NASDAQ:SUPN Supernus Pharmaceuticals Q4 2023 Earnings Report $32.22 +0.87 (+2.78%) Closing price 04/25/2025 04:00 PM EasternExtended Trading$31.57 -0.65 (-2.00%) As of 04/25/2025 07:57 PM 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 Supernus Pharmaceuticals EPS ResultsActual EPS$0.02Consensus EPS $0.41Beat/MissMissed by -$0.39One Year Ago EPS$0.43Supernus Pharmaceuticals Revenue ResultsActual Revenue$164.30 millionExpected Revenue$155.03 millionBeat/MissBeat by +$9.27 millionYoY Revenue Growth-1.80%Supernus Pharmaceuticals Announcement DetailsQuarterQ4 2023Date2/27/2024TimeAfter Market ClosesConference Call DateTuesday, February 27, 2024Conference Call Time4:30PM ETUpcoming EarningsSupernus Pharmaceuticals' Q1 2025 earnings is scheduled for Tuesday, May 6, 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 TranscriptPress Release (8-K)Annual Report (10-K)Earnings HistoryCompany ProfilePowered by Supernus Pharmaceuticals Q4 2023 Earnings Call TranscriptProvided by QuartrFebruary 27, 2024 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:00Good afternoon, and welcome to the Supernus Pharmaceuticals 4th Quarter and Full Year 2023 Financial Results Conference Call. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session. Instructions will follow at that time. As a reminder, this conference call is being recorded. Operator00:00:20I would now like to turn the conference over to Peter Vozzo of ICR Westwick, Investor Relations Representative for Supernus Pharmaceuticals. You may begin. Speaker 100:00:30Thank you, Rivka. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' Q4 and full year 2023 financial results conference call. Today, after the close of the market, the company issued a press release announcing these results. Speaker 200:00:45On the call with Speaker 100:00:45me today are Supernus' Chief Executive Officer, Jack Catar and Chief Financial Officer, Tim Deck. Today's call is being made available via the Investor Relations section of the company's website at ir.supernus.com. During the course of this call, management may make certain forward looking statements regarding future events and the company's future performance. These forward looking statements reflect Sifydas' current perspective on existing trends and information. Any such forward looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factors section of the company's latest SEC filings. Speaker 100:01:23Actual results may differ materially from those projected in these forward looking statements. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on February 27, 2024. Since then, the company may have made additional announcements related to the topics discussed. Please reference the company's most recent press releases and current filings with the SEC. Supernus declines any obligation to update these forward looking statements, except as required by applicable securities laws. Speaker 100:01:54I will now turn the call over to Chad. Speaker 200:01:56Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us on today's call. Our performance in 2023 underscored our strong execution and emphasis on growing our revenue base despite the loss of exclusivity on Trokendi XR. Excluding Trokendi XR, Supernus delivered strong growth of 26% in total revenues in 2023 compared to 2022. Specifically, our growth products, Calvary and GOCOVRI delivered robust 57% growth in combined net sales compared to last year. Speaker 200:02:35In addition, combined full year 2023 net sales for Calvary and GOCOVRI reached approximately $260,000,000 which significantly exceeded the $167,000,000 decline in net sales of Trokendi XR. As a result of our emphasis on growing the rest of our portfolio throughout 2023, Trokendi XR closed the year representing only 13% of total revenues in the last quarter of 2023. Regarding Calvary, the year 2023 was the first full year with both pediatric and adult indications. For the full year, Calvary's prescriptions as reported by IQVIA reached 617,192 prescriptions, representing a growth rate of 91% compared to 2022. Net sales for 2023 recorded an even stronger growth rate of 129%, benefiting from the prescription growth and the steady improvement in gross to net throughout the year. Speaker 200:03:42Moreover, Calgary finished the year with a strong 4th quarter reaching net sales of $46,400,000 That represents a 97% increase over the growth quarter of the Q4 of 2022 and a 25% sequential quarter to quarter increase from the Q3 of 2023. In the Q4, prescriptions grew by 47% compared to 2022 and we exceeded our goal of lowering the gross the gross to net deductions to the 50% to 55% range. Actual gross to net for the Q4 2023 was 49.5%, resulting in an average net price per prescription of $2.68 compared to 61% $201 respectively in the same period last year. For the year 2024, we expect the gross to net for Calgary to be in the range of 50% to 55% with fluctuations that you would typically expect on a quarterly basis. In 2023, Kelvry also expanded its base of prescribers ending the Q4 with approximately 25,938 prescribers, up from 16,822 in the Q4 of 2022. Speaker 200:05:08We continue to be encouraged by the high level of satisfaction by Calvary's prescribers. Satisfaction with Calvary among heavy prescribers is as high as their satisfaction with extended release stimulants and is significantly higher than their satisfaction with Strattera. In 2024, we will be placing more emphasis on the adult segment that represents prescription growth rate in line with the 3% growth rate it had in 2023 when it reached an all time high of 93,400,000 annual prescriptions. Switching now to GOCOVRI for full year 2023, prescriptions increased by 10% compared to 2022 and net sales increased by 15%, reaching a record of $120,000,000 We continue to be pleased with the performance of the brand based on its unique position in the marketplace treating both of episodes and dyskinesia. The 2023 4th quarter net sales were $32,000,000 up 10% compared to last year and flat compared to the Q3 as they were impacted by the timing of orders at year end. Speaker 200:06:31Switching to our legacy products, Oxtellar XR net sales were $113,000,000 for full year 2023, essentially stable compared to 2022. In September 2024, we expect the introduction of the first generic of Oxtellar XR. For Trokendi XR, full year net sales were $94,000,000 down by 64% from the $261,000,000 in 2022. In 2024, we don't expect an increase in the number of generic players in the market, but expect further erosion in Trokendi XR sales. We anticipate combined net sales of Trokendi XR and Oxtellar XR in 2024 to be in the range of $125,000,000 to $135,000,000 Regarding SPN830, the FDA has scheduled a preapproval manufacturing facility inspection, which will take place in Europe this month and the FDA's review of the NDA remains ongoing with a PDUFA date of April 5, 2024. Speaker 200:07:41Assuming FDA approval, the company plans to launch SPN-eight thirty in the second half of twenty twenty four, capitalizing on its existing infrastructure, including the sales force, nurse educators, hub and patient services. Moving on to our CNS pipeline of novel product candidates, we made great progress in 2023, setting the stage for a rich calendar of clinical milestones and data releases over the next 12 to 18 months across several programs. First, the company initiated a Phase 4 study with Calvary in ADHD patients with comorbid mood disorders such as depression and anxiety. This trial is expected to include approximately 500 patients with data expected in the first half of twenty twenty five. 2nd, the company also initiated a Phase 2 open label study with SPN-eight twenty and approximately 40 subjects with major depressive disorder. Speaker 200:08:43This study has the potential of providing data on this 1st in class molecule by the end of this year. 3rd, our ongoing Phase 2b multicenter randomized double blind placebo controlled study of SPN-eight twenty in adults with treatment resistant depression has now enrolled approximately 120 patients. We expect top line data from this trial in the first half of twenty twenty five. 4th, the company expects to report interim results from approximately 1 half of the targeted randomized patients from its Phase 2a study on SPN-eight seventeen in treatment resistant seizures in May 2024. This study is examining the safety and tolerability and efficacy of SPN-eight seventeen as adjunctive therapy in adult patients with treatment resistant seizures. Speaker 200:09:37Top line results for the full study are expected in the second half of twenty twenty four. 5th, the initiation of the Phase 2b placebo controlled study with SPN-eight seventeen in patients with treatment resistant focal seizures in the second half of this year. And finally, initiation of a Phase 1 single dose study of SPN-four forty three in healthier dose following the submission of an IND. SPN-four forty three is our new stimulant like product candidate for ADHD and other CNS disorders. Regarding corporate development, the company continues to be active looking for strategic opportunities to further strengthen our future growth and leadership position in CNS. Speaker 200:10:24With that, I will now turn the call over to Tim. Speaker 300:10:28Thank you, Jack. Good afternoon, everyone. As I review our Q4 and full year 2023 results, please refer to today's press release and 10 ks that was filed earlier today. Total revenue for the Q4 of 2023 was $164,300,000 compared to $167,300,000 in the prior year quarter. Total revenue in the Q4 of 2023 was comprised of net product sales of 156,000,000 dollars and royalty and licensing revenues of $8,300,000 The $7,800,000 decrease in net product sales was primarily due to a $37,600,000 decline in net product sales of Trokendi XR, partially offset by a $25,600,000 increase in net product sales of our growth products, Keldry and GOCOVRI. Speaker 300:11:27Excluding net product sales of Trokendi XR in both periods, total revenues for the Q4 of 2023 increased 31% compared to the prior year quarter. For the Q4 of 2023, combined R and D and SG and A expenses were $104,600,000 as compared to $91,700,000 for the same period in 2022. The increase was primarily due to R and D spend associated with the clinical programs for SPN-eight seventeen and SPN-eight twenty as we continue to progress our pipeline and an increase in selling and marketing expenses due to increase in the ADHD sales personnel and other Kelvey marketing initiatives. During the Q4 of 2023, we booked a $20,200,000 intangible asset impairment charge mainly related to Zydago. This non cash charge reflects the forthcoming loss of exclusivity of Xydago in December of 2027. Speaker 300:12:34As a result of the impairment charge, operating loss for the Q4 of 2023 was approximately $1,000,000 as compared to operating earnings of $34,300,000 for the same period in 2022. Income tax benefit in the Q4 of 2023 was $185,000 as compared to income tax expense of 9 point $7,000,000 in the same period of 2022. Net earnings was $1,700,000 for the Q4 of 2023 or earnings per diluted share of $0.02 compared to net earnings of $25,500,000 or earnings per diluted share of $0.43 in the same prior year quarter. On a non GAAP basis, which excludes amortization of intangibles, impairment charges, share based compensation, contingent consideration and depreciation, adjusted operating earnings for the Q4 of 2023 was $47,100,000 compared to $57,600,000 in the same quarter of 2022. Total revenue for the full year 2023 was $607,500,000 compared to $667,200,000 in 2022. Speaker 300:13:52Total revenue was comprised of net product sales of $573,900,000 and royalty and licensing revenues of 33,600,000 dollars The $75,500,000 decrease in net product sales was primarily due to $166,900,000 decline in net product sales of Trokendi XR, partially offset by $94,100,000 increase in net product sales of our growth products, Calvary and GOCOVRI. Excluding net product sales for Trokendi XR in both periods, total revenues for full 2023 increased 26% compared to full year 2022. Combined R and D and SG and A expenses for the full year 2023 was $428,000,000 as compared to $451,800,000 for the prior year. The decrease was primarily due to higher sales and marketing expenses in 2022 to support the launch of Calgary in the adult population, partially offset by an increase in R and D expenses associated with the clinical programs for SBN-eight seventeen and SBN-eight twenty as we continue to progress our pipeline. In addition to the items above, full year 2023 include the aforementioned non cash impairment charge of $20,200,000 resulting in an operating loss for full year 2023 of $5,300,000 as compared to operating earnings of $46,100,000 for the prior year. Speaker 300:15:32Income tax expense for full year 2023 was $1,500,000 as compared to income tax expense of 32,000 for full year 2022. Net earnings were $1,300,000 for the full year 2023 or $0.02 per diluted share compared to $60,700,000 or $1.04 per diluted share for the full year 2022. On a non GAAP basis, adjusted operating earnings was $125,100,000 for the full year 2023 compared Speaker 100:16:09to $148,800,000 Speaker 300:16:12the prior year. As of December 31, 2023, the company had approximately $271,500,000 in cash, cash equivalents and marketable securities, compared to $555,200,000 as of December 31, 2022. The decrease was due to the repayment of the convertible security notes due 2023 offset by approximately 120,000,000 dollars of cash generated from operations. The company has a strong balance sheet and significant financial flexibility for potential M and A and other value creating opportunities. Now turning to guidance. Speaker 300:16:574, we expect total revenue to range from $580,000,000 to $620,000,000 comprised of net product sales and royalty and licensing revenues. Note the total revenue guidance for full year 2024 assumes approximately 125 $1,000,000 to $135,000,000 of combined net sales of Trokendi XR and Xtether XR. We anticipate the increase in net sales of our growth products in 2024 will substantially offset the expected decline in combined net sales of Trokendi XR and Oxtellar XR. For the full year 2024, we expect combined R and D and SG and A expenses to range from $430,000,000 to $460,000,000 This reflects an increased level of R and D spend in 2024 as our pipeline progresses, especially for the Phase 2 programs for SPN-eight seventeen and SPN-eight twenty. Overall, we expect full year 2024 operating loss in the range of $30,000,000 to breakeven. Speaker 300:18:09And finally, we expect non GAAP operating earnings to range from $80,000,000 to $110,000,000 dollars Please refer to the press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non GAAP. We expect 2024 will be the year we substantially transition from our legacy products to our growth products. Despite the anticipated erosion of sales on Trokendi XR and Oxtellar XR, we expect our growth products to help drive this anticipated level of non GAAP earnings in 2024. With that, I now turn the call back over to the operator for Q and A. Operator00:18:53Thank you. At this time, we will conduct a question and answer session. Our first question comes from the line of Andrew Tsai of Jefferies. Your line is now open. Speaker 400:19:23Hey, good afternoon. Thanks for taking my questions and congrats on the quarter. Maybe two questions on my side. The first one on overall guidance and Calgary. So in terms of the total revenue guidance, just curious what dynamics are you guys specifically assuming for you to guide to low end as well as the high end of your total revenue guidance? Speaker 400:19:47And secondly, if we backed out the individual products other than Calvary from your total revenue guidance for 2024, is it reasonable to assume, your guidance might imply Calvary sales could come in above consensus of around 210 currently? Thanks. Speaker 200:20:08Yes. Hi, Andrew. This is Jack. I mean, when we try to build the guidance, we try to accomplish couple of things. 1st, to help folks with the Trokendi XR, Oxtellar XR situation and the potential impact of the genetics. Speaker 200:20:25So that's why we try to isolate these two components. What's really left is of course as a main drivers are GOCOVRI and CALBRI. So with GOCOVRI, if you try to assume growth rates that are fit pretty much in line with the last couple of years, I think you can get to a reasonable estimate there on what that product could end up being or doing in 2024. You back out also something similar on ApoPen and the other products. So yes, I mean, Calvary, could Calvary be in the 200 to 220 or somewhere in that range. Speaker 200:21:04I mean, that is a possibility and it's not out of reach or an unreasonable level. So hopefully that will address both questions. Speaker 400:21:14Perfect. Thanks. And then maybe a follow-up question is the SPN-eight 17 epilepsy top line interim data Phase 2 data coming up. Will that be a distinct press release in May? Or will that be shared in conjunction with your Q1 EPS? Speaker 400:21:34And then secondly, could you give us a flavor of what you plan to share that day? Should we expect efficacy curves, safety AE breakdowns and other detailed information? So basically just curious how much detail you're planning to provide? Thank you. Speaker 200:21:52Yes. The plan is and hopefully all the data will be available for that timing is to really issue the data with our earnings call. So the earnings call typically is like the 1st week or early 2nd week of May. So that's typically and that's what the plan is to issue the data as part of the earnings call. What would the data include? Speaker 200:22:19Certainly, it will include efficacy, seizure reductions, some of the key endpoints that we're looking at in the study as well as, of course, safety, AEs and so forth. So absolutely, I mean, we're trying to give as much of a full picture as possible for the first 50% of the patients, which is the target by May. And then ideally, I know we did say on the call that the full study will be given in the second half. I mean, clearly, we will work hard to try to do it maybe in August, which would be our next earnings call where we can report for the full study. I mean, that will be great if we can do that. Speaker 200:22:59But for now, until we know the flow of the data, how quickly these patients will finish the maintenance period and when would the data be available, We can't say for sure now August, we're saying second half, but certainly in May, we will be able to update you at that time. Speaker 400:23:18Great. Thanks for the color. Appreciate the updates. Operator00:23:24One moment for our next question. Our next question comes from the line of David Amform of Piper Sandler. Your line is now open. Speaker 500:23:38Hey, thanks. So, wanted to dig a little deeper on Calvary. So looking at the prescription trends recently and also in the Q4, it looks a little softer than what we had been seeing. So I wanted to get some perspective on the different moving parts in both the peds and adult ADHD market and what might be driving the volume trajectory currently? And also how that ties into your commentary regarding co pay assistance? Speaker 500:24:19I think, Jack, you had mentioned recently that you were pairing back some of that co pay assistance. So how should we think about the impact there? And what does that mean for the prescription directory of Calvary going forward? And then just another question on the guide, do you have any risk adjusted contribution for 830 in there? Just wanted to clarify what you may or may not have on that product as it relates to the overall top line guidance? Speaker 500:24:50Thank you. Speaker 200:24:52Yes. Sure. I'll take the second one first. I mean, the pump or SPN-eight thirty, we really don't have much in the guidance, so nothing meaningful. So the guidance doesn't include really much there. Speaker 200:25:06As far as your question on Calvary, so I'll start by going back to really the Q3 of back to school season. Some of you may remember, at that time and throughout the year, we kept saying our target for gross to net is 50% to 55%. And we obviously didn't want to do anything significant as far as any changes in the co pay card and the features of the co pay card and the levels of benefits that that card offers during the back to school season because we didn't want to impact the momentum behind the lot of these changes more at the tail end of Q3 and beginning during Q4. And that's why actually we've been able to achieve our goal or even surpass that goal by hitting around 49.5% gross to net on Calgary. Now clearly that always comes at the cost or sacrificing certain things on the prescription trends. Speaker 200:26:16Mean, you always put more pressure on the prescriptions when you make changes like this. But basically, you're resetting the stage and you're resetting the baseline. So you won't have that pressure every single quarter moving forward. But when you first make these changes on the co pay, you're going to get that biggest impact from a prescription trend perspective and momentum. And that's why alluding to your question, yes, in the Q4, we saw a sequential growth of about, if I'm not mistaken, 5% or 6%. Speaker 200:26:48And then in 1Q of 2024, it is a little bit even softer because of course in 1Q, you always have the additional pressures of high deductibles, insurance resets and so forth. So all these factors are converging as far as 1Q is concerned and that's why you're seeing the softness that we're all looking at with the prescriptions. So that's pretty much the trending. So we're very happy that this is behind us more or less. This is behind us, meaning the major changes in the co pay are now behind us. Speaker 200:27:24I think we've been able to really manage it extremely well. The team has done an amazing job in the Q4 despite the pressures on the prescriptions and so forth. From a net sales perspective, we had a very, very strong quarter despite the pressure on the prescriptions. And as I mentioned in my prepared remarks, the average net price went up to $2.68 So that's a very healthy increase and improvement clearly with the value of the prescription. And we'll continue to do that throughout 2024. Speaker 200:27:57Any other opportunities we see, any other areas we see to continue that improvement, again without hurting too much the prescription momentum. Now as far as prescription and the underlying business, I mean, we continue to really be very remarks, I mean, prescribers will actually use Calvary, especially heavy prescribers. Their satisfaction level with Calvary is equivalent to their satisfaction level with stimulants. If you really pause for a second and think about that, I mean, that is truly remarkable for a non stimulant to be delivering and really performing in physicians' minds as well as extended release stimulants because extended release stimulants are the gold standard in treating ADHD. And for Kelby to be performing around that same level and to deliver a satisfaction among prescribers that is really equivalent to XR stimulants that is very remarkable for the product and continues to give us confidence that the product will continue to grow. Speaker 200:29:13I mean, we have still so much room to grow in a 93,000,000 prescriptions a year market where we did last year 617,000 prescriptions. So clearly, we have a lot of room to go and we look to 2024 for even further growth on all the momentum that we built in the 2023. The other thing we also should have in 2024 is a full impact of our expansion of the sales force clearly, which started in mid last year. So 2024 should have that impact with extend beyond extra reach among physicians or higher frequency among certain physicians that are more important for us who are heavy prescribers of ADHD. So all in all, we are very much looking forward to another strong year for Calvary in 2024. Speaker 500:30:06That's very helpful, Jack. Just one quick follow-up. What do you expect the mix between adults and peds will look like as we move through the latter part of this year? Speaker 200:30:19Yes. We closed the year in 2023 a little bit above 30%, somewhere in the 31%, 31.5%. And as I mentioned in my remarks, our goal is to continue to push in the adult segment because obviously the adult segment is very important to us. We're finding out interestingly in that attitude and usage study we did is that about 40% of the usage of Calvary in adult is in combination with stimulants. And that has a lot of ramifications, a lot of dynamics around it. Speaker 200:30:53It looks like that is really good, 40%, but also that could mean initially they're using lower doses than what we would like them to be. So from a total daily dose, we would hope as time goes on and we're seeing that, but it's marginal. We see a creep up in the daily dose into what should be the total daily dose for adults. So as time goes along, we'll see them building up to the right levels, which should be in the 400 to 500 milligram total daily dose in adult. But given that initially a lot of folks are using it in combination with stimulants, most of them are starting with much lower doses than they really should. Speaker 200:31:36And we are working on that to encourage them to continue to push towards the target total daily dose because that also helps us in the from an efficacy perspective, perception of efficacy and so forth. Speaker 500:31:50Okay. Very helpful. Thank you. Operator00:31:54One moment for our next question. Our next question comes from the line of Stacy Ku of C. G. Cowen. Your line is now open. Speaker 600:32:09Thanks for taking our questions. We have a few. So first, just on payer access reimbursement. Do you have any remaining overall goals this year and any guidance around any additional formulary wins? So just wondering if you expect any additional contracting this year for Calvary. Speaker 600:32:25And related to that, what do you think will be gross to nets this year? Are you providing any guidance for how it might settle over the year? Just curious since you're saying that right now the adult dose is a touch lower, but might be driving kind of the net pricing as we kind of drive that adult growth? And that's my questions for now. Thanks. Speaker 200:32:48Yes. Regarding the payer access, we have contracts now with 2 major PBMs out of the 3 major ones. So, I mean, we'll continue. The door is always open. We always are talking to everybody all the time. Speaker 200:33:04And within the states, we continue to renew contracts, improve our position as time goes on. And we've made a lot of progress actually across several states, especially on the Medicaid side and improving our position as time goes on. So we're pretty happy with the commercial coverage as well as the Medicaid coverage on Calvary at this point. It's actually especially on the commercial side, it's pretty much at par with some of the other products or most of the products, the branded products in ADHD in the marketplace as well as at par with what we used to have for years of Prokendi XR and so on. So we're very happy there, but there is always room for improvement, of course, as different cycles come up and renewal of certain contracts. Speaker 200:33:51And therefore, leading to the gross to net question, as we mentioned, I mean, the target will still be in the 50% to 55%, But of course, we're going to have the fluctuations that you typically see in the quarterly, 1 quarter to the another. So Q1 will always be the worst as always is the case across our industry, across all products. And then it will improve in the 2nd quarter, improve a little bit better than the 3rd quarter and then will be the best one in the 4th quarter. So you're going to follow the same natural trend that we've seen with Trokendi XR or Oxtellar XR as time goes on. But at this point, it looks like the 50 to 55 is still a good target and will stay. Speaker 200:34:31We'll try to be, I mean, below it if we can, of course. But for the whole year combined, it will be in the 50% to 55%. So when you look actually at 2023, the total year gross to net was around 58, just to give you a benchmark for the full year. So for us to continue to target 50 to 55 for full year 2024, that still is a significant improvement. Operator00:34:57Got it. Speaker 600:34:58And then And then finally, Speaker 200:34:59I'm sorry, go ahead. Speaker 600:35:01Go ahead. I can follow-up with my third question. Go ahead. Speaker 200:35:04No, I mean, the other part was the total daily dose question. I mean, as I mentioned earlier, I mean, that actually applies to both pediatric and adult as you will typically expect with a new product still in its embryonic kind of stages of with the launch, it's only been 2.5 or 3 years. It takes time for physicians to finally get to the total average daily dose that you would expect them. Some get there earlier than others. But as they gain more and more experience with the product, as we continue to educate them on how they should titrate and how they should target which total daily dose, eventually we will get there. Speaker 200:35:45And the target daily dose for kids is in the 300 milligram range and for the adults is in the 400 milligram to 500 milligram range. Speaker 600:35:56Perfect. You just answered my last question. Thank you. Operator00:36:15Our next question comes from the line of Annabel Samimini of Stifel. Your line is now open. Speaker 700:36:23Hi, this is Jack on for Annabel. Thanks for taking our questions. So kind of on the topic of the previous quarter's call, I know you had mentioned that the start of the 2023 back to school season was relatively tempered and the ADHD market might be normalizing to pre COVID levels. Have you already kind of seen a rebound there or is Calvary just performing particularly well in relation to a weaker market? Speaker 200:36:50Yes. I mean, the total ADHD market in 2023 in total grew by about 3%. If you compare that to 2022, 2021, that's much lower. In the previous couple of years, the market grew in the 7% to 9%. So clearly, we did see that burst of increased demand in medications for ADHD in the 2021, 2022, even a little bit in the 2020 timeframe. Speaker 200:37:25And then in 2023, it took a little breather and started to normalize. And that's what we as you rightfully pointed out, that's what we referred to back when we talked about the back to school season in November of last year. So for the full year, it's about 3%, and we expect this year for the market to probably deliver something in line. I mean, whether it's 3%, 4%, maybe 5%, I really don't know. But it will be in the single digit, probably more in the 5% and lower in that zip code. Speaker 200:37:56Now as far as Calgary, of course, I mean, we last year, the market grew by 3%, but we grew by 91%. So obviously, we're outpacing the market and we continue to do that and that's really what we need to continue to do to continue to increase our market share and penetration of both segments, not just the adult that I talked about, but also pediatric. I mean pediatric will continue to be a very important segment for us as well. Speaker 700:38:25Great. And so building off that, are you considering doing any DTC campaigns to kind of maximize the opportunity for Calvary? Or is that something that you're already doing? I know this category is particularly sensitive promotion. So is there any way that you can kind of take advantage of that further? Speaker 200:38:45Yes. I mean on DTC, we have been doing and will continue to do. So direct to consumer is extremely important. The difference is always is the channel that you use in reaching the consumer. And it's heavily digital as you would expect in today's times. Speaker 200:39:04I mean, people don't sit in front of TV and watch prime TV anymore as they used to long time ago. So we clearly use different channels to reach our audience. A lot of it is digital. The majority of it is digital and we are very much in touch with patient advocacy groups, patient programs. We have significant amount of programs to get to the patients from an education perspective as well as even within the office, the physician's office and so forth. Speaker 200:39:34So we have several programs and many efforts in the digital space, which are all DTC. We also have different influencers who are as well as folks people who speak on behalf of the product because they have direct experience with the product and they have a strong influence among consumers as well. Speaker 700:40:00Great, helpful. Thank you. Operator00:40:04I am showing no further questions at this time. I would now like to turn it back to Jack Attar for closing remarks. Speaker 200:40:12In concluding our call this afternoon, we're very pleased with our performance in 2023. We finished the year in a position of strength with both KELRI and GOCOVRI achieving record sales with strong prescription growth. In addition, as mentioned earlier, 2023 was a year of significant progress on our pipeline with numerous clinical milestones and catalysts over the next 12 to 18 months. We believe that we are well positioned for continued growth beyond the current transition and are focused on 3 key strategic areas. 1st, driving significant growth with Calvary and GOCOVRI and together with the rest of the portfolio generating strong cash flow allowing us to continue our investments in our pipeline. Speaker 200:41:01Excluding our legacy products Trokendi XR and Oxtellar XR, our guidance for 2024 represents a healthy growth rate of approximately 22% in net sales. 2nd, the potential launch of the 3rd growth product in our portfolio assuming the FDA approval of SPN-eight thirty NDA in April. And third, advancing our innovative R and D portfolio of differentiated 1st in class molecules that have several exciting and upcoming clinical milestones. Finally, we will continue to be focused on corporate development to augment our growth through external opportunities. Thanks for joining us this afternoon. Speaker 200:41:43We look forward to updating you on our next call. Operator00:41:47Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallSupernus Pharmaceuticals Q4 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Annual report(10-K) Supernus Pharmaceuticals Earnings HeadlinesSupernus Pharmaceuticals (SUPN) Receives a Buy from TD CowenApril 24 at 7:55 PM | markets.businessinsider.comSupernus Pharmaceuticals to Announce First Quarter 2025 Financial Results and Host Conference ...April 23 at 5:42 PM | gurufocus.comGold Alert: The Truth About Fort Knox Is ComingOwning physical gold isn’t the best way to profit. I’ve found a better way to invest in gold—one that’s already performing nearly twice as well as gold this year and looks ready to go much higher. If you wait for the news to hit, you’ll already be too late.April 26, 2025 | Golden Portfolio (Ad)Supernus Pharmaceuticals to Announce First Quarter 2025 Financial Results and Host Conference Call and Webcast on May 6, 2025April 23 at 5:14 PM | globenewswire.comCritical Review: Liquidia (NASDAQ:LQDA) and Supernus Pharmaceuticals (NASDAQ:SUPN)April 23 at 2:41 AM | americanbankingnews.comIs Supernus Pharmaceuticals, Inc. (SUPN) the Best Pharma Stock to Buy for Long Term Growth?April 17, 2025 | insidermonkey.comSee More Supernus Pharmaceuticals Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Supernus Pharmaceuticals? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Supernus Pharmaceuticals and other key companies, straight to your email. Email Address About Supernus PharmaceuticalsSupernus Pharmaceuticals (NASDAQ:SUPN), a biopharmaceutical company, focuses on the development and commercialization of products for the treatment of central nervous system (CNS) diseases in the United States. The company's commercial products are Trokendi XR, an extended release topiramate product indicated for the treatment of epilepsy, as well as for the prophylaxis of migraine headache; and Oxtellar XR, an extended release oxcarbazepine for the monotherapy treatment of partial onset seizures in adults and children between 6 to 17 years of age. It also offers comprise Qelbree, a novel non-stimulant indicated for the treatment of attention-deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older; APOKYN for the acute intermittent treatment of hypomobility or off episodes in patients with advanced Parkinson's Disease (PD); XADAGO for treating levodopa/carbidopa in patients with PD experiencing off episodes; MYOBLOC, a Type B toxin product indicated for the treatment of cervical dystonia and sialorrhea in adults; GOCOVRI for the treatment of dyskinesia in patients with PD; and Osmolex ER for the treatment of Parkinson's disease and drug-induced extrapyramidal reaction in adult patients. In addition, the company's product candidates include SPN-830, a late-stage drug/device combination product candidate for the treatment of off episodes in PD patients; SPN-817, a novel first-in-class selective acetylcholinesterase inhibitor, which is in Phase II clinical trials for the treatment of epilepsy; SPN-820, a product candidate in Phase II clinical trials for treating resistant depression; SPN-443, a preclinical product for the treatment of ADHD/CNS; and SPN-446 for narcolepsy and SPN-448 for the treatment of CNS which is in discovery stage. It markets and sells its products through pharmaceutical wholesalers, specialty pharmacies, and distributors. Supernus Pharmaceuticals, Inc. was incorporated in 2005 and is headquartered in Rockville, Maryland.View Supernus Pharmaceuticals 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 Markets Think Robinhood Earnings Could Send the Stock UpIs the Floor in for Lam Research After Bullish Earnings?Market Anticipation Builds: Joby Stock Climbs Ahead of EarningsIs Intuitive Surgical a Buy After Volatile Reaction to Earnings?Seismic Shift at Intel: Massive Layoffs Precede Crucial EarningsRocket Lab Lands New Contract, Builds Momentum Ahead of EarningsAmazon's Earnings Could Fuel a Rapid Breakout Upcoming Earnings Cadence Design Systems (4/28/2025)Welltower (4/28/2025)Waste Management (4/28/2025)AstraZeneca (4/29/2025)Mondelez International (4/29/2025)PayPal (4/29/2025)Starbucks (4/29/2025)DoorDash (4/29/2025)Honeywell International (4/29/2025)Regeneron Pharmaceuticals (4/29/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 8 speakers on the call. Operator00:00:00Good afternoon, and welcome to the Supernus Pharmaceuticals 4th Quarter and Full Year 2023 Financial Results Conference Call. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session. Instructions will follow at that time. As a reminder, this conference call is being recorded. Operator00:00:20I would now like to turn the conference over to Peter Vozzo of ICR Westwick, Investor Relations Representative for Supernus Pharmaceuticals. You may begin. Speaker 100:00:30Thank you, Rivka. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' Q4 and full year 2023 financial results conference call. Today, after the close of the market, the company issued a press release announcing these results. Speaker 200:00:45On the call with Speaker 100:00:45me today are Supernus' Chief Executive Officer, Jack Catar and Chief Financial Officer, Tim Deck. Today's call is being made available via the Investor Relations section of the company's website at ir.supernus.com. During the course of this call, management may make certain forward looking statements regarding future events and the company's future performance. These forward looking statements reflect Sifydas' current perspective on existing trends and information. Any such forward looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factors section of the company's latest SEC filings. Speaker 100:01:23Actual results may differ materially from those projected in these forward looking statements. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on February 27, 2024. Since then, the company may have made additional announcements related to the topics discussed. Please reference the company's most recent press releases and current filings with the SEC. Supernus declines any obligation to update these forward looking statements, except as required by applicable securities laws. Speaker 100:01:54I will now turn the call over to Chad. Speaker 200:01:56Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us on today's call. Our performance in 2023 underscored our strong execution and emphasis on growing our revenue base despite the loss of exclusivity on Trokendi XR. Excluding Trokendi XR, Supernus delivered strong growth of 26% in total revenues in 2023 compared to 2022. Specifically, our growth products, Calvary and GOCOVRI delivered robust 57% growth in combined net sales compared to last year. Speaker 200:02:35In addition, combined full year 2023 net sales for Calvary and GOCOVRI reached approximately $260,000,000 which significantly exceeded the $167,000,000 decline in net sales of Trokendi XR. As a result of our emphasis on growing the rest of our portfolio throughout 2023, Trokendi XR closed the year representing only 13% of total revenues in the last quarter of 2023. Regarding Calvary, the year 2023 was the first full year with both pediatric and adult indications. For the full year, Calvary's prescriptions as reported by IQVIA reached 617,192 prescriptions, representing a growth rate of 91% compared to 2022. Net sales for 2023 recorded an even stronger growth rate of 129%, benefiting from the prescription growth and the steady improvement in gross to net throughout the year. Speaker 200:03:42Moreover, Calgary finished the year with a strong 4th quarter reaching net sales of $46,400,000 That represents a 97% increase over the growth quarter of the Q4 of 2022 and a 25% sequential quarter to quarter increase from the Q3 of 2023. In the Q4, prescriptions grew by 47% compared to 2022 and we exceeded our goal of lowering the gross the gross to net deductions to the 50% to 55% range. Actual gross to net for the Q4 2023 was 49.5%, resulting in an average net price per prescription of $2.68 compared to 61% $201 respectively in the same period last year. For the year 2024, we expect the gross to net for Calgary to be in the range of 50% to 55% with fluctuations that you would typically expect on a quarterly basis. In 2023, Kelvry also expanded its base of prescribers ending the Q4 with approximately 25,938 prescribers, up from 16,822 in the Q4 of 2022. Speaker 200:05:08We continue to be encouraged by the high level of satisfaction by Calvary's prescribers. Satisfaction with Calvary among heavy prescribers is as high as their satisfaction with extended release stimulants and is significantly higher than their satisfaction with Strattera. In 2024, we will be placing more emphasis on the adult segment that represents prescription growth rate in line with the 3% growth rate it had in 2023 when it reached an all time high of 93,400,000 annual prescriptions. Switching now to GOCOVRI for full year 2023, prescriptions increased by 10% compared to 2022 and net sales increased by 15%, reaching a record of $120,000,000 We continue to be pleased with the performance of the brand based on its unique position in the marketplace treating both of episodes and dyskinesia. The 2023 4th quarter net sales were $32,000,000 up 10% compared to last year and flat compared to the Q3 as they were impacted by the timing of orders at year end. Speaker 200:06:31Switching to our legacy products, Oxtellar XR net sales were $113,000,000 for full year 2023, essentially stable compared to 2022. In September 2024, we expect the introduction of the first generic of Oxtellar XR. For Trokendi XR, full year net sales were $94,000,000 down by 64% from the $261,000,000 in 2022. In 2024, we don't expect an increase in the number of generic players in the market, but expect further erosion in Trokendi XR sales. We anticipate combined net sales of Trokendi XR and Oxtellar XR in 2024 to be in the range of $125,000,000 to $135,000,000 Regarding SPN830, the FDA has scheduled a preapproval manufacturing facility inspection, which will take place in Europe this month and the FDA's review of the NDA remains ongoing with a PDUFA date of April 5, 2024. Speaker 200:07:41Assuming FDA approval, the company plans to launch SPN-eight thirty in the second half of twenty twenty four, capitalizing on its existing infrastructure, including the sales force, nurse educators, hub and patient services. Moving on to our CNS pipeline of novel product candidates, we made great progress in 2023, setting the stage for a rich calendar of clinical milestones and data releases over the next 12 to 18 months across several programs. First, the company initiated a Phase 4 study with Calvary in ADHD patients with comorbid mood disorders such as depression and anxiety. This trial is expected to include approximately 500 patients with data expected in the first half of twenty twenty five. 2nd, the company also initiated a Phase 2 open label study with SPN-eight twenty and approximately 40 subjects with major depressive disorder. Speaker 200:08:43This study has the potential of providing data on this 1st in class molecule by the end of this year. 3rd, our ongoing Phase 2b multicenter randomized double blind placebo controlled study of SPN-eight twenty in adults with treatment resistant depression has now enrolled approximately 120 patients. We expect top line data from this trial in the first half of twenty twenty five. 4th, the company expects to report interim results from approximately 1 half of the targeted randomized patients from its Phase 2a study on SPN-eight seventeen in treatment resistant seizures in May 2024. This study is examining the safety and tolerability and efficacy of SPN-eight seventeen as adjunctive therapy in adult patients with treatment resistant seizures. Speaker 200:09:37Top line results for the full study are expected in the second half of twenty twenty four. 5th, the initiation of the Phase 2b placebo controlled study with SPN-eight seventeen in patients with treatment resistant focal seizures in the second half of this year. And finally, initiation of a Phase 1 single dose study of SPN-four forty three in healthier dose following the submission of an IND. SPN-four forty three is our new stimulant like product candidate for ADHD and other CNS disorders. Regarding corporate development, the company continues to be active looking for strategic opportunities to further strengthen our future growth and leadership position in CNS. Speaker 200:10:24With that, I will now turn the call over to Tim. Speaker 300:10:28Thank you, Jack. Good afternoon, everyone. As I review our Q4 and full year 2023 results, please refer to today's press release and 10 ks that was filed earlier today. Total revenue for the Q4 of 2023 was $164,300,000 compared to $167,300,000 in the prior year quarter. Total revenue in the Q4 of 2023 was comprised of net product sales of 156,000,000 dollars and royalty and licensing revenues of $8,300,000 The $7,800,000 decrease in net product sales was primarily due to a $37,600,000 decline in net product sales of Trokendi XR, partially offset by a $25,600,000 increase in net product sales of our growth products, Keldry and GOCOVRI. Speaker 300:11:27Excluding net product sales of Trokendi XR in both periods, total revenues for the Q4 of 2023 increased 31% compared to the prior year quarter. For the Q4 of 2023, combined R and D and SG and A expenses were $104,600,000 as compared to $91,700,000 for the same period in 2022. The increase was primarily due to R and D spend associated with the clinical programs for SPN-eight seventeen and SPN-eight twenty as we continue to progress our pipeline and an increase in selling and marketing expenses due to increase in the ADHD sales personnel and other Kelvey marketing initiatives. During the Q4 of 2023, we booked a $20,200,000 intangible asset impairment charge mainly related to Zydago. This non cash charge reflects the forthcoming loss of exclusivity of Xydago in December of 2027. Speaker 300:12:34As a result of the impairment charge, operating loss for the Q4 of 2023 was approximately $1,000,000 as compared to operating earnings of $34,300,000 for the same period in 2022. Income tax benefit in the Q4 of 2023 was $185,000 as compared to income tax expense of 9 point $7,000,000 in the same period of 2022. Net earnings was $1,700,000 for the Q4 of 2023 or earnings per diluted share of $0.02 compared to net earnings of $25,500,000 or earnings per diluted share of $0.43 in the same prior year quarter. On a non GAAP basis, which excludes amortization of intangibles, impairment charges, share based compensation, contingent consideration and depreciation, adjusted operating earnings for the Q4 of 2023 was $47,100,000 compared to $57,600,000 in the same quarter of 2022. Total revenue for the full year 2023 was $607,500,000 compared to $667,200,000 in 2022. Speaker 300:13:52Total revenue was comprised of net product sales of $573,900,000 and royalty and licensing revenues of 33,600,000 dollars The $75,500,000 decrease in net product sales was primarily due to $166,900,000 decline in net product sales of Trokendi XR, partially offset by $94,100,000 increase in net product sales of our growth products, Calvary and GOCOVRI. Excluding net product sales for Trokendi XR in both periods, total revenues for full 2023 increased 26% compared to full year 2022. Combined R and D and SG and A expenses for the full year 2023 was $428,000,000 as compared to $451,800,000 for the prior year. The decrease was primarily due to higher sales and marketing expenses in 2022 to support the launch of Calgary in the adult population, partially offset by an increase in R and D expenses associated with the clinical programs for SBN-eight seventeen and SBN-eight twenty as we continue to progress our pipeline. In addition to the items above, full year 2023 include the aforementioned non cash impairment charge of $20,200,000 resulting in an operating loss for full year 2023 of $5,300,000 as compared to operating earnings of $46,100,000 for the prior year. Speaker 300:15:32Income tax expense for full year 2023 was $1,500,000 as compared to income tax expense of 32,000 for full year 2022. Net earnings were $1,300,000 for the full year 2023 or $0.02 per diluted share compared to $60,700,000 or $1.04 per diluted share for the full year 2022. On a non GAAP basis, adjusted operating earnings was $125,100,000 for the full year 2023 compared Speaker 100:16:09to $148,800,000 Speaker 300:16:12the prior year. As of December 31, 2023, the company had approximately $271,500,000 in cash, cash equivalents and marketable securities, compared to $555,200,000 as of December 31, 2022. The decrease was due to the repayment of the convertible security notes due 2023 offset by approximately 120,000,000 dollars of cash generated from operations. The company has a strong balance sheet and significant financial flexibility for potential M and A and other value creating opportunities. Now turning to guidance. Speaker 300:16:574, we expect total revenue to range from $580,000,000 to $620,000,000 comprised of net product sales and royalty and licensing revenues. Note the total revenue guidance for full year 2024 assumes approximately 125 $1,000,000 to $135,000,000 of combined net sales of Trokendi XR and Xtether XR. We anticipate the increase in net sales of our growth products in 2024 will substantially offset the expected decline in combined net sales of Trokendi XR and Oxtellar XR. For the full year 2024, we expect combined R and D and SG and A expenses to range from $430,000,000 to $460,000,000 This reflects an increased level of R and D spend in 2024 as our pipeline progresses, especially for the Phase 2 programs for SPN-eight seventeen and SPN-eight twenty. Overall, we expect full year 2024 operating loss in the range of $30,000,000 to breakeven. Speaker 300:18:09And finally, we expect non GAAP operating earnings to range from $80,000,000 to $110,000,000 dollars Please refer to the press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non GAAP. We expect 2024 will be the year we substantially transition from our legacy products to our growth products. Despite the anticipated erosion of sales on Trokendi XR and Oxtellar XR, we expect our growth products to help drive this anticipated level of non GAAP earnings in 2024. With that, I now turn the call back over to the operator for Q and A. Operator00:18:53Thank you. At this time, we will conduct a question and answer session. Our first question comes from the line of Andrew Tsai of Jefferies. Your line is now open. Speaker 400:19:23Hey, good afternoon. Thanks for taking my questions and congrats on the quarter. Maybe two questions on my side. The first one on overall guidance and Calgary. So in terms of the total revenue guidance, just curious what dynamics are you guys specifically assuming for you to guide to low end as well as the high end of your total revenue guidance? Speaker 400:19:47And secondly, if we backed out the individual products other than Calvary from your total revenue guidance for 2024, is it reasonable to assume, your guidance might imply Calvary sales could come in above consensus of around 210 currently? Thanks. Speaker 200:20:08Yes. Hi, Andrew. This is Jack. I mean, when we try to build the guidance, we try to accomplish couple of things. 1st, to help folks with the Trokendi XR, Oxtellar XR situation and the potential impact of the genetics. Speaker 200:20:25So that's why we try to isolate these two components. What's really left is of course as a main drivers are GOCOVRI and CALBRI. So with GOCOVRI, if you try to assume growth rates that are fit pretty much in line with the last couple of years, I think you can get to a reasonable estimate there on what that product could end up being or doing in 2024. You back out also something similar on ApoPen and the other products. So yes, I mean, Calvary, could Calvary be in the 200 to 220 or somewhere in that range. Speaker 200:21:04I mean, that is a possibility and it's not out of reach or an unreasonable level. So hopefully that will address both questions. Speaker 400:21:14Perfect. Thanks. And then maybe a follow-up question is the SPN-eight 17 epilepsy top line interim data Phase 2 data coming up. Will that be a distinct press release in May? Or will that be shared in conjunction with your Q1 EPS? Speaker 400:21:34And then secondly, could you give us a flavor of what you plan to share that day? Should we expect efficacy curves, safety AE breakdowns and other detailed information? So basically just curious how much detail you're planning to provide? Thank you. Speaker 200:21:52Yes. The plan is and hopefully all the data will be available for that timing is to really issue the data with our earnings call. So the earnings call typically is like the 1st week or early 2nd week of May. So that's typically and that's what the plan is to issue the data as part of the earnings call. What would the data include? Speaker 200:22:19Certainly, it will include efficacy, seizure reductions, some of the key endpoints that we're looking at in the study as well as, of course, safety, AEs and so forth. So absolutely, I mean, we're trying to give as much of a full picture as possible for the first 50% of the patients, which is the target by May. And then ideally, I know we did say on the call that the full study will be given in the second half. I mean, clearly, we will work hard to try to do it maybe in August, which would be our next earnings call where we can report for the full study. I mean, that will be great if we can do that. Speaker 200:22:59But for now, until we know the flow of the data, how quickly these patients will finish the maintenance period and when would the data be available, We can't say for sure now August, we're saying second half, but certainly in May, we will be able to update you at that time. Speaker 400:23:18Great. Thanks for the color. Appreciate the updates. Operator00:23:24One moment for our next question. Our next question comes from the line of David Amform of Piper Sandler. Your line is now open. Speaker 500:23:38Hey, thanks. So, wanted to dig a little deeper on Calvary. So looking at the prescription trends recently and also in the Q4, it looks a little softer than what we had been seeing. So I wanted to get some perspective on the different moving parts in both the peds and adult ADHD market and what might be driving the volume trajectory currently? And also how that ties into your commentary regarding co pay assistance? Speaker 500:24:19I think, Jack, you had mentioned recently that you were pairing back some of that co pay assistance. So how should we think about the impact there? And what does that mean for the prescription directory of Calvary going forward? And then just another question on the guide, do you have any risk adjusted contribution for 830 in there? Just wanted to clarify what you may or may not have on that product as it relates to the overall top line guidance? Speaker 500:24:50Thank you. Speaker 200:24:52Yes. Sure. I'll take the second one first. I mean, the pump or SPN-eight thirty, we really don't have much in the guidance, so nothing meaningful. So the guidance doesn't include really much there. Speaker 200:25:06As far as your question on Calvary, so I'll start by going back to really the Q3 of back to school season. Some of you may remember, at that time and throughout the year, we kept saying our target for gross to net is 50% to 55%. And we obviously didn't want to do anything significant as far as any changes in the co pay card and the features of the co pay card and the levels of benefits that that card offers during the back to school season because we didn't want to impact the momentum behind the lot of these changes more at the tail end of Q3 and beginning during Q4. And that's why actually we've been able to achieve our goal or even surpass that goal by hitting around 49.5% gross to net on Calgary. Now clearly that always comes at the cost or sacrificing certain things on the prescription trends. Speaker 200:26:16Mean, you always put more pressure on the prescriptions when you make changes like this. But basically, you're resetting the stage and you're resetting the baseline. So you won't have that pressure every single quarter moving forward. But when you first make these changes on the co pay, you're going to get that biggest impact from a prescription trend perspective and momentum. And that's why alluding to your question, yes, in the Q4, we saw a sequential growth of about, if I'm not mistaken, 5% or 6%. Speaker 200:26:48And then in 1Q of 2024, it is a little bit even softer because of course in 1Q, you always have the additional pressures of high deductibles, insurance resets and so forth. So all these factors are converging as far as 1Q is concerned and that's why you're seeing the softness that we're all looking at with the prescriptions. So that's pretty much the trending. So we're very happy that this is behind us more or less. This is behind us, meaning the major changes in the co pay are now behind us. Speaker 200:27:24I think we've been able to really manage it extremely well. The team has done an amazing job in the Q4 despite the pressures on the prescriptions and so forth. From a net sales perspective, we had a very, very strong quarter despite the pressure on the prescriptions. And as I mentioned in my prepared remarks, the average net price went up to $2.68 So that's a very healthy increase and improvement clearly with the value of the prescription. And we'll continue to do that throughout 2024. Speaker 200:27:57Any other opportunities we see, any other areas we see to continue that improvement, again without hurting too much the prescription momentum. Now as far as prescription and the underlying business, I mean, we continue to really be very remarks, I mean, prescribers will actually use Calvary, especially heavy prescribers. Their satisfaction level with Calvary is equivalent to their satisfaction level with stimulants. If you really pause for a second and think about that, I mean, that is truly remarkable for a non stimulant to be delivering and really performing in physicians' minds as well as extended release stimulants because extended release stimulants are the gold standard in treating ADHD. And for Kelby to be performing around that same level and to deliver a satisfaction among prescribers that is really equivalent to XR stimulants that is very remarkable for the product and continues to give us confidence that the product will continue to grow. Speaker 200:29:13I mean, we have still so much room to grow in a 93,000,000 prescriptions a year market where we did last year 617,000 prescriptions. So clearly, we have a lot of room to go and we look to 2024 for even further growth on all the momentum that we built in the 2023. The other thing we also should have in 2024 is a full impact of our expansion of the sales force clearly, which started in mid last year. So 2024 should have that impact with extend beyond extra reach among physicians or higher frequency among certain physicians that are more important for us who are heavy prescribers of ADHD. So all in all, we are very much looking forward to another strong year for Calvary in 2024. Speaker 500:30:06That's very helpful, Jack. Just one quick follow-up. What do you expect the mix between adults and peds will look like as we move through the latter part of this year? Speaker 200:30:19Yes. We closed the year in 2023 a little bit above 30%, somewhere in the 31%, 31.5%. And as I mentioned in my remarks, our goal is to continue to push in the adult segment because obviously the adult segment is very important to us. We're finding out interestingly in that attitude and usage study we did is that about 40% of the usage of Calvary in adult is in combination with stimulants. And that has a lot of ramifications, a lot of dynamics around it. Speaker 200:30:53It looks like that is really good, 40%, but also that could mean initially they're using lower doses than what we would like them to be. So from a total daily dose, we would hope as time goes on and we're seeing that, but it's marginal. We see a creep up in the daily dose into what should be the total daily dose for adults. So as time goes along, we'll see them building up to the right levels, which should be in the 400 to 500 milligram total daily dose in adult. But given that initially a lot of folks are using it in combination with stimulants, most of them are starting with much lower doses than they really should. Speaker 200:31:36And we are working on that to encourage them to continue to push towards the target total daily dose because that also helps us in the from an efficacy perspective, perception of efficacy and so forth. Speaker 500:31:50Okay. Very helpful. Thank you. Operator00:31:54One moment for our next question. Our next question comes from the line of Stacy Ku of C. G. Cowen. Your line is now open. Speaker 600:32:09Thanks for taking our questions. We have a few. So first, just on payer access reimbursement. Do you have any remaining overall goals this year and any guidance around any additional formulary wins? So just wondering if you expect any additional contracting this year for Calvary. Speaker 600:32:25And related to that, what do you think will be gross to nets this year? Are you providing any guidance for how it might settle over the year? Just curious since you're saying that right now the adult dose is a touch lower, but might be driving kind of the net pricing as we kind of drive that adult growth? And that's my questions for now. Thanks. Speaker 200:32:48Yes. Regarding the payer access, we have contracts now with 2 major PBMs out of the 3 major ones. So, I mean, we'll continue. The door is always open. We always are talking to everybody all the time. Speaker 200:33:04And within the states, we continue to renew contracts, improve our position as time goes on. And we've made a lot of progress actually across several states, especially on the Medicaid side and improving our position as time goes on. So we're pretty happy with the commercial coverage as well as the Medicaid coverage on Calvary at this point. It's actually especially on the commercial side, it's pretty much at par with some of the other products or most of the products, the branded products in ADHD in the marketplace as well as at par with what we used to have for years of Prokendi XR and so on. So we're very happy there, but there is always room for improvement, of course, as different cycles come up and renewal of certain contracts. Speaker 200:33:51And therefore, leading to the gross to net question, as we mentioned, I mean, the target will still be in the 50% to 55%, But of course, we're going to have the fluctuations that you typically see in the quarterly, 1 quarter to the another. So Q1 will always be the worst as always is the case across our industry, across all products. And then it will improve in the 2nd quarter, improve a little bit better than the 3rd quarter and then will be the best one in the 4th quarter. So you're going to follow the same natural trend that we've seen with Trokendi XR or Oxtellar XR as time goes on. But at this point, it looks like the 50 to 55 is still a good target and will stay. Speaker 200:34:31We'll try to be, I mean, below it if we can, of course. But for the whole year combined, it will be in the 50% to 55%. So when you look actually at 2023, the total year gross to net was around 58, just to give you a benchmark for the full year. So for us to continue to target 50 to 55 for full year 2024, that still is a significant improvement. Operator00:34:57Got it. Speaker 600:34:58And then And then finally, Speaker 200:34:59I'm sorry, go ahead. Speaker 600:35:01Go ahead. I can follow-up with my third question. Go ahead. Speaker 200:35:04No, I mean, the other part was the total daily dose question. I mean, as I mentioned earlier, I mean, that actually applies to both pediatric and adult as you will typically expect with a new product still in its embryonic kind of stages of with the launch, it's only been 2.5 or 3 years. It takes time for physicians to finally get to the total average daily dose that you would expect them. Some get there earlier than others. But as they gain more and more experience with the product, as we continue to educate them on how they should titrate and how they should target which total daily dose, eventually we will get there. Speaker 200:35:45And the target daily dose for kids is in the 300 milligram range and for the adults is in the 400 milligram to 500 milligram range. Speaker 600:35:56Perfect. You just answered my last question. Thank you. Operator00:36:15Our next question comes from the line of Annabel Samimini of Stifel. Your line is now open. Speaker 700:36:23Hi, this is Jack on for Annabel. Thanks for taking our questions. So kind of on the topic of the previous quarter's call, I know you had mentioned that the start of the 2023 back to school season was relatively tempered and the ADHD market might be normalizing to pre COVID levels. Have you already kind of seen a rebound there or is Calvary just performing particularly well in relation to a weaker market? Speaker 200:36:50Yes. I mean, the total ADHD market in 2023 in total grew by about 3%. If you compare that to 2022, 2021, that's much lower. In the previous couple of years, the market grew in the 7% to 9%. So clearly, we did see that burst of increased demand in medications for ADHD in the 2021, 2022, even a little bit in the 2020 timeframe. Speaker 200:37:25And then in 2023, it took a little breather and started to normalize. And that's what we as you rightfully pointed out, that's what we referred to back when we talked about the back to school season in November of last year. So for the full year, it's about 3%, and we expect this year for the market to probably deliver something in line. I mean, whether it's 3%, 4%, maybe 5%, I really don't know. But it will be in the single digit, probably more in the 5% and lower in that zip code. Speaker 200:37:56Now as far as Calgary, of course, I mean, we last year, the market grew by 3%, but we grew by 91%. So obviously, we're outpacing the market and we continue to do that and that's really what we need to continue to do to continue to increase our market share and penetration of both segments, not just the adult that I talked about, but also pediatric. I mean pediatric will continue to be a very important segment for us as well. Speaker 700:38:25Great. And so building off that, are you considering doing any DTC campaigns to kind of maximize the opportunity for Calvary? Or is that something that you're already doing? I know this category is particularly sensitive promotion. So is there any way that you can kind of take advantage of that further? Speaker 200:38:45Yes. I mean on DTC, we have been doing and will continue to do. So direct to consumer is extremely important. The difference is always is the channel that you use in reaching the consumer. And it's heavily digital as you would expect in today's times. Speaker 200:39:04I mean, people don't sit in front of TV and watch prime TV anymore as they used to long time ago. So we clearly use different channels to reach our audience. A lot of it is digital. The majority of it is digital and we are very much in touch with patient advocacy groups, patient programs. We have significant amount of programs to get to the patients from an education perspective as well as even within the office, the physician's office and so forth. Speaker 200:39:34So we have several programs and many efforts in the digital space, which are all DTC. We also have different influencers who are as well as folks people who speak on behalf of the product because they have direct experience with the product and they have a strong influence among consumers as well. Speaker 700:40:00Great, helpful. Thank you. Operator00:40:04I am showing no further questions at this time. I would now like to turn it back to Jack Attar for closing remarks. Speaker 200:40:12In concluding our call this afternoon, we're very pleased with our performance in 2023. We finished the year in a position of strength with both KELRI and GOCOVRI achieving record sales with strong prescription growth. In addition, as mentioned earlier, 2023 was a year of significant progress on our pipeline with numerous clinical milestones and catalysts over the next 12 to 18 months. We believe that we are well positioned for continued growth beyond the current transition and are focused on 3 key strategic areas. 1st, driving significant growth with Calvary and GOCOVRI and together with the rest of the portfolio generating strong cash flow allowing us to continue our investments in our pipeline. Speaker 200:41:01Excluding our legacy products Trokendi XR and Oxtellar XR, our guidance for 2024 represents a healthy growth rate of approximately 22% in net sales. 2nd, the potential launch of the 3rd growth product in our portfolio assuming the FDA approval of SPN-eight thirty NDA in April. And third, advancing our innovative R and D portfolio of differentiated 1st in class molecules that have several exciting and upcoming clinical milestones. Finally, we will continue to be focused on corporate development to augment our growth through external opportunities. Thanks for joining us this afternoon. Speaker 200:41:43We look forward to updating you on our next call. Operator00:41:47Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.Read morePowered by