Collegium Pharmaceutical (NASDAQ:COLL) Q3 2020 Earnings Call

0:01 Greetings and welcome to the Collegium Pharmaceutical, Inc., third quarter 2020 conference call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If you would like to ask a question, you may do so by pressing star one on your telephone keypad. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Ms. Alex Dasala, Head of Investor Relations for Collegium. Thank you. Please go ahead. Welcome to Collegium Pharmaceutical's third quarter 2020 earnings conference call. This is Alex Dasala, Head of Investor Relations for Collegium. I am joined today by Joe Schifoni, our Chief Executive Officer, Paul Granley, our Chief Financial Officer, and Scott Dreyer, our Chief Commercial Officer.

0:53 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 impact of the COVID-19 pandemic, the risks that we may not successfully commercialize Exams at ER and the New Center Franchise, and that we may 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.

1:44 Our future results may differ materially from our current expectations discussed today. Thanks, Alex. Good afternoon, and thank you, everyone, for joining the call. I want to start by acknowledging the challenging situation the COVID-19 pandemic continues to present for so many people. Our thoughts and hearts go out to everyone who has been impacted. I am pleased to report that our people are healthy, our supply chain is secure, and our business is strong. In a year of extraordinary challenges, 2020 will be a transformative year for Collegium Pharmaceutical.

2:38 We are on track to achieve our operational objectives in 2020, while concurrently setting the foundation for success in 2021. I want to take a moment to thank my colleagues at Collegium for their commitment to our mission to become the leader in responsible pain management. I appreciate the effort that they put forth every day and admire their adaptability and resolve. Business highlights for the third quarter include record net revenue of $79.2 million, which represents an 8.5% increase over the third quarter of 2019. Xtansya ER third quarter net revenue of $32.1 million which represents a 21% increase versus the third quarter of 2019.

3:24 Total prescriptions were on 19% versus Q3 2019. As anticipated, Xtansya ER grew at a moderated rate on a sequential basis. and we expect prescriptions to grow at a similar rate in the fourth quarter. NuSynda franchise net revenue of $47.1 million, which represents a 1% increase versus the third quarter of 2019. Total prescriptions were down 10% versus Q3 2019, but it is worth noting that franchise prescriptions were stable sequentially and that Ducente ER TRX share has grown or been stable for six consecutive quarters. OPEX for the quarter was down compared to the third quarter of 2019 and sequentially.

4:14 We were being committed to leveraging, not growing Collegium's cost structure in 2020 and beyond. We were profitable on a gap basis for the third consecutive quarter, meaningfully increased cash on hand and paying down debt. and we settled the TEVA Expanse ER and the litigation. The settlement contemplates a generic launch no earlier than September 2033. We believe this settlement confirms the strength of the Expanse ER patent state. Looking forward to 2021, we believe that we have set the foundation upon which Expanse ER will accelerate beginning in January and on which sequential annual revenue stability will be achieved with the nuisance of franchise.

5:04 Our market active team has done a great job executing our portfolio payer strategy. As it pertains to Examsa ER, Collegium's market active team has secured additional exclusive ER oxycodone formulary wins that cover approximately 7 million commercial and Medicare Part D lots. The biggest new win is UnitedHealthcare's Medicare Part D, AARP, PPP preferred business, which is a high-control plan and the second-largest plan in terms of ER Oxycodone prescription. Starting January 1, 2021, Xtansyn ER will be the exclusive ER Oxycodone for over 92 million commercial and Part D lots.

5:51 In addition, the team has secured parity formulary positions that cover approximately 5 million lives. These wins also take effect on January 1, 2021. From the perspective of managed care pull-through, our commercial team's focus in 2021 will be on three buckets of growth. New 2021 wins, 2020 exclusive wins, in the 2020 Austin Commercial Parity win, which covers approximately 17 million lives. With regards to the new SINTA franchise, we improved rebates with a few plans and opted not to renew some unfavorable contracts that we inherited. We anticipate that the evolution of the payer landscape will have a positive impact on revenue, meaningfully offsetting any pressure on prescription.

6:43 As a company committed to being the leader of responsible pain management, we will continue to work with payers whenever possible to remove non-clinical barriers to our pain portfolio, which healthcare providers view favorably and as highly differentiated. The collegium team is encouraged by, but not satisfied with the progress that we have made thus far in 2020. Every person in our organization is focused on finishing 2020 strong, while simultaneously preparing for a fast start to 2021. I'm confident that we have the people in the portfolio to make it happen. I will now hand the call over to Paul for a discussion of the financials. Thanks, Joe. Good afternoon, everyone. In the face of COVID-19, we ended the third quarter in a strong financial position.

7:33 In the two quarters since we've closed the Nusenta transaction, we generated $78 million in cash from operations, and repaid $25 million of our term loan. Our September 30th cash balance was $165.4 million compared to our June 30th cash balance of $145.7 million. Total product revenue was $79.2 million for the third quarter of 2020. Xtamza ER revenue was $32.1 million which is an increase of 21% from the third quarter of 2019 and a decrease of 4% from the second quarter of 2020. The gross to net discount for Xtam ZDR was 60.9% for the third quarter compared to 59% in the second quarter.

8:27 The increase in our gross to net discount was driven by Medicare coverage gap. We continue to expect gross to net discount may be lumpy throughout the year and to be in the low 60% range for 2020. New Center revenue was $47.1 million for the third quarter of 2020, which is a 1% increase from the third quarter of 2019 and a 6% increase from the second quarter of this year. Operating expenses were $28.6 million for the third quarter of 2020, which is a 10% decrease from the second quarter of this year. Our GAAP net income was $11.3 million for the third quarter of 2020 compared to a GAAP net loss of $6.1 million for the prior year quarter.

9:21 Our non-GAAP adjusted income was $36.1 million for the third quarter of 2020 compared to $1.7 million for the prior year quarter. Similar to the last two years, we expect to issue 2021 financial guidance in January. We anticipate providing guidance for adjusted EBITDA instead of non-GAAP adjusted income like we did this year. We believe that adjusted EBITDA is a more helpful metric for investors and analysts. Please see our earnings release in 10Q for additional information about adjusted EBITDA. In the third quarter, we had record net income, generated significant cash flow from operations, and we continued to maintain financial discipline.

10:10 We are on track to make 2020 a financially transformative year for the organization, and we've built a strong foundation upon which we can continue to grow in 2021 and beyond. I will now hand the call over to Scott for commercial update. Thanks, Paul. As COVID-19 cases increase across the country, it continues to adversely impact in-office patient visits and in-person calls by our sales professionals. It's estimated that weekly in-office patient visits are down about 20% versus pre-COVID levels, which manifests in a corresponding decrease in the new-to-brand market. Our field force is adapting and continues to make progress. That being said, in-person calls are still down about 40%.

10:57 As we've described previously, we believe the growth rate of Xtamsa is adversely impacted by these dynamics, and conversely, the new Sinsa franchise benefits from continuity of care. In the face of these dynamics, Xtamsa ER grew modestly in the third quarter, achieving new highs in total prescriptions, market share, and total prescribers. Total prescriptions for Xtamsa ER grew to 142,686, up 1% versus the second quarter of 2020. Xtamsa ER extended release Oxycodone market share grew to 24%, and there were 14,700 unique prescribers. The Nucinta franchise stabilized in the third quarter, and for the first time in over three years, the prescriber basis for both Nucinta ER and IR grew.

11:45 New Cynthia ER has now had a stable or growing market share for six straight quarters. I appreciate the efforts of the commercial team, and I'm encouraged by the progress that we're making. Although we don't anticipate a return to normal in 2020, I believe that we can and will do better the remainder of the year. We're focused on improving execution and impact of both remote and in-person interactions, pulling through our strong market access positions, and leveraging our new capabilities to generate momentum in the fourth quarter. Turning to 2021, our market access team has done a great job executing our portfolio payer strategy. We've put a foundation in place to accelerate extamps at ER beginning in January and to achieve annual net revenue stability for the new Cinta franchise.

12:33 I'm pleased to announce that the Market Access team has strengthened the formulary position of Xtamsa ER, securing new exclusive and parity wins across 12 million lives. These wins will fortify the foundation for accelerated growth in 2021. In 2021, the commercial team will be focused on three buckets of growth. The first bucket is the new exclusive ER oxycodone wins taking effect on January 1st. The most significant new win is UnitedHealthcare Medicare Part D AARP PDP Preferred Business. This is a high control plan and the second largest individual plan as measured by OxyContin prescriptions. XtanSe ER is now the exclusive ER Oxycodone for all of UnitedHealthcare's 10 million Medicare Part D lives. We've also secured several new exclusive wins with regional commercial plans representing approximately 3 million lives.

13:28 The second bucket is the 2020 exclusive ER oxycodone wins, which represents significant opportunity for continued growth in 2021. In both commercial and Part D, our team is focused on capturing the market share that we anticipated getting in 2020. In addition, many plans are making operational adjustments to drive better formulary adherence. The third bucket is the Optum National Commercial formulary win, where Xtamsa ER was moved into a parity preferred position in 2020. As a reminder, this win went into effect in July and is the first parity position for Xtamsa ER, covering approximately 17 million lives. Optum Commercial will serve as a bellwether and impact our contracting strategy for 2022.

14:17 The team also achieved several parity wins with smaller regional plans that take effect in January and cover approximately 5 million lives. For the NuCinta franchise, the team was able to improve rebates at several plans. We also opted not to renew several contracts that were underperforming. Although these decisions will pressure NuCinta franchise prescription volume, they will result in increased revenue. As a company committed to being a leader in responsible pain management, We continue to engage payers to remove non-clinical barriers that complicate access to our pain portfolio, which healthcare providers view favorably and as highly differentiated. The commercial team is focused on generating portfolio momentum for the remainder of 2020, while preparing to accelerate growth with Xtensa ER and maximize the potential of the new Sinsa franchise in 2021.

15:09 I'm confident that the team has set the foundation to accomplish both of these objectives. With that, I'll turn it back to Jeff. Thanks, Scott. I will now open the call for questions. Thank you. Ladies and gentlemen, if you would like to ask a question, you may press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove yourself from the queue. Participants using speaker equipment may be necessary to pick up your handset before pressing the star keys. Once again, that's star 1 to register questions at this time. Our first question is coming from David Amsel of Piper Sandler. Please go ahead. Hey, thanks. Just a couple of questions. So first on the formulae wins and particularly the United Part D, can you talk about how we should think about the pace of new – New Expanza ads or passive switching. One thing we've seen in past years when you get a big exclusivity contract is, you know, a big bolus of volume growth in the first quarter, and it moderates to some extent in the second quarter and moderates further in the second half of the year. So should we think about the dynamics next year as being similar to past years? So that's number one. And then number two, just on gross-to-net, can you talk through what you think gross-to-net's

16:39 will be for Extanza. And I'm particularly interested in what your gross nets will be on the Nuscenta franchise given the discontinuation of certain contracts, how we should think about those dynamics for 2021. Thanks. Hey, David, this is Joe. I'm going to pass the United Part B question over to Scott, and then Paul will take the gross net question. Yeah, thanks, David. So, yes, to answer your question first about the PDP win, we do expect acceleration right out of the gate in the first quarter, like we see every time we have an exclusive win. To give some perspective, the PDP business right now has about a 5% market share, and as a high control plan, we know that will accelerate. It will be more protracted as a PDP, right?

17:26 So compared to commercial, it will be a little more protracted throughout the year, but will absolutely accelerate aggressively in the first quarter. Great, and hi, David. So for Xtamsa gross to net, as we've said, we believe we can continue to manage Xtamsa in the low 60% range on a go-forward basis. But we will give guidance, and we expect to give guidance in January, so we could give more detail at that point when we're done modeling out what we think uptake will be next year. For the new CINTA franchise, it's been fairly stable in the low 50% range now. And so that could certainly, we could see some benefits in gross to net as we change these payer contracts.

18:16 So that's something that will also be included in our work done for coming out with 2021 guidance and our communications with that. Okay, and then if I may just ask a follow-up. This is for Joe. You know, you talked about biz dev in the past. I wanted to get your latest thoughts, and, you know, you talked about the addition of an asset that has some line of sight into commercialization down the road. You're obviously looking at keeping an eye on the loss of accessibility in a few years, so With all that in mind, what are your latest thoughts and what are you prioritizing these days?

19:03 Yeah, David, thank you, and I appreciate the question. As always, when I get that question, I like to emphasize the confidence that we have in the runway of the core business and how it is that we anticipate that it will perform. In terms of our focus, our focus remains the same. Our highest priority is looking at late-stage development non-opioid pain solutions I would say we're focused, we know what it is that we prioritize, and we're active from that perspective. And then I guess the final point that I think is always important for us to emphasize is because of the strength of the overall business, we're also really locked into value and making sure that not just in terms of value of the asset, in terms of being a meaningful solution, but also being able to action around it in a way that we think makes sense for the organization and the utilization of our capital.

20:02 All right. Thanks, David. Thanks, David. Thank you. Our next question is coming from Tim Luzzo of William Blair. Please go ahead. Hey, guys. This is Lachlan on for Tim. Thanks for taking the question. So I was just interested, can you give a sense of sort of what your penetration into current plans is and as you think about You know, sort of future growth, sort of 2021 and beyond, how that's going to be driven by increasing penetration versus, you know, continued expansion of coverage and formulary, you know, lives under formulary? Yeah, thanks for the question, Lachlan. So, yeah, so with the wins we just announced, in commercial, about 45% of lives will be in exclusive position and about 42% of Part D lives. So, Strong penetration, but obviously if we need to pull that lever more, there's still more room to grow from a standpoint of exclusivity.

21:03 The parity wins are big. That's 22 million addition lives that will be in parity with Optum in some of these regional plans. Okay, great. Thanks. Is that – no, wait a minute. Thanks. Thank you. Our next question is coming from Greg Frazier of Truist Securities. Please go ahead. Thanks. This is Greg Frazier for Greg Gilbert. On the recent part, the United Part D plan, can you give us a sense of the volume of that plan in terms of Oxy prescriptions? You mentioned 5% market share. I wasn't sure if that referred to the volume or the size of that plan. Yeah. So Greg, this is Joe. On United Part D, What I would say right now, we're really confirming the final numbers as we work through our forecast for 2021. And as you know, there's ins and outs of lives.

22:01 What I can tell you with confidence is it's the second biggest individual payer of extended release oxycodone. Oxycontin, obviously, in this case, is what is most important. and as Scott referenced and speaks to the level of control at United PDP, we currently have a 5% market share, which is why we expect to see significant growth right out of the gate in 2021. And that's the second largest payer for Pardir overall, I see. That's the second largest individual payer of OxyContin. Got it. Okay. And then Just curious what you see as the potential implications on the OxyER market or potential opportunities for you due to the new ownership structure of Purdue and what that company is going through.

22:55 Yeah, so I'll take that one. And if you might imagine, I don't want to speculate or get into the potential outcomes or impact of what it is that one of our competitors is going through. What I would say is from a collegium perspective, We feel really good that our paying portfolio is viewed as highly differentiated and favorable by paying specialists. We are really excited about the foundation that we continue to put into place to accelerate extensa, to continue to be able to stabilize from an annual revenue basis to do since the franchise. So we're focused on Collegium executing around our strategy, feel there's a long runway of growth.

23:42 and we're committed that we believe we're on track for Xtamsa to be the number one branded ER product by 2023. Got it. Thanks for taking the questions. You got it. Thank you. Our next question is coming from Serge Bellinger of Needham & Company. Please go ahead. Yes, we have a question for you. First, can you talk about the current business and the whole environment from both the stanza and the stanza? Has there been any improvement throughout the third quarter? And I think in the past days, you talked about there was still a lot of inpatient starts, mostly due to induction and patient visits. How do you think about that ahead of I'm going to apologize.

24:44 We couldn't hear your question. You were breaking up. So I'm going to ask you to repeat it. On our end, we just couldn't hear you. You're still breaking up. No worse. Would you like to respond to the next question? Yeah, why don't we do that? Okay, thank you. Our next question is coming from David Steinberg of Jefferies. Please go ahead. Thanks very much. I have a couple questions.

25:30 The first is, you know, this year, The ramp of the scripts has been slower than most people thought, largely attributed to the fact that there's just been a lot of less in-person visits to the doctor in order to get the handover from OxyContin to Xtamsa script-wise. And I'm just curious, in the third quarter, has there been any improvement in the number of direct visits And then, secondly, you touched on business development. I'm just curious. We're getting different messages from different companies.

26:21 Some companies say they paused business development because they can't have face-to-face meetings during the pandemic. Dave, this is John. I'm going to pass the first question off to Scott, and then I'll come back and talk about business development. Yeah, thanks, David. Look, when we look at patient visits, really what we're seeing is still they're down over 20% since pre-COVID time period, and with cases rising across the country, we don't really see any improvement in that, and we're not counting on that for the rest of the year.

27:15 And then, David, from a business development perspective, what I would say is we're focused, we're active, I would say active but selective. Okay, thanks. Thank you. Our next question is coming from Brandon Foulkes of Cantor Fitzgerald. Please go ahead. Hi, thanks for the questions and congratulations on the win.

28:02 Joe, in the past you've talked about prescription growth in the second half of the year being a focus and somewhere where you want to sort of improve, right? And you did mention, and Scott gave some color, obviously things remain challenging in terms of getting that patient, I mean, in-person salesperson visits and patient visits. But how do you think about this going forward? Is this something that a parity contract could help with and you're looking at that to maybe drive growth, you know, not just that bolus we get in the beginning of the year, but also in the second half of the year in terms of around extanza? Any time you can provide that would be great. Thank you. Yeah, Brandon, so thanks for the question.

28:48 I appreciate it. The first thing is with regards to exclusive plans, and as we look to 2021, I think, one, we're excited about the new plans that will be taking effect on January 1st and look at those as a source of acceleration and with a trajectory kind of in line to what we have seen when we've implemented exclusive plans. The second bucket of growth that I really want to emphasize is the opportunity for the plans that took effect on January 1st in 2020. You may recall in previous calls we talked about at the beginning of the year when you added all of those new plans in, our market share in exclusive plans went from 60% down to about 40%.

29:38 Right now we're in the low approaching the mid-50%, so the difference of that 60 in the mid-50s of where we would expect to end this year we think is the opportunity to capture share than we would have anticipated capturing this year. When you look at the parity wins, in particular Austin, which is the biggest, but overall we have 22 million lives, we think that that will have a different trajectory. and will continue to be something that improves each month as time goes on and will be a different curve than the exclusive. So, to the degree when they return to normal in terms of in-person visits and the ability of our sales professionals to see physicians in person, I think that will be a more consistent and steady growth, which certainly we would anticipate having positive impact for the second half of the year.

30:41 Thank you very much. Once again, ladies and gentlemen, that is star one to register a question at this time. Our next question is coming from Kevin Kendra of G Research. Please go ahead. Hi. Thanks for taking the questions. Joe, you mentioned that 60% level for the exclusive plans. Just wondering on the parity plans, what sort of – What level of share within those plans would you need to get on the same level from an economic standpoint as what you're getting on exclusives? Obviously, I would imagine that you need less penetration on a parity plan given favorable pricing, but can you give us any sort of color around where that would have to come out to be on par with the economics you would get with an exclusive plan?

31:34 So, Kevin, I appreciate the question. For a multitude of reasons, I'm probably not going to give you a specific answer, but what I would say to you is it is correct. Because it is better margins, we would need to achieve a much lower market share from an economics perspective. Okay. Even if it's, you know, with the timelines, do you think within, you know, two years on a parity plan, could you start getting to an economic level where you – anticipate being after the first year on an exclusive plan? You know, Kevin, I'm not going to get into too much detail. One thing I'd ask you to keep in mind with the parity approach, this is the first one that we've had. The reason we reference it as a bellwether is although we have hypotheses, we model what it is we think it will be, we actually need to see it. and we need to see it in a world where it returns to normal, meaning post-COVID. So that plan in particular with the parity positions overall will really help us understand what it is we can achieve in this space, in that position and it certainly will have impact as we think about contracting on a going forward basis depending upon what it is that we see.

32:58 Okay, that's helpful. And then I wanted to ask about, you mentioned going forward in 2021, you're going to give adjusted EBITDA as opposed to net income outlook. Just wondering kind of rationale behind it. Is it in any way functioning kind of volatility you might see in tax rate as you utilize NOLs and kind of how should we think about NOL utilization in 2021? Yeah, it's a great question, Kevin. So for us, the main reason to do it is to It's a more comparable metric for investors and analysts to use to compare collegium to other companies that they follow. So that's a reason we're doing it. As far as our tax rate and things going forward, for 2020 and 2021, We shouldn't pay any federal income tax. We think our NOLs shield us on the federal side.

33:58 We'll have a minimal amount of state exposure, though, in that time frame. As you're probably aware, some states have changed the use of of NOLs because of the pandemic and their budget issues. So we'll pay a couple percent in state taxes over the next year or two, and then we'll become a full taxpayer probably in the 2023 time period. Okay. I'm going to squeeze one last one in. You guys have recently published some real-world data on extensa and kind of misuse and abuse. There was a time when the FDA was kind of really pushing the idea that that kind of data could eventually find its way onto a product label. Is there still an opportunity or pathway there with the FDA to eventually put some real-world abuse data on the label, or are we kind of past that point?

34:53 Yeah, so kind of this is Joe. I would say, you know, while the data that we continue to see we're encouraged by, we certainly share it and make decisions. I'm sure the agency is aware of it. And along those lines, we also have some post-marketing regulatory requirements that we need to fulfill. And I'll leave it there. All right. Thanks. Okay. Thanks. Thank you. At this time, I would like to turn the floor back over to Mr. Schiaffone for closing comments. Thank you. Thank you, everyone, for participating in our call this afternoon. Collegium Pharmaceutical is on track to make 2020 a transformative year, and we look forward to updating you on our progress.

35:39 Have a great evening. Be well.