Good day, ladies and gentlemen, and welcome to Q4 2018 Collegium Pharmaceutical, Inc. Earnings Conference Call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] Also, as a reminder, this conference call is being recorded. At this time, I would like to turn the call over to your host, Alex Dasalla, Head of Investor Relations. Please go ahead.

Welcome to the Collegium Pharmaceutical’s fourth quarter 2018 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 patent infringement litigation or other litigation pertaining to our products and product candidates. 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 release and this call will include discussion of certain non-GAAP information. You can find our earnings 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.

Thank you, Alex. Good afternoon, and thank you, everyone, for joining the call. 2018 was a transformative year for Collegium, fueled by exclusive ER oxycodone payer wins and improved operational execution, Xtampza ER total prescriptions grew 233% and Xtampza ER was the fastest growing extended-release opioid in 2018. Xtampza ER net revenue grew $69.4 million in 2018, representing a 144% increase versus 2017. The acquisition of the U.S. commercialization rights to the Nucynta franchise broadened the Collegium portfolio, increased Collegium's relevance to all stakeholders and achieved the financial objectives of expanding Collegium's revenue base, being accretive in 2018 and accelerating time to profitability. Collegium achieved full-year net revenue of $280.4 million, up 885% versus 2017. Cash burn improved each quarter in 2018 and for the eighth consecutive quarter overall. Collegium ended the year with $146.6 million of cash on hand, exceeding our guidance of $145 million. The Xtampza ER patent state was strengthened with the addition of two Orange Book listed patents in 2018, bringing the total to 14. We made significant investments in personnel, systems and processes to enable Collegium to deliver on its commitment to be the leader in responsible pain management. Importantly, we completed a thorough strategic review that culminated in the strategic plan that we will be executing against moving forward. Collegium Pharmaceuticals is focused on and well-positioned to become the leader in responsible pain management. We believe that 2019 will be a breakthrough year for Collegium. We expect Xtampza ER total prescriptions to accelerate as a result of 13 new exclusive ER oxycodone payer wins that took effect on January 1, 2019. As was the case in 2018, we anticipate a faster rate of growth in the first half of the year, followed by sustained growth and a moderated rate in the second half of…

Thanks, Joe. Good afternoon, everyone. For the fourth quarter of 2018, we recorded net product revenue of $73.4 million compared to $10.8 million in the prior year quarter and $70.2 million in the third quarter of 2018. For the fourth quarter of 2018, net product revenue was $18.4 million for Xtampza ER and $55 million for the Nucynta franchise. For the full-year 2018, net product revenue for Xtampza ER was $69.4 million and $211 million for the Nucynta franchise. Xtampza ER prescriptions and net revenue both grew by 8% during the fourth quarter compared to the third quarter of 2018. Nucynta revenue grew by 3% in the fourth quarter compared to the third quarter of 2018 due to a slight improvement in the gross-to-net discount. For the fourth quarter of 2018, we had net income of $9.1 million, compared to a net loss of $17.4 million for the prior year quarter. While revenue increased and SG&A expenses decreased in the fourth quarter compared to the third quarter of 2018, the improvement to net income was primarily driven by one-time accounting adjustments, of $18.3 million due to the amended Nucynta agreement. In order to supplement our GAAP financial supplement, we’ve included non-GAAP adjusted loss in our earnings press release and 10-K. We believe that the non-GAAP adjusted loss provides investors insight into management's view of the Company's core operating performance. The non-GAAP adjusted loss for the fourth quarter of 2018 was $3.4 million, which is an improvement of $4.9 million from the third quarter of 2018. As of December 31, 2018, our cash balance was $146.6 million, which exceeds our cash guidance of $145 million and represents an increase of $27.9 from the prior year and $6.8 million from September 30, 2018. As Joe stated, this marks the eighth consecutive quarter of improving cash flows after adjusting for stock offerings and term loan draw downs. As discussed on our third quarter call, the amended Nucynta commercialization agreement improves Collegium's net cash flow at all net revenue levels. Additionally, our yearend financial statements are simplified with removal of the asset acquisition obligation as well as the substantial reduction of the corresponding Nucynta intangible asset on our balance sheet. In 2019, Nucynta royalties will flow through cost of products revenues on our P&L within operating activities in our statement of cash flow. For additional details related to the amendment of the commercialization agreement, please refer to our 10-K filed with the SEC. Since this is our first conference call since we issued guidance on January 7th, we are reaffirming our previous guidance. For 2019, we expect Xtampza revenues between $95 million and $105 million, this implies Xtampza revenue growth of 37% to 51%, Nucynta revenue between $200 million and $210 million, and operating expenses, excluding cost of goods sold between $125 million and $135 million. Going forward, we do not plan on reaffirming guidance on our quarterly earnings calls. I will now turn the call over to Scott for commercial update.

Thanks, Paul. In the fourth quarter, we made progress against our commercial priorities of finishing the year strong and setting up for a fast start in 2019. Xtampza ER total prescriptions for the fourth quarter came in at 94,153, which is 8% growth over the third quarter and 147% growth over the fourth quarter of 2017. There were 2,426 new writers in the fourth quarter, bringing the launch to date total to over 18,000 prescribers. Xtampza ER ended 2018, achieving new total prescription highs, five of the last seven weeks. Within the 10 exclusive ER oxycodone formulary positions that were in place in 2018, Xtampza ER is the number one prescribed branded ER opioid within all six commercial plans and two of the Medicare Part D plans. The Nucynta franchise delivered a 157,055 total prescriptions in the fourth quarter, down 1% from the third quarter. Total prescriptions for Nucynta ER were flat from the third to the fourth quarter and had been stable since the second quarter of 2018. Nucynta IR total prescriptions declined 2% in the fourth quarter compared to a decline of 6.1% in the third quarter and were in line with the overall IR market. In 2019, our commercial priorities are clear, establishing Xtampza ER as the ER oxycodone of choice and maximizing the potential of the Nucynta franchise. For Xtampza ER, we are focused on displacing OxyContin and leveraging our differentiated label. Xtampza ER is the only single agent ER oxycodone with oral intranasal and intravenous abuse-deterrent labeling. For the Nucynta franchise, our focus is on establishing tapentadol as a differentiated opioid with a novel dual mechanism of action. We are also focused on the fact that Nucynta ER is the only opioid indicated for neuropathic pain associated with diabetic peripheral neuropathy. Operational execution and improving the quality of our interactions with pain specialists is a priority. Across 25 exclusive formulary positions, Xtampza ER is now the exclusive ER oxycodone for 20% of commercial lives and 38% of Medicare Part D lives. Overall, market access coverage is strong with Xtampza ER being covered for 91% of commercial lives and 49% of Medicare Part D lives. 13 new exclusive oxycodone ER formulary wins went into effect on January 1st, and we are focused on pulling through those opportunities as well as leveraging Xtampza ER’s broad market access coverage to establish Xtampza ER as the ER oxycodone of choice. Through the first seven weeks of 2019, the prescription trends for Xtampza ER are encouraging. With the exception of holiday weeks and a week impacted by extreme weather, Xtampza ER has consistently achieved new total prescription highs. The Collegium team is committed to ensuring that 2019 is a breakthrough year. I'll now turn it back to Joe.

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

[Operator Instructions] Our first question comes from Serge Belanger from Needham & Company. Please go ahead.

Hi. Good afternoon. Just first question on the formulary coverage of Xtampza. As you look to 2019 and beyond, is the goal to continue expanding exclusive positioning of Xtampza on the commercial side? And then, on the Medicare Part D side, there is only three additions in 2019, how do you see that expanding over the year?

Okay. Hey, Serge, this is Joe. I'll take that question. With regards to Xtampza ER, what we're trying to accomplish in the payer space, the first thing we’re focused on is pulling through the new wins and ensuring we are maximizing those opportunities along with continuing to grow where we have exclusive ER position along with leveraging the broad 91% commercial availability that we have. As we think about 2019, we continue to engage in discussions with payers around Xtampza ER. And as we go forward from a commercial perspective, we will look to add and strengthen ER oxycodone positions as we think about 2020. The key there is we are focused on plans now more at the regional and state level that have high control and the willingness to displace and block OxyContin. From the Medicare Part D perspective, there are essentially two significant players left. And as you know, those opportunities are negotiated a year in advance. So, we'll see how it is that that plays out. But, in general, our focus will be more to the commercial side than Medicare Part D, as we think about moving forward.

And then, a question for Paul, just I guess an update on gross-to-nets in the fourth quarter and where did inventory stand at yearend?

So, overall gross-to-nets for the year ended at 54% on a portfolio basis. And we previously discussed having -- finishing the year around 55%. With that, Xtampza remains in the low 60% range. And Nucynta though had a positive sort of surprise there that for the fourth quarter, we were at 50.2%. So, that's one of the reasons that Nucynta was higher in the fourth quarter. And so, we believe that Xtampza for 2019 should remain in the low-60s and that Nucynta should stay around 52%, 53% gross-to-net discount and throughout 2019. But for both products, it should be lumpy over the course of the year, but average out to those numbers.

Inventory?

Yes. Sorry. So, as far as inventory, you mean days on…

Yes.

Okay. So, Nucynta, as has been the pattern with Nucynta, even when Depomed had it. The wholesalers order a lot at the end of the year. So, that was one of the reasons for a little bit of a surprise in Q4 when it came to Nucynta. On average, it went about five days between the Nucynta IR and ER. Xtampza went up slightly and went up a little over day about a day and half in the fourth quarter, but that's a level that we expect to keeping at going forward.

Let me sneak one last one, I'll get back in queue. FDA issued comments earlier this week, I mean they have new plan to address the opioids crisis and have discussed for opioid companies to conduct additional efficacy studies, just wanted to hear your comments on those steps.

Yes. So, Serge, this is Joe. I'll comment on that. First off, when you look at the FDA statement that was issued this week, the first thing that I would emphasize is as a company that’s committed to being the leader in responsible pain management, we are aligned with Health and Human Services, the FDA and Commissioner Gottlieb in terms of the areas that they are focused on to ensure appropriate treatment of people suffering with pain and also addressing the opioid epidemic. As you know, the areas of focus, they talked about innovative medication, that’s obviously something we are positioning the company and want to be a part of in terms of monitoring of supply chain and taking steps to avoid diversion. When you look at the -- trying to eliminate illicit fentanyl and other things pertaining to reversion, all of those aspects of it we’re fully aligned with. As it pertains to the safety comments around hyperalgesia, that's work that is done through the consortium and that's something that has been worked on. As it pertains to the efficacy study, I won't speculate on that because we haven't been notified with regards to what is the agency is thinking. So, we saw the article and the statement. I would emphasize, if you look at Collegium through its history with Xtampza, what we've demonstrated in the approval of the product, the approval of the sNDA is we will take all of the required steps as it pertains to studies, and you can also see that along with our -- how we meet the post-marketing requirements that the agency asked for. So, whatever it is that ultimately, if we were to be notified that they're looking for us to do, we will certainly respond and meet those requirements.

Thank you. Our next question comes from David Amsellem from Piper Jaffray. Please go ahead.

So, I just had a few. So, first on Nucynta. So, the product is admittedly -- has some points of differentiation and it's not a pure new opioid agonist, and yet, it is flattish and its footprint is not growing. So, I guess the question here is what do you think you can do to grow that product's footprint given that it's not just your garden variety ER opioid? So that's number one. Number two, another Nucynta question. Is there anything significantly different that you need to be doing or should be doing regarding contracting? I know you inherited contracts from Depo. Anything we should expect in terms of major changes there? Then lastly, the color on your M&A strategy is helpful. I guess the question is how wide of a net are you going to cast when you -- when we think about novel assets? In other words, are you prioritizing R&D-stage assets versus commercial? And in terms of deal size, what kind of dry powder do you have? Thanks.

Okay. David, I am going to hand the Nucynta questions off to Scott and then I'll comment on the M&A strategy.

So, first, regarding kind of Nucynta growth. I want to reinforce what our focus is on that at this point. So right now what we're focused on is continued stabilization of Nucynta ER, which we feel we've accomplished over the last few quarters. And so in '19, we're looking to drive modest growth of that business. When we look at Nucynta IR, our goal is simple and that is to slow the erosion of IR to a level over the year that is better than the decline of the overall IR market. So that's what we're trying to accomplish overall to achieve the guidance we've put out from a revenue standpoint of $200 million to $210 million. And what's encouraging to us about the product is when we look at our market research, pain specialists view Nucynta as favorable, highly differentiated, and 50% of prescribers intend to increase their prescribing. So we think focusing on operational execution can support what we're trying to accomplish with the franchise. To your second point about contracting, yes, we inherited a bunch of contracts that we've moved over. As we reevaluate those contracts, our focus is profitability. So what we're looking to do is continue contracts that we think provide the best profitably and if there's ones that are not performing the way we want to, we would move in another direction. But our focal point in renegotiation is ensuring profitability of the contracts.

And David, one comment I would make on contracting too, that we're seeing in the analysis that we're doing is Nucynta seems to benefit in accounts where it is that we have also displaced OxyContin. So although it sources business distinctly different than what we see with Xtampza ER, that is something that is playing out to this point to be synergistic, and that will be something we'll continue to focus on and potentially action around. With regards to M&A and how wide of a net did we cast through the strategic review, we have looked at hundreds of assets and put them through a series of filters. The thing I would comment on today, number one, is we are focused on assets that are relevant to the office space pain specialists. And that's something that's important for us to anchor people on. That's where we feel we have a real point of competitive differentiation, the way that the market has evolved. Our highest priority is we're looking for development-stage assets post Phase II that have the potential to be generating revenue in 2022. The assets that we're targeting there are predominantly novel mechanisms of action and non-opioid solutions. From a short-term perspective, because of how bullish we are on the in-line business and in particular the runway that Xtampza has and the cash that will be generated over the five-year window, we have a very high bar. And the high bar is anchored to differentiation so we don't want to be a commoditizer or an aggregator of commoditized asset value. And then the third point is that it'd be accretive either in the year we action around it or the following year. And maybe Paul can give some color in terms of financing.

Yes. So on the financing front, the important thing for us is what you've seen with the Nucynta agreement is that we would -- we'd try to come up with innovative deal structures with one key difference. Any deal we would do in the future will retain much more the economics than we did with the Nucynta transaction.

Just one question, a clarification question. When we think about the basket of assets you're looking at, I mean, it doesn't have to necessarily be chronic pain, it could be neuropathic pain, it could be even migraine, it could be, in other words, adjacencies within the office space pain specialists setting. Is that a fair way of thinking about how you're looking at assets?

It is David. With the point, think of it and you're hitting right on it. The key is things that are valuable to or relevant to the office space pain specialists and then we are a pain Company.

I think you're right on it.

Okay. That's helpful. Thanks.

Thank you.

Thank you. Our next question comes from Tim Lugo from William Blair. Please go ahead.

Can you comment a bit about what you're seeing in the market from your competitors? Obviously, the largest players pulled away from the market from a kind of sales and marketing perspective. But are you still seeing them when you're looking to contract with payers?

Yes. So Tim, I'll hand that one off to Scott.

So, yes, from a contracting standpoint, Purdue is still active, but they have stepped away from their personal promotion. The thing that we'd emphasize there, so when we look at the environment that we play in, the market's more complex and competitive. Our still number one challenge is displacing OxyContin, which is an entrenched market leader. And so when you look at the dynamics in the market and the pulling out of Purdue, what we are encouraged by is the fact that it gives us more time with our customers and office space pain specialists, allows us more time to raise awareness, educate around our meaningfully differentiated projects and move them forward.

And maybe another comment from the market. You mentioned in your prepared comments that the scripts were expected to accelerate and then in the second half kind of moderate similar to what we saw last year. We've already seen very solid growth in the weekly scripts. Can I just get your comment on how you view that growth? Has that been as planned? Is that kind of the acceleration we should expect for the remainder of the beginning the year or are you looking for something above and beyond that or maybe is it pacing better than expected?

So, Tim, this is Joe. I'll take that one. So I would emphasize that, one, it's early in the year. We're encouraged by the trends we're seeing. As we looked at the year and the guidance we gave, we saw a like opportunity in terms of the incremental exclusive ER oxycodone wins, and we forecasted in our guidance a light capture rate of that opportunity. We look at that many different ways through various data that we're looking at. The one data point I would point you to is if you look at through the first seven weeks of the year and look at 2019 versus 2018, and then if you look at the first seven weeks of the year and 2018 versus 2017, you would see that the capture is comparable at around 24,000. The one caveat that I would put out that we view as a positive in terms of being on par at this point in the quarter was there was a significant impact in the week that the polar vortex occurred, and we saw a bounce back, which was good to see. So I would just leave it there. But right now, we're in line in terms of capturing off of life-size opportunity, a similar rate, and we're very encouraged by the other indicators that we're looking at.

Fair enough. And maybe one last one on OpEx. You guided to flat OpEx essentially year-over-year. And on a quarter-by-quarter basis, will that fluctuate? And are there any quarters during the year that may be have a higher marketing spend than others?

Yes. So, overall, there will be some fluctuation depending on marketing a little bit, which is a little bit more predictable, and then legal fees, which are less predictable. And marketing spend will decrease a little bit over the course of the year. But litigation and some other things like that are the ones that we're not -- aren't under our control and could fluctuate more through the year. But in general, it's spending a little bit higher early in the year and decrease a little bit because of that marketing piece.

Thank you. Our next question comes from Brandon Folkes from Cantor Fitzgerald. Please go ahead.

So, as we look out toward the second half of the year, can you perhaps give us some thought on what you have implemented to drive growth in the second half of the year given your learnings in 2018 there? I get the pull-through in the first half of the year. So just any color on what we may see in the second half of the year?

So, when we look at the year, our focus in the first half is pulling through these exclusive ER oxycodone opportunities where we know there's staff conversion in the new wins that come on. I think where I focus is the second half of the year being driven by the broad access that we have, the 91% commercial availability and the 49% coverage in Part D. And so as you look at the year, yes, there will be greater growth in the first half and more moderation in the second half, but the focal point for that second half will be growth in that nonexclusive business.

Okay. And maybe just one follow-up. So your growth in your nonexclusive business, is that safe to say that, that could be kind of higher margin to you?

Yes. So Brandon, this is Joe. When you look at the simplistic way we look at the business, there's contracted exclusive, there's contracted nonexclusive and then there's non-contracted. And then those other two books are already significantly better margin. And that's one of the reasons why as we look to the second half of the year a metric that we'll be looking at to assess our commercial effectiveness is how we do in those other two books of business. And we also believe as we're the significant player that's continuing to step into the marketplace, our commercial effectiveness is improving along with the other players being out. We would expect to see a better performance there in the back half of '19 than we saw in '18, and that also has a positive impact on margin.

And maybe one more if I could just on the strategic review. You mentioned you had looked at a number of transactions. So maybe could you give us some color on how you're seeing the value and the pricing of those transactions? Are sellers rational to the pricing within this space right now? Thank you.

So Brandon, thank you for that question. I won't comment too much on it other than to emphasize that as we did the strategic review because of the underlying strength in the runway of the in-line portfolio, I would emphasize our priority is one to that mid-stage build of the pipeline and those novel non-opioid mechanisms of action. And then the second thing is independent of the market, because of the position we're in, we are looking for value. So we're not forced to do a move, and we're not in a position where we would be overpaying for assets.

Thank you. [Operator Instructions] Our next question comes from Ed Arce from H.C. Wainwright & Co. Please go ahead.

Hi, guys. Thanks for taking my question. Most of them have been asked and answered. But, I will just ask one sort of bigger picture qualitative question, and that is recently in the last few days, there were some new revelations about the founding family and certain members of Purdue. And just wondering across the different lines of business, I know some of that is annualized like the exclusive wins and so forth. But at -- is that having any sort of tangible effect? I know that this is a long sort of process of switching. So wondering if you have any comments there.

I don't necessarily have a comment relative to the question as you posed it. What I would say is what we see in the marketplace is Xtampza ER and the Nucynta franchise are viewed favorably and are differentiated, most importantly, in the minds and through the eyes of the healthcare professionals that we're calling upon. Within the payer space, we see Xtampza ER in particular gaining significant traction and is of high interest to the payers, one, because of the clinical profile and the differentiated label of the product. Number two, people can now look at a pretty wide list of successful pull-through case studies. And so it's credible for us as we talk about Xtampza ER and the receptivity of it to the market when it's put into that position. And I would leave the comments at that.

Thank you. Our next question comes from Kevin Kedra from G. Research. Please go ahead.

Thanks for taking the question. I think most of mine have been asked and answered. But maybe more of a longer-term outlook question. Certainly with the contract that you have been doing for Xtampza, even working to build up that volume and you guys are probably around low teens of the market share versus OxyContin. Where does that market share need to get to before you kind of shift direction to making -- to focusing more on the margin profitability of that business versus taking share?

So, Kevin, this is Joe. That's a great question. As I said in my comments, our expectation is that Xtampza ER becomes to the number one prescribed ER oxycodone. Our whole strategy is focused on balancing volume uptake while maintaining margin, which is why we're very disciplined in our approach to the exclusive ER oxycodone contract and that we look for plans that are high control and have the willingness to block OxyContin. So, we are always cognizant of that. We also focus on the 91% broad availability, which is important for Xtampza ER from a margin perspective. And we're now focused more at a state and regional level than a national level as we're trying to create significant breadth in terms of the physician experience with Xtampza ER. So, that's something we will continually look at and will become the basis to how much more we try to add from an exclusive perspective versus how it is that we're able to compete and pull through when we're at parity with OxyContin.

Thank you. This concludes our Q&A session. At this time, I'd like to turn the call to Mr. Joe Ciaffoni, CEO of Collegium Pharmaceutical, for closing remarks. Please go ahead.

Thank you. Once again, thank you for joining us this afternoon. 2018 was a transformative year for Collegium. We made significant progress towards becoming the leader in responsible pain management. Collegium is well-positioned and focused on making 2019 a breakthrough year. We look forward to updating you on our progress. Have a good evening.

Thank you, ladies and gentlemen, for attending today's conference. This concludes the program. You may all disconnect. Good day.