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spk09: Greetings, and welcome to the Collegium Pharmaceutical Third Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operating assistance during this conference call, please press star zero on your telephone keypad. Please note that this conference call is being recorded. I'll now turn the call over to Dawn Shopland at Argo Partners. Thank you. You may begin.
spk04: Welcome to Collegium Pharmaceuticals third quarter 2022 earnings conference call. I am joined today by Joe Schifoni, Collegium's chief executive officer, Colleen Tupper, chief financial officer, and Scott Dreyer, chief commercial officer. Before we begin today's call, I 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 pursuant to the safe harbor provision of the Private Securities Litigation and Reform Act of 1995. You will caution that such forward-looking statements involve risks and uncertainties, including and without limitation, the risks that we may not be able to derive the expected benefits of the acquisition of BioDelivery Sciences International on the proposed schedule or at all. The reason we have to successfully commercialize our products and that may incur significant expenses and may not prevail in the current or future litigation pertaining to our business. The risks and other risks of the company are detailed at 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 collegiumfarmer.com. I will now turn the call over to Collegium CEO, Joe Schifoni.
spk08: Thank you, Dawn. Good afternoon, and thank you, everyone, for joining the call. Today we will discuss our performance during the third quarter and through the first nine months of the year and provide perspective on our outlook for the remainder of 2022 and why we expect 2023 to be a bad year. At Collegium, we are focused on building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. During the third quarter, Collegium continued to support the communities where we live and work, highlighted by our charitable donation to an additional sponsorship of the MassBioEd Foundation's 2022 Life Science Workforce Conference. education, recruitment, inclusion, and retention of a more diversified talent pool for our growing industry. Mass BioEd is a nonprofit which provides life sciences educational programs to teachers and students of all backgrounds. We are also proud to have held our second annual day of service in which our employees nationwide volunteered in service of organizations that are important to them. At our corporate headquarters on the day of service, we partnered with Science from Scientists, packing over 400 STEM lesson kits for underserved students in the Brockton, Massachusetts school system. We remain focused on growing our business and creating value for our shareholders. We do this by maximizing the potential of our differentiated portfolio, focusing on achieving our near-term operational and financial goals, and strategically investing in our long-term growth. I want to thank the Collegium team for their hard work, dedication and commitment to our mission. 2022 has been a pivotal year for Collegium. Throughout the first nine months of 2022, we executed on our strategic priorities and delivered on the goals we communicated at the beginning of the year. We closed the financially transformative BDSI deal, establishing Collegium as the leader in responsible pain management. We completed the seamless integration of BDSI and expect to achieve run rate synergies of approximately $85 million, up from the $75 million target we shared when we announced the transaction. We delivered record net revenue and adjusted EBITDA driven by the acquisition of BDSI. We completed the renegotiation of Xtamsa ER contracts that represent 54% of all prescriptions. Based on the planned decisions we have received, we are pleased to share that we achieved the goal of materially rolling back the discount rates and maintaining broad access. Starting in January 2023, Xtamsa ER gross to net will be less than 65%. which we expect will immediately accelerate top line growth. We advanced our position as the leader in responsible pain management, growing the market share of our branded extended release pain portfolio. We participated in pain week this past September with 11 poster presentations, highlighting and raising awareness of clinical and real world data on our differentiated and distinctly positioned product portfolio. And in March, we executed a master settlement agreement, resolving all 27 pending opioid industry related lawsuits brought against the company by cities, counties, and other subdivisions in the United States. Each of those lawsuits has now been dismissed. We made significant progress against our key objectives in these first nine months of 2022. We are on track to achieve all of our 2022 strategic and financial goals, and because of our strong execution, we are updating our 2022 four-year guidance. We are confident that our recent achievements position us for a banner year in 2023. We remain laser focused on executing our three-phase action agenda. In the second quarter, we successfully completed phase one, the seamless integration of BDSI, and our efforts are yielding results. We are on track to exceed our original run rate synergies target of $75 million and now expect to achieve approximately $85 million in run rate synergies within the first 12 months of closing the BDSI transaction. At the start of the second quarter, we transitioned to phase two, generate momentum, and have made significant progress versus most of our operational objectives. Of note, we successfully completed Xtansa ER contract renegotiations, which ensures a gross net of less than 65% beginning on January 1st, 2023. We expect Belbuca and Xtansa ER to grow volume and market share moving forward. Both products are highly differentiated, distinctly positioned, and fundamentally well positioned to grow. Our commercial organization is fully trained, engaged in building on their learnings to generate prescription momentum in 2022 and growth in 2023. Our execution in 2022 positions Collegium for a banner year in 2023. We will transition to phase three of our action agenda accelerate in January. We expect to see an immediate acceleration of top and bottom line growth in 2023 propelled by Xtamsa ER gross to net of less than 65%, prescription growth of Belbuca and Xtamsa ER, and the full-year impact of the synergized cost structure. Our singular focus in deploying capital is to create value for our shareholders, and our top priority is business development. We are committed to taking a disciplined approach and we believe current market conditions are conducive to delivering on our business development objectives. We are focused on commercial stage opportunities with peak sales potential of over $150 million. Importantly, we are looking for assets that are differentiated with exclusivity that runs into the 2030s. Our strong financial position, including robust cash generation and rapid pay down of debt, leaves us well-positioned to allocate capital in a focused and thoughtful manner. We are committed to strategically investing in the growth of our business to create long-term value, as well as leveraging our share repurchase program to opportunistically return value to shareholders. Our third quarter results reinforce the conviction we have in our business strategy. We are making meaningful progress on our goals and are strongly positioned for top and bottom line growth in 2023. I will now hand the call over to Colleen for a discussion of the financials.
spk01: Thanks, Joe. Good afternoon, everyone. Q3 was another strong quarter for Collegium. We generated record revenue, record adjusted EBITDA, and leveraged our strong cash flows to pay down debt while returning cash to shareholders through the share repurchases. As a reflection of our execution, we increased our targeted run rate synergies for the BDSI acquisition to approximately 85 million. Collegium strengthened its financial position throughout 2022, and we expect to capitalize on this momentum in 2023. Financial highlights for the third quarter include total product revenue was a record 127 million for the third quarter, an increase of 61% from the third quarter of 2021. Belbuca net revenue was $38.8 million in the third quarter of 2022. Belbuca sales were impacted by a transient destocking of the channel at the end of the quarter. Xamsa ER net revenue was $38.8 million and Xamsa ER gross to net in the third quarter was 66%. The lower gross to net was primarily driven by a one-time benefit to returns, which I will speak about shortly. For the full year 2022, we now expect gross to net to be less than 73%, and starting in January 2023, as a result of the successful contract renegotiations, gross to net will be less than 65%. New CINTA franchise net revenue was $44.4 million in the third quarter. Operating expenses, which include stock-based compensation expense, were $38.4 million in the third quarter, compared to 32 million in the third quarter of 2021. Adjusted operating expenses, which exclude stock-based compensation and acquisition-related expenses, were 32.5 million in the third quarter, an increase of 25% from the third quarter of 2021. Net income for the third quarter was 0.5 million. Income from operations was 20.5 million in the third quarter. Non-GAAP adjusted EBITDA was a record 74.9 million for the third quarter versus 37.3 million in the third quarter of 2021. GAAP EPS was one penny in the third quarter of 2022 versus 23 cents GAAP earnings per share basic and 22 cents GAAP earnings per share diluted in the third quarter of 2021. Non-GAAP adjusted EPS was $1.10 in the third quarter versus $0.65 in the third quarter of 2021. In addition, related to the returns matter that we disclosed in February of this year, I am pleased to share that we have reached comprehensive resolutions of our returns-related disputes with all three wholesalers. Overall, the returns adjustment resulted in a one-time positive impact to revenue in the quarter of $4.7 million. We see our press release issued earlier today for a reconciliation of GAAP to non-GAAP results. As of September 30th, our cash balance increased to $134.1 million. During the quarter, we paid off $25 million in debt. We expect that our net leverage will be below three times net debt to EBITDA by the end of this year. Our strong operational performance in the third quarter demonstrates the strength of our business model. We are on track to achieve all of our 2022 financial goals, notably growing revenue at greater than two times the rate of adjusted OPEX. We are pleased with our performance and are poised to continue strengthening our financial position. Moving to our 2022 financial guidance, as we've successfully executed on our financial priorities, we are updating the guidance ranges for product revenue, adjusted operating expenses, and adjusted EBITDA. For 2022, we now expect total product revenues in the range of $455 million to $465 million. We expect our adjusted operating expenses in the range of $125 million to $130 million, and total adjusted EBITDA in the range of $250 million to $255 million. We look forward to providing 2023 financial guidance in early January, which will reflect an acceleration in top and bottom line growth. We are focused on creating value for our shareholders through thoughtful and disciplined business development. BD remains our top priority for capital deployment and given our strong financial position, we have the ability to support additional transactions near term. We are rapidly deleveraging the balance sheet with net leverage expected to be below three times net debt to EBITDA by the end of this year and to be at less than two times by the end of 2023. We expect to pay down $100 million in debt by March 2023 and fully repay our Pharmacon term loan by March 2026. Our ability to deliver quickly is a testament to our strong cash generation. Our financial strength enables us to pursue acquisitions, pay down debt, and opportunistically return value to our shareholders through our board authorized $100 million share repurchase program. During the third quarter and in October 2022, we returned $10 million in capital to shareholders through repurchases under the $100 million share repurchase program authorized by our board. We have approximately $42 million remaining under this program. Overall, we are pleased with our performance this quarter, and our solid financial position reflects our ability to execute on our strategic priorities. We are in a phase of growth and value creation and are focused on finishing 2022 strong and entering 2023 even stronger. I will now turn it over to Scott.
spk11: Thanks, Colleen. I'm excited to report that we've successfully completed the contract renegotiations with plans that account for 54% of all extant ER prescriptions. This was the top commercial priority in 2022. and it will fuel the acceleration of Xtamsa ER revenue in 2023. I can now confirm with certainty that Xtamsa ER gross to net will be less than 65% beginning in January. Importantly, in addition to materially rolling back rebates, we were able to maintain our exclusive and parity access positions for the vast majority of the renegotiation opportunity. Let me take a moment to highlight the results of the Xtamsa ER contract renegotiations. In plans that represent approximately 90% of the current prescription base that was subject to renegotiation, Xtamsa ER will maintain its exclusive ER oxycodone position or parity position with OxyContin. The plans where Xtamsa ER maintains its exclusive position are both the largest plans and the plans that have demonstrated an ability to control and drive market share over the past several years. We expect volume growth from these plans in 2023. In plans that represent approximately 10% of the current prescription base that was subject to renegotiation, XtamsaER will move to a non-formulary position. It's important to note that this change puts XtamsaER in a parity position with OxyContin at these accounts. As a group, these plans are smaller and have demonstrated less control. We expect that the benefit of no longer paying discounts will offset any potential pressure on prescriptions. Overall, we expect to grow Xtamsa ER volume and market share in 2023 in the accounts in which Xtamsa ER maintained its access position at a level that offsets any potential pressure where Xtamsa ER was moved to non-formulary. Lastly, I want to emphasize that we have ample room to opportunistically secure new wins moving forward, which will serve as a catalyst for prescription growth while maintaining Xtamsa ER growth to net below 65%. From now until the end of the year, we're focused on taking actions to ensure we grow Xtamsa ER within the accounts where Xtamsa continues to have exclusive access. These actions include building joint action plans with the payers to tighten formulary control and utilization management to move patients who remain on OxyContin to Xtamsa ER, to communicate to HCPs and patients the preferred formulary position of Xtamsa ER versus OxyContin, and the associated lower co-pays for patients, and to launch new personal and non-personal promotional tools to pull through the exclusive access position of Xtansy ER and accelerate growth. Collegium Pharmaceutical is the leader in responsible pain management. Our organization and our pain portfolio are viewed favorably by HCPs. Belbuca, Xtansy ER, and Nucenta ER have a combined 50% share of the branded ER market, The fundamentals of our growth drivers, Belbuca and Xtamsa, are strong. Specifically, both products are seen as highly differentiated by HCPs, have broad prescriber bases, strong market access positions, and are the only products growing market share in the branded ER market in 2022. Both products are well positioned to grow volume and share in 2023. That being said, thus far in 2022, prescription volume is flat with both brands versus 2021. We plan to address this through improved commercial execution. The paying market isn't competitive, but it's complex. To succeed requires exquisite execution in terms of education on our products and the navigation of the payer landscape. Beyond commercial execution, there are internal and external factors that contributed to Belbuque and Xtensa ER volume trends in 2022. Externally, In-person patient office visits have still not returned to pre-COVID levels, adversely impacting the new-to-brand market. Paying practices continue to experience significant turnover in mid-level prescribers and administrative staff. These people understand how to navigate the complex payer landscape. From a collegium perspective, our commercial organization experienced a fair amount of disruption in the first half of 22. Due to our fourth quarter 2021 restructuring, and the first quarter 2022 acquisition of BDSI. This resulted in changes to our field force's territory alignments, customers, and portfolio. For most of our field force, Belbuco was a new product that's far more complicated than Xtamsa ER. I believe that our commercial team is just beginning to hit its full stride with Belbuco. From now until the end of the year, our commercial organization is focused on taking action to fuel the growth of Xtamsa and Belbuco in 2023. These actions include executing training to strengthen the knowledge and impact of our sales professionals, launching new educational resources for our sales team to use during their interactions with HCPs and pharmacists, introducing new non-personal promotional content and channels which reinforce the clinical differentiation of Xtamsa ER and Belbuca, launching new personal and non-personal promotional tools to pull through the strong access positions of Xtamsa ER and Belbuca, and supporting payers as they ensure that the value of Xtamsa ER is clearly understood, enabling stronger formulary controls where Xtamsa ER is exclusive. In closing, I'm proud of the many accomplishments that the commercial organization has achieved this year, especially the successful renegotiation of contracts for Xtamsa ER, which will drive gross to net for Xtamsa below 65% starting on January 1st, and fuel the acceleration of Xtamsa ER revenue in 2023. I'm confident that the actions we're taking now will elevate our level of commercial execution, generate momentum for the remainder of the year, and drive acceleration in 2023. I'll now turn the call back to Judd.
spk08: Thanks, Scott. We are making significant strides forward as we build a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. 2022 has been a pivotal year for Collegium, and we remain focused on executing our three-phased action agenda. I am encouraged by our progress in 2022 and confident that 2023 will be a banner year. I will now open the call up for questions.
spk09: And at this time, we will be conducting a question and answer session. If you would like to ask a question, please 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 your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. And our first question comes from the line of David Anselm with Piper Sandler. Please proceed with your question.
spk05: Hey, thanks. So I just had a few. So I just wanted to clarify. So you said, I think, it was 54% of all XFAMS AER prescriptions represented by the contracts renegotiated. So I'm just sort of wondering, of the remaining RXs, you know, what are those and is it just safe to say that, you know, you're at a place where it's status quo for next year? Just wanted to clarify there. So that's number one. Number two is you talked about XTAMSA-ER returning to volume growth next year. It's not just better economics. And, you know, the comments about, you know, better commercial execution. certainly are not lost on me. But, you know, in the context of the shrinking oxycodone ER pie, you know, what do you think, just beyond commercial execution, in other words, external factors, do you think can get the product back to, you know, a more aggressive growth trajectory next year from a volume perspective? And then, you know, the same question, I guess, is for Belbuca. Again, I mean, is growth... of Bell Buca sort of beyond commercial execution just predicated on more in-person office visits? I mean, what else do you think are factors that could get that product growing in a more aggressive direction? Thank you. Great.
spk08: Thanks, David. This is Joe. I'll take the first question and then hand the Xtamsa and Bell Buca questions off to Scott. So when you think about the payer landscape as we move forward with regards to Xtamsa ER, This year, we had the opportunity to renegotiate with plans that represented 54% of prescriptions. Next year, we'll have an opportunity to renegotiate with plans that account for another 30% of all prescriptions. And I think it's important that we also emphasize with what it is we accomplish, we also have more than enough headroom to opportunistically go out and try to secure additional wins. which will also serve, if we're successful in doing so, as a catalyst for prescription growth with Xtamsa ER. And then Scott can take the other two questions.
spk11: Yeah, thanks, David. And to your other two about the growth of Xtamsa and Belbuca, look, first and foremost, again, we need to execute better, right? As I mentioned in my prepared remarks, these internal and external factors were a real thing in 2022. And so the way I look at it is there's the controllables and the non-controllables, right? From an external standpoint, those are non-controllables in terms of patient office visits and new to brand. But the fact of the matter is I believe that over time we'll see some bounce back there. The other thing is if you look at growth opportunity and I look at the market, there's plenty of room for both brands to grow in the market, right? Xtamps is sitting with a 35 share in OER, so there's plenty of room for us to grow from there. And, you know, you look at Belbuca, same thing, about a mid-30s share of the buprenorphine market, plenty of opportunities to grow. So I don't see any issue with the markets in terms of us being able to grow. The last thing is on those internal factors. Look, those are controllables, and that's where all our focus is right now. 100% of our focus is on those controllables and taking actions to grow next year. Lastly, the fundamentals of these brands are really strong, right? Still in market research, the brands reviewed is highly differentiated. really broad and growing prescriber bases, and strong market access positions. So all of that put together is what makes me feel confident that as we move into next year, we'll be able to reinvigorate growth.
spk05: Okay. That's helpful. Thanks, guys. Great.
spk08: Thanks, David.
spk09: Our next question comes from the line of Tim Lugo with William Blair. Please proceed with your question.
spk06: Thanks for the excellent breakdown and congrats on the progress during the quarter. You know, you answered a lot of my questions during David's question, but maybe as you kind of weigh share buyback potential, investing in a current franchise and kind of additional development, can you just talk to us about, you know, can you give us a sense of where these areas rank internally for capital deployments?
spk08: Sure, David. Sorry, Tim, I'll hand that one off to Colleen.
spk01: Hi, Tim. Thanks for the question. So as far as capital allocation priorities, they remain consistent with past discussions, which we will prioritize business development, seeking out commercial stage assets as our first priority. Our terms of our Pharmacon note in that we will be paying those down pretty rapidly with $100 million paid off in the first year, so paying down our debt. and then also opportunistically continuing to return capital to shareholders via the share buyback program. We have about 42 million remaining through the end of the year.
spk08: And Tim, the only other thing I would say, we're working through our planning process. If we believe that there would be value in making additional investment in support of the current portfolio, obviously we have the wherewithal to do that. When you look from a size structure, the big part, of the cost structure we believe were sized correctly, and there's not a need to make additional investment in the current in-line portfolio, at least from the big parts of the cost structure.
spk06: Okay, understood. And, you know, maybe digging back into BD a little bit more, can you just give us kind of a refresher on areas you're looking at? Obviously, elected was, you know, something that came in, Babuco. and some products previously. Can you just kind of refresh us on opportunities and give us a sense of the opportunities that you come across?
spk08: Sure. Great question, Tim. Look, I think when we look at the current market environment, which we think is really conducive to getting a deal done, we're not thinking of it so much through the lens of a therapeutic priority. but are really anchored to, one, we're looking for assets that are meaningfully differentiated, which we think is critical for a multitude of reasons, in particular reimbursement. The peak sales potential of over $150 million is the threshold that matters to us. And then, of course, we're looking for exclusivity into the 2030s. From a Look, if there was something in the pain space directly that leverages the infrastructure we have in place, that certainly would be a preference. I've spoken in the past about neurology being an adjacency that we think makes sense, but when we assess the current market conditions, we want to be a little bit more flexible and opportunistic.
spk06: Understood. Thank you.
spk08: You got it. Thank you.
spk09: Our next question comes from the line of Brandon Foulkes with Cambridge Fitzgerald. Please proceed with your question.
spk02: Hi, thanks for taking my questions and congratulations on the progress. Maybe just one for me, following on from the earlier line of questioning. Do you have to compromise any gross to net on any of the other products in the portfolio, obviously a much broader portfolio, to achieve that extent of gross to nets? Or should we think of the other products remaining relatively stable? across the portfolio in 23, and Extensa grows to net, improving to that less than 65%. Sure.
spk08: Thanks for the question, Brandon. I'll hand that one off to Colleen.
spk01: Thanks, Brandon. No, for the Extensa renegotiation, there was no compromises or link to any other products within our portfolio, and broadly, for the remaining products, we do expect stability.
spk02: Thanks. And just one follow-up, sorry. This may have been asked in the first question. I must be on time. Earlier in the year, I think we talked about 50% of contracts being renegotiated this year. I think, you know, you talked about 54% on the call and then maybe 30% next year. Is that how we should still think about it? Are there 30% of the extensor contracts up for renegotiation next year?
spk08: Yeah, Brandon, this is Joe. There is an additional 30% of extamps of contracts up for renegotiation in 2023. That's correct.
spk02: And is your focus on those 30% now that you've sort of achieved success on such a large majority of the contracts this year still going to be gross-to-net driven, or could we see sort of something else where maybe they could be volume-driven? How should we just think about if you have any change in your approach on the negotiation on those 30%?
spk08: Yeah, so great question. I think with existing contracts with Xtamsa, the approach will be similar to what it is that we did from a renegotiation in 2022, which from our view really speaks to the value and the performance of Xtamsa ER over time and plans recognizing the clinical differentiation and the positive impact that Xtamsa ER can make. The other point that is important to continue to emphasize is we now have significant headroom, which enables us to opportunistically look to secure new payer wins when the opportunity presents itself. And if we're successful in doing so, that certainly would serve as a potential catalyst for prescription growth and market share gains.
spk02: Great. Thank you very much, and congratulations again. Great. Thanks, Brandon.
spk09: Our next question comes from the line of Serge Blanger with Needham & Company. Please proceed with your questions.
spk07: Good afternoon, and thanks for taking my questions. I guess the first one, a follow-up on the first question. With the 54% of contracts that's been renegotiated and the other 30% coming up next year, Should we expect a continued growth to net improvement on an annual basis going forward? And then are similar renegotiation opportunities available for Bellvuca?
spk08: Yeah. So, Serge, great question. The way I would think about it, and I don't want to get ahead of ourselves, our commitment is managing extamps of ER gross to net to less than 65% on a forever basis. Now, with the renegotiation opportunity, that would certainly have a margin benefit, but we also, with the headroom we have, will be looking to secure opportunistically new additional payer wins, which we think would serve as a catalyst of growth And most important, as a company committed and as the leader in responsible pain management, we always want to try to improve the access to Xtamsa ER for physicians, their staffs, and most of all to the patients. And I'll let Scott comment on Belbuca.
spk11: Yeah, thanks, sir. So, yeah, when we look at Belbuca and the rest of the portfolio, the fact of the matter is, first, to reiterate what you said, our goal is always to have as broad of access as we can for our full portfolio. We want patients to have access to our products. Right now, when we look at where we are in this negotiating season, the gross finesse for Belbuca are very reasonable, similar to Nucinta. And so we always are looking at things come up to do what we call pruning, whether that may be reducing a discount rate while maintaining access or in situations where it's a bad contract, we'll walk away. And any additional things, I have nothing to report on right now, but that will all be contemplated and reflected in the guidance that we give in January.
spk07: Great. And then just one last one. Any update on the Alexa launch in migraine? It's been a couple quarters now. You know, it's the first foray into CNS. Just give us color on how that's going.
spk08: Yeah. So, Serge, great question. The first thing I would emphasize is when we did the BDSI acquisition, we were clear that the driver of the acquisition was, one, the associated synergies because of the direct overlap of the two core businesses. Number two, the opportunity to add a differentiated growth driver in Belbuca to the portfolio. And then the elixir launch was underway and we've said, we're going to synthesize learnings through the course of the year and make a decision on how it is. We'll handle the asset, uh, moving forward. So we're synthesizing those learnings and expect to be making some decisions very soon on how it is that we're going to handle it. But when you think about, you know, collegium on a going forward basis, it's really, maximizing the potential of our pain portfolio and building the company through acquisition of commercial stage assets with all of the parameters that we've outlined. Thank you.
spk09: Our next question comes from the line of Ray Frazier with Truist Securities. Please proceed with your question.
spk10: Great. Thanks for taking the questions and congrats on the progress. I'm curious if you have a sense for where the gross net could reach in 2023. I understand mix will play an important role and might be hard to predict, but I'm curious if you can talk about anything beyond kind of the target of less than 65. Sure.
spk08: Greg, appreciate the question. For now, what I would say is we can confirm it will be less than 65%. We'll be issuing our guidance in early January, which will certainly you know, frame the acceleration and extamps to ER revenue. And at that time, we'll also give some perspective on how to think about extamps to ER gross to net.
spk10: Got it. That's helpful. On Velbusa and the things that you can control, when do you think those start to yield results? Are we sort of weeks away from reinvigorated share growth, quarters away? I'm curious how you're thinking about that.
spk08: Sure. So great question. I'm going to start on that because I think Scott gave a very good answer to the overall question. The one thing that I would emphasize that I think is really important to understand was a learning for us and in particular the people in our commercial organization is just how different Belbuca is in terms of one, physicians' awareness of the product, two, the complexity associated with education around Bell Buca and the navigation both at the pharmacy and payer level in terms of to get the prescription adjudicated and filled. So that's a long way of saying I believe we're on the verge of hitting our stride and when we do I believe we'll be in a position where we will see growth and volume and market share and that's been a process of learning, re-education, focusing in on education, and it's a little bit of a different dynamic than Xtamsa because, as you know, the buprenorphine market is in fact growing, which really should benefit Belbuca because it's so differentiated for a multitude of reasons, one of which is the dosing range relative to Butranspatch. So we think there's really good opportunity to get Belbuca growing from a volume and share perspective moving forward. That one more so than extamsa, is about execution along with just hitting our stride and being as good as we can be in the promotion of the product.
spk10: Got it. Then I just wanted to follow up on your comments on assets that could be of interest. I'm curious on areas beyond pain and neurology, what other areas might make sense? Thank you.
spk08: Yeah, great question. I'm not going to get into calling out therapeutic areas, but rather reinforce what it is that we're looking to accomplish. So one, we're looking for commercial stage assets that are meaningfully differentiated. So we don't want commoditized or me too assets. We think that's aligned to the mission of the company and critical from a reimbursement perspective. We're looking for assets that have peak sales potential of over $150 million. And we want exclusivity into the 2030s. And when we assess the current market conditions, contrasting our financially strong position to the current marketplace, we think it's conducive to getting a transaction done. And we want to remain opportunistic and flexible.
spk10: Great. Thanks for taking the question.
spk08: Great. Thanks, Greg.
spk09: And our last final question comes from the line of Oren Livnat with AC Wainwright. Please proceed with your question.
spk03: All right, thanks. I have a few. Clearly, you're not going to give us any more color on what less than 65% means, I guess, until you give some guidance. So that'll be highly anticipated. I guess just as we think about how you even look at and approach that guidance in terms of conservatism, since I guess you won't really know the mix of product until, you know, you get into the year and then even later get the sort of, I guess, the rebates coming back your way. You know, how do you approach that guidance? You know, do you have just a sort of a volume bogey you have in mind and then just say, hey, to start, let's go at 65 or 64.9%, so to speak, and then we'll work through the year and see how it goes? Or is there some other approach? And I have a couple of follow-ups. Thanks.
spk08: Sure. Thanks for the question, Oren. I'll hand that one off to Colleen.
spk01: Hi, Oren. Thanks for the question. I think how we'll approach guidance will be we'll have, you know, robust, thoughtful guidance that we set out through the year. As far as the forecasting, the in and out dynamics for Expanse, as you would in any given year, we have our forecasting model. And for payer shifts, there are all sorts of analogs that we'll leverage to come up with what will be reasonable estimates for the year, and that will be incorporated into our planning and guidance.
spk03: Okay. And one thing you mentioned that was pretty interesting, I don't think anyone asked about, is this notion of growing market share within, I guess, established exclusive contracts. I think you worded it as? you know, improving control or increasing control on those formularies. How much share do you already have in the sort of mature exclusive contracts now? And what is going on with those straggler OxyContin patients? So, you know, what could change going forward that hasn't already changed to date?
spk08: Okay. Thanks, Oren. I'll pass that one off to Scott.
spk11: Yeah, thanks, Oren. So when you think about it, as we've through the years talked about the exclusives, right, and the ramp, we feel good that we can achieve market shares above 65%. So what's behind my commentary is with all of the plans, they have stepwise approaches as the years go on. So with the exclusive that had been in place for a year or two, now we turn the year, there's an opportunity to literally just control, right, where they identify OxyContin patients. and they move them over to Xtamsa. So that's what we're referring to when we talk about that. And in general, we can see getting to market shares above 65. Okay.
spk03: And can you talk about the weighted average of your total share now across the exclusive contracts?
spk08: Yeah, Oren, so... This is Joe. I'll take that one. So there is a range of share within exclusive contracts that we're not going to get into the specifics. What I would say to you is there is a significant opportunity in every one of the exclusive plans to grow volume and market share, the size of which is also dependent upon their season and the in and out and movement of patients to the various plans. So what we feel really good about is we've maintained the exclusive positions on the biggest Medicare Part D plans that have the highest controls in which there's a significant opportunity to continue to grow, which we believe will offset any potential pressure where we were moved to a non-formulary parity position with OxyContin in that 10%, which is lower control.
spk03: Okay. And just on the growth to net, I wasn't sure if you quantified the impact from that one-time revenue gain. What would have gross-to-nets been on Xtansy ER without that positive adjustment in this quarter? Or I guess another way to look at it is what is the gross-to-net on that, recognized on that piece that was added?
spk01: Great question, Oren, and I didn't specifically state this yet. So the gross-to-nets for Xtansy ER for the quarter, absent the returns adjustment, would have been 73%.
spk03: Thank you. And just sorry, one last thing. My connection was fuzzy when you gave the individual product sales results for this quarter. Do you mind just running through those three or four numbers real quickly? I apologize.
spk01: Sure. So for the third quarter of 22, so total is $127 million. That's $38.8 for Belbuca, $38.8 for Extensa, New Cinta Franchise $44.4 million, Simproic, 3.6. Elixib, another 1.4 total.
spk03: Thank you so much. I look forward to your guidance. Great. Thank you, Warren. Thanks, Warren.
spk09: And we have reached the end of the question and answer session. I'll now turn the call back over to Joe for closing remarks.
spk08: Great. Thank you. And thank you, everyone, for joining the call today. I look forward to updating you on our progress. Have a great evening.
spk09: And this concludes today's conference. You may disconnect your lines at this time. Thank you for your
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