NASDAQ:COLL Collegium Pharmaceutical Q1 2023 Earnings Report $27.01 -0.01 (-0.04%) Closing price 04/17/2025 04:00 PM EasternExtended Trading$26.98 -0.04 (-0.13%) As of 07:40 AM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Collegium Pharmaceutical EPS ResultsActual EPS$1.18Consensus EPS $1.20Beat/MissMissed by -$0.02One Year Ago EPSN/ACollegium Pharmaceutical Revenue ResultsActual Revenue$144.77 millionExpected Revenue$139.11 millionBeat/MissBeat by +$5.66 millionYoY Revenue GrowthN/ACollegium Pharmaceutical Announcement DetailsQuarterQ1 2023Date5/4/2023TimeN/AConference Call DateThursday, May 4, 2023Conference Call Time4:30PM ETUpcoming EarningsCollegium Pharmaceutical's Q1 2025 earnings is scheduled for Thursday, May 8, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Collegium Pharmaceutical Q1 2023 Earnings Call TranscriptProvided by QuartrMay 4, 2023 ShareLink copied to clipboard.There are 10 speakers on the call. Operator00:00:00Greetings, and welcome to the Collegium Pharmaceutical First Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note that this conference call is being recorded. I will now turn the call over to Christopher James, Vice President of Investor Relations at Collegium. Operator00:00:29Thank you. You may begin. Speaker 100:00:32Welcome to Collegium Pharmaceuticals' 1st quarter 2023 earnings conference call. I'm joined today by Joe Ciaffoni, our Chief Executive Officer Cummings Tupper, 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 our products, that we may incur significant expense and that we may not prevail in current or future litigation pertaining to our business. These risks and other risks of the company are detailed in the company's periodic reports filed with the Securities and Exchange Commission. Speaker 100:01:31Our future results may differ materially from our current expectations discussed today. Our earnings press release on 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 atcolesiumfraubit.com. I will now turn the call over to our CEO, Joe Ciaffoni. Speaker 200:01:52Thank you, Chris. Good afternoon and thank you everyone for joining the call. Today, we will discuss our financial performance during the Q1 and provide an update on our progress towards achieving a banner year in 2023. At Collegium, we are focused on building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with Our commitment to improving lives extends to our communities and in support of that during the Q1, We made a charitable donation to Kids in Tech, a non profit organization leading STEM education initiatives for kids from low income households, and we donated 1,000 hygiene and essential kits for people in need through life science cares. I'd like to thank our team for their commitment to our mission and for making Collegium a great place to work. Speaker 200:02:49In the Q1 of 2023, we delivered strong financial results and made progress against our strategic priorities. Key accomplishments in the Q1 include: we delivered record quarterly revenue and adjusted EBITDA We generated record quarterly BELBUCA and Xtampza ER revenue. We achieved gross to net for Xtampza ER of 55%, Reflecting the immediate impact of the successful contract renegotiations completed last year, we presented 4 posters At the American Academy of Pain Medicine's Annual Meeting and we increased our cash balance leaving us well positioned to execute on our capital deployment strategy. With our strong performance in the Q1, we are confident 2023 will be a banner year. As we move through 2023, we expect to recognize significant top and bottom line growth. Speaker 200:03:49Top line drivers include Xtampza ER gross to net improvement, full year BELBUCA revenues And BELBUCA and Xtampza ER prescription growth on a full year basis. We believe our fully synergized cost structure And financial discipline will further fuel bottom line growth and enable us to deploy capital to create long term value for our shareholders. Our 2023 financial guidance includes growing adjusted EBITDA by over 1.5 times revenue and over 2 times adjusted operating expenses. We are confident in our ability to deliver on our financial and strategic goals and have already made progress in the Q1 of the year. We are dedicated to making 2023 a banner year by executing our 2 pronged strategy, maximizing the potential of our pain portfolio and deploying capital. Speaker 200:04:47We plan to maximize the potential of our pain portfolio through strong commercial execution. During the Q1, we saw an immediate Acceleration of Xtampza ER revenue to a record level with year over year growth of approximately 52%, primarily driven by gross to net improvement to 55%. We also delivered record quarterly BELBUCA revenue And we'll recognize the benefit of owning BELBUCA for the full year. We do expect BELBUCA and Xtampza ER prescription growth on a full year basis, And we anticipate that the Nucynta franchise and Symproic will be steady contributors. Our capital deployment strategy is focused on Creating long term value for our shareholders. Speaker 200:05:35Our top priority is business development. We are focused, active and engaged. We are looking for differentiated commercial stage assets that generate that have the potential to generate over $150,000,000 in Annual revenues with exclusivity into the 2030s. We believe market conditions are conducive to potentially getting a deal done. We are in a strong financial position, which gives us the flexibility to evaluate a range of deals That could be a great strategic fit for Collegium. Speaker 200:06:11We will remain disciplined in our approach. We are committed to rapidly paying down debt and opportunistically utilizing our share repurchase program to return capital to our shareholders. We are encouraged by our Q1 performance And confident that we are on track to achieve our financial objectives. Our strategy is clear and our organization is focused on execution. I will now hand the call over to Colleen to discuss the financials. Speaker 300:06:41Thanks, Joe. Good afternoon, everyone. We had a strong Q1 in which we delivered record quarterly revenue and adjusted EBITDA, maintained financial discipline and generated strong cash closed while paying down debt. Financial highlights for the Q1 include net product revenues were a record $144,800,000 for the first compared to $83,800,000 for the Q1 of 2022, an increase of 73%. BELBUCA net revenue was a record $44,200,000 in the Q1. Speaker 300:07:17Xtampza ER net revenue was a record $47,900,000 in the first quarter, an increase of 52% over the Q1 of 2022 And Xtampza ER gross to net was 55% in the Q1. The lower gross to net was primarily driven by the Xtampza ER contract renegotiations we completed last year. As a reminder, gross to net is generally more favorable in the Q1 of each year due to the lower coverage GAAP expense, also known as the donut hole in Medicare coverage. As we move through the year, gross to nets are expected to be less favorable in the second and third quarters and improved sequentially in the 4th quarter, but remain less favorable than the Q1 level. This is consistent with what we have experienced in past years. Speaker 300:08:06We expect full year Xtampza ER gross to net to be between 61% to 63% in 2023. Nucynta franchise net revenue was $49,000,000 in the Q1, an increase of 1% over the Q1 of 2022. GAAP operating expenses were $52,800,000 in the first quarter, which decreased 10% compared to $58,500,000 in the Q1 of 2020 Yes. Adjusted operating expenses were $38,200,000 in the first quarter, which increased 52% compared to $25,200,000 in the first quarter of 2022. Our operating expenses were front loaded into the Q1, reflecting investment in our growth initiatives for the year. Speaker 300:08:50We expect operating expenses will trend lower in the subsequent quarters of 2023. Net loss for the first Quarter was $17,400,000 compared to a net loss of $13,100,000 in the Q1 of 2022. Included in GAAP net loss, Among other items that do not represent our ongoing operations is a $23,500,000 loss on extinguishment of debt related to the repurchase of a portion of our 2026 convertible notes and an $8,500,000 charge related to our settlement agreement with Aquestive Therapeutics. Non GAAP adjusted EBITDA was a record $87,600,000 for the Q1 compared to $43,500,000 in the Q1 of 2022, an increase of 101%. GAAP loss per share was $0.51 basic and diluted in the first quarter compared to GAAP loss per share of $0.39 basic and diluted in the Q1 of 2022. Speaker 300:09:51Non GAAP adjusted earnings per share was $1.32 in the Q1 compared to $0.71 in the Q1 of 2022, an increase of 86%. Please see our press release issued earlier today for a reconciliation of GAAP to non GAAP results. As of March 31, 2023, our cash Balance increased to $269,500,000 During the quarter, we paid down $25,000,000 in debt related to our term notes. We also completed a $241,500,000 convertible note offering with a maturity in February 2029 as a matter of good corporate hygiene. The later maturity provides us with more financial flexibility in the management of our debt. Speaker 300:10:37We used $140,100,000 Proceeds from the offering to repurchase a portion of our convertible senior notes due in 2026. After note issuance costs, We had approximately $97,000,000 of net proceeds, which we intend to use for general corporate purposes, including the implementation of our capital deployment We ended the Q1 at 1.5x net debt to adjusted EBITDA and expect to end the year at approximately 1x. We are pleased with our strong first quarter performance, which reflects the progress we are making as we execute our financial objectives for the year. We are reaffirming our financial guidance for 2023. We expect net product revenues in the range of $565,000,000 to $580,000,000 Adjusted operating expenses in the range of $135,000,000 to $145,000,000 and adjusted EBITDA in the range of $355,000,000 to $370,000,000 Our capital deployment strategy is focused on creating long term value for our shareholders. Speaker 300:11:45Our strong financial position allows us to execute our capital deployment strategy. Our top priority is business and we are committed to taking a disciplined approach in a market that we believe is conducive to potentially getting a transaction done. We are locked into rapidly deleveraging our balance sheet. We're on track to repay $162,500,000 of debt in 2023, which would put us at approximately 1x net debt to adjusted EBITDA at year end. Our ability to delever quickly is a testament to our strong cash Finally, we have the ability to return capital to our shareholders by strategically leveraging our share repurchase program. Speaker 300:12:28In January 2023, our Board authorized a new share repurchase program for $100,000,000 We are very pleased with our first quarter performance and strong start to 2023 as we positively track against our key financial and strategic priorities. I will now turn it over to Scott. Speaker 400:12:49Thanks, Colleen. As we look at performance in the Q1, there are 2 key takeaways. First, The contract renegotiations for Xtampza ER that we completed in 2022 have had an immediate positive impact, driving gross to net improvements and accelerating net revenue. This year, we have the opportunity to renegotiate contracts that represent 30% of prescriptions, And we've created room to opportunistically secure new payer wins, while ensuring gross to net for Xtampza ER remains below 65% forever. 2nd, as we look at BELBUCA and Xtampza ER, prescription performance was generally in line with our expectations. Speaker 400:13:29We believe the growth of Xtampza and BELBUCA were pressured by typical first quarter dynamics where deductibles reset and increased out of pocket costs for patients. Consistent with past years, we expect this to normalize in the 2nd quarter. Additionally, Xtampza ER prescription growth was pressured due to Xtampza being removed from formulary on January 1 within plans we renegotiated last year that represented approximately 10% of Xtampza ER prescriptions. We believe that on a full year basis, we will see prescription volume growth for BELBUCA and Xtampza ER. This is our number one commercial priority. Speaker 400:14:09The fundamentals of both brands are strong, and we believe they are positioned for growth. Xtampza ER and BELBUCA are viewed favorably and are considered highly differentiated by health care professionals. These same HCPs have indicated a strong intent to increase prescribing of Xtampza and BELBUCA. The prescriber basis of both Xtampza and BELBUCA are large, with approximately 19,000 effectively. This reflects the value these products bring to pain management. Speaker 400:14:43Both products have broad commercial coverage And Xtampza ER has strong coverage within Medicare Part D. Xtampza and BELBUCA grew market share in the Q1 compared to the Q4 of 2022, and Xtampza, BELBUCA and Nucynta ER have a combined 49% share of the branded ER market. The commercial organization is taking specific actions to differentiate our portfolio and fuel growth. These actions include the following: launching new promotional campaigns and educational resources for our sales team to use during interactions with HCPs and pharmacists Launching new digital and non personal promotional content, which reinforces the clinical differentiation of Xtampza and BELBUCA launching new personal and non personal promotional tools and working with payers to pull through the strong access positions of Xtampza ER and BELBUCA. In March, we had a national sales meeting to reinforce the brand strategies and messaging for our differentiated products. Speaker 400:15:48Our commercial organization, a highly motivated group of people who believe deeply in our paying products, aligned on our priorities in numerous workshops and practice sessions designed to strengthen the impact of their customer engagements. Every member of the commercial organization is focused on executing our plan. Our second commercial priority is winning in Managed Care. Our first step to winning is pulling through the strong access positions that we have for Xtampza ER and BELBUCA. Our second step is renegotiating Xtampza ER contracts that expire this year, which represent an additional 30% of prescriptions. Speaker 400:16:29Our 3rd step to winning in managed care is securing new access positions for BELBUCA and Xtampza in 2024. For BELBUCA, our priority is improving access within Medicare Part D. We believe that the clinical differentiation of BELBUCA warrants broader coverage within Medicare Part D, and we're actively engaged with payers to find a path to better access for patients. We're highly engaged with payers discussing the clinical value of Xtampza ER and BELBUCA and the difference both products can bring to patients. We're encouraged by the level of engagement. Speaker 400:17:05In closing, we're committed to achieving our commercial priorities in 2023 of growing Xtampza ER and BELBUCA prescriptions and achieving wins in managed care. I'll now turn the call back to Joe. Speaker 200:17:17Thanks, Scott. We are encouraged by our performance in the Q1, which demonstrates the progress we are making on our strategic priorities. We have a lot of work ahead of us, but we are confident that 2023 will be a banner year for Collegium. I will now open the call up for questions. Operator? Operator00:17:38Thank you. Our first question comes from David Amsellem with Piper Sandler. Please state your question. Speaker 500:18:11Hey, thanks. So just a couple. First, Joe, I know you talked about Xtampza and Belbuca Volume growth or your expectations for volume growth. So I was wondering if you can elaborate more On what you're doing to drive renewed volume growth for Xtampza and also what you're doing From a sales and marketing perspective on BELBUCA, that's number 1. And then number 2 is For Bill Duca, I think historically Medicare Part D Access was a real challenge. Speaker 500:18:51So Is there anything that's changed regarding your dialogue with payers in terms of Part D? And What are your expectations on the Part D front for Bilbuca as this year progresses and looking beyond this year? Thank you. Speaker 200:19:11Okay. Thanks, David. I'm going to have Scott answer the first question around the actions we're taking to grow volume with Xtampza ER and BELBUCA. And then maybe I'll share some perspective on Medicare Part D. Speaker 600:19:23All right. Speaker 400:19:24Yes, thanks, David. Yes, look, when you look at actions that we're taking, I put them into a couple of buckets. First, we're launching a lot of new resources to improve the engagement of our customers through the sales representatives. So I mentioned at the national sales meeting, We went through a lot of training and workshops. And the critical piece is we're now a year into the acquisition of BELBUCA, and I can see that people are comfortable with the product, Comfortable with the resources and excited to continue to drive that product forward. Speaker 400:19:52Also from a non personal digital standpoint, we continue to put new content into the marketplace to To raise awareness around the profile of our products. So those are the primary actions that we're taking, David, to reinvigorate growth. Speaker 200:20:04Okay. And then David, with regards to Medicare Part D, I think what we've chosen to do because we think it is a product that certainly merits Availability to that patient population is to take a blank canvas approach or assume that the payers Knew nothing about BELBUCA and we started foundationally with clinical presentations and we were surprised to learn that they We didn't have high awareness and the knowledge that you would expect around BELBUCA. And those are the encouraging discussions that Scott referenced that we've had to this point. So we'll continue to work towards it. Our hope is based off of those Positive conversations that we'll be able to unlock some opportunity in Medicare Part D and that would have impact In 2024, if we were successful in doing so. Speaker 200:20:58And as we always do in our November call, we'll provide an update On the payer landscape and its evolution. Speaker 500:21:07That's helpful. If I may just follow-up, in terms of The BELBUCA gross to net, I know it's early and this is fluid, but do you have a sense of, I guess, where you would take The gross to net up to for Belbuca to in exchange essentially For better Part D access? Speaker 200:21:33Yes. So what I would say, David, I don't want to give any Specific perspective on that, but I would distinguish any approach that we take with BELBUCA would be much Different than what it is we've historically done with Xtampza ER where we were Speaker 500:21:54Got it. Okay. Thank you. Operator00:21:59Thank you. And our next question comes from Tim Lugo with William Blair. Please state your question. Speaker 600:22:06Thanks for taking the question. It sounds like business development It is kind of ripe for deals. Can you talk you mentioned $100,000,000 kind of revenue type of product. Can you discuss maybe the profile These products a bit more, are they similar margin profile? Probably going to be almost overlapping sales force. Speaker 600:22:30So can you just maybe give us a little bit more flavor for what the type of products you're looking at? Operator00:25:08Thank you for your patience. We're having some technical issues. Just stand by, please. Thank you. Please continue. Operator00:26:28Thank you. Speaker 100:26:31Next up in queue, please. Operator00:26:33Thank you. And Tim Lugo was on the line. Speaker 600:26:38Hi, Tim. Sorry about that. I think everyone's going to be coughing well, Getting over something. I was talking about business development. It sounds like there are a couple of deals that you're looking at. Speaker 600:26:51I think you mentioned $100,000,000 in product revenue. Can you just talk about kind of profile of the deals you're looking for in terms of margins as well Overach is the sales force. Speaker 200:27:04Yes, sure. So thanks, Tim. And let me apologize, everyone. Our Systems here went down. So I appreciate you hanging in there with us. Speaker 200:27:13Look, from a business development perspective, Because we believe the current market conditions are conducive to getting a deal done, we're being agile in In terms of what potential therapeutic area and what we're focused on is number 1 differentiated assets. We think that's critical in order to be able to get reimbursement, which is critical to commercial success. From a peak sales perspective, we're looking for assets that have greater than $150,000,000 of peak sales potential and then Assets that have runway into the 2030s. And you're correct, Tim. We are very focused and active Right now with regards to our business development efforts and Colleen maybe can give a perspective in terms of How we think about it from a size and capacity perspective? Speaker 300:28:08Yes. Thanks for the question, Tim. What I'd add on to that from a size and capacity perspective Divas, we have flexibility with the strength of our balance sheet. As we've stated previously, we would be comfortable for a commercial stage asset To go up to 4x net debt to adjusted EBITDA and we're generally looking at assets with the market caps $1,000,000,000 or lower and we would be looking for something that potentially not accretive in the 1st year, but is Very rapidly accretive in year 2, definitely by year 3. Speaker 600:28:41Great to hear. Thank you. Speaker 300:28:43Thank you. Operator00:28:46Our next question comes from Brandon Folkes with Cantor Fitzgerald. Please state your question. Speaker 700:28:54Hi. Thanks for taking my question. So maybe just a few from me. Congratulations firstly on the gross to net performance in the quarter. Can you just talk about that Q1 gross to net performance though in light of your expectation and in light of the guidance? Speaker 700:29:11Obviously, you reiterated guidance on the gross to net side today. Should we expect 1 or 2 quarters, maybe 2Q, 3Q outside of that gross to net range and kind of averaging back into it? Or is it just sort of conservatism at this stage reiterating that guidance range? Maybe we'll start Speaker 300:29:33there. Thanks, Brandon. Great question. No, we're still expecting from a full year perspective It's in the 61% to the 63% range. With the portion of business for Xtampza that's weighted to Medicare Part D, we will see the Greatest impact of coverage gap in the 2nd Q3 and then we'll have that bit of sequential improvement in the Q4, but it won't be as good. Speaker 300:29:54We wouldn't expect it to be as good as what we saw in the Q1. And so what we see is the typical seasonality associated with the coverage gap And for the full year, you'll see that net out in the 61% to 63% range. Speaker 700:30:07Great. Thank you. And maybe just a high level one. So I appreciate all the color on the Xtampza and BELBUCA volume growth and the initiatives to drive growth in the back half of the year there. But how do you feel about bringing or how should we think about bringing in additional commercial assets at this stage While you still sort of execute on those initiatives and sort of try and get those 2 assets Back to volume growth, obviously, I'd imagine it's going to be an adjacent Okay, Puneet product, but just how do you think about it strategically in terms of focusing on volume growth versus business developments and maybe kind of executing those 2 in parallel? Speaker 700:30:49Thank you. Speaker 200:30:50Sure. Thanks for the question, Brandon. And I think that gets to our 2 pronged strategy. Prong 1 is maximizing the potential of the pain portfolio. When you think from a business development The types of things we're looking at will be lower synergy deals than what we've previously done, and that's really Highlighting that we'll be pivoting to another therapeutic focus, which will set a second beachhead for the organization and have a separate Field force and commercial infrastructure. Speaker 200:31:24So and that's important to the type of question you're asking because it will have no disruption Something that we believe will be able to absorb, bring over the individuals and be able to be successful with whatever it is we acquire to. Speaker 700:31:49Great. Thank you very much and congrats. Speaker 200:31:51Thank you. Operator00:31:53Our next question comes from Serge Belanger with Needham and Company. Please state your question. Speaker 800:32:00Hi, good afternoon. Just wanted to dig in a little bit on the 1Q performance. Just curious if The usual earlier impacts were more pronounced than usual this year. You talked about gross finesse on Xtampza, But what about the BELBUCA and Nucynta growth in that? And then maybe just comment on prescription volumes through the Q1? Speaker 800:32:28Thank you. Speaker 200:32:28Okay. Thanks, Serge. I'll have Colleen start off and take the gross to net question. Speaker 300:32:35Thanks for the question, Serge. So I would say overall expectations on gross to nets were aligned with where we saw them come in for the Q1. To give you a bit of additional context on what we saw by a product beyond Xtampza that I already mentioned, BELBUCA gross to nets in the first Quarter were 47.8 percent, Nucynta IR was 41% and Nucynta ER was 40 point And those are all in line with our expectations from and built into our guidance. Speaker 200:33:06Yes. And Serge, with regards to prescription trends in the Q1, I don't think that there was anything out of the ordinary with the following caveat. This is the first time In the history of Xtampza, where we didn't add any new payer wins and so it was subjected to that Q1 dynamic. And although the team did an outstanding job and you can see that in the revenue and gross to net performance of renegotiating Those 54% those contracts that represented 54% of all Xtampza ER prescriptions, we did come off formulary And 10% of those plans, which we think also in the Q1 put some pressure on prescriptions. With regards to BELBUCA, I think it's in line to what you would historically see. Speaker 800:33:57Thank you. Nice quarter. Speaker 200:34:00You got it. Thank you. Appreciate it. Operator00:34:02Our next question comes from Greg Fraser with Truist Securities. Please state your Speaker 900:34:08Good afternoon, folks. Thanks for taking the questions. I had a question on the topic of BELBUCA generics. And I'm curious if you have insight into the technical issues that Chemo Research had with this ANDA filing, and whether those challenges, if you know what they are, could Potentially be faced by other generic filers. Speaker 200:34:29Okay. Greg, thanks for the question. So Unfortunately, that's not something that I'm going to be able to comment on, on this call. What I would say is we believe That BELBUCA is a very hard product to achieve all doses successfully without infringing Upon the IP. And we will always continue to vigorously defend the intellectual property of BELBUCA. Speaker 200:35:00I'll also remind you that Chemo had attached themselves to the Alvogen litigation from an invalidity perspective. So both from that perspective are barred from entering the market until 2,032. Speaker 900:35:17Got it. Thank you. Quick one on Nucynta ER. Sales were higher than expected given the Rx Trajectory, was there anything to note in terms of inventory or gross net dynamics that benefited sales in the quarter? Speaker 700:35:32Collyn? Speaker 300:35:33Hi, Greg. No, nothing related to inventory, but in the beginning of every year, we typically have a bit of a Profitability acceleration because as new center being late in its lifecycle, there are fewer contracts that are renewing. And so that led To the net sales that we had in the quarter of for ER of $21,000,000 Speaker 900:35:53Got it. Okay. And then sorry if I missed this, but Could you comment on whether you repurchase shares under the new program or are you holding off on buybacks, pending visibility on a potential deal? Thanks. Speaker 200:36:05So Greg, we have not purchased any share we did not purchase any shares in the Q1 Of this year with the new share repurchase program. And we certainly, as I've commented on, are very active and engaged from a business development perspective, which will always be our top priority and a key consideration as you think about when we Utilize the share repurchase program. I would also emphasize over the history of the share repurchase programs we've We have acquired back $62,000,000 worth of our stock at an average price of $19.14 Operator00:37:10Our next question comes from Glenn Santangelo with Jefferies. Please state your question. Speaker 600:37:15Yes. Thanks for taking my questions. I just want to follow-up on a couple of the previous questions. First, with respect to driving the scripts I think Scott said, it sort of sounds like you're going to be adding some resources. And Colleen, I'm trying to reconcile that to the SG and A reported this quarter, which was a little bit higher than what we're looking for. Speaker 600:37:37But I thought I heard you say you expected that to sort of tail off As the year sort of progresses. So I was wondering if you could just sort of reconcile all those comments. Speaker 300:37:48Yes, absolutely, Glenn. So we did we came into the year strong and those investments that we set up in the 4th quarter and initiated in the first Quarter impacted our overall adjusted operating expenses. So we had $38,200,000 in the quarter of investment, Which is higher than what you'll see in the next couple of quarters. We're still projecting full year and guiding full year operating expenses between $135,000,000 100 and $45,000,000 Speaker 600:38:16Okay. And maybe just following up to Greg's question on BELBUCA. I mean, what's your latest thoughts with respect to LOE? I don't know if you're willing to share your expectation at this point. Speaker 200:38:30Yes, Glenn, this is Joe. I appreciate the question. I would emphasize that there's no change to our thinking. What I can articulate for you is our base case when we did the BDSI acquisition was that There would be a generic entrant in January of 2027. That's because there was a settlement with Teva. Speaker 200:38:53So that's our base case. I would emphasize they do not have an approved product and they also relinquished their first filer exclusivity. The remainder the remaining ANDA filers Alvogen and Chemo in their pursuit of in trying to invalidate the BELBUCA patents, There was a favorable ruling in support of BELBUCA that was upheld on appeal. So they're held out of the market That formulation until 2,032. And then I think as you know, recently, Chemo, who is Pursuing non infringement received another CRL on their product. Speaker 200:39:32They had communicated that last week. And as I said in response to Greg's question, we do believe it is very challenging to achieve all doses of BELBUCA without infringing Upon the patents and we're committed to very strongly defending the IP. The final thing is we have an authorized generic in the event There was a launch if Teva were to launch and that's an arrangement with Par Pharmaceuticals. So BELBUCA would have a long tail in that scenario. And the final comment I would make, if you contrast it to what we're doing with Nucynta, Where we're pulling back on our investment and managing the payer landscape accordingly, we are committed to investing through 20 27 with BELBUCA. Speaker 600:40:25Perfect. Thanks for the comments, Joe. Speaker 200:40:27You got it. Thank you. Speaker 900:40:30Thank you. And there are no Operator00:40:31further questions at this time. I'll hand the floor back to Joseph Ciaffoni for closing remarks. Thank you. Speaker 200:40:38Thank you everyone for joining the call today. We look forward to updating you on our progress and I hope that everybody has a great evening. Speaker 600:40:46ThankRead morePowered by Conference Call Audio Live Call not available Earnings Conference CallCollegium Pharmaceutical Q1 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Collegium Pharmaceutical Earnings Headlines2 Reasons to Watch COLL and 1 to Stay CautiousApril 14, 2025 | msn.comCollegium Pharmaceutical (NASDAQ:COLL) Upgraded by StockNews.com to "Strong-Buy" RatingApril 14, 2025 | americanbankingnews.comTrump to redistribute trillions of dollars Trump’s Final Reset Inside the shocking plot to re-engineer America’s financial system…and why you need to move your money now.April 21, 2025 | Porter & Company (Ad)7COLL : What Analysts Are Saying...April 9, 2025 | benzinga.comA Look Back at Branded Pharmaceuticals Stocks’ Q4 Earnings: Collegium Pharmaceutical (NASDAQ:COLL) Vs The Rest Of The PackApril 2, 2025 | msn.comCollegium to Participate in 24th Annual Needham Virtual Healthcare ConferenceApril 1, 2025 | globenewswire.comSee More Collegium Pharmaceutical Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Collegium Pharmaceutical? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Collegium Pharmaceutical and other key companies, straight to your email. Email Address About Collegium PharmaceuticalCollegium Pharmaceutical (NASDAQ:COLL), a specialty pharmaceutical company, engages in the development and commercialization of medicines for pain management. Its portfolio includes Xtampza ER, an abuse-deterrent, extended-release, and oral formulation of oxycodone for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment; Nucynta ER and Nucynta IR, which are extended-release and immediate-release formulations of tapentadol, indicated for the management of acute, severe, and persistent pain; Belbuca, a buccal film that contains buprenorphine; and Symproic, an oral formulation of naldemedine for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain. The company was formerly known as Collegium Pharmaceuticals, Inc. and changed its name to Collegium Pharmaceutical, Inc. in October 2003. Collegium Pharmaceutical, Inc. was incorporated in 2002 and is headquartered in Stoughton, Massachusetts.View Collegium Pharmaceutical ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Archer Aviation Unveils NYC Network Ahead of Key Earnings Report3 Reasons to Like the Look of Amazon Ahead of EarningsTesla Stock Eyes Breakout With Earnings on DeckJohnson & Johnson Earnings Were More Good Than Bad—Time to Buy? 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There are 10 speakers on the call. Operator00:00:00Greetings, and welcome to the Collegium Pharmaceutical First Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note that this conference call is being recorded. I will now turn the call over to Christopher James, Vice President of Investor Relations at Collegium. Operator00:00:29Thank you. You may begin. Speaker 100:00:32Welcome to Collegium Pharmaceuticals' 1st quarter 2023 earnings conference call. I'm joined today by Joe Ciaffoni, our Chief Executive Officer Cummings Tupper, 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 our products, that we may incur significant expense and that we may not prevail in current or future litigation pertaining to our business. These risks and other risks of the company are detailed in the company's periodic reports filed with the Securities and Exchange Commission. Speaker 100:01:31Our future results may differ materially from our current expectations discussed today. Our earnings press release on 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 atcolesiumfraubit.com. I will now turn the call over to our CEO, Joe Ciaffoni. Speaker 200:01:52Thank you, Chris. Good afternoon and thank you everyone for joining the call. Today, we will discuss our financial performance during the Q1 and provide an update on our progress towards achieving a banner year in 2023. At Collegium, we are focused on building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with Our commitment to improving lives extends to our communities and in support of that during the Q1, We made a charitable donation to Kids in Tech, a non profit organization leading STEM education initiatives for kids from low income households, and we donated 1,000 hygiene and essential kits for people in need through life science cares. I'd like to thank our team for their commitment to our mission and for making Collegium a great place to work. Speaker 200:02:49In the Q1 of 2023, we delivered strong financial results and made progress against our strategic priorities. Key accomplishments in the Q1 include: we delivered record quarterly revenue and adjusted EBITDA We generated record quarterly BELBUCA and Xtampza ER revenue. We achieved gross to net for Xtampza ER of 55%, Reflecting the immediate impact of the successful contract renegotiations completed last year, we presented 4 posters At the American Academy of Pain Medicine's Annual Meeting and we increased our cash balance leaving us well positioned to execute on our capital deployment strategy. With our strong performance in the Q1, we are confident 2023 will be a banner year. As we move through 2023, we expect to recognize significant top and bottom line growth. Speaker 200:03:49Top line drivers include Xtampza ER gross to net improvement, full year BELBUCA revenues And BELBUCA and Xtampza ER prescription growth on a full year basis. We believe our fully synergized cost structure And financial discipline will further fuel bottom line growth and enable us to deploy capital to create long term value for our shareholders. Our 2023 financial guidance includes growing adjusted EBITDA by over 1.5 times revenue and over 2 times adjusted operating expenses. We are confident in our ability to deliver on our financial and strategic goals and have already made progress in the Q1 of the year. We are dedicated to making 2023 a banner year by executing our 2 pronged strategy, maximizing the potential of our pain portfolio and deploying capital. Speaker 200:04:47We plan to maximize the potential of our pain portfolio through strong commercial execution. During the Q1, we saw an immediate Acceleration of Xtampza ER revenue to a record level with year over year growth of approximately 52%, primarily driven by gross to net improvement to 55%. We also delivered record quarterly BELBUCA revenue And we'll recognize the benefit of owning BELBUCA for the full year. We do expect BELBUCA and Xtampza ER prescription growth on a full year basis, And we anticipate that the Nucynta franchise and Symproic will be steady contributors. Our capital deployment strategy is focused on Creating long term value for our shareholders. Speaker 200:05:35Our top priority is business development. We are focused, active and engaged. We are looking for differentiated commercial stage assets that generate that have the potential to generate over $150,000,000 in Annual revenues with exclusivity into the 2030s. We believe market conditions are conducive to potentially getting a deal done. We are in a strong financial position, which gives us the flexibility to evaluate a range of deals That could be a great strategic fit for Collegium. Speaker 200:06:11We will remain disciplined in our approach. We are committed to rapidly paying down debt and opportunistically utilizing our share repurchase program to return capital to our shareholders. We are encouraged by our Q1 performance And confident that we are on track to achieve our financial objectives. Our strategy is clear and our organization is focused on execution. I will now hand the call over to Colleen to discuss the financials. Speaker 300:06:41Thanks, Joe. Good afternoon, everyone. We had a strong Q1 in which we delivered record quarterly revenue and adjusted EBITDA, maintained financial discipline and generated strong cash closed while paying down debt. Financial highlights for the Q1 include net product revenues were a record $144,800,000 for the first compared to $83,800,000 for the Q1 of 2022, an increase of 73%. BELBUCA net revenue was a record $44,200,000 in the Q1. Speaker 300:07:17Xtampza ER net revenue was a record $47,900,000 in the first quarter, an increase of 52% over the Q1 of 2022 And Xtampza ER gross to net was 55% in the Q1. The lower gross to net was primarily driven by the Xtampza ER contract renegotiations we completed last year. As a reminder, gross to net is generally more favorable in the Q1 of each year due to the lower coverage GAAP expense, also known as the donut hole in Medicare coverage. As we move through the year, gross to nets are expected to be less favorable in the second and third quarters and improved sequentially in the 4th quarter, but remain less favorable than the Q1 level. This is consistent with what we have experienced in past years. Speaker 300:08:06We expect full year Xtampza ER gross to net to be between 61% to 63% in 2023. Nucynta franchise net revenue was $49,000,000 in the Q1, an increase of 1% over the Q1 of 2022. GAAP operating expenses were $52,800,000 in the first quarter, which decreased 10% compared to $58,500,000 in the Q1 of 2020 Yes. Adjusted operating expenses were $38,200,000 in the first quarter, which increased 52% compared to $25,200,000 in the first quarter of 2022. Our operating expenses were front loaded into the Q1, reflecting investment in our growth initiatives for the year. Speaker 300:08:50We expect operating expenses will trend lower in the subsequent quarters of 2023. Net loss for the first Quarter was $17,400,000 compared to a net loss of $13,100,000 in the Q1 of 2022. Included in GAAP net loss, Among other items that do not represent our ongoing operations is a $23,500,000 loss on extinguishment of debt related to the repurchase of a portion of our 2026 convertible notes and an $8,500,000 charge related to our settlement agreement with Aquestive Therapeutics. Non GAAP adjusted EBITDA was a record $87,600,000 for the Q1 compared to $43,500,000 in the Q1 of 2022, an increase of 101%. GAAP loss per share was $0.51 basic and diluted in the first quarter compared to GAAP loss per share of $0.39 basic and diluted in the Q1 of 2022. Speaker 300:09:51Non GAAP adjusted earnings per share was $1.32 in the Q1 compared to $0.71 in the Q1 of 2022, an increase of 86%. Please see our press release issued earlier today for a reconciliation of GAAP to non GAAP results. As of March 31, 2023, our cash Balance increased to $269,500,000 During the quarter, we paid down $25,000,000 in debt related to our term notes. We also completed a $241,500,000 convertible note offering with a maturity in February 2029 as a matter of good corporate hygiene. The later maturity provides us with more financial flexibility in the management of our debt. Speaker 300:10:37We used $140,100,000 Proceeds from the offering to repurchase a portion of our convertible senior notes due in 2026. After note issuance costs, We had approximately $97,000,000 of net proceeds, which we intend to use for general corporate purposes, including the implementation of our capital deployment We ended the Q1 at 1.5x net debt to adjusted EBITDA and expect to end the year at approximately 1x. We are pleased with our strong first quarter performance, which reflects the progress we are making as we execute our financial objectives for the year. We are reaffirming our financial guidance for 2023. We expect net product revenues in the range of $565,000,000 to $580,000,000 Adjusted operating expenses in the range of $135,000,000 to $145,000,000 and adjusted EBITDA in the range of $355,000,000 to $370,000,000 Our capital deployment strategy is focused on creating long term value for our shareholders. Speaker 300:11:45Our strong financial position allows us to execute our capital deployment strategy. Our top priority is business and we are committed to taking a disciplined approach in a market that we believe is conducive to potentially getting a transaction done. We are locked into rapidly deleveraging our balance sheet. We're on track to repay $162,500,000 of debt in 2023, which would put us at approximately 1x net debt to adjusted EBITDA at year end. Our ability to delever quickly is a testament to our strong cash Finally, we have the ability to return capital to our shareholders by strategically leveraging our share repurchase program. Speaker 300:12:28In January 2023, our Board authorized a new share repurchase program for $100,000,000 We are very pleased with our first quarter performance and strong start to 2023 as we positively track against our key financial and strategic priorities. I will now turn it over to Scott. Speaker 400:12:49Thanks, Colleen. As we look at performance in the Q1, there are 2 key takeaways. First, The contract renegotiations for Xtampza ER that we completed in 2022 have had an immediate positive impact, driving gross to net improvements and accelerating net revenue. This year, we have the opportunity to renegotiate contracts that represent 30% of prescriptions, And we've created room to opportunistically secure new payer wins, while ensuring gross to net for Xtampza ER remains below 65% forever. 2nd, as we look at BELBUCA and Xtampza ER, prescription performance was generally in line with our expectations. Speaker 400:13:29We believe the growth of Xtampza and BELBUCA were pressured by typical first quarter dynamics where deductibles reset and increased out of pocket costs for patients. Consistent with past years, we expect this to normalize in the 2nd quarter. Additionally, Xtampza ER prescription growth was pressured due to Xtampza being removed from formulary on January 1 within plans we renegotiated last year that represented approximately 10% of Xtampza ER prescriptions. We believe that on a full year basis, we will see prescription volume growth for BELBUCA and Xtampza ER. This is our number one commercial priority. Speaker 400:14:09The fundamentals of both brands are strong, and we believe they are positioned for growth. Xtampza ER and BELBUCA are viewed favorably and are considered highly differentiated by health care professionals. These same HCPs have indicated a strong intent to increase prescribing of Xtampza and BELBUCA. The prescriber basis of both Xtampza and BELBUCA are large, with approximately 19,000 effectively. This reflects the value these products bring to pain management. Speaker 400:14:43Both products have broad commercial coverage And Xtampza ER has strong coverage within Medicare Part D. Xtampza and BELBUCA grew market share in the Q1 compared to the Q4 of 2022, and Xtampza, BELBUCA and Nucynta ER have a combined 49% share of the branded ER market. The commercial organization is taking specific actions to differentiate our portfolio and fuel growth. These actions include the following: launching new promotional campaigns and educational resources for our sales team to use during interactions with HCPs and pharmacists Launching new digital and non personal promotional content, which reinforces the clinical differentiation of Xtampza and BELBUCA launching new personal and non personal promotional tools and working with payers to pull through the strong access positions of Xtampza ER and BELBUCA. In March, we had a national sales meeting to reinforce the brand strategies and messaging for our differentiated products. Speaker 400:15:48Our commercial organization, a highly motivated group of people who believe deeply in our paying products, aligned on our priorities in numerous workshops and practice sessions designed to strengthen the impact of their customer engagements. Every member of the commercial organization is focused on executing our plan. Our second commercial priority is winning in Managed Care. Our first step to winning is pulling through the strong access positions that we have for Xtampza ER and BELBUCA. Our second step is renegotiating Xtampza ER contracts that expire this year, which represent an additional 30% of prescriptions. Speaker 400:16:29Our 3rd step to winning in managed care is securing new access positions for BELBUCA and Xtampza in 2024. For BELBUCA, our priority is improving access within Medicare Part D. We believe that the clinical differentiation of BELBUCA warrants broader coverage within Medicare Part D, and we're actively engaged with payers to find a path to better access for patients. We're highly engaged with payers discussing the clinical value of Xtampza ER and BELBUCA and the difference both products can bring to patients. We're encouraged by the level of engagement. Speaker 400:17:05In closing, we're committed to achieving our commercial priorities in 2023 of growing Xtampza ER and BELBUCA prescriptions and achieving wins in managed care. I'll now turn the call back to Joe. Speaker 200:17:17Thanks, Scott. We are encouraged by our performance in the Q1, which demonstrates the progress we are making on our strategic priorities. We have a lot of work ahead of us, but we are confident that 2023 will be a banner year for Collegium. I will now open the call up for questions. Operator? Operator00:17:38Thank you. Our first question comes from David Amsellem with Piper Sandler. Please state your question. Speaker 500:18:11Hey, thanks. So just a couple. First, Joe, I know you talked about Xtampza and Belbuca Volume growth or your expectations for volume growth. So I was wondering if you can elaborate more On what you're doing to drive renewed volume growth for Xtampza and also what you're doing From a sales and marketing perspective on BELBUCA, that's number 1. And then number 2 is For Bill Duca, I think historically Medicare Part D Access was a real challenge. Speaker 500:18:51So Is there anything that's changed regarding your dialogue with payers in terms of Part D? And What are your expectations on the Part D front for Bilbuca as this year progresses and looking beyond this year? Thank you. Speaker 200:19:11Okay. Thanks, David. I'm going to have Scott answer the first question around the actions we're taking to grow volume with Xtampza ER and BELBUCA. And then maybe I'll share some perspective on Medicare Part D. Speaker 600:19:23All right. Speaker 400:19:24Yes, thanks, David. Yes, look, when you look at actions that we're taking, I put them into a couple of buckets. First, we're launching a lot of new resources to improve the engagement of our customers through the sales representatives. So I mentioned at the national sales meeting, We went through a lot of training and workshops. And the critical piece is we're now a year into the acquisition of BELBUCA, and I can see that people are comfortable with the product, Comfortable with the resources and excited to continue to drive that product forward. Speaker 400:19:52Also from a non personal digital standpoint, we continue to put new content into the marketplace to To raise awareness around the profile of our products. So those are the primary actions that we're taking, David, to reinvigorate growth. Speaker 200:20:04Okay. And then David, with regards to Medicare Part D, I think what we've chosen to do because we think it is a product that certainly merits Availability to that patient population is to take a blank canvas approach or assume that the payers Knew nothing about BELBUCA and we started foundationally with clinical presentations and we were surprised to learn that they We didn't have high awareness and the knowledge that you would expect around BELBUCA. And those are the encouraging discussions that Scott referenced that we've had to this point. So we'll continue to work towards it. Our hope is based off of those Positive conversations that we'll be able to unlock some opportunity in Medicare Part D and that would have impact In 2024, if we were successful in doing so. Speaker 200:20:58And as we always do in our November call, we'll provide an update On the payer landscape and its evolution. Speaker 500:21:07That's helpful. If I may just follow-up, in terms of The BELBUCA gross to net, I know it's early and this is fluid, but do you have a sense of, I guess, where you would take The gross to net up to for Belbuca to in exchange essentially For better Part D access? Speaker 200:21:33Yes. So what I would say, David, I don't want to give any Specific perspective on that, but I would distinguish any approach that we take with BELBUCA would be much Different than what it is we've historically done with Xtampza ER where we were Speaker 500:21:54Got it. Okay. Thank you. Operator00:21:59Thank you. And our next question comes from Tim Lugo with William Blair. Please state your question. Speaker 600:22:06Thanks for taking the question. It sounds like business development It is kind of ripe for deals. Can you talk you mentioned $100,000,000 kind of revenue type of product. Can you discuss maybe the profile These products a bit more, are they similar margin profile? Probably going to be almost overlapping sales force. Speaker 600:22:30So can you just maybe give us a little bit more flavor for what the type of products you're looking at? Operator00:25:08Thank you for your patience. We're having some technical issues. Just stand by, please. Thank you. Please continue. Operator00:26:28Thank you. Speaker 100:26:31Next up in queue, please. Operator00:26:33Thank you. And Tim Lugo was on the line. Speaker 600:26:38Hi, Tim. Sorry about that. I think everyone's going to be coughing well, Getting over something. I was talking about business development. It sounds like there are a couple of deals that you're looking at. Speaker 600:26:51I think you mentioned $100,000,000 in product revenue. Can you just talk about kind of profile of the deals you're looking for in terms of margins as well Overach is the sales force. Speaker 200:27:04Yes, sure. So thanks, Tim. And let me apologize, everyone. Our Systems here went down. So I appreciate you hanging in there with us. Speaker 200:27:13Look, from a business development perspective, Because we believe the current market conditions are conducive to getting a deal done, we're being agile in In terms of what potential therapeutic area and what we're focused on is number 1 differentiated assets. We think that's critical in order to be able to get reimbursement, which is critical to commercial success. From a peak sales perspective, we're looking for assets that have greater than $150,000,000 of peak sales potential and then Assets that have runway into the 2030s. And you're correct, Tim. We are very focused and active Right now with regards to our business development efforts and Colleen maybe can give a perspective in terms of How we think about it from a size and capacity perspective? Speaker 300:28:08Yes. Thanks for the question, Tim. What I'd add on to that from a size and capacity perspective Divas, we have flexibility with the strength of our balance sheet. As we've stated previously, we would be comfortable for a commercial stage asset To go up to 4x net debt to adjusted EBITDA and we're generally looking at assets with the market caps $1,000,000,000 or lower and we would be looking for something that potentially not accretive in the 1st year, but is Very rapidly accretive in year 2, definitely by year 3. Speaker 600:28:41Great to hear. Thank you. Speaker 300:28:43Thank you. Operator00:28:46Our next question comes from Brandon Folkes with Cantor Fitzgerald. Please state your question. Speaker 700:28:54Hi. Thanks for taking my question. So maybe just a few from me. Congratulations firstly on the gross to net performance in the quarter. Can you just talk about that Q1 gross to net performance though in light of your expectation and in light of the guidance? Speaker 700:29:11Obviously, you reiterated guidance on the gross to net side today. Should we expect 1 or 2 quarters, maybe 2Q, 3Q outside of that gross to net range and kind of averaging back into it? Or is it just sort of conservatism at this stage reiterating that guidance range? Maybe we'll start Speaker 300:29:33there. Thanks, Brandon. Great question. No, we're still expecting from a full year perspective It's in the 61% to the 63% range. With the portion of business for Xtampza that's weighted to Medicare Part D, we will see the Greatest impact of coverage gap in the 2nd Q3 and then we'll have that bit of sequential improvement in the Q4, but it won't be as good. Speaker 300:29:54We wouldn't expect it to be as good as what we saw in the Q1. And so what we see is the typical seasonality associated with the coverage gap And for the full year, you'll see that net out in the 61% to 63% range. Speaker 700:30:07Great. Thank you. And maybe just a high level one. So I appreciate all the color on the Xtampza and BELBUCA volume growth and the initiatives to drive growth in the back half of the year there. But how do you feel about bringing or how should we think about bringing in additional commercial assets at this stage While you still sort of execute on those initiatives and sort of try and get those 2 assets Back to volume growth, obviously, I'd imagine it's going to be an adjacent Okay, Puneet product, but just how do you think about it strategically in terms of focusing on volume growth versus business developments and maybe kind of executing those 2 in parallel? Speaker 700:30:49Thank you. Speaker 200:30:50Sure. Thanks for the question, Brandon. And I think that gets to our 2 pronged strategy. Prong 1 is maximizing the potential of the pain portfolio. When you think from a business development The types of things we're looking at will be lower synergy deals than what we've previously done, and that's really Highlighting that we'll be pivoting to another therapeutic focus, which will set a second beachhead for the organization and have a separate Field force and commercial infrastructure. Speaker 200:31:24So and that's important to the type of question you're asking because it will have no disruption Something that we believe will be able to absorb, bring over the individuals and be able to be successful with whatever it is we acquire to. Speaker 700:31:49Great. Thank you very much and congrats. Speaker 200:31:51Thank you. Operator00:31:53Our next question comes from Serge Belanger with Needham and Company. Please state your question. Speaker 800:32:00Hi, good afternoon. Just wanted to dig in a little bit on the 1Q performance. Just curious if The usual earlier impacts were more pronounced than usual this year. You talked about gross finesse on Xtampza, But what about the BELBUCA and Nucynta growth in that? And then maybe just comment on prescription volumes through the Q1? Speaker 800:32:28Thank you. Speaker 200:32:28Okay. Thanks, Serge. I'll have Colleen start off and take the gross to net question. Speaker 300:32:35Thanks for the question, Serge. So I would say overall expectations on gross to nets were aligned with where we saw them come in for the Q1. To give you a bit of additional context on what we saw by a product beyond Xtampza that I already mentioned, BELBUCA gross to nets in the first Quarter were 47.8 percent, Nucynta IR was 41% and Nucynta ER was 40 point And those are all in line with our expectations from and built into our guidance. Speaker 200:33:06Yes. And Serge, with regards to prescription trends in the Q1, I don't think that there was anything out of the ordinary with the following caveat. This is the first time In the history of Xtampza, where we didn't add any new payer wins and so it was subjected to that Q1 dynamic. And although the team did an outstanding job and you can see that in the revenue and gross to net performance of renegotiating Those 54% those contracts that represented 54% of all Xtampza ER prescriptions, we did come off formulary And 10% of those plans, which we think also in the Q1 put some pressure on prescriptions. With regards to BELBUCA, I think it's in line to what you would historically see. Speaker 800:33:57Thank you. Nice quarter. Speaker 200:34:00You got it. Thank you. Appreciate it. Operator00:34:02Our next question comes from Greg Fraser with Truist Securities. Please state your Speaker 900:34:08Good afternoon, folks. Thanks for taking the questions. I had a question on the topic of BELBUCA generics. And I'm curious if you have insight into the technical issues that Chemo Research had with this ANDA filing, and whether those challenges, if you know what they are, could Potentially be faced by other generic filers. Speaker 200:34:29Okay. Greg, thanks for the question. So Unfortunately, that's not something that I'm going to be able to comment on, on this call. What I would say is we believe That BELBUCA is a very hard product to achieve all doses successfully without infringing Upon the IP. And we will always continue to vigorously defend the intellectual property of BELBUCA. Speaker 200:35:00I'll also remind you that Chemo had attached themselves to the Alvogen litigation from an invalidity perspective. So both from that perspective are barred from entering the market until 2,032. Speaker 900:35:17Got it. Thank you. Quick one on Nucynta ER. Sales were higher than expected given the Rx Trajectory, was there anything to note in terms of inventory or gross net dynamics that benefited sales in the quarter? Speaker 700:35:32Collyn? Speaker 300:35:33Hi, Greg. No, nothing related to inventory, but in the beginning of every year, we typically have a bit of a Profitability acceleration because as new center being late in its lifecycle, there are fewer contracts that are renewing. And so that led To the net sales that we had in the quarter of for ER of $21,000,000 Speaker 900:35:53Got it. Okay. And then sorry if I missed this, but Could you comment on whether you repurchase shares under the new program or are you holding off on buybacks, pending visibility on a potential deal? Thanks. Speaker 200:36:05So Greg, we have not purchased any share we did not purchase any shares in the Q1 Of this year with the new share repurchase program. And we certainly, as I've commented on, are very active and engaged from a business development perspective, which will always be our top priority and a key consideration as you think about when we Utilize the share repurchase program. I would also emphasize over the history of the share repurchase programs we've We have acquired back $62,000,000 worth of our stock at an average price of $19.14 Operator00:37:10Our next question comes from Glenn Santangelo with Jefferies. Please state your question. Speaker 600:37:15Yes. Thanks for taking my questions. I just want to follow-up on a couple of the previous questions. First, with respect to driving the scripts I think Scott said, it sort of sounds like you're going to be adding some resources. And Colleen, I'm trying to reconcile that to the SG and A reported this quarter, which was a little bit higher than what we're looking for. Speaker 600:37:37But I thought I heard you say you expected that to sort of tail off As the year sort of progresses. So I was wondering if you could just sort of reconcile all those comments. Speaker 300:37:48Yes, absolutely, Glenn. So we did we came into the year strong and those investments that we set up in the 4th quarter and initiated in the first Quarter impacted our overall adjusted operating expenses. So we had $38,200,000 in the quarter of investment, Which is higher than what you'll see in the next couple of quarters. We're still projecting full year and guiding full year operating expenses between $135,000,000 100 and $45,000,000 Speaker 600:38:16Okay. And maybe just following up to Greg's question on BELBUCA. I mean, what's your latest thoughts with respect to LOE? I don't know if you're willing to share your expectation at this point. Speaker 200:38:30Yes, Glenn, this is Joe. I appreciate the question. I would emphasize that there's no change to our thinking. What I can articulate for you is our base case when we did the BDSI acquisition was that There would be a generic entrant in January of 2027. That's because there was a settlement with Teva. Speaker 200:38:53So that's our base case. I would emphasize they do not have an approved product and they also relinquished their first filer exclusivity. The remainder the remaining ANDA filers Alvogen and Chemo in their pursuit of in trying to invalidate the BELBUCA patents, There was a favorable ruling in support of BELBUCA that was upheld on appeal. So they're held out of the market That formulation until 2,032. And then I think as you know, recently, Chemo, who is Pursuing non infringement received another CRL on their product. Speaker 200:39:32They had communicated that last week. And as I said in response to Greg's question, we do believe it is very challenging to achieve all doses of BELBUCA without infringing Upon the patents and we're committed to very strongly defending the IP. The final thing is we have an authorized generic in the event There was a launch if Teva were to launch and that's an arrangement with Par Pharmaceuticals. So BELBUCA would have a long tail in that scenario. And the final comment I would make, if you contrast it to what we're doing with Nucynta, Where we're pulling back on our investment and managing the payer landscape accordingly, we are committed to investing through 20 27 with BELBUCA. Speaker 600:40:25Perfect. Thanks for the comments, Joe. Speaker 200:40:27You got it. Thank you. Speaker 900:40:30Thank you. And there are no Operator00:40:31further questions at this time. I'll hand the floor back to Joseph Ciaffoni for closing remarks. Thank you. Speaker 200:40:38Thank you everyone for joining the call today. We look forward to updating you on our progress and I hope that everybody has a great evening. Speaker 600:40:46ThankRead morePowered by