Driven by operational stability and execution, we expect Xtampza ER to continue to grow over the remainder of 2019 at a moderated pace compared to the first half of the year.

With respect to the Nucynta franchise, we saw signs of stability in the second quarter. Sequentially, total prescriptions and market share were flat compared to the first quarter of 2019. We believe that Nucynta ER volumes will grow modestly over the remainder of 2019, and we expect Nucynta IR to decline in line with the IR market.

Importantly, and as we said at the start of the year, we believe the organization is sized appropriately to maximize the potential of the portfolio. We're committed to leveraging, not growing Collegium's cost structure, and evidence of that commitment was reflected in lower sequential quarter and year-over-year quarterly operating expenses. As we strive to become the leader in responsible pain management, we recognize that our most important brand is Collegium Pharmaceutical. Our entire organization works hard every day to differentiate Collegium Pharmaceutical and to earn the trust and respect of our various stakeholders.

Recent headlines related to opioid litigation developments reinforce the importance of good corporate citizenship and the need to operate from a position of trust and accountability, putting the best interest of patients and our communities at the forefront of all that we do. Quantitative market research conducted in the second quarter shows that among our targeted health care providers, Collegium was ranked second only to Pfizer as a leader in responsible pain management, a testament to the quality and professionalism of our team and to the growing recognition of Collegium's commitment.

As part of that same research, Collegium was rated #1 based on ethical business practices, a belief that the company's product portfolio and materials, services and websites support responsible pain management and a positive reputation among the public and medical community. As we continue to build awareness around our commitment to being the leader in responsible pain management, we recognize the importance of leading with the science and that evidence-based outcomes are a key component to differentiating our brands. Since joining the team in the spring, our Chief Medical Officer, Dr. Richard Malamut, has been evaluating our scientific communications efforts in developing a plan for future enhancements. We now have a comprehensive publication plan in place and will have a strong presence at this year's PAINWeek in September, the largest U.S. pain conference for clinicians dedicated to pain management.

The presentation of new real-world data regarding Xtampza ER and the Nucynta franchise, including data derived from surveillance systems that track abuse and diversion, allow us to enhance our discussions with numerous stakeholders, including payers. Before I conclude my opening remarks, I would also like to take a moment to address the ongoing industry-wide opioid litigation. Prior to doing so, I want to emphasize that our organization stepped into this space in 2016, at a time when others began to step out because of a belief that Xtampza ER and our proprietary DETERx technology has the potential to make a positive difference in the lives of people suffering from pain and could play a role in responsibly addressing the opioid epidemic.

As of today, there are over 2,000 law suits against opioid manufacturers, distributors and other participants in the supply chain brought by various plaintiffs from cities to states to attorneys general and other parties. Of these, we are aware of 27 in which we are currently named. Where we have an opportunity to do so, we are pursuing dismissal based on Collegium's late entry to the market and the absence of allegations that we engaged in conduct that could contribute to the crisis. To date, Collegium has been dropped from 8 of the 11 lawsuits currently consolidated in the Ohio multi-district litigation that we have been named in, and we're awaiting dismissal in 2 cases brought against us in the Pennsylvania state courts. Collegium was never a party to the prominent Oklahoma AG suit that has recently garnered national attention, and Collegium was dismissed from an opioid lawsuit in Arkansas State Court. We are not named in any case in the multi-district litigation that is a track of bellwether case and do not expect to have involvement or engagement in the MDL for some time.

Finally, we did not assume any liability for Nucynta promotion or sales that occurred prior to January 2018. Instead, any such liability is retained by Assertio. While we typically refrain from commenting on litigation of any sort, we realize that this is an area of ongoing inquiry due to the high-profile nature of the opioid epidemic and the seriousness of the allegations made against various parties in the industry. Today's commentary is intended to address some of the common questions we have been receiving from the investment community. However, beyond these brief remarks, we will have no further comment on this topic during this call and would refer you to our quarterly and annual reports filed with the SEC, which contain both detailed descriptions of the status of litigation matters as well as descriptions of the risks associated with them.

Looking to the balance of the year, we remain focused on execution. We are encouraged by, but not satisfied, with our accomplishments in the first half of 2019, and we have a lot of work to do in the second half of the year. I am confident that Collegium has the right capabilities and most importantly the right people in place to make it happen.

And at this time, I would now like to hand the call over to Paul Brannelly, for a discussion of the financials.

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Paul J. Brannelly, Collegium Pharmaceutical, Inc. - Executive VP & CFO [4]

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Thanks, Joe. Good afternoon, everyone. During the second quarter of 2019, we achieved several milestones, including total net product revenue exceeded $75 million for the first time, operating activities provided almost $15 million in cash, and although we had a net loss of $4.7 million on a GAAP basis, we were profitable on a non-GAAP basis for the first time.

Additional financial details for the quarter included net product revenue for Xtampza of $26 million, which is a 44% increase from Q2 2018 and a 4% increase from Q1 2019. Xtampza ER revenue growth was driven by prescription growth partially offset by a reduction in channel inventory, which had a net revenue impact of approximately $500,000. The gross-to-net discount for Xtampza ER was 58.4% in Q2 2019 compared to 59.1% in Q1 2019. The improvement in gross-to-net discount was driven by a 1.4% reduction in reserves for potential returns, which was partially offset by higher rebates. We believe that the gross-to-net discount for Xtampza will average in the low 60s for the year.

Revenue for the Nucynta franchise was $49 million in the second quarter of 2019, down from $49.4 million in the first quarter and from $54.9 million in the second quarter of 2018. The decrease in Nucynta net product revenue was driven by lower prescription volume.

Operating expenses, excluding cost of product revenues, were $31.4 million for the second quarter of 2019 compared to approximately $35.3 million for the first quarter of 2019. The decrease was primarily due to lower sales and marketing-related expenses.

For the second quarter of 2019, our net loss was $4.7 million compared to a net loss of $13.1 million for the prior year quarter. The second quarter of 2019 includes approximately $4.2 million of stock-based compensation expense and $3.7 million of amortization expense related to the Nucynta intangible asset.

Our non-GAAP adjusted income for the second quarter of 2019 was $3.1 million compared to a non-GAAP adjusted loss of $4.9 million for the second quarter of 2018 and a non-GAAP adjusted loss of $1.7 million for the first quarter of 2019.

Please see our press release issued earlier today for a reconciliation of GAAP to non-GAAP results.

As of June 30, 2019, our cash balance was $148.7 million, which is a $13.8 million increase from our March 31, 2019, balance. We remain encouraged by our financial progress for the first half of the year both in terms of total net revenues and operating expenses, which reflects our stated objective of continuing to grow the business while leveraging our existing cost structure.

With that, I will now turn the call over to Scott Dreyer for a commercial update.

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Scott Dreyer, Collegium Pharmaceutical, Inc. - Executive VP & Chief Commercial Officer [5]

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Thanks, Paul. In the second quarter, we saw continued growth for Xtampza ER and stabilization of the Nucynta franchise. Xtampza ER achieved all-time highs for total prescriptions, market share and total prescribers in the quarter. Total prescriptions were 116,593, representing 11% growth over the first quarter of 2019 and 51% growth over the second quarter of 2018. Xtampza ER exited the second quarter with branded ER market share of 12.6% and oxycodone ER market share of 17%, an increase of 1% and 1.4%, respectively, versus the end of the first quarter.

There were over 13,000 unique prescribers in the second quarter, an increase of 7% versus the first quarter and 29% versus the end of 2018. We saw strong market share performance for Xtampza ER across the exclusive oxycodone ER formulary position and significant share acceleration within the new formulary position that went into effect in 2019. In fact, Xtampza ER achieved branded ER market share leadership within 19 of the 26 contracts that went into effect at the start of 2019.

Total prescriptions for Nucynta for the franchise in the second quarter were 135,257, and we saw stability in prescriptions and market share compared to the first quarter.

In the second quarter, we conducted quantitative market research with our targeted health care providers and are encouraged by the results. Unaided brand awareness for Xtampza was 69%, up from 62% in the fourth quarter of 2018. Xtampza was rated the #1 product on product favorability among branded ER products and its abuse-deterrent technology was rated higher than OxyContin. 58% of prescribers intend to increase their utilization of Xtampza ER and 63% intend to decrease their prescribing of OxyContin.

Nucynta ER was ranked second on product differentiation, and 50% of prescribers intend to increase their prescribing of Nucynta ER.

In this same body of research, our sales organization was highly rated by pain specialists on overall favorability, knowledge, support and customer engagement. In the second half of the year, we're taking specific actions to drive performance across the portfolio. These actions include launching new educational resources to enable interactive engagement with HCPs, leveraging new digital content to continue to grow brand awareness and executing comprehensive plans to maximize the broad market access coverage of our portfolio. Specific to Xtampza ER, the market access team is working diligently to strengthen existing payer positions and to secure new exclusive ER oxycodone formulary wins for 2020. We're in the midst of the negotiating season, and we're actively engaged with a large number of national and regional payers. Thus far, we're encouraged by how the discussions are evolving.

For Xtampza ER, the messages to payers are clear, and they're compelling. Xtampza ER has a differentiated label relative to OxyContin. Xtampza ER offers a lower net price than OxyContin when added to formulary. And there's numerous case studies demonstrating favorable market receptivity to an exclusive formulary position. We believe that we have a strong case to support the addition of Xtampza ER to payer formularies, and we look forward to continuing our interactions to raise awareness around the opportunity Xtampza ER represents for their coverage universe. The commercial team is laser-focused on operational execution and taking the necessary actions to grow Xtampza ER and continue to stabilize the Nucynta franchise.

With that, I'll turn it back to Joe.

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Joseph J. Ciaffoni, Collegium Pharmaceutical, Inc. - President, CEO & Director [6]

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Thanks, Scott. I will now open up the call for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from David Amsellem of Piper Jaffray.

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David A. Amsellem, Piper Jaffray Companies, Research Division - MD and Senior Research Analyst [2]

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Just a few. So on the exclusive contracts you already have in place, can you talk about what you can do or need to do to further increase your share? I mean I know you're already in a position of leadership in the broad ER opioid space, but how do you grow your share would be intuitive that you can continue to grow your share given that you have exclusive access. And yet, there's still quite a bit of OxyContin volumes that we see weekly. So help us understand what you can do there.

And secondly, can you elaborate on your negotiations for new contracts? You mentioned national plans, and I don't know that you can give specifics, but maybe frame for us how many covered lives you think the new contracts could encompass theoretically if you were to execute according to plan.

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Scott Dreyer, Collegium Pharmaceutical, Inc. - Executive VP & Chief Commercial Officer [3]

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Yes. Thanks for the question, David. So first, on the current plans that are in place. As I said, we feel really good about our performance. We've achieved branded ER leadership at 19 of the 26 plans. As you referenced, when we look at weekly share performance, we see continued progress and growth of share. So we think we're doing exactly what we need to do there to pull-through those plans. When it comes to what's on the table for 2020, I would just reinforce that I'm not going to speculate on the size of the opportunity. But we're in negotiations with numerous national and regional payers. We're really encouraged by those discussions, and we're looking to add both new wins or strengthen our existing position. And we'll be happy to share more on the next call when we have results of our work.

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David A. Amsellem, Piper Jaffray Companies, Research Division - MD and Senior Research Analyst [4]

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And maybe as a follow-up -- yes, go ahead, Joe, sorry.

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Joseph J. Ciaffoni, Collegium Pharmaceutical, Inc. - President, CEO & Director [5]

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And David -- sure. David, I was just going to add, where we have the exclusive wins that have been in place, a couple of the things that we do, do is we work it from the plan side and working with them to ensure that the controls that they're trying to implement from our on-the-ground -- the on-the-ground intelligence are, in fact, being implemented. And then the second thing that we do is we continue to ensure that our people are refined in identifying, on a physician-by-physician basis, where opportunities to continue to grow share exist. And then with regards to our negotiations, I always like to emphasize that in many respects, we're just getting started. So if you look from an opportunity to improve our exclusive positions, we have a long runway, with about 70% of the market to go. And if you look in Medicare Part D, we're at about 50% of those lives in an exclusive position. So we feel really good about where we are. We're encouraged by the negotiations that are ongoing. And as Scott said, we'll provide an update on our next call in terms of how 2020 is shaping up.

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David A. Amsellem, Piper Jaffray Companies, Research Division - MD and Senior Research Analyst [6]

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Okay. And then just a quick follow-up. Any color on where you think gross-to-net on Xtampza will be next year, low 60s is a good way to think about it? Or is it going to be higher as you have more exclusives on-boarding?

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Paul J. Brannelly, Collegium Pharmaceutical, Inc. - Executive VP & CFO [7]

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Yes, we think we can continue to manage within the low 60s, David.

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Operator [8]

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Our next question comes from Greg Fraser of SunTrust.

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Gregory Daniel Fraser, SunTrust Robinson Humphrey, Inc., Research Division - Research Analyst [9]

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It's Greg Fraser on for Greg Gilbert. On your speech, you already mentioned that you expect to grow volumes modestly in the second half. But just to clarify, are you referring to growth in the second half versus the first half or on a year-over-year basis?

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Joseph J. Ciaffoni, Collegium Pharmaceutical, Inc. - President, CEO & Director [10]

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Yes, Greg, this is Joe. I was referencing on a sequential quarterly basis, we expect to see modest growth with Nucynta ER.

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Gregory Daniel Fraser, SunTrust Robinson Humphrey, Inc., Research Division - Research Analyst [11]

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Okay, got it. And then just a quick question on the opioid litigation. I appreciate all of your earlier commentary. But I guess outside of MDL, are there any cases in which you are a defendant and that have been moving forward that could go to trial in 2020?

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Joseph J. Ciaffoni, Collegium Pharmaceutical, Inc. - President, CEO & Director [12]

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Yes. Greg, as I said in my comments on the call, we're not going to communicate beyond what it is that I outlined. But if you -- look, what I would emphasize in the perspective that we're trying to provide is that there's over 2,000 total cases, of which Collegium is currently named in 27 of those. 23 are state cases, and they're unlikely to go to trial in 2020.

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Gregory Daniel Fraser, SunTrust Robinson Humphrey, Inc., Research Division - Research Analyst [13]

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Got it. Okay. And then just the last question is in terms of business development. How is the stock price and the market environment impacted your appetite for BD, if at all?

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Joseph J. Ciaffoni, Collegium Pharmaceutical, Inc. - President, CEO & Director [14]

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Yes. So Greg, this is Joe. I appreciate the question. What I would emphasize from a BD perspective is the stock price has not impacted where -- what it is we're focused on. So as we outlined on the last call, our highest priority is looking in that midterm window, where we're looking for novel mechanisms of action, nonopioid pain solutions, and things that would be of value to the office-based pain specialists and the patients that they treat. And then, of course, the other window is in the short term, where we're certainly open to and looking at potentially differentiated assets that if we executed around, it would be accretive in the year we did it. And if not that year, the following year.

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Operator [15]

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Our next question comes from Serge Belanger of Needham.

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Tian Sun, Needham & Company, LLC, Research Division - Research Analyst [16]

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This is Tian on for Serge. So just 1 or 2. I've noticed that the FDA recently had a guidance for the future approvals of opioids, and it seems that in terms of drugs with abuse-deterrent properties, they're somehow concerned about the AEs that are -- that they're seeing. So how do you think this might impact the products that are already on the market versus those who might be looking into entering this space? Any thoughts would be great.

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Joseph J. Ciaffoni, Collegium Pharmaceutical, Inc. - President, CEO & Director [17]

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Yes. Tian, this is Joe. I appreciate the question. I'm not sure what it is that you're referencing as it pertains to abuse-deterrent formulation. What I would comment with regards to the hearing that the agency is having on the 17th with a focus on both the future approval of opioid analgesics and also incentives and ways to incent innovation to novel treatments for pain, those are 2 topics that we believe are very important. We think because opioids are serious medications, that it's important that anything that were to be approved to the market, there's a high bar, and it would need to bring something different than currently available therapies.

And then, of course, as we've talked about, we're trying to position the company to be a part of ushering in the next wave of nonopioid pain solutions. So from our perspective, anything that were to incent innovation is a positive.

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Tian Sun, Needham & Company, LLC, Research Division - Research Analyst [18]

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Okay, great. And then just on the constant lawsuits that's going on in the news regarding opioids, have you seen any change as far as your encounters with physicians that are prescribing opioids or even with payers as you start negotiating contracts?

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Joseph J. Ciaffoni, Collegium Pharmaceutical, Inc. - President, CEO & Director [19]

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Yes. Tian, this is Joe. I would emphasize what we're focused on is what it is that Collegium is driving each and every day to do in terms of being the leader in responsible pain management. I think the biggest change we're seeing as a result of our efforts is that the Collegium Pharmaceutical brand is rising to the top of the list with the health care providers that we're calling on each and every day, and they value the information and education that our people are providing them. They see our portfolio as innovative and differentiated, and they look at the content of our materials, whether it be our websites and other educational information that we provide to be best-in-class.

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Operator [20]

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Our next question comes from David Steinberg of Jefferies.

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David Michael Steinberg, Jefferies LLC, Research Division - Equity Analyst [21]

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I have 2 questions. The first one is on the status of some of your new contracts. Since they commenced, have you seen any increase at all in volume from Ohio Workers' and a large Mountain West plan?

And secondly, related to Medicare Part D. I know that you thought last year they would start kicking in, in a significant way in the second half of the year, and that didn't quite materialize. What are your thoughts about the second half of this year compared to last year for Part D plans?

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Scott Dreyer, Collegium Pharmaceutical, Inc. - Executive VP & Chief Commercial Officer [22]

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Yes. Thanks for the question, David. So first, on the new wins that we announced that went into effect in the Mountain West and Ohio Bureau of Workers' Comp, it's very early, but we're encouraged by what we're seeing there. Right out of the gate, we're seeing market share growth consistently week after week, but it's early to draw any other conclusions. And then on Med D and your question about continued growth, what we've referenced is, as the year resets, kind of the reset or the second chance at Med D. What we saw in the first quarter was absolutely share acceleration within the Med D plans, and we expect to see continued growth in the second half of the year.

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Operator [23]

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Our next question comes from Tim Lugo of William Blair.

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Lachlan Hanbury-Brown, William Blair & Company L.L.C., Research Division - Associate [24]

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This is Lachlan on for Tim. I got a couple. First of all, with Nucynta now starting to stabilize, how confident are you that you'll hit the free cash flow expectations you had when you licensed the franchise? And then secondly, just you were talking about your new contracts for Xtampza ER for next year. Should we expect similar discounting in those contracts? And at what point do you think you'll be potentially able to get sort of more favorable discounting in new contracts?

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Paul J. Brannelly, Collegium Pharmaceutical, Inc. - Executive VP & CFO [25]

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Great. Well, thanks for the question. And your phone's going in and out a little bit, so if we don't answer your questions exactly, please ask them over again after we comment. As far as meeting our goals as far as free cash flow, we're managing the Nucynta franchise closely. And as we've said, we view the Nucynta franchise is a great fit into our portfolio, a lot of advantages to having it in our commercial organization. But it's really a financial transaction for us, where we hope to manage the franchise to help us get to profitability sooner and to generate cash. And we believe that it's meeting those expectations.

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Joseph J. Ciaffoni, Collegium Pharmaceutical, Inc. - President, CEO & Director [26]

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And this is Joe. As it pertains to new payer wins for 2020 and how we think of that in terms of an impact on gross-to-net, we believe and are committed to both in 2019 and 2020 that we can manage the gross-to-net of Xtampza ER in the low 16%.

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Operator [27]

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Our next question comes from Brandon Folkes of Cantor Fitzgerald.

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Brandon Richard Folkes, Cantor Fitzgerald & Co., Research Division - Analyst [28]

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I was wondering if you could provide any color on the percentage of Xtampza scripts which currently are not going through the exclusive contracts.

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Scott Dreyer, Collegium Pharmaceutical, Inc. - Executive VP & Chief Commercial Officer [29]

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Yes. Yes, that's a great question. So right now, roughly 65% of prescriptions go through exclusive and 35% go through nonexclusive or noncontracted.

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Joseph J. Ciaffoni, Collegium Pharmaceutical, Inc. - President, CEO & Director [30]

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And Brandon, this is Joe. One other piece of color I would provide there is we are growing Xtampza ER across exclusive contracted, contracted nonexclusive and the noncontracted books of business.

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Brandon Richard Folkes, Cantor Fitzgerald & Co., Research Division - Analyst [31]

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Great. And maybe one just follow-up. As we look at new patient starts in the second half of the year, are you willing to provide some color in terms of where those are coming from, just so we can get a semblance of do they tend to start on the lower doses? Or are they actually coming from at a product where we could see patients switching and starting on the higher doses of Xtampza?

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Joseph J. Ciaffoni, Collegium Pharmaceutical, Inc. - President, CEO & Director [32]

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Yes. Brandon, this is Joe. I'll take that one. With the exception of when there is forced conversion from disruption from the payers, the dose utilization of Xtampza is consistent. So when patients are forced from a payer off of OxyContin to Xtampza, we'll see a slight increase to the higher doses. When we're through those conversion periods or those heavy periods of conversion, you get back to the steady state of the market, and it skews to the lower doses.

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Operator [33]

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Our next question comes from Kevin Kedra of G. Research.

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Kevin Kedra, G. Research, LLC - Research Analyst [34]

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I wanted to ask about the FDA. We had a change at the top. I know it was a big priority addressing opioids under the Gottlieb FDA. Wondering what you're seeing from the Sharpless FDA, if there's been a change in the way that they're approaching opioids and whether the concept of addressing some of the older products without abuse-deterrent formulations, if that's something that you think this leadership at the FDA may be willing to address.

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Joseph J. Ciaffoni, Collegium Pharmaceutical, Inc. - President, CEO & Director [35]

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Yes, Kevin. So this is Joe. I would say that what we're seeing is the work that Dr. Gottlieb has done when we headed the agency, along with the focus continuing as there's been a transition to leadership. As it pertains specifically to anything as it pertains to non-abuse-deterrent opioids, I wouldn't want to speculate on that. But I think from our perspective, the focus of the agency, the work that was put into place and started under Dr. Gottlieb are all things that we are supportive of, participate in when we have an opportunity to comment and certainly look forward to continuing to see how it evolves from here.

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Kevin Kedra, G. Research, LLC - Research Analyst [36]

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All right. And then secondly, would you be able to give some kind of view on what your mix is between IR and ER for Nucynta sales? I would imagine that as that mix shifts over time, it would be useful to know since IR is kind of a diminishing asset, whereas ER is something that you talked about being able to stabilize or grow.

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Paul J. Brannelly, Collegium Pharmaceutical, Inc. - Executive VP & CFO [37]

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Yes. Kevin, if you refer to our 10-Q, we have that listed each quarter. In the MD&A section of our 10-Q, we break out Nucynta IR and ER within that. So you can track it there.

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Operator [38]

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There are no further questions. I'd like to turn the call back over to Joe Ciaffoni for any closing remarks.

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Joseph J. Ciaffoni, Collegium Pharmaceutical, Inc. - President, CEO & Director [39]

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Thank you, everyone, for joining us today. Our priorities for the remainder of the year are clear and remain: number one, taking actions to further establish and differentiate Collegium Pharmaceutical as the leader in responsible pain management; number two, to grow Xtampza ER, stabilize the Nucynta franchise and leverage our existing cost structure to deliver a breakthrough year; number three, to strengthen existing formulary positions and/or achieve new ER oxycodone wins for Xtampza ER that will take effect in 2020; number four, to lead with the science by generating and presenting real-world data on the Collegium pain portfolio; and number five, to execute against our midterm growth strategy.

Before we sign off, I want to take a moment to thank and recognize my colleagues at Collegium for their focus on achieving our goals, ensuring that 2019 is a breakthrough year and for their unwavering dedication to our mission of becoming the leader in responsible pain management.

We look forward to updating you on our progress next quarter. And I want to thank you for your time, and I hope you have a great evening.

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Operator [40]

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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.